PT  - JOURNAL ARTICLE
AU  - Atsushi Masamune
AU  - Isao Nishimori
AU  - Kazuhiro Kikuta
AU  - Ichiro Tsuji
AU  - Nobumasa Mizuno
AU  - Tatsuo Iiyama
AU  - Atsushi Kanno
AU  - Yuichi Tachibana
AU  - Tetsuhide Ito
AU  - Terumi Kamisawa
AU  - Kazushige Uchida
AU  - Hideaki Hamano
AU  - Hiroaki Yasuda
AU  - Junichi Sakagami
AU  - Akira Mitoro
AU  - Masashi Taguchi
AU  - Yasuyuki Kihara
AU  - Hiroyuki Sugimoto
AU  - Yoshiki Hirooka
AU  - Satoshi Yamamoto
AU  - Kazuo Inui
AU  - Osamu Inatomi
AU  - Akira Andoh
AU  - Kazuyuki Nakahara
AU  - Hiroyuki Miyakawa
AU  - Shin Hamada
AU  - Shigeyuki Kawa
AU  - Kazuichi Okazaki
AU  - Tooru Shimosegawa
TI  - Randomised controlled trial of long-term maintenance corticosteroid therapy in patients with autoimmune pancreatitis
AID  - 10.1136/gutjnl-2016-312049
DP  - 2017 Mar 01
TA  - Gut
PG  - 487--494
VI  - 66
IP  - 3
4099  - http://gut.bmj.com/content/66/3/487.short
4100  - http://gut.bmj.com/content/66/3/487.full
SO  - Gut2017 Mar 01; 66
AB  - 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initial oral prednisolone (PSL) treatment, maintenance therapy with PSL at 5–7.5 mg/day was continued for 3 years or withdrawn at 26 weeks.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.