Low‐dose rituximab and concurrent adjuvant therapy for pemphigus: Protocol and single‐centre long‐term review of nine patients

Abstract

Pemphigus is an autoimmune B-cell mediated blistering disease associated with significant morbidity and mortality. Rituximab has proven effective for the treatment of steroid-refractory pemphigus, although there is controversy over the optimum dosing protocol. Additionally, effective disease control often requires long-term immunosuppression, even in disease-free periods. We present a case series of a single-centre long-term follow up of nine patients with pemphigus, treated with two 500-mg doses of rituximab separated by 14 days along with concurrent adjuvant therapy. In all these patients, low-dose rituximab resulted in B-cell depletion, along with a reduction in blistering disease. Three of these patients required repeat dosing cycles due to either relapsed disease or incomplete disease control following the first dosing cycle, and have remained disease free up to 154 weeks thus far. Six patients developed minor infections during the course of their treatment, but no major complications were observed.

Role of Rituximab in the Treatment of Pemphigus Vulgaris: Patient Selection and Acceptability

“…31 A 2021 review collected published evidence on the use of low-dose RTX for the treatment of PV: nine studies were included, with RTX dosages varying between modified dose (3 × 375 mg/m 2 or 3 × 500 mg), low dose (2 × 375 mg/m 2 or 2 × 500 mg), and ultra-low dose (≤500 mg for a cycle, either single or multiple infusions). [32][33][34][35][36][37][38][39][40] The authors of the review suggested that low-dose and ultra-low-dose protocols should be used to induce the remission in patients with mild-to-moderate PV, with the possibility of repeated infusions for more severe forms. 41 These data confirmed the results of a 2015 systematic review and meta-analysis, comparing different RTX regimens in the treatment of PV.…”

“…Response to both high and low doses of RTX has been documented by several studies in the literature (Table 2). [31][32][33][34][35][36][37][38][39][40]58,59 Compared to steroid-only therapy, regimens containing RTX achieve a three-fold higher chance of complete remission. 52,60 However, rates of response after administration of different doses of RTX are not easily comparable considering potential confounders such as the extreme variability of the cumulative dosing of corticosteroids administered.…”

Prospects for Anti-B-Cell Therapy in Immuno-Inflammatory Rheumatic Diseases

“…В то же время необходимо принимать во внимание дозозависимые НЛР на фоне лечения РТМ, такие как поздняя нейтропения [367] и гипогаммаглобулинемия [368]. Необходимо также учитывать и успешные результаты применения низких доз РТМ при других аутоиммунных заболеваниях, таких как пузырчатка [369,370], мембранозный нефрит [371], идиопатическая аутоиммунная гемолитическая анемия [372] и первичная иммунная тромбоцитопения [373], резистентная тромбоцитопения при СКВ [374].…”

The Efficacy and Safety of Rituximab Biosimilar (Acellbia®) in Rheumatoid Arthritis as the First Biological Agent: Results of Phase Iii (Alterra) Clinical Trial

“…В то же время необходимо прини-мать во внимание дозозависимые НЯ на фоне лечения РТМ, такие как поздняя нейтропения [52] и гипогаммагло-булимнемия [53]. Необходимо также учитывать и успеш-ные результаты применения низких доз РТМ при других аутоиммунных заболеваниях, таких как пузырчатка [54,55], мембранозный нефрит [56], идиопатическая аутоим-мунная гемолитическая анемия [57] и первичная иммун-ная тромбоцитопения [58], резистентная тромбоцитопе-ния при системной красной волчанке [59].…”