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

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


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initial oral prednisolone (PSL) treatment, maintenance therapy with PSL at 5-7.5 mg/day was continued for 3 years or withdrawn at 26 weeks.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


Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Anti-Inflammatory Agents / administration & dosage*
  • Anti-Inflammatory Agents / adverse effects
  • Autoimmune Diseases / drug therapy*
  • Disease-Free Survival
  • Female
  • Follow-Up Studies
  • Humans
  • Maintenance Chemotherapy
  • Male
  • Middle Aged
  • Pancreatitis / drug therapy*
  • Prednisolone / administration & dosage*
  • Prednisolone / adverse effects
  • Recurrence
  • Time Factors
  • Withholding Treatment


  • Anti-Inflammatory Agents
  • Prednisolone

Associated data

  • JPRN/UMIN000001818