Journal des essais cliniques
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Efficacy of adalimumab or an early immunomodulator on the maintenance of postoperative remission in patients with Crohn's disease: a randomized study

Akihiro Yamada, Hiroaki Iwashita, Shin-ichi Okazumi, Hidemasa Kikuchi, Yasuo Suzuki, Katsuyoshi Matsuoka

Background and objective: The objective of this study was to clarify the efficacy of early adalimumab (ADA) and azathioprine (AZA) in postoperative recurrence of Crohn's disease (CD). Methods: In a 78-week prospective single-center study, patients undergoing intestinal resection were randomly assigned to ADA 160-80-40 mg subcutaneously (SC) or AZA 0.5-1.5 mg/kg/day. The primary endpoint was endoscopic remission at 18 months (Rutgeerts i0, i1 and simple endoscopic score for CD (SES-CD) ≤ 4). Results: A total of 47 patients (median age 39.0 years, disease duration 9.5 years, 19.1% smokers, 44.6% prior resections) were enrolled, 39 patients received study drugs. Endoscopic remission was confirmed in 5/16 patients in the AZA group (31.2%) and 7/12 patients in the ADA group (58.3%) (p = 0.24) in the intention-to-treat population. In the per-protocol population (19 patients with evaluable images), remission was recorded in 3/9 (33.3%) patients in the AZA group and 7/10 (70.0%) in the ADA group (p = 0.17). The reintervention rate tended to be higher in the AZA group (21.1%) than in the ADA group (0%) (p = 0.10). Treatment was discontinued due to adverse events in 6 patients (15.3%), with serious adverse events being significantly more frequent in the AZA group than in the ADA group (AZA, 25.0% vs. ADA, 0%; p = 0.04). Conclusions: Early ADA did not show statistically superior efficacy to AZA for postoperative CD recurrence in this study, although the safety profile of ADA was better. (UMIN000032485).