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M Dougados - One of the best experts on this subject based on the ideXlab platform.

  • evaluation of whether extremely high enthesitis or bath ankylosing spondylitis disease activity index BASDAI scores suggest fibromyalgia and confound the anti tnf response in early non radiographic axial spondyloarthritis
    Clinical and Experimental Rheumatology, 2017
    Co-Authors: M Dougados, I Logeart, A Szumski, Javier Coindreau, H Jones
    Abstract:

    OBJECTIVES Differentiating between pain from spondyloarthritis (SpA) and pain from fibromyalgia is challenging. We evaluated patients with non-radiographic axial SpA (nr-axSpA) to determine the percentage of patients with extremely high enthesitis and/or Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores, the relationship between extreme scores and depression, and the effect of extreme scores on treatment outcomes with etanercept. METHODS Patients with nr-axSpA received double-blind etanercept 50 mg or placebo weekly and were divided into those who did vs did not have extreme scores at baseline. Extreme scores were defined as the highest quintile for enthesitis score (≥6), and/or scores ≥8 on three of five BASDAI items (excluding morning stiffness duration). Depression was assessed with the Hospital Anxiety and Depression Scale, depression subscale (HADS-D) and medication use. Week 12 outcomes included Assessment of SpondyloArthritis (ASAS) 40 and ASAS partial remission. RESULTS At baseline, 35/213 (16.4%) patients met extreme enthesitis criteria, 31 (14.6%) met extreme BASDAI criteria, 12 (5.6%) met both, and 135 (63.4%) met neither. More patients with extreme scores than without met the HADS-D definition of depression: 35/68 (51.5%) vs. 27/118 (22.9%), p<0.0001. For patients with vs. without extreme scores who received etanercept, no significant difference existed in week 12 ASAS 40: 13/41 (31.7%) vs. 21/60 (35.0%), respectively, or ASAS partial remission: 8/41 (19.5%) vs. 19/60 (31.7%). CONCLUSIONS Extreme enthesitis and/or BASDAI scores were associated with measurements of depression, but did not affect week 12 ASAS 40 or ASAS partial remission.

  • effect of secukinumab on patient reported outcomes in patients with active ankylosing spondylitis a phase iii randomized trial measure 1
    Arthritis & Rheumatism, 2016
    Co-Authors: Atul Deodhar, M Dougados, H Richards, Piet Geusens, James Chengchung Wei, Dominique Baeten, Ruvie Martin, Aimee Readie, Brian Porter
    Abstract:

    Objective To evaluate the effect of secukinumab (interleukin-17A inhibitor) on patient-reported outcomes in patients with active ankylosing spondylitis (AS). Methods In this phase III study, 371 patients were randomized (1:1:1) to receive intravenous (IV) secukinumab 10 mg/kg at baseline and weeks 2 and 4 followed by subcutaneous (SC) secukinumab 150 mg every 4 weeks (IV→150 mg group), or SC secukinumab 75 mg every 4 weeks (IV→75 mg group), or placebo. Patient-reported outcomes included the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), BASDAI criteria for 50% improvement (BASDAI 50), Short Form 36 (SF-36) physical component summary (PCS) score and mental component summary (MCS) score, Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire, Bath Ankylosing Spondylitis Functional Index (BASFI), EuroQol 5-domain (EQ-5D) questionnaire, Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F), and Work Productivity and Activity Impairment–General Health questionnaire (WPAI-GH). Results At week 16, secukinumab IV→150 mg or IV→75 mg was associated with statistically and clinically significant improvements from baseline versus placebo in the BASDAI (−2.3 for both regimens versus −0.6; P < 0.0001 and P < 0.001, respectively), SF-36 PCS (5.6 for both regimens versus 1.0; P < 0.0001 and P < 0.001, respectively), and ASQoL (−3.6 for both regimens versus −1.0; P < 0.0001 and P < 0.001, respectively). Clinically significant improvements in the SF-36 MCS, BASFI, EQ-5D, and BASDAI 50 were observed with both secukinumab groups versus placebo at week 16; improvements were also observed in the FACIT-F and WPAI-GH. All improvements were sustained through week 52. Conclusion Our findings indicate that secukinumab provides significant and sustained improvements in patient-reported disease activity and health-related quality of life, and reduces functional impairment, fatigue, and impact of disease on work productivity in patients with active AS.

  • thu0385 patient and physician agreement in all bath ankylosing spondylitis disease activity index questions is excellent except for enthesitis
    Annals of the Rheumatic Diseases, 2016
    Co-Authors: L Ghukasyan, A Moltό, A Etcheto, M Dougados
    Abstract:

    Background The BASDAI is a validated and widely used instrument to assess disease activity in SpA. Despite being a self-administered questionnaire, in daily practice, physicians often ask the questions themselves to the patients. To the authors best knowledge no data has been reported evaluating the agreement between patient and physician for the BASDAI. Objectives To assess the agreement between patients and physicians reported BASDAI in axial SpA patients in daily practice. Methods Patients with axial SpA according to the treating rheumatologist were included. First, patients were asked to fill out the BASDAI questionnaire in the waiting room. Thereafter, and being unaware of the results reported by the patients, the rheumatologist collected another BASDAI by reading out loud the questions to the patient and giving explanations if needed. Agreement for the total score and for each question was calculated by the intraclass correlation coefficient and its 95%CI. Evaluation of the agreement for the axial BASDAI (i.e. removing questions 3 and 4) was performed identically. Results Fifty patients were included, aged 44 (±10) y and 32 (64%) males. Mean disease duration was 15 (±10) y and among them 34 (69,4%) had a radiographic sacroiliitis. Agreement between patient and physician was excellent both for the BASDAI and axial BASDAI: ICC 0.91 [95% CI, 0.84–0.95] and ICC 0.94 [95% CI, 0.90–0.97], respectively. The lowest agreement was found for question 4 (i.e. referring to enthesitis) with an ICC [95%CI] =0.51 [0.28 – 0.69]. Conclusions An excellent agreement was found between patients and physicians for the BASDAI and its axial version. However, the question for enthesitis yielded only a moderate agreement, even in a group of patients with long-standing disease, and therefore used to fill this questionnaire. This should encourage physicians to use BASDAI as a self-administered questionnaire. Acknowledgement This research was conducted while the first author Liana Ghukasyan was an ARTICULUM Fellow. Disclosure of Interest None declared

  • discriminant capacity of clinical efficacy and nonsteroidal antiinflammatory drug sparing endpoints alone or in combination in axial spondyloarthritis
    The Journal of Rheumatology, 2015
    Co-Authors: M Dougados, Emily Wood, L Gossec, Arnaud Dubanchet, Isabelle Logeart, Desiree Van Der Heijde
    Abstract:

    Objective. Using data from a randomized, double-blind, placebo-controlled study, we assessed the capacity of clinical and nonsteroidal antiinflammatory drug (NSAID)-sparing endpoints, alone and in combination, to discriminate between treatment effects in axial spondyloarthritis (axSpA). Methods. Patients with active NSAID-resistant axSpA received etanercept (ETN) 50 mg/week or placebo for 8 weeks and tapered/discontinued NSAID. In posthoc logistic regression analyses, OR were calculated that indicated the capacity of the following endpoints to discriminate between the effects of ETN and placebo at Week 8: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50; BASDAI ≤ 3; Assessment of Spondyloarthritis international Society (ASAS) 20; ASAS40; Ankylosing Spondylitis Disease Activity Score (ASDAS) with C-reactive protein (CRP) < 1.3 and ASDAS-CRP < 2.1; ≥ 50% decrease from baseline in ASAS-NSAID score, score < 10, and score = 0; and each clinical and/or each NSAID measure. Results. In 90 randomized patients (ETN, n = 42; placebo, n = 48), disease activity was similar between groups at baseline: mean (± SD) BASDAI (ETN vs placebo) 6.0 ± 1.6 versus 5.9 ± 1.5. NSAID intake was high: ASAS-NSAID score 98.2 ± 39.0 versus 93.0 ± 23.4. OR ranged from 1.6 (95% CI 0.5–5.4) for ASDAS-CRP < 1.3 to 5.8 (95% CI 1.2–29.1) for BASDAI50 and NSAID score of 0; most measures (34/45) reached statistical significance (α = 0.05) favoring ETN. Most combined outcome variables using OR were more discriminant than single outcome measures. Conclusion. These findings suggest that changes in NSAID intake during treatment do not prevent demonstration of clinically relevant effects of biologic treatment, and combined (i.e., clinical with NSAID-sparing) endpoints were frequently more discriminant than single (i.e., clinical) endpoints. [ClinicalTrials.gov][1] ([NCT01298531][2]). [1]: http://ClinicalTrials.gov [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01298531&atom=%2Fjrheum%2F42%2F12%2F2361.atom

  • higher disease activity leads to more structural damage in the spine in ankylosing spondylitis 12 year longitudinal data from the oasis cohort
    Annals of the Rheumatic Diseases, 2014
    Co-Authors: Sofia Ramiro, Desiree Van Der Heijde, M Dougados, Astrid Van Tubergen, C Stolwijk, Filip Van Den Bosch, R Landewe
    Abstract:

    Objectives To analyse the long-term relationship between disease activity and radiographic damage in the spine in patients with ankylosing spondylitis (AS). Methods Patients from the Outcome in AS International Study (OASIS) were followed up for 12 years, with 2-yearly clinical and radiographic assessments. Two readers independently scored the X-rays according to the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). Disease activity measures include the Bath AS Disease Activity Index (BASDAI), AS Disease Activity Index (ASDAS)-C-reactive protein (CRP), CRP, erythrocyte sedimentation rate (ESR), patient’s global assessment and spinal pain. The relationship between disease activity measures and radiographic damage was investigated using longitudinal, autoregressive models with 2-year time lags. Results 184 patients were included (70% males, 83% HLA-B27 positive, mean (SD) age 43 (12) years, 20 (12) years symptom duration). Disease activity measures were significantly longitudinally associated with radiographic progression. Neither medication nor the presence of extraarticular manifestations confounded this relationship. The models with ASDAS as disease activity measure fitted the data better than models with BASDAI, CRP or BASDAI +CRP. An increase of one ASDAS unit led to an increase of 0.72 mSASSS units/2 years. A ‘very high disease activity state’ (ie, ASDAS >3.5) compared with ‘inactive disease’ (ie, ASDAS <1.3) resulted in an additional 2-year progression of 2.31 mSASSS units. The effect of ASDAS on mSASSS was higher in males versus females (0.98 vs −0.06 mSASSS units per ASDAS unit) and in patients with <18 years vs ≥18 years symptom duration (0.84 vs 0.16 mSASSS units per ASDAS unit). Conclusions This is the first study showing that disease activity contributes longitudinally to radiographic progression in the spine in AS. This effect is more pronounced in men and in the earlier phases of the disease.

D Van Der Heijde - One of the best experts on this subject based on the ideXlab platform.

  • physical function in ankylosing spondylitis is independently determined by both disease activity and radiographic damage of the spine
    Annals of the Rheumatic Diseases, 2009
    Co-Authors: R Landewe, M Dougados, H Mielants, H Van Der Tempel, D Van Der Heijde
    Abstract:

    Aim: To study the relationship between disease activity, radiographic damage and physical function in patients with ankylosing spondylitis (AS) Patients and methods: Baseline and 2-year data of the Outcome in Ankylosing Spondylitis International Study (OASIS)(217 patients) were used. Physical function was expressed by the Bath Ankylosing Spondylitis Functional Index (BASFI) and the Dougados Functional Index (DFI); disease activity by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and by erythrocyte sedimentation rate and C-reactive protein; and structural damage by the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). Syndesmophyte- and non-syndesmophyte sum cores, and numbers of affected (bridged) vertebral units were derived from the mSASSS. Univariate correlations were calculated on baseline values using the Spearman rank correlation. Multivariate associations were investigated by generalised estimating equations (GEE) on baseline and 2-year data. Results: mSASSS correlated moderately well with BASFI (Spearman’s r = 0.45) and DFI (r = 0.38). BASDAI correlated well with BASFI (r = 0.66) and DFI (r = 0.59). Correlation coefficients for mSASSS versus BASFI and DFI decreased by increasing levels of BASDAI, being zero at the highest quintile of BASDAI. GEE showed that both BASDAI and mSASSS independently and significantly helped to explain either BASFI or DFI. Results were similar for syndesmophyte sum score, non-syndesmophyte sum score, number of affected VUs or number of VUs with bridging. The lumbar part of the mSASSS contributed similarly to the cervical part in explaining BASFI/DFI. Conclusion: Physical function impairment in AS is independently caused by patient-reported disease activity and the level of structural damage of the lumbar and cervical spine. Syndesmophytes and other radiographic abnormalities contribute to physical function impairment.

  • first update of the international asas consensus statement for the use of anti tnf agents in patients with ankylosing spondylitis
    Annals of the Rheumatic Diseases, 2006
    Co-Authors: J Braun, M Dougados, J Sieper, John C Davis, S Van Der Linden, D Van Der Heijde
    Abstract:

    Objective: To update the international recommendations for use of anti-tumour necrosis factor (TNF) agents in the treatment of ankylosing spondylitis. Methods: The published recommendations on anti-TNF treatment in ankylosing spondylitis formed the basis of the update. A questionnaire was sent to the ASAS (assessment in ankylosing spondylitis) members before the final decisions were agreed upon at an international meeting of the ASAS working group. Results: Only minor changes to the original consensus statement were required. For the initiation of anti-TNF treatment, there should be: a diagnosis of definitive ankylosing spondylitis (normally based on modified New York criteria); active disease for at least four weeks, as defined by a sustained Bath ankylosing spondylitis disease activity index (BASDAI) of ⩾4 on a 0–10 scale and expert opinion based on clinical findings; refractory disease, defined by failure of at least two non-steroidal anti-inflammatory drugs during a three month period, failure of intra-articular steroids (if indicated), and failure of sulfasalazine in patients with predominantly peripheral arthritis; and application of the usual precautions and contraindications for biological treatment. For monitoring anti-TNF treatment: both the ASAS core set for clinical practice and the BASDAI should be followed after the initiation of treatment. Discontinuation of anti-TNF treatment in non-responders should be considered after 6–12 weeks. Response is defined by improvement of at least 50% or 2 units (on a 0–10 scale) of the BASDAI. Conclusions: This updated consensus statement is recommended in guiding clinical practice and as a basis for developing national guidelines. Evaluation and regular update of this consensus statement is subject to further research by the ASAS group.

  • international asas consensus statement for the use of anti tumour necrosis factor agents in patients with ankylosing spondylitis
    Annals of the Rheumatic Diseases, 2003
    Co-Authors: J Braun, M Dougados, J Sieper, John C Davis, S Van Der Linden, T Pham, D Van Der Heijde
    Abstract:

    Objective: To obtain an international consensus about the use of anti-tumour necrosis factor α (anti-TNFα) for treating patients with ankylosing spondylitis (AS). Methods: These recommendations were developed by a review of published reports in combination with expert opinion, including a Delphi exercise, and a consensus meeting of the ASsessments in AS (ASAS) Working Group. Results: The final consensus comprises the following requirements: (1) For the initiation of anti-TNFα therapy: ( a ) a diagnosis of definitive AS; ( b ) presence of active disease for at least four weeks as defined by both a sustained Bath AS Disease Activity Index (BASDAI) of at least 4 and an expert opinion based on clinical features, acute phase reactants, and imaging modalities; ( c ) presence of refractory disease defined by failure of at least two non-steroidal anti-inflammatory drugs during a single three month period, failure of intra-articular steroids if indicated, and failure of sulfasalazine in patients with peripheral arthritis; ( d ) application and implementation of the usual precautions and contraindications for biological therapy. (2) For the monitoring of anti-TNFα therapy: both the BASDAI and the ASAS core set for clinical practice should be followed regularly. (3) For the discontinuation of anti-TNFα therapy: in non-responders, consideration should be made after 6–12 weeks’ treatment. Response is defined as improvement of ( a ) at least 50% or 2 units (on a 0–10 scale) of the BASDAI, ( b ) expert opinion that treatment should be continued. Conclusion: This consensus statement on anti-TNFα treatment in AS may be used for guidance in clinical decision making and as the basis for the development of guidelines. Evaluation of the healthcare consequences of this consensus is subject to further research by the ASAS group.

  • assessment of enthesitis in ankylosing spondylitis
    Annals of the Rheumatic Diseases, 2003
    Co-Authors: L Heuftdorenbosch, M Dougados, R Landewe, H Mielants, H Van Der Tempel, Astrid Van Tubergen, A Spoorenberg, D Van Der Heijde
    Abstract:

    Objective: To assess, firstly, the validity of the enthesis index published by Mander (Mander enthesis index (MEI)) and, secondly, to investigate whether it is possible to define a new enthesis index that is less time consuming to perform with at least similar or better properties. Methods: Data from the OASIS cohort, an international, longitudinal, observational study on outcome in ankylosing spondylitis, were used. In this study, measures of disease activity, including the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the MEI, were assessed regularly in 217 patients. With the MEI, for each measurement period independently, a process of data reduction was performed to identify the entheses most commonly reported as painful by the patients. A more concise enthesis index was constructed with aid of the entheses found in this way. Correlations with measures of disease activity were used to test the validity of several entheses indices. Results: Reduction of the number of entheses from 66 to 13 and omitting grading of the intensity of pain resulted in an index which was named the “Maastricht Ankylosing Spondylitis Enthesitis Score” (MASES). The MASES (range 0–13) has much greater feasibility than the MEI (range 0–90). However, up to 21% of patients with a score >0 on the MEI were not identified by a score on the MASES >0. Only 2.1% of the patients with an original enthesis score >0 had an original score on the MEI >3 (range 0–90) and it can be questioned whether a low score on the MEI index represents clinically important enthesitis. The Spearman correlation coefficient between the MASES score and the MEI was 0.90 and between the MASES and the BASDAI was 0.53 compared with a correlation of 0.59 between the MEI and the BASDAI. Conclusions: MASES seems to be a good alternative to the MEI with much better feasibility.

P. J. Mease - One of the best experts on this subject based on the ideXlab platform.

  • Efficacy of guselkumab on axial involvement in patients with active psoriatic arthritis and sacroiliitis: a post-hoc analysis of the phase 3 DISCOVER-1 and DISCOVER-2 studies
    'Elsevier BV', 2021
    Co-Authors: P. J. Mease, Ps Helliwell, Dd Gladman, Poddubnyy D, Baraliakos X, Sd Chakravarty, Ap Kollmeier, Ec Hsia, Sheng S
    Abstract:

    Background Guselkumab was efficacious in reducing signs and symptoms of psoriatic arthritis in the phase 3 DISCOVER-1 and DISCOVER-2 studies. We aimed to evaluate the efficacy of guselkumab in post-hoc analyses of patients with psoriatic arthritis with imaging-confirmed sacroiliitis consistent with axial involvement. Methods In DISCOVER-1, 381 patients with active psoriatic arthritis (defined as ≥3 swollen joints, ≥3 tender joints, and C-reactive protein [CRP] ≥0·3 mg/dL) and in DISCOVER-2, 739 patients with active psoriatic arthritis (defined as ≥5 swollen joints, ≥5 tender joints, and CRP ≥0·6 mg/dL) were randomly allocated to receive guselkumab 100 mg every 4 weeks, guselkumab 100 mg every 8 weeks (week 0, week 4, then every 8 weeks), or placebo. These pooled, post-hoc analyses included patients with axial disease documented by previous imaging or pelvic radiography at screening consistent with sacroiliitis (confirmed by investigator). Efficacy assessments included least squares mean changes, with 95% CIs, in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score, modified BASDAI (mBASDAI; excluding peripheral joint pain), spinal pain, and Ankylosing Spondylitis Disease Activity Score (ASDAS), and proportions of patients achieving at least a 50% improvement in BASDAI score (BASDAI50) and achieving ASDAS responses of inactive disease (score

  • op0054 efficacy of guselkumab a monoclonal antibody that specifically binds to the p19 subunit of il 23 on endpoints related to axial involvement in patients with active psa with imaging confirmed sacroiliitis week 24 results from two phase 3 randomized double blind placebo controlled studies
    Annals of the Rheumatic Diseases, 2020
    Co-Authors: P Helliwell, P. J. Mease, Dd Gladman, Denis Poddubnyy, Xenofon Baraliakos, Elizabeth C Hsia, A Kollmeier, S Sheng, Prasheen Agarwal
    Abstract:

    Background: Guselkumab (GUS), an interleukin-23 inhibitor, was efficacious in reducing signs and symptoms of active psoriatic arthritis (PsA) in patients (pts) in two phase 3 trials (DISCOVER-1 and DISCOVER-2). Objectives: To evaluate the efficacy of GUS in PsA pts with imaging-confirmed axial involvement consistent with sacroiliitis in DISCOVER-1&2. Methods: In DISCOVER-1, 381 pts with active PsA (≥ 3 swollen joints, ≥ 3 tender joints; C-reactive protein ≥ 0.3mg/dL despite standard therapies) and in DISCOVER-2, 739 pts with active PsA (≥ 5 swollen joints, ≥ 5 tender joints, CRP ≥ 0.6mg/dL despite standard therapies) were randomized 1:1:1 to GUS 100mg Q4W, GUS 100mg Q8W (Wk0, Wk4, then Q8W), or PBO. This analysis included pts with sacroiliitis at baseline who had either documented imaging confirmation of sacroiliitis in the past or pelvic X-ray confirmation of sacroiliitis at screening (pooled data from DISCOVER-1&2) based on investigators’ judgment of presence/absence of sacroiliitis. Efficacy was assessed by BASDAI score, BASDAI50, modified BASDAI (mBASDAI; excludes Q#3), spinal pain (BASDAI Q#2), ASDAS-CRP score, and ASDAS responses of inactive disease ( Results: 312 pts presented with axial involvement (PBO, n= 118; GUS q8w, n = 91; GUS q4w, n = 103). The LS mean changes from baseline to wk24 in BASDAI, spinal pain, mBASDAI, and ASDAS-CRP were greater in the two GUS groups vs PBO (Table). Greater proportions of GUS-treated pts achieved BASDAI50 (Table) and ASDAS responses of inactive disease, major improvement, and clinically important improvement (Figure) at wk24 vs PBO. Conclusion: GUS improved axial symptoms over 24 weeks in active PsA patients with imaging-confirmed sacroiliitis. Acknowledgments: None Disclosure of Interests: Philip Helliwell: None declared, Dafna D Gladman Grant/research support from: AbbVie, Amgen Inc., BMS, Celgene Corporation, Janssen, Novartis, Pfizer, UCB – grant/research support, Consultant of: AbbVie, Amgen Inc., BMS, Celgene Corporation, Janssen, Novartis, Pfizer, UCB – consultant, Denis Poddubnyy Grant/research support from: AbbVie, MSD, Novartis, and Pfizer, Consultant of: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, MSD, Novartis, Pfizer, Roche, UCB, Philip J Mease Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Janssen, Eli Lilly, Novartis, Pfizer, Sun Pharma, UCB Pharma, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Galapagos, Gilead, Novartis, Pfizer, Sun Pharma, UCB Pharma, Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, Janssen, Novartis, Pfizer, UCB Pharma, Xenofon Baraliakos Grant/research support from: Grant/research support from: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Consultant of: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Alexa Kollmeier Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Elizabeth C Hsia Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Xie L Xu Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Shihong Sheng Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Prasheen Agarwal Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Bei Zhou Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Soumya D Chakravarty Shareholder of: Johnson & Johnson, Employee of: Janssen Scientific Affairs, LLC, May Shawi Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Chetan Karyekar Shareholder of: Johnson & Johnson, Consultant of: Janssen, Employee of: Janssen Global Services, LLC. Previously, Novartis, Bristol-Myers Squibb, and Abbott Labs., Atul Deodhar Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Desiree van der Heijde Consultant of: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Eli-Lilly, Galapagos, Gilead Sciences, Inc., Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology BV

  • fri0512 apremilast an oral phosphodiesterase 4 inhibitor is associated with long term 156 week improvements in BASDAI in psoriatic arthritis patients pooled results from 3 phase iii randomized controlled trials
    Annals of the Rheumatic Diseases, 2017
    Co-Authors: P. J. Mease, Helena Marzoortega, Airi Poder, F Van Den Bosch, J Wollenhaupt, Eric Lespessailles, M Mcilraith, L Teng, Stephen Hall
    Abstract:

    Background In PALACE psoriatic arthritis (PsA) studies, the Bath Ankylosing Spondylitis Disease Activity Index score (BASDAI) was used as an exploratory measure in a subset of patients (pts) considered by investigators to have axial involvement, although PsA spondylitis was not confirmed by imaging. Objectives Report the impact of apremilast 30 mg BID (APR) treatment on BASDAI over 156 wks using pooled PALACE 1–3 data of pts with active PsA despite prior conventional DMARDs and/or biologics. Methods APR treatment outcomes were evaluated in a subset of pts with baseline (BL) BASDAI ≥4 (“subset”) over 156 wks. Results BL BASDAI ≥4 was reported for 454/1493 (30%) pts. Mean PsA duration was similar between the subset and rest of the PALACE 1–3 population (n=1039); mean BL psoriasis body surface area (BSA) and percentage of pts with BSA ≥3% were slightly higher. The subset had higher mean BL values vs the rest of PALACE 1–3 pts for C-reactive protein (1.12 vs 0.93), pain VAS (63.6 vs 53.8 mm), pt9s global assessment of disease activity (62.2 vs 53.5 mm), and physician9s global assessment of disease activity (PhGA; 59.0 vs 53.0 mm) and markedly worse mean HAQ-DI (1.41 vs 1.08), SF-36v2 Physical Functioning (30.6 vs 35.8), and FACIT-F (25.7 vs 31.8) scores. Despite disease activity differences, BL concomitant oral DMARDs were similar in both groups: 1 DMARD in 61.0% (subset) vs 57.8% (rest of PALACE 1–3 pts); methotrexate was the most common DMARD. In the subset, 73.6% had been treated with only oral DMARDs prestudy (44.9% with only 1); 25.1% had prior biologic use. Mean BL BASDAI in the subset was 6.6 with APR and 6.4 with placebo (PBO). Mean BL BASDAI question 2 score, referring directly to spinal and hip pain, was 6.7. APR resulted in greater mean improvement in BASDAI vs PBO at Wk 16 (−1.53 vs −0.91; P=0.0173) and Wk 24 (Table). As early as Wk 16, a 19% mean decrease in the question 2 score was seen with APR vs an increase with PBO. Other disease measures significantly improved early in treatment, including HAQ-DI, fatigue, PhGA, and mPsARC (Table). Long-term improvement was seen across measures, with mean BASDAI reductions of 2.18 at Wk 52 and 2.19 at Wk 156 (Table) and question 2 reductions of 1.94 and 2.28, respectively; treatment resulted in a shift toward lower BASDAI across the subset, with a significant proportion reaching BASDAI Conclusions In this post hoc analysis of pooled data, pts reporting BASDAI ≥4 at BL appear to experience greater disease burden, including disability, pain, and fatigue; effective treatment strategies may not have been available. APR treatment resulted in long-term improvements in BASDAI and other measures in pts with clinically suspected axial disease. Disclosure of Interest P. Mease Grant/research support from: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Genentech, Janssen, Eli Lilly, Novartis, Pfizer, Roche, UCB, Consultant for: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Genentech, Janssen, Eli Lilly, Novartis, Pfizer, Roche, UCB, Speakers bureau: Abbott, Amgen, Biogen Idec, BMS, Genentech, Janssen, Eli Lilly, Pfizer, UCB, H. Marzo-Ortega: None declared, A. Poder: None declared, F. Van den Bosch Consultant for: AbbVie, Celgene Corporation, Merck, Pfizer, UCB, Janssen, J. Wollenhaupt Grant/research support from: Abbott, BMS, MSD, Pfizer, UCB, Consultant for: Abbott, BMS, MSD, Pfizer, UCB, E. Lespessailles Grant/research support from: Amgen, Eli Lilly, Novartis, Servier, Speakers bureau: Amgen, Eli Lilly, Novartis, Servier, M. McIlraith Employee of: Celgene Corporation, L. Teng Employee of: Celgene Corporation, S. Hall Consultant for: Boehringer Ingelheim, MSD, Roche, Schering-Plough, Servier, Wyeth, Paid instructor for: Amgen, AstraZeneca, Boehringer Ingelheim, Centocor, GSK, MSD, Pfizer, Sanofi Aventis, Sanofi Pasteur, Schering-Plough, Serono, Wyeth, Speakers bureau: Boehringer Ingelheim, GSK, MSD, Pfizer, Roche, Sanofi Aventis, Schering-Plough, Wyeth

  • thu0420 apremilast an oral phosphodiesterase 4 inhibitor is associated with long term 52 week improvements in BASDAI in patients with psoriatic arthritis pooled results from 3 phase iii randomized controlled trials
    Annals of the Rheumatic Diseases, 2016
    Co-Authors: P. J. Mease, Helena Marzoortega, Airi Poder, F Van Den Bosch, J Wollenhaupt, Eric Lespessailles, M Mcilraith, L Teng, Stephen Hall
    Abstract:

    Background In the PALACE psoriatic arthritis (PsA) trials, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score was obtained as an exploratory measure in a subset of patients (pts) considered by investigators to have axial involvement, although PsA spondylitis was not confirmed by more objective measures such as MRI. Objectives Assess the impact of apremilast 30 mg BID (APR) on BASDAI over 52 wks using PALACE 1 (NCT01172938), 2 (NCT01212757), and 3 (NCT01212770) pooled data of pts with active PsA despite prior conventional DMARDs and/or biologics. Methods APR was evaluated in a subset of pts with baseline (BL) BASDAI ≥4 (“subset”) over 16, 24, and 52 wks. Results BL BASDAI ≥4 was reported in 454/1493 (30%) pts. Mean PsA duration was similar between the subset and the rest of the PALACE 1–3 population (BL BASDAI Conclusions In this post-hoc analysis, pts reporting BASDAI ≥4 appear to have added disease burden, with greater disability, pain, fatigue, and global disease ratings; this may not be captured by some disease activity measures, and effective treatment strategies may not have been available. APR resulted in long-term improvements in BASDAI scores and other measures. Further evaluation objectively assessing presence of inflammatory spine disease in PsA and its response to APR is warranted. Disclosure of Interest P. Mease Grant/research support from: AbbVie Amgen, BiodenIdec, Bristol-Myers Squibb, Celgene, Genentech, Janssen, GlaxoSmithKline, Lilly, Merck, Novartix, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, BiogenIdec, Bristol-Myers Squibb, Genentech, Janssen GlaxoSmithKline, Lilly, Pfizer, UCB, H. Marzo-Ortega: None declared, A. Poder: None declared, F. Van den Bosch Grant/research support from: AbbVie, Celgene Corporation, Janssen, Merck, Pfizer Inc, UCB, J. Wollenhaupt Consultant for: Abbott Laboratories, Bristol-Myers Squibb, MSD, Pfizer, and UCB, E. Lespessailles Grant/research support from: Novartis, Lilly, Servier, Amgen; Speaker9s Bureau: Novartis and Lilly, M. McIlraith Employee of: Celgene Corporation, L. Teng Employee of: Celgene Corporation, S. Hall Grant/research support from: Amgen, AstraZeneca, Boehringer Ingelheim, Centocor, GlaxoSmithKline, MSD, Pfizer, Sanofi Aventis, Sanofi Pasteur, Schering-Plough, Serono, and Wyeth, Speakers bureau: Boehringer Ingelheim, GlaxoSmithKline, MSD, Pfizer, Roche, Sanofi Aventis, Schering-Plough, and Wyeth

  • efficacy and safety of adalimumab in patients with non radiographic axial spondyloarthritis results of a randomised placebo controlled trial ability 1
    Annals of the Rheumatic Diseases, 2013
    Co-Authors: Joachim Sieper, P. J. Mease, Desiree Van Der Heijde, M Dougados, Walter P Maksymowych, Matthew A Brown, Vipin Arora, Aileen L Pangan
    Abstract:

    Purpose To evaluate the efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis (nr-axSpA). Methods Patients fulfilled Assessment of Spondyloarthritis international Society (ASAS) criteria for axial spondyloarthritis, had a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ≥ 4, total back pain score of ≥ 4 (10 cm visual analogue scale) and inadequate response, intolerance or contraindication to non-steroidal anti-inflammatory drugs (NSAIDs); patients fulfilling modified New York criteria for ankylosing spondylitis were excluded. Patients were randomised to adalimumab (N=91) or placebo (N=94). The primary endpoint was the percentage of patients achieving ASAS40 at week 12. Efficacy assessments included BASDAI and Ankylosing Spondylitis Disease Activity Score (ASDAS). MRI was performed at baseline and week 12 and scored using the Spondyloarthritis Research Consortium of Canada (SPARCC) index. Results Significantly more patients in the adalimumab group achieved ASAS40 at week 12 compared with patients in the placebo group (36% vs 15%, p<0.001). Significant clinical improvements based on other ASAS responses, ASDAS and BASDAI were also detected at week 12 with adalimumab treatment, as were improvements in quality of life measures. Inflammation in the spine and sacroiliac joints on MRI significantly decreased after 12 weeks of adalimumab treatment. Shorter disease duration, younger age, elevated baseline C-reactive protein or higher SPARCC MRI sacroiliac joint scores were associated with better week 12 responses to adalimumab. The safety profile was consistent with what is known for adalimumab in ankylosing spondylitis and other diseases. Conclusions In patients with nr-axSpA, adalimumab treatment resulted in effective control of disease activity, decreased inflammation and improved quality of life compared with placebo. Results from ABILITY-1 suggest that adalimumab has a positive benefit–risk profile in active nr-axSpA patients with inadequate response to NSAIDs.

Stephen Hall - One of the best experts on this subject based on the ideXlab platform.

  • fri0512 apremilast an oral phosphodiesterase 4 inhibitor is associated with long term 156 week improvements in BASDAI in psoriatic arthritis patients pooled results from 3 phase iii randomized controlled trials
    Annals of the Rheumatic Diseases, 2017
    Co-Authors: P. J. Mease, Helena Marzoortega, Airi Poder, F Van Den Bosch, J Wollenhaupt, Eric Lespessailles, M Mcilraith, L Teng, Stephen Hall
    Abstract:

    Background In PALACE psoriatic arthritis (PsA) studies, the Bath Ankylosing Spondylitis Disease Activity Index score (BASDAI) was used as an exploratory measure in a subset of patients (pts) considered by investigators to have axial involvement, although PsA spondylitis was not confirmed by imaging. Objectives Report the impact of apremilast 30 mg BID (APR) treatment on BASDAI over 156 wks using pooled PALACE 1–3 data of pts with active PsA despite prior conventional DMARDs and/or biologics. Methods APR treatment outcomes were evaluated in a subset of pts with baseline (BL) BASDAI ≥4 (“subset”) over 156 wks. Results BL BASDAI ≥4 was reported for 454/1493 (30%) pts. Mean PsA duration was similar between the subset and rest of the PALACE 1–3 population (n=1039); mean BL psoriasis body surface area (BSA) and percentage of pts with BSA ≥3% were slightly higher. The subset had higher mean BL values vs the rest of PALACE 1–3 pts for C-reactive protein (1.12 vs 0.93), pain VAS (63.6 vs 53.8 mm), pt9s global assessment of disease activity (62.2 vs 53.5 mm), and physician9s global assessment of disease activity (PhGA; 59.0 vs 53.0 mm) and markedly worse mean HAQ-DI (1.41 vs 1.08), SF-36v2 Physical Functioning (30.6 vs 35.8), and FACIT-F (25.7 vs 31.8) scores. Despite disease activity differences, BL concomitant oral DMARDs were similar in both groups: 1 DMARD in 61.0% (subset) vs 57.8% (rest of PALACE 1–3 pts); methotrexate was the most common DMARD. In the subset, 73.6% had been treated with only oral DMARDs prestudy (44.9% with only 1); 25.1% had prior biologic use. Mean BL BASDAI in the subset was 6.6 with APR and 6.4 with placebo (PBO). Mean BL BASDAI question 2 score, referring directly to spinal and hip pain, was 6.7. APR resulted in greater mean improvement in BASDAI vs PBO at Wk 16 (−1.53 vs −0.91; P=0.0173) and Wk 24 (Table). As early as Wk 16, a 19% mean decrease in the question 2 score was seen with APR vs an increase with PBO. Other disease measures significantly improved early in treatment, including HAQ-DI, fatigue, PhGA, and mPsARC (Table). Long-term improvement was seen across measures, with mean BASDAI reductions of 2.18 at Wk 52 and 2.19 at Wk 156 (Table) and question 2 reductions of 1.94 and 2.28, respectively; treatment resulted in a shift toward lower BASDAI across the subset, with a significant proportion reaching BASDAI Conclusions In this post hoc analysis of pooled data, pts reporting BASDAI ≥4 at BL appear to experience greater disease burden, including disability, pain, and fatigue; effective treatment strategies may not have been available. APR treatment resulted in long-term improvements in BASDAI and other measures in pts with clinically suspected axial disease. Disclosure of Interest P. Mease Grant/research support from: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Genentech, Janssen, Eli Lilly, Novartis, Pfizer, Roche, UCB, Consultant for: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Genentech, Janssen, Eli Lilly, Novartis, Pfizer, Roche, UCB, Speakers bureau: Abbott, Amgen, Biogen Idec, BMS, Genentech, Janssen, Eli Lilly, Pfizer, UCB, H. Marzo-Ortega: None declared, A. Poder: None declared, F. Van den Bosch Consultant for: AbbVie, Celgene Corporation, Merck, Pfizer, UCB, Janssen, J. Wollenhaupt Grant/research support from: Abbott, BMS, MSD, Pfizer, UCB, Consultant for: Abbott, BMS, MSD, Pfizer, UCB, E. Lespessailles Grant/research support from: Amgen, Eli Lilly, Novartis, Servier, Speakers bureau: Amgen, Eli Lilly, Novartis, Servier, M. McIlraith Employee of: Celgene Corporation, L. Teng Employee of: Celgene Corporation, S. Hall Consultant for: Boehringer Ingelheim, MSD, Roche, Schering-Plough, Servier, Wyeth, Paid instructor for: Amgen, AstraZeneca, Boehringer Ingelheim, Centocor, GSK, MSD, Pfizer, Sanofi Aventis, Sanofi Pasteur, Schering-Plough, Serono, Wyeth, Speakers bureau: Boehringer Ingelheim, GSK, MSD, Pfizer, Roche, Sanofi Aventis, Schering-Plough, Wyeth

  • thu0420 apremilast an oral phosphodiesterase 4 inhibitor is associated with long term 52 week improvements in BASDAI in patients with psoriatic arthritis pooled results from 3 phase iii randomized controlled trials
    Annals of the Rheumatic Diseases, 2016
    Co-Authors: P. J. Mease, Helena Marzoortega, Airi Poder, F Van Den Bosch, J Wollenhaupt, Eric Lespessailles, M Mcilraith, L Teng, Stephen Hall
    Abstract:

    Background In the PALACE psoriatic arthritis (PsA) trials, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score was obtained as an exploratory measure in a subset of patients (pts) considered by investigators to have axial involvement, although PsA spondylitis was not confirmed by more objective measures such as MRI. Objectives Assess the impact of apremilast 30 mg BID (APR) on BASDAI over 52 wks using PALACE 1 (NCT01172938), 2 (NCT01212757), and 3 (NCT01212770) pooled data of pts with active PsA despite prior conventional DMARDs and/or biologics. Methods APR was evaluated in a subset of pts with baseline (BL) BASDAI ≥4 (“subset”) over 16, 24, and 52 wks. Results BL BASDAI ≥4 was reported in 454/1493 (30%) pts. Mean PsA duration was similar between the subset and the rest of the PALACE 1–3 population (BL BASDAI Conclusions In this post-hoc analysis, pts reporting BASDAI ≥4 appear to have added disease burden, with greater disability, pain, fatigue, and global disease ratings; this may not be captured by some disease activity measures, and effective treatment strategies may not have been available. APR resulted in long-term improvements in BASDAI scores and other measures. Further evaluation objectively assessing presence of inflammatory spine disease in PsA and its response to APR is warranted. Disclosure of Interest P. Mease Grant/research support from: AbbVie Amgen, BiodenIdec, Bristol-Myers Squibb, Celgene, Genentech, Janssen, GlaxoSmithKline, Lilly, Merck, Novartix, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, BiogenIdec, Bristol-Myers Squibb, Genentech, Janssen GlaxoSmithKline, Lilly, Pfizer, UCB, H. Marzo-Ortega: None declared, A. Poder: None declared, F. Van den Bosch Grant/research support from: AbbVie, Celgene Corporation, Janssen, Merck, Pfizer Inc, UCB, J. Wollenhaupt Consultant for: Abbott Laboratories, Bristol-Myers Squibb, MSD, Pfizer, and UCB, E. Lespessailles Grant/research support from: Novartis, Lilly, Servier, Amgen; Speaker9s Bureau: Novartis and Lilly, M. McIlraith Employee of: Celgene Corporation, L. Teng Employee of: Celgene Corporation, S. Hall Grant/research support from: Amgen, AstraZeneca, Boehringer Ingelheim, Centocor, GlaxoSmithKline, MSD, Pfizer, Sanofi Aventis, Sanofi Pasteur, Schering-Plough, Serono, and Wyeth, Speakers bureau: Boehringer Ingelheim, GlaxoSmithKline, MSD, Pfizer, Roche, Sanofi Aventis, Schering-Plough, and Wyeth

F Van Den Bosch - One of the best experts on this subject based on the ideXlab platform.

  • fri0512 apremilast an oral phosphodiesterase 4 inhibitor is associated with long term 156 week improvements in BASDAI in psoriatic arthritis patients pooled results from 3 phase iii randomized controlled trials
    Annals of the Rheumatic Diseases, 2017
    Co-Authors: P. J. Mease, Helena Marzoortega, Airi Poder, F Van Den Bosch, J Wollenhaupt, Eric Lespessailles, M Mcilraith, L Teng, Stephen Hall
    Abstract:

    Background In PALACE psoriatic arthritis (PsA) studies, the Bath Ankylosing Spondylitis Disease Activity Index score (BASDAI) was used as an exploratory measure in a subset of patients (pts) considered by investigators to have axial involvement, although PsA spondylitis was not confirmed by imaging. Objectives Report the impact of apremilast 30 mg BID (APR) treatment on BASDAI over 156 wks using pooled PALACE 1–3 data of pts with active PsA despite prior conventional DMARDs and/or biologics. Methods APR treatment outcomes were evaluated in a subset of pts with baseline (BL) BASDAI ≥4 (“subset”) over 156 wks. Results BL BASDAI ≥4 was reported for 454/1493 (30%) pts. Mean PsA duration was similar between the subset and rest of the PALACE 1–3 population (n=1039); mean BL psoriasis body surface area (BSA) and percentage of pts with BSA ≥3% were slightly higher. The subset had higher mean BL values vs the rest of PALACE 1–3 pts for C-reactive protein (1.12 vs 0.93), pain VAS (63.6 vs 53.8 mm), pt9s global assessment of disease activity (62.2 vs 53.5 mm), and physician9s global assessment of disease activity (PhGA; 59.0 vs 53.0 mm) and markedly worse mean HAQ-DI (1.41 vs 1.08), SF-36v2 Physical Functioning (30.6 vs 35.8), and FACIT-F (25.7 vs 31.8) scores. Despite disease activity differences, BL concomitant oral DMARDs were similar in both groups: 1 DMARD in 61.0% (subset) vs 57.8% (rest of PALACE 1–3 pts); methotrexate was the most common DMARD. In the subset, 73.6% had been treated with only oral DMARDs prestudy (44.9% with only 1); 25.1% had prior biologic use. Mean BL BASDAI in the subset was 6.6 with APR and 6.4 with placebo (PBO). Mean BL BASDAI question 2 score, referring directly to spinal and hip pain, was 6.7. APR resulted in greater mean improvement in BASDAI vs PBO at Wk 16 (−1.53 vs −0.91; P=0.0173) and Wk 24 (Table). As early as Wk 16, a 19% mean decrease in the question 2 score was seen with APR vs an increase with PBO. Other disease measures significantly improved early in treatment, including HAQ-DI, fatigue, PhGA, and mPsARC (Table). Long-term improvement was seen across measures, with mean BASDAI reductions of 2.18 at Wk 52 and 2.19 at Wk 156 (Table) and question 2 reductions of 1.94 and 2.28, respectively; treatment resulted in a shift toward lower BASDAI across the subset, with a significant proportion reaching BASDAI Conclusions In this post hoc analysis of pooled data, pts reporting BASDAI ≥4 at BL appear to experience greater disease burden, including disability, pain, and fatigue; effective treatment strategies may not have been available. APR treatment resulted in long-term improvements in BASDAI and other measures in pts with clinically suspected axial disease. Disclosure of Interest P. Mease Grant/research support from: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Genentech, Janssen, Eli Lilly, Novartis, Pfizer, Roche, UCB, Consultant for: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Genentech, Janssen, Eli Lilly, Novartis, Pfizer, Roche, UCB, Speakers bureau: Abbott, Amgen, Biogen Idec, BMS, Genentech, Janssen, Eli Lilly, Pfizer, UCB, H. Marzo-Ortega: None declared, A. Poder: None declared, F. Van den Bosch Consultant for: AbbVie, Celgene Corporation, Merck, Pfizer, UCB, Janssen, J. Wollenhaupt Grant/research support from: Abbott, BMS, MSD, Pfizer, UCB, Consultant for: Abbott, BMS, MSD, Pfizer, UCB, E. Lespessailles Grant/research support from: Amgen, Eli Lilly, Novartis, Servier, Speakers bureau: Amgen, Eli Lilly, Novartis, Servier, M. McIlraith Employee of: Celgene Corporation, L. Teng Employee of: Celgene Corporation, S. Hall Consultant for: Boehringer Ingelheim, MSD, Roche, Schering-Plough, Servier, Wyeth, Paid instructor for: Amgen, AstraZeneca, Boehringer Ingelheim, Centocor, GSK, MSD, Pfizer, Sanofi Aventis, Sanofi Pasteur, Schering-Plough, Serono, Wyeth, Speakers bureau: Boehringer Ingelheim, GSK, MSD, Pfizer, Roche, Sanofi Aventis, Schering-Plough, Wyeth

  • thu0420 apremilast an oral phosphodiesterase 4 inhibitor is associated with long term 52 week improvements in BASDAI in patients with psoriatic arthritis pooled results from 3 phase iii randomized controlled trials
    Annals of the Rheumatic Diseases, 2016
    Co-Authors: P. J. Mease, Helena Marzoortega, Airi Poder, F Van Den Bosch, J Wollenhaupt, Eric Lespessailles, M Mcilraith, L Teng, Stephen Hall
    Abstract:

    Background In the PALACE psoriatic arthritis (PsA) trials, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score was obtained as an exploratory measure in a subset of patients (pts) considered by investigators to have axial involvement, although PsA spondylitis was not confirmed by more objective measures such as MRI. Objectives Assess the impact of apremilast 30 mg BID (APR) on BASDAI over 52 wks using PALACE 1 (NCT01172938), 2 (NCT01212757), and 3 (NCT01212770) pooled data of pts with active PsA despite prior conventional DMARDs and/or biologics. Methods APR was evaluated in a subset of pts with baseline (BL) BASDAI ≥4 (“subset”) over 16, 24, and 52 wks. Results BL BASDAI ≥4 was reported in 454/1493 (30%) pts. Mean PsA duration was similar between the subset and the rest of the PALACE 1–3 population (BL BASDAI Conclusions In this post-hoc analysis, pts reporting BASDAI ≥4 appear to have added disease burden, with greater disability, pain, fatigue, and global disease ratings; this may not be captured by some disease activity measures, and effective treatment strategies may not have been available. APR resulted in long-term improvements in BASDAI scores and other measures. Further evaluation objectively assessing presence of inflammatory spine disease in PsA and its response to APR is warranted. Disclosure of Interest P. Mease Grant/research support from: AbbVie Amgen, BiodenIdec, Bristol-Myers Squibb, Celgene, Genentech, Janssen, GlaxoSmithKline, Lilly, Merck, Novartix, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, BiogenIdec, Bristol-Myers Squibb, Genentech, Janssen GlaxoSmithKline, Lilly, Pfizer, UCB, H. Marzo-Ortega: None declared, A. Poder: None declared, F. Van den Bosch Grant/research support from: AbbVie, Celgene Corporation, Janssen, Merck, Pfizer Inc, UCB, J. Wollenhaupt Consultant for: Abbott Laboratories, Bristol-Myers Squibb, MSD, Pfizer, and UCB, E. Lespessailles Grant/research support from: Novartis, Lilly, Servier, Amgen; Speaker9s Bureau: Novartis and Lilly, M. McIlraith Employee of: Celgene Corporation, L. Teng Employee of: Celgene Corporation, S. Hall Grant/research support from: Amgen, AstraZeneca, Boehringer Ingelheim, Centocor, GlaxoSmithKline, MSD, Pfizer, Sanofi Aventis, Sanofi Pasteur, Schering-Plough, Serono, and Wyeth, Speakers bureau: Boehringer Ingelheim, GlaxoSmithKline, MSD, Pfizer, Roche, Sanofi Aventis, Schering-Plough, and Wyeth

  • brief report six week treatment of axial spondyloarthritis patients with an optimal dose of nonsteroidal antiinflammatory drugs early response to treatment in signal intensity on magnetic resonance imaging of the sacroiliac joints
    Arthritis & Rheumatism, 2016
    Co-Authors: G Varkas, Lennart Jans, H Cypers, L Van Praet, Philippe Carron, Dirk Elewaut, F Van Den Bosch
    Abstract:

    Objective To evaluate the early effect of full-dose nonsteroidal antiinflammatory drugs (NSAIDs) on the extent and intensity of bone marrow edema of the sacroiliac (SI) joints on magnetic resonance imaging (MRI) in axial spondyloarthritis (SpA). Methods A single-center, 6-week study of a cohort of consecutive patients with clinically suspected axial SpA was conducted. A total of 117 patients were screened. Forty patients who were diagnosed as having axial SpA and had presented with a positive MRI of the SI joints as defined by the Assessment of SpondyloArthritis international Society (ASAS) criteria were considered for a followup MRI after 6 weeks of an optimal dose of NSAIDs. Twenty patients completed the study. Disease activity was monitored by determining the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score every 2 weeks and the Bath Ankylosing Spondylitis Functional Index score at baseline and week 6. NSAID intake was assessed by the ASAS NSAID index. Primary end points were improvement in bone marrow edema of the SI joints on MRI and BASDAI response at week 6. Results Approximately one-third of eligible patients newly diagnosed as having axial SpA were unable to continue the full-dose NSAID schedule. The median NSAID index was 97% in patients who completed the study. There was a reduction of 1.1 units (10.5%) in mean Spondyloarthritis Research Consortium of Canada (SPARCC) scores at week 6 in comparison to baseline (P = 0.032). Overall, only 30% of the patients (6 of 20) had a minimal clinically important difference of ≥2.5 in SPARCC score. However, 80% of the patients displayed high-intensity lesions on STIR images at baseline, which decreased significantly at week 6 (P = 0.011). There was a significant decrease in the relative intensity of the region of interest (P = 0.007) and a mean decrease of 0.6 in the BASDAI score per 2 weeks of therapy (P = 0.001). Only 29.4% of the patients met the BASDAI criteria for 50% improvement (BASDAI50) at week 6. Conclusion Our findings indicate a high level of dropout among patients receiving full-dose NSAID therapy in daily practice. In those who tolerated NSAID therapy, there was no clinically relevant decrease in SPARCC scores and low BASDAI50 response. However, we found a decrease in signal intensity of bone marrow edema of the SI joints as an early response to 6 weeks of optimal NSAID therapy in patients newly presenting with axial SpA.

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