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 alpha agent to immunomodulator (IM) treatment, as a step‐up strategy, affects long‐term outcomes in ulcerative colitis. This retrospective study investigated persistence associated with biologic anti‐tumor necrosis factor alpha agents combined with IMs 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 IM, as step‐up (Bio + prior IM) or simultaneously (Bio + IM). RESULTS: Three hundred and sixty‐nine eligible patients were analyzed (233, 78, and 58 in the Bio, Bio + prior IM, and Bio + IM subgroups, respectively). Multivariate analysis showed a lower probability of nonpersistence 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 nonpersistence during maintenance in the Bio + IM subgroup was not significantly different from that in the Bio subgroup in either the biologic subpopulation or in the overall population. CONCLUSIONS: Adding infliximab to an existing IM results in a lower probability of nonpersistence compared with infliximab monotherapy in ulcerative colitis patients. This effect is not seen in adalimumab‐treated patients.