Phase III reSURFACE trials of Ilumya shows response was maintained for 4 years in moderate-to-severe plaque psoriasis.- Sun Pharma

Sun Pharmaceutical Industries announced new long-term follow-up data from Ilumya (tildrakizumab-asmn) Phase III reSURFACE 1 and 2 trials in moderate-to-severe plaque psoriasis. The data showed that the significant response rates seen in the initial 52 and 64 weeks, respectively, were maintained over four years for people with moderate-to-severe plaque psoriasis, with more than half of participants achieving at least 90 percent skin clearance (Psoriasis Area Sensitivity Index (PASI) 90) and no new safety concerns recorded.

Additional study analyses showed that the 75 to 100 percent skin clearance achieved with Ilumya treatment over three years was sustained equally in people with and without metabolic syndrome, a common condition in people with psoriasis. Eligible participants in the Ilumya Phase III reSURFACE 1 and 2 trials who remained on treatment for the open-label extension studies received Ilumya for a total of 208 weeks (reSURFACE 1) and 200 weeks (reSURFACE 2). After four years, Ilumya treatment led to significant and durable observed improvements in PASI and Physician Global Assessment (PGA) scores � key measures of disease severity. The PASI 75 score was 82 percent and 89 percent respectively for Ilumya 100 mg in reSURFACE 1 and reSURFACE 2. PASI 90 score was 56 percent and 64 percent respectively and PASI 100 was 28 percent and 35 percent respectively. The percentage of participants with favorable PGA response was 58 percent and 65 percent respectively. Ilumya 100 mg was well-tolerated, with a low rate of adverse events (AEs) that were comparable or numerically lower than placebo based upon exposure-adjusted rates for many AE categories.

Researchers also analyzed the reSURFACE 1 and reSURFACE 2 studies to glean insights into whether Ilumya's efficacy was similar in people with metabolic syndrome (defined as elevated blood pressure, body mass index/obesity, triglycerides and glucose and low HDL cholesterol levels), as this co-morbid condition can negatively affect people's response to most biologic psoriasis medicines. This post-hoc analysis showed that the skin clearance levels achieved and sustained with Ilumya 100 mg at three years were comparable in participants with and without metabolic syndrome. Data were presented at the 28th European Academy of Dermatology and Venereology Congress (EADV) in Madrid, Spain.