Sun Pharma Presents Long-term Study Results that Show Significant Skin Clearance with ILUMYA

Sun Pharma Presents Long-term Study Results that Show Significant Skin Clearance with ILUMYA

Sun Pharmaceutical Industries Ltd. has 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 28th 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.1,2 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):

o PASI 75: 82 percent, 89 percent

o PASI 90: 56 percent, 64 percent

o PASI 100: 28 percent, 35 percent

o 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.6 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:

o PASI 75: 69 percent with metabolic syndrome; 71 percent without metabolic syndrome

o PASI 90: 42 percent with metabolic syndrome; 51 percent without metabolic syndrome

o PASI 100: 27 percent with metabolic syndrome; 23 percent without metabolic syndrome

· reSURFACE 2:

o PASI 75: 73 percent with metabolic syndrome; 79 percent without metabolic syndrome

o PASI 90: 57 percent with metabolic syndrome; 60 percent without metabolic syndrome

o 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.”

About the Studies

reSURFACE 1 Extension Study

reSURFACE 1 was a three-part, double-blind, randomized, controlled, 64-week study that evaluated ILUMYA 100 mg and 200 mg at weeks 0 and 4, and every subsequent 12 weeks in adults with moderate-to-severe chronic plaque psoriasis. Participants with at least 50 percent improvement in PASI 50 at base study completion who received ILUMYA within 12 weeks of base study end (week 64) were eligible to enroll in the extension study and continued on the same ILUMYA dose once every 12 weeks. Researchers evaluated PASI and PGA response (score of 0 or 1 with ≥2 grade reduction from baseline) and incidence rates for prespecified adverse events, including severe infections, cardiovascular events and drug-related hypersensitivities.

reSURFACE 2 Extension Study

reSURFACE 2 was a three-part, double-blind, randomized, controlled, 52-week study that compared the safety and efficacy of ILUMYA 100 mg and 200 mg to placebo and etanercept 50 mg. At Week 12, patients with at least a 50 percent improvement in PASI 50 at base study completion on ILUMYA 100 or 200 mg were eligible to enroll in the extension study and continued on the same ILUMYA dose every 12 weeks. Partial and non-responders to etanercept were converted to treatment with ILUMYA 200 mg, while responders (PASI ≥75) were discontinued. Researchers evaluated PASI and PGA response (score of 0 or 1 with ≥2 grade reduction from baseline) and incidence rates for prespecified adverse events, including severe infections, cardiovascular events and drug-related hypersensitivities.

reSURFACE 1 and reSURFACE 2 Post-Hoc Analyses

Post-hoc analyses of reSURFACE 1 and reSURFACE 2 were conducted to evaluate changes in ILUMYA’s efficacy in people with and without metabolic syndrome, which was previously defined as those who met the National Cholesterol Education Program-Adult Treatment Panel III criteria (including elevated blood pressure, body mass index [BMI], triglycerides, and glucose). Researchers stratified efficacy results – determined by proportion of patients with at least PASI 75 and absolute and median percent PASI change from baseline – up to week 148 in both studies.

About ILUMYA® (tildrakizumab-asmn)

ILUMYA® (tildrakizumab-asmn) is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. ILUMYA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy, in the United States. ILUMYA has also been approved for moderate-to-severe plaque psoriasis in Australia and under the brand name ILUMETRITM in Europe.