Long-Term Data Support Deucravacitinib’s Efficacy in Treating Plaque Psoriasis

Current phase 3 trial research supports the use of deucravacitinib for plaque psoriasis as an oral alternative to biologic therapies, a recent literature review suggests, with efficacy and a favorable safety profile being highlighted.1

This analysis on current data related to deucravacitinib was authored by investigators such as Nickoulet Babaei, from Loma Linda University School of Medicine in California. Babaei et al noted that the drug itself, an oral, selective, allosteric tyrosine kinase 2 (TYK2) and member of the Janus kinase (JAK) inhibitor family, is designed to mediate interleukin (IL)-23 signaling.2

“In the following article, we review the results of clinical phase III trials concerning the efficacy and safety of deucravacitinib in patients with moderate-to-severe plaque psoriasis,” Babaei and colleagues wrote.1

Literature Review Findings on Deucravacitinib

The investigative team performed their systematic literature review by searching the Cochrane, PubMed, and MEDLINE databases, with publications in English released between 2012 - 2025 being explored. Babaei and coauthors' aim was to identify and assess all phase 3 randomized controlled trials (RCTs) that evaluated the use of deucravacitinib as a treatment for plaque psoriasis. The search terms they implemented included “deucravacitinib" and “psoriasis,” as well “phase III.”

A variety of pivotal studies were identified by the investigators, including the POETYK phase 3 program. POETYK's findings demonstrated that deucravacitinib therapy provided sustained clinical benefits among those with moderate-to-severe plaque psoriasis. Both POETYK PSO-1 and PSO-2 showed that deucravacitinib's use was linked with significantly higher Psoriasis Area and Severity Index (PASI)-75, PASI 90, and PASI 100 rates of response compared with placebo and compared with apremilast. These data underscored the drug's potential as a more effective oral option.

During the POETYK PSO-1 study, Babaei and colleagues noted that 58.4% of those involved as participants attained PASI 75 at the 16-week mark, compared with 12.7% of those given a placebo and 35.1% given apremilast. The POETYK PSO-2 study also resulted in comparable findings on deucravacitinib, with PASI 75 having been attained among 53.0% of trial subjects on deucravacitinib versus 9.4% in the placebo arm and 39.8% in the apremilast arm.

Such outcomes would suggest this JAK inhibitor may be especially helpful for individuals showing insufficient responses to other oral drugs. It could also indicate that deucravacitinib is useful for those with a preference for oral administration over injections. The investigative team also highlighted the results of extension studies, noting evidence of the drug's long-term durability.

The results of POETYK LTE and the 3-year LTE studies highlighted by the team showed that PASI 75 was maintained among 73.2% of participants at the 148-week mark, with PASI 90 and sPGA 0/1 responses being attained by 48.1% and 54.1% of participants, respectively. Babaei et al also pointed to the POETYK PSO-4 trial, conducted among Japanese patients, which also reinforced the drug's efficacy across different populations.

Specifically, these data suggested that PASI 75 was achieved among 76.2% of patients at the 16-week mark and 86.7% at the 52-week mark. Such findings would suggest that treatment responses are consistent across different subgroups, including diverse ethnic backgrounds, individuals with varying BMI, and patients with prior exposure to biologics.

In terms of safety data, the investigators' review of POETYK overall trials' findings showed that deucravacitinib had been generally well-tolerated, with the most frequent adverse events (AEs) being upper respiratory tract infections, nasopharyngitis, acne, and headaches. Serious events (SAEs) were shown to be uncommon. In the 3-year results of the LTE study, exposure-adjusted incidence rate (EAIR) of SAEs was 5.5 per 100 patient-years, occurrences of herpes zoster were shown to be low, and all reported cases were mild or moderate. Additionally, there were no observed risk increases for major adverse cardiovascular events (MACE), malignancies, or venous thromboembolism (VTE). Most deaths shown to have occurred during the extension phase were linked with COVID-19.

Overall, deucravacitinib’s safety profile was consistent, though infection and mortality outcomes were likely influenced by the pandemic.

“Its oral administration, selective TYK2 inhibition, and emerging safety profile could make it a promising option for patients looking for an alternative to biologics,” the investigators concluded.1 “However, head-to-head trials against IL-17 and IL-23 inhibitors and longer-term safety data beyond 3 years will be crucial in better defining its role in the treatment of psoriasis.”

References

1. N Babaei, D Kim, M JJ Wu, et al. “ A Review of Phase III and Long-Term Data for Deucravacitinib for Plaque Psoriasis,” International Journal of Dermatology (2025): 1–7, https://doi.org/10.1111/ijd.70023.

2. G Martin. “Novel Therapies in Plaque Psoriasis: A Review of Tyrosine Kinase 2 Inhibitors,” Dermatologic Therapy 13, no. 2 (2023): 417–435.