Meta-Analysis Assesses Safety and Efficacy of Rituximab in Patients With Systemic Sclerosis

Credit: Shutter Stock
Authors of a meta-analysis aimed to systematically assess the safety and efficacy profile of rituximab in patients with systemic sclerosis.

Rituximab is relatively safe and effective in stabilizing organ involvement and improving skin scores in patients with systemic sclerosis (SSc), according to study results published in Clinical Rheumatology.

There is still debate surrounding the clinical benefits of treating SSc with rituximab; therefore, study authors in Iran conducted a meta-analysis to systematically review the safety and efficacy profile of rituximab in this patient population.

Data collected for the meta-analysis included  skin scores and organ involvement, as well as quality of life (QOL) of patients with SSc. Primary outcomes were variations in the modified Rodnan skin score (mRSS) for skin function and forced vital capacity, and/or diffusing capacity of the lungs for carbon monoxide for lung function. Other outcomes included pulmonary involvement measured by total lung capacity and forced expiratory volume, left ventricular ejection fraction, and systolic pulmonary artery pressure. In addition, daily functioning and QOL was measured by the Health Assessment Questionnaire Disability Index (HAQ-DI) and medical outcome study Short Form 36 (SF-36). Following predefined inclusion and exclusion parameters, 24 studies were selected for further review.

After 6, 12, and 24 months, mRSS values dropped to 0.8, 0.58, and 0.433, respectively (P =.000), which suggested improved skin scores over time among patients treated with rituximab. During follow-up, there was a significant reduction in activity index (P =.000); however, the overall pooled estimate of the severity index at the final follow-up was 0.68 (P =.35). In addition, the HAQ-DI value decreased at 12 months (P =.003) and SF-36 scores stabilized during the time of treatment.

All cardiopulmonary involvement measures were stable during follow-up with rituximab, and both left ventricle ejection fraction and systolic pulmonary artery pressure parameters were stabilized during the time of treatment.

Infiltrating B cells, immunoglobulin (Ig) M, IgG, and IgA did not vary during the course of rituximab treatment. Prevalence of death, cancer, infection, and infusion in patients treated with rituximab were 9%, 5%, 18%, and 10%, respectively.

According to these results, the authors noted that the administration of rituximab to patients with SSc may significantly improve skin scores and disease indices, which can improve QOL.

Limitations of the analysis included the open-label design and the small sample size of included studies.

“Still, these promising results about [rituximab] efficacy should be confirmed in large-scale and multicenter phase [3] randomized-controlled trials compared with matched-control [patients with SSc disease] who do not receive [rituximab] treatment,” the authors concluded.


Moradzadeh M, Aghaei M, Mehrbakhsh Z, Arab-Bafrani Z, Abdollahi N. Efficacy and safety of rituximab therapy in patients with systemic sclerosis disease (SSc): systematic review and meta-analysis. Clin Rheumatol. Published online April 2, 2021. doi:10.1007/s10067-021-05698-4