Adults with moderate to severe plaque psoriasis (PsO) treated with deucravacitinib had higher long-term response rates that remained stable at 2 years, compared with patients whose PsO was treated with adalimumab, according to study results published in Dermatology and Therapy.
Researchers conducted a matching-adjusted indirect comparison (MAIC) using data from the open-label POETYK PSO-long-term extension (LTE) study (ClinicalTrials.gov Identifier: NCT04036435) matched to data from the REVEAL open-label extension (OLE) study (ClinicalTrials.gov Identifier: NCT00195676) to examine the long-term efficacy of deucravacitinib compared with adalimumab. To ensure study design comparability, they compared patients in both trials who were initially randomly assigned to placebo but then switched to deucravacitinib or adalimumab after 16 weeks of treatment. The Psoriasis Area and Severity Index (PASI) was used to measure disease severity.
The primary outcome was PASI 75 at week 112 postrandomization. Secondary outcomes were PASI 75 or greater at week 52 and PASI 90 or greater at weeks 52 and 112.
Included in the analysis were patients enrolled in POETYK PSO LTE with moderate to severe PsO who received placebo from baseline to week 16 and then crossed over in a blinded manner to receive deucravacitinib at 6 mg once daily through week 52 and continued on deucravacitinib. The comparator arm for the analysis included patients in REVEAL OLE who crossed over from blinded treatment with placebo to receive open-label adalimumab at 40 mg every other week at week 16 of REVEAL and throughout the OLE (group D).
The POETYK PSO LTE cohort included 329 patients (28 were excluded because they had received adalimumab prior to enrollment), and the REVEAL OLE cohort included 345 patients. Patient demographics, such as age, body weight, and race, differed among those enrolled in the 2 studies. In POETYK PSO LTE, the mean age was 47.6 years, mean body weight was 89.9 kg, and 85.4% of patients were White. In REVEAL OLE, the mean age was 45.3 years, mean body weight was 94.9 kg, and 91.3% of patients were White. Additionally, in POETYK PSO LTE, more patients had received previous treatment with biologic (29.5%) or systemic nonbiologic (44.7%) medications, compared with patients in REVEAL OLE (13.9% biologic, 20.0% systemic nonbiologic therapy).
Following adjustments for differences in baseline characteristics between the 2 studies, the base case analysis showed the PASI 75 response rate at week 112 to be higher for patients treated with deucravacitinib (67.2%) vs adalimumab (54.0%), for a mean difference of 13.2 percentage points (95% CI, 4.0-22.5). While PASI 90 response rates at week 112 were also higher for deucravacitinib (mean difference, 7.3 percentage points; 95% CI, −2.0 to 16.7), rates of PASI 90 at week 52 were comparable to those of patients treated with adalimumab. Sensitivity analyses confirmed the base case results.
The study was limited by the indirect comparison between treatment groups, which may have resulted in a higher level of uncertainty vs a randomized controlled trial. Additionally, there may be variations in the associations between outcomes and baseline factors at the study level vs the patient level.
The researchers concluded, “Our study findings highlight the therapeutic role of deucravacitinib 6 mg once daily and illustrate its long-term effect versus adalimumab 40 mg every other week in patients with moderate to severe [psoriasis].” They added, “Future research on the relationship between patient genetic profile and inadequate treatment response is recommended to help improve treatment decision making.
Disclosure: This research was supported by Bristol Myers Squibb. Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
This article originally appeared on Dermatology Advisor
Armstrong AW, Park SH, Patel V, et al. Matching-adjusted indirect comparison of the long-term efficacy of deucravacitinib versus adalimumab for moderate to severe plaque psoriasis. Dermatol Ther (Heidelb). Published online July 31, 2023. doi:10.1007/s13555-023-00977-1