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

Dermatol Ther. 2022 Jul 9:e15704. doi: 10.1111/dth.15704. Online ahead of print.

ABSTRACT

BACKGROUND: 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.

METHODS: 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.

RESULTS: A total of 62 (82.7%) attained complete remission on/off treatment, out of which 42 were off therapy. Mean interval between first dose 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, pemphigus subtype or disease duration.

CONCLUSION: This study substantiates the long-term efficacy and safety of single cycle of Rituximab in pemphigus.

PMID:35808907 | DOI:10.1111/dth.15704

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