Background LEF is a new DMARD for the treatment of active RA in adults. Large phase III clinical trials have shown that LEF significantly improves the signs and symptoms of RA compared to placebo. LEF also significantly improved patient functional ability and individual health-related quality of life compared with placebo and methotrexate, and slowed radiographically assessed disease progression. In addition, LEF has an early onset of action, with a clinical response being seen by 4 weeks and a sustained response observed at up to 2 years.
Objectives To evaluate the efficacy of, and predisposing factors for response to LEF in a large multinational, multicenter, open-label cohort study at 24 weeks.
Methods Patients with active RA classified by a disease activity score (DAS >3.2) were enrolled and treated with LEF (100 mg loading dose x 3 days with 20 mg QD thereafter). The efficacy variables analysed at week 24 were the DAS 28 responder rate, the response rate according to ACR 20%, ACR 50% and ACR 70%, and change from baseline for both scores. All subjects who received at least one dose of study medication were included in the intent-to-treat with last observation carried forward analysis. At week 24, baseline data (including RA duration and ARA functional class) from patients who were classified as responders compared with non-responders at week 24 were analysed to determine predictive factors of response.
Results Of the 966 patients treated with LEF for 24 weeks, 720 (75%) were female with a mean age of 55 years (range 19?75). The mean duration of previous RA was 7.5 years with 62% patients first being diagnosed >2 years. The mean duration of morning stiffness was 2.1 h and 83% of patients tested positive for rheumatoid factor at baseline. For those patients who had previously had DMARD treatment (72%), the mean number of previous treatments was 2.6. At week 24, 78% of patients were responders according to the DAS 28 responder rate. The percentage of patient responders at week 24 for ACR 20%, ACR 50% and ACR 70% were 67, 36, and 10% respectively. At week 24, 13% patients fulfilled the disease remission criteria (DAS 28 < = 3.2). Of the patients, 35% and 50% were responders at week 4 and 8, respectively, and maintained efficacy until week 24. One hundred and ninety patients were withdrawn from the study (11% due to an adverse event, 3% for a lack of efficacy). ARA functional class 1 and RA duration >2 years were identified as predisposing factors for treatment response.
Conclusion This study confirms the efficacy of LEF in patients with RA. Further evaluation may suggest the clinical relevance of identified predisposing factors for treatment response.
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