Therapeutic Research

Abstract

Background: In Japan, combination therapy is recommended for the treatment of mild and moderate ulcerative colitis（ UC）, when treatment of oral therapy with 5 –aminosalicylic acid（ OT5ASA）or topical therapy（ TT） is ineffectve. However, the actual situation of the combination therapy for UC is unclear. Objective: We evaluated combination proportion of OT5ASA and TT, trend to be withdrawal from combination therapy and continuation proportion of OT5ASA. Methods: We conducted a retrospective cohort study using Japanese Claims Data （JMDC）. We included subjects who was diagnosed with UC and prescribed therapeutic medicines from June 1, 2017, to June 30, 2020, in the study. Study subjects were also categorized into cohort 1（OT5ASA only）, 2 （TT only） and 3 （combination OT5ASA and TT） at the first of prescribing. We analized proportion of combination OT5ASA and TT tended to be withdrew from combination therapy and continuation proportion of OT5ASA from prescription initiation to 180 days, and the differences between cohorts and therapeutic medicines. Results: The combination proportion of OT5ASA and TT from prescription initiation were 21.5％ and 21.6％ in cohorts 1 and 2, respectively, with no differences between cohorts and therapeutic medicines. For the proportion of subjects, which prescribing initiation was OT5ASA, with less than 25％ of TT combinations, proportion of time–dependent, pH–dependent and MMX was 28.4, 28.1 and 42.9％ , respectively, and also OT5ASA continuation proportion were 46.9, 44.9 and 65.9％ , respectively. Conclusion: The proportion of patients who changed to the combination therapy from OT5ASA or TT as single agent was both about 1/5 of the total, and there was no difference betweem cohorts and formulations. MMX formulations tended to be more withdrew from combination therapy and maintained OT5ASA continuation compared to other OT5ASA at initiate treatment of OT5ASA.