Genentech a member of Switzerland's Roche Group (SIX: RO) (OTCQX: RHHBY).
The study met the primary endpoint, and demonstrated that Rituxan is superior to MMF in achieving sustained complete remission.
The primary endpoint was the percentage of participants who achieved sustained complete remission off corticosteroid therapy (no disease activity, as evaluated by Pemphigus Disease Area Index, without the use of steroids for 16 consecutive weeks or more) at Week 52.
Rituxan also met the secondary endpoints, including cumulative corticosteroid dose, number of flares, time to sustained remission and time to disease flare. Adverse events were generally consistent with those seen in previous Rituxan clinical studies for other autoimmune indications.
PV is a rare, serious and potentially life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes.
MMF is an unapproved treatment for PV that is accepted as standard of care.
In June 2018, Rituxan became the first biologic therapy approved by the FDA for PV and the first major advancement in the treatment of the disease in more than 60 years.
This approval was based on the Ritux 3 clinical trial.
This PEMPHIX trial provided additional clinical evidence on the effectiveness of Rituxan for PV. Complete data from the PEMPHIX study will be presented at an upcoming medical congress.
PEMPHIX is a Phase III, randomised, double-blind, double-dummy, active-comparator, parallel-arm multicenter study (NCT02383589) designed to evaluate the efficacy and safety of Rituxan compared with mycophenolate mofetil in patients with moderate to severe active pemphigus vulgaris requiring 60-120 mg/day oral prednisone (or equivalent).
Participants were randomly assigned to receive Rituxan plus MMF placebo or Rituxan placebo plus MMF. Rituxan was administered at a dose of 1000 mg via IV infusion on day 1 and 15, with a repeat administration on days 168 and 182.
MMF was administered at a dose of 2 grams orally daily from day 1 to week 52.
The primary endpoint is the percentage of participants who achieved sustained complete remission, evaluated by the Pemphigus Disease Area Index Activity Score, for at least 16 consecutive weeks at Week 52.
Secondary endpoints include cumulative oral corticosteroid dose, number of disease flares, time to sustained complete remission, time to disease flare and health-related quality of life, as measured by the Dermatology Life Quality Index.
Pemphigus vulgaris is an autoimmune blistering disease affecting the skin and mucous membranes.
This rare, potentially life-threatening condition accounts for up to 80% of cases of pemphigus, a group of autoimmune disorders which affect 30,000 to 40,000 people in the United States.
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