\n\u201cThe European approval of\u00a0Sotyktu<\/i>\u00a0for active psoriatic arthritis represents an important advancement in addressing both the skin and joint symptoms of this chronic immune-mediated disease,\u201d said Al Reba, senior vice president, Cardiovascular & Immunology Commercialization, Bristol Myers Squibb. \u201cThis milestone marks a new approach to treating psoriatic arthritis, and we look forward to continuing the development of Sotyktu<\/i> for other serious rheumatic conditions as part of our commitment to addressing the life-altering impact of these diseases.\u201d<\/p>\n
\nThis EU approval is based on positive results from the pivotal POETYK PsA-1 and POETYK PsA-2 Phase 3 clinical trials, which evaluated the efficacy and safety of Sotyktu<\/i> 6 mg once daily in adults with active PsA. 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) (key secondary endpoint).<\/p>\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. The most common adverse reactions (\u22651%) are upper respiratory infections, blood creatine phosphokinase increased, herpes simplex infections, oral ulcers, acneiform rash and folliculitis. Sotyktu <\/i>is associated with the following special warnings and precautions for use: infections; pre-treatment evaluation for tuberculosis; malignancies; major adverse cardiovascular events, deep venous thrombosis and pulmonary embolism; immunizations; and excipients (lactose, sodium).<\/p>\n
\n\u201cPsoriatic arthritis presents differently from patient to patient, often combining widespread musculoskeletal inflammation and challenging skin symptoms with a debilitating impact on quality of life,\u201d said Frank Behrens, MD, Professor of Rheumatology, Immunology, and Inflammation Medicine, Goethe-University Hospital, Frankfurt. \u201cThe impressive safety and the efficacy profile observed in the pivotal POETYK PsA trials demonstrate the ability of Sotyktu<\/i>, the first approved TYK2 inhibitor, to provide comprehensive relief for adults living with this chronic, immune-mediated inflammatory disease.\u201d<\/p>\n
\nIn 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), with improvements maintained in both POETYK PsA trials up to Week 52.<\/p>\n
Sotyktu <\/i>was approved by the U.S. Food and Drug Administration (FDA) on March 6, 2026 for the treatment of adults with active PsA. Sotyktu<\/i> was first approved in 2022 by the U.S. FDA for the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy. Per that approval, Sotyktu<\/i> is not recommended for use with other potent immunosuppressants in the PsO population. In 2023, Sotyktu<\/i> was approved by the European Commission for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. 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
\nBristol Myers Squibb thanks the patients and investigators who participated in the POETYK PsA clinical trials.<\/p>\n
About Psoriatic Arthritis<\/b><\/p>\n
\nPsoriatic 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.Up to 30 percent of patients with psoriasis go on to develop PsA. In addition to impairments in physical function, pain and fatigue caused by PsA, the disease can significantly impact the well-being of patients. Patients with PsA are also at increased risk of serious comorbidities.<\/p>\n
About the Sotyktu<\/i> Phase 3 Psoriatic Arthritis Trial Program<\/b><\/p>\n
\nThe Phase 3 Sotyktu<\/i> psoriatic arthritis (PsA) program includes two Phase 3, multicenter, randomized, double-blind, placebo-controlled trials evaluating the efficacy and safety 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 \u22653 swollen and \u22653 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.<\/p>\n \nIn both POETYK PsA-1 and POETYK PsA-2 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) (key secondary endpoint).<\/p>\n Efficacy Results in Adults with Psoriatic Arthritis<\/b><\/p>\n
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