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Azathioprine, methotrexate perform similarly with infliximab in biologic-naive patients with IBD
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LAS VEGAS — Biologic-naive patients with IBD who treated with infliximab and received methotrexate as an adjuvant therapy experienced similar outcomes to those who received azathioprine in a study presented at the 2012 American College of Gastroenterology Annual Scientific Meeting.
During a follow-up of 3 years, researchers evaluated 116 patients with IBD who were naive to anti-tumor necrosis factor (anti-TNF) and began an infliximab (IFX) regimen between 2000 and 2011. All participants either initiated or already had been taking either azathioprine/6-mercaptopurine (AZA/6-MP) (n=84) or methotrexate (MTX) (n=32) upon starting IFX.
“We know from [previous trials] that individuals who can be on both [AZA and IFX], who’ve never seen prior [IFX] therapy before, do better,” researcher Jason W. Harper, MD, a gastroenterology fellow at the University of Washington, told Healio.com. “Rheumatologists have a lot more experience using MTX, and they observe the same kinds of things we do: Individuals with rheumatoid arthritis who are on MTX and [IFX] do better than individuals on [IFX] alone. What we’re trying to figure out is whether that same comparison holds true for patients with Crohn’s disease or ulcerative colitis, because it will provide more options for clinicians who feel that AZA isn’t the right choice for their patients.”
No difference was observed between the treatment groups in the time to dose escalation (HR=0.87; P=.68) or to switching to a different anti-TNF agent (HR=0.92; P=.9). The lack of significance in the difference between groups for time to dose escalation remained after adjusting for covariates (adjusted HR=1.08; P=.86).
Patients receiving AZA had similar incidence of hospitalization (HR=1.44; P=.58) and surgery (HR=1.01; P=.99) to those receiving MTX, and the need for corticosteroids also was not significantly different (HR=1.38; P=.57).
“Individuals who are starting biologic therapy for the very first time, who were either already taking AZA or MTX or starting on AZA or MTX concurrently, appear to do equally well regardless of whether they’re on AZA or MTX, for up to 3 years after starting [IFX],” Harper said. Additional studies on MTX should be conducted to further clarify its potential as an adjuvant therapy in the IBD population, researchers concluded.
For more information:
Harper JW. P1515: Azathioprine versus Methotrexate as Adjuvant Therapy with Infliximab in Biologic Naïve Patients: Equivalent Responses Over Three-year Follow-up. Presented at: the 2012 American College of Gastroenterology Annual Scientific Meeting; Oct. 19-24, Las Vegas.