Comparing Clinical Outcomes of Steroid-Sparing Therapy With Rituximab Versus Rituximab Alone in Pemphigus
March 2024 | Volume 23 | Issue 3 | e97 | Copyright © March 2024
Published online February 14, 2024
Danielle E. Mustin MEnga, Emily F. Cole MD MPHb, Rebecca Leibowitz BSa, Ron J. Feldman MD PhDc
aEmory University School of Medicine, Atlanta, GA
bDepartment of Dermatology, Duke University Medical Center, Durham, NC
cDepartment of Dermatology, Emory School of Medicine, Atlanta, GA
Abstract
Background: Previous clinical trials have demonstrated that rituximab therapy combined with conventional steroid-sparing therapy (SST) has increased rates of disease control for mucous membrane pemphigoid compared with rituximab alone. However, limited data is available regarding the role of SST with rituximab therapy in pemphigus.
Objective: This study aimed to examine clinical outcomes in pemphigus patients treated with rituximab with SST versus without the addition of SST.
Methods: A retrospective chart review was performed for adult pemphigus patients in the Southeastern US at Emory between January 1, 2011, and December 31, 2021. Primary outcomes, including time to remission, time to prednisone dose of 10 mg or less, time to cessation of prednisone therapy, and time to relapse after a rituximab cycle, were compared between patients on SST and patients without SST.
Results: Following rituximab therapy, there was no difference in time to remission, time to prednisone dose of 10 mg or less, time to cessation of prednisone therapy, or time to relapse for patients with or without SST.
Limitations: Our study is limited by its retrospective decline, setting at a single academic center, and inclusion of a high proportion of patients with moderate disease.
Conclusions: The use of SST with rituximab dosing did not improve clinical outcomes related to time to remission, reduction in prednisone dosing, or relapse. These data provide further evidence for the use of rituximab in the majority of pemphigus patients without the need for SST.
J Drugs Dermatol. 2024;23(3):e97-e99 doi:10.36849/JDD.7949e
INTRODUCTION
Pemphigus is a rare autoimmune blistering disease that is associated with significant morbidity and mortality. Rituximab demonstrated superiority over oral steroid monotherapy and steroid-sparing agent mycophenolate in prior clinical trials and is FDA-approved as first-line therapy for pemphigus.1,2 Despite improved efficacy, rates of relapse remain high with estimates of 40-50%.3 While the use of rituximab therapy with conventional steroid-sparing therapy (SST) in patients with mucous membrane pemphigoid showed improved disease control, limited data are available regarding the role of SST as an adjunct to rituximab therapy in pemphigus.4 A small retrospective study demonstrated decreased relapse rates when severe pemphigus patients were maintained on low-dose SST following rituximab.5 However, it is unclear whether SST following rituximab offers better outcomes for non-severe pemphigus patients, particularly given the added risk of adverse effects such as infection. Here, we examined a larger, more diverse cohort of pemphigus patients to determine the difference in clinical outcomes including time to remission, relapse, tapering to minimal therapy of prednisone, and adverse events for patients on or off SST at the time of rituximab dosing.
MATERIALS AND METHODS
A retrospective analysis was performed for adult pemphigus patients treated with rituximab at the Emory Clinic between October 2011 and December 2021. Patients included in the analysis had clinically, histologically, and/or serologically confirmed pemphigus. Pemphigus Disease Area Index (PDAI) scores and endpoints were determined by the same provider (RJF) at the time of the visit. Remission (including partial and complete remission) and relapse (3 or more new lesions a month without resolution within one week) were defined by consensus statement.6 Data are presented as mean (SD) and differences in observed variables were assessed using one-way ANOVA and Fisher's exact tests for numerical and categorical covariates, respectively. A P-value of 0.05 or less
