Significantly more psoriatic arthritis (PsA) patients treated with deucravacitinib (Sotyktu, BMS) achieved at least a 20 percent improvement in signs and symptoms of disease (American College of Rheumatology [ACR] 20) compared with placebo at Week 16, according to new data from the Phase 3 POETYK PsA-1 trial presented at the European Alliance of Associations for Rheumatology (EULAR) Congress in Barcelona, Spain.

Fully 54.2% of patients taking deucravacitinib who were not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD) achieved an ACR20 response, compared with 34.1% of their counterparts who received placebo, the study showed.

The safety profile of deucravacitinib through 16 weeks of treatment was consistent with what has been reported throughout the clinical trial programs for the oral, selective tyrosine kinase 2 (TYK2) inhibitor.

“Psoriatic arthritis can be a complex, multifaceted and heterogeneous disease, underscoring the significant need to equip healthcare providers with new safe and effective oral treatment options,” says Philip Mease, MD, Director of Rheumatology Research at Providence Swedish Medical Center and Clinical Professor at the University of Washington School of Medicine in Seattle, WA, in a news release. “Improvements in joint and skin symptoms, as well as quality of life, are important treatment goals, and the results demonstrated in this Phase 3 study across these parameters highlight the potential of Sotyktu as a new way of treating this debilitating disease.”

Patients treated with deucravacitinib saw improvements across a wide range of clinical measures of disease activity, patient-reported outcomes, and extra-articular manifestations of PsA at Week 16. Several key secondary endpoints were met, including Psoriasis Area and Severity Index (PASI) 75 response, Health Assessment Questionnaire-Disability Index (HAQ-DI) score, 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) score, and Minimal Disease Activity (MDA) response. Additionally, improvements were observed for ACR50 and ACR70 responses.

Nominally significant differences were observed in Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) score, 28-Joint Disease Activity Score-C-Reactive Protein (DAS28-CRP) score, and dactylitis resolution pooled analysis, the study showed.

Moreover, inhibition of radiographic progression was observed with deucravacitinib at Week 16 in post hoc analyses. While the prespecified analysis did not show a statistically significant difference between deucravacitinib and placebo in mean change from baseline (CfB) in the modified Sharp-van der Heijde (mSvdH) score, results from a post hoc analysis demonstrated a statistically significant difference between the treatment groups.

Further, a significantly greater proportion of patients treated with deucravacitinib did not have radiographic progression (defined as a CfB to Week 16 in mSvdH score of less than or equal to 0) versus placebo.

No new safety signals were identified in the POETYK PsA-1 trial. The most frequent adverse event (AE) in both the deucravacitinib and placebo arms was upper respiratory tract infection (5.1% versus 3.0%, respectively). Serious AEs (1.8% versus 2.4%, respectively) and AEs that led to discontinuation (2.4% versus 1.8%, respectively) were infrequent though Week 16.

Continued improvement of clinical responses and maintenance of outcomes through Week 52 in POETYK PsA-2

New data from the Phase 3 POETYK PsA-2 trial, which evaluated patients with active PsA who were bDMARD naïve or had previously received TNFα inhibitor treatment, showed superior efficacy of deucravacitinib compared with placebo at Week 16. Additionally, through Week 52, clinical responses continued to improve for those who remained on or switched to deucravacitinib treatment, and outcomes were maintained for those receiving continuous deucravacitinib treatment.

At Week 16, 54.2% of deucravacitinib-treated patients achieved ACR20 response versus 39.4% of those receiving placebo. At Week 52, 62.2% of patients receiving continuous deucravacitinib treatment and 67.3% of patients who switched from placebo to deucravacitinib after Week 16 achieved ACR20 response. Similar trends were observed for ACR50 and ACR70.

Additionally, key secondary endpoints continued to be maintained with deucravacitinib treatment compared with placebo at Week 52, including PASI 75 response, MDA response, HAQ-DI score, and SF-36 PCS score. Deucravacitinib was well tolerated through Week 52, demonstrating a safety profile consistent with previous results of Sotyktu in PsA and PsO.

Deucravacitinib is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.