Efficacy and safety of rituximab in treatment of systemic sclerosis: A retrospective study

Background: Conventional treatment of systemic sclerosis with drugs for symptom control and broad-spectrum immunosuppression has remained unsatisfactory. Depletion of B-lymphocytes, which are a crucial element in pathogenesis, with rituximab (RTX) has produced encouraging results. Objective: This study aimed to retrospectively analyze the safety and efficacy of RTX in systemic sclerosis. Materials and Methods: Baseline, 6- and 12-month follow-up data of 13 systemic sclerosis (11 diffuse and 2 limited) patients (10 adult and 3 adolescent) who received 4 infusions of 500 mg RTX at 2-weekly intervals was accessed and retrospectively analyzed. Results: Modified Rodnan Skin Score progressively improved from a baseline of 22.2 ± 7.97 to 17.7 ± 7.95 at 6 months ( P < 0.05) and 14 ± 7.12 at 12 months ( P < 0.05 vs. baseline and 6-month), and mouth opening increased from 2.23 ± 0.44 fingers to 3.5 ± 0.52 fingers at 12 months ( P < 0.05). Pruritus and melanoderma improved in all those affected. Raynaud’s phenomenon improved in 12/13, whereas digital ulcers improved significantly in 9/12 patients. Arthritis remitted in the six affected patients, and percentage predicted forced vital capacity improved from a baseline of 70 ± 9.09 to 76.54 ± 7.5 at 12 months ( P < 0.05). There were no serious adverse effects. Conclusion: RTX showed good outcome in cutaneous, joint, and pulmonary features of systemic sclerosis without any significant adverse event.