A Retrospective Claims Database Study on Drug Utilization in Japanese Patients with Crohn’s Disease Treated with Adalimumab or Infliximab

Abstract

IntroductionCrohn’s disease (CD) is a chronic and progressive disease in which the long-term management is important. This study sought to assess treatment persistence and dose escalation in the maintenance phase with adalimumab (ADA) or infliximab (IFX) in a Japanese real-world setting.MethodsA retrospective analysis was conducted using the Japan Medical Data Center database. CD patients with either ADA or IFX prescriptions between January 2012 and February 2015 were included. Outcomes of interest were (1) failure in the induction phase (defined as switch or discontinuation) and (2) persistence in the maintenance phase (defined as the absence of switch or discontinuation over 12 months since maintenance initiation).ResultsOverall, 133 patients (53 ADA; 80 IFX) were included. Of them, treatment failed in 26 patients (19.6%) in the induction phase. During the induction phase, there was a trend towards fewer treatment failures with ADA than IFX (88.7% vs. 75.0%; p = 0.051). Of those who completed induction, 64 patients (33 ADA; 31 IFX) had at least 12 months of valid insurance enrolment after the initiation of maintenance and 13 (5 ADA; 8 IFX) had either switch or discontinuation within 12 months after the initiation of maintenance. Probabilities of switch or discontinuation over 12 months after the maintenance date were 15.2% and 20.9% for ADA and IFX groups, respectively (p-log rank = 0.7764).ConclusionJapanese patients have a high primary response to anti-tumor necrosis factor therapy in the real-world setting, in line with the results of clinical trials. This initial therapeutic advantage can be lost during the maintenance phase, leading to dose escalation, treatment switch, or discontinuation. This study suggests that those events occurred in comparable proportions of patients treated with either ADA or IFX. However, these findings should be considered with caution given the retrospective nature and small size of the study.FundingAbbvie GK, Tokyo, Japan.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-016-0406-6) contains supplementary material, which is available to authorized users.

Long‐term outcomes of patients with Crohn's disease who received infliximab or adalimumab as the first‐line biologics

“…The short‐term efficacy, including achievement of steroid‐free remission, and the continuation of the first anti‐TNF agent were similar between the patients treated with IFX first and those treated with ADA first, and these results were consistent with those reported in previous studies . The similarity of our patient characteristics and short‐term outcomes with those in previous studies suggests a high level of confidence in the quality of our long‐term outcome analysis, which is the highlight of the current study.…”

“…No head‐to‐head comparisons have been performed regarding which agent, IFX or ADA, should be administered first for biologic‐naïve CD patients. Therefore, several retrospective and a few prospective studies have compared the rates of clinical or steroid‐free remission, surgery, loss of response (LOR), and adverse events between patients who received IFX first and those who received ADA first . However, most of these previous reports evaluated relatively short‐term outcomes only and discontinued observation of patient clinical courses at the first episode of LOR.…”

“…Therefore, several retrospective and a few prospective studies have compared the rates of clinical or steroid-free remission, surgery, loss of response (LOR), and adverse events between patients who received IFX first and those who received ADA first. [2][3][4][5][6][7][8][9][10][11][12][13][14] However, most of these previous reports evaluated relatively short-term outcomes only and discontinued observation of patient clinical courses at the first episode of LOR. Therefore, long-term outcomes of the patients who were administered each agent as the first-line biologic have scarcely been reported.…”

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

“…23 The secondary outcome measure was hospitalizations (where hospitalizations were defined as any inpatient procedure with a code of "hospitalization" or "other hospitalization") during the maintenance phase. The primary outcome measure was biologic persistence during the maintenance phase, assessed from the date of first maintenance prescription.…”

“…Persistence was defined as the absence of a switch or discontinuation of adalimumab or infliximab (Supporting Information). 23 The secondary outcome measure was hospitalizations (where hospitalizations were defined as any inpatient procedure with a code of "hospitalization" or "other hospitalization") during the maintenance phase.…”