Real-World Study Confirms Ixekizumab Outperforms Ustekinumab in Psoriasis
Key Takeaways
The SPEECH cohort replicated the IXORA-S trial findings using real-world data.
Ixekizumab showed higher PASI 90 response rates than ustekinumab at 12 weeks.
Observational registries like SPEECH can extend RCT findings to broader populations.
A recent real-world studyreplicated the results of the IXORA-S trial, which demonstrated the efficacy of ixekizumab over ustekinumab for treating moderate-to-severe plaque psoriasis.
Researchers for the observational analysis, conducted using data from the Shanghai Psoriasis Effectiveness Evaluation CoHort (SPEECH), adds weight to the external validity of randomized controlled trial (RCT) findings and offers insights into broader patient populations often underrepresented in trials.
The prospective cohort study followed 367 adults with moderate-to-severe plaque psoriasis from 2021 to 2023. Patients received either ixekizumab (n = 203) or ustekinumab (n = 164). The primary endpoint was the proportion of patients achieving PASI 90 at week 12. To reduce confounding and missing data bias, investigators employed propensity score adjustment and multiple imputation techniques. Findings demonstrated that ixekizumab yielded significantly higher PASI 90 response rates than ustekinumab—mirroring the efficacy observed in the IXORA-S trial.
Notably, the effect size, direction, and statistical significance were aligned with the RCT results, despite differences in eligibility criteria and baseline disease severity. The authors suggest that such differences partially explain the efficacy-effectiveness gap and highlight the value of well-designed registries for extending evidence to real-world settings.
“The results of IXORA-S were successfully replicated using real-world data from SPEECH,” the authors wrote. “This demonstrates that registry-based observational data can yield reliable estimates of treatment effects and may be used to investigate effectiveness questions not feasible to study in randomized trials, such as long-term outcomes and effects in underrepresented populations.”
Source: Yu N, et al. Value in Healthcare. 2025. Doi:10.1016/j.jval.2025.11.009