ADALIMUMAB (HUMIRA®) IS AS EFFECTIVE WHEN USED WITH OTHER CONCOMITANT DMARDS AS WHEN USED WITH METHOTREXATE IN TREATING RHEUMATOID ARTHRITIS IN WIDESPREAD CLINICAL PRACTICE: THE REACT STUDY

Background: Methotrexate (MTX) is the most commonly used traditional disease-modifying antirheumatic drug (DMARD) in the treatment of rheumatoid arthritis (RA) and is considered the gold standard. Biologic antirheumatic therapies have typically been evaluated with primarily MTX as concomitant medication.Objectives: To investigate the effects that MTX, leflunomide (LEF), sulfasalazine (SSZ), and chloroquine/hydroxychloroquine (CQ/HCQ) have on key efficacy parameters after 12 weeks of treatment with adalimumab in a large cohort of patients with long-standing RA in real-life clinical practice.Methods: Patients with long-standing, moderate to severe RA received adalimumab in addition to their concomitant but insufficient antirheumatic therapies in the Adalimumab Research in Active RA (ReAct) trial. Patients at more than 450 sites in 11 European countries and Australia received 40 mg adalimumab sc every other week. Routine safety and efficacy evaluations were conducted at 2, 6, and 12 weeks. For this interim analysis, efficacy outcomes were assessed after 12 weeks per type of concomitant DMARD.Results: Data for 4241 patients were available as of Nov. 2, 2004 for a 12-week interim analysis. The mean baseline age=54; disease duration=11years; DAS28=6.0; HAQ=1.63. Of these patients, 22% received adalimumab monotherapy, 57% were taking 1 concomitant DMARD, 16% were taking 2, and 5% were taking 3 or more. Efficacy outcomes following 12 weeks of therapy for patients treated with adalimumab plus MTX, LEF, SSZ or QC/HQC exclusively, and the most frequently used combinations of these DMARDs are shown in the table. Efficacy of adalimumab with concomitant LEF, SSZ, QC/HQC was similar to that observed with adalimumab plus MTX. Table 1. Clinical Response to Adalimumab by Type of Concomitant DMARD Therapy Efficacy Criteria Concomitant MTX only Concomitant LEF only Concomitant SSZ only Concomitant QC/HQC Concomitant MTX +LEF Concomitant MTX+SSZ N 1561 557 89 85 123 141 ACR20 (%) 72 64 59 68 70 75 ACR50 (%) 45 34 41 36 41 42 Moderate EULAR response (%) 84 79 75 85 86 89 Good EULAR response (%) 39 31 39 25 29 41 Change in DAS28* –2.2 –2.0 –1.9 –2.1 –2.3 –2.3 Change in HAQ* –0.52 –0.47 –0.47 –0.63 –0.53 –0.53 Change in TJC (0-28)* –8 –8 –7 –9 –10 –8 Change in SJC (0-28)* –7 –6 –6 –7 –8 –7 *Mean change from baseline *Mean change from baselineConclusion: Adalimumab 40 mg sc eow led to clinically significant improvements at 12 weeks in all major efficacy parameters irrespective of the type of concomitant DMARD. Adalimumab demonstrated similar efficacy when combined with MTX, LEF, SSZ or QC/HQC, respectively, or combinations of these DMARDs, in short-term treatment. In patients with insufficient response to concomitant DMARD therapy, the addition of adalimumab provided substantial improvement in the signs and symptoms of RA. Adalimumab is efficacious in the real-life clinical practice of treating RA with various combinations of DMARDs.Citation: Ann Rheum Dis, volume 64, supplement III, year 2005, page 424Session: Rheumatoid Arthritis – Treatment