Sustained Remission Without Corticosteroids Among Patients With Pemphigus Who Had Rituximab as First-Line Therapy:...

Area of Science:

• Dermatology
• Immunology
• Clinical Trials

Background:

• Pemphigus is a rare autoimmune blistering disease with significant morbidity.
• Short-term efficacy of rituximab (Ritux 3 trial) in pemphigus was previously established.
• Long-term data on first-line rituximab treatment for pemphigus were lacking.

Purpose of the Study:

• To evaluate the long-term efficacy and safety of the Ritux 3 treatment regimen in pemphigus patients.
• To assess disease-free survival (DFS) without corticosteroids at 5 and 7 years.
• To analyze relapse rates, severe adverse events (SAEs), and the predictive value of anti-Dsg antibodies.

Main Methods:

• A 7-year follow-up study of the Ritux 3 trial involving patients with pemphigus.
• Patients were randomized to rituximab plus prednisone or prednisone alone.
• Kaplan-Meier curves assessed DFS; relapse rates, SAEs, and anti-Dsg antibody levels were secondary outcomes.

Main Results:

• 93% of patients receiving first-line rituximab achieved complete remission without corticosteroids versus 39% with prednisone alone.
• 5- and 7-year DFS rates were significantly higher with rituximab (76.7% and 72.1%) compared to prednisone alone (35.3%).
• Rituximab group experienced fewer SAEs (0.67/patient vs 1.32/patient) and relapses (42.2% vs 83.7%).

Conclusions:

• First-line rituximab treatment provides long-term sustained remission in pemphigus without requiring additional maintenance infusions.
• Rituximab demonstrates superior efficacy and safety compared to prednisone alone for pemphigus management.
• Anti-Dsg antibody levels can predict long-term relapse risk.