Background We conducted this systematic reviews and meta-analysis to investigate the safety and efficacy of ocrelizumab in patients with active rheumatoid arthritis (RA) who exhibited resistance or intolerance to methotrexate or TNF inhibitors.
Materials and methods We performed a web-based literature search of PubMed, Google Scholar, EBSCO, Scopus, Embase, and Web of science for studies that compared ocrelizumab plus methotrexate versus methotrexate plus placebo in RA patients. Data were extracted from eligible studies and pooled as risk ratios (RR), using RevMan software.
Results Pooling data from four RCTs (2230 patients) showed that ocrelizumab plus methotrexate were superior to methotrexate plus placebo at 24 weeks in terms of the American college of rheumatology (ACR20, ACR50, and ACR70) improvement criteria (p<0.00001), disease activity score 28-ESR (RR=3.77, 95% CI [2.47, 5.74], p<0.00001), and Sharp/van der Heijde radiological improvement score (RR=1.63, 95% CI [1.43, 1.85], p<0.00001). These effects were consistent among all ocrelizumab doses. The rates of serious adverse events were comparable between the ocrelizumab and placebo containing groups (RR=1, 95% CI [0.78, 1.28], p=0.98). However, infusion related reactions were significantly higher in ocrelizumab group (RR=2.13, 95% CI [1.69, 2.68], p<0.00001), compared to placebo group.
Conclusion The combination of ocrelizumab plus methotrexate was superior to methotrexate plus placebo on all clinical and radiographic improvement scales. The incidence of adverse events, including serious adverse events, was comparable between both groups. Future trials should investigate the efficacy of ocrelizumab alone and develop strategies to alleviate its related infusion reactions.