Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial

Armstrong, April W.; Gooderham, Melinda; Warren, Richard B.; Papp, Kim; Strober, Bruce; Thaçi, Diamant; Morita, Akimichi; Szepietowski, Jacek; Imafuku, Shinichi; Colston, Elizabeth; Throup, John; Kundu, Sudeep; Schoenfeld, Steven; Linaberry, Misti; Banerjee, Subhashis; Blauvelt, Andrew

doi:10.1016/j.jaad.2022.07.002

Cited by 189 publications

(219 citation statements)

References 18 publications

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“…This experiment further confirmed that no meaningful changes in laboratory parameters associated with JAK1/2/3 inhibitors were detected during treatment with BMS-986165. 72 The clinical trial data further confirmed the efficacy, safety and durability of BMS-986165 oral administration compared to placebo and Apremilast, which provides sufficient evidence for its use in the treatment of psoriasis. Three phases 3 trials for plaque psoriasis are still currently underway (NCT03611751, NCT04036435, and NCT03924427).…”

Section: Bms-986165mentioning

confidence: 68%

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TYK2 in Immune Responses and Treatment of Psoriasis

Shang¹,

Cao²,

Zhao³

et al. 2022

JIR

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Tyrosine kinase 2 (TYK2), a key part of the Janus kinase-signal transducer and activator of transcription (JAK-STAT) pathway, plays an integral role in the differentiation and immune responses of intrinsic immune cells and regulates the mediation of cytokines. TYK2 leads to inflammatory cascade responses in the pathogenesis of immune-mediated inflammatory diseases (IMIDs), especially psoriasis. Small-molecule TYK2 inhibitors are considered to be an effective strategy for modulating psoriasis. Here, we attempt to review the pro-inflammatory mechanisms of the JAK-STAT signaling pathway, the regulatory roles of TYK2 in the pathogenesis of psoriasis, and provide updates on ongoing and recently completed trials of TYK2 inhibitors.

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Section: Bms-986165mentioning

confidence: 68%

“…This experiment further confirmed that no meaningful changes in laboratory parameters associated with JAK1/2/3 inhibitors were detected during treatment with BMS-986165. 72 …”

Section: Tyk2 Inhibitors Progressmentioning

confidence: 99%

TYK2 in Immune Responses and Treatment of Psoriasis

Shang¹,

Cao²,

Zhao³

et al. 2022

JIR

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“…Deucravacitinib-treated patients reported greater quality of life improvement in comparison with other groups, with a significantly greater DLQI 0/1 response rate at week 16 (41.0%) versus patients who received placebo (10.6%; p < 0.0001) or apremilast (28.6%; p = 0.0088) [44].…”

Section: Phase III Trialsmentioning

confidence: 85%

“…Two large, phase III, double-blinded, 52-week trials on plaque psoriasis were recently completed: NCT03624127 (POETYK PSO-1) and NCT03611751 (POETYK PSO-2) [44,44].…”

Section: Phase III Trialsmentioning

confidence: 99%

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Deucravacitinib for the Treatment of Psoriatic Disease

2022

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Psoriasis is an immune-mediated disease, with the interleukin (IL)-23/IL-17 axis currently considered its main pathogenic pathway. Tyrosine kinase 2 (TYK2) is responsible for mediating immune signalling of IL-12, IL-23 and type I interferons, without interfering with other critical systemic functions as other JAK proteins do. This article aims to review the current knowledge on deucravacitinib, a new oral drug that selectively inhibits TYK2, granting it a low risk of off-target effects. After good efficacy and safety results in a phase II, placebo-controlled trial, two phase III, 52-week trials evaluated deucravacitinib 6 mg against placebo and apremilast-an active comparator. POETYK PSO-1 and PSO-2 involved 1688 patients with moderate-to-severe psoriasis. After 16 weeks, in both studies, over 50% of patients treated with deucravacitinib reached PASI75, which was significantly superior to placebo and apremilast. In POETYK PSO-1, these results improved until week 24 and were maintained through week 52, with over 65% of patients achieving PASI75 at this point. A reduction in signs and symptoms was also reported by patients, with greater impact on itch. Deucravacitinib was well tolerated and safe. There were no reports of serious infections, thromboembolic events, or laboratory abnormalities, which are a concern among other JAK inhibitors. Persistent efficacy and consistent safety profiles were reported for up to 2 years. Despite advances in the treatment of psoriasis, namely among biologic agents, an oral, effective and safe new drug can bring several advantages to prescribers and patients. Further investigation is required to understand where to place deucravacitinib among current psoriasis treatment options.

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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, placebo-controlled phase 3 POETYK PSO-1 trial

Cited by 189 publications

References 18 publications

TYK2 in Immune Responses and Treatment of Psoriasis

TYK2 in Immune Responses and Treatment of Psoriasis

Deucravacitinib for the Treatment of Psoriatic Disease

Janus Kinase Inhibitors and Adverse Events of Acne

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