Efficacy and safety of rituximab on lung and skin involvement in systemic sclerosis: a systematic review and metaanalysis

Objective To evaluate the efficacy and safety of rituximab (RTX), an antiB cell monoclonal antibody, on lung and skin involvement in systemic sclerosis (SSc). Methods All literature published in Embase and Medline before September 2019 were comprehensively searched. Two independent reviewers selected eligible studies, extracted relevant data, and assessed the quality of the included studies. We only considered randomized, controlled trials (RCTs), cohort studies, and case-control studies that compared RTX with a placebo, other immunosuppressive agents, or corticosteroids. All analyses were performed using RevMan (version 5.3). Results A total of 8 studies (3 RCTs and 5 cohort studies) met our inclusion criteria. The pooled analysis showed a significant improvement of modified Rodnan skin score in the RTX group only in the cohort studies (mean difference [SD] − 3.31 [− 4.95, − 1.68]; I 2 = 82%). As to the PFT, the RTX group showed a significant improvement in the forced vital capacity only in 3 RCTs (mean difference [SD] 6.59 [3.51, 9.68]; I 2 = 0%). Additionally, the RTX group demonstrated a statistically significant improvement in the diffuse capacity of carbon monoxide only in the cohort studies (mean difference [SD] 7.42 [1.08, 13.76]; I 2 = 97%). There were no significant differences in the AEs of the RTX and control groups. Conclusions RTX may be effective for lung and skin involvement in SSc, with no serious AEs. However, further studies with high quality and a large sample size are necessary to firmly establish the efficacy and safety of the use of RTX with SSc patients. Key Points • RTX may be an alternative treatment for cutaneous and pulmonary manifestations in patients with SSc with a favorable safety profile. • However, further studies with a high quality and large sample size are necessary to firmly establish its efficacy and safety.