TOPLINE:
Exciting news for patients with pemphigus who have received rituximab as first-line therapy: sustained remission without corticosteroids or additional rituximab infusions is now a reality, an analysis has shown.
METHODOLOGY:
- We know that the short-term efficacy and safety of first-line treatment with rituximab for pemphigus have already been demonstrated in the Ritux 3 trial. However, until now, the rates of long-term remission have remained unknown.
- A recent investigation conducted by French investigators from 25 dermatology departments took a closer look at 83 patients from the Ritux 3 trial between January 1, 2010, and December 31, 2015.
- To determine the 5- and 7-year rates of disease-free survival (DFS) without corticosteroids, the researchers used Kaplan-Meir curves.
TAKEAWAY:
- Out of the 83 patients evaluated, 44 were in the rituximab plus prednisone group, while 39 were in the prednisone-only group, showing a median follow-up of 87.3 months (7.3 years).
- Patients in the rituximab plus prednisone group achieved complete remission without corticosteroids at any point during follow-up, which amounted to 93.5% of the group, compared to 39% in the prednisone-only group.
- Results showed that the patients in the rituximab plus prednisone group statistically fared better in terms of DFS (without corticosteroid therapy) at 5 years (76.7% vs 35.3%, respectively) and 7 years (72.1% vs 35.3%; P < .001 for both associations) when compared to the prednisone-only group.
- Additionally, the group receiving rituximab plus prednisone experienced fewer serious adverse events (SAEs) compared to the prednisone-only group, with 0.67 SAEs per patient versus 1.32 SAEs per patient, respectively (P = .003).
IN PRACTICE:
The study results clearly highlight “the superiority of rituximab over a standard corticosteroids regimen, both in the short term and the long term,” according to the authors.
SOURCE:
The study was led by corresponding author Billal Tedbirt, MD, of the Department of Dermatology at CHU Rouen, Rouen, France, and was published online on January 24, 2024, in JAMA Dermatology.
LIMITATIONS:
It is worth noting that nearly 8% of patients did not attend the end of the follow-up visit. Serum samples used to predict relapse were drawn at month 36; however, the researchers observed that a window of every 4-6 months might provide higher accuracy of relapses.
DISCLOSURES:
Tedbirt reported having no disclosures. Four of the study authors reported being investigators for and/or receiving personal fees from several pharmaceutical companies. The study was supported by a grant from the French Society of Dermatology.