title: Randomised controlled trial of long-term maintenance corticosteroid therapy in patients with autoimmune pancreatitis.
abstract: 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.
  
  
  
  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initial oral prednisolone (PSL) treatment, maintenance therapy with PSL at 5-7.5 mg/day was continued for 3 years or withdrawn at 26 weeks.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.
  
  
  
  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.
  
  
  
  Maintenance corticosteroid therapy for 3 years may decrease relapses in patients with AIP compared with those who discontinued the therapy at 26 weeks.
  
  
  
  UMIN000001818; Results.
authors.affiliation: Division of Gastroenterology, Tohoku University Graduate School of Medicine, Sendai, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Masamune
authors.affiliation: Nishimori Clinic, Kochi, Japan.
authors.forename: Isao
authors.initials: I
authors.lastname: Nishimori
authors.affiliation: Division of Gastroenterology, Tohoku University Graduate School of Medicine, Sendai, Japan.
authors.forename: Kazuhiro
authors.initials: K
authors.lastname: Kikuta
authors.affiliation: Division of Epidemiology, Department of Health Informatics and Public Health, Tohoku University School of Public Health, Graduate School of Medicine, Sendai, Japan.
authors.forename: Ichiro
authors.initials: I
authors.lastname: Tsuji
authors.affiliation: Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan.
authors.forename: Nobumasa
authors.initials: N
authors.lastname: Mizuno
authors.affiliation: Integrated Center for Advanced Medical Technologies (ICAM-Tech), Kochi Medical School, Kochi, Japan.
authors.forename: Tatsuo
authors.initials: T
authors.lastname: Iiyama
authors.affiliation: Division of Gastroenterology, Tohoku University Graduate School of Medicine, Sendai, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Kanno
authors.affiliation: Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Yuichi
authors.initials: Y
authors.lastname: Tachibana
authors.affiliation: Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
authors.forename: Tetsuhide
authors.initials: T
authors.lastname: Ito
authors.affiliation: Department of Internal Medicine, Tokyo Metropolitan Komagome Hospital, Tokyo, Japan.
authors.forename: Terumi
authors.initials: T
authors.lastname: Kamisawa
authors.affiliation: Department of Gastroenterology and Hepatology, Kansai Medical University, Hirakata, Japan.
authors.forename: Kazushige
authors.initials: K
authors.lastname: Uchida
authors.affiliation: Medical Informatics Division and Internal Medicine, Gastroenterology, Shinshu University Hospital, Matsumoto, Japan.
authors.forename: Hideaki
authors.initials: H
authors.lastname: Hamano
authors.affiliation: Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Yasuda
authors.affiliation: Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
authors.forename: Junichi
authors.initials: J
authors.lastname: Sakagami
authors.affiliation: Department of Gastroenterology, Endocrinology and Metabolism, Nara Medical University, Nara, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Mitoro
authors.affiliation: Third Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan.
authors.forename: Masashi
authors.initials: M
authors.lastname: Taguchi
authors.affiliation: Kitakyushu General Hospital, Kitakyushu, Japan.
authors.forename: Yasuyuki
authors.initials: Y
authors.lastname: Kihara
authors.affiliation: Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Sugimoto
authors.affiliation: Department of Endoscopy, Nagoya University Hospital, Nagoya, Japan.
authors.forename: Yoshiki
authors.initials: Y
authors.lastname: Hirooka
authors.affiliation: Department of Gastroenterology, Second Teaching Hospital, Fujita Health University, Nagoya, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Yamamoto
authors.affiliation: Department of Gastroenterology, Second Teaching Hospital, Fujita Health University, Nagoya, Japan.
authors.forename: Kazuo
authors.initials: K
authors.lastname: Inui
authors.affiliation: Department of Medicine, Shiga University of Medical Science, Otsu, Japan.
authors.forename: Osamu
authors.initials: O
authors.lastname: Inatomi
authors.affiliation: Department of Medicine, Shiga University of Medical Science, Otsu, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Andoh
authors.affiliation: Department of Gastroenterology, Kumamoto Regional Medical Center, Kumamoto, Japan.
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Nakahara
authors.affiliation: Department of Bilio-Pancreatology, Sapporo Kosei General Hospital, Sapporo, Japan.
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Miyakawa
authors.affiliation: Division of Gastroenterology, Tohoku University Graduate School of Medicine, Sendai, Japan.
authors.forename: Shin
authors.initials: S
authors.lastname: Hamada
authors.affiliation: Center for Health, Safety, and Environmental Management, Shinshu University, Matsumoto, Japan.
authors.forename: Shigeyuki
authors.initials: S
authors.lastname: Kawa
authors.affiliation: Department of Gastroenterology and Hepatology, Kansai Medical University, Hirakata, Japan.
authors.forename: Kazuichi
authors.initials: K
authors.lastname: Okazaki
authors.affiliation: Division of Gastroenterology, Tohoku University Graduate School of Medicine, Sendai, Japan.
authors.forename: Tooru
authors.initials: T
authors.lastname: Shimosegawa
mesh_terms: D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001327:Autoimmune Diseases / Q000188:drug therapy*; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D010195:Pancreatitis / Q000188:drug therapy*; D011239:Prednisolone / Q000008:administration & dosage* / Q000009:adverse effects; D012008:Recurrence; D013997:Time Factors; D028761:Withholding Treatment
chemical_list: D000893:Anti-Inflammatory Agents; D011239:Prednisolone
keywords: AUTOIMMUNE DISEASE; PANCREATIC DISEASE