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New data from a systematic review of randomized control trials indicated that moderate-to-severe psoriasis patients benefited from deucravacitinib as a first line treatment.
Deucravacitinib is an effective first-line treatment with a strong safety profile for patients with moderate-to-severe plaque psoriasis, according to recent findings.1
These findings were the result of a systematic review and meta-analysis of deucravacitinib data following the treatment’s approval as a first-in-class TYK2 small molecule inhibitor oral treatment for those with psoriasis.
The drug was previously approved for the treatment of psoriasis in adult patients who are also candidates for systemic therapy or phototherapy.2
The study’s investigators reviewed data taken from randomized controlled trials (RCTs) to synthesize the drug’s utility. The research was authored by Joy Q. Jin, an MD candidate from the School of Medicine at University of California at San Francisco.
“To our knowledge, no systematic review has been conducted—here, we performed a systematic review with meta-analysis to synthesize the findings from randomized controlled trials (RCTs) studying deucravacitinib for psoriasis,” Jin and colleagues wrote.
The investigators noted that the clinical trials for new psoriasis treatments utilized standardized metrics like the Psoriasis Area and Severity Index (PASI) and Physician Global Assessment (PGA) to assess disease severity.
Given that psoriasis greatly affects patients' psychosocial health and quality of life, assessments of these kinds of aspects, such as the Dermatology Life Quality Index (DLQI), were also considered in clinical trials.
The investigators’ review focused on RCTs that involved human subjects with moderate-to-severe psoriasis and only phase 2 trials and above were included, while phase 1 trials conducted on healthy participants were excluded.
The RCTs included in the analysis had investigated the use of deucravacitinib and required a static PGA (sPGA) of ≥3, PASI of ≥12, and body surface area (BSA) of ≥10% for participant inclusion. The research team’s review involved data abstraction, screening studies, and assessment of the risks of bias.
Primary outcomes of interest for the team were determined to be participants achieving an sPGA of 0 or 1, while secondary outcomes included various levels of improvement in PASI score, scalp-specific PGA (ss-PGA), DLQI score, and PGA of Fingernail Psoriasis (PGA-F). They determined the final endpoint to be the efficacy measures reported within Week 12 - 16 by the studies they included.
Overall, the investigators’ review encompassed one phase 2 randomized controlled trial (RCT) using a placebo and two phase 3 RCTs using both placebo and an active comparator. In total, 1953 patients were included in the analysis.
Those treated with the daily dosage of 6 mg of deucravacitinib were found to have shown substantial improvements in disease severity based on various measurements such as the PASI, sPGA, and quality-of-life outcomes.
When compared to the patients who had been given either the comparator drug (apremilast) or placebo, those in the group treated with deucravacitinib ended up showing notable clinical improvement in scalp psoriasis but not fingernail psoriasis.
Additionally, a meta-analysis the team used, involving 888 patients given deucravacitinib and 466 patients given placebo, indicated that deucravacitinib exhibited superior efficacy in achieving clearance (sPGA 0/1) compared to the placebo arm (odds ratio: 12.87; 95% confidence interval: 8.97 – 18.48; χ2=4.08, I2=51%).
In sum, the investigators found that deucravacitinib was well-tolerated, with a similar occurrence rate and type of adverse events noted by the team compared to those treated with placebo or apremilast between Weeks 12 and 16. Notably, no major infections, cardiovascular events, or laboratory abnormalities were observed in relation to the drug.
“While further studies should be conducted to evaluate the long-term safety and efficacy of deucravacitinib and compare it to existing biologics, deucravacitinib holds promising clinical utility and represents an important step forward as a first-in-class treatment option for psoriasis patients,” they wrote.