Abstract
Objectives
To compare the impact of Psoriasis Area and Severity Index (PASI) response on total work productivity impairment (TWPI) in patients with moderate-to-severe psoriasis; to compare TWPI and associated indirect costs among patients treated with risankizumab, adalimumab, ustekinumab, and placebo.
Methods
Data from REVEAL (adalimumab phase III trial) were used to assess differences in trial-observed TWPI across PASI response cohorts. A machine learning model used REVEAL data to predict TWPI for patients in the risankizumab trials. These values were used to estimate work loss hours and work impairment-related indirect costs for each treatment cohort.
Results
Among REVEAL patients (N = 741), TWPI in the PASI 100, 90–99, 75–89 cohorts was lower than the PASI <75 cohort (p < .05); mean TWPI was lowest with PASI 100 (1.7%) vs. 90–99 (2.5%) vs. 75–89 (4.8%) vs. <75 (14.3%). There was a significant (p < .0001) monotonic relationship between higher PASI response and lower TWPI. In the risankizumab trials (N = 2046), incremental TWPI relative to risankizumab was 3.4%/week for ustekinumab/adalimumab, and 17.1%/week for placebo; incremental indirect cost savings for risankizumab were $2179/year vs. adalimumab, $2321/year vs. ustekinumab, and $11,284/year vs. placebo.
Conclusions
Higher PASI responses were associated with reduced TWPI. Risankizumab was associated with less work impairment/indirect costs vs. ustekinumab/adalimumab/placebo.
Acknowledgments
Medical writing support was provided by a professional medical writer, Christine Tam, an employee of Analysis Group, Inc., which has received funding from AbbVie Inc.
Disclosure statement
Mark Lebwohl provided unpaid consulting services to AbbVie Inc. Ahmed M. Soliman is an employee of AbbVie Inc. Hongbo Yang, Jessie Wang, and Jonathan Freimark are employees of Analysis Group, Inc., a consulting company that has provided paid consulting services to AbbVie Inc. Lluís Puig provided paid consulting services to AbbVie Inc.
The study sponsor was involved in several aspects of the research including the study design, the interpretation of data, the writing of the manuscript, and the decision to submit the manuscript for publication. No honoraria or payments were made for authorship.
Data availability statement
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and Clinical Study Reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
This clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. For more information on the process, or to submit a request, visit the following link: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html.