Early Vunakizumab Response at 2 Weeks Predicts Long-Term Efficacy in Psoriasis

Individuals with moderate-to-severe plaque psoriasis treated with vunakizumab can expect a favourable clinical response, recent post hoc data suggest, though early response can predict the long-term efficacy of this medication.1

Xiaoying Sun, MD, from Shanghai Academy of Traditional Chinese Medicine’s Institute of Dermatology, authored this study alongside a team of other researchers. In the background portion of the study, Sun and colleagues describe vunakizumab as an interleukin (IL)-17A monoclonal antibody approved for the systemic treatment of psoriasis.

The team also highlighted a previous phase 3 analysis (NCT04839016) pointing to vunakizumab’s efficacy at Week 12 and up to Week 52.2 Nevertheless, prior to this analysis, it had been unclear whether those with early response have superior long-term outcomes versus patients without an early response to the medication.

“[This] post hoc study used data from a Phase III trial (NCT04839016), with the aim of investigating the effect of early response on long-term efficacy in vunakizumab-treated moderate-to-severe plaque psoriasis patients,” Sun et al noted.1

Design and Background Details

The investigators’ post hoc analysis involved assessing individuals who were given vunakizumab therapy in a phase 3 clinical study. Those evaluated were categorized based upon their Psoriasis Area and Severity Index (PASI) response at the 2-week mark following the initiation of the drug. They defined early response as attainment of 50% improvement in PASI (PASI 50) by Week 2. This definition was established by the team in advance and documented in the statistical analysis plan.

Those who did not reach PASI 50 at the 2-week mark were classified as not showing an early response to vunakizumab. There were 461 individuals with moderate-to-severe disease who Sun and colleagues included in their analysis. Among these subjects, 249 had met the investigators’ criteria for an early response and 212 were not able to. All of the data implemented in this evaluation were gathered by Sun et al from the original phase 3 trial, and no additional data were needed.

Clinical variables and characteristics were assessed at baseline, with the team paying attention to any previous medication exposure, demographic variables, comorbid conditions, baseline PASI score, duration of psoriasis, static physician’s global assessment (sPGA), and body surface area (BSA) involvement. Long-term clinical efficacy measures, patient-reported outcomes, and safety findings were also investigated by Sun and coauthors.

Their efficacy assessments focused on PASI 75, PASI 90, and PASI 100 response rates. Additionally, they looked at achievement of sPGA scores of 0 or 1. Safety outcomes were assessed in this post hoc analysis in both of the early and non-early responding cohorts.

Findings on Response Timing and Vunakizumab for Psoriasis

Participants by the 12-week mark showing an early response were noted by Sun et al as showing a significantly higher rate of response across all efficacy endpoints versus those without an early response. In specific, the investigative team observed PASI 75 responses in 98.4% of those labaled as early responders.

This was compared to 88.2% of those labaled as non-early responders. They also highlighted PASI 90 responses in 88.0% as opposed to 66.0%, PASI 100 responses in 50.2% as opposed to 25.0%, and sPGA 0/1 responses among 84.7% as opposed to 64.6%, respectively. In all of these comparisons, the data were statistically significant (P < .001).

These observed differences continued to be seen over time, as a greater proportion of early responders maintained sPGA 0/1, PASI 75, PASI 90, PASI 100 responses from the 12 through 52-week points, versus individuals without an early treatment response (68.7% versus 54.2%, 88.8% versus 76.4%, 74.7% versus 54.7%, 39.4% versus 20.8%; P < .001).

In Sun and coauthors’ multivariate logistic regression analysis, they noted early response achievement among subjects was independently linked with PASI 100 attainment at Week 52, with an odds ratio of 1.772 (P = .027). Adverse events rates were noted as comparable between the 2 arms of the post hoc analysis. Overall, vunakizumab treatment led to favorable clinical outcomes in individuals with moderate-to-severe psoriasis. This was regardless of early response status. However, those who had such a response by Week 2 were significantly more likely to report superior long-term treatment efficacy.

“In conclusion, this post hoc study shows that vunakizumab provides good efficacy and safety in patients with moderate-to-severe plaque psoriasis, whether these patients achieve early response or not,” the investigators wrote.1

References

1. Sun X, Zhang Y, Li X, et al. Early Response to Vunakizumab at Week 2 Predicts Favourable Long-Term Efficacy in Patients With Moderate-To-Severe Plaque Psoriasis: A Post Hoc Analysis of a Phase III, Randomised Controlled Trial. Immunology. 2026 Jan 1. doi: 10.1111/imm.70099. Epub ahead of print. PMID: 41479228.

2. Yan K, Li F, Xu J, et al. Efficacy and safety of vunakizumab in moderate-to-severe chronic plaque psoriasis: A randomized, double-blind, placebo-controlled phase 3 trial. J Am Acad Dermatol. 2025 Jan;92(1):92-99. doi: 10.1016/j.jaad.2024.09.031. Epub 2024 Sep 26. PMID: 39332633.