Deucravacitinib Safe, Effective Through 3 Years for Patients with Psoriasis

There is a consistent safety profile and durable clinical response of continuous deucravacitinib therapy through 3 years of use among individuals with psoriasis, according to recent findings.¹

These data resulted from a pooled analysis of the POETYK PSO-1, PSO-2, and nonrandomized long-term extension (LTE) trials. The investigators who authored this study were led by April W. Armstrong, MD, MPH, from the division of dermatology at the University of California Los Angeles David Geffen School of Medicine.

Following either the PSO-1 or PSO-2 analyses, subjects were permitted to take part in the ongoing POETYK nonrandomized LTE study. In such prior data, deucravacitinib therapy had demonstrated maintenance of clinical efficacy and consistent results with Year 1 through to Year 2, with a lack of new safety signals.²

“Three-year data represent an important milestone to inform the clinical community regarding the long-term safety and efficacy of a systemic medication,” Armstrong et al. wrote. “We present the long-term safety and efficacy of deucravacitinib through a cumulative period of 3 years (PSO-1 and PSO-2 parent trials, 1 year; LTE trial, 2 years).”¹

Trial Design Details

The investigators highlighted several elements of the prior PSO-1 and PSO-2 studies, noting that these global, phase 3 clinical studies had been carried out over the course of a 52-week timeframe for the purposes of assessing moderate-to-severe plaque psoriasis therapies. The randomized, double-blind analyses first began their period for enrollment in the LTE phase of their research in August 2019.

A collection of efficacy and safety data continued throughout the LTE phase up until June 2022, with the research team’s subsequent analysis being completed by June 2024. The participants who had been deemed eligible were given the option, following the initial 52-week treatment period in PSO-1 and PSO-2, to take part in the ongoing, nonrandomized LTE study that also coincided with the peak of the global COVID-19 pandemic.

Prior to the LTE, participants had been randomly assigned in a 1:2:1 ratio to be treated with either deucravacitinib 6 mg once-per-day, a placebo, or apremilast 30 mg at a twice-daily dosing schedule. For the subjects who decided to transition to the LTE study, they were given open-label deucravacitinib 6 mg on a once-daily regimen.

The investigators’ efficacy analysis throughout the LTE trial was aimed at several different outcomes: A 75% or 90% Psoriasis Area and Severity Index (PASI 75/90) score reduction and the achievement of a static Physician Global Assessment scores of 0 (clear) or 1 (almost clear) (sPGA 0/1). In terms of safety, the team assessed related findings for all individuals who received at least a single dose of deucravacitinib.

Notable Findings on Deucravacitinib

The investigative team concluded that among the 1519 individuals who were given at least a single administration of deucravacitinib, there were 513 such subjects who maintained continuous treatment with the drug from the beginning of the parent trials and entered the LTE phase.

The team reported that for serious adverse events (SAEs), exposure-adjusted incidence rates (EAIRs) per 100 person-years for adverse events (AEs), discontinuations due to treatment-related AEs, and deaths were all found to have either been lowered or remained consistent when comparing the 1-year and 3-year cumulative periods.

Specifically, the researchers noted that discontinuations at 4.4 compared to 2.4, AEs had rates of 229.2 compared to 144.8, SAEs at 5.7 compared to 5.5, and deaths at 0.2 compared to 0.3. The investigative team looked at AEs such as COVID-19, nasopharyngitis, and upper respiratory tract infections, highlighting the varying rates of AE incidence across the cumulative periods.

The research team expressed that COVID-19 cases increased from 0.5 to 8.0, whereas nasopharyngitis was reported at rates of 26.1 vs. 11.4. This increase in COVID-19 infections was attributed to the global pandemic’s aforementioned overlap with the analyses.

In addition, the team noted that EAIRs for significant AEs deemed to be of interest, such as major adverse cardiovascular events, herpes zoster, and malignant diseases, were shown to have continued to be low and remain stable over the course of time. Deucravacitinib clinical responses were found to be sustained through the full 3-year follow-up.

“These findings provide additional support for deucravacitinib as an efficacious and well-tolerated, long-term treatment for patients with moderate to severe plaque psoriasis,” they wrote.¹

References

1. ^{Armstrong AW, Lebwohl M, Warren RB, et al. Safety and Efficacy of Deucravacitinib in Moderate to Severe Plaque Psoriasis For Up to 3 Years: An Open-Label Extension of Randomized Clinical Trials. JAMA Dermatol. Published online November 27, 2024. doi:10.1001/jamadermatol.2024.4688.}
2. ^{Lebwohl M, Warren RB, Sofen H, et al. Deucravacitinib in plaque psoriasis: 2-year safety and efficacy results from the phase III POETYK trials. Br J Dermatol. 2024;190(5):668-679. doi:10.1093/bjd/ljae014.}