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J Gastroenterol Hepatol. 2019 Aug 8. doi: 10.1111/jgh.14825. [Epub ahead of print]

Impact of immunomodulator use on treatment persistence in patients with ulcerative colitis: a claims database analysis.

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Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.
Japan Medical Affairs, Takeda Pharmaceutical Company Limited, Tokyo, Japan.
The Third Department of Internal Medicine, Kyorin University School of Medicine, Mitaka, Tokyo, Japan.



It is unclear how adding an anti-tumor necrosis factor-α (TNFα) agent to immunomodulator treatment, as a step-up strategy, affects long-term outcomes in ulcerative colitis. This retrospective study investigated persistence associated with biologic anti-TNFα agents combined with immunomodulators versus biologic monotherapy in patients with ulcerative colitis.


This was a longitudinal cohort study of patients in the Japan Medical Data Center claims database who had been newly prescribed infliximab or adalimumab as induction (completed) and maintenance (2010-2016). Biologic persistence (i.e. no switch/discontinuation during maintenance) was compared among patients prescribed biologic monotherapy (Bio) and those prescribed a biologic combined with an immunomodulator, as step-up (Bio + prior IM) or simultaneously (Bio + IM).


369 eligible patients were analyzed (233, 78, and 58 in the Bio, Bio + prior IM, and Bio + IM subgroups). Multivariate analysis showed a lower probability of non-persistence during maintenance for infliximab-treated patients in the Bio + prior IM versus Bio subgroup (hazard ratio: 0.53; 95% confidence interval: 0.29-0.99; P = 0.045). No such effect was seen in adalimumab-treated patients (P = 0.222) or in the overall population (P = 0.398). The probability of non-persistence during maintenance in the Bio + IM subgroup was not significantly different from that in the Bio subgroup in either biologic subpopulation or in the overall population.


Adding infliximab to an existing IM results in a lower probability of non-persistence compared with infliximab monotherapy in ulcerative colitis patients. This effect is not seen in adalimumab-treated patients.


Outcome assessment (health care); colitis, ulcerative; medication adherence; retrospective studies


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