Bristol Myers Squibb's Sotyktu Shows Promise in Psoriatic Arthritis Trial

Bristol Myers Squibb (BMS) has presented encouraging data from one of its two successful phase 3 trials of Sotyktu (deucravacitinib) in psoriatic arthritis (PsA), bolstering the company's bid to expand the drug's indications. The results, unveiled at the American Academy of Dermatology's annual meeting, demonstrate Sotyktu's potential to address both joint and skin symptoms in PsA patients.

POETYK PsA-2 Trial Results

In the POETYK PsA-2 trial, Sotyktu significantly outperformed placebo in achieving a 20% improvement in disease symptoms (ACR20 response). At Week 16, 54% of patients receiving Sotyktu reached the ACR20 response standard, compared to 39% on placebo. The trial enrolled 730 patients who were either biologic disease-modifying anti-rheumatic drug (bDMARD) naïve or had previously used a TNF blocker.

Dr. Philip Mease, a clinical professor at the University of Washington, commented on the results, stating, "Given the complex, multifaceted and heterogenous nature of psoriatic arthritis, there continues to be a significant need for safe and effective oral treatments. These results are particularly encouraging because they support the potential for Sotyktu to impact both joint and skin symptoms, as well as patient-reported quality of life outcomes."

The study also met key secondary endpoints, with a significantly higher proportion of Sotyktu patients achieving a 75% reduction in symptoms as measured by the Psoriasis Area and Severity Index (PASI). Additionally, Sotyktu-treated patients reported better outcomes in the Health Assessment Questionnaire-Disability Index (HAQ-DI) compared to those on placebo.

Competitive Landscape and Future Prospects

Sotyktu, an oral tyrosine kinase 2 (TYK2) inhibitor, was approved for plaque psoriasis in 2022. BMS estimates its peak sales potential across multiple indications at $4 billion. However, the drug's uptake has been slower than projected, with sales reaching $246 million in 2024, a 45% increase from the previous year.

The PsA market is highly competitive, with several established treatments and emerging therapies vying for market share. Amgen's Otezla, an oral PDE4 inhibitor, generated $2.1 billion in sales last year despite a 3% drop from 2023. Takeda's TAK-279, another TYK2 inhibitor acquired through the $4 billion purchase of Nimbus Lakshmi, has shown promising results in phase 2b studies for PsA.

Johnson & Johnson is also making strides in the field with JNJ-2113, an oral IL-23 antagonist developed in partnership with Protagonist Therapeutics. Recent head-to-head trials against Sotyktu in plaque psoriasis have yielded positive results for J&J's candidate.

BMS is continuing to investigate Sotyktu for other autoimmune diseases, including discoid lupus erythematosus (DLE), systemic lupus erythematosus (SLE), and Sjögren's syndrome. The company has advanced its DLE study to phase 2, while the others are in phase 3.

As the pharmaceutical industry continues to focus on developing oral therapies for autoimmune disorders, the success of Sotyktu in psoriatic arthritis could potentially reshape the treatment landscape for patients seeking alternatives to injectable biologics.