Tildrakizumab's Safety Maintained for Nearly 4 Years in Psoriatic Arthritis

Tildrakizumab (Ilumya; Sun Pharma), an IL-23p19 monoclonal antibody, maintained long-term safety through week 208 in patients with active psoriatic arthritis (PsA), according to new data from a phase 2b open-label extension study (NCT02980692) presented at the American College of Rheumatology (ACR) Convergence 2025.¹ Among 281 participants, adverse events were consistent with previous findings, and no new safety concerns emerged, supporting continued development of tildrakizumab for PsA treatment.

Earlier this year, 2 phase 3 studies—INSPIRE-1 (NCT04314544) and INSPIRE-2 (NCT04314531)—evaluating tildrakizumab 100 mg in adults with active PsA had positive top-line results.² After 24 weeks of treatment, patients achieved significant improvements in PsA signs and symptoms compared with placebo, meeting the primary end point of ACR20 response in both trials. The studies included more than 800 participants across the US, Europe, and Asia and demonstrated consistent efficacy and safety, aligning with the well-established safety profile of tildrakizumab in plaque psoriasis.

In the study presented at the ACR Convergence, patients who completed the initial phase 2b trial of tildrakizumab for active PsA, achieved an ACR20 response at week 52, and demonstrated sufficient clinical benefit per investigator assessment were eligible to enter the open-label long-term extension study.¹ Participants continued their assigned tildrakizumab dosing regimen of 200 mg every 4 weeks, 200 mg every 12 weeks, or 100 mg every 12 weeks until the parent study database lock, after which all patients received tildrakizumab 100 mg every 12 weeks through week 208.

Safety was evaluated in all patients who received at least 1 long-term extension dose, based on the frequency and severity of adverse events (AEs), serious AEs (SAEs), AEs of special or clinical interest, and the presence of antidrug antibodies and neutralizing antibodies to tildrakizumab. Analyses were conducted according to the treatment received.

Of the 303 patients screened in the parent study, 281 entered the long-term extension and received at least one dose of tildrakizumab, with 205 completing treatment through week 208. AEs occurred in 79.7% of patients, though most were mild or moderate. Treatment-related AEs occurred in 19.6% of participants, with upper respiratory tract infection and nasopharyngitis being the most common.

SAEs occurred in 14.2% of patients, and only 0.7% experienced treatment-related serious AEs. A small percentage of patients (6.0%) discontinued due to AEs, most commonly infections. AEs of special interest were reported in 4.6% of patients, including rare cardiac disorders and malignancies, none of which were linked to the study drug. Two deaths occurred, both unrelated to treatment. The incidence of antidrug and neutralizing antibodies was low and not associated with safety concerns. Overall, no new safety signals were identified through week 208.

References

1. Mease PJ, Chohan S, Fructuoso FJG, et al. Long-term safety of tildrakizumab through week 208 in patients with psoriatic arthritis: Results from the phase 2b open-label extension study. Poster presented at: ACR Convergence 2025; October 24–29, 2025; Chicago, IL.

2. Bosslett M. Sun Pharma announces positive phase 3 results for tildrakizumab in psoriatic arthritis. Dermatology Times®. July 22, 2025. Accessed October 28, 2025. https://www.dermatologytimes.com/view/sun-pharma-announces-positive-phase-3-results-for-tildrakizumab-in-psoriatic-arthritis