Clinical research studyTumor Necrosis Factor Antagonist Responsiveness in a United States Rheumatoid Arthritis Cohort
Section snippets
Materials and Methods
Patients with a diagnosis of rheumatoid arthritis and no previous biologic agent use who were enrolled in the registry and prescribed a TNF antagonist for the first time were included. The study period was from March of 2002 to May of 2006. The Consortium of Rheumatology Researchers of North America registry is a prospective observational study of patients with arthritis who were enrolled by participating rheumatologists at both academic and private practice sites; the details have been
Patient and Baseline Disease Activity Characteristics
Baseline characteristics and disease activity levels of patients in cohorts A and B are summarized and compared in Table 1, showing no significant differences with the exception that patients in cohort A were less frequently rheumatoid factor positive (69.8% vs 82.8%, P = .016). Similar proportions of patients prescribed TNF antagonists in cohorts A (27.9%) and B (28.4%) had high Clinical Disease Activity Index scores at baseline. The proportion of patients in cohort A with low, moderate, and
Discussion
In this multicentered US-based cohort study of patients with rheumatoid arthritis who were prescribed TNF antagonists, we had 2 principal findings. First, we observed that less than one fifth of patients with rheumatoid arthritis in the study cohorts prescribed a TNF antagonist would have met the eligibility requirements from 3 major TNF antagonist trials, primarily because of disease activity requirements. The proportion of patients with rheumatoid arthritis satisfying requirements for trial
Conclusions
This study of a large US cohort with rheumatoid arthritis indicates that less than one fifth of patients prescribed TNF antagonists meet typical eligibility requirements from TNF antagonist trials, and that patients failing to meet these criteria achieve inferior responses. These findings highlight the tradeoff between defining a treatment-responsive population and generalizing data from randomized controlled trials to the larger population of patients with rheumatoid arthritis who are treated
Acknowledgment
Dr. Greenberg was supported by Grant Number K23AR054412 from the National Institute of Arthritis And Musculoskeletal And Skin Diseases and a Clinical Translational Research Award in Rheumatoid Arthritis from the Arthritis Foundation. Dr. Greenberg serves as Chief Scientific Officer for CORRONA.
References (33)
- et al.
Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trialATTRACT Study Group
Lancet
(1999) - et al.
The benefit/risk profile of TNF-blocking agents: findings of a consensus panel
Semin Arthritis Rheum
(2005) - et al.
Infliximab therapy in established rheumatoid arthritis: an observational study
Am J Med
(2005) - et al.
Clinical trials of unfractionated heparin and low-molecular-weight heparin in addition to aspirin for the treatment of unstable angina pectoris: do the results apply to all patients?
Am J Cardiol
(2000) - et al.
Coexistent chronic conditions and asthma quality of life: a population-based study
Chest
(2006) - et al.
Threats to the validity of clinical trials employing enrichment strategies for sample selection
Control Clin Trials
(1998) - et al.
Etanercept therapy in rheumatoid arthritisA randomized, controlled trial
Ann Intern Med
(1999) - et al.
Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial
Arthritis Rheum
(2003) - et al.
Results from controlled clinical trials: how relevant for clinical practice?
J Rheumatol
(2003) - et al.
Etanercept, infliximab, and leflunomide in established rheumatoid arthritis: clinical experience using a structured follow up programme in southern Sweden
Ann Rheum Dis
(2002)
Predictors of response to anti-TNF-{alpha} therapy among patients with rheumatoid arthritis: results from the British Society for Rheumatology Biologics Register
Rheumatology (Oxford)
Towards an epidemiology of rheumatoid arthritis outcome with respect to treatment: randomized controlled trials overestimate treatment response and effectiveness
Rheumatology (Oxford)
Adalimumab plus methotrexate is more effective than adalimumab alone in patients with established rheumatoid arthritis: results from a 6-month longitudinal, observational, multicenter study
Ann Rheum Dis
Real-world effectiveness of select biologic and DMARD monotherapy and combination therapy in the treatment of rheumatoid arthritis: results from the RADIUS observational registry
Curr Med Res Opin
Effectiveness of tumor necrosis factor inhibitors in rheumatoid arthritis in an observational cohort study: comparison of patients according to their eligibility for major randomized clinical trials
Arthritis Rheum
The efficacy of anti-TNF in rheumatoid arthritis, a comparison between randomized controlled trials and clinical practice
Ann Rheum Dis
Cited by (0)
Dr Greenberg was supported by grant number K23AR054412 from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and a Clinical Translational Research Award in Rheumatoid Arthritis from the Arthritis Foundation. Dr Kishimoto was funded by a fellowship grant from the Consortium of Rheumatology Researchers of North America.