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Jeanclaude Becker – One of the best experts on this subject based on the ideXlab platform.

  • long term safety efficacy and inhibition of radiographic progression with Abatacept treatment in patients with rheumatoid arthritis and an inadequate response to methotrexate 3 year results from the aim trial
    Annals of the Rheumatic Diseases, 2011
    Co-Authors: Joel M Kremer, Jeanclaude Becker, R Aranda, Paul Emery, Anthony S Russell, Rene Westhovens, Carlos Abudmendoza, Jacek Szechinski, Xianhuang Zhou, Charles Peterfy
    Abstract:

    Objective To evaluate Abatacept treatment over 3 years in patients with rheumatoid arthritis (RA) refractory to methotrexate (MTX). Methods Patients randomised to Abatacept or placebo (+MTX) during the 1-year double-blind period of the Abatacept in Inadequate responders to Methotrexate (AIM) trial received open-label Abatacept (+MTX) in the long-term extension (LTE). Safety was assessed for patients who received ≥1 dose of Abatacept, regardless of randomisation group. Efficacy was assessed for patients randomised to Abatacept who entered the LTE. Results 433 and 219 patients were randomised and treated with Abatacept or placebo, respectively; 378 and 161 entered the LTE. At year 3, 440/539 patients were ongoing. No unexpected safety events were observed in the LTE. By year 3, incidence rates of adverse event and serious adverse events were 249.8/100 and 15.1/100 patient-years, respectively. Incidence rates were generally stable over time. At year 3, 84.8%, 63.4% and 37.5% of patients achieved American College of Rheumatology (ACR) criteria of 20, 50 and 70, respectively, compared with 82.3%, 54.3% and 32.4% of patients at year 1. Mean changes in Genant-modified Sharp scores were reduced progressively over 3 years, with significantly greater inhibition during year 3 compared with year 2 (p=0.022 for total score). Conclusion In MTX-inadequate responders with RA, Abatacept provided consistent safety and sustained efficacy over 3 years. The data suggest an increasing inhibitory disease-modifying effect on radiographic progression.

  • Clinical response and tolerability to Abatacept in patients with rheumatoid arthritis previously treated with infliximab or Abatacept: open-label extension of the ATTEST Study
    Annals of the rheumatic diseases, 2011
    Co-Authors: Michael Schiff, Jeanclaude Becker, M. Keiserman, Christine E Codding, Suthin Songcharoen, Alberto Berman, S Nayiager, Cristina Saldate, R Aranda, Marleen Nys
    Abstract:

    Objective To assess the efficacy and safety of Abatacept in biological-naive patients with rheumatoid arthritis and an inadequate response to methotrexate treated in the long-term extension (LTE) of the ATTEST trial. Methods Patients randomly assigned to Abatacept, placebo or infliximab completing the 1-year double-blind period were eligible to receive Abatacept ~10 mg/kg in the open-label LTE. Efficacy to year 2 is presented for patients randomly assigned to Abatacept or infliximab who switched to open-label Abatacept. Safety data are presented for all patients entering LTE regardless of double-blind treatment. Results Of 431 patients randomly assigned, 79.8% remained on Abatacept at year 2. At years 1 and 2, 19.7% and 26.1% of Abatacept and 13.3% and 28.6% of infliximab-to-Abatacept patients achieved disease activity score 28-defined remission ( Conclusion In methotrexate-inadequate responders, Abatacept efficacy was maintained over 2 years. For infliximab-to-Abatacept patients, efficacy improvements were seen in year 2 after patients switched to Abatacept. Switching directly from infliximab to Abatacept was well tolerated. These data demonstrate that Abatacept provides sustained responses and consistent safety, suggesting that switching from infliximab to Abatacept is a viable treatment option.

  • Abatacept in the treatment of patients with psoriatic arthritis results of a six month multicenter randomized double blind placebo controlled phase ii trial
    Arthritis & Rheumatism, 2011
    Co-Authors: Philip J. Mease, Jeanclaude Becker, Mark C. Genovese, Paul P Tak, Geoffrey Gladstein, Alan J Kivitz, Christopher T Ritchlin, J Wollenhaupt, Orna Bahary, S. Kelly
    Abstract:

    Objective To assess the safety and efficacy of Abatacept, a selective T cell costimulation modulator, in patients with psoriatic arthritis (PsA). Methods In this 6-month, multicenter, randomized, double-blind, placebo-controlled, phase II study, 170 PsA patients with a psoriasis target lesilesion (TL) ≥2 cm who had previously taken disease-modifying antirheumatic drugs (DMARDs), including anti–tumor necrnecrosis factor (anti-TNF) agents, were randomized (1:1:1:1) to receive placebo or Abatacept at doses of 3 mg/kg, 10 mg/kg, or 30/10 mg/kg (2 initial doses of 30 mg/kg, followed by 10 mg/kg) on days 1, 15, and 29 and then once every 28 days thereafter. The primary end point was the American College of Rheumatology 20% criteria for improvement (ACR20 response) on day 169. Other key end points were magnetic resoresonanceging (MRI) scores for joint erosion, osteitis, and synovitis, scores on the Health Assessment Questionnaire (HAQ) and the Short Form-36 (SF-36) health survey, the investigator’s global assessment of psoriasis, the TL score, and the Psoriasis Area and Severity Index (PASI) score. Results Proportions of patients achieving an ACR20 response were 19%, 33%, 48%, and 42% in the placebo, the Abatacept 3 mg/kg, the Abatacept 10 mg/kg, and the Abatacept 30/10 mg/kg groups, respectively. Compared with placebo, improvements were significantly higher for the Abatacept 10 mg/kg (P = 0.006) and 30/10 mg/kg (P = 0.022) groups, but not for 3 mg/kg group (P = 0.121). All Abatacept regimens resulted in improved MRI, HAQ, and SF-36 scores, with 10 mg/kg showing the greatest improvements. Improvements in the TL and PASI scores were observed in all Abatacept arms; a response according to the investigator’s global assessment was seen only with 3 mg/kg of Abatacept. The safety profiles were similar among the treatment arms. Conclusion The results of this study suggest that 10 mg/kg of Abatacept, the approved dosage for rheumatoid arthritis and juvenile idiopathic arthritis, may be an effective treatment option for PsA.

Joel M Kremer – One of the best experts on this subject based on the ideXlab platform.

  • Abatacept in subjects who switch from intravenous to subcutaneous therapy results from the phase iiib attune study
    Annals of the Rheumatic Diseases, 2012
    Co-Authors: Edward C Keystone, Joel M Kremer, R Aranda, Ingrid Delaet, Allison Luo, Carlos Abudmendoza, Anthony H Russell, Jane Box, Mario Alberto Garza Elizondo, Rene Swanink
    Abstract:

    Objective To assess safety, immunogenicity and efficacy in rheumatoid arthritis (RA) patients switched from long-term intravenous to subcutaneous (SC) Abatacept. Methods In this phase IIIb, open-label, single-arm trial, patients who completed ≥4 years of intravenous Abatacept (in long-term extensions of two phase III studies) were enrolled to receive SC Abatacept (125 mg/week). The primary objective was safety during the first 3 months after switching from intravenous therapy. Results 123 patients entered the study (mean Disease Activity Score 28 (based on C reactive protein) and HAQ-DI of 3.4 and 0.94, respectively). At month 3, 120 (97.6%) patients were continuing to receive SC Abatacept; no patients discontinued due to lack of efficacy. Adverse events (AEs) were reported in 49 (39.8%) patients through month 3. One patient (0.8%) discontinued due to an AE and one patient (0.8%) experienced a serious AE. Two (1.6%) patients had SC injection site reactions (erythema, pain), both with mild intensity. Clinical efficacy was maintained throughout. Limited impact on immunogenicity was observed when switching routes of administration. Conclusion These data demonstrate that patients can switch from long-term monthly intravenous Abatacept to a weekly fixed dose of 125 mg SC Abatacept with no increased safety concerns. This study further supports SC Abatacept as an alternative treatment option for patients with RA.

  • long term safety efficacy and inhibition of radiographic progression with Abatacept treatment in patients with rheumatoid arthritis and an inadequate response to methotrexate 3 year results from the aim trial
    Annals of the Rheumatic Diseases, 2011
    Co-Authors: Joel M Kremer, Jeanclaude Becker, R Aranda, Paul Emery, Anthony S Russell, Rene Westhovens, Carlos Abudmendoza, Jacek Szechinski, Xianhuang Zhou, Charles Peterfy
    Abstract:

    Objective To evaluate Abatacept treatment over 3 years in patients with rheumatoid arthritis (RA) refractory to methotrexate (MTX). Methods Patients randomised to Abatacept or placebo (+MTX) during the 1-year double-blind period of the Abatacept in Inadequate responders to Methotrexate (AIM) trial received open-label Abatacept (+MTX) in the long-term extension (LTE). Safety was assessed for patients who received ≥1 dose of Abatacept, regardless of randomisation group. Efficacy was assessed for patients randomised to Abatacept who entered the LTE. Results 433 and 219 patients were randomised and treated with Abatacept or placebo, respectively; 378 and 161 entered the LTE. At year 3, 440/539 patients were ongoing. No unexpected safety events were observed in the LTE. By year 3, incidence rates of adverse event and serious adverse events were 249.8/100 and 15.1/100 patient-years, respectively. Incidence rates were generally stable over time. At year 3, 84.8%, 63.4% and 37.5% of patients achieved American College of Rheumatology (ACR) criteria of 20, 50 and 70, respectively, compared with 82.3%, 54.3% and 32.4% of patients at year 1. Mean changes in Genant-modified Sharp scores were reduced progressively over 3 years, with significantly greater inhibition during year 3 compared with year 2 (p=0.022 for total score). Conclusion In MTX-inadequate responders with RA, Abatacept provided consistent safety and sustained efficacy over 3 years. The data suggest an increasing inhibitory disease-modifying effect on radiographic progression.

  • Abatacept inhibits progression of structural damage in rheumatoid arthritis results from the long term extension of the aim trial
    Annals of the Rheumatic Diseases, 2008
    Co-Authors: Harry K Genant, Jeanclaude Becker, R Aranda, Charles Peterfy, Rene Westhovens, George Vratsanos, Julie Teng, Joel M Kremer
    Abstract:

    Objective: Assess the effect of Abatacept on progression of structural damage over 2 years in patients with rheumatoid arthritis who had an inadequate response to methotrexate. Methods: 539 patients entered an open-label extension of the AIM (Abatacept in Inadequate responders to Methotrexate) trial and received Abatacept. Radiographic assessment of the hands and feet was performed at baseline, year 1 and year 2. At year 2, each patient’s radiographs were scored for progression blinded to sequence and treatment allocation. Results: In patients treated with Abatacept for 2 years, greater reduction in progression of structural damage was observed in year 2 than in year 1. The mean change in total Genant-modified Sharp scores was reduced from 1.07 units in year 1 to 0.46 units in year 2. Similar reductions were observed in erosion and joint space narrowing scores. Following 2 years of treatment with Abatacept, 50% of patients had no progression of structural damage as defined by a change in the total score of ⩽0 compared with baseline. 56% of patients treated with Abatacept had no progression during the first year compared with 45% of patients treated with placebo. In their second year of treatment with Abatacept, more patients had no progression than in the first year (66% vs 56%). Conclusions: Abatacept has a sustained effect that inhibits progression of structural damage. Furthermore, the mean change in radiographic progression in patients treated with Abatacept for 2 years was significantly lower in year 2 versus year 1, suggesting that Abatacept may have an increasing disease-modifying effect on structural damage over time.

R Aranda – One of the best experts on this subject based on the ideXlab platform.

  • longterm safety and efficacy of Abatacept through 5 years of treatment in patients with rheumatoid arthritis and an inadequate response to tumor necrosis factor inhibitor therapy
    The Journal of Rheumatology, 2012
    Co-Authors: Mark C. Genovese, Michael Schiff, Michael E Luggen, R Aranda, Manuela Le Bars, A Elegbe, M Dougados
    Abstract:

    Objective. To evaluate Abatacept safety and efficacy over 5 years in patients with rheumatoid arthritis (RA) who had inadequate response to anti-tumor necrnecrosis factor (TNF) therapy in the ATTAIN trial. Methods. Patients completing the 6-month, double-blind (DB) placebo-controlled period were eligible to enter the longterm extension (LTE), where all patients received Abatacept every 4 weeks (∼10 mg/kg, according to weight range). Safety, efficacy, physical function, and health-related quality of life were monitored throughout. Results. In total, 317 patients (218 DB Abatacept, 99 DB placebo) entered the LTE; 150 (47.3%) completed it. Overall incidences of serious adverse events, infections, serious infections, malignant neoplasms, and autoimmune events did not increase during the LTE versus the DB period. American College of Rheumatology responses with Abatacept at Month 6 were maintained over 5 years. At Year 5, among patients who received Abatacept for 5 years and had available data, 38/103 (36.9%) achieved low disease activity as defined by the 28-joint Disease Activity Score (DAS28)/C-reactive protein (CRP); 23/103 (22.3%) achieved DAS28/CRP-defined remission. Health Assessment Questionnaire response was achieved by 62.5% of patients remaining on treatment at Year 5; mean improvements from baseline in physical component summary and mental component summary scores were 7.34 and 6.42, respectively. High proportions of patients maintained efficacy and physical function benefits or improved their disease state at each timepoint throughout the LTE, if remaining on Abatacept treatment. Conclusion. Safety remained consistent, and Abatacept efficacy was maintained from 6 months to 5 years, demonstrating the benefits of switching to Abatacept in this difficult-to-treat population of patients with RA previously failing anti-TNF therapy.

  • Abatacept for Crohn’s Disease and Ulcerative Colitis
    Gastroenterology, 2012
    Co-Authors: William J. Sandborn, Jean-frederic Colombel, Bruce E. Sands, Paul Rutgeerts, Stephan R. Targan, Remo Panaccione, Brian Bressler, K. Geboes, Stefan Schreiber, R Aranda
    Abstract:

    Background & Aims The efficacy of Abatacept, a selective costimulation modulator, in Crohn’s disease (CD) and ulcerative colitis (UC) is unknown. Methods Four placebo-controlled trials evaluated the efficacy and safety of Abatacept as induction (IP) and maintenance (MP) therapy in adults with active, moderate-to-severe CD (CD-IP; CD-MP) and UC (UC-IP1; UC-MP). In CD-IP and UC-IP1, 451 patients with CD and 490 patients with UC were randomized to Abatacept 30, 10, or 3 mg/kg (according to body weight) or placebo, and dosed at weeks 0, 2, 4, and 8. In MP, 90 patients with CD and 131 patients with UC who responded to Abatacept at week 12 in the induction trials were randomized to Abatacept 10 mg/kg or placebo every 4 weeks through week 52. Results In CD-IP, 17.2%, 10.2%, and 15.5% of patients receiving Abatacept 30, 10, and 3 mg/kg achieved a clinical response at weeks 8 and 12, vs 14.4% receiving placebo ( P = .611, P = .311, and P = .812, respectively). In UC-IP1, 21.4%, 19.0%, and 20.3% of patients receiving Abatacept 30, 10, and 3 mg/kg achieved a clinical response at week 12, vs 29.5% receiving placebo ( P = .124, P = .043, and P = .158, respectively). In CD-MP, 23.8% vs 11.1% of Abatacept vs placebo patients were in remission at week 52. In UC-MP, 12.5% vs 14.1% of patients receiving Abatacept vs placebo were in remission at week 52. Safety generally was comparable between groups. Conclusions The studies showed that Abatacept is not efficacious for the treatment of moderate-to-severe CD or UC. ClinicalTrials.gov NCT00406653, NCT00410410.

  • Abatacept in subjects who switch from intravenous to subcutaneous therapy results from the phase iiib attune study
    Annals of the Rheumatic Diseases, 2012
    Co-Authors: Edward C Keystone, Joel M Kremer, R Aranda, Ingrid Delaet, Allison Luo, Carlos Abudmendoza, Anthony H Russell, Jane Box, Mario Alberto Garza Elizondo, Rene Swanink
    Abstract:

    Objective To assess safety, immunogenicity and efficacy in rheumatoid arthritis (RA) patients switched from long-term intravenous to subcutaneous (SC) Abatacept. Methods In this phase IIIb, open-label, single-arm trial, patients who completed ≥4 years of intravenous Abatacept (in long-term extensions of two phase III studies) were enrolled to receive SC Abatacept (125 mg/week). The primary objective was safety during the first 3 months after switching from intravenous therapy. Results 123 patients entered the study (mean Disease Activity Score 28 (based on C reactive protein) and HAQ-DI of 3.4 and 0.94, respectively). At month 3, 120 (97.6%) patients were continuing to receive SC Abatacept; no patients discontinued due to lack of efficacy. Adverse events (AEs) were reported in 49 (39.8%) patients through month 3. One patient (0.8%) discontinued due to an AE and one patient (0.8%) experienced a serious AE. Two (1.6%) patients had SC injection site reactions (erythema, pain), both with mild intensity. Clinical efficacy was maintained throughout. Limited impact on immunogenicity was observed when switching routes of administration. Conclusion These data demonstrate that patients can switch from long-term monthly intravenous Abatacept to a weekly fixed dose of 125 mg SC Abatacept with no increased safety concerns. This study further supports SC Abatacept as an alternative treatment option for patients with RA.

Michael Schiff – One of the best experts on this subject based on the ideXlab platform.

  • head to head comparison of subcutaneous Abatacept versus adalimumab for rheumatoid arthritis two year efficacy and safety findings from ample trial
    Annals of the Rheumatic Diseases, 2014
    Co-Authors: Michael Schiff, Michael E Weinblatt, Robert M. Valente, Desiree Van Der Heijde, Gustavo Citera, A Elegbe, M Maldonado, Roy Fleischmann
    Abstract:

    Objectives To compare over 2 years the safety, efficacy and radiographic outcomes of subcutaneous Abatacept versus adalimumab, in combination with methotrexate (MTX), in patients with rheumatoid arthritis (RA). Methods AMPLE is a phase IIIb, 2-year, randomised, investigator-blinded study with a 1-year primary endpoint. Biologic-naive patients with active RA and an inadequate response to MTX were randomised to 125 mg Abatacept weekly or 40 mg adalimumab bi-weekly, both with a stable dose of MTX. Results Of 646 patients randomised, 79.2% Abatacept and 74.7% adalimumab patients completed year 2. At year 2, efficacy outcomes, including radiographic, remained comparable between groups and with year 1 results. The American College Rheumatology 20, 50 and 70 responses at year 2 were 59.7%, 44.7% and 31.1% for Abatacept and 60.1%, 46.6% and 29.3% for adalimumab. There were similar rates of adverse events (AEs) and serious adverse events (SAEs). More serious infections occurred with adalimumab (3.8% vs 5.8%) including two cases of tuberculosis with adalimumab. There were fewer discontinuations due to AEs (3.8% vs 9.5%), SAEs (1.6% vs 4.9%) and serious infections (0/12 vs 9/19 patients) in the Abatacept group. Injection site reactions (ISRs) occurred less frequently with Abatacept (4.1% vs 10.4%). Conclusions Through 2 years of blinded treatment in this first head-to-head study between biologic disease-modifying antirheumatic drugs in RA patients with an inadequate response to MTX, subcutaneous Abatacept and adalimumab were similarly efficacious based on clinical, functional and radiographic outcomes. Overall, AE frequency was similar in both groups but there were less discontinuations due to AEs, SAEs, serious infections and fewer local ISRs with Abatacept. ClinicalTrials.gov Identifier NCT00929864.

  • Subcutaneous Abatacept for the treatment of rheumatoid arthritis
    Rheumatology (Oxford England), 2013
    Co-Authors: Michael Schiff
    Abstract:

    The efficacy, safety and tolerability of i.v. Abatacept are well established in patients with active RA. A s.c. Abatacept formulation is now available in some countries. Here, we review clinical data for s.c. Abatacept. Six trials are presented (Phase II dose-finding study, ACQUIRE, ALLOW, ACCOMPANY, ATTUNE and AMPLE) and issues important to both patients and clinicians are addressed. The primary focus assesses whether the i.v. and s.c. Abatacept formulations have similar efficacy, including whether the recommended fixed dose of s.c. Abatacept is comparable to the weight-tiered i.v. dosing and whether efficacy is sustained with long-term treatment. Safety and immunogenicity are also discussed, including the short- and long-term safety of s.c. Abatacept, and whether immunogenicity is increased following a switch from i.v. to s.c. Abatacept, after withdrawal or reintroduction of s.c. Abatacept or in the absence of MTX. Year 1 data from the AMPLE study, comparing s.c. Abatacept with the TNF antagonist adalimumab, are discussed. Although fewer patient-years of exposure are available for s.c. compared with i.v. Abatacept, observations suggest that s.c. Abatacept has a similar long-term efficacy to the i.v. formulation, improving the signs, symptoms, disease activity and physical function in patients with RA. With continued treatment, these improvements are maintained over time with high retention rates, similar to i.v. Abatacept. s.c. Abatacept is associated with low immunogenicity and short- and long-term safety that is consistent with i.v. Abatacept. In addition, s.c. Abatacept demonstrates comparable efficacy, kinetics of response, safety and radiographic inhibition to adalimumab.

  • longterm safety and efficacy of Abatacept through 5 years of treatment in patients with rheumatoid arthritis and an inadequate response to tumor necrosis factor inhibitor therapy
    The Journal of Rheumatology, 2012
    Co-Authors: Mark C. Genovese, Michael Schiff, Michael E Luggen, R Aranda, Manuela Le Bars, A Elegbe, M Dougados
    Abstract:

    Objective. To evaluate Abatacept safety and efficacy over 5 years in patients with rheumatoid arthritis (RA) who had inadequate response to anti-tumor necrosis factor (TNF) therapy in the ATTAIN trial. Methods. Patients completing the 6-month, double-blind (DB) placebo-controlled period were eligible to enter the longterm extension (LTE), where all patients received Abatacept every 4 weeks (∼10 mg/kg, according to weight range). Safety, efficacy, physical function, and health-related quality of life were monitored throughout. Results. In total, 317 patients (218 DB Abatacept, 99 DB placebo) entered the LTE; 150 (47.3%) completed it. Overall incidences of serious adverse events, infections, serious infections, malignant neoplasms, and autoimmune events did not increase during the LTE versus the DB period. American College of Rheumatology responses with Abatacept at Month 6 were maintained over 5 years. At Year 5, among patients who received Abatacept for 5 years and had available data, 38/103 (36.9%) achieved low disease activity as defined by the 28-joint Disease Activity Score (DAS28)/C-reactive protein (CRP); 23/103 (22.3%) achieved DAS28/CRP-defined remission. Health Assessment Questionnaire response was achieved by 62.5% of patients remaining on treatment at Year 5; mean improvements from baseline in physical component summary and mental component summary scores were 7.34 and 6.42, respectively. High proportions of patients maintained efficacy and physical function benefits or improved their disease state at each timepoint throughout the LTE, if remaining on Abatacept treatment. Conclusion. Safety remained consistent, and Abatacept efficacy was maintained from 6 months to 5 years, demonstrating the benefits of switching to Abatacept in this difficult-to-treat population of patients with RA previously failing anti-TNF therapy.

Michael E Weinblatt – One of the best experts on this subject based on the ideXlab platform.

  • head to head comparison of subcutaneous Abatacept versus adalimumab for rheumatoid arthritis two year efficacy and safety findings from ample trial
    Annals of the Rheumatic Diseases, 2014
    Co-Authors: Michael Schiff, Michael E Weinblatt, Robert M. Valente, Desiree Van Der Heijde, Gustavo Citera, A Elegbe, M Maldonado, Roy Fleischmann
    Abstract:

    Objectives To compare over 2 years the safety, efficacy and radiographic outcomes of subcutaneous Abatacept versus adalimumab, in combination with methotrexate (MTX), in patients with rheumatoid arthritis (RA). Methods AMPLE is a phase IIIb, 2-year, randomised, investigator-blinded study with a 1-year primary endpoint. Biologic-naive patients with active RA and an inadequate response to MTX were randomised to 125 mg Abatacept weekly or 40 mg adalimumab bi-weekly, both with a stable dose of MTX. Results Of 646 patients randomised, 79.2% Abatacept and 74.7% adalimumab patients completed year 2. At year 2, efficacy outcomes, including radiographic, remained comparable between groups and with year 1 results. The American College Rheumatology 20, 50 and 70 responses at year 2 were 59.7%, 44.7% and 31.1% for Abatacept and 60.1%, 46.6% and 29.3% for adalimumab. There were similar rates of adverse events (AEs) and serious adverse events (SAEs). More serious infections occurred with adalimumab (3.8% vs 5.8%) including two cases of tuberculosis with adalimumab. There were fewer discontinuations due to AEs (3.8% vs 9.5%), SAEs (1.6% vs 4.9%) and serious infections (0/12 vs 9/19 patients) in the Abatacept group. Injection site reactions (ISRs) occurred less frequently with Abatacept (4.1% vs 10.4%). Conclusions Through 2 years of blinded treatment in this first head-to-head study between biologic disease-modifying antirheumatic drugs in RA patients with an inadequate response to MTX, subcutaneous Abatacept and adalimumab were similarly efficacious based on clinical, functional and radiographic outcomes. Overall, AE frequency was similar in both groups but there were less discontinuations due to AEs, SAEs, serious infections and fewer local ISRs with Abatacept. ClinicalTrials.gov Identifier NCT00929864.

  • Safety of Abatacept Administered Intravenously in Treatment of Rheumatoid Arthritis: Integrated Analyses of up to 8 Years of Treatment from the Abatacept Clinical Trial Program
    The Journal of rheumatology, 2013
    Co-Authors: Michael E Weinblatt, Rene Westhovens, Ramesh Pappu, Ingrid Delaet, Larry W. Moreland, Roger B. Cohen, S. Kelly, Nader Khan, Allison Luo, Sheila Gujrathi
    Abstract:

    Objective. To assess the overall safety, including rare events, of intravenous (IV) Abatacept treatment in rheumatoid arthritis (RA). Methods. Data from 8 clinical trials of IV Abatacept in RA were pooled. Safety events were assessed during the short-term (duration ≤ 12 months) and cumulative (short-term plus longterm extensions) Abatacept treatment periods. Incidence rates per 100 patient-years were calculated. Standardized incidence ratios (SIR) for hospitalized infections and malignancies were compared with external RA cohorts and, for malignancies, with the US general population. Results. There were 3173 IV Abatacept-treated patients with 2331 patient-years of exposure in the short-term periods, and 4149 IV Abatacept-treated patients with 12,132 patient-years of exposure in the cumulative period. Incidence rates for serious infections were low and consistent over time (3.68 for Abatacept vs 2.60 for placebo during the short-term, and 2.87 for Abatacept during the cumulative period). Hospitalized infections were generally similar to external RA patient cohorts and were consistent over time. Incidence rates of malignancies were similar for Abatacept– and placebo-treated patients during the short-term period (0.73 vs 0.59) and remained low during the Abatacept cumulative period (0.73). SIR of some tissue-specific malignancies (e.g., colorectal and breast) in the cumulative period tended to be lower, while others (lymphoma and lung) tended to be higher, compared with the general population; however, incidence rates were comparable with RA cohorts. Autoimmune events were rare and infusion reactions uncommon. Conclusion. Longterm safety of IV Abatacept was consistent with the short-term, with no unexpected events and low incidence rates of serious infections, malignancies, and autoimmune events.

  • Abatacept in the treatment of rheumatoid arthritis.
    International journal of clinical practice, 2007
    Co-Authors: Derrick J. Todd, Karen H. Costenbader, Michael E Weinblatt
    Abstract:

    Over the past decade, biological immunotherapy has revolutionised the treatment of rheumatoid arthritis (RA). The most widely used of these therapies targets tumour necrosis factor-alpha (TNF-alpha). Approximately 20% of patients fail to respond to TNF-alpha antagonism, however, and a significant number of additional patients become refractory to anti-TNF-alpha therapy over time. Thus investigators have sought to target other pathogenic elements of RA using novel biological therapies. Abatacept is the first immunotherapy directed against the process of T-cell costimulation. Abatacept has shown clinical effectiveness in RA by improving disease activity, quality of life measures and radiographic progression of disease. In this article, we review the immunology of T-cell activation and costimulation, define the role of Abatacept in this process, and discuss the clinical trials that led to the approval of Abatacept as the latest biological therapy in RA in the USA and Canada. We also address the role of Abatacept in the greater context of biological therapy for RA.