TYK2 Inhibitor Deucravacitinib FDA Approved for Psoriatic Arthritis Save

Deucravacitinib was previously FDA approved in 2022 for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Deucravacitinib inhibits TYK2, and thus 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.

Positive results from the pivotal POETYK PsA-1 (670 biologic naive patients) and POETYK PsA-2 (624 patients) trials demonstrated the efficacy and safety of deucravacitinib 6 mg once daily in adults with active psoriatic arthritis. In both trials, the ACR 20 (primary endpoint) and Minimal Disease Activity (MDA) response (key secondary endpoint) were superior to placebo at week 16.  Patients in both trials completing 52 weeks of treatment were potentially eligible to enroll in open-label extensions through 156 weeks.

Most common adverse reactions (≥1% ) were: upper respiratory infections, blood creatine phosphokinase increased, herpes simplex, mouth ulcers, folliculitis, and acne. The drug comes with the following warnings and precautions: hypersensitivity reactions, infections, tuberculosis, malignancy including lymphomas, rhabdomyolysis and elevated CPK, laboratory abnormalities, immunizations, and potential risks related to JAK inhibition.

Important considerations from the updated deucravacitinib package insert:

• New Indication: the treatment of active psoriatic arthritis in adults
• Recommended dosage is 6 mg orally once daily, with or without food
• Sotyktu is not recommended for use with other potent immunosuppressants in this population
• Infection warnings: DEUCRA may increase the risk of infection. Avoid use in patients with active or serious infection. If a serious infection develops, discontinue DEUCRA until the infection resolves.  
  • Patients should be tested for latent or active TB prior to initiating treatment
  • Avoid with live vaccines
  • Herpes zoster and herpes simplex adverse events have been reported
• Lab abnormalities: Elevated LFTs, triglcyerides and CPK have been reported.  Most CPK elevations have been asymptomatic. But there have been reports of rhabdomyolysis with CPK elevation. Stopping the drug is advised in these rare situations.