FDA Approves Tildrakizumab for Active Psoriatic Arthritis

The US Food and Drug Administration (FDA) has approved tildrakizumab-asmn (ILUMYA; Sun Pharma) for the treatment of adults with active psoriatic arthritis (PsA), expanding the interleukin (IL)-23 inhibitor’s indications beyond moderate-to-severe plaque psoriasis.¹

The approval follows the FDA’s review of a supplemental Biologics License Application (sBLA) submitted by Sun Pharmaceutical Industries. Tildrakizumab is a humanized monoclonal antibody that selectively targets the p19 subunit of IL-23, a cytokine involved in inflammatory pathways associated with psoriasis and PsA.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,” Rick Ascroft, North America CEO of Sun Pharma, said in a news release.¹

As clinicians, we need a range of therapeutic options that allow us to individualize care based on each patient's symptoms and treatment goals. — Philip Mease, MD, director of rheumatology research

According to the company, tildrakizumab is the only IL-23 inhibitor for PsA that is administered exclusively by a health care provider. The treatment is administered as a 100-mg subcutaneous injection at weeks 0 and 4, followed by dosing every 12 weeks.¹

Phase 3 INSPIRE Program Supports Approval

The approval was supported by data from the phase 3 INSPIRE-1 (NCT04314544) and INSPIRE-2 (NCT04314531) trials, 2 randomized, double-blind, placebo-controlled studies evaluating tildrakizumab 100 mg in adults with active PsA.¹

Both trials met their primary end point, demonstrating a statistically significant improvement in American College of Rheumatology 20% response (ACR20) at week 24 compared with placebo.¹

In INSPIRE-1, 61% of patients treated with tildrakizumab achieved ACR20 at week 24 compared with 35% of patients receiving placebo. In INSPIRE-2, ACR20 was achieved by 64% and 33% of patients, respectively.¹

Clinical responses were observed as early as week 8 and continued through week 24. Tildrakizumab also demonstrated improvements across several secondary measures of PsA disease activity, including ACR50, ACR70, minimal disease activity, and resolution of enthesitis and dactylitis.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,” Philip Mease, MD, director of rheumatology research at Swedish Medical Center and Providence St Joseph Health and clinical professor at the University of Washington School of Medicine in Seattle, said in the release.¹

Mease added that having an IL-23 inhibitor administered by a health care provider provides another option for appropriate patients while allowing additional engagement with their health care team.¹

Safety Findings Consistent With Established Profile

The safety profile of tildrakizumab in the INSPIRE trials was consistent with its established safety profile in plaque psoriasis, with no new safety signals identified.¹

Tildrakizumab may increase the risk of infection, and clinicians should evaluate patients for tuberculosis before initiating treatment. According to the prescribing information reported by Sun Pharma, the most common adverse reactions occurring in at least 3% of patients receiving tildrakizumab for PsA were upper respiratory tract infections and COVID-19.¹

Expanding Treatment Across Psoriatic Disease

PsA is a chronic inflammatory disease that can affect peripheral and axial joints, entheses, digits, and the skin. Without appropriate treatment, persistent inflammation can contribute to irreversible joint damage and disability.

Approximately 2.4 million people in the US are living with PsA, according to Sun Pharma. An estimated 1 in 3 patients with psoriasis develops PsA, while more than 15% of patients with psoriasis may have undiagnosed PsA.¹

The new indication builds upon tildrakizumab’s existing use across psoriatic disease. The therapy was initially approved by the FDA in 2018 for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Its label was subsequently expanded to include moderate-to-severe scalp psoriasis in 2024 and moderate to severe nail psoriasis in 2025.²

The PsA approval further broadens the role of tildrakizumab in managing patients with psoriatic disease and provides clinicians with an additional IL-23–targeted option for adults experiencing active joint disease.

References

1. Sun Pharma. ILUMYA (tildrakizumab-asmn) approved in the U.S. for the treatment of adults with active psoriatic arthritis. Newswise. Published October 30, 2026. Accessed October 30, 2026.
2. Sun Pharma announces US FDA acceptance of supplemental Biologics License (sBLA) application for ILUMYA (tildrakizumab-asmn) for the treatment of adults with active psoriatic arthritis. Sun Pharmaceutical Industries Ltd. Published March 16, 2026. Accessed October 30, 2026.