Roche said that the phase 3 PEMPHIX trial of MabThera (rituximab) in moderate to severe pemphigus vulgaris (PV) met its primary endpoint at Week 52.
The PEMPHIX trial also showed that MabThera was superior to mycophenolate mofetil (MMF) in the late-stage trial held in adult patients. PEMPHIX has been taken up by Roche to present additional clinical evidence of the effectiveness of the drug for pemphigus vulgaris.
As per the results of the PEMPHIX trial, 40.3% of patients treated with the Roche drug achieved sustained complete remission (CR) without having to use steroids for 16 consecutive weeks or more. This was in comparison to 9.5% recorded in the MMF arm.
Furthermore, secondary endpoints of the phase 3 efficacy and safety trial were statistically significant in favour of MabThera/Rituxan, said Roche.
The Swiss drugmaker said that adverse events observed in the investigational arm were generally in line with those recorded in previous clinical studies of the Roche drug in pemphigus vulgaris and other approved autoimmune indications.
Roche presented results of the PEMPHIX trial at the 28th Congress of the European Academy of Dermatology and Venereology in Madrid, Spain.
Considered to be a rare condition, pemphigus vulgaris is distinguished by progressive painful blistering of the skin and/or mucous membranes.
In March 2019, the drug was approved in the European Union for the treatment of adults with moderate to severe pemphigus vulgaris. In June 2018, rituximab, which is branded as Rituxan in the US, was approved by the US Food and Drug Administration (FDA) for the same indication.
The approvals for the drug for the rare autoimmune disease were based on the results of the Roche-supported Ritux 3 clinical study.
Roche chief medical officer and global product development head 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 percent 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.”