ADALIMUMAB (HUMIRA®) IS EFFECTIVE AND SAFE IN TREATING RHEUMATOID ARTHRITIS (RA) IN REAL-LIFE CLINICAL PRACTICE: FINAL SUMMARY OF THE 6610 PATIENTS IN THE REACT STUDY

Background: The efficacy and safety of TNF-antagonists in treating pts with active RA have been confirmed in clinical trials and supported in post-marketing observations. The completed Adalimumab Research in Active RA (ReAct) trial offers the largest database available for a prospective evaluation of the efficacy and safety of adalimumab (Ada) in patients with active, insufficiently treated RA, various co-morbidities, a broad range of antirheumatic co-medications, and varied social care systems.Objectives: To assess and summarize the efficacy and safety of adalimumab in the final analysis of the ReAct trial.Methods: Patients with active RA and prior DMARD therapy enrolled in the ReAct trial at 448 sites in 11 European countries and Australia. Patients entering ReAct received Ada 40 mg sc eow for 12 weeks in addition to their current anti-rheumatic therapy, and optionally continued therapy until Ada was commercially available. Efficacy and safety evaluations were conducted at Wks 2, 6, 12, and every 8 wks thereafter. Adverse events (AE) were collected throughout the treatment period.Results: In all, 6610 pts enrolled in the ReAct trial. Adalimumab was used alone (25%) or in combination with existing DMARD(s), leading to 45 Ada-DMARD combinations. After 12 wks, 93% of pts remained and retention in the study was 79% overall. The mean exposure to Ada was 33 wks (120 wks, maximum). Mean baseline characteristics included: age, 54 yrs; disease duration, 11 yrs; DAS28, 6.0; HAQ, 1.64; prior DMARDs, 3; RF+, 73%; and 14% had failed prior anti-TNF therapy. Efficacy was similar across subpopulations using different Ada-DMARD combinations, and responses were seen irrespective of RF status or previous failure of anti-TNF therapy. The table presents key efficacy outcomes to Wk 12 and at last observation.Adalimumab was well-tolerated, and no new safety signals were observed. Overall, reasons for withdrawals included lack of efficacy in 6.8% and AE in 10.3% of patients. Serious adverse events of lupus or demyelinating disease were rarely seen, with only 2 and 4 events reported, respectively. The incidence of malignancies, including lymphomas, was similar to the general population. The rate of malignancies (1.1/100PY) gave a Standard Incidence Ratio (SIR) of 0.71 vs. an age and sex matched population. Two lymphomas (0.05/100PY; SIR 1.09) were reported. The rate of serious infections (5.5/100PY) was within the range previously reported in RA. Adalimumab Efficacy: Patients With Long-Standing, Highly Active RA (Mean BL DAS28=6.0) Week 2 Week 6 Week 12 Last Visit * ACR20 (%) 42 59 69 67 ACR50 (%) 12 28 40 45 ACR70 (%) 3 10 18 25 DeltaDAS28** –1.4 –1.8 –2.1 –2.3 DAS28<2.6 (%) n.a. n.a. 20 26 DeltaHAQ** –0.32 –0.45 –0.54 –0.57 Observed values; *Mean exposure 33 wks; **MeansConclusion: Adalimumab therapy led to clinically significant and sustained improvements in all key efficacy parameters. ReAct data confirmed observations from adalimumab pivotal trials, and demonstrated a positive benefit/risk ratio for the treatment of severe RA when adalimumab is combined with standards of care in real-life settings.Citation: Ann Rheum Dis, volume 65, supplement II, year 2006, page 181Session: Rheumatic arthritis – treatment biologics