Changes in patient characteristics in anti-tumour necrosis factor clinical trials for rheumatoid arthritis: results of an analysis of the literature over the past 16 years
Open Access
- 27 June 2011
- journal article
- review article
- Published by BMJ in Annals Of The Rheumatic Diseases
- Vol. 70 (9), 1631-1640
- https://doi.org/10.1136/ard.2010.146043
Abstract
Objective To evaluate changes in baseline patient characteristics and entry criteria of randomised, controlled studies of tumour necrosis factor alpha (TNFα) inhibitors in rheumatoid arthritis (RA) patients. Methods A systematic literature review was performed using predefined inclusion criteria to identify randomised, double-blind, controlled trials that evaluated TNFα inhibitors in adult RA patients. Entry criteria and baseline clinical characteristics were evaluated over time for methotrexate-experienced and methotrexate-naive study populations. Enrolment start date for each trial was the time metric. The anchor time was the study with the earliest identifiable enrolment start date. Results 44 primary publications (reporting the primary study endpoint) from 1993 to 2008 met the inclusion criteria. Enrolment start dates of August 1993 and May 1997 were identified as time anchors for the 37 methotrexate-experienced studies and the seven methotrexate-naive studies, respectively. In methotrexate-experienced trials, no significant change was observed over the years included in this study in any inclusion criteria (including swollen joint counts and C-reactive protein (CRP)), but a significant decrease over time was observed in the baseline swollen joint count, CRP and total Sharp or van der Heijde modified Sharp score, but not in baseline tender joint counts. In the methotrexate-naive studies, significant decreases over the years were observed in swollen joint and tender joint inclusion criteria, but not in baseline tender joint count, baseline CRP, CRP inclusion criteria or baseline total Sharp or van der Heijde modified Sharp score. Conclusion Inclusion criteria and baseline characteristics of RA patients enrolled in studies of TNFα inhibitors have changed, with more recent trials enrolling cohorts with lower disease activity, especially in methotrexate-experienced trials.Keywords
This publication has 68 references indexed in Scilit:
- Randomized controlled trial design in rheumatoid arthritis: the past decadeArthritis Research & Therapy, 2009
- Golimumab, a human antibody to tumour necrosis factor given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD StudyAnnals Of The Rheumatic Diseases, 2008
- Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trialAnnals Of The Rheumatic Diseases, 2008
- Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD studyAnnals Of The Rheumatic Diseases, 2008
- Efficacy, safety and patient-reported outcomes of combination etanercept and sulfasalazine versus etanercept alone in patients with rheumatoid arthritis: a double-blind randomised 2-year studyAnnals Of The Rheumatic Diseases, 2008
- Abatacept inhibits progression of structural damage in rheumatoid arthritis: results from the long-term extension of the AIM trialAnnals Of The Rheumatic Diseases, 2008
- Clinical investigation in highly disease-affected rheumatoid arthritis patients in Japan with adalimumab applying standard and general evaluation: the CHANGE studyModern Rheumatology, 2008
- Rituximab for rheumatoid arthritis refractory to anti–tumor necrosis factor therapy: Results of a multicenter, randomized, double‐blind, placebo‐controlled, phase III trial evaluating primary efficacy and safety at twenty‐four weeksArthritis & Rheumatism, 2006
- Factors predicting response to treatment in rheumatoid arthritis: The importance of disease durationArthritis & Rheumatism, 2000
- Treatment of rheumatoid arthritis with chimeric monoclonal antibodies to tumor necrosis factor αArthritis & Rheumatism, 1993