{"id":62754,"date":"2026-03-07T04:06:42","date_gmt":"2026-03-07T03:06:42","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/u-s-fda-approves-bristol-myers-squibbs-sotyktu-deucravacitinib-for-the-treatment-of-adults-with-active-psoriatic-arthritis\/"},"modified":"2026-03-07T04:06:42","modified_gmt":"2026-03-07T03:06:42","slug":"u-s-fda-approves-bristol-myers-squibbs-sotyktu-deucravacitinib-for-the-treatment-of-adults-with-active-psoriatic-arthritis","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/u-s-fda-approves-bristol-myers-squibbs-sotyktu-deucravacitinib-for-the-treatment-of-adults-with-active-psoriatic-arthritis\/","title":{"rendered":"U.S. FDA Approves Bristol Myers Squibb\u2019s Sotyktu\u00ae (deucravacitinib) for the Treatment of Adults with Active Psoriatic Arthritis"},"content":{"rendered":"
\n

\nSignificantly more patients treated with once-daily, oral <\/i>Sotyktu achieved an ACR20 response compared with placebo at Week 16 in the pivotal Phase 3 POETYK PsA-1 and POETYK PsA-2 clinical trials<\/i><\/b><\/p>\n

\nSotyktu is the first and only tyrosine kinase 2 (TYK2) inhibitor to be approved for this indication<\/i><\/b><\/p>\n

PRINCETON, N.J.–(BUSINESS WIRE)–$BMY<\/a> #FDA<\/a>—Bristol Myers Squibb<\/a> (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Sotyktu<\/i>\u00ae<\/sup> (deucravacitinib) for the treatment of adults with active psoriatic arthritis (PsA).1<\/sup> Sotyktu<\/i>, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, is the first TYK2 inhibitor to be approved for PsA.<\/p>\n

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\n\u201cToday\u2019s announcement marks the introduction of a new, differentiated option to treat adults with active psoriatic arthritis,\u201d said Al Reba, senior vice president, Cardiovascular & Immunology Commercialization, Bristol Myers Squibb. \u201cThis latest approval of Sotyktu<\/i> confirms its important role in managing both skin and joint symptoms of psoriatic disease and is a key milestone as we continue to explore its development in diseases that have limited or no treatment options.\u201d<\/p>\n

\nThis FDA approval is based on positive results from the pivotal POETYK PsA-1 and POETYK PsA-2 trials, which evaluated the efficacy and safety of Sotyktu<\/i> 6 mg once daily in adults with active psoriatic arthritis. In both trials, treatment with Sotyktu<\/i> resulted in significant improvement in disease activity, as measured by American College of Rheumatology (ACR) 20 (the primary endpoint) and Minimal Disease Activity (MDA) response (key secondary endpoint).<\/p>\n

\nEfficacy Results at Week 16 in Adults with Psoriatic Arthritis (NRIa<\/sup>)1<\/sup><\/b><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

\n\u00a0<\/p>\n<\/td>\n

\n

\nPsA-1<\/b><\/p>\n<\/td>\n

\n

\nPsA-2<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

\nEndpoint<\/b><\/p>\n<\/td>\n

\n

\nSotyktu<\/i><\/b><\/p>\n

\n(N=336)<\/p>\n<\/td>\n

\n

\nPlacebo<\/b><\/p>\n

\n(N=334)<\/p>\n<\/td>\n

\n

\nDifference from Placebo<\/b><\/p>\n

\n(95% CI)<\/p>\n<\/td>\n

\n

\nSotyktu<\/i><\/b><\/p>\n

\n(N=312)<\/p>\n<\/td>\n

\n

\nPlacebo<\/b><\/p>\n

\n(N=312)<\/p>\n<\/td>\n

\n

\nDifference from Placebo<\/b><\/p>\n

\n(95% CI)<\/p>\n<\/td>\n<\/tr>\n

\n

\nACR20 response, %<\/p>\n<\/td>\n

\n

\n54b<\/sup><\/p>\n<\/td>\n

\n

\n34<\/p>\n<\/td>\n

\n

\n20(12, 27)<\/p>\n<\/td>\n

\n

\n54b<\/sup><\/p>\n<\/td>\n

\n

\n39<\/p>\n<\/td>\n

\n

\n15 (7, 23)<\/p>\n<\/td>\n<\/tr>\n

\n

\nACR50 response, %<\/p>\n<\/td>\n

\n

\n24<\/p>\n<\/td>\n

\n

\n14<\/p>\n<\/td>\n

\n

\n11 (5, 17)<\/p>\n<\/td>\n

\n

\n29<\/p>\n<\/td>\n

\n

\n16<\/p>\n<\/td>\n

\n

\n13 (6, 19)<\/p>\n<\/td>\n<\/tr>\n

\n

\nACR70 response, %<\/p>\n<\/td>\n

\n

\n12<\/p>\n<\/td>\n

\n

\n5<\/p>\n<\/td>\n

\n

\n6 (2, 10)<\/p>\n<\/td>\n

\n

\n10<\/p>\n<\/td>\n

\n

\n5<\/p>\n<\/td>\n

\n

\n5 (1, 9)<\/p>\n<\/td>\n<\/tr>\n

\n

\nMinimal disease activity response, %<\/p>\n<\/td>\n

\n

\n19c<\/sup>*<\/p>\n<\/td>\n

\n

\n10<\/p>\n<\/td>\n

\n

\n9 (4, 14)<\/p>\n<\/td>\n

\n

\n26c\u2020<\/sup><\/p>\n<\/td>\n

\n

\n15<\/p>\n<\/td>\n

\n

\n11 (5, 17)<\/p>\n<\/td>\n<\/tr>\n

\n

\nAmerican College of Rheumatology ><\/span>20% (or ><\/span>50% or ><\/span>70%) improvement)<\/p>\n<\/td>\n<\/tr>\n

ACR50 and ACR70 were additional endpoints. Additional endpoints were not adjusted for multiplicity; therefore, statistical significance has not been established.<\/b><\/td>\n<\/tr>\n
N is number of randomized and treated subjects<\/td>\n<\/tr>\n
* Statistically significant from placebo (p=0.0012)<\/td>\n<\/tr>\n
\u2020<\/sup> Statistically significant from placebo (p=0.0007)<\/td>\n<\/tr>\n
a<\/sup> NRI = Non-Responder Imputation<\/td>\n<\/tr>\n
b<\/sup> Multiplicity-controlled p<<\/span>0.0002, Sotyktu<\/i> vs. placebo comparison<\/td>\n<\/tr>\n
c<\/sup> Minimal disease activity (MDA) = 5 out of 7 outcomes: tender joint count <<\/span>1; swollen joint count <<\/span>1; Psoriasis Activity and Severity Index <<\/span>1 or body surface area <<\/span>3; patient pain visual analogue scale (VAS) <<\/span>15; patient global disease activity VAS <<\/span>20; Health Assessment Questionnaire Disability Index <<\/span>0.5; tender entheseal points <<\/span>1<\/td>\n<\/tr>\n<\/table>\n

\nThe overall safety profile of Sotyktu<\/i> observed in individuals with active psoriatic arthritis was generally consistent with the safety profile in those with plaque psoriasis. Most common adverse reactions (\u22651% in Sotyktu<\/i> and greater than placebo) are: upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis, and acne. Sotyktu<\/i> is associated with the following warnings and precautions: hypersensitivity reactions, infections, tuberculosis, malignancy including lymphomas, rhabdomyolysis and elevated CPK, laboratory abnormalities, immunizations, and potential risks related to JAK inhibition.1<\/sup><\/p>\n

\n\u201cPsoriatic arthritis is a chronic, progressive autoimmune condition that often involves both the joints and skin. Patients often have trouble moving and staying active and can experience pain in the joints, and tendons, or ligaments,\u201d2-4<\/sup> said Philip J. Mease, MD, director of rheumatology research, Providence Swedish Medical Center, and clinical professor, University of Washington School of Medicine. \u201cNew oral, effective first-line treatments are needed. In clinical trials, health-related quality of life was assessed by the 36-Item Short Form Health Survey (SF-36). Patients treated with Sotyktu<\/i> showed improvements in SF-36 Physical Component Summary (PCS) score at Week 16 compared to placebo (key secondary endpoint).1<\/sup> There were also improvements in all four SF-36 PCS domain scale scores: physical functioning, role-physical, bodily-pain, and general health.1 <\/sup>By aiding in symptom management, Sotyktu<\/i> could make a meaningful difference for patients.\u201d<\/p>\n

\n\u201cThe psoriatic disease community has been waiting for an additional oral treatment to address the debilitating joint and skin symptoms of this disease,\u201d said Steven Taylor, President & Chief Executive Officer of the Arthritis Foundation. \u201cWe welcome this new treatment option for people living with psoriatic arthritis.\u201d<\/p>\n

\nThe FDA first approved Sotyktu<\/i> in 2022 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Sotyktu<\/i> is not recommended for use with other potent immunosuppressants in this population. Since then, multiple global regulatory authorities have approved Sotyktu<\/i> for that indication. Sotyktu<\/i> has five years of clinical efficacy and safety data in patients with moderate-to-severe plaque psoriasis.<\/p>\n

\nToday’s approval of Sotyktu<\/i> in psoriatic arthritis is a tangible demonstration of Bristol Myers Squibb\u2019s commitment to develop medicines that help fill unmet needs in the treatment landscape.<\/p>\n

\nAbout Psoriatic Arthritis
\n
<\/b>Psoriatic arthritis (PsA) is a chronic, immune-mediated, heterogenous disease with multiple musculoskeletal and skin manifestations, including inflammatory arthritis, enthesitis (inflammation where tendon or ligament attaches to the bone), dactylitis (swelling of finger and toe joints) and psoriatic skin and nail lesions.2<\/sup> Up to 30 percent of patients with psoriasis go on to develop PsA.5<\/sup> In addition to impairments in physical function, pain and fatigue caused by PsA, the disease can significantly impact the well-being of patients.6<\/sup> Patients with PsA are also at increased risk of serious comorbidities.<\/p>\n

\nAbout the Sotyktu<\/i> Phase 3 Psoriatic Arthritis Trial Program
\n
<\/b>The Phase 3 Sotyktu<\/i> PsA program includes two Phase 3, multicenter, randomized, double-blind, placebo-controlled trials evaluating the efficacy and safety of Sotyktu <\/i>in adults 18 years of age and older with active PsA: POETYK PsA-1 (IM011-054; NCT04908202<\/a>) and POETYK PsA-2 (IM011-055; NCT04908189<\/a>).<\/p>\n

\nPOETYK PsA-1 included 670 patients with active PsA who were not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD na\u00efve). POETYK PsA-2 included 624 patients with active PsA who were bDMARD na\u00efve or had previously received TNF\u03b1 inhibitor treatment. Patients met the CASPAR criteria for PsA, with at least 3 swollen and 3 tender joints and had an active or documented history of plaque psoriasis. Both trials include a 52-week treatment period comprised of a placebo-controlled treatment period through Week 16, followed by a reallocation and continued active treatment period from Week 16 to Week 52. POETYK PsA-2 also included an apremilast safety reference arm.<\/p>\n

\nThe primary endpoint of both trials was the proportion of participants achieving an ACR20 response at Week 16. Key secondary endpoints were also assessed at Week 16 across measures of PsA disease activity.<\/p>\n

\nPatients in both trials completing 52 weeks of treatment were potentially eligible to enroll in open-label extensions through 156 weeks.7,8<\/sup><\/p>\n

\nAbout Sotyktu<\/i><\/span><\/b>\u00ae<\/sup><\/span> (deucravacitinib)
\n
<\/span><\/b>Sotyktu<\/i> is an oral, selective, tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action. It is the first selective TYK2 inhibitor in clinical studies across moderate-to-severe plaque psoriasis and active psoriatic arthritis.9<\/sup> Bristol Myers Squibb scientists designed Sotyktu<\/i> to selectively target TYK2, thereby mediating the signaling of interleukin (IL)-23, IL-12 and Type 1 interferons (IFN), key cytokines involved in the pathogenesis of plaque psoriasis and psoriatic arthritis. Sotyktu<\/i> achieves a high degree of selectivity by binding to the regulatory domain of TYK2, resulting in allosteric inhibition of TYK2 and mediation of its downstream functions. Sotyktu <\/i>has been shown to have high selectivity for TYK2 at physiologically relevant concentrations and has not been shown to inhibit JAK1, JAK2 or JAK3 in in vitro assays.9 <\/sup>The precise mechanism linking inhibition of TYK2 enzyme to therapeutic effectiveness is not currently known.<\/p>\n

\nSotyktu<\/i> is approved in numerous countries around the world for the treatment of adults with moderate-to-severe plaque psoriasis.10-12<\/sup><\/p>\n

\nThe efficacy and safety of Sotyktu<\/i> in patients with moderate-to-severe plaque psoriasis were evaluated in POETYK PSO-1 and POETYK PSO-2, multi-national, randomized, double-blind, placebo- and active comparator-controlled 52-week Phase 3 studies. In total, 664 patients were enrolled in POETYK PSO-1, and 1,020 patients were enrolled in POETYK PSO-2. All participants had moderate-to-severe plaque psoriasis and were candidates for phototherapy or systemic therapy.<\/p>\n

\nIMPORTANT SAFETY INFORMATION<\/span><\/b><\/p>\n

\nINDICATIONS<\/span><\/b><\/p>\n

\nSOTYKTU\u00ae<\/sup> (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
\n
Limitations of Use:
\n
<\/span>SOTYKTU is not recommended for use in combination with other potent immunosuppressants.<\/p>\n

\nSOTYKTU\u00ae<\/sup> is indicated for the treatment of active psoriatic arthritis in adults.<\/p>\n

\nIMPORTANT SAFETY INFORMATION<\/span><\/b><\/p>\n

\nCONTRAINDICATIONS<\/b><\/p>\n

\nSOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU.<\/p>\n

\nWARNINGS AND PRECAUTIONS<\/b><\/p>\n

\nHypersensitivity Reactions<\/b>: Hypersensitivity reactions such as angioedema have been reported. If a clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue SOTYKTU.<\/p>\n

\nInfections<\/b>: SOTYKTU may increase the risk of infections. Serious infections have been reported in patients who received SOTYKTU. The most common serious infections reported with SOTYKTU included pneumonia and COVID-19. Avoid use of SOTYKTU in patients with an active or serious infection. Consider the risks and benefits of SOTYKTU prior to initiating treatment in patients:<\/p>\n