When Trials Don’t Meet: A Retrospective Statistical Analysis Using Matching-Adjusted Indirect Comparison (MAIC) and Individual Patient Data (IPD) to Compare Catiolanze® With Other Preservative-Free (PF) Latanoprost in Open-Angle Glaucoma (OAG)
Author(s)
Jieyi Li, MSc1, Zifan Pei, MSc, PhD2, Kay Tatsuoka, MSc, PhD2, Kun Shi-van Wielink, BSc, MSc, PhD1.
1Santen SA, Amsterdam, Netherlands, 2Santen Ltd, Emeryville, CA, USA.
1Santen SA, Amsterdam, Netherlands, 2Santen Ltd, Emeryville, CA, USA.
OBJECTIVES: Assessing the comparative effectiveness of Catiolanze® versus other PF-latanoprost for treating OAG and ocular hypertension using a MAIC approach. Given the absence of head-to-head (H2H) trials and limited comparable data, this analysis demonstrates how MAIC serves as a robust, transparent method to generate meaningful comparative insights from IPD.
METHODS: All PF-latanoprost late-phases studies were screened; those that used Xalatan as the control arm were further selected. Four potential trials were analyzed by this retrospective anchored MAIC methodology against the Catiolanze® trial. Ten baseline characteristics from the Catiolanze® trial IPD were re-weighted to match the mean baseline characteristics of the selected studies where published aggregate data was available. Weight-adjusted (1) mean IOP changes from baseline, (2) percentage changes from baseline diurnal IOP at Day 84, (3) percentage of conjunctival hyperemia by severity at Day 84, and (4) tear break-up time (TBUT) at Day 84 were compared.
RESULTS: Three of the four selected trials were with Monoprost and one was with Lotacryn. Due to limitations in matching feasibility especially low ESS scores, three of the four trials were unsuitable for anchored MAIC. One trial (Monoprost) was matched successfully, and the outcomes of IOP change from baseline to Day 84 were compared. Age, sex, and baseline IOP were selected for baseline matching adjustment. The ESS was 86.31% and 90.09% in the control and treatment arms, respectively. While the control arms between the two trials were comparable (p = 0.482), the Catiolanze-treated arm showed a significant IOP reduction (p = 0.016). The percentage of conjunctival hyperemia at Day 84 was difficult to assess due to different scoring methods.
CONCLUSIONS: When a H2H trial is not available, MAIC can supplement NMA. While outcome showed better IOP reduction with Catiolanze®, baseline matching remains a general challenge in MAIC studies. Further analysis is needed to reconfirm the findings.
METHODS: All PF-latanoprost late-phases studies were screened; those that used Xalatan as the control arm were further selected. Four potential trials were analyzed by this retrospective anchored MAIC methodology against the Catiolanze® trial. Ten baseline characteristics from the Catiolanze® trial IPD were re-weighted to match the mean baseline characteristics of the selected studies where published aggregate data was available. Weight-adjusted (1) mean IOP changes from baseline, (2) percentage changes from baseline diurnal IOP at Day 84, (3) percentage of conjunctival hyperemia by severity at Day 84, and (4) tear break-up time (TBUT) at Day 84 were compared.
RESULTS: Three of the four selected trials were with Monoprost and one was with Lotacryn. Due to limitations in matching feasibility especially low ESS scores, three of the four trials were unsuitable for anchored MAIC. One trial (Monoprost) was matched successfully, and the outcomes of IOP change from baseline to Day 84 were compared. Age, sex, and baseline IOP were selected for baseline matching adjustment. The ESS was 86.31% and 90.09% in the control and treatment arms, respectively. While the control arms between the two trials were comparable (p = 0.482), the Catiolanze-treated arm showed a significant IOP reduction (p = 0.016). The percentage of conjunctival hyperemia at Day 84 was difficult to assess due to different scoring methods.
CONCLUSIONS: When a H2H trial is not available, MAIC can supplement NMA. While outcome showed better IOP reduction with Catiolanze®, baseline matching remains a general challenge in MAIC studies. Further analysis is needed to reconfirm the findings.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
SA104
Topic
Clinical Outcomes, Methodological & Statistical Research, Study Approaches
Topic Subcategory
Meta-Analysis & Indirect Comparisons
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Sensory System Disorders (Ear, Eye, Dental, Skin)