Roche has said that its MabThera/Rituxan (rituximab) has been found to be superior to mycophenolate mofetil (MMF) in patients with pemphigus vulgaris (PV) in the Phase III Pemphix study.
PV is an autoimmune disease affecting the skin and mucous membranes.
The randomised, double-blind, double-dummy, multicentre study has been designed to assess the efficacy and safety of MabThera/Rituxan compared to MMF in patients with moderate to severe active PV who need a 60mg or 120mg dose of oral prednisone or equivalent every day.
Patients received MabThera/Rituxan plus MMF placebo or MabThera/Rituxan placebo plus MMF for 52 weeks in combination with 60mg or 80mg oral prednisone, with the aim of tapering to 0mg a day by week 24.
The active-comparator, parallel-arm, international study met the primary endpoint at week 52, with 40% of PV patients achieving sustained complete remission without using steroids for 16 weeks or more when treated with MabThera/Rituxan compared to 9.5% of patients on MMF.
Roche said all secondary endpoints were statistically significant in favour of MabThera/Rituxan.
Roche chief medical officer and head of global product development Levi Garraway said: “The approval of MabThera/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.
“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 Mabthera/Rituxan may be a superior treatment option to mycophenolate mofetil.”
The company is continuing to gather data in a 48-week follow-up period, giving it the chance to monitor the safety of MabThera after treatment completion or discontinuation.
In June 2018, the US Food and Drug Administration approved MabThera/Rituxan for PV, while the European Commission gave its approval in March 2019. The approvals were based on data from the Roche-supported Ritux 3 clinical trial.