Three-year clinical outcomes in patients with rheumatoid arthritis treated with certolizumab pegol: results from the observational ECLAIR study.

OBJECTIVES: To describe the long-term effectiveness and safety of certolizumab pegol in patients with moderate-to-severe rheumatoid arthritis (RA) in a real-world setting in France. METHODS: ECLAIR was a 3-year longitudinal, prospective, observational, multicentre study. The primary objective was to describe the EULAR response after 1 year of certolizumab pegol treatment. Other endpoints included DAS28, clinical disease activity index, health assessment questionnaire disability index, fatigue assessment scale, patient's assessment of arthritis pain, patient and physician global assessments of disease activity, patient quality of life, and long-term safety. RESULTS: A total of 792 patients were enrolled, of whom 776 comprised the safety set, and 733 the full analysis set. In the full analysis set, 559, 469 and 430 patients had a 12-, 24- and 36-month visit, respectively. This included 378, 296 and 246 patients still receiving certolizumab pegol at these visits. The percentage of EULAR responders was 75.3% (305/405 patients with an available EULAR response) at 12, 76.5% (261/341) at 24, and 79.6% (226/284) at 36 months. Among those still receiving certolizumab pegol, the percentage of EULAR responders was 81.7% (237/290) at 12, 81.1% (185/228) at 24, and 87.3% (158/181) at 36 months. Sustained improvements were observed in other effectiveness outcomes. Overall, 45.1% (350/776) of patients experienced 776 adverse drug reactions. No new safety signals were identified. CONCLUSIONS: This is the first prospective, observational study of an anti-TNF treatment in France. The results confirm the effectiveness and safety profile of certolizumab pegol treatment in patients with RA in a real-world setting.

Comparison of certolizumab pegol with other anticytokine agents for treatment of rheumatoid arthritis: a multiple-treatment Bayesian metaanalysis.

OBJECTIVE: To compare the clinical efficacy of certolizumab pegol (CZP) with that of other anticytokine agents indicated for the treatment of rheumatoid arthritis (RA) with identical therapeutic indication (anti-tumor necrosis factor-α, anti-interleukin 1 or 6), with the objective of determining the noninferiority of CZP. METHODS: A systematic review was performed to identify randomized controlled trials that assessed the efficacy of anticytokine agents in combination with conventional disease-modifying antirheumatic drugs (DMARD) after 6 months of treatment, using the American College of Rheumatology (ACR) response criteria, in patients with RA who have shown inadequate response to DMARD including methotrexate. Indirect treatment comparisons were carried out by a multiple-treatment Bayesian random-effects metaanalysis. Data were analyzed using the Markov chain Monte Carlo simulation. Noninferiority of CZP was assessed in comparison with a predefined equivalence margin of 5%. RESULTS: Nineteen placebo-controlled studies were identified: 14 evaluated the efficacy of 5 anti-TNF-α agents (infliximab, etanercept, adalimumab, golimumab, CZP) and 5 evaluated efficacy of 2 anti-interleukin agents (anakinra, tocilizumab). Every treatment showed significant efficacy versus placebo in individual studies. The multiple-treatment metaanalysis showed a highest OR for CZP on ACR20 response. Metaanalysis indicates that the efficacy of CZP according to ACR20 response is superior to that of infliximab, adalimumab, and anakinra, and equivalent or superior to that of etanercept, golimumab, and tocilizumab. According to ACR50 response, the efficacy of CZP is equivalent or superior to that of all other anticytokines. CONCLUSION: Results of this original multiple-treatment Bayesian metaanalysis indicate that certolizumab pegol is at least as efficacious as the preexisting antirheumatic anticytokine biotherapies.

Medicoeconomic evaluation of hyaluronic acid for knee osteoarthritis in everyday practice: the MESSAGE study.

INTRODUCTION: Medicoeconomic data on treatments for osteoarthritis are scant. We investigated the impact of hyaluronic acid therapy on the cost of management of knee osteoarthritis. Our primary objective was to compare medical costs (admissions, outpatient visits, investigations, and treatments) and non-medical costs (sick leaves and transportation) from the perspective of the national health insurance system during the 3 months before and the 6 months after three intraarticular injections of hyaluronic acid. Our secondary objective was to evaluate treatment benefits in terms of pain, function, and quality of life. METHODS: Observational, multicenter, longitudinal, before-after study of the medical and economic effects of hyaluronic acid therapy for symptomatic knee osteoarthritis. RESULTS: Of the 296 assessable patients (mean age, 69 years; 30% with obesity; 65% women), only 5% of patients were withdrawn prematurely from the study. Significant improvements in the Lequesne index were found 3 and 6 months after treatment; the improvement was greater than 50% in over half the patients. Pain and quality-of-life scores improved significantly. Total cost of the disease decreased from 334 euros for the 3 pretreatment months to 295 euros and 233 euros for posttreatment months 1-3 and 4-6, respectively. CONCLUSION: The costs of knee osteoarthritis decreased during the 6 months after Suplasyn therapy, indicating that the cost of the medication was more than offset by the decreased need for other treatments. Concomitantly, clinical benefits were obtained. Under the conditions of everyday practice, hyaluronic acid may provide medical benefits at an acceptable cost.