**Sotyktu® (Deucravacitinib Tablets) Approved in China for Psoriatic Arthritis Indication**

Ushering in the “Dual Psoriasis” Treatment Era with Oral Small-Molecule Targeted Therapy

• Sotyktu^® (deucravacitinib) is the world’s first and currently only approved tyrosine kinase 2 (TYK2) allosteric inhibitor for clinical use, and is currently the only oral small-molecule targeted therapy approved in China for the simultaneous treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis ^[1]
• This approval for the psoriatic arthritis indication is based on positive results from two Phase III clinical trials, POETYK PsA-1 and POETYK PsA-2 ^[2],[3],[4], confirming that Sotyktu^® significantly improves multiple key disease assessment indicators, including ACR20, MDA, and PASI75, with benefits sustained through 52 weeks
• In both trials, the safety profile of Sotyktu^® was consistent with previous clinical findings, demonstrating good overall tolerability with no new safety signals identified

ShanghaiJune 15, 2026 /PRNewswire/ — Bristol Myers Squibb China announced that the world’s first tyrosine kinase 2 (TYK2) allosteric inhibitor, Sotyktu^® (deucravacitinib), has been approved by the National Medical Products Administration (NMPA) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to prior disease-modifying antirheumatic drugs (DMARDs). This product can be used alone or in combination with methotrexate (MTX). This also makes Sotyktu the only oral small-molecule targeted therapy currently approved in China for the simultaneous treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis^[1], offering a new oral targeted treatment option for the vast population of patients with psoriatic disease (PsD) in China.

“In China, approximately 6% to 13% of psoriasis patients also develop psoriatic arthritis, leading to joint pain, stiffness, functional impairment, and even irreversible disability. Furthermore, as psoriatic arthritis commonly affects young and middle-aged adults aged 30-50, it further increases the burden on individuals, families, and society.” Professor Xiaofeng Zeng, Director of the National Clinical Research Center for Rheumatic and Autoimmune Diseases, Tenured Professor at the Chinese Academy of Medical Sciences & Peking Union Medical College, and National Coordinating Investigator for the POETYK PsA-2 Phase III study, stated, “Like psoriasis, psoriatic arthritis is currently incurable and requires long-term medication. Therefore, there is a significant clinical need for highly effective, safe, and convenient oral therapies. The approval of deucravacitinib for the psoriatic arthritis indication provides a much-needed new oral treatment option for psoriatic arthritis, which is a welcome development for both physicians and patients.”

This approval of Sotyktu for the PsA indication is primarily based on positive results from two global Phase III clinical trials, POETYK PsA-1 and POETYK PsA-2, which confirmed the efficacy and safety of Sotyktu (6 mg, once daily, oral) in treating adult patients with active PsA. In both trials, treatment with Sotyktu resulted in significant and multifaceted improvements in disease symptoms, with clinical benefits sustained through 52 weeks. Trial assessment indicators included ACR20 response (primary endpoint), as well as multidimensional key secondary endpoints such as Minimal Disease Activity (MDA) response and PASI75 response.

Summary of Key Study Data from POETYK PsA-1 and POETYK PsA-2^{[2],[3],[4],[5]}

* After Week 16, patients entered the active treatment period, and those in the placebo group were switched to Sotyktu treatment

Notably, a post-hoc analysis of the POETYK PsA-1 trial observed Sotyktu inhibition of radiographic progression with continued treatment through Week 16^[2]. Although the prespecified analysis did not show a statistically significant difference between the Sotyktu group and the placebo group in the mean change from baseline (CfB) in modified mSvdH score, the post-hoc analysis revealed a statistically significant difference between the two groups. Furthermore, compared with the placebo group, a significantly higher proportion of patients in the Sotyktu group achieved no radiographic progression (defined as CfB ≤ 0 in mSvdH score at Week 16).

In both trials, Sotyktu demonstrated a generally favorable safety and tolerability profile, consistent with the safety characteristics observed in prior long-term follow-up data spanning up to 5 years in patients with moderate-to-severe plaque psoriasis^[6], with no new safety signals identified.

“From the skin to the joints, PsD brings multifaceted challenges to patients. With the approval of the psoriatic arthritis indication, Sotyktu can offer patients a ‘simplified’ treatment regimen, providing them the opportunity to enjoy a high quality of life. This is not only a practical interpretation of Bristol Myers Squibb’s ‘patient-centric’ mission but also reflects our deep expertise and steadfast commitment in the field of immunology.” Jiang Qian, President of Bristol Myers Squibb China, stated, “In the future, we will continue to explore the value and potential of Sotyktu in more diseases, and will remain focused on immune system diseases with significant unmet needs, accelerating the introduction of more innovative drugs to benefit patients in China, fulfilling our long-term commitment under the ‘China 2030 Strategy’.”

The information contained in this material is for reference purposes only. Please follow the advice or guidance of your physician or other healthcare professional.

About Psoriatic Arthritis

Psoriatic arthritis (PsA) is a chronic, immune-mediated, heterogeneous disease with diverse musculoskeletal and cutaneous manifestations, including inflammatory arthritis, enthesitis (inflammation at the site where tendons or ligaments attach to bone), dactylitis (swelling of an entire finger or toe), and psoriatic skin and nail lesions^[7]. In addition to causing physical functional impairment, pain, and fatigue, the disease significantly impacts patients’ overall health status. Patients with psoriatic arthritis also have an increased risk of developing serious comorbidities.

About Sotyktu (Deucravacitinib)

Sotyktu is an oral, highly selective tyrosine kinase 2 (TYK2) allosteric inhibitor with a unique mechanism of action, representing a new class of oral small-molecule targeted drugs. It is the first selective TYK2 allosteric inhibitor to be investigated in clinical trials for moderate-to-severe plaque psoriasis and active psoriatic arthritis. Bristol Myers Squibb scientists designed deucravacitinib to selectively target TYK2, thereby mediating the signaling of IL-23, IL-12, and type I interferons (IFN), cytokines that are key players in the pathogenesis of plaque psoriasis and psoriatic arthritis. Sotyktu achieves high selectivity for TYK2 by binding to its regulatory domain, inducing allosteric inhibition and thereby modulating its downstream signal transduction function. Within the physiological concentration range, deucravacitinib selectively inhibits TYK2. In in vitro assays, deucravacitinib has not been shown to inhibit JAK1, JAK2, or JAK3^[8]. Currently, the exact mechanism linking TYK2 enzyme inhibition to its clinical efficacy requires further clarification.

Sotyktu has been approved in multiple countries and regions worldwide for the treatment of adult patients with moderate-to-severe plaque psoriasis, accumulating 5 years of clinical efficacy and safety data in this treatment area^[6]. Since March 2026, Sotyktu has been approved in countries and regions including the United States and the European Union for the treatment of adult patients with active psoriatic arthritis.

About the Sotyktu Psoriatic Arthritis Phase III Trial Program

POETYK PsA-1 enrolled approximately 670 patients with active psoriatic arthritis who had not previously received biologic disease-modifying antirheumatic drugs (bDMARDs). POETYK PsA-2 enrolled approximately 624 patients with active psoriatic arthritis who were either bDMARD-naïve or had previously received tumor necrosis factor-alpha (TNF-α) inhibitor therapy. Enrolled patients met the CASPAR classification criteria for psoriatic arthritis, had at least 3 swollen joints and 3 tender joints, and had active or documented history of plaque psoriasis. Both trials included a 52-week treatment period, comprising a 16-week placebo-controlled period followed by a re-randomization and active treatment period from Week 16 to Week 52. The POETYK PsA-2 trial also included an apremilast safety reference arm.

The primary endpoint for both studies was the proportion of subjects achieving an ACR20 response (at least 20% improvement in disease signs and symptoms) at Week 16. Psoriatic arthritis disease activity at Week 16 was also evaluated as a key secondary endpoint.

Patients who completed 52 weeks of treatment in these two trials were eligible to participate in an open-label extension trial, with follow-up potentially extending up to Week 156^[2],[3].