Deucravacitinib in Psoriasis Patients with a History of Malignancy: Follow-up after 4 Years of Deucravacitinib Treatment in the POETYK PSO Program

Introduction: The global phase 3 POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) trials of deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, included psoriasis patients with a history of malignancy. This descriptive analysis evaluated malignancy events in deucravacitinib-treated patients with malignancy prior to enrolling in the POETYK PSO-1, PSO-2, and long-term extension (NCT04036435) trials. Methods: Patients in the pooled population who received ≥1 dose of deucravacitinib at any time over 4 years (data cutoff, November 1, 2023) were screened to identify those with a history of malignancy at baseline with no evidence of recurrence for >5 years prior to enrollment. Baseline patient demographics and clinical characteristics, type of prior malignancy, total deucravacitinib exposure, deucravacitinib treatment discontinuation, and occurrence of malignancy were evaluated for each patient with a history of malignancy. Results: Among 1519 deucravacitinib-treated patients, 19 had a history of malignancy (12 had a history of malignancy excluding nonmelanoma skin cancer [NMSC]; 7 had NMSC). Patients with a history of malignancy were older (mean age, 64.3 vs 46.6 years), had longer disease duration (mean, 36.2 vs 18.7 years), and had shorter deucravacitinib exposure (median, 814 vs 1298 days) compared with the total pooled population. Six of the 12 (50.0%) patients with a history of malignancy excluding NMSC discontinued treatment due to patient withdrawal (n=2), occurrence of malignancy (n=1), adverse events (n=1), lost to follow-up (n=1), or study site termination (n=1). Among the 12 patients with a history of malignancy excluding NMSC, there was 1 occurrence of malignancy. Conclusion: Malignancies were infrequently observed with deucravacitinib treatment in psoriasis patients with a history of malignancy. Analysis of larger patient populations over a longer duration of follow-up using real-world data will help to further characterize the safety of deucravacitinib in psoriasis patients with a history of malignancy.