Long‐term efficacy and safety analysis of single cycle of biosimilar rituximab in pemphigus: A retrospective study of 76 patients from India

Abstract

Pemphigus poses a therapeutic challenge and rituximab is increasingly used in its treatment. Long-term data regarding efficacy and safety of rituximab in pemphigus is limited.This study was a retrospective analysis of 76 pemphigus patients with primary endpoint being the percentage of patients achieving complete remission (CR) on/off therapy. Secondary endpoints were time to relapse, mean cumulative dose of prednisolone after rituximab infusion, mean duration of follow up, and adverse events to rituximab if any. A total of 62 (82.7%) attained complete remission on/off treatment, out of which 42 were off therapy. Mean interval between rituximab administration and complete remission off treatment was 6.9 ± 3.7 months. Complete remission off treatment was sustained for a mean duration of 21.4 ± 17.8 months before relapse. Over a mean follow-up duration of 42.7 ± 24.9 months (median 41, maximum 83 months), 22 of 62 patients (35.5%) who had achieved complete remission after the first cycle of rituximab relapsed. A mean total cumulative dose of 8716.3 ± 10533.8 mg prednisolone was prescribed over a mean duration of 18.05 ± 15.64 months after the first cycle of rituximab. Adverse events were noted in 18 out of 76 patients (23.7%) which included infusion reactions (n = 3), minor infections (n = 7), transitory disease flare (n = 6), and mortality (n = 2). No statistically significant correlation was found between remission/relapse rates and age, gender or pemphigus subtype. This study substantiates the long-term efficacy and safety of single cycle of rituximab in pemphigus.

Suppression of Autoimmune Rheumatoid Arthritis with Hybrid Nanoparticles That Induce B and T Cell Tolerance to Self-Antigen

“…Many if not most autoimmune diseases involve antibodies to self-antigens that mediate disease pathology. − Some of the most promising strategies for treating the cause of these diseases directly or indirectly target either B cells or T cells involved in the production of autoimmune antibodies. ,− B cell depletion via CD20-targeting monoclonal antibody rituximab has been FDA approved to treat rheumatoid arthritis and pemphigus and is being evaluated for treatment of many other autoimmune diseases such as SLE. ,− While remission of symptoms in pemphigus is achieved in most patients, relapses occur when B cells are replenished, requiring additional rounds of treatment. , T cell directed therapies include depletion of T cells at the induction/expansion of tolerogenic Tregs that suppress immune responses. ,, For example, administration of low doses of interleukin 2 to expand Tregs has shown promise in the treatment of systemic lupus erythematosus (SLE) and type I diabetes . Cellular therapies using CD19-CAR T cells to deplete B cells or administering expanded Tregs are also beginning to show promise in clinical trials. − …”

“…10,62−64 While remission of symptoms in pemphigus is achieved in most patients, relapses occur when B cells are replenished, requiring additional rounds of treatment. 62,63 T cell directed therapies include depletion of T cells at the induction/expansion of tolerogenic Tregs that suppress immune responses. 56,58,65 For example, administration of low doses of interleukin 2 to expand Tregs has shown promise in the treatment of systemic lupus erythematosus (SLE) and type I diabetes.…”