Early Response is Associated With Stable Long-Term Response in Psoriasis Patients Receiving Ixekizumab or Ustekinumab
February 2022 | Volume 21 | Issue 2 | Original Article | 122 | Copyright © February 2022
Published online January 31, 2022
Mathias Augustin MD,a Gaia Gallo MD,b Kyoungah See PhD,b Missy McKean-Matthews MS,c Russel Burge PhD,b,d Melinda Gooderham MSc MD,e Kristian Reich MDf
aUniversity Medical Center Hamburg-Eppendorf, Institute for Health Services Research in Dermatology and Nursing, Hamburg, Germany
bEli Lilly and Company, Indianapolis, IN
cSyneos Health, Raleigh, NC
dDepartment of Sciences & Health, University of Cincinnati, Cincinnati, OH
eSKiN for Dermatology, Queen’s University and Probity Medical Research, Peterborough, Canada
fUniversity Medical Center Hamburg-Eppendorf, Center for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, Hamburg, Germany
Abstract
Background: The identification of early treatment factors that predict the long-term success of maintenance therapy for psoriasis may help optimize individual therapy.
Objective: To determine early treatment response rates to ixekizumab and ustekinumab and assess whether early response was associated with stable long-term response to these treatments in patients with moderate-to-severe psoriasis.
Methods: This post hoc subgroup analysis of the IXORA-S study (NCT02561806) measured disease severity using the Psoriasis Area Severity Index (PASI) and determined the percentage of patients treated with ixekizumab or ustekinumab who showed PASI 50 at week 2 or 4 (early response) and assessed whether early response was associated with maintaining complete (PASI 100) or almost complete (PASI 90) skin clearance at 80% of monthly visits during weeks 16−52 of treatment (stable response). Nonresponder imputation was used for missing PASI response status.
Results: A numerically higher portion of patients treated with ixekizumab were early responders and were significantly more likely to achieve a stable PASI 90 response (
P<.0001) or PASI 100 response (
P<.0001) than patients treated with ustekinumab. Patients treated with ixekizumab or ustekinumab who were early responders were more likely to achieve a stable response of PASI 90 or 100 (odds ratio>1).
Conclusion: In patients with moderateâ€toâ€severe psoriasis treated with ixekizumab or ustekinumab, early response was a significant factor in maintaining stable complete or almost complete skin clearance. Therefore, rapid response is a clinically relevant factor to consider when optimizing individual therapeutic strategies.
J Drugs Dermatol. 2022;21(2):122-126. doi:10.36849/JDD.6063
INTRODUCTION
For health care professionals, defining and predicting high levels of clinical response, as well as identifying which patients are at risk of not having high levels of response, is instrumental when tailoring treatment plans for patients with moderate-to-severe psoriasis.1 Due to newer and more efficacious biologic therapies, treatment success today is generally defined as reaching 90% improvement in Psoriasis Area Severity Index (PASI 90) in patients with moderate-to-severe psoriasis;2 however, baseline PASI and duration of treatment may need to be accounted for, especially in patients with lower disease burden who have body surface area involvement of less than 10%.2,3 Higher disease activity at baseline (baseline PASI ≥10) has been shown to be a strong predictor for patients achieving PASI 90 at week 24.1 Although baseline body mass index is a modifiable predictor of response,1 reports of baseline PASI and body mass index as predictors of response are not consistent among biologic therapies.4 Preliminary data have shown early response to treatment is predictive of subsequent clinical improvement in patients with psoriasis.5 During ixekizumab (IXE) treatment, patients who achieve at least a 40% improvement in PASI score (PASI 40) to at least a 50% improvement in PASI score (PASI 50) at weeks 4 and 6 often reach at least a 75% improvement in PASI score (PASI 75) at week 12 with ≥90% predictability.6 Nevertheless, the extent to
