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

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initial oral prednisolone (PSL) treatment, maintenance therapy with PSL at 5-7.5 mg/day was continued for 3 years or withdrawn at 26 weeks.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.

journal_name

Gut

journal_title

Gut

authors

Masamune A,Nishimori I,Kikuta K,Tsuji I,Mizuno N,Iiyama T,Kanno A,Tachibana Y,Ito T,Kamisawa T,Uchida K,Hamano H,Yasuda H,Sakagami J,Mitoro A,Taguchi M,Kihara Y,Sugimoto H,Hirooka Y,Yamamoto S,Inui K,Inatomi O,

doi

10.1136/gutjnl-2016-312049

subject

Has Abstract

pub_date

2017-03-01 00:00:00

pages

487-494

issue

3

eissn

0017-5749

issn

1468-3288

pii

gutjnl-2016-312049

journal_volume

66

pub_type

杂志文章,多中心研究,随机对照试验

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