Vunakizumab Phase III for psoriasis

[Fred]

Vunakizumab is a subcutaneous anti-interleukin (IL)-17A humanized monoclonal IgG1/κ antibody being developed by Suzhou Suncadia Biopharmaceutical for the systemic treatment of psoriasis and psoriatic arthritis.

This is a post hoc analysis of a phase III, randomised controlled trial.

Quote:

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This study was a post hoc analysis of a Phase III trial (NCT04839016), which aims to investigate whether early response to vunakizumab can predict long-term efficacy in plaque psoriasis patients.

A total of 461 plaque psoriasis patients receiving vunakizumab treatment were included for analysis. Early response to vunakizumab was defined by patients achieving a psoriasis area and severity index (PASI) 50 at week (W) 2. Efficacy analysis included PASI 75/90/100 and static physician's global assessment (sPGA) 0/1 response rates in both groups. Safety was analysed in both groups.

At W2, 249 patients achieved an early response; 212 did not. At W12, higher proportions of patients in the early response group achieved PASI 75/90/100 and sPGA 0/1 versus the without early response group (98.4% vs. 88.2%, 88.0% vs. 66.0%, 50.2% vs. 25.0%, 84.7% vs. 64.6%, respectively; all p < 0.001). The early response group had higher proportions of patients who maintained PASI 75/90/100 and sPGA 0/1 from W12 to W52 versus the without early response group (88.8% vs. 76.4%, 74.7% vs. 54.7%, 39.4% vs. 20.8%, 68.7% vs. 54.2%, respectively; all p < 0.001).

Multivariate logistic regression analysis showed that early response to vunakizumab was independently associated with PASI 100 response at W52 (odds ratio = 1.772, p = 0.027). The incidence of adverse events was similar between groups. Patients with moderate-to-severe plaque psoriasis receiving vunakizumab show a favourable clinical response, regardless of achieving early response or not. Particularly, patients with early response at Week 2 are significantly more likely to achieve better long-term treatment outcomes.

Source: onlinelibrary.wiley.com

*Funding: CACMS Innovation Fund

[Caroline]

Very nice results, although the study shows that patients with an early response to vunakizumab tend to achieve better long-term outcomes, this association is likely driven by underlying treatment responsiveness rather than a causal effect of early improvement.

Of course, the post hoc design does not establish causality, nor does it exclude the possibility that patients without an early response may still achieve meaningful long-term benefit.
But it makes it possible for the doc, if he/she sees a quick response to tell the patient that she/he probably also will have a good long term effect.