Oral selective tyrosine kinase 2 (TYK2) inhibitor deucravacitinib was found to be well tolerated and effective in treating psoriatic arthritis (PsA), according to study results published in Annals of the Rheumatic Diseases.
Investigators sought to evaluate the safety and efficacy of deucravacitinib in patients with active PsA in a phase 2 double-blind trial (ClinicalTrials.gov Identifier: NCT03881059).
The study included participants randomly assigned 1:1:1 to receive deucravacitinib 6 mg daily, deucravacitinib 12 mg daily, or placebo.
Primary study endpoint was the week-16 American College of Rheumatology 20 (ACR20) response. Secondary endpoints included change from baseline in Psoriasis Area and Severity Index (PASI)-75 response and Health Assessment Questionnaire Disability Index (HAQ-DI) and Short Form-36 (SF-36) Physical Component Summary score.
Logistic regression was used to examine associations between dose level and ACR20 at week 16.
A total of 203 participants (n=70 for 6 mg deucravacitinib; n=67 for 12 mg deucravacitinib; and 66 for placebo) were included in the study, with 180 participants 180 (89%) completing the full 16-week treatment course.
Compared with placebo, a significantly higher ACR20 response was observed at week 16 among participants who received deucravacitinib 6 mg daily (31.8% vs 52.9%; odds ratio [OR] 2.4; 95% CI, 1.2-4.8; P =.0134) and deucravacitinib 12 mg daily (31.8% vs 62.7%; OR 3.6; 95% CI, 1.8-7.4; P =.0004). Both deucravacitinib doses were also associated with significant improvements compared with placebo in secondary endpoints (P ≤.05), as well as other exploratory endpoints, including intergroup comparisons over time.
Adverse events among those who received deucravacitinib included diarrhea, headache, rash, bronchitis, sinusitis, upper respiratory tract infection, and nasopharyngitis; however, none were serious. No cases of major adverse cardiovascular events, opportunistic infections, herpes zoster, or significant changes in laboratory parameters occurred.
Limitations to this study included the small sample size and limited generalizability.
The study researchers concluded that “selective inhibition of TYK2 with deucravacitinib is a promising therapeutic option for PsA,” demonstrating “efficacy across multiple disease domains and patient-reported outcomes.” They also noted that larger, longer trials “are warranted to establish the long-term efficacy and safety profile of deucravacitinib in patients with active PsA.”
Disclosure: This clinical trial was supported by Bristol Myers Squibb. Please see the original reference for a full list of authors’ disclosures.
Mease PJ, Deodhar AA, van der Heijde D, et al. Efficacy and safety of selective TYK2 inhibitor, deucravacitinib, in a phase II trial in psoriatic arthritis. Ann Rheum Dis. Published online March 3, 2022. doi:10.1136/annrheumdis-2021-221664