Investigational treatment PRN1008 demonstrated efficacy in this difficult-to-treat condition.
The Believe-PV trial of patients with pemphigus vulgaris met its primary endpoint, with 54% of participants achieving control of disease activity within 4 weeks of treatment.
Dedee Murrell, MD, professor and chair of dermatology at the University of New South Wales, Kensington, Australia, spoke with MD Magazine® about the Believe-PV trial data at the 2019 Annual Meeting of the American Academy of Dermatology (AAD) in Washington, DC.
Murrell highlighted that while many studies in patients with pemphigus vulgaris measure complete remission at 2 years of treatment, in this study, a quarter of participants experienced remission by 24 weeks.
MD Mag: What were the primary and secondary outcomes of the trial?
Murrell: The primary outcome chosen for this study was control of disease activity and in this study more than half the patients—54%—got control of disease activity within 4 weeks of starting the medication. In fact, a few patients—27%—were already under control within 2 weeks, which is very fast, and nearly all of them—almost 75%—by 12 weeks.
Secondary outcomes, such as remissions, were also very good. The complete remission rate at the end of the 12 weeks—and that's a hard ask in pemphigus because it means no more lesions, no new lesions happening—was 17% at 12 weeks, but it increased even in the off-treatment phase by a quarter of the patients by 24 weeks. And many other studies are looking at 2 years—how many people are in complete remission. So, these are very fast for a disease that's hard to get under control and it was very encouraging.