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Abstract
Purpose
To compare the 26-week cost-effectiveness of adalimumab-corticosteroids (ADA-CS) and cyclosporine-corticosteroids (CSA-CS) for Vogt-Koyanagi-Harada (VKH).
Methods
A preplanned cost-effectiveness analysis based on the per-protocol population of a randomized-controlled trial. VKH subjects were randomized to receive either cyclosporine (100-200 mg daily) combined with corticosteroids or adalimumab (40 mg twice monthly) combined with corticosteroids. The primary outcome of this cost-effectiveness study was the incremental cost-effectiveness ratio (ICER). Costs and quality-adjusted life-years (QALYs) data were calculated by the medical records and health utility, respectively. Subgroup (early and late-phase VKH) analysis and sensitivity analyses were performed.
Results
The ICER at 26 weeks was $62,425/QALY for the total participants. Compared to the CSA-CS group, costs in the ADA-CS group were more expensive (mean difference [ΔA-C]: $2,497) with more gains in QALYs (mean difference [ΔA-C]: 0.04). The probability of ADA-CS being cost-effective was 0.17 and 0.41 at willingness to pay (WTP) thresholds of $12,000/QALY and $36,000/QALY, respectively. Subgroup analysis and sensitivity analyses showed consistent findings with the primary analysis.
Conclusions
Regardless of early or late-phase VKH, the CSA-CS strategy may be recommended as the preferred initial choice for the majority of VKH.
Author contributions
P.Y., L.D. and Z.Z. conceived and designed the study. P.Y. was the chief investigator and oversaw the trial throughout. P.Y., L.D., Q.W., Y.G., Y.P., G.S., X.L., F.Z., C.T., Y.W. and C.Z recruited patients and collected the data. L.D. and Z.Z. conducted the data analysis. L.D. wrote the first draft of the manuscript and P.Y. contributed to critical revision of the manuscript for important intellectual content.
Disclosure statement
Dr. Yang ever received grant support from Occumension and Arctic Vision to conduct other clinical trials. This trial had no financial or non-financial relationships to the above-mentioned commercial grants and entities. The authors declare no other potential conflict of interest relevant to this article.
Compliance with ethics guidelines
The study protocol was reviewed and approved by the Institutional Ethics Committee of First Affiliated Hospital of Chongqing Medical University (approval number: 20210103) and all research procedures adhered to the tenets of the Declaration of Helsinki. Written informed consent was obtained from all participants before enrollment. This study was registered at Chinese Clinical Trial Register (ChiCTR2100043061).
Data availability statement
All data relevant to the study are included in the article or uploaded as supplemental information. Further inquiries can be directed to the corresponding author.