Deucravacitinib 6mg tablets

Introduction: Psoriasis is a chronic, immune-mediated skin condition with significant detriments to physical/mental health. While systemic therapies are available for the treatment of moderate-to-severe psoriasis, patients can experience therapeutic failure, loss of efficacy, or medical contraindications that require other therapeutic options. Objective: With the recent approval of deucravacitinib, a first-in-class TYK2 small molecule inhibitor administered orally for psoriasis patients, we reviewed data from randomized controlled trials (RCTs) to synthesize its clinical utility. To our knowledge, this is the first systematic review and meta-analysis of deucravacitinib comparing its clinical efficacy to placebo in psoriasis. Methods: A literature search was conducted in PubMed (MEDLINE), Embase, and the Cochrane Central Register of Controlled Trials to identify RCTs studying deucravacitinib in human patients with moderate-to-severe psoriasis. Results: One placebo-controlled Phase II RCT and two placebo-controlled/active-comparator Phase III RCTs were included for review. Patients (N=1953) treated with deucravacitinib 6 mg daily showed marked improvement in disease severity (Psoriasis Area and Severity Index (PASI), static Physician Global Assessment (sPGA) and quality-of-life outcomes compared to patients administered comparator (apremilast) and placebo. Clinical improvement given deucravacitinib was noted for scalp psoriasis but not fingernail psoriasis. Meta-analysis (deucravacitinib, n=888; placebo, n=466) comparing rates of clearance (sPGA 0/1) demonstrated superior efficacy of deucravacitinib compared to placebo (odds ratio, 12.87; 95% confidence interval, 8.97– 18.48; χ 2 =4.08, I 2 =51%). Deucravacitinib was well-tolerated, with similar rate of occurrence and type of adverse events reported among patients treated with placebo or apremilast at Week 12– 16. No cardiovascular events, serious infections, or lab abnormalities were noted. Conclusion: Deucravacitinib possesses good efficacy, with no report of safety concerns associated with prior JAK inhibitors used for psoriasis. Meta-analysis demonstrated deucravacitinib’s superiority compared to placebo, indicating its promising clinical utility. Further studies are needed to observe long-term safety and efficacy, and to compare deucravacitinib to existing treatments. Keywords: apremilast, deucravacitinib, meta-analysis, placebo, plaque psoriasis, systematic review

Abstract licence: CC BY-NC 3.0

Background: Deucravacitinib, an oral selective tyrosine kinase 2 (TYK2) inhibitor, represents a novel therapeutic class for moderate-to-severe plaque psoriasis. This systematic review and meta-analysis evaluates its efficacy and safety. The objective is to evaluate the efficacy and safety of deucravacitinib compared to placebo and active controls (e.g., apremilast) in patients with moderate-to-severe chronic plaque psoriasis. Material and Methods: We systematically searched PubMed, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov from inception to December 2023 for randomized controlled trials (RCTs). Primary outcomes were the proportion of patients achieving ≥75% improvement in Psoriasis Area and Severity Index (PASI 75) and a static Physician's Global Assessment (sPGA) score of 0/1 at Week 16. Safety outcomes included adverse events. Data were pooled using a random-effects model. Results: Eight RCTs (N=5,243 patients) were included. Deucravacitinib was significantly superior to placebo and apremilast. The risk ratio (RR) for achieving PASI 75 vs. placebo was 4.59 (95% CI: 3.82–5.51; p<0.001) and vs. apremilast was 1.66 (95% CI: 1.42–1.95; p<0.001). PASI 90 and PASI 100 responses were also significantly higher. The incidence of serious adverse events was low (<2%) and comparable to placebo. Deucravacitinib had a lower incidence of gastrointestinal events than apremilast. Conclusion: Deucravacitinib is an effective and well-tolerated oral treatment for moderate-to-severe plaque psoriasis, demonstrating superior efficacy to apremilast and a favorable safety profile. It presents a valuable therapeutic option, particularly for patients seeking an effective oral therapy. Keywords: Psoriasis; Deucravacitinib; Tyrosine Kinase 2 (TYK2) inhibitor; Systematic review, Efficacy; Safety.

Abstract licence: CC BY-NC-SA