Department of Immunodermatology, Istituto Dermopatico dell'Immacolata, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Rome, Italy.
J Am Acad Dermatol. 2012 Oct;67(4):617-22. doi: 10.1016/j.jaad.2011.11.007. Epub 2012 Jan 13.
Rituximab induces depletion of B cells and has shown efficacy in antibody-mediated autoimmune disorders. In studies on small series of patients with pemphigus, rituximab administration results in significant improvement. However, differences in inclusion criteria, treatment protocols, and follow-up make it difficult to derive uniform conclusions.
We sought to test the efficacy and tolerability of rituximab as adjuvant therapy to corticosteroids in the treatment of pemphigus.
In all, 42 patients with pemphigus were treated with rituximab and followed up for up to 5 years. No additional immunosuppressive agents were used. Steroids were rapidly tapered. Outcomes were the proportion of patients who achieved a complete response on or off therapy, the rate of discontinuation of corticosteroid within 6 months, length of remission, time to relapses, and occurrence of adverse events.
In all, 36 of 42 patients (86%; 95% confidence interval 75%-96%) achieved a complete response on or off therapy and discontinued steroids within 6 months from induction therapy. Six patients had a complete response off therapy with an additional infusion of rituximab 6 months after initial treatment. Twenty patients experienced a total of 34 relapses; the time to relapse was 8 to 64 months. Every relapse was treated with rituximab (500 mg) without corticosteroids, which induced a new complete response. No serious adverse events were observed.
Lack of a control group is a limitation.
Rituximab therapy induces prolonged clinical remission in patients with pemphigus. Coadministration of other immunosuppressive agents is not necessary. Relapses can be managed with additional infusions administered on demand.
利妥昔单抗可诱导 B 细胞耗竭，并已显示出在抗体介导的自身免疫性疾病中的疗效。在小系列天疱疮患者的研究中，利妥昔单抗给药可显著改善病情。然而，纳入标准、治疗方案和随访的差异使得难以得出统一的结论。
我们旨在测试利妥昔单抗作为辅助治疗天疱疮的皮质类固醇的疗效和耐受性。
共 42 例天疱疮患者接受利妥昔单抗治疗并随访长达 5 年。未使用其他免疫抑制剂。皮质类固醇迅速减量。主要结局为治疗或不治疗时完全缓解的患者比例、6 个月内停用皮质类固醇的比例、缓解持续时间、复发时间和不良反应的发生。
共有 42 例患者中的 36 例（86%；95%置信区间 75%-96%）在治疗或不治疗时达到完全缓解，并在诱导治疗后 6 个月内停用皮质类固醇。6 例患者在初始治疗后 6 个月额外输注利妥昔单抗后出现完全缓解。20 例患者共发生 34 次复发；复发时间为 8 至 64 个月。每次复发均用利妥昔单抗（500mg）治疗，未使用皮质类固醇，诱导新的完全缓解。未观察到严重不良事件。
缺乏对照组是一个限制。
利妥昔单抗治疗可诱导天疱疮患者获得长期临床缓解。不需要联合使用其他免疫抑制剂。可按需给予额外输注来治疗复发。
