Ixekizumab for Psoriasis Led to More Acceptable Responses at Week 12 Versus Other Biologics

April Armstrong, MD, MPH

Ixekizumab (IXE) treatment of psoriasis led to success according to a National Psoriasis Foundation (NPF) target and in terms of acceptable responses at the 12-week mark, according to new findings, with success seen in both clinical trial and real-world settings and among both biologic-naïve and bio-experienced individuals.¹

These findings resulted from a new post-hoc analysis assessing ixekizumab’s strengths in achieving the National Psoriasis Foundation’s 12-week target response of ≤ 1% body surface area (BSA) impacted by psoriasis. The analysis also assessed the drug’s ability to achieve an ‘acceptable response’ which was defined as a BSA improvement of ≤ 3% or ≥ 75%.

This research was led by April Armstrong, MD, MPH, associate dean of clinical research at the University of Southern California Keck School of Medicine. Armstrong and colleagues noted the prior existence of real-world studies of ixekizumab as well as comparisons between other biologics.^2,3

“Here, we assessed head-to-head clinical trial and real-world data to compare the achievement of NPF target and acceptable responses at week 12 in patients with plaque psoriasis treated with IXE versus other biologics,” Armstrong and colleagues wrote.

Background and Methods

The investigators assessed the overall outcomes at the 12-week mark among individuals who had been diagnosed with moderate-to-severe plaque psoriasis. They carried out this analysis of 4 head-to-head randomized clinical trials (UNCOVER-2, UNCOVER-3, IXORA-R, and IXORA-S) in addition to a single real-world prospective observational study known as the Psoriasis Study of Health Outcomes (PSoHO)

During the course of the different randomized clinical trials (RCTs), those participating as subjects were treated with ixekizumab or etanercept during the UNCOVER-2/3 studies, guselkumab during the IXORA-R study, or ustekinumab during the IXORA-S study. Subjects participating in the PSoHO trial were given anti-interleukin (IL)-17A biologics such as ixekizumab, secukinumab, and other approved biologics for treatment of psoriasis.

The research team utilized non-responder imputation for those that had missing outcomes following the conclusion of these RCTs. They also made statistical comparisons between the different treatment arms within the RCT data.

The investigators evaluated the real-world setting data through the use of frequentist model averaging (FMA) for an adjusted comparative analysis, and this was reported as odds ratios (ORs).

The research team noted that the US Food and Drug Administration’s (FDA) approved on-label dosing for adults patients that have moderate-to-severe plaque psoriasis was noted as 160 mg at the point of Week 0, then 80 mg over a course every 2 weeks from the 2–12-week marks, followed then by 80 mg during every 4 weeks thereafter.

Findings

Overall, the investigators reported that in their analysis of the 4 head-to-head studies, there were shown to be higher percentages of subjects who had had the target and acceptable responses by the 12-week mark with ixekizumab compared to the other biologics compared in the studies. The drug itself also was shown to have a higher proportion of PSoHO patients who could achieve the target and acceptable responses at the same 12-week mark versus individually with other types of biologics.

The research team’s adjusted comparative analyses results demonstrated that ixekizumab showed much greater odds of reaching the pre-determined target and acceptable responses at the 12-week point versus guselkumab, secukinumab, risankizumab, adalimumab, ustekinumab, and tildrakizumab. The team also noted that the drug had a numerically higher odds of achieving target and acceptable responses at the same time point compared to brodalumab.

“A strength of the current study is that it assessed the achievement of NPF target and acceptable responses at week 12 using both clinical and real-world data,” they wrote. “The results showed that numerically higher proportions of patients with plaque psoriasis treated with IXE achieved NPF target and acceptable responses at week 12 compared with those treated with other biologics across both clinical and real-world settings.”

References

1. ^{Armstrong, A., González-Cantero, A., Khattri, S. et al. Comparing Achievement of National Psoriasis Foundation Treatment Targets among Patients with Plaque Psoriasis Treated with Ixekizumab versus Other Biologics in Clinical and Real-World Studies. Dermatol Ther (Heidelb) (2024). https://doi.org/10.1007/s13555-024-01136-w.}
2. ^{Lynde C, Riedl E, Maul JT, Torres T, Pinter A, Fabbrocini G, et al. Comparative effectiveness of biologics across subgroups of patients with moderate-to-severe plaque psoriasis: results at week 12 from the PSoHO study in a real-world setting. Adv Ther. 2023;40(3):869–86.}
3. ^{Pinter A, Puig L, Schäkel K, Reich A, Zaheri S, Costanzo A, et al. Comparative effectiveness of biologics in clinical practice: week 12 primary outcomes from an international observational psoriasis study of health outcomes (PSoHO). J Eur Acad Dermatol Venereol. 2022;36(11):2087–100.}