14 June 2019 | News
Over 71% of Patients Treated with ILUMYA™ Achieved ACR20 Response After 24 Weeks, with Significant Improvement as Early as 8 Weeks
Sun Pharmaceutical Industries Ltd. recently announced interim results from a Phase 2 study of interleukin-23 (IL-23) inhibitor ILUMYA™ (tildrakizumab-asmn) in patients with active psoriatic arthritis that was presented in a late-breaking oral presentation at the Annual European Congress of Rheumatology (EULAR 2019) in Madrid, Spain.
The interim analysis revealed that over 71 percent of patients treated with ILUMYA™ experienced a 20 percent improvement in joint and skin symptoms (ACR20), meeting the primary endpoint of the study. The interim results showed ILUMYA™ was well tolerated with a low rate of serious treatment-emergent adverse events.
ILUMYA™ is approved in the U.S. for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy and is being investigated for psoriatic arthritis. Psoriatic arthritis, which affects up to 42 percent of people with plaque psoriasis, is an inflammatory condition that impacts both the joints and skin. It is painful, causes fatigue, and can lead to swelling and stiffness of the joints that may reduce range of motion. If left untreated, this chronic condition can lead to permanent joint damage.
The Phase 2 study interim results showed that across all patients receiving ILUMYA™, 75.3 percent experienced a 20 percent improvement in symptoms of psoriatic arthritis (ACR20) at week 24 compared to 50.6 percent of patients on placebo. The findings were similar in patients receiving 100 mg or 200 mg of ILUMYA™ on a quarterly dosing schedule. For some patients on 100 mg ILUMYA™, results were seen as early as 8 weeks. Furthermore, an average of 47.1 percent of all patients receiving ILUMYA™ achieved an ACR50 response with some results seen as early as 12 weeks, compared to 24.1 percent of patients on placebo.
The interim results also showed ILUMYA™ was well tolerated with a low and comparable rate of adverse events to placebo. Serious treatment-emergent adverse events occurred in 2.2 percent of patients treated with ILUMYA™ and 2.5 percent in those on placebo, with no patients discontinuing treatment due to these events. The most common adverse events through week 24 included common cold (nasopharyngitis), upper respiratory tract infection, and headache. There were no reports of candidiasis, inflammatory bowel disease, major adverse cardiac events, malignancy, or deaths.