A Phase III, Randomized, Double-Blind, Controlled Study (PEMPHIX) to Evaluate the Efficacy and Safety of Rituximab Versus Mycophenolate Mofetil in Patients With Pemphigus Vulgaris
In this Phase 3, randomized, double-blind, double-dummy, superiority, active-control trial, patients with moderate to severe pemphigus vulgaris were randomized to either rituximab or mycophenolate mofetil for 52 weeks. The primary outcome was the proportion of patients who achieved sustained complete remission for at least four consecutive months. Secondary outcomes included cumulative oral corticosteroids, total number of flares, time to sustained complete remission, time to flare, and change in health-related quality of life. Safety was also assessed.