Roche has announced that its monoclonal antibody, Rituxan (rituximab), met all primary and secondary endpoints in the Phase III PEMPHIX study.
The drug demonstrated superiority to current standard-of-care to CellCept (mycophenolate mofetil), in achieving sustained complete remission in adults with moderate-to-severe pemphigus vulgaris (PV).
“The PEMPHIX study provides additional clinical evidence for the use of Rituxan for the treatment of pemphigus vulgaris,” said Sandra Horning, chief medical officer and head of Global Product Development.
The primary endpoint reached was the percentage of participants who achieved sustained complete remission off corticosteroid therapy at week 52, and secondary endpoints included cumulative corticosteroid dose, number of flares, time to sustained remission and time to disease flare.
Rituxan was administered at a dose of 1000 mg via IV infusion on day one and 15, with a repeat administration on days 168 and 182 and CellCept was administered at a dose of two grams orally daily from day one to week 52.
She continued, “These data also demonstrated that Rituxan may provide complete remission rates and successful tapering of corticosteroid therapy that is superior to MMF in adults with pemphigus vulgaris.”
The drug is developed by Genentech, a member of the Roche group, and is often used in the indication of rheumatoid arthritis (RA).
Pemphigus vulgaris is an autoimmune blistering disease affecting the skin and mucous membranes. The rare, potentially life-threatening condition accounts for up to 80% of cases of pemphigus, a group of autoimmune disorders.