Sun Pharma Presents Long-Term Study Results That Show Significant Skin Clearance With ILUMYA®

Sun Pharmaceutical Industries Ltd. announced that one of its wholly owned subsidiaries presented long-term follow-up data from ILUMYA^® (tildrakizumab-asmn) Phase 3 reSURFACE 1 and 2 trials at the 28^th European Academy of Dermatology and Venereology Congress (EADV) in Madrid, Spain.

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.

“Psoriasis is an individualized condition and it can be a challenge for clinicians to prescribe a medicine that’s effective over time, especially for patients with co-morbid conditions like metabolic syndrome,” said Jeffrey Crowley, M.D., Bakersfield Dermatology, Bakersfield, California. “These data provide confidence that ILUMYA can help patients with moderate-to-severe plaque psoriasis, regardless of metabolic syndrome, achieve and maintain significant skin clearance over the long-term.”

Eligible participants in the ILUMYA Phase 3 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.

• ILUMYA 100 mg (reSURFACE 1, reSURFACE 2):
  • PASI 75: 82 percent, 89 percent
  • PASI 90: 56 percent, 64 percent
  • PASI 100: 28 percent, 35 percent
  • Percentage of participants with favorable PGA response: 58 percent, 65 percent

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.

• reSURFACE 1:
  • PASI 75: 69 percent with metabolic syndrome; 71 percent without metabolic syndrome
  • PASI 90: 42 percent with metabolic syndrome; 51 percent without metabolic syndrome
  • PASI 100: 27 percent with metabolic syndrome; 23 percent without metabolic syndrome
• reSURFACE 2:
  • PASI 75: 73 percent with metabolic syndrome; 79 percent without metabolic syndrome
  • PASI 90: 57 percent with metabolic syndrome; 60 percent without metabolic syndrome
  • PASI 100: 34 percent with metabolic syndrome; 32 percent without metabolic syndrome

Three-year adverse event rates usually associated with metabolic syndrome, such as infections, cardiovascular events or complications of diabetes, were no different in study participants with and without metabolic syndrome.^3,4

“Moderate-to-severe psoriasis is a lifelong condition, and at Sun Pharma we’re committed to helping people find treatment options that work consistently over time, regardless of any co-morbid conditions, to help manage the frustrating symptoms that for so many years are a part of everyday life,” said Alan Mendelsohn, M.D., Associate Vice President, Dermatology Medical Affairs, Sun Pharma. “ILUMYA has been proven to provide significant skin clearance that begins soon after initial use and is maintained for years, with just four doses a year following two starter doses, without demonstrating any new or increased risk of safety events.” – PR Newswire