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Original article
Randomised controlled trial of long-term maintenance corticosteroid therapy in patients with autoimmune pancreatitis
  1. Atsushi Masamune1,
  2. Isao Nishimori2,
  3. Kazuhiro Kikuta1,
  4. Ichiro Tsuji3,
  5. Nobumasa Mizuno4,
  6. Tatsuo Iiyama5,
  7. Atsushi Kanno1,
  8. Yuichi Tachibana6,
  9. Tetsuhide Ito6,
  10. Terumi Kamisawa7,
  11. Kazushige Uchida8,
  12. Hideaki Hamano9,
  13. Hiroaki Yasuda10,
  14. Junichi Sakagami10,
  15. Akira Mitoro11,
  16. Masashi Taguchi12,
  17. Yasuyuki Kihara13,
  18. Hiroyuki Sugimoto14,
  19. Yoshiki Hirooka15,
  20. Satoshi Yamamoto16,
  21. Kazuo Inui16,
  22. Osamu Inatomi17,
  23. Akira Andoh17,
  24. Kazuyuki Nakahara18,
  25. Hiroyuki Miyakawa19,
  26. Shin Hamada1,
  27. Shigeyuki Kawa20,
  28. Kazuichi Okazaki8,
  29. Tooru Shimosegawa1
  30. for the Research Committee of Intractable Pancreas Diseases in Japan
  1. 1Division of Gastroenterology, Tohoku University Graduate School of Medicine, Sendai, Japan
  2. 2Nishimori Clinic, Kochi, Japan
  3. 3Division of Epidemiology, Department of Health Informatics and Public Health, Tohoku University School of Public Health, Graduate School of Medicine, Sendai, Japan
  4. 4Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan
  5. 5Integrated Center for Advanced Medical Technologies (ICAM-Tech), Kochi Medical School, Kochi, Japan
  6. 6Department of Medicine and Bioregulatory Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
  7. 7Department of Internal Medicine, Tokyo Metropolitan Komagome Hospital, Tokyo, Japan
  8. 8Department of Gastroenterology and Hepatology, Kansai Medical University, Hirakata, Japan
  9. 9Medical Informatics Division and Internal Medicine, Gastroenterology, Shinshu University Hospital, Matsumoto, Japan
  10. 10Department of Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan
  11. 11Department of Gastroenterology, Endocrinology and Metabolism, Nara Medical University, Nara, Japan
  12. 12Third Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan
  13. 13Kitakyushu General Hospital, Kitakyushu, Japan
  14. 14Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan
  15. 15Department of Endoscopy, Nagoya University Hospital, Nagoya, Japan
  16. 16Department of Gastroenterology, Second Teaching Hospital, Fujita Health University, Nagoya, Japan
  17. 17Department of Medicine, Shiga University of Medical Science, Otsu, Japan
  18. 18Department of Gastroenterology, Kumamoto Regional Medical Center, Kumamoto, Japan
  19. 19Department of Bilio-Pancreatology, Sapporo Kosei General Hospital, Sapporo, Japan
  20. 20Center for Health, Safety, and Environmental Management, Shinshu University, Matsumoto, Japan
  1. Correspondence to Dr Atsushi Masamune, Division of Gastroenterology, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai 980-8574 Japan; amasamune{at}med.tohoku.ac.jp

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.

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