Randomised controlled trial of long-term maintenance corticosteroid therapy in patients with autoimmune pancreatitis

Atsushi Masamune, Isao Nishimori, Kazuhiro Kikuta, Ichiro Tsuji, Nobumasa Mizuno, Tatsuo Iiyama, Atsushi Kanno, Yuichi Tachibana, Tetsuhide Ito, Terumi Kamisawa, Kazushige Uchida, Hideaki Hamano, Hiroaki Yasuda, Junichi Sakagami, Akira Mitoro, Masashi Taguchi, Yasuyuki Kihara, Hiroyuki Sugimoto, Yoshiki Hirooka, Satoshi YamamotoKazuo Inui, Osamu Inatomi, Akira Andoh, Kazuyuki Nakahara, Hiroyuki Miyakawa, Shin Hamada, Shigeyuki Kawa, Kazuichi Okazaki, Tooru Shimosegawa

Research output: Contribution to journalArticle

74 Citations (Scopus)

Abstract

Objective Corticosteroid has been established as the standard therapy for autoimmune pancreatitis (AIP), but the requirement for maintenance corticosteroid therapy is controversial. We conducted a randomised controlled trial to clarify the efficacy of maintenance corticosteroid therapy in patients with AIP. Design We conducted a multicentre, tertiary setting, randomised controlled trial. After the induction of remission with the initial oral prednisolone (PSL) treatment, maintenance therapy with PSL at 5-7.5 mg/day was continued for 3 years or withdrawn at 26 weeks. The primary endpoint was relapse-free survival over 3 years and the secondary endpoint was serious corticosteroid-related complications. All analyses were performed on an intention-to-treat basis. Results Between April 2009 and March 2012, 49 patients with AIP were randomly assigned to the maintenance therapy group (n=30) or the cessation group (n=19). Baseline characteristics were not different between the two groups. Relapses occurred within 3 years in 11 out of 19 (57.9%) patients assigned to the cessation group, and in 7 of 30 (23.3%) patients in the maintenance therapy group. The relapse rate over 3 years was significantly lower in the maintenance therapy group than that in the cessation group (p=0.011). The relapse-free survival was significantly longer in the maintenance therapy group than that in the cessation group (p=0.007). No serious corticosteroid-related complications requiring discontinuation of PSL were observed. Conclusions Maintenance corticosteroid therapy for 3 years may decrease relapses in patients with AIP compared with those who discontinued the therapy at 26 weeks. Trial registration number UMIN000001818; Results.

Original languageEnglish
Pages (from-to)487-494
Number of pages8
JournalGut
Volume66
Issue number3
DOIs
Publication statusPublished - 01-03-2017

All Science Journal Classification (ASJC) codes

  • Gastroenterology

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