Journal of Investigative Dermatology’s Post

PEGASUS’ was a randomised double blind placebo controlled #trial of a Bruton Tyrosine Kinase Inhibitor (BTKI) in pemphigus. Rilzabrutinib is a reversible BTKI. In this global study, new onset and recalcitrant pemphigus vulgaris (PV-90%) and foliaceus (PF-10%) patients were treated with medium doses of prednisone (o.5 mg/kg/d) and randomised to rilza vs placebo. The primary outcome was the proportion of PV patients in Complete remission (no lesions- PDAI zero for at least 8 weeks) on minimal therapy at week 37. In this original protocol, p<0.05 but the trial was completed during the pandemic and FDA mandated excluding patients with remote visits and that minimal therapy be increased to 10mg/d pred; with these restrictions, p>0.05. Murrell et al https://lnkd.in/dNg8iNrU #derm #RCT #pemphigus #rilzabrutinib #clinicaltrial #phase3 #outcomes #PDAI #safety #international #dermatology #principiabio #sanofi #BTKI The PEGASUS study was conducted from January 8, 2019 through October 8, 2021, in 19 countries (Argentina, Australia, Brazil, Bulgaria, Canada, Croatia, France, Germany, Greece, Israel, Italy, Poland, Serbia, Spain, Taiwan, Turkey, Ukraine, United Kingdom, and United States).

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