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Gut. 2017 Mar;66(3):487-494. doi: 10.1136/gutjnl-2016-312049. Epub 2016 Aug 19.

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

Author information

1
Division of Gastroenterology, Tohoku University Graduate School of Medicine, Sendai, Japan.
2
Nishimori Clinic, Kochi, Japan.
3
Division of Epidemiology, Department of Health Informatics and Public Health, Tohoku University School of Public Health, Graduate School of Medicine, Sendai, Japan.
4
Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan.
5
Integrated Center for Advanced Medical Technologies (ICAM-Tech), Kochi Medical School, Kochi, Japan.
6
Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
7
Department of Internal Medicine, Tokyo Metropolitan Komagome Hospital, Tokyo, Japan.
8
Department of Gastroenterology and Hepatology, Kansai Medical University, Hirakata, Japan.
9
Medical Informatics Division and Internal Medicine, Gastroenterology, Shinshu University Hospital, Matsumoto, Japan.
10
Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
11
Department of Gastroenterology, Endocrinology and Metabolism, Nara Medical University, Nara, Japan.
12
Third Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.
13
Kitakyushu General Hospital, Kitakyushu, Japan.
14
Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
15
Department of Endoscopy, Nagoya University Hospital, Nagoya, Japan.
16
Department of Gastroenterology, Second Teaching Hospital, Fujita Health University, Nagoya, Japan.
17
Department of Medicine, Shiga University of Medical Science, Otsu, Japan.
18
Department of Gastroenterology, Kumamoto Regional Medical Center, Kumamoto, Japan.
19
Department of Bilio-Pancreatology, Sapporo Kosei General Hospital, Sapporo, Japan.
20
Center for Health, Safety, and Environmental Management, Shinshu University, Matsumoto, Japan.

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.

KEYWORDS:

AUTOIMMUNE DISEASE; PANCREATIC DISEASE

PMID:
27543430
DOI:
10.1136/gutjnl-2016-312049
[Indexed for MEDLINE]

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