Roche has released data from the Phase III PEMPHIX study evaluating the efficacy and safety of Rituxan (rituximab), compared to mycophenolate mofetil (MMF).
The study, for adults with moderate to severe pemphigus vulgaris, met its primary endpoint at Week 52 and demonstrated that Rituxan is superior to MMF, with 40.3% of patients treated with the Roche drug achieving sustained complete remission (CR) without the use of steroids for 16 consecutive weeks or more.
All secondary endpoints were also statistically significant in favour of Rituxan, such as lower cumulative oral corticosteroid dose, fewer flares, a greater likelihood of sustained CR and a greater improvement in the Dermatology Life Quality Index at week 52.
The study is still ongoing, with patients participating in a 48-week safety follow-up period after treatment completion or discontinuation.
“The approval of Rituxan for the treatment of pemphigus vulgaris was the first major advancement in the treatment of this rare, serious disease in more than 60 years,” said Levi Garraway, Roche’s chief medical officer and head of global product development. “The PEMPHIX study showed that 40% of people in the study could achieve complete remission from painful blistering without the need for corticosteroids for 16 weeks or more and that Rituxan may be a superior treatment option to mycophenolate mofetil.”
Pemphigus vulgaris is an autoimmune, blistering disease, affecting the skin and mucous membranes. It is the most common type of a group of autoimmune disorders collectively called pemphigus, and it is estimated that around three in every 100,000 people are diagnosed with this disease globally.