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Patients with pemphigus vulgaris more likely to achieve sustained complete remission with Rituxan
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Rituxan met a primary endpoint and demonstrated it is superior to mycophenolate mofetil in adults with moderate to severe pemphigus vulgaris in the phase 3 PEMPHIX study, which was presented at the European Academy of Dermatology and Venereology Congress.
In the double-blind, randomized, active-comparator study, participants were randomly assigned to receive Rituxan (rituximab, Genentech) plus placebo or placebo plus mycophenolate mofetil (MMF) for 52 weeks in combination with 60 mg or 80 mg oral prednisone with the aim of tapering to 0 mg daily by week 24, according to a Genentech press release.
On days 1 and 15, Rituxan was administered at 1,000 mg via IV infusion, with repeat administration on days 168 and 182. MMF was administered at 2 g orally, which began as 1 g daily on day 1 and titrated to 2 g daily by week 2.
Researchers defined sustained complete remission, the study’s primary endpoint, as achieving lesion healing with no new active lesions while on 0 mg daily of prednisone or equivalent and maintaining this response for at least 16 consecutive weeks. A total of 40.3% of patients achieved complete remission in the Rituxan group vs. 9.5% of patients in the MMF group (P < .0001), according to the release.
Patients treated with Rituxan had a lower cumulative oral corticosteroid dose, with a mean difference of 1,595 mg (P = .0005). They also experienced fewer flares (six) vs. the MMF group (44) (P < .0001) and less likelihood of flare (HR = 0.15; P < .0001). Rituxan-treated patients showed a greater likelihood of sustained complete remission (HR = 4.83; P = .0003) as well as a greater improvement in the Dermatology Life Quality Index at week 52 (P = .0012).
The study is ongoing, and after treatment completion or discontinuation, patients are participating in a 48-week safety follow-up.
Rituxan was approved by the FDA in June 2018 and the European Commission in March 2019.