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. 2023 Nov;13(11):2589-2603.
doi: 10.1007/s13555-023-00977-1. Epub 2023 Jul 31.

Matching-Adjusted Indirect Comparison of the Long-Term Efficacy of Deucravacitinib Versus Adalimumab for Moderate to Severe Plaque Psoriasis

April W Armstrong  1 , Sang Hee Park  2 , Vardhaman Patel  3 , Malcolm Hogan  4 , Wei-Jhih Wang  5 , David Davidson  2 , Viktor Chirikov  5
Affiliations

Matching-Adjusted Indirect Comparison of the Long-Term Efficacy of Deucravacitinib Versus Adalimumab for Moderate to Severe Plaque Psoriasis

April W Armstrong et al. Dermatol Ther (Heidelb). 2023 Nov.

Erratum in

Abstract

Introduction: Deucravacitinib, an oral tyrosine kinase 2 (TYK2) inhibitor, is approved in the United States to treat adults with moderate-to-severe plaque psoriasis (PsO). This study compared the long-term efficacy of deucravacitinib and adalimumab using results from long-term extension (LTE) trials.

Methods: Open-label LTE trials were identified for an indirect treatment comparison (deucravacitinib: POETYK PSO-LTE [NCT04036435]; adalimumab: REVEAL extension [NCT00195676]). To ensure study design comparability, patients initially randomized to placebo and switched to deucravacitinib or adalimumab after week 16 were compared. The primary outcome was an ≥ 75% reduction in Psoriasis Area and Severity Index score (PASI 75) at week 112 postrandomization. Secondary outcomes were PASI 75 at week 52 and an ≥ 90% reduction in PASI score (PASI 90) at weeks 52 and 112. Missing PASI data were imputed. A matching-adjusted indirect comparison was conducted; individual patient-level data from POETYK PSO-LTE were reweighted to balance baseline characteristics with those from the REVEAL extension.

Results: Before reweighting, on average, patients in the POETYK PSO-LTE (N = 329) versus the REVEAL (N = 345) extension were older, had a lower body weight, received more prior systemic treatments, and had higher baseline PASI scores and week 16 placebo PASI 75 and PASI 90 response rates. Following reweighting, adjusted week 112 PASI 75 response rates were significantly higher for deucravacitinib versus adalimumab (67.2% vs. 54.0%; mean difference [95% CI], 13.2 [4.0-22.5] percentage points). Deucravacitinib had a numerically higher adjusted week 112 PASI 90 response rate (41.3% vs. 34.0%; mean difference [95% CI], 7.3 [-2.0 to 16.7] percentage points). The treatments had similar week 52 adjusted PASI 75 and PASI 90 response rates.

Conclusion: In this interim analysis, adults with moderate to severe PsO had higher long-term response rates at 2 years when treated with deucravacitinib versus adalimumab. Deucravacitinib response rates remained stable whereas adalimumab response rates declined in year 2.

Keywords: Adalimumab; Deucravacitinib; Indirect comparison; MAIC; Plaque psoriasis.

Plain language summary

Plaque psoriasis is an inflammatory disease that causes red, itchy, dry patches (called plaques) on the skin. The disease cannot be cured, but the symptoms can be treated. Deucravacitinib and adalimumab are two treatments approved for use in adults with moderate to severe plaque psoriasis; deucravacitinib is an oral medication and adalimumab is injected with a needle under the skin. Each treatment has proven its efficacy compared with placebo (a pill or injection with no active effect) in separate clinical trials, but because no two clinical trials are exactly alike, the results cannot be accurately compared. Matching-adjusted indirect comparison is a method used to compare the results of one clinical trial with those of another when a direct comparison is not possible; characteristics from the patients in one trial are made to match the patient population in the other trial, and the adjusted results are compared. We performed a matching-adjusted indirect comparison of an open-label extension trial of deucravacitinib with an open-label extension trial of adalimumab to study the long-term efficacy of each treatment. At 1 year of treatment, we observed that similar proportions of patients receiving each treatment achieved a 75% or 90% improvement from their baseline Psoriasis Area and Severity Index score, called PASI 75 or PASI 90, respectively. At 2 years of treatment, similar proportions achieved PASI 90, but the proportion of patients receiving deucravacitinib who achieved PASI 75 was greater than that of patients receiving adalimumab.

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Conflict of interest statement

April W. Armstrong has received research grants and personal fees from Bristol Myers Squibb, Eli Lilly, Janssen, Leo Pharma, and Novartis; personal fees from Boehringer Ingelheim/Parexel, Celgene, Dermavant, Genentech, GlaxoSmithKline, Menlo Therapeutics, Merck, Modernizing Medicine, Ortho Dermatologics, Pfizer, Regeneron, Sanofi Genzyme, Science 37, Sun Pharma, and Valeant; and grants from Dermira, Kyowa Hakko Kirin, and UCB outside the submitted work. Sang Hee Park and Vardhaman Patel are employees of and may own stock options in Bristol Myers Squibb. David Davidson was an employee of Bristol Myers Squibb at the time of this study. Malcolm Hogan is an employee of Syneos Health, which provides services to Bristol Myers Squibb. Viktor Chirikov and Wei-Jhih Wang are employees of OPEN Health Evidence & Access, which was contracted by Bristol Myers Squibb to support this research.

Figures

Fig. 1
Fig. 1
POETYK and REVEAL study designs for the included comparator groups. aExcluding patients with prior adalimumab treatment. bIn the REVEAL trial, patients with < PASI 75 at week 16 entered the open-label adalimumab arm. EOW every other week; PASI 75  ≥ 75% improvement from baseline in Psoriasis Area and Severity Index score; QD once daily
Fig. 2
Fig. 2
Base case results: adjusted PASI 75 response rates at weeks 52 and 112 for deucravacitinib and adalimumab.a aAdjusted for age, sex, race, weight, duration of PsO, baseline body surface area, baseline PASI, previous use of phototherapy/systemic nonbiologic/systemic biologic therapy, and PASI 75/90 response post-placebo at week 16 postrandomization. CI confidence interval; ESS effective sample size; PASI 75  ≥ 75% reduction from baseline in Psoriasis Area and Severity Index score
Fig. 3
Fig. 3
Base case results: adjusted PASI 90 response rates at weeks 52 and 112 for deucravacitinib and adalimumab.a aAdjusted for age, sex, race, weight, duration of psoriasis, baseline body surface area, baseline PASI, previous use of phototherapy/systemic nonbiologic/systemic biologic therapy, and PASI 75/90 response post-placebo at week 16 postrandomization. CI confidence interval; ESS effective sample size; PASI 90  ≥ 90% reduction from baseline in Psoriasis Area and Severity Index score
Fig. 4
Fig. 4
Base case and sensitivity analyses: mean difference in adjusted PASI 75 response rates at weeks 52 and 112 between deucravacitinib and adalimumab. aBase case adjusted for age, sex, race, weight, duration of psoriasis, baseline body surface area, baseline PASI, previous use of phototherapy/systemic nonbiologic/systemic biologic therapy, and PASI 75/90 response post-placebo at week 16 postrandomization. Adalimumab, N = 345; deucravacitinib, ESS = 147. bSensitivity analysis 1: base-case variables adjustment with history of psoriatic arthritis and PGA added. Adalimumab, N  = 345; deucravacitinib, ESS = 86. cSensitivity analysis 2: base-case variables adjustment with prior treatment history (i.e., phototherapy/systemic nonbiologic/systemic biologic therapy) removed. Adalimumab, N = 345; deucravacitinib, ESS = 238. dSensitivity analysis 3: base-case variables adjustment with treatment history limited to the 12 months prior to study initiation. Adalimumab, N = 345; deucravacitinib, ESS = 221. eSensitivity analysis 4: base-case variables adjustment with truncation of extreme weights. Adalimumab, N = 345; deucravacitinib, ESS = 150. CI confidence interval; ESS effective sample size; PASI 75  ≥ 75% reduction from baseline in Psoriasis Area and Severity Index score
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