Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 Program fOr Evaluation of TYK2 inhibitor psoriasis second trial

Strober, Bruce; Thaçi, Diamant; Sofen, Howard; Kircik, Leon; Gordon, Kenneth B.; Foley, Peter; Rich, Phoebe; Paul, Carle; Bagel, Jerry; Colston, Elizabeth; Throup, John; Kundu, Sudeep; Sekaran, Chitra; Linaberry, Misti; Banerjee, Subhashis; Papp, Kim

doi:10.1016/j.jaad.2022.08.061

Cited by 108 publications

(151 citation statements)

References 15 publications

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“…The incidence of herpes zoster infections and acne cases were also low among patients receiving deucravacitinib [59]. The POETYK PSO-2 trial, another 52-week phase III study sharing the same primary outcome, published consistent results [60]. Ongoing trials investigating deucravacitinib in plaque psoriasis, as well as in nail psoriasis, scalp psoriasis, and among adolescents are summarized in Table 2.…”

Section: Janus Kinase Inhibitorsmentioning

confidence: 95%

A Review of the Clinical Trial Landscape in Psoriasis: An Update for Clinicians

Drakos

Vender

2022

Dermatol Ther (Heidelb)

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As our understanding of the pathogenesis of psoriasis has evolved over the past two decades, so has the number of treatment options. The introduction of biologic agents targeting specific cytokines in the interleukin (IL)-23/IL-17 pathway has proven successful in promoting skin clearance among patients. However, their use is often limited owing to cost, parenteral administration, and possible reduced efficacy over time. Topical therapies have also seen limited advancement, with agents such as corticosteroids and vitamin D derivatives remaining the mainstay of treatment, despite side effects limiting their long-term use. New therapeutic agents are needed to improve disease management for patients. In this review, we summarize pipeline and recently approved therapies undergoing clinical trials for psoriasis during a 12-month search period (30 June 2021 to 30 June 2022) using ClinicalTrials.gov. New-generation biologics and oral small molecules in phase II or III development were included, and pivotal data identified through various search modalities (PubMed, conference presentations, etc.) evaluating each drug candidate will be discussed. Topical therapies will also be discussed in line with recent US Food and Drug Administration approvals. As new therapies continue to enter the treatment landscape, long-term data and comparative trials will be needed to better understand their place among existing therapeutic agents.

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Section: Janus Kinase Inhibitorsmentioning

confidence: 95%

A Review of the Clinical Trial Landscape in Psoriasis: An Update for Clinicians

Drakos

Vender

2022

Dermatol Ther (Heidelb)

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“…Therapy with oral deucravacitinib 6 mg once daily was effective in reducing the severity and extent of moderate to severe plaque psoriasis in adults participating in two 52-week, randomized, double-blind, placebo- and active comparator-controlled, multinational phase III studies [POETYK PSO-1 (NCT03624127) [ 16 ] and POETYK PSO-2 (NCT03611751) [ 17 ]]. Eligible patients had a Psoriasis Area and Severity Index (PASI) score of ≥ 12, a static Physician’s Global Assessment (sPGA) score of ≥ 3 (i.e.…”

Section: Scientific Summarymentioning

confidence: 99%

“…moderate or severe) and ≥ 10% body surface a (BSinvolvement, and were randomized 2:1:1 to receive deucravacitinib ( n = 332 and 511 in POETYK PSO-1 and POETYK PSO-2), placebo ( n = 166 and 255) or apremilast (30 mg twice daily) [ n = 168 and 254]. Patients receiving placebo were switched to deucravacitinib at week 16 in both studies [ 16 , 17 ], while those randomized to deucravacitinib in POETYK PSO-1 received it continuously for 52 weeks [ 16 ]. POETYK PSO-2 included a randomized withdrawal period: patients originally randomized to deucravacitinib who achieved a ≥ 75% improvement from baseline in the PASI score (i.e.…”

Section: Scientific Summarymentioning

confidence: 99%

“…POETYK PSO-2 included a randomized withdrawal period: patients originally randomized to deucravacitinib who achieved a ≥ 75% improvement from baseline in the PASI score (i.e. a PASI 75 response) at week 24 were re-randomized 1:1 to deucravacitinib or placebo, while those who did not achieve a PASI 75 response at this timepoint continued to receive deucravacitinib [ 17 ]. In each study, the key secondary endpoints were evaluated in a split hierarchical manner (i.e.…”

Section: Scientific Summarymentioning

confidence: 99%

“…In each study, the key secondary endpoints were evaluated in a split hierarchical manner (i.e. deucravacitinib versus placebo and deucravacitinib versus apremilast) only if the between-group differences in both co-primary endpoints were significant [ 16 , 17 ].…”

Section: Scientific Summarymentioning

confidence: 99%

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Deucravacitinib: First Approval

Hoy

2022

Drugs

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Deucravacitinib (SOTYKTU™) is a first-in-class, highly selective, oral tyrosine kinase 2 (TYK2) inhibitor. It acts via an allosteric mechanism, binding to the catalytically inactive pseudokinase regulatory domain of TYK2 and stabilizing an inhibitory interaction between the regulatory and catalytic domains. Deucravacitinib is being developed by Bristol Myers Squibb for the treatment of multiple immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus and inflammatory bowel disease. It received its first approval (in the USA on 9 September 2022) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. On 26 September 2022, it was subsequently approved in Japan for the treatment of plaque psoriasis, generalized pustular psoriasis and erythrodermic psoriasis. The Marketing Authorisation Application for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis has been validated in the EU, and clinical development of the drug for the treatment of multiple immune-mediated diseases is underway in numerous countries worldwide. This article summarizes the milestones in the development of deucravacitinib leading to this first approval for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Supplementary Information The online version contains supplementary material available at 10.1007/s40265-022-01796-y.

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Janus Kinase Inhibitors and Adverse Events of Acne

Martinez,

Manjaly,

Manjaly

et al. 2023

JAMA Dermatol

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ImportanceJanus kinase (JAK) inhibitors are increasingly used across a range of dermatologic conditions. Adverse events of acne have been noted in some studies in clinical practice, but the scope of this outcome across JAK inhibitors has not been established.ObjectiveTo systematically analyze all published phase 2 and 3 placebo-controlled randomized clinical trials (RCTs) of JAK inhibitors for the risk of acne as an adverse effect of these medications.Data SourcesComprehensive search of Ovid MEDLINE and PubMed databases through January 31, 2023.Study SelectionInclusion criteria were phase 2 and 3 placebo-controlled RCTs of JAK inhibitors published in English with reported adverse events of acne.Data Extraction and SynthesisTwo reviewers independently reviewed and extracted information from all included studies.Main Outcomes and MeasuresThe primary outcome of interest was the incidence of acne following JAK inhibitor use. A meta-analysis was conducted using random-effects models.ResultsA total of 25 unique studies (10 839 unique participants; 54% male and 46% female) were included in the final analysis. The pooled odds ratio (OR) was calculated to be 3.83 (95% CI, 2.76-5.32) with increased ORs for abrocitinib (13.47 [95% CI, 3.25-55.91]), baricitinib (4.96 [95% CI, 2.52-9.78]), upadacitinib (4.79 [95% CI, 3.61-6.37]), deucravacitinib (2.64 [95% CI, 1.44-4.86]), and deuruxolitinib (3.30 [95% CI, 1.22-8.93]). Estimated ORs were higher across studies investigating the use of JAK inhibitors for the management of dermatologic compared with nondermatologic conditions (4.67 [95% CI, 3.10-7.05]) as well as for JAK1-specific inhibitors (4.69 [95% CI, 3.56-6.18]), combined JAK1 and JAK2 inhibitors (3.43 [95% CI, 2.14-5.49]), and tyrosine kinase 2 inhibitors (2.64 [95% CI, 1.44-4.86]).Conclusions and RelevanceIn this systematic review and meta-analysis, JAK inhibitor use was associated with an elevated odds of acne. Patients should be properly counseled on this potential adverse effect of these medications before treatment initiation. Future studies are needed to further elucidate the pathophysiology of this association.

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Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 Program fOr Evaluation of TYK2 inhibitor psoriasis second trial

Cited by 108 publications

References 15 publications

A Review of the Clinical Trial Landscape in Psoriasis: An Update for Clinicians

A Review of the Clinical Trial Landscape in Psoriasis: An Update for Clinicians

Deucravacitinib: First Approval

Janus Kinase Inhibitors and Adverse Events of Acne

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