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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).
“The European approval of Sotyktu for active psoriatic arthritis represents an important advancement in addressing both the skin and joint symptoms of this chronic immune-mediated disease,” said Al Reba, senior vice president, cardiovascular & immunology commercialization, Bristol Myers Squibb. “This milestone marks a new approach to treating psoriatic arthritis, and we look forward to continuing the development of Sotyktu for other serious rheumatic conditions as part of our commitment to addressing the life-altering impact of these diseases.”
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).
“Psoriatic arthritis presents differently from patient to patient, often combining widespread musculoskeletal inflammation and challenging skin symptoms with a debilitating impact on quality of life,” said Frank Behrens, MD, Professor of Rheumatology, Immunology, and Inflammation Medicine, Goethe-University Hospital, Frankfurt. “The impressive safety and the efficacy profile observed in the pivotal POETYK PsA trials demonstrate the ability of Sotyktu, the first approved TYK2 inhibitor, to provide comprehensive relief for adults living with this chronic, immune-mediated inflammatory disease.”
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 US 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 US 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.
Bristol Myers Squibb thanks the patients and investigators who participated in the POETYK PsA clinical trials.
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. Up to 30 per cent 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.
The phase 3 Sotyktu psoriatic arthritis (PsA) programme 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. 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.
The 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.
Patients in both trials completing 52 weeks of treatment were potentially eligible to enroll in open-label extensions.
In both POETYK PsA-1 and POETYK PsA-2 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).
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 signalling 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 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.
Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. For people living with immune-mediated diseases, the debilitating reality of enduring chronic symptoms and disease progression can make simple tasks and daily life a challenge. Driven by our deep understanding of the immune system that spans over 20 years of experience, we continue to pursue bold science as we work to deliver life-changing medicines that elevate new standards of care across rheumatology, dermatology and pulmonology. Our sequential immunotherapy research framework aims to address the root cause of disease by controlling inflammation, resetting the immune system and promoting immune homeostasis with the goal of achieving transformational efficacy. By continuously pushing the boundaries of scientific knowledge, we strive to bring forward tailored approaches, treatments and combinations that may lead to durable remissions, improved quality of life and functional cures. Our collaborations with patients, caregivers, healthcare providers and researchers inform our patient-centric approach as we aim to break efficacy ceilings and deliver what matters most — the promise of living a better life.
Sotyktu (deucravacitinib) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.
Bristol Myers Squibb’s mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. The company pursuing bold science to define what’s possible for the future of medicine and the patients we serve.
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