Tildrakizumab Receives FDA Approval for Active Psoriatic Arthritis

The US Food and Drug Administration (FDA) has approved tildrakizumab-asmn (Ilumya) for adults with active psoriatic arthritis (PsA), according to Sun Pharmaceutical Industries.¹

The approval of the supplemental Biologics License Application (sBLA) is based on the 52-week phase 3 INSPIRE-1 and INSPIRE-2 trials, which evaluated efficacy at week 24. Sun Pharma notes the interleukin (IL)-23p19 inhibitor is administered exclusively by a health care provider.¹

"Psoriatic arthritis is a complex and chronic disease. As clinicians, we need a range of therapeutic options that allow us to individualize care based on each patient's symptoms and treatment goals. Adding an IL-23 inhibitor option that is administered by a healthcare provider gives us a new way to offer appropriate patients additional support and engagement with their healthcare team," Philip Mease, Director of Rheumatology Research at the Swedish Medical Center and Providence St Joseph Health and Clinical Professor at the University of Washington School of Medicine, said in a statement.¹

The decision follows an October 29, 2026, Prescription Drug User Fee Act (PDUFA) target date, set when the FDA accepted the sBLA for review in March. Tildrakizumab was first approved in 2018 for moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.¹ With roughly 1 in 3 patients with psoriasis also living with PsA, the new indication carries the agent from dermatology into rheumatology practice.¹

How Was Tildrakizumab Studied in Psoriatic Arthritis?

INSPIRE-1 and INSPIRE-2 are global, multicenter, randomized, double-blind, placebo-controlled phase 3 trials of tildrakizumab 100 mg in adults with active PsA.¹ INSPIRE-1 enrolled patients previously exposed to a tumor necrosis factor (TNF) inhibitor, and INSPIRE-2 enrolled anti-TNF–naive patients.² Together, the trials enrolled more than 800 adults at sites in the US, Europe, and Asia.²

The INSPIRE trials did not include the week 4 dose used in the psoriasis program. Instead, tildrakizumab was given at week 0 and every 12 weeks thereafter, and stable background methotrexate or leflunomide was permitted.² Sun Pharma said efficacy was assessed after only 2 doses.¹

The primary endpoint in both trials was the proportion of patients achieving at least 20% improvement in American College of Rheumatology criteria (ACR20) at week 24.² Both trials met the primary endpoint: more tildrakizumab-treated patients achieved ACR20 than patients receiving placebo (P < .05).² Key secondary endpoints at week 24 included ACR50, ACR70, and 75% improvement in Psoriasis Area and Severity Index (PASI75).²

What is the Safety Profile of Tildrakizumab in Psoriatic Arthritis?

Sun Pharma reported safety data from INSPIRE-1 and INSPIRE-2 were consistent with the established profile of tildrakizumab, with no new safety signals identified. In the PsA trials, the most common adverse reactions (≥3%) were upper respiratory tract infections and COVID-19. In plaque psoriasis, the most common adverse reactions (≥1%) are upper respiratory infections, injection site reactions, and diarrhea.¹

The warnings and precautions from the existing label carry over. Tildrakizumab is contraindicated in patients with a history of serious hypersensitivity to the drug or its excipients, and cases of angioedema and urticaria have been reported. Patients should be evaluated for tuberculosis before initiation, latent infection should be treated first, and therapy should not be started during a clinically important active infection.¹

Live vaccines should be avoided during treatment, and age-appropriate immunizations should be considered before starting therapy. The approval announcement did not include numeric efficacy or safety results from the INSPIRE program.¹

"FDA approval of ILUMYA for adults with active psoriatic arthritis represents another important innovative medicine milestone for Sun Pharma and builds on the established clinical experience of ILUMYA in plaque psoriasis," said Rick Ascroft, North America CEO, Sun Pharma.¹ "As an IL-23 inhibitor administered exclusively by a healthcare provider, ILUMYA is now an option for adults with active psoriatic arthritis who are unable to self-administer treatment or who may benefit from regular in-office care."

Patients from both trials were eligible to roll over into an open-label long-term extension study (NCT04991116).³ Outside the US, tildrakizumab is approved for plaque psoriasis in India, Australia, Canada, China, and Japan, and Almirall markets it in Europe as Ilumetri.¹

References

1. Sun Pharmaceutical Industries. ILUMYA (tildrakizumab-asmn) approved in the US for the treatment of adults with active psoriatic arthritis. Published October 30, 2026. Accessed October 30, 2026. https://www.prnewswire.com/news-releases/ilumya-tildrakizumab-asmn-approved-in-the-us-for-the-treatment-of-adults-with-active-psoriatic-arthritis-302924320.html
2. Sun Pharmaceutical Industries. Sun Pharma’s phase 3 clinical studies evaluating tildrakizumab 100 mg (ILUMYA) in active psoriatic arthritis meet their primary endpoint. Published July 21, 2025. Accessed October 30, 2026. https://sunpharma.com/blog/sun-pharmas-phase-3-clinical-studies-evaluating-tildrakizumab-100-mg-ilumya-in-active-psoriatic-arthritis-meet-their-primary-endpoint/
3. Long term evaluation of safety and efficacy of tildrakizumab in patients with psoriatic arthritis. ClinicalTrials.gov identifier: NCT04991116. Accessed October 30, 2026. https://clinicaltrials.gov/study/NCT04991116