Deucravacitinib Superior to Placebo, Apremilast in Moderate to Severe Plaque Psoriasis

Estie Mermelstein, MSN, FNP-BC
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Psoriasis is a chronic, immune-mediated skin disorder, affecting ~2% of the US general population.7 Characteristic findings include well-demarcated symmetrical erythematous patches or plaques with silver scales. Psoriasis appears to be more common in people with certain comorbidities, including HCV. In a single-institution study from Japan, where estimated prevalence is <1%, HCV infection was identified in 7.5% of psoriatic patients (54 of 717).8,9 In ~80% of cases, HCV infection preceded onset of psoriasis, but HCV treatment was also found to cause new lesions or exacerbate existing ones.8 A recently published small study assessed the relationship between HCV and psoriasis by comparing biopsies of patients with psoriatic with (n=7) and without (n=10) HCV.10 The findings suggest HCV increases susceptibility to psoriasis by upregulating inflammatory cytokines, including cathelicidin, TLR9, and interferon γ.10 The association between HCV, HCV treatment, and psoriasis requires elucidation in larger, prospective studies. Photo Credit: Hercules Robinson.

Psoriasis is a chronic, immune-mediated skin disorder, affecting ~2% of the US general population.7 Characteristic findings include well-demarcated symmetrical erythematous patches or plaques with silver scales. Psoriasis appears to be more common in people with certain comorbidities, including HCV. In a single-institution study from Japan, where estimated prevalence is <1%, HCV infection was identified in 7.5% of psoriatic patients (54 of 717).8,9 In ~80% of cases, HCV infection preceded onset of psoriasis, but HCV treatment was also found to cause new lesions or exacerbate existing ones.8

A recently published small study assessed the relationship between HCV and psoriasis by comparing biopsies of patients with psoriatic with (n=7) and without (n=10) HCV.10 The findings suggest HCV increases susceptibility to psoriasis by upregulating inflammatory cytokines, including cathelicidin, TLR9, and interferon γ.10 The association between HCV, HCV treatment, and psoriasis requires elucidation in larger, prospective studies.

Photo Credit: Hercules Robinson.

Researchers compared the safety and efficacy of treatment with deucravacitinib vs placebo and apremilast in patients with moderate to severe plaque psoriasis.

The following article is part of our coverage of the American Academy of Dermatology’s annual meeting (AAD 2021) that is being held virtually from April 23-25, 2021. Dermatology Advisor‘s staff will report on the top research in dermatologic advances and clinical care. Check back for the latest news from AAD 2021.

 

Two phase 3 trials showed that treatment with deucravacitinib may be superior to placebo and apremilast with regard to therapy response and skin clearance in psoriasis, according to a recent press release and research results presented at the American Academy of Dermatology’s Virtual Meeting Experience (AAD VMX) 2021, held online from April 23 to April 25, 2021.

Selective tyrosine kinase 2 (TYK2) inhibitor deucravacitinib typically inhibits interleukin (IL)-1, IL-23, and type 1 interferon (IFN), the key cytokines in psoriasis pathogenesis.

The Program to Evaluate TYK2 Inhibitor Deucravacitinib (POETYK) PSO-1 (ClinicalTrial.gov Identifier: NCT03624127) and PSO-2 (ClinicalTrial.gov Identifier: NCT03611751) trials were global, multicenter, randomized, double-blind, placebo-controlled phase 3 studies that evaluated the safety and efficacy of deucravacitinib vs placebo and apremilast in patients with moderate to severe plaque psoriasis.

In the current analysis, the researchers randomly assigned 666 patients in POETYK PSO-1 and 1020 patients in POETYK PSO-2 1:1:1 to receive once-daily 6 mg deucravacitinib, twice-daily 30 mg apremilast, or placebo for 24 weeks. Primary key endpoints for both the POETYK PSO-1 and PSO-2 trials were percentage of patients who achieved Psoriasis Area and Severity Index (PASI) 75 response and a static Physician’s Global Assessment score of 0 or 1 (sPGA 0/1) vs placebo at week 16. Key secondary endpoints were percentage of patients who achieved PASI 75 and sPGA 0/1 response vs apremilast at week 16.

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In POETYK PSO-1, 58.7% of patients receiving deucravacitinib had a PASI 75 response compared with 12.7% receiving placebo and 35.1% receiving apremilast (P <.0001 for both) at week 16. At week 24, 69.0% of patients receiving deucravacitinib had a PASI 75 response compared with 38.1% of patients receiving apremilast (P <.0001).

In POETYK PSO-2, 53.6% of patients receiving deucravacitinib had a PASI 75 response compared with 9.4% of patients receiving placebo and 40.2% of patients receiving apremilast (P =.0003) at week 16. At week 24, 59.3% of patients receiving deucravacitinib had a PASI 75 response compared with 37.8% of patients receiving apremilast (P <.0001).

In POETYK PSO-1, 53.6% of patients receiving deucravacitinib had an sPGA 0/1 response compared with 7.2% receiving placebo and 32.1% receiving apremilast (P <.0001 for both) at week 16. At week 24, 58.4% of patients receiving deucravacitinib had an sPGA 0/1 response compared with 31.0% of patients receiving apremilast (P <.0001). In POETYK PSO-2, 50.3% of patients receiving deucravacitinib had an sPGA 0/1 response compared with 8.6% receiving placebo (P <.0001) and 34.3% receiving apremilast (P <.0001) at week 16. At week 24, 50.4% of patients receiving deucravacitinib had an sPGA 0/1 response compared with 29.5% of patients receiving apremilast (P <.0001).

Deucravacitinib was well tolerated by participants in both studies, with a majority completing the study. Overall, rates of serious adverse events (such as malignancy, major adverse cardiovascular events, venous thromboembolism, and serious infections) were low at week 16 – 2.9% of 419 patients receiving placebo, 1.8% of 842 patients receiving deucravacitinib, and 1.2% of 422 patients receiving apremilast.

The company noted that deucravacitinib “may become an oral treatment of choice for people living with psoriasis” based on the safety and efficacy it exhibited in the trials.

Visit Dermatology Advisor‘s conference section for more coverage from AAD 2021.
 

Reference

Bristol Myers Squibb presents positive data from two pivotal Phase 3 psoriasis studies demonstrating superiority of deucravacitinib compared to placebo and Otezla (apremilast) [press release]. Bristol Myers Squibb. Published April 23, 2021. Accessed April 26, 2021. https://news.bms.com/news/details/2021/Bristol-Myers-Squibb-Presents-Positive-Data-from-Two-Pivotal-Phase-3-Psoriasis-Studies-Demonstrating-Superiority-of-Deucravacitinib-Compared-to-Placebo-and-Otezla-apremilast/default.aspx

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