Sun Pharma's psoriasis drug delivers positive results in arthritis trials

Sun Pharma's psoriasis drug Ilumya shows promising results in late-stage psoriatic arthritis trials, paving the way for potential regulatory filings and expansion into the immunology market.

Sun Pharmaceutical Industries 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 US. The latest trial results come at a time when Ilumya is gaining commercial traction globally.

 

In FY25, Sun Pharma reported a 17 per cent year-on-year rise in Ilumya’s global sales, reaching $681 million. The growth was largely driven by its commercialization in Europe, which has opened up new market opportunities for the drug.

 

Building on this momentum, the company revealed during its Q4 earnings call that it is evaluating the potential launch of a 200 mg version of Ilumya in the US market, following its rollout by a partner in Europe. This move could further expand the drug’s utility and competitive positioning in the immunology space. 

 

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 for arthritis treatment effectiveness—compared to placebo at Week 24.

 

The INSPIRE-1 trial included patients with prior exposure to anti-TNF therapies, while INSPIRE-2 focused on anti-TNF-naive 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. No induction dose was given.

 

Sun Pharma stated that the safety outcomes in the psoriatic arthritis trials were consistent with Ilumya’s known safety profile from earlier studies in plaque psoriasis. No new safety signals were reported.

 

If approved for psoriatic arthritis, Ilumya could significantly broaden its addressable market. PsA affects an estimated 2.4 million Americans, and nearly a third of psoriasis patients may go on to develop the joint condition—many of whom remain undiagnosed or undertreated.

 

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 is yet to be evaluated by regulatory authorities. 

 

Detailed findings from the INSPIRE studies will be presented at upcoming medical conferences and submitted for publication in peer-reviewed journals.

 

Ilumya is a monoclonal antibody that targets the p19 subunit of interleukin-23 (IL-23), thereby inhibiting inflammatory pathways. Common adverse reactions reported in prior clinical studies include upper respiratory infections, injection-site reactions, and diarrhoea. The drug carries warnings related to hypersensitivity, infections, and tuberculosis risk.

 

Sun Pharma is the largest pharmaceutical company in India and among the leading generic drugmakers globally, with operations in over 100 countries and a growing portfolio in dermatology, ophthalmology, and onco-dermatology.