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Paul Emery - One of the best experts on this subject based on the ideXlab platform.

  • fri0044 exceeding predefined thresholds for mri bone oedema and erosion and haq di can predict relapse after withdrawal of all treatment in mtx naive patients with ra in remission after 12 months of abatacept therapy in the avert trial
    Annals of the Rheumatic Diseases, 2018
    Co-Authors: Harris A Ahmad, Paul Emery, T W J Huizinga, Joshua F Baker, Mikkel Ostergaard, Yedid Elbez, S Banerjee, P G Conaghan
    Abstract:

    Background To assist in clinical decision making it is important to understand the factors, and their thresholds, that might predict relapse following treatment withdrawal in patients with RA in remission. In a previous post hoc analysis of the AVERT trial (NCT01142726), in which several potential factors were assessed, erosions, synovitis and bone oedema scores on MRI and HAQ-DI scores in patients with DAS28 (CRP) Objectives To evaluate post hoc the association between different thresholds of MRI and HAQ-DI scores at Month 12 and the risk of relapse at Months 18 and 24 in AVERT. Methods This analysis compared relapse event rates at Months 18 and 24 in patients with DAS28 (CRP) 3 for synovitis,>2 for bone oedema,>7 for (weighted) combined synovitis and bone oedema,>5 for erosion and >0.5 for HAQ-DI. Univariate logistic models were conducted for comparisons and odds ratios (OR) with 95% CI and associated p values. Results All randomised and treated patients with DAS28 (CRP) 3), 28 (18.1%) had a higher bone oedema score (>2), 39 (25.2%) had a higher combined score (>7), 73 (47.1%) had a higher erosion score (>5) and 42 (27.1%) had a higher HAQ-DI score (>0.5). Relapse events at Months 18 and 24 were significantly associated with supra-threshold MRI bone oedema, erosion and combined scores and with supra-threshold HAQ-DI score at Month 12 (figure 1). There was a trend toward association of relapse at Months 18 and 24 with high synovitis score (figure 1). Conclusions It was possible to define MRI and HAQ-DI scores in patients with DAS28 (CRP) remission that were predictive of relapse 6 and 12 months after complete drug withdrawal in AVERT. Assessment of imaging and physical function, using predefined thresholds, in patients achieving remission may aid clinical decisions on when to withdraw therapy in MTX-naive patients with RA. References [1] Emery P, et al. Ann Rheum Dis2015;74:19–26. [2] Ahmad H, et al. Ann Rheum Dis2017;76(suppl 2):240. Disclosure of Interest H. Ahmad Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, J. Baker: None declared, M. Ostergaard Grant/research support from: AbbVie, Bristol-Myers Squibb, Janssen, Merck, Speakers bureau: AbbVie, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Eli Lilly, Centocor, GSK, Hospira, Janssen, Merck, Mundipharma, Novartis, Novo Nordisk, Orion, Pfizer, Regeneron, Schering-Plough, Roche, Takeda, UCB, Wyeth, P. Emery Consultant for: AbbVie, Bristol-Myers Squibb, Merck, Pfizer, Roche, Lilly, Novartis, Samsung Bioepis, T. Huizinga Grant/research support from: EU and Dutch Arthritis Foundation, Consultant for: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Crescendo Bioscience, Novartis, Pfizer, Roche, sanofi-aventis, Schering-Plough, UCB, Eli Lilly, Speakers bureau: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough, Y. Elbez Consultant for: Bristol-Myers Squibb, S. Banerjee Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, P. Conaghan Grant/research support from: Bristol-Myers Squibb, Consultant for: AbbVie, GSK, Lilly, Novartis, Pfizer, Roche, Speakers bureau: AbbVie, Bristol-Myers Squibb, Novartis

  • sat0153 abatacept plus methotrexate can effectively and safely regain the target of remission following re treatment for flares after drug free withdrawal in patients with early rheumatoid Arthritis
    Annals of the Rheumatic Diseases, 2016
    Co-Authors: Paul Emery, Gerd-rüdiger Burmester, Benard Combe, M Maldonado, Vivian P Bykerk, Daniel E Furst, Tom W J Huizinga
    Abstract:

    Background AVERT was a Phase IIIb, randomized, active-controlled study to evaluate the efficacy and safety of abatacept (ABA) treatment in three phases: treatment period (TP), withdrawal period (WP) and re-exposure period (RP). The TP and first 6 months (M) of the WP have previously been reported. 1 Objectives To describe efficacy and safety of re-treatment with ABA + MTX following RA disease flare after all treatment withdrawal. Methods MTX-naive, anti-cyclic citrullinated peptide-2-positive patients (pts) with early RA (active synovitis in ≥2 joints for ≥8 weeks, DAS28 [CRP] ≥3.2 and symptom onset within ≤2 years) were randomized to 12M of weekly SC ABA 125 mg + MTX, ABA 125 mg monotherapy (mono) or MTX alone. Pts with DAS28 (CRP) Results Most pts entered the WP (225/351); of 176 pts with DAS28 (CRP) Conclusions Re-treatment with abatacept + MTX can effectively recapture prior remission following flare after complete withdrawal of therapy. The lower rate of infections in the RP versus initial TP suggests re-treatment is well tolerated. References Emery P, et al. Ann Rheum Dis 2015;74:19–26. Disclosure of Interest P. Emery Grant/research support from: AbbVie, Merck, Pfizer, Roche, Consultant for: AbbVie, Bristol-Myers Squibb, Merck, Pfizer, Roche, Lilly, Novartis, Samsung Bioepis, G. Burmester Grant/research support from: Clinical trials for BMS, AbbVie, Pfizer, Medimmune, Novartis, Roche, UCB, Lilly, Consultant for: Bristol-Myers Squibb, AbbVie, Pfizer, MSD, MedImmune, Roche, UCB, Speakers bureau: Bristol-Myers Squibb, AbbVie, Pfizer, MSD, Roche, UCB, V. Bykerk Grant/research support from: Amgen, Pfizer, BMS, Janssen, UCB, Sanofi, Roche/Genentech, Consultant for: Amgen, AbbVie, Pfizer, Bristol-Myers Squibb, UCB, Roche, Regeneron, B. Combe Grant/research support from: Pfizer, Roche-Chugai, UCB, Speakers bureau: Bristol-Myers Squibb, Merck, Pfizer, Roche-Chugai, UCB, Janssen, Lilly, Novartis, D. E. Furst Grant/research support from: AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Consultant for: AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Cytori, Janssen, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Speakers bureau: AbbVie, Actelion, UCB, M. A. Maldonado Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, T. W. Huizinga Grant/research support from: EU & Dutch Arthritis Foundation, Consultant for: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Crescendo Bioscience, Novartis, Pfizer, Roche, sanofi-aventis, Schering-Plough, UCB, Eli Lilly, Speakers bureau: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Novartis, Pfizer, Roche, sanofi-aventis, Schering-Plough

  • ab0446 treatment effects and minimal clinically important differences in patient reported outcomes following treatment and withdrawal of abatacept methotrexate or combination therapy in patients with early rheumatoid Arthritis
    Annals of the Rheumatic Diseases, 2015
    Co-Authors: Daniel E Furst, Gerd-rüdiger Burmester, Vivian P Bykerk, D Wong, T W J Huizinga, Bernard Combe, E Alemao, Paul Emery
    Abstract:

    Background Early biologic use can improve long-term control of RA. 1,2 Minimal clinically important differences (MCIDs) in patient (pt)-reported outcomes (PROs) that are of particular importance to pts with RA, such as pain, fatigue and physical function, can provide benchmarks for intervention. In the AVERT (Assessing Very Early Rheumatoid Arthritis Treatment) trial, more anti-cyclic citrullinated peptide 2 seropositive (CCP2+) pts with early RA achieved DAS28 (CRP) 3 Objectives To investigate the overall treatment effect on PROs and the percentage (%) of pts achieving MCIDs during treatment (baseline to Mth 12) and up to 6 mths after treatment withdrawal in pts who participated in AVERT. Methods Pts were MTX naive, anti-CCP2+, ≥18 years old, with active synovitis, DAS28 (CRP) ≥3.2, disease onset of ≤2 years. Pts were randomized to weekly ABA (125 mg) + MTX, ABA (125 mg) or MTX. All RA treatments (biologic agent, MTX and steroids) were withdrawn after 12 mths in pts with DAS28 (CRP) post hoc analysis, overall treatment effect and treatment differences between ABA + MTX or ABA versus MTX were obtained using a longitudinal repeated-measures model including fixed categorical effects of treatment, visit mth and prior corticosteroid use as well as the continuous fixed covariate of baseline value. The % of pts achieving MCIDs was analysed. Results A total of 351 pts were enrolled (119 ABA + MTX, 116 ABA, 116 MTX). ABA + MTX had statistically significant effects on fatigue and SF-36 physical component summary (PCS) score versus MTX alone during the treatment period (Table). Numerically greater percentages of pts being treated with ABA + MTX achieved MCIDs than ABA or MTX alone (Table). In all groups, treatment withdrawal provided continued benefits but at reduced magnitude. Conclusions Clinically meaningful improvements and significant benefits were seen in physical function and fatigue over 12 mths in an anti-CCP2+, early RA cohort treated with abatacept + MTX. Continued beneficial effects were observed at the group level up to 6 mths even after all RA drugs were withdrawn. References Westhovens R et al. Ann Rheum Dis 2009;68:1870–7. Emery P et al. Ann Rheum Dis 2010;69:510–6. Emery P et al. Ann Rheum Dis 2014;73(Suppl 2):69. Disclosure of Interest D. E. Furst Grant/research support from: AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Consultant for: AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Cytori, Janssen, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Speakers bureau: (CME ONLY) AbbVie, Actelion, UCB, V. P. Bykerk Grant/research support from: Amgen, Pfizer, Bristol-Myers Squibb, Janssen, UCB, Roche/Genentech, Consultant for: Amgen, Pfizer, Bristol-Myers Squibb, UCB, Roche, G. R. Burmester Grant/research support from: Bristol-Myers Squibb, AbbVie, Pfizer, Medimmune, Novartis, Roche, UCB, Lilly, Consultant for: Bristol-Myers Squibb, AbbVie, Pfizer, MSD, Medimmune, Roche, UCB, Speakers bureau: Bristol-Myers Squibb, AbbVie, Pfizer, MSD, Roche, UCB, B. G. Combe Grant/research support from: Pfizer, Roche-Chugai, Speakers bureau: Bristol-Myers Squibb, Merck, Pfizer, Roche-Chugai, UCB, T. W. J. Huizinga Grant/research support from: EU & Dutch Arthritis Foundation, Consultant for: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Crescendo Bioscience, Inc, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough, UCB, Inc., Eli Lilly, Meteor Board, Speakers bureau: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough, E. Alemao Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, D. A. Wong Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, P. Emery Grant/research support from: AbbVie, Merck, Pfizer, Roche, Consultant for: AbbVie, Bristol-Myers Squibb, Merck, Pfizer, Roche, Lilly, Novartis

  • op0026 induction of clinical remission followed by drug free withdrawal with abatacept combination and monotherapy in early ra results from the avert study over 18 months
    Annals of the Rheumatic Diseases, 2014
    Co-Authors: Paul Emery, Gerd-rüdiger Burmester, Benard Combe, Emilie Barre, Chetan S Karyekar, D A Wong, Vivian P Bykerk, Daniel E Furst, Tom W J Huizinga
    Abstract:

    Background AVERT (Assessing Very Early Rheumatoid arthirits Treatment) is a Phase IIIb, randomized, active-controlled study to evaluate the efficacy and safety of subcutaneous (SC) abatacept (ABA) in pts with early RA. Objectives To assess ABA + MTX or ABA monotherapy in inducing clinical remission at 12 mths and then maintain it following rapid withdrawal of all RA treatment (biologics, DMARDs, steroids) in pts with early RA. Methods MTX-naive, anti-CCP2+ pts with early RA (active synovitis in ≥2 joints for ≥8 wks, DAS28 (CRP) >3.2 and onset of symptoms within ≤2 yrs) were included. Pts were randomized to 12 mths of weekly SC ABA 125 mg + MTX, ABA 125 mg monotherapy or MTX alone. Pts with DAS28 (CRP) Results 351 pts (n=119, 116 and 116 pts in the ABA + MTX, ABA and MTX arms, respectively) with early RA, highly active disease and poor prognosis (at baseline: mean RA duration of 0.56 yrs, mean DAS28 (CRP) of 5.4, mean HAQ of 1.4; 95.2% RF+ and anti-CCP2+) entered the study. At 12 mths, 60.9, 42.5 and 45.2% achieved DAS28 (CRP) Conclusions In this study, in pts with highly active early RA with poor prognosis, abatacept + MTX resulted in significantly higher rates of remission and comparable safety vs MTX alone at 12 mths. At most time points, abatacept monotherapy was more effective than MTX alone. A small but significantly higher number of patients treated with abatacept + MTX were able to maintain drug-free remission compared to MTX. Disclosure of Interest P. Emery Grant/research support: AbbVie, BMS, Merck, Pfizer, Roche, Consultant for: AbbVie, BMS, Merck, Pfizer, Roche, Takeda, G. Burmester Grant/research support: BMS, AbbVie, Pfizer, Medimmune, Novartis, Roche, UCB, Lilly, Consultant for: BMS, AbbVie, Pfizer, MSD, Medimmune, Roche, UCB, Speakers bureau: BMS, AbbVie, Pfizer, MSD, Roche, UCB, V. Bykerk Grant/research support: Amgen, Pfizer, BMS, Janssen, UCB, Roche/Genentech, B. Combe Grant/research support: Pfizer, Roche-Chugai, Speakers bureau: BMS, Merck, Pfizer, Roche-Chugai, UCB, D. Furst Grant/research support: AbbVie, Actelion, Amgen, BMS, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Consultant for: AbbVie, Actelion, Amgen, BMS, Janssen, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Speakers bureau: AbbVie, Actelion, UCB, E. Barre Employee of: BMS, C. Karyekar Employee of: BMS, D. Wong Employee of: BMS, T. Huizinga Grant/research support: EU & Dutch Arthritis Foundation, Consultant for: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Crescendo Bioscience, Inc, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough, UCB, Inc., Eli Lilly, Speakers bureau: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough DOI 10.1136/annrheumdis-2014-eular.2132

  • op0030 mri results from the avert study a randomized active controlled trial to evaluate induction of remission and maintenance of drug free remission using abatacept in combination with methotrexate or as monotherapy in patients with early ra
    Annals of the Rheumatic Diseases, 2014
    Co-Authors: Charles Peterfy, Gerd-rüdiger Burmester, Benard Combe, Tom W J Huizinga, Chetan S Karyekar, Vivian P Bykerk, Daniel E Furst, D Wong, P G Conaghan, Paul Emery
    Abstract:

    Background AVERT (Assessing Very Early Rheumatoid arthirits Treatment) is a Phase IIIb, randomized, active-controlled trial to evaluate the efficacy and safety of abatacept (ABA) in combination with methotrexate (+ MTX) in patients (pts) with early RA. Objectives To assess joint damage progression by magnetic resonance imaging (MRI) in pts with early RA from the AVERT study who were treated with ABA + MTX or ABA monotherapy, compared with MTX alone. Methods MTX-naive, anti-CCP2+ pts with early RA (active synovitis in ≥2 joints for ≥8 weeks, DAS28 (CRP) >3.2 and onset of symptoms within ≤2 yrs) were included. Pts were randomized to 12 mths of weekly SC ABA 125 mg + MTX, ABA 125 mg monotherapy or MTX alone. Pts with DAS28 (CRP) Results During the 12-mth treatment period, benefits in synovitis, osteitis and erosion scores were numerically greater for ABA + MTX than for MTX alone; while numerically greater benefits were observed in synovitis and osteitis scores for ABA monotherapy than for MTX alone (Table 1). A post hoc analysis of pts who maintained DAS28 (CRP) Conclusions Consistent with the clinical outcomes of the AVERT study in pts with early RA with high disease activity, there were greater reductions in MRI outcomes with abatacept treatment in combination with MTX than with MTX alone. MRI changes with abatacept monotherapy treatment were intermediate between abatacept in combination with MTX and MTX treatment alone. Disclosure of Interest C. Peterfy Shareholder of: Spire Sciences Inc., Synarc Inc., Consultant for: AbbVie, Inc., Amgen Inc., Articulinx, AstraZeneca, Bristol-Myers Squibb, Five Prime Therapeutics, Genentech, Hoffmann-La Roche, Inc., Lilly USA, LLC, Medimmune, Merck Pharmaceuticals, Moximed, Novartis Pharmaceuticals Corporation, Novo Nordisk, Plexxikon, Pfizer Inc, Sanofi, Salix-Santarus, Samsung, UCB, Inc., Employee of: Spire Sciences Inc., G. Burmester Grant/research support: BMS, AbbVie, Pfizer, Medimmune, Novartis, Roche, UCB, Lilly, Consultant for: BMS, AbbVie, Pfizer, MSD, Medimmune, Roche, UCB, Speakers bureau: BMS, AbbVie, Pfizer, MSD, Roche, UCB, V. Bykerk Grant/research support: Amgen, Pfizer, BMS, Janssen, UCB, Roche/Genentech, B. Combe Grant/research support: Pfizer, Roche-Chugai, Speakers bureau: BMS, Merck, Pfizer, Roche-Chugai, UCB, D. Furst Grant/research support: AbbVie, Actelion, Amgen, BMS, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Consultant for: AbbVie, Actelion, Amgen, BMS, Janssen, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Speakers bureau: AbbVie, Actelion, UCB, T. Huizinga Grant/research support: EU & Dutch Arthritis Foundation, Consultant for: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Crescendo Bioscience, Inc, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough, UCB, Inc., Eli Lilly, Speakers bureau: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough, C. Karyekar Employee of: BMS, D. Wong Employee of: BMS, P. Conaghan Grant/research support: Centocor Research and Development, Inc., Pfizer Inc., Speakers bureau: AbbVie, BMS, Janssen, Pfizer, Roche, UCB, P. Emery Grant/research support: AbbVie, BMS, Merck, Pfizer, Roche, Consultant for: AbbVie, BMS, Merck, Pfizer, Roche, Takeda DOI 10.1136/annrheumdis-2014-eular.1524

David T Felson - One of the best experts on this subject based on the ideXlab platform.

  • 2019 american college of rheumatology Arthritis Foundation guideline for the management of osteoArthritis of the hand hip and knee
    Arthritis Care and Research, 2020
    Co-Authors: Sharon L Kolasinski, Leigh F. Callahan, Tuhina Neogi, Marc C Hochberg, Carol A Oatis, Gordon H Guyatt, Joel A Block, Cindy Copenhaver, Carole Dodge, David T Felson
    Abstract:

    Objective To develop an evidence-based guideline for the comprehensive management of osteoArthritis (OA) as a collaboration between the American College of Rheumatology (ACR) and the Arthritis Foundation, updating the 2012 ACR recommendations for the management of hand, hip, and knee OA. Methods We identified clinically relevant population, intervention, comparator, outcomes questions and critical outcomes in OA. A Literature Review Team performed a systematic literature review to summarize evidence supporting the benefits and harms of available educational, behavioral, psychosocial, physical, mind-body, and pharmacologic therapies for OA. Grading of Recommendations Assessment, Development and Evaluation methodology was used to rate the quality of the evidence. A Voting Panel, including rheumatologists, an internist, physical and occupational therapists, and patients, achieved consensus on the recommendations. Results Based on the available evidence, either strong or conditional recommendations were made for or against the approaches evaluated. Strong recommendations were made for exercise, weight loss in patients with knee and/or hip OA who are overweight or obese, self-efficacy and self-management programs, tai chi, cane use, hand orthoses for first carpometacarpal (CMC) joint OA, tibiofemoral bracing for tibiofemoral knee OA, topical nonsteroidal antiinflammatory drugs (NSAIDs) for knee OA, oral NSAIDs, and intraarticular glucocorticoid injections for knee OA. Conditional recommendations were made for balance exercises, yoga, cognitive behavioral therapy, kinesiotaping for first CMC OA, orthoses for hand joints other than the first CMC joint, patellofemoral bracing for patellofemoral knee OA, acupuncture, thermal modalities, radiofrequency ablation for knee OA, topical NSAIDs, intraarticular steroid injections and chondroitin sulfate for hand OA, topical capsaicin for knee OA, acetaminophen, duloxetine, and tramadol. Conclusion This guideline provides direction for clinicians and patients making treatment decisions for the management of OA. Clinicians and patients should engage in shared decision-making that accounts for patients' values, preferences, and comorbidities. These recommendations should not be used to limit or deny access to therapies.

  • 2019 american college of rheumatology Arthritis Foundation guideline for the management of osteoArthritis of the hand hip and knee
    Arthritis Care and Research, 2020
    Co-Authors: Sharon L Kolasinski, Leigh F. Callahan, Tuhina Neogi, Marc C Hochberg, Carol A Oatis, Gordon H Guyatt, Joel A Block, Cindy Copenhaver, Carole Dodge, David T Felson
    Abstract:

    Author(s): Kolasinski, Sharon L; Neogi, Tuhina; Hochberg, Marc C; Oatis, Carol; Guyatt, Gordon; Block, Joel; Callahan, Leigh; Copenhaver, Cindy; Dodge, Carole; Felson, David; Gellar, Kathleen; Harvey, William F; Hawker, Gillian; Herzig, Edward; Kwoh, C Kent; Nelson, Amanda E; Samuels, Jonathan; Scanzello, Carla; White, Daniel; Wise, Barton; Altman, Roy D; DiRenzo, Dana; Fontanarosa, Joann; Giradi, Gina; Ishimori, Mariko; Misra, Devyani; Shah, Amit Aakash; Shmagel, Anna K; Thoma, Louise M; Turgunbaev, Marat; Turner, Amy S; Reston, James | Abstract: OBJECTIVE:To develop an evidence-based guideline for the comprehensive management of osteoArthritis (OA) as a collaboration between the American College of Rheumatology (ACR) and the Arthritis Foundation, updating the 2012 ACR recommendations for the management of hand, hip, and knee OA. METHODS:We identified clinically relevant population, intervention, comparator, outcomes questions and critical outcomes in OA. A Literature Review Team performed a systematic literature review to summarize evidence supporting the benefits and harms of available educational, behavioral, psychosocial, physical, mind-body, and pharmacologic therapies for OA. Grading of Recommendations Assessment, Development and Evaluation methodology was used to rate the quality of the evidence. A Voting Panel, including rheumatologists, an internist, physical and occupational therapists, and patients, achieved consensus on the recommendations. RESULTS:Based on the available evidence, either strong or conditional recommendations were made for or against the approaches evaluated. Strong recommendations were made for exercise, weight loss in patients with knee and/or hip OA who are overweight or obese, self-efficacy and self-management programs, tai chi, cane use, hand orthoses for first carpometacarpal (CMC) joint OA, tibiofemoral bracing for tibiofemoral knee OA, topical nonsteroidal antiinflammatory drugs (NSAIDs) for knee OA, oral NSAIDs, and intraarticular glucocorticoid injections for knee OA. Conditional recommendations were made for balance exercises, yoga, cognitive behavioral therapy, kinesiotaping for first CMC OA, orthoses for hand joints other than the first CMC joint, patellofemoral bracing for patellofemoral knee OA, acupuncture, thermal modalities, radiofrequency ablation for knee OA, topical NSAIDs, intraarticular steroid injections and chondroitin sulfate for hand OA, topical capsaicin for knee OA, acetaminophen, duloxetine, and tramadol. CONCLUSION:This guideline provides direction for clinicians and patients making treatment decisions for the management of OA. Clinicians and patients should engage in shared decision-making that accounts for patients' values, preferences, and comorbidities. These recommendations should not be used to limit or deny access to therapies.

Tom W J Huizinga - One of the best experts on this subject based on the ideXlab platform.

  • sat0153 abatacept plus methotrexate can effectively and safely regain the target of remission following re treatment for flares after drug free withdrawal in patients with early rheumatoid Arthritis
    Annals of the Rheumatic Diseases, 2016
    Co-Authors: Paul Emery, Gerd-rüdiger Burmester, Benard Combe, M Maldonado, Vivian P Bykerk, Daniel E Furst, Tom W J Huizinga
    Abstract:

    Background AVERT was a Phase IIIb, randomized, active-controlled study to evaluate the efficacy and safety of abatacept (ABA) treatment in three phases: treatment period (TP), withdrawal period (WP) and re-exposure period (RP). The TP and first 6 months (M) of the WP have previously been reported. 1 Objectives To describe efficacy and safety of re-treatment with ABA + MTX following RA disease flare after all treatment withdrawal. Methods MTX-naive, anti-cyclic citrullinated peptide-2-positive patients (pts) with early RA (active synovitis in ≥2 joints for ≥8 weeks, DAS28 [CRP] ≥3.2 and symptom onset within ≤2 years) were randomized to 12M of weekly SC ABA 125 mg + MTX, ABA 125 mg monotherapy (mono) or MTX alone. Pts with DAS28 (CRP) Results Most pts entered the WP (225/351); of 176 pts with DAS28 (CRP) Conclusions Re-treatment with abatacept + MTX can effectively recapture prior remission following flare after complete withdrawal of therapy. The lower rate of infections in the RP versus initial TP suggests re-treatment is well tolerated. References Emery P, et al. Ann Rheum Dis 2015;74:19–26. Disclosure of Interest P. Emery Grant/research support from: AbbVie, Merck, Pfizer, Roche, Consultant for: AbbVie, Bristol-Myers Squibb, Merck, Pfizer, Roche, Lilly, Novartis, Samsung Bioepis, G. Burmester Grant/research support from: Clinical trials for BMS, AbbVie, Pfizer, Medimmune, Novartis, Roche, UCB, Lilly, Consultant for: Bristol-Myers Squibb, AbbVie, Pfizer, MSD, MedImmune, Roche, UCB, Speakers bureau: Bristol-Myers Squibb, AbbVie, Pfizer, MSD, Roche, UCB, V. Bykerk Grant/research support from: Amgen, Pfizer, BMS, Janssen, UCB, Sanofi, Roche/Genentech, Consultant for: Amgen, AbbVie, Pfizer, Bristol-Myers Squibb, UCB, Roche, Regeneron, B. Combe Grant/research support from: Pfizer, Roche-Chugai, UCB, Speakers bureau: Bristol-Myers Squibb, Merck, Pfizer, Roche-Chugai, UCB, Janssen, Lilly, Novartis, D. E. Furst Grant/research support from: AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Consultant for: AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Cytori, Janssen, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Speakers bureau: AbbVie, Actelion, UCB, M. A. Maldonado Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, T. W. Huizinga Grant/research support from: EU & Dutch Arthritis Foundation, Consultant for: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Crescendo Bioscience, Novartis, Pfizer, Roche, sanofi-aventis, Schering-Plough, UCB, Eli Lilly, Speakers bureau: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Novartis, Pfizer, Roche, sanofi-aventis, Schering-Plough

  • op0026 induction of clinical remission followed by drug free withdrawal with abatacept combination and monotherapy in early ra results from the avert study over 18 months
    Annals of the Rheumatic Diseases, 2014
    Co-Authors: Paul Emery, Gerd-rüdiger Burmester, Benard Combe, Emilie Barre, Chetan S Karyekar, D A Wong, Vivian P Bykerk, Daniel E Furst, Tom W J Huizinga
    Abstract:

    Background AVERT (Assessing Very Early Rheumatoid arthirits Treatment) is a Phase IIIb, randomized, active-controlled study to evaluate the efficacy and safety of subcutaneous (SC) abatacept (ABA) in pts with early RA. Objectives To assess ABA + MTX or ABA monotherapy in inducing clinical remission at 12 mths and then maintain it following rapid withdrawal of all RA treatment (biologics, DMARDs, steroids) in pts with early RA. Methods MTX-naive, anti-CCP2+ pts with early RA (active synovitis in ≥2 joints for ≥8 wks, DAS28 (CRP) >3.2 and onset of symptoms within ≤2 yrs) were included. Pts were randomized to 12 mths of weekly SC ABA 125 mg + MTX, ABA 125 mg monotherapy or MTX alone. Pts with DAS28 (CRP) Results 351 pts (n=119, 116 and 116 pts in the ABA + MTX, ABA and MTX arms, respectively) with early RA, highly active disease and poor prognosis (at baseline: mean RA duration of 0.56 yrs, mean DAS28 (CRP) of 5.4, mean HAQ of 1.4; 95.2% RF+ and anti-CCP2+) entered the study. At 12 mths, 60.9, 42.5 and 45.2% achieved DAS28 (CRP) Conclusions In this study, in pts with highly active early RA with poor prognosis, abatacept + MTX resulted in significantly higher rates of remission and comparable safety vs MTX alone at 12 mths. At most time points, abatacept monotherapy was more effective than MTX alone. A small but significantly higher number of patients treated with abatacept + MTX were able to maintain drug-free remission compared to MTX. Disclosure of Interest P. Emery Grant/research support: AbbVie, BMS, Merck, Pfizer, Roche, Consultant for: AbbVie, BMS, Merck, Pfizer, Roche, Takeda, G. Burmester Grant/research support: BMS, AbbVie, Pfizer, Medimmune, Novartis, Roche, UCB, Lilly, Consultant for: BMS, AbbVie, Pfizer, MSD, Medimmune, Roche, UCB, Speakers bureau: BMS, AbbVie, Pfizer, MSD, Roche, UCB, V. Bykerk Grant/research support: Amgen, Pfizer, BMS, Janssen, UCB, Roche/Genentech, B. Combe Grant/research support: Pfizer, Roche-Chugai, Speakers bureau: BMS, Merck, Pfizer, Roche-Chugai, UCB, D. Furst Grant/research support: AbbVie, Actelion, Amgen, BMS, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Consultant for: AbbVie, Actelion, Amgen, BMS, Janssen, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Speakers bureau: AbbVie, Actelion, UCB, E. Barre Employee of: BMS, C. Karyekar Employee of: BMS, D. Wong Employee of: BMS, T. Huizinga Grant/research support: EU & Dutch Arthritis Foundation, Consultant for: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Crescendo Bioscience, Inc, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough, UCB, Inc., Eli Lilly, Speakers bureau: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough DOI 10.1136/annrheumdis-2014-eular.2132

  • op0030 mri results from the avert study a randomized active controlled trial to evaluate induction of remission and maintenance of drug free remission using abatacept in combination with methotrexate or as monotherapy in patients with early ra
    Annals of the Rheumatic Diseases, 2014
    Co-Authors: Charles Peterfy, Gerd-rüdiger Burmester, Benard Combe, Tom W J Huizinga, Chetan S Karyekar, Vivian P Bykerk, Daniel E Furst, D Wong, P G Conaghan, Paul Emery
    Abstract:

    Background AVERT (Assessing Very Early Rheumatoid arthirits Treatment) is a Phase IIIb, randomized, active-controlled trial to evaluate the efficacy and safety of abatacept (ABA) in combination with methotrexate (+ MTX) in patients (pts) with early RA. Objectives To assess joint damage progression by magnetic resonance imaging (MRI) in pts with early RA from the AVERT study who were treated with ABA + MTX or ABA monotherapy, compared with MTX alone. Methods MTX-naive, anti-CCP2+ pts with early RA (active synovitis in ≥2 joints for ≥8 weeks, DAS28 (CRP) >3.2 and onset of symptoms within ≤2 yrs) were included. Pts were randomized to 12 mths of weekly SC ABA 125 mg + MTX, ABA 125 mg monotherapy or MTX alone. Pts with DAS28 (CRP) Results During the 12-mth treatment period, benefits in synovitis, osteitis and erosion scores were numerically greater for ABA + MTX than for MTX alone; while numerically greater benefits were observed in synovitis and osteitis scores for ABA monotherapy than for MTX alone (Table 1). A post hoc analysis of pts who maintained DAS28 (CRP) Conclusions Consistent with the clinical outcomes of the AVERT study in pts with early RA with high disease activity, there were greater reductions in MRI outcomes with abatacept treatment in combination with MTX than with MTX alone. MRI changes with abatacept monotherapy treatment were intermediate between abatacept in combination with MTX and MTX treatment alone. Disclosure of Interest C. Peterfy Shareholder of: Spire Sciences Inc., Synarc Inc., Consultant for: AbbVie, Inc., Amgen Inc., Articulinx, AstraZeneca, Bristol-Myers Squibb, Five Prime Therapeutics, Genentech, Hoffmann-La Roche, Inc., Lilly USA, LLC, Medimmune, Merck Pharmaceuticals, Moximed, Novartis Pharmaceuticals Corporation, Novo Nordisk, Plexxikon, Pfizer Inc, Sanofi, Salix-Santarus, Samsung, UCB, Inc., Employee of: Spire Sciences Inc., G. Burmester Grant/research support: BMS, AbbVie, Pfizer, Medimmune, Novartis, Roche, UCB, Lilly, Consultant for: BMS, AbbVie, Pfizer, MSD, Medimmune, Roche, UCB, Speakers bureau: BMS, AbbVie, Pfizer, MSD, Roche, UCB, V. Bykerk Grant/research support: Amgen, Pfizer, BMS, Janssen, UCB, Roche/Genentech, B. Combe Grant/research support: Pfizer, Roche-Chugai, Speakers bureau: BMS, Merck, Pfizer, Roche-Chugai, UCB, D. Furst Grant/research support: AbbVie, Actelion, Amgen, BMS, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Consultant for: AbbVie, Actelion, Amgen, BMS, Janssen, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Speakers bureau: AbbVie, Actelion, UCB, T. Huizinga Grant/research support: EU & Dutch Arthritis Foundation, Consultant for: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Crescendo Bioscience, Inc, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough, UCB, Inc., Eli Lilly, Speakers bureau: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough, C. Karyekar Employee of: BMS, D. Wong Employee of: BMS, P. Conaghan Grant/research support: Centocor Research and Development, Inc., Pfizer Inc., Speakers bureau: AbbVie, BMS, Janssen, Pfizer, Roche, UCB, P. Emery Grant/research support: AbbVie, BMS, Merck, Pfizer, Roche, Consultant for: AbbVie, BMS, Merck, Pfizer, Roche, Takeda DOI 10.1136/annrheumdis-2014-eular.1524

Daniel E Furst - One of the best experts on this subject based on the ideXlab platform.

  • sat0153 abatacept plus methotrexate can effectively and safely regain the target of remission following re treatment for flares after drug free withdrawal in patients with early rheumatoid Arthritis
    Annals of the Rheumatic Diseases, 2016
    Co-Authors: Paul Emery, Gerd-rüdiger Burmester, Benard Combe, M Maldonado, Vivian P Bykerk, Daniel E Furst, Tom W J Huizinga
    Abstract:

    Background AVERT was a Phase IIIb, randomized, active-controlled study to evaluate the efficacy and safety of abatacept (ABA) treatment in three phases: treatment period (TP), withdrawal period (WP) and re-exposure period (RP). The TP and first 6 months (M) of the WP have previously been reported. 1 Objectives To describe efficacy and safety of re-treatment with ABA + MTX following RA disease flare after all treatment withdrawal. Methods MTX-naive, anti-cyclic citrullinated peptide-2-positive patients (pts) with early RA (active synovitis in ≥2 joints for ≥8 weeks, DAS28 [CRP] ≥3.2 and symptom onset within ≤2 years) were randomized to 12M of weekly SC ABA 125 mg + MTX, ABA 125 mg monotherapy (mono) or MTX alone. Pts with DAS28 (CRP) Results Most pts entered the WP (225/351); of 176 pts with DAS28 (CRP) Conclusions Re-treatment with abatacept + MTX can effectively recapture prior remission following flare after complete withdrawal of therapy. The lower rate of infections in the RP versus initial TP suggests re-treatment is well tolerated. References Emery P, et al. Ann Rheum Dis 2015;74:19–26. Disclosure of Interest P. Emery Grant/research support from: AbbVie, Merck, Pfizer, Roche, Consultant for: AbbVie, Bristol-Myers Squibb, Merck, Pfizer, Roche, Lilly, Novartis, Samsung Bioepis, G. Burmester Grant/research support from: Clinical trials for BMS, AbbVie, Pfizer, Medimmune, Novartis, Roche, UCB, Lilly, Consultant for: Bristol-Myers Squibb, AbbVie, Pfizer, MSD, MedImmune, Roche, UCB, Speakers bureau: Bristol-Myers Squibb, AbbVie, Pfizer, MSD, Roche, UCB, V. Bykerk Grant/research support from: Amgen, Pfizer, BMS, Janssen, UCB, Sanofi, Roche/Genentech, Consultant for: Amgen, AbbVie, Pfizer, Bristol-Myers Squibb, UCB, Roche, Regeneron, B. Combe Grant/research support from: Pfizer, Roche-Chugai, UCB, Speakers bureau: Bristol-Myers Squibb, Merck, Pfizer, Roche-Chugai, UCB, Janssen, Lilly, Novartis, D. E. Furst Grant/research support from: AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Consultant for: AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Cytori, Janssen, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Speakers bureau: AbbVie, Actelion, UCB, M. A. Maldonado Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, T. W. Huizinga Grant/research support from: EU & Dutch Arthritis Foundation, Consultant for: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Crescendo Bioscience, Novartis, Pfizer, Roche, sanofi-aventis, Schering-Plough, UCB, Eli Lilly, Speakers bureau: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Novartis, Pfizer, Roche, sanofi-aventis, Schering-Plough

  • ab0446 treatment effects and minimal clinically important differences in patient reported outcomes following treatment and withdrawal of abatacept methotrexate or combination therapy in patients with early rheumatoid Arthritis
    Annals of the Rheumatic Diseases, 2015
    Co-Authors: Daniel E Furst, Gerd-rüdiger Burmester, Vivian P Bykerk, D Wong, T W J Huizinga, Bernard Combe, E Alemao, Paul Emery
    Abstract:

    Background Early biologic use can improve long-term control of RA. 1,2 Minimal clinically important differences (MCIDs) in patient (pt)-reported outcomes (PROs) that are of particular importance to pts with RA, such as pain, fatigue and physical function, can provide benchmarks for intervention. In the AVERT (Assessing Very Early Rheumatoid Arthritis Treatment) trial, more anti-cyclic citrullinated peptide 2 seropositive (CCP2+) pts with early RA achieved DAS28 (CRP) 3 Objectives To investigate the overall treatment effect on PROs and the percentage (%) of pts achieving MCIDs during treatment (baseline to Mth 12) and up to 6 mths after treatment withdrawal in pts who participated in AVERT. Methods Pts were MTX naive, anti-CCP2+, ≥18 years old, with active synovitis, DAS28 (CRP) ≥3.2, disease onset of ≤2 years. Pts were randomized to weekly ABA (125 mg) + MTX, ABA (125 mg) or MTX. All RA treatments (biologic agent, MTX and steroids) were withdrawn after 12 mths in pts with DAS28 (CRP) post hoc analysis, overall treatment effect and treatment differences between ABA + MTX or ABA versus MTX were obtained using a longitudinal repeated-measures model including fixed categorical effects of treatment, visit mth and prior corticosteroid use as well as the continuous fixed covariate of baseline value. The % of pts achieving MCIDs was analysed. Results A total of 351 pts were enrolled (119 ABA + MTX, 116 ABA, 116 MTX). ABA + MTX had statistically significant effects on fatigue and SF-36 physical component summary (PCS) score versus MTX alone during the treatment period (Table). Numerically greater percentages of pts being treated with ABA + MTX achieved MCIDs than ABA or MTX alone (Table). In all groups, treatment withdrawal provided continued benefits but at reduced magnitude. Conclusions Clinically meaningful improvements and significant benefits were seen in physical function and fatigue over 12 mths in an anti-CCP2+, early RA cohort treated with abatacept + MTX. Continued beneficial effects were observed at the group level up to 6 mths even after all RA drugs were withdrawn. References Westhovens R et al. Ann Rheum Dis 2009;68:1870–7. Emery P et al. Ann Rheum Dis 2010;69:510–6. Emery P et al. Ann Rheum Dis 2014;73(Suppl 2):69. Disclosure of Interest D. E. Furst Grant/research support from: AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Consultant for: AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Cytori, Janssen, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Speakers bureau: (CME ONLY) AbbVie, Actelion, UCB, V. P. Bykerk Grant/research support from: Amgen, Pfizer, Bristol-Myers Squibb, Janssen, UCB, Roche/Genentech, Consultant for: Amgen, Pfizer, Bristol-Myers Squibb, UCB, Roche, G. R. Burmester Grant/research support from: Bristol-Myers Squibb, AbbVie, Pfizer, Medimmune, Novartis, Roche, UCB, Lilly, Consultant for: Bristol-Myers Squibb, AbbVie, Pfizer, MSD, Medimmune, Roche, UCB, Speakers bureau: Bristol-Myers Squibb, AbbVie, Pfizer, MSD, Roche, UCB, B. G. Combe Grant/research support from: Pfizer, Roche-Chugai, Speakers bureau: Bristol-Myers Squibb, Merck, Pfizer, Roche-Chugai, UCB, T. W. J. Huizinga Grant/research support from: EU & Dutch Arthritis Foundation, Consultant for: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Crescendo Bioscience, Inc, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough, UCB, Inc., Eli Lilly, Meteor Board, Speakers bureau: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough, E. Alemao Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, D. A. Wong Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, P. Emery Grant/research support from: AbbVie, Merck, Pfizer, Roche, Consultant for: AbbVie, Bristol-Myers Squibb, Merck, Pfizer, Roche, Lilly, Novartis

  • thu0114 effect of anti cyclic citrullinated peptide 2 immunoglobulin m serostatus on efficacy outcomes following treatment with abatacept plus methotrexate in the avert trial
    Annals of the Rheumatic Diseases, 2015
    Co-Authors: T W J Huizinga, Gerd-rüdiger Burmester, Vivian P Bykerk, Daniel E Furst, D Wong, Bernard Combe, Sean E Connolly, Alyssa Johnsen, J Zhu, Leendert A Trouw
    Abstract:

    Background Anti-citrullinated protein antibodies (ACPA) are a marker of RA, and the presence of the immunoglobulin M (IgM) isotype indicates an ongoing immune response involving the recruitment of naive B cells. 1 Abatacept (ABA) modulates T-cell co-stimulation and has been shown to impact ACPA maturation, including seroconversion of IgM, in the AVERT (Assessing Very Early Rheumatoid Arthritis Treatment) trial. 2 Objectives To assess the efficacy of treatment with ABA+MTX, ABA monotherapy or MTX alone in patients (pts) from the AVERT trial based on their anti-cyclic citrullinated peptide 2 (CCP2; a surrogate for ACPA) IgM serostatus at baseline (BL), and seroconversion (anti-CCP2 IgM positive to negative) through 1 year. Methods The AVERT trial has been described previously. 3 In this post hoc analysis, pt samples were analysed by ELISA to determine anti-CCP2 IgM serostatus. Efficacy outcomes analysed by BL anti-CCP2 IgM serostatus included remission rate at 12 mths (CDAI, SDAI, Boolean and DAS28 [CRP] Results In the ABA+MTX treatment arm, a higher proportion of pts who were anti-CCP2 IgM positive at BL achieved remission by all indices compared with pts who were BL IgM negative (Figure). This trend was most clearly observed in the stringent indices of CDAI, SDAI and Boolean remission, compared with DAS28 (CRP)-defined remission. This trend was not observed in either the ABA monotherapy or MTX alone arms. Mean improvement in DAS28 (CRP) and HAQ-DI over time was also greatest in BL anti-CCP2 IgM-positive pts treated with ABA+MTX. A numerically higher proportion of pts who seroconverted from anti-CCP2 IgM positive at BL to negative at Mth 12 achieved Boolean remission versus pts who remained seropositive in the ABA+MTX and ABA monotherapy arms (Table). Conclusions Abatacept in combination with MTX had greater clinical efficacy in pts who were anti-CCP2 IgM positive at BL than in those who were anti-CCP2 IgM negative at BL, and in those who seroconverted over time than those who did not, suggesting that the impact on ACPA is associated with clinical benefit. References Verpoort KN, et al. Arthritis Rheum 2006;54:3799–808. Huizinga TWJ, et al. Arthritis Rheum 2014;66:S666. Poster 1515. Emery P, et al. Ann Rheum Dis 2015:74:19–26. Disclosure of Interest T. W. J. Huizinga Grant/research support from: EU & Dutch Arthritis Foundation, Consultant for: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Crescendo Bioscience, Inc, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough, UCB, Inc., Eli Lilly, Meteor Board, Speakers bureau: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough, S. E. Connolly Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, A. Johnsen Employee of: Bristol-Myers Squibb, J. Zhu Employee of: Bristol-Myers Squibb, D. E. Furst Grant/research support from: AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Consultant for: AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Cytori, Janssen, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Speakers bureau: (CME only) AbbVie, Actelion, UCB, V. P. Bykerk Grant/research support from: Amgen, Pfizer, Bristol-Myers Squibb, Janssen, UCB, Roche/Genentech, Consultant for: Amgen, Pfizer, Bristol-Myers Squibb, UCB, Roche, G. R. Burmester Grant/research support from: Bristol-Myers Squibb, AbbVie, Pfizer, Medimmune, Novartis, Roche, UCB, Lilly, Consultant for: Bristol-Myers Squibb, AbbVie, Pfizer, MSD, Medimmune, Roche, UCB, Speakers bureau: Bristol-Myers Squibb, AbbVie, Pfizer, MSD, Roche, UCB, B. G. Combe Grant/research support from: Pfizer, Roche-Chugai, Speakers bureau: Bristol-Myers Squibb, Merck, Pfizer, Roche-Chugai, UCB, D. A. Wong Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, L. A. Trouw: None declared, R. E. M. Toes: None declared, P. Emery Grant/research support from: Abbvie, Merck, Pfizer, Roche, Consultant for: Abbvie, Bristol-Myers Squibb, Merck, Pfizer, Roche, Lilly, Novartis

  • op0026 induction of clinical remission followed by drug free withdrawal with abatacept combination and monotherapy in early ra results from the avert study over 18 months
    Annals of the Rheumatic Diseases, 2014
    Co-Authors: Paul Emery, Gerd-rüdiger Burmester, Benard Combe, Emilie Barre, Chetan S Karyekar, D A Wong, Vivian P Bykerk, Daniel E Furst, Tom W J Huizinga
    Abstract:

    Background AVERT (Assessing Very Early Rheumatoid arthirits Treatment) is a Phase IIIb, randomized, active-controlled study to evaluate the efficacy and safety of subcutaneous (SC) abatacept (ABA) in pts with early RA. Objectives To assess ABA + MTX or ABA monotherapy in inducing clinical remission at 12 mths and then maintain it following rapid withdrawal of all RA treatment (biologics, DMARDs, steroids) in pts with early RA. Methods MTX-naive, anti-CCP2+ pts with early RA (active synovitis in ≥2 joints for ≥8 wks, DAS28 (CRP) >3.2 and onset of symptoms within ≤2 yrs) were included. Pts were randomized to 12 mths of weekly SC ABA 125 mg + MTX, ABA 125 mg monotherapy or MTX alone. Pts with DAS28 (CRP) Results 351 pts (n=119, 116 and 116 pts in the ABA + MTX, ABA and MTX arms, respectively) with early RA, highly active disease and poor prognosis (at baseline: mean RA duration of 0.56 yrs, mean DAS28 (CRP) of 5.4, mean HAQ of 1.4; 95.2% RF+ and anti-CCP2+) entered the study. At 12 mths, 60.9, 42.5 and 45.2% achieved DAS28 (CRP) Conclusions In this study, in pts with highly active early RA with poor prognosis, abatacept + MTX resulted in significantly higher rates of remission and comparable safety vs MTX alone at 12 mths. At most time points, abatacept monotherapy was more effective than MTX alone. A small but significantly higher number of patients treated with abatacept + MTX were able to maintain drug-free remission compared to MTX. Disclosure of Interest P. Emery Grant/research support: AbbVie, BMS, Merck, Pfizer, Roche, Consultant for: AbbVie, BMS, Merck, Pfizer, Roche, Takeda, G. Burmester Grant/research support: BMS, AbbVie, Pfizer, Medimmune, Novartis, Roche, UCB, Lilly, Consultant for: BMS, AbbVie, Pfizer, MSD, Medimmune, Roche, UCB, Speakers bureau: BMS, AbbVie, Pfizer, MSD, Roche, UCB, V. Bykerk Grant/research support: Amgen, Pfizer, BMS, Janssen, UCB, Roche/Genentech, B. Combe Grant/research support: Pfizer, Roche-Chugai, Speakers bureau: BMS, Merck, Pfizer, Roche-Chugai, UCB, D. Furst Grant/research support: AbbVie, Actelion, Amgen, BMS, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Consultant for: AbbVie, Actelion, Amgen, BMS, Janssen, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Speakers bureau: AbbVie, Actelion, UCB, E. Barre Employee of: BMS, C. Karyekar Employee of: BMS, D. Wong Employee of: BMS, T. Huizinga Grant/research support: EU & Dutch Arthritis Foundation, Consultant for: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Crescendo Bioscience, Inc, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough, UCB, Inc., Eli Lilly, Speakers bureau: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough DOI 10.1136/annrheumdis-2014-eular.2132

  • op0030 mri results from the avert study a randomized active controlled trial to evaluate induction of remission and maintenance of drug free remission using abatacept in combination with methotrexate or as monotherapy in patients with early ra
    Annals of the Rheumatic Diseases, 2014
    Co-Authors: Charles Peterfy, Gerd-rüdiger Burmester, Benard Combe, Tom W J Huizinga, Chetan S Karyekar, Vivian P Bykerk, Daniel E Furst, D Wong, P G Conaghan, Paul Emery
    Abstract:

    Background AVERT (Assessing Very Early Rheumatoid arthirits Treatment) is a Phase IIIb, randomized, active-controlled trial to evaluate the efficacy and safety of abatacept (ABA) in combination with methotrexate (+ MTX) in patients (pts) with early RA. Objectives To assess joint damage progression by magnetic resonance imaging (MRI) in pts with early RA from the AVERT study who were treated with ABA + MTX or ABA monotherapy, compared with MTX alone. Methods MTX-naive, anti-CCP2+ pts with early RA (active synovitis in ≥2 joints for ≥8 weeks, DAS28 (CRP) >3.2 and onset of symptoms within ≤2 yrs) were included. Pts were randomized to 12 mths of weekly SC ABA 125 mg + MTX, ABA 125 mg monotherapy or MTX alone. Pts with DAS28 (CRP) Results During the 12-mth treatment period, benefits in synovitis, osteitis and erosion scores were numerically greater for ABA + MTX than for MTX alone; while numerically greater benefits were observed in synovitis and osteitis scores for ABA monotherapy than for MTX alone (Table 1). A post hoc analysis of pts who maintained DAS28 (CRP) Conclusions Consistent with the clinical outcomes of the AVERT study in pts with early RA with high disease activity, there were greater reductions in MRI outcomes with abatacept treatment in combination with MTX than with MTX alone. MRI changes with abatacept monotherapy treatment were intermediate between abatacept in combination with MTX and MTX treatment alone. Disclosure of Interest C. Peterfy Shareholder of: Spire Sciences Inc., Synarc Inc., Consultant for: AbbVie, Inc., Amgen Inc., Articulinx, AstraZeneca, Bristol-Myers Squibb, Five Prime Therapeutics, Genentech, Hoffmann-La Roche, Inc., Lilly USA, LLC, Medimmune, Merck Pharmaceuticals, Moximed, Novartis Pharmaceuticals Corporation, Novo Nordisk, Plexxikon, Pfizer Inc, Sanofi, Salix-Santarus, Samsung, UCB, Inc., Employee of: Spire Sciences Inc., G. Burmester Grant/research support: BMS, AbbVie, Pfizer, Medimmune, Novartis, Roche, UCB, Lilly, Consultant for: BMS, AbbVie, Pfizer, MSD, Medimmune, Roche, UCB, Speakers bureau: BMS, AbbVie, Pfizer, MSD, Roche, UCB, V. Bykerk Grant/research support: Amgen, Pfizer, BMS, Janssen, UCB, Roche/Genentech, B. Combe Grant/research support: Pfizer, Roche-Chugai, Speakers bureau: BMS, Merck, Pfizer, Roche-Chugai, UCB, D. Furst Grant/research support: AbbVie, Actelion, Amgen, BMS, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Consultant for: AbbVie, Actelion, Amgen, BMS, Janssen, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Speakers bureau: AbbVie, Actelion, UCB, T. Huizinga Grant/research support: EU & Dutch Arthritis Foundation, Consultant for: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Crescendo Bioscience, Inc, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough, UCB, Inc., Eli Lilly, Speakers bureau: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough, C. Karyekar Employee of: BMS, D. Wong Employee of: BMS, P. Conaghan Grant/research support: Centocor Research and Development, Inc., Pfizer Inc., Speakers bureau: AbbVie, BMS, Janssen, Pfizer, Roche, UCB, P. Emery Grant/research support: AbbVie, BMS, Merck, Pfizer, Roche, Consultant for: AbbVie, BMS, Merck, Pfizer, Roche, Takeda DOI 10.1136/annrheumdis-2014-eular.1524

Vivian P Bykerk - One of the best experts on this subject based on the ideXlab platform.

  • sat0153 abatacept plus methotrexate can effectively and safely regain the target of remission following re treatment for flares after drug free withdrawal in patients with early rheumatoid Arthritis
    Annals of the Rheumatic Diseases, 2016
    Co-Authors: Paul Emery, Gerd-rüdiger Burmester, Benard Combe, M Maldonado, Vivian P Bykerk, Daniel E Furst, Tom W J Huizinga
    Abstract:

    Background AVERT was a Phase IIIb, randomized, active-controlled study to evaluate the efficacy and safety of abatacept (ABA) treatment in three phases: treatment period (TP), withdrawal period (WP) and re-exposure period (RP). The TP and first 6 months (M) of the WP have previously been reported. 1 Objectives To describe efficacy and safety of re-treatment with ABA + MTX following RA disease flare after all treatment withdrawal. Methods MTX-naive, anti-cyclic citrullinated peptide-2-positive patients (pts) with early RA (active synovitis in ≥2 joints for ≥8 weeks, DAS28 [CRP] ≥3.2 and symptom onset within ≤2 years) were randomized to 12M of weekly SC ABA 125 mg + MTX, ABA 125 mg monotherapy (mono) or MTX alone. Pts with DAS28 (CRP) Results Most pts entered the WP (225/351); of 176 pts with DAS28 (CRP) Conclusions Re-treatment with abatacept + MTX can effectively recapture prior remission following flare after complete withdrawal of therapy. The lower rate of infections in the RP versus initial TP suggests re-treatment is well tolerated. References Emery P, et al. Ann Rheum Dis 2015;74:19–26. Disclosure of Interest P. Emery Grant/research support from: AbbVie, Merck, Pfizer, Roche, Consultant for: AbbVie, Bristol-Myers Squibb, Merck, Pfizer, Roche, Lilly, Novartis, Samsung Bioepis, G. Burmester Grant/research support from: Clinical trials for BMS, AbbVie, Pfizer, Medimmune, Novartis, Roche, UCB, Lilly, Consultant for: Bristol-Myers Squibb, AbbVie, Pfizer, MSD, MedImmune, Roche, UCB, Speakers bureau: Bristol-Myers Squibb, AbbVie, Pfizer, MSD, Roche, UCB, V. Bykerk Grant/research support from: Amgen, Pfizer, BMS, Janssen, UCB, Sanofi, Roche/Genentech, Consultant for: Amgen, AbbVie, Pfizer, Bristol-Myers Squibb, UCB, Roche, Regeneron, B. Combe Grant/research support from: Pfizer, Roche-Chugai, UCB, Speakers bureau: Bristol-Myers Squibb, Merck, Pfizer, Roche-Chugai, UCB, Janssen, Lilly, Novartis, D. E. Furst Grant/research support from: AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Consultant for: AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Cytori, Janssen, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Speakers bureau: AbbVie, Actelion, UCB, M. A. Maldonado Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, T. W. Huizinga Grant/research support from: EU & Dutch Arthritis Foundation, Consultant for: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Crescendo Bioscience, Novartis, Pfizer, Roche, sanofi-aventis, Schering-Plough, UCB, Eli Lilly, Speakers bureau: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Novartis, Pfizer, Roche, sanofi-aventis, Schering-Plough

  • ab0446 treatment effects and minimal clinically important differences in patient reported outcomes following treatment and withdrawal of abatacept methotrexate or combination therapy in patients with early rheumatoid Arthritis
    Annals of the Rheumatic Diseases, 2015
    Co-Authors: Daniel E Furst, Gerd-rüdiger Burmester, Vivian P Bykerk, D Wong, T W J Huizinga, Bernard Combe, E Alemao, Paul Emery
    Abstract:

    Background Early biologic use can improve long-term control of RA. 1,2 Minimal clinically important differences (MCIDs) in patient (pt)-reported outcomes (PROs) that are of particular importance to pts with RA, such as pain, fatigue and physical function, can provide benchmarks for intervention. In the AVERT (Assessing Very Early Rheumatoid Arthritis Treatment) trial, more anti-cyclic citrullinated peptide 2 seropositive (CCP2+) pts with early RA achieved DAS28 (CRP) 3 Objectives To investigate the overall treatment effect on PROs and the percentage (%) of pts achieving MCIDs during treatment (baseline to Mth 12) and up to 6 mths after treatment withdrawal in pts who participated in AVERT. Methods Pts were MTX naive, anti-CCP2+, ≥18 years old, with active synovitis, DAS28 (CRP) ≥3.2, disease onset of ≤2 years. Pts were randomized to weekly ABA (125 mg) + MTX, ABA (125 mg) or MTX. All RA treatments (biologic agent, MTX and steroids) were withdrawn after 12 mths in pts with DAS28 (CRP) post hoc analysis, overall treatment effect and treatment differences between ABA + MTX or ABA versus MTX were obtained using a longitudinal repeated-measures model including fixed categorical effects of treatment, visit mth and prior corticosteroid use as well as the continuous fixed covariate of baseline value. The % of pts achieving MCIDs was analysed. Results A total of 351 pts were enrolled (119 ABA + MTX, 116 ABA, 116 MTX). ABA + MTX had statistically significant effects on fatigue and SF-36 physical component summary (PCS) score versus MTX alone during the treatment period (Table). Numerically greater percentages of pts being treated with ABA + MTX achieved MCIDs than ABA or MTX alone (Table). In all groups, treatment withdrawal provided continued benefits but at reduced magnitude. Conclusions Clinically meaningful improvements and significant benefits were seen in physical function and fatigue over 12 mths in an anti-CCP2+, early RA cohort treated with abatacept + MTX. Continued beneficial effects were observed at the group level up to 6 mths even after all RA drugs were withdrawn. References Westhovens R et al. Ann Rheum Dis 2009;68:1870–7. Emery P et al. Ann Rheum Dis 2010;69:510–6. Emery P et al. Ann Rheum Dis 2014;73(Suppl 2):69. Disclosure of Interest D. E. Furst Grant/research support from: AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Consultant for: AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Cytori, Janssen, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Speakers bureau: (CME ONLY) AbbVie, Actelion, UCB, V. P. Bykerk Grant/research support from: Amgen, Pfizer, Bristol-Myers Squibb, Janssen, UCB, Roche/Genentech, Consultant for: Amgen, Pfizer, Bristol-Myers Squibb, UCB, Roche, G. R. Burmester Grant/research support from: Bristol-Myers Squibb, AbbVie, Pfizer, Medimmune, Novartis, Roche, UCB, Lilly, Consultant for: Bristol-Myers Squibb, AbbVie, Pfizer, MSD, Medimmune, Roche, UCB, Speakers bureau: Bristol-Myers Squibb, AbbVie, Pfizer, MSD, Roche, UCB, B. G. Combe Grant/research support from: Pfizer, Roche-Chugai, Speakers bureau: Bristol-Myers Squibb, Merck, Pfizer, Roche-Chugai, UCB, T. W. J. Huizinga Grant/research support from: EU & Dutch Arthritis Foundation, Consultant for: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Crescendo Bioscience, Inc, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough, UCB, Inc., Eli Lilly, Meteor Board, Speakers bureau: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough, E. Alemao Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, D. A. Wong Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, P. Emery Grant/research support from: AbbVie, Merck, Pfizer, Roche, Consultant for: AbbVie, Bristol-Myers Squibb, Merck, Pfizer, Roche, Lilly, Novartis

  • thu0114 effect of anti cyclic citrullinated peptide 2 immunoglobulin m serostatus on efficacy outcomes following treatment with abatacept plus methotrexate in the avert trial
    Annals of the Rheumatic Diseases, 2015
    Co-Authors: T W J Huizinga, Gerd-rüdiger Burmester, Vivian P Bykerk, Daniel E Furst, D Wong, Bernard Combe, Sean E Connolly, Alyssa Johnsen, J Zhu, Leendert A Trouw
    Abstract:

    Background Anti-citrullinated protein antibodies (ACPA) are a marker of RA, and the presence of the immunoglobulin M (IgM) isotype indicates an ongoing immune response involving the recruitment of naive B cells. 1 Abatacept (ABA) modulates T-cell co-stimulation and has been shown to impact ACPA maturation, including seroconversion of IgM, in the AVERT (Assessing Very Early Rheumatoid Arthritis Treatment) trial. 2 Objectives To assess the efficacy of treatment with ABA+MTX, ABA monotherapy or MTX alone in patients (pts) from the AVERT trial based on their anti-cyclic citrullinated peptide 2 (CCP2; a surrogate for ACPA) IgM serostatus at baseline (BL), and seroconversion (anti-CCP2 IgM positive to negative) through 1 year. Methods The AVERT trial has been described previously. 3 In this post hoc analysis, pt samples were analysed by ELISA to determine anti-CCP2 IgM serostatus. Efficacy outcomes analysed by BL anti-CCP2 IgM serostatus included remission rate at 12 mths (CDAI, SDAI, Boolean and DAS28 [CRP] Results In the ABA+MTX treatment arm, a higher proportion of pts who were anti-CCP2 IgM positive at BL achieved remission by all indices compared with pts who were BL IgM negative (Figure). This trend was most clearly observed in the stringent indices of CDAI, SDAI and Boolean remission, compared with DAS28 (CRP)-defined remission. This trend was not observed in either the ABA monotherapy or MTX alone arms. Mean improvement in DAS28 (CRP) and HAQ-DI over time was also greatest in BL anti-CCP2 IgM-positive pts treated with ABA+MTX. A numerically higher proportion of pts who seroconverted from anti-CCP2 IgM positive at BL to negative at Mth 12 achieved Boolean remission versus pts who remained seropositive in the ABA+MTX and ABA monotherapy arms (Table). Conclusions Abatacept in combination with MTX had greater clinical efficacy in pts who were anti-CCP2 IgM positive at BL than in those who were anti-CCP2 IgM negative at BL, and in those who seroconverted over time than those who did not, suggesting that the impact on ACPA is associated with clinical benefit. References Verpoort KN, et al. Arthritis Rheum 2006;54:3799–808. Huizinga TWJ, et al. Arthritis Rheum 2014;66:S666. Poster 1515. Emery P, et al. Ann Rheum Dis 2015:74:19–26. Disclosure of Interest T. W. J. Huizinga Grant/research support from: EU & Dutch Arthritis Foundation, Consultant for: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Crescendo Bioscience, Inc, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough, UCB, Inc., Eli Lilly, Meteor Board, Speakers bureau: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough, S. E. Connolly Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, A. Johnsen Employee of: Bristol-Myers Squibb, J. Zhu Employee of: Bristol-Myers Squibb, D. E. Furst Grant/research support from: AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Consultant for: AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Cytori, Janssen, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Speakers bureau: (CME only) AbbVie, Actelion, UCB, V. P. Bykerk Grant/research support from: Amgen, Pfizer, Bristol-Myers Squibb, Janssen, UCB, Roche/Genentech, Consultant for: Amgen, Pfizer, Bristol-Myers Squibb, UCB, Roche, G. R. Burmester Grant/research support from: Bristol-Myers Squibb, AbbVie, Pfizer, Medimmune, Novartis, Roche, UCB, Lilly, Consultant for: Bristol-Myers Squibb, AbbVie, Pfizer, MSD, Medimmune, Roche, UCB, Speakers bureau: Bristol-Myers Squibb, AbbVie, Pfizer, MSD, Roche, UCB, B. G. Combe Grant/research support from: Pfizer, Roche-Chugai, Speakers bureau: Bristol-Myers Squibb, Merck, Pfizer, Roche-Chugai, UCB, D. A. Wong Shareholder of: Bristol-Myers Squibb, Employee of: Bristol-Myers Squibb, L. A. Trouw: None declared, R. E. M. Toes: None declared, P. Emery Grant/research support from: Abbvie, Merck, Pfizer, Roche, Consultant for: Abbvie, Bristol-Myers Squibb, Merck, Pfizer, Roche, Lilly, Novartis

  • op0026 induction of clinical remission followed by drug free withdrawal with abatacept combination and monotherapy in early ra results from the avert study over 18 months
    Annals of the Rheumatic Diseases, 2014
    Co-Authors: Paul Emery, Gerd-rüdiger Burmester, Benard Combe, Emilie Barre, Chetan S Karyekar, D A Wong, Vivian P Bykerk, Daniel E Furst, Tom W J Huizinga
    Abstract:

    Background AVERT (Assessing Very Early Rheumatoid arthirits Treatment) is a Phase IIIb, randomized, active-controlled study to evaluate the efficacy and safety of subcutaneous (SC) abatacept (ABA) in pts with early RA. Objectives To assess ABA + MTX or ABA monotherapy in inducing clinical remission at 12 mths and then maintain it following rapid withdrawal of all RA treatment (biologics, DMARDs, steroids) in pts with early RA. Methods MTX-naive, anti-CCP2+ pts with early RA (active synovitis in ≥2 joints for ≥8 wks, DAS28 (CRP) >3.2 and onset of symptoms within ≤2 yrs) were included. Pts were randomized to 12 mths of weekly SC ABA 125 mg + MTX, ABA 125 mg monotherapy or MTX alone. Pts with DAS28 (CRP) Results 351 pts (n=119, 116 and 116 pts in the ABA + MTX, ABA and MTX arms, respectively) with early RA, highly active disease and poor prognosis (at baseline: mean RA duration of 0.56 yrs, mean DAS28 (CRP) of 5.4, mean HAQ of 1.4; 95.2% RF+ and anti-CCP2+) entered the study. At 12 mths, 60.9, 42.5 and 45.2% achieved DAS28 (CRP) Conclusions In this study, in pts with highly active early RA with poor prognosis, abatacept + MTX resulted in significantly higher rates of remission and comparable safety vs MTX alone at 12 mths. At most time points, abatacept monotherapy was more effective than MTX alone. A small but significantly higher number of patients treated with abatacept + MTX were able to maintain drug-free remission compared to MTX. Disclosure of Interest P. Emery Grant/research support: AbbVie, BMS, Merck, Pfizer, Roche, Consultant for: AbbVie, BMS, Merck, Pfizer, Roche, Takeda, G. Burmester Grant/research support: BMS, AbbVie, Pfizer, Medimmune, Novartis, Roche, UCB, Lilly, Consultant for: BMS, AbbVie, Pfizer, MSD, Medimmune, Roche, UCB, Speakers bureau: BMS, AbbVie, Pfizer, MSD, Roche, UCB, V. Bykerk Grant/research support: Amgen, Pfizer, BMS, Janssen, UCB, Roche/Genentech, B. Combe Grant/research support: Pfizer, Roche-Chugai, Speakers bureau: BMS, Merck, Pfizer, Roche-Chugai, UCB, D. Furst Grant/research support: AbbVie, Actelion, Amgen, BMS, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Consultant for: AbbVie, Actelion, Amgen, BMS, Janssen, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Speakers bureau: AbbVie, Actelion, UCB, E. Barre Employee of: BMS, C. Karyekar Employee of: BMS, D. Wong Employee of: BMS, T. Huizinga Grant/research support: EU & Dutch Arthritis Foundation, Consultant for: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Crescendo Bioscience, Inc, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough, UCB, Inc., Eli Lilly, Speakers bureau: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough DOI 10.1136/annrheumdis-2014-eular.2132

  • op0030 mri results from the avert study a randomized active controlled trial to evaluate induction of remission and maintenance of drug free remission using abatacept in combination with methotrexate or as monotherapy in patients with early ra
    Annals of the Rheumatic Diseases, 2014
    Co-Authors: Charles Peterfy, Gerd-rüdiger Burmester, Benard Combe, Tom W J Huizinga, Chetan S Karyekar, Vivian P Bykerk, Daniel E Furst, D Wong, P G Conaghan, Paul Emery
    Abstract:

    Background AVERT (Assessing Very Early Rheumatoid arthirits Treatment) is a Phase IIIb, randomized, active-controlled trial to evaluate the efficacy and safety of abatacept (ABA) in combination with methotrexate (+ MTX) in patients (pts) with early RA. Objectives To assess joint damage progression by magnetic resonance imaging (MRI) in pts with early RA from the AVERT study who were treated with ABA + MTX or ABA monotherapy, compared with MTX alone. Methods MTX-naive, anti-CCP2+ pts with early RA (active synovitis in ≥2 joints for ≥8 weeks, DAS28 (CRP) >3.2 and onset of symptoms within ≤2 yrs) were included. Pts were randomized to 12 mths of weekly SC ABA 125 mg + MTX, ABA 125 mg monotherapy or MTX alone. Pts with DAS28 (CRP) Results During the 12-mth treatment period, benefits in synovitis, osteitis and erosion scores were numerically greater for ABA + MTX than for MTX alone; while numerically greater benefits were observed in synovitis and osteitis scores for ABA monotherapy than for MTX alone (Table 1). A post hoc analysis of pts who maintained DAS28 (CRP) Conclusions Consistent with the clinical outcomes of the AVERT study in pts with early RA with high disease activity, there were greater reductions in MRI outcomes with abatacept treatment in combination with MTX than with MTX alone. MRI changes with abatacept monotherapy treatment were intermediate between abatacept in combination with MTX and MTX treatment alone. Disclosure of Interest C. Peterfy Shareholder of: Spire Sciences Inc., Synarc Inc., Consultant for: AbbVie, Inc., Amgen Inc., Articulinx, AstraZeneca, Bristol-Myers Squibb, Five Prime Therapeutics, Genentech, Hoffmann-La Roche, Inc., Lilly USA, LLC, Medimmune, Merck Pharmaceuticals, Moximed, Novartis Pharmaceuticals Corporation, Novo Nordisk, Plexxikon, Pfizer Inc, Sanofi, Salix-Santarus, Samsung, UCB, Inc., Employee of: Spire Sciences Inc., G. Burmester Grant/research support: BMS, AbbVie, Pfizer, Medimmune, Novartis, Roche, UCB, Lilly, Consultant for: BMS, AbbVie, Pfizer, MSD, Medimmune, Roche, UCB, Speakers bureau: BMS, AbbVie, Pfizer, MSD, Roche, UCB, V. Bykerk Grant/research support: Amgen, Pfizer, BMS, Janssen, UCB, Roche/Genentech, B. Combe Grant/research support: Pfizer, Roche-Chugai, Speakers bureau: BMS, Merck, Pfizer, Roche-Chugai, UCB, D. Furst Grant/research support: AbbVie, Actelion, Amgen, BMS, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Consultant for: AbbVie, Actelion, Amgen, BMS, Janssen, Gilead, GSK, NIH, Novartis, Pfizer, Roche/Genentech, UCB, Speakers bureau: AbbVie, Actelion, UCB, T. Huizinga Grant/research support: EU & Dutch Arthritis Foundation, Consultant for: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Crescendo Bioscience, Inc, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough, UCB, Inc., Eli Lilly, Speakers bureau: Abbott Laboratories, Biotest AG, Bristol-Myers Squibb, Novartis Pharmaceuticals Corporation, Pfizer Inc, Roche, sanofi-aventis, Schering-Plough, C. Karyekar Employee of: BMS, D. Wong Employee of: BMS, P. Conaghan Grant/research support: Centocor Research and Development, Inc., Pfizer Inc., Speakers bureau: AbbVie, BMS, Janssen, Pfizer, Roche, UCB, P. Emery Grant/research support: AbbVie, BMS, Merck, Pfizer, Roche, Consultant for: AbbVie, BMS, Merck, Pfizer, Roche, Takeda DOI 10.1136/annrheumdis-2014-eular.1524

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