A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER TRIAL OF MURINE ANTI-CD4 MONOCLONAL-ANTIBODY THERAPY IN RHEUMATOID-ARTHRITIS

Objective. To assess safety and efficacy of a murine anti-CD4 monoclon al antibody (Mab) in a population of patients with rheumatoid arthriti s (RA) compared to treatment with placebo. Methods. Fifty-eight patien ts with defined RA were included in this placebo controlled, randomize d, double blind, multicenter study. Of the 48 women and 10 men (mean a ge 54.5 years), 25 were functional class II and 31 were class III, wit h 9 years' disease duration; the mean of previous disease modifying an tirheumatic drugs was 4; 49 were taking steroids (mean dosage 11 mg/da y of prednisone). Eighty percent were rheumatoid factor positive. All were in an active state of the disease with: pain > 4 (mean at inclusi on 6.6), tender joints > 4 (mean 12), swollen joint count > 3 (mean 9) , morning stiffness > 45 min (mean 185), erythrocyte sedimentation rat e > 30 mm (mean 59) or C-reactive protein (CRP) > 30 mg/l (mean 63). T reatment was randomized between murine anti-CD4 Mab (B-F5, Diaclone, 2 0 mg/day) or placebo intravenously for 10 consecutive days. Efficacy w as assessed with a composite index (Paulus), with evaluation of number of patients with 20 or 50% improvement in each group. Changes in meas ures of single clinical or biological variables were also evaluated. R esults. The 2 groups were comparable at inclusion. Treatment was well tolerated. Mild side effects (chills, fever, rash) were seen in both g roups. percentage of patients with global 20 or 50% response did not d iffer between placebo and Mab groups at Day 10 or at Day 30. Evaluatio n of single variables showed reduced CRP, swollen joint count, and Rit chie index in some B-F5 patients at Day 10, although in the B-F5 group as a whole only CRP was significant. Conclusion. No significant impro vement in RA after murine anti-CD4 Mab was observed.