Overview of a First-in-Class Oral Innovation
Bristol Myers Squibb has announced the U.S. Food and Drug Administration (FDA) approval of Sotyktu™ (deucravacitinib). This medication represents a significant milestone as a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor. It is currently the only approved TYK2 inhibitor globally and stands as the first innovative oral treatment for moderate-to-severe plaque psoriasis to reach the market in nearly a decade.
Indications and Usage Guidelines
Sotyktu is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are eligible for systemic therapy or phototherapy. Clinical guidelines specify that Sotyktu is not recommended for use in combination with other potent immunosuppressants.
Superior Clinical Efficacy in POETYK PSO Trials
The FDA approval is rooted in the results of the pivotal Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials. These studies involved 1,684 patients aged 18 and older and demonstrated the following:
Comparative Performance against Placebo and Otezla®
Once-daily Sotyktu showed superior efficacy in improving skin clearance compared to both placebo and twice-daily Otezla® (apremilast). This superiority was clearly demonstrated at the 16-week and 24-week benchmarks.
Sustained Response and Long-term Treatment
The clinical trials confirmed that the therapeutic responses achieved with Sotyktu were not only rapid but also persistent, with efficacy maintained through 52 weeks of treatment.
Impact on the Psoriasis Patient Landscape
Psoriasis is a chronic, systemic immune-mediated disease affecting approximately 7.5 million people in the U.S. Plaque psoriasis is the most common form, characterized by silvery white scales and distinct plaques.
Addressing Unmet Medical Needs
With nearly two million people in the U.S. suffering from moderate-to-severe cases, many patients remain undertreated or dissatisfied with current topical and conventional options. Sotyktu offers a new mechanism of action that has the potential to become a new standard of care for oral treatment.
Safety and Tolerability Profile
Sotyktu has demonstrated a well-characterized safety profile. Based on the POETYK PSO trials at Week 16, the data revealed specific trends in patient experience:
Common Adverse Reactions
The most frequent adverse reactions (occurring in $ge 1%$ of patients and higher than the placebo group) included:
Upper respiratory infections (19.2%)
Blood creatine phosphokinase increase (2.7%)
Herpes simplex (2.0%)
Mouth ulcers (1.9%)
Folliculitis (1.7%)
Acne (1.4%)
Low Discontinuation Rates
The tolerability of the drug is further evidenced by discontinuation rates due to adverse events. Only 2.4% of patients on Sotyktu discontinued treatment, compared to 3.8% for placebo and 5.2% for Otezla.
Market Availability
Following its approval, Sotyktu was scheduled to become available to patients in the United States in September 2022, providing a new first-line systemic treatment option for the psoriasis community.
