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STRIDE phase II 52‑week OLE: Envudeucitinib in moderate-to-severe plaque PsO
Results from the phase II, 52‑week open-label extension (OLE) of the STRIDE study (NCT05739435), assessing the long-term safety and efficacy of envudeucitinib, an oral tyrosine kinase 2 inhibitor (TYK2i), in adults with moderate-to-severe plaque psoriasis (PsO), were published in the Journal of the American Academy of Dermatology by Papp et al. The primary endpoints were incidence of treatment-emergent adverse events (TEAEs) and incidence of serious adverse events (SAEs). Secondary endpoints included change from baseline in Psoriasis Area and Severity Index (PASI), static Physician’s Global Assessment (sPGA), psoriasis body surface area (BSA) coverage, and pruritus Numerical Rating Scale (NRS), as well as change from baseline in Dermatology Life Quality Index (DLQI) and pharmacokinetic (PK) parameters.
Key data: Of the 165 patients enrolled in the OLE, 76.4% of patients remained on treatment at data cutoff. Over 52 weeks of treatment with envudeucitinib, 65.9% of patients experienced ≥1 TEAE, most of which were mild (23.8%) or moderate (37.2%). The most common adverse events (AEs) were nasopharyngitis (8.5%), upper respiratory tract infection (URTI; 9.8%), headache (6.1%), and COVID-19 infection (6.7%). Overall, 3.7% of patients experienced an SAE. The overall frequency of AEs did not significantly differ between the 40 mg once daily (QD) and the 40 mg twice daily (BID) arms. Efficacy response rates were greater in the 40 mg BID group and were maintained for the duration of treatment; at Week 52, 78%, 61%, 39%, and 39% of patients had PASI‑75, PASI‑90, PASI‑100, and sPGA‑0 responses, respectively, in the 40 mg BID arm.
Key learning: Long-term treatment with envudeucitinib demonstrated a manageable safety profile while maintaining efficacy over 52 weeks. Results support envudeucitinib as a potential oral treatment option for patients with moderate-to-severe plaque PsO. Limitations of this study include the small sample size and absence of a control arm.
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