Add-on ozoralizumab safe, effective in rheumatoid arthritis

Ozoralizumab, when used in combination with methotrexate (MTX), appears to yield significant reductions in the signs and symptoms of rheumatoid arthritis (RA) while having an acceptable tolerability, according to data from a double-blind, parallel-group, placebo-controlled phase II/III trial.

The trial included 381 RA patients (mean age 55 years, 74.8 percent female) whose disease remained active despite MTX therapy. They were randomized to receive placebo, ozoralizumab 30 mg, or ozoralizumab 80 mg administered subcutaneously every 4 weeks for 24 weeks.

The mean disease duration of the patients was 7.4 years, the mean Disease Activity Score in 28 joints using the CRP level (DAS28-CRP) at baseline was 5.13, and the mean Sharp/van der Heijde score (SHS) score was 27.46. Most (89.2 percent) patients were seropositive for rheumatoid factor and/or anticitrullinated protein antibodies.

The primary endpoints were American College of Rheumatology (ACR) criteria response at week 16 and change in SHS from baseline to week 24. Compared with placebo, both ozoralizumab doses led to higher rates of ACR20 response at week 16 (79.6 percent with 30 mg and 75.3 percent with 80 mg vs 37.3 percent; p<0.001).

However, the proportion of the patients with structural nonprogression (ΔSHS ≤0) was significantly higher in both ozoralizumab groups than in the placebo group.

For some secondary endpoints (eg, ACR50/70 response, patient global assessment of disease activity score, patient's assessment of pain, among others), there were marked improvements seen from as early as day 3.

Four patients in the ozoralizumab 30-mg group and five patients in the ozoralizumab 80-mg group experienced serious adverse events. There were no new safety signals detected when compared with other antibodies against tumour necrosis factor.