Corticosteroid maintenance may curb relapses in autoimmune pancreatitis

Last Updated: 2016-09-06

By Marilynn Larkin

NEW YORK (Reuters Health) - Maintenance corticosteroid therapy may curb relapses and improve relapse-free survival in patients with autoimmune pancreatitis (AIP), researchers in Japan suggest.

Corticosteroid therapy is standard for patients with AIP but the consequences of long-term therapy aren't clear, according to members of the Research Committee of Intractable Pancreas Diseases in Japan. To investigate, the team recruited patients for a multicenter randomized controlled trial between April 2009 and March 2012.

As reported in Gut, online August 19, 131 patients with autoimmune pancreatitis were assessed for eligibility and 49 were enrolled. Thirty were assigned to maintenance therapy for three years and 19 to cessation of therapy after 26 weeks. To induce remission, patients were given 0.6 mg/kg/day of oral prednisolone, which was reduced over a period of up to 12 weeks to a maintenance dose of 5-7.5 mg/day. The maintenance dose was stopped at 26 weeks in the cessation group but continued for three years in the long-term intervention group.

The team defined remission as the disappearance of clinical symptoms and resolution of pancreatic and/or extrapancreatic manifestations on imaging studies. Relapse in the pancreas was diagnosed on the basis of diffuse or segmental reswelling of the pancreas and renarrowing of the main pancreatic duct. Relapse outside the pancreas included lesions such as sclerosing cholangitis and the need to resume or increase corticosteroid therapy.

The relapse rate was significantly lower in the maintenance therapy group, at 24%, compared with 58% in the therapy cessation group (p=0.011). Also, relapse-free survival was significantly longer in the maintenance therapy group (p=0.007).

None of the participants experienced serious corticosteroid-related complications that required discontinuation of prednisolone, according to the authors, who concluded that "low-dose maintenance corticosteroid therapy for a long period would be an option to decreases relapses in patients with AIP, especially those with high disease activity and risk of relapse."

Dr. Sergey Kantsevoy, director of the Center for Therapeutic Endoscopy at Mercy Medical Center in Baltimore, commented, "I agree that long-term corticosteroids can reduce relapses, but because so many patients were rejected, the numbers are small and the study was not powered enough to make such a big conclusion."

"Prednisolone is associated with serious side effects such as damage to joints, bone loss and diabetes, so the decision to start on long-term prednisone can't be taken lightly," he told Reuters Health by phone. "I'd say this is a good pilot study to open up the discussion and look more into the issue. We definitely need a larger study to confirm these initial results."

Dr. Ashkan Farhadi, a gastroenterologist at Orange Coast Memorial Medical Center in Fountain Valley, California, also agrees that the use of long-term corticosteroids reduces flares in these patients. "However, I do not see this option as a sustainable alternative," he told Reuters Health by email.

"The model of this disease is fairly similar to other gastrointestinal autoimmune processes such as ulcerative colitis, Crohn's disease or autoimmune hepatitis," he continued. "In all of these conditions, we opted out of using long-term corticosteroids due to significant risks associated with (this treatment). We are using immunomodulators to spare the patient long-term use of corticosteroids. Currently, we are doing the same for (autoimmune pancreatitis).The results of this study confirm that is the appropriate action."

The authors did not respond to requests for a comment.

SOURCE: http://bit.ly/2cpHU5M

Gut 2016.