Bristol Myers Launches Novel Drug for Treatment of Adults with Psoriasis
Bristol Myers Squibb has introduced Sotyktu (deucravacitinib), a groundbreaking selective tyrosine kinase 2 (TYK2) inhibitor, as a treatment option for adults with moderate-to-severe plaque psoriasis who are eligible for systemic therapy.
This innovative approach marks a new paradigm in addressing the challenges posed by this chronic immune-mediated disease.
Notably, the European Commission has granted approval for this novel drug, further validating its efficacy and safety for patients.
Sotyktu (deucravacitinib) is an oral medication that belongs to a novel class of small molecules. It acts as a selective, allosteric inhibitor of tyrosine kinase 2 (TYK2) with a distinctive mechanism of action.
This makes it the first selective TYK2 inhibitor being studied in clinical trials for various immune-mediated diseases. Sotyktu is specifically designed to target TYK2 and effectively block the signaling of crucial cytokines such as interleukin (IL)-23, IL-12, and Type 1 interferons (IFN). These cytokines play a significant role in the development of multiple immune-mediated diseases.
Through its mechanism of action, Sotyktu exhibits an exceptional level of selectivity by binding specifically to the regulatory domain of TYK2. This binding enables Sotyktu to exert allosteric inhibition, effectively dampening the downstream functions of TYK2.
Particularly, Sotyktu selectively inhibits TYK2 at physiologically relevant concentrations, while maintaining its therapeutic effects. Importantly, this selectivity profile ensures that Sotyktu does not interfere with other closely related kinases such as JAK1, JAK2, or JAK3 at therapeutic doses.
The approval of Sotyktu was supported by findings from the Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials. These trials showcased the remarkable effectiveness of Sotyktu, administered once daily, surpassing the outcomes of both placebo and the twice-daily medication Otezla® (apremilast) at 16 and 24 weeks. Furthermore, the positive responses to Sotyktu were sustained throughout the duration of 52 weeks.
The approval of Sotyktu was further supported by additional data from the long-term extension trial (LTE) of the POETYK PSO study. This LTE trial provided valuable evidence to strengthen the approval decision. Moreover, the comprehensive POETYK study program demonstrated a consistent safety profile in patients over a continuous treatment period of three years.
Psoriasis, a systemic immune-mediated disease, is highly prevalent, affecting an estimated 14 million individuals in Europe, making the approval of Sotyktu a significant advancement in addressing this chronic condition.
Psoriasis vulgaris, or plaque psoriasis, affects approximately 90% of patients with psoriasis. This type of psoriasis is characterized by distinctive round or oval plaques that are commonly covered by silvery-white scales. Nearly one-quarter of individuals with psoriasis experience moderate to severe cases. Existing treatment options for psoriasis include topical medications, oral therapies, and biologics. However, there is a growing demand for oral treatments that are both effective and well-tolerated, as patients and healthcare providers seek additional viable options to manage this chronic condition.
The most commonly reported adverse reaction associated with Sotyktu was upper respiratory infections, particularly nasopharyngitis, occurring in 18.9% of patients. The incidence of serious infections in the Sotyktu group (0.6%) was comparable to that of the placebo group (0.5%). The majority of infections were mild to moderate in severity and non-serious, resulting in no discontinuation of Sotyktu treatment.
During the initial 16 weeks, infections were observed in 29.1% of patients in the Sotyktu group, while the placebo group had a rate of 21.5%. Notably, the rate of infections and serious infections did not increase over the course of 52 weeks, indicating a consistent safety profile for Sotyktu in the longer term, aligning with previous findings.
