Announcement • 10h
Bristol Myers Squibb Receives European Commission Approval of Sotyktu for the Treatment of Active Psoriatic Arthritis in Adults
Bristol Myers Squibb announced that the European Commission has granted approval to Sotyktu (deucravacitinib), alone or in combination with methotrexate, for the treatment of active psoriatic arthritis (PsA) in adults who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic (DMARD) therapy. Sotyktu, a once-daily oral, selective tyrosine kinase 2 (TYK2) inhibitor, is the first TYK2 inhibitor to be approved for the treatment of active PsA in the European Union (EU). This 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 6 mg once daily in adults with active PsA. In both trials, treatment with Sotyktu 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). The overall safety profile of Sotyktu observed in individuals with active psoriatic arthritis was generally consistent with the safety profile in those with plaque psoriasis. The most common adverse reactions (=1%) are upper respiratory infections, blood creatine phosphokinase increased, herpes simplex infections, oral ulcers, acneiform rash and folliculitis. Sotyktu 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). In clinical trials, health-related quality of life was assessed by the 36-Item Short Form Health Survey (SF-36). Patients treated with Sotyktu 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. Sotyktu was approved by the U.S. Food and Drug Administration (FDA) on March 6, 2026 for the treatment of adults with active PsA. Sotyktu 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 is not recommended for use with other potent immunosuppressants in the PsO population. In 2023, Sotyktu 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 for that indication. Sotyktu has five years of clinical efficacy and safety data in patients with moderate-to-severe plaque psoriasis. The Phase 3 Sotyktu 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) and POETYK PsA-2 (IM011-055; NCT04908189). POETYK PsA-1 included 670 patients with active PsA who were not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD naïve). POETYK PsA-2 included 624 patients with active PsA who were bDMARD naïve or had previously received TNFa inhibitor treatment. Patients met the CASPAR criteria for PsA, with =3 swollen and =3 tender joints and had an active or documented history of plaque psoriasis. Non-responder imputation (NRI) was used up to Week 16. After Week 16, observed data is shown with no imputation. N is number of randomized patients. a p=0.0002 b p=0.001 c Nominal p=0.0002 d Nominal p=0.02 * Data are shown for available subjects in the format of % (n/N) observed Minimal disease activity (MDA) = 5 out of 7 outcomes: tender joint count =1; swollen joint count =1; Psoriasis Activity and Severity Index =1 or body surface area =3%; patient pain visual analogue scale (VAS) =15; patient global disease activity VAS =20; Health Assessment Questionnaire Disability Index =0.5; tender entheseal points =1 Sotyktu 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. Bristol Myers Squibb scientists designed Sotyktu 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 achieves a high degree of selectivity by binding to the regulatory domain of TYK2, resulting in inhibition of TYK2 and mediation of its downstream functions. Sotyktu 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 vitro assays. The precise mechanism linking inhibition of TYK2 enzyme to therapeutic effectiveness is not currently known. Sotyktu is approved in numerous countries around the world for the treatment of adults with moderate-to-severe plaque psoriasis and is also approved in the United States for the treatment of active psoriatic arthritis in adults. The efficacy and safety of Sotyktu 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. SOTYKTU (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. SOTYKTU is not recommended for use in combination with other potent immunosuppressants. SOTYKTU is indicated for the treatment of active psoriatic arthritis in adults. SOTYKTU is contraindicated in patients with a history of hypersensitivity reaction to deucravacitinib or to any of the excipients in SOTYKTU. 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: with chronic or recurrent infection; who have been exposed to tuberculosis; with a history of a serious or an opportunistic infection; with underlying conditions that may predispose them to infection.
