Roche Rituximab shows positive data in rare skin disease Pemphigus Vulgaris

New Delhi: Roche recently announced data from the Phase III PEMPHIX study evaluating the efficacy and safety of MabThera/Rituxan (rituximab) compared to mycophenolate mofetil (MMF) in adults with moderate to severe pemphigus vulgaris (PV).

PV is a rare, serious and potentially life-threatening condition characterised by progressive painful blistering of the skin and mucous membranes. MMF is a commonly used, unapproved treatment for PV that is recommended in published treatment guidelines.

MabThera/Rituxan became the first biologic therapy for PV when it was approved by the FDA in June 2018 and the European Commission on March 2019. These approvals were based on data from the Roche-supported Ritux 3 clinical trial. The PEMPHIX study provides additional clinical evidence of the effectiveness of MabThera/Rituxan for PV.

The study met the primary endpoint at Week 52 and demonstrated that MabThera/Rituxan is superior to MMF, with 40.3% of patients treated with MabThera/Rituxan achieving sustained complete remission (CR) without the use of steroids for 16 consecutive weeks or more, compared to 9.5% in the MMF arm (p<0.0001).

The phase 3 PEMPHIX study met its primary endpoint at week 52 and demonstrated that Rituxan is superior to mycophenolate mofetil (MMF), with 40.3% of patients treated with Rituxan achieving sustained complete remission (CR) without the use of steroids for 16 consecutive weeks or more, compared to 9.5% in the MMF arm.

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Commenting on the same, Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development 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 per cent 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, ” Levi added.

The study is ongoing, with patients participating in a 48-week safety follow-up period after treatment completion or discontinuation.

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