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

BACKGROUND AND AIM: 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.

METHODS: 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).

RESULTS: 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.

CONCLUSIONS: 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.