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Sun Pharma's ILUMYA delivers positive psoriatic arthritis trial results

Sun Pharmaceutical Industries has announced that its psoriasis drug ILUMYA (tildrakizumab 100 mg) delivered positive results in two late-stage clinical trials for active psoriatic arthritis (PsA), potentially paving the way for regulatory filings in the United States. The Phase 3 INSPIRE-1 and INSPIRE-2 studies evaluated the efficacy and safety of ILUMYA over a 24-week period. According to the company, both trials achieved statistically significant improvements in ACR20 response rates—a standard measure of arthritis treatment effectiveness—compared with placebo at Week 24. INSPIRE-1 included patients with prior exposure to anti-TNF therapies, while INSPIRE-2 focused on anti-TNF naïve patients. More than 800 adult participants were enrolled across clinical sites in the US, Europe, and Asia. ILUMYA was administered at Week 0 and every 12 weeks thereafter, with no induction dose. Consistent safety profile supports regulatory case Sun Pharma stated that the safety outcomes in the psoriatic arthritis trials were consistent with ILUMYA's established safety profile from earlier studies in plaque psoriasis. No new safety signals were identified. ILUMYA is currently approved in the US and other countries for the treatment of moderate-to-severe plaque psoriasis in adults. Its use in psoriatic arthritis remains investigational and has not yet been evaluated by regulatory authorities. Detailed results from the INSPIRE studies will be presented at upcoming medical conferences and submitted for publication in peer-reviewed journals. Targeting IL-23 in chronic inflammatory pathways ILUMYA is a monoclonal antibody that targets the p19 subunit of interleukin-23 (IL-23), thereby inhibiting inflammatory pathways associated with chronic autoimmune conditions. Common adverse reactions reported in previous studies include upper respiratory infections, injection-site reactions, and diarrhoea. The drug carries warnings related to hypersensitivity, infections, and tuberculosis risk. Psoriatic arthritis affects an estimated 2.4 million people in the United States. Approximately one-third of psoriasis patients may develop the joint condition, though many cases remain undiagnosed. Strategic pipeline strengthens global presence Sun Pharma is India's largest pharmaceutical company and one of the world's leading generic drug manufacturers. The company operates in over 100 countries and has a growing specialty portfolio in dermatology, ophthalmology, and onco-dermatology.