For dermatologists and other clinicians prescribing systemic therapies, SOTYKTU provides an oral TYK2 inhibitor option for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy ^[1][4]. The source data show higher proportions of patients achieved sPGA 0/1 and PASI 75 at Week 16 with deucravacitinib versus placebo in Trial PSO-1, and apremilast was included as an active comparator arm in the POETYK PSO trials ^[4][3]. What are the longer-term comparative effectiveness and safety outcomes of deucravacitinib versus biologic systemic therapies in routine clinical practice beyond the trial comparisons with apremilast?

Q1 What is deucravacitinib (SOTYKTU) approved for?

Deucravacitinib (SOTYKTU) is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The U.S. prescribing information also lists an indication for the treatment of active psoriatic arthritis in adults in more recent labeling updates. The FDA originally approved SOTYKTU on September 9, 2022 for plaque psoriasis based on data from the POETYK PSO trials.

Q2 How does deucravacitinib work?

Deucravacitinib is an inhibitor of tyrosine kinase 2 (TYK2). It binds to the regulatory domain of TYK2 and stabilizes an inhibitory interaction between the regulatory and catalytic domains, resulting in allosteric inhibition of receptor-mediated TYK2 activation and downstream activation of STATs as described in cell-based assays in the prescribing information.

Q3 What is the recommended dose of deucravacitinib (SOTYKTU)?

The recommended dosage of SOTYKTU is 6 mg taken orally once daily, with or without food, which is the dose described in the prescribing information and labeling. SOTYKTU tablets should not be crushed, cut, or chewed, and the label provides guidance about use in hepatic impairment and pre-initiation evaluations for infections and immunizations. Clinicians should consult current prescribing information for complete dosing guidance.

Q4 What are the most common side effects of deucravacitinib?

The most common adverse reactions reported at a frequency ≥1% in the pooled placebo-controlled periods of Trials PSO-1 and PSO-2 included upper respiratory infections, blood creatine phosphokinase increased, herpes simplex infections, mouth ulcers, folliculitis, and acne. Serious infections such as pneumonia and COVID-19 were reported; other safety findings in the label include hypersensitivity reactions (e.g., angioedema), herpes zoster, malignancies including lymphomas, rhabdomyolysis, triglyceride elevations, and liver enzyme elevations.

Clinicians should consult current prescribing information for complete dosing guidance.