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Business Standard
2 days ago
- Health
- Business Standard
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.
Business Standard
2 days ago
- Health
- Business Standard
Sun Pharma announces top-line results of tildrakizumab 100 mg Phase 3 studies
For treatment of active psoriatic arthritis Sun Pharmaceutical Industries announced top-line results from two Phase 3 clinical studies evaluating the efficacy and safety of tildrakizumab 100 mg (ILUMYA) administered over 24 weeks for treatment of active psoriatic arthritis. Treatment with tildrakizumab 100 mg (ILUMYA) resulted in greater improvements in PsA signs and symptoms at Week 24 compared to treatment with placebo. Both the INSPIRE-1 and INSPIRE-2 studies achieved the primary endpoint, with a higher proportion of patients in the INSPIRE-1 and INSPIRE-2 studies treated with tildrakizumab achieving ACR20 responses at week 24, compared to those receiving placebo (p < 0.05). "We are excited to share that both the INSPIRE-1 and INSPIRE-2 clinical trials have successfully met their primary endpoints. These top-line results reinforce the therapeutic potential of ILUMYA as a treatment option for patients with active psoriatic arthritis. We extend our sincere gratitude to the patients, healthcare professionals and administrators whose contributions made the studies possible. We look forward to sharing the complete clinical data in the near future, said Marek Honczarenko, MD, PhD, Senior Vice President and Head of Global Specialty Development at Sun Pharma.
Business Upturn
2 days ago
- Health
- Business Upturn
Sun Pharma reports positive results from Phase 3 trials for ILUMYA
Sun Pharmaceutical Industries has shared encouraging top-line results from two (Phase 3) clinical trials evaluating its biologic drug tildrakizumab 100 mg, marketed as ILUMYA®, for the treatment of active psoriatic arthritis (PsA). The studies, named INSPIRE-1 and INSPIRE-2, tested ILUMYA over a 24-week period. Patients who received ILUMYA showed significant improvements in symptoms of psoriatic arthritis compared to those who received a placebo. Both trials successfully met their primary goal—a higher proportion of patients treated with ILUMYA achieved ACR20 responses, a standard measure used to assess improvement in joint disease, by Week 24. The results were statistically significant. On the safety front, the drug performed as expected. There were no new safety concerns, and the data remained in line with ILUMYA's existing safety record. The drug is already approved to treat moderate-to-severe plaque psoriasis, and these latest findings suggest it may have potential in addressing PsA as well. However, it's important to note that ILUMYA is not yet approved for psoriatic arthritis, and its use for this indication has not been reviewed or authorized by health regulators. Marek Honczarenko, MD, PhD, Senior Vice President and Head of Global Specialty Development at Sun Pharma, stated, 'We are excited to share that both the INSPIRE-1 and INSPIRE-2 clinical trials have successfully met their primary endpoints. These top-line results reinforce the therapeutic potential of ILUMYA as a treatment option for patients with active psoriatic arthritis. We extend our sincere gratitude to the patients, healthcare professionals and administrators whose contributions made the studies possible. We look forward to sharing the complete clinical data in the near future.' Sun Pharma plans to present the full results from these studies at upcoming medical conferences and publish them in peer-reviewed journals. Ahmedabad Plane Crash Aman Shukla is a post-graduate in mass communication . A media enthusiast who has a strong hold on communication ,content writing and copy writing. Aman is currently working as journalist at
