FDA Approves Tildrakizumab for Adults With Psoriatic Arthritis

The FDA has approved tildrakizumab-asmn (Ilumya; Sun Pharma) for the treatment of adults with active psoriatic arthritis (PsA) , expanding the IL-23 inhibitor’s label beyond moderate to severe plaque psoriasis, for which it was approved in 2018. Tildrakizumab is administered exclusively by a health care provider, and it is positioned as an option for patients who are unable to self-administer treatment or may benefit from regular in-office care, a distinction that shapes how pharmacists approach access and site-of-care questions for this agent.¹

Approximately 2.4 million Americans live with PsA, a chronic immune-mediated disease that causes pain, swelling, and stiffness in joints and entheses and can lead to permanent joint damage. Roughly 1 in 3 people with psoriasis also have PsA, and more than 15% of people with psoriasis may have undiagnosed PsA.¹

INSPIRE Trials Supported the Approval

The approval is based on the phase 3 INSPIRE-1 (NCT04314544) and INSPIRE-2 (NCT04314531) trials, which are 52-week, global, multicenter, randomized, double-blind, placebo-controlled studies of tildrakizumab 100 mg. INSPIRE-1 enrolled patients with prior exposure to an antitumor necrosis factor (TNF) agent, whereas INSPIRE-2 enrolled anti–TNF-naive patients. More than 800 adults were enrolled across sites in the US, Europe, and Asia. In the trials, tildrakizumab was given at week 0 and then every 12 weeks, without the week 4 induction dose used in the plaque psoriasis program, and stable concomitant methotrexate or leflunomide was permitted.²

Both trials met their primary end point, the proportion of patients achieving at least 20% improvement in American College of Rheumatology criteria (ACR20) at week 24, after only 2 doses. In INSPIRE-1 (n = 510), 41% of patients receiving tildrakizumab achieved ACR20 vs 25% of those receiving placebo. In INSPIRE-2 (n = 296), the rates were 35% vs 23%, respectively.^1,2,4