Abstract
BackgroundThere are few reports of the efficacy of adalimumab (ADA) for clinical remission and preventing postoperative recurrence in Crohn's disease (CD) in Asian real practice settings. We conducted a Japanese multicenter retrospective observational study.MethodsWe evaluated patients with CD who were treated with ADA at 11 medical institutions in Japan to investigate the clinical efficacy of remission up to 52 weeks and the associated factors to achieve remission with a CD Activity Index (CDAI) < 150. The effects of preventing postoperative recurrence were also evaluated.ResultsIn 62 patients, the remission rates were 33.9, 74.2, 75.8, 77.4, and 66.1 % at 0, 4, 12, 26, and 52 weeks, respectively. Although 10 patients discontinued treatment due to primary nonresponse, secondary nonresponse, or adverse events, the ongoing treatment rate at 52 weeks was 83.9 %. Comparison of remission and non-remission on univariate analysis identified colonic type and baseline CDAI value as significant associated factors (P < 0.05). In 16 patients who received ADA to prevent postoperative recurrence, the clinical remission maintenance rate was 93.8 % and the mucosal healing rate was 64.3 % during a mean postoperative follow-up period of 32.3 months.ConclusionsADA effectively induced remission and prevented postoperative recurrence in patients with CD in a real practice setting.
Highlights
There are few reports of the efficacy of adalimumab (ADA) for clinical remission and preventing postoperative recurrence in Crohn's disease (CD) in Asian real practice settings
Patient demographics Of 71 patients who received ADA treatment during the study period, 62 were included in the analysis set, while the other nine were excluded: three who failed to complete follow-up due to transfer to another hospital before 52 weeks, five who missed the CD Activity Index (CDAI) evaluation, and one who intentionally withdrew from treatment due to pregnancy (Fig. 1)
ADA has been demonstrated effective against CD in the CLASSIC I [11], CLASSIC II [13], GAIN [12], CHARM [14], and EXTEND [15] placebo-controlled double-blind studies
Summary
There are few reports of the efficacy of adalimumab (ADA) for clinical remission and preventing postoperative recurrence in Crohn's disease (CD) in Asian real practice settings. There is currently no cure for CD, the inflammatory cytokine tumor necrosis factor-α (TNF-α) is involved in clinical condition [5], against which anti-TNF-α monoclonal antibody (anti-TNF-α antibody) is highly effective [6, 7]. As for genetics, nucleotide oligomerization domain-2 (NOD2) variants and autophagy-related 16-like 1(ATG16L1) variants, which have been firmly associated with CD in the West have not been detected in the patients with CD in Asia [16]. Taking account of these differences, the data from Asia is important in spite of the numerous data from West.
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