Real-World Adherence and Relapse Risk in Mesalamine Treatment for Ulcerative Colitis: Insights from a Large Japanese...

Area of Science:

• Gastroenterology
• Pharmacology
• Health Services Research

Background:

• 5-Aminosalicylic acid (5-ASA, mesalamine) is crucial for maintaining remission in mild-to-moderate ulcerative colitis (UC).
• Nonadherence to mesalamine increases UC relapse risk, yet real-world data comparing adherence across formulations is limited.
• Understanding formulation-specific adherence and relapse is vital for optimizing UC management.

Purpose of the Study:

• To compare adherence and relapse risk among four oral 5-ASA formulations in UC patients.
• To evaluate the real-world effectiveness of different mesalamine delivery systems.
• To identify formulation-specific factors influencing UC relapse.

Main Methods:

• Retrospective analysis of a Japanese nationwide claims database (2008-2022).
• Inclusion of UC patients prescribed time-dependent, pH-dependent, multi-matrix system (MMX), or salazosulfapyridine mesalamine.
• Assessment of adherence via Proportion of Days Covered (PDC) and relapse via hospitalization or therapy escalation.

Main Results:

• Multi-matrix system (MMX) mesalamine exhibited the highest adherence (91.6% PDC) and lowest relapse rate (2.9%).
• Salazosulfapyridine was associated with the highest relapse rate (14.8%).
• pH-dependent and MMX mesalamine significantly reduced relapse risk compared to time-dependent mesalamine (HRs 0.60 and 0.53, respectively), while salazosulfapyridine increased it (HR 1.51).

Conclusions:

• MMX mesalamine offers superior adherence and lower relapse rates in UC patients.
• The choice of 5-ASA formulation significantly influences treatment outcomes and relapse risk.
• These findings highlight the importance of formulation selection in optimizing ulcerative colitis management.