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European Academy of Dermatology and Venereology (EADV) | 2024 | iPharmaCenter

New Four-Year Data on Sotyktu (deucravacitinib) Highlight Sustained Efficacy and Consistent Safety in Moderate-to-Severe Plaque Psoriasis

Four years of continuous Sotyktu treatment have shown durable clinical responses in over 70% of patients for PASI 75 in the POETYK PSO long-term extension study. The safety profile remains stable, with no new concerns identified.

Bristol Myers Squibb has shared new four-year results from the POETYK PSO long-term extension (LTE) study, focusing on Sotyktu (deucravacitinib) for adults with moderate-to-severe plaque psoriasis.

Continuous treatment over four years led to Week 208 outcomes with 71.7% of patients achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI 75), 47.5% achieving PASI 90, and 57.2% attaining a static Physician’s Global Assessment (sPGA) score of 0/1 (clear/almost clear).

These results were calculated using modified nonresponder imputation (mNRI). Importantly, the safety profile of Sotyktu after four years remained consistent with previous data, with no new safety issues.

The efficacy analysis encompassed 513 patients who had received uninterrupted Sotyktu treatment from the start of the pivotal POETYK PSO-1 and POETYK PSO-2 trials, continuing into the POETYK PSO-LTE study. These patients maintained clinical efficacy with continuous treatment, as demonstrated by the sustained response rates: PASI 75 at 71.7% at Year 4 (compared to 72.0% at Year 1 and 73.8% at Year 3), PASI 90 at 47.5% (45.6% at Year 1 and 49.0% at Year 3), and sPGA 0/1 at 57.2% (57.7% at Year 1 and 55.2% at Year 3).

The safety analysis included 1,519 patients who received at least one dose of Sotyktu in the POETYK PSO-1, POETYK PSO-2, and POETYK PSO-LTE trials. The cumulative exposure for safety analysis was 4,392.8 patient-years. Over time, the exposure-adjusted incidence rates (EAIRs) per 100 patient-years at Year 4 showed a decline or stability compared to Year 1 for various adverse events (AEs): AEs (Year 1: 229.2; Year 4: 131.7), serious AEs (Year 1: 5.7; Year 4: 5.0), discontinuations due to AEs (Year 1: 4.4; Year 4: 2.2), herpes zoster (Year 1: 0.8; Year 4: 0.6), malignancies (Year 1: 1.0; Year 4: 0.9), major adverse cardiovascular events (Year 1: 0.3; Year 4: 0.3), venous thromboembolism (Year 1: 0.2; Year 4: 0.1), and deaths (Year 1: 0.2; Year 4: 0.3).

The POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) trials were global Phase 3 studies evaluating Sotyktu against placebo and Otezla (apremilast) in patients with moderate-to-severe plaque psoriasis. These multicenter, randomized, double-blind trials compared Sotyktu (6 mg once daily) to placebo and Otezla (30 mg twice daily). POETYK PSO-2 included a period of randomized withdrawal and retreatment post-Week 24.

The primary endpoints for both POETYK PSO-1 and POETYK PSO-2 were the proportion of patients achieving PASI 75 and a sPGA score of 0 or 1 at Week 16 versus placebo. Key secondary endpoints involved comparisons with Otezla at Week 16 and other measures.

Across all trials, significantly more patients treated with Sotyktu reached PASI 75, PASI 90, and sPGA 0/1, with responses persisting through Week 52. In POETYK PSO-1, 82% of patients maintaining PASI 75 at Week 24 continued their response at Week 52, while in POETYK PSO-2, 80% maintained PASI 75 compared to 31% of those withdrawn from Sotyktu.

After the 52-week POETYK PSO-1 and POETYK PSO-2 studies, patients could join the ongoing POETYK PSO-LTE trial (NCT04036435) to receive open-label Sotyktu. In this LTE trial, 1,221 patients received at least one dose of Sotyktu. Efficacy was assessed using treatment failure rules (TFR) and sensitivity analyses, including mNRI and as-observed analysis.

Bristol Myers Squibb is also conducting two other Phase 3 studies, POETYK PSO-3 (NCT04167462) and POETYK PSO-4 (NCT03924427), to evaluate Sotyktu in psoriasis.


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