1. Patients with pemphigus treated with first-line rituximab showed sustained complete remission rates without corticosteroids for up to 7 years post-treatment
2. High-risk patients for pemphigus relapse could be assessed with enzyme-linked immunosorbent assay (ELISA) values of anit-Dsg antibodies.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Pemphigus is a life-threatening rare autoimmune bullous disease affecting the skin and mucosae. The Ritux 3 trial demonstrated that combining anti-CD20 monoclonal Ab rituximab with low-dose corticosteroids is more effective than corticosteroid monotherapy, resulting in higher complete remission rates with fewer severe adverse events. Studies have shown a short-term low relapse rate following rituximab infusions for pemphigus; however, there is no data on the long-term follow-up of patients who received rituximab as first-line therapy for pemphigus. Therefore, this follow-up study of the Ritux trial assessed the 5- and 7-year disease-free survival without corticosteroids. Overall, patients with pemphigus treated with first-line rituximab were associated with long-term complete remission without needing corticosteroid therapy or maintenance rituximab infusions. Limitations of this study included a drop-out rate of 7.8% (7 patients) and a lack of close monitoring of anit-Dsg antibodies.
Click to read the study in JAMA Dermatology
In-Depth [randomized control trial]: This study was a follow-up to the Ritux 3 trial, which was conducted in 25 French dermatology departments between January 1, 2010 and December 31, 2015. The primary outcome of this follow-up study included the 5- and 7-year disease-free survival without corticosteroids. Secondary outcomes included relapse, severe adverse events, and evolution of antidesmoglein (Dsg) antibodies (predicts long-term relapse). Inclusion criteria included patients who completed the Ritux 3 trial. Patients were randomized into the rituximab plus prednisone group or prednisone-monotherapy group. Follow-ups of patients were completed seven years post-enrollment in the Ritux 3 trial, and extracted information included clinical status (complete response without corticosteroids therapy or receiving minimal therapy, partial remission, or relapse), number and doses of rituximab infusions, and the occurrence of severe adverse events. At month 36 and at the end of the follow-up visit, serum samples were collected to measure anti-Dsg1 and anti-Dsg3 IgB antibodies. Of the 90 patients in the Ritux 3 trial, 83 (44 in the rituximab plus prednisone group; 39 in the prednisone monotherapy group) completed the follow-up visit with a median follow-up of 87.3 months. Forty-three (93%) of patients from the rituximab plus prednisone group and 17 (39%) from the prednisone monotherapy group achieved complete remission without corticosteroids. The 5- and 7-year disease-free survival was more prolonged for patients from the rituximab group than in the prednisone monotherapy group (76.7% and 72.1% vs 35.3% and 35.3%, respectively; P < .001). The rituximab group also had fewer relapses (42.2% vs 83.7%; P < .001) and fewer adverse events (31 vs. 58; P = .003). Anti-Dsg1 levels equal to or exceeding 20 IU/mL and anti-Dsg3 levels equal to or exceeding 48 IU/mL demonstrated a positive predictive value of 0.83 and a negative predictive value of 0.94 for anticipating long-term relapse. Overall, first-line treatment with rituximab for pemphigus was associated with long-term complete remission without corticosteroids or maintenance rituximab infusions.
Image: PD
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