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Long-term methotrexate monotherapy safe, tolerable in Crohn’s disease patients
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Nearly half of patients with Crohn’s disease treated with methotrexate after poor response to thiopurines experienced sustained clinical benefit with relatively few and mild adverse events in a recent study.
Researchers assessed the tolerability and sustained clinical benefit of methotrexate (MTX) monotherapy in 174 patients with Crohn’s disease (CD) (mean age at MTX initiation, 35 years; 65% women) treated at three facilities between 2000 and 2010. All participants received methotrexate as maintenance therapy (median duration, 10 months) following failure or intolerance of treatment with thiopurine derivates including azathioprine or mercaptopurine. Twenty-three percent of the cohort also had failed previous anti-tumor necrosis factor therapy with infliximab or adalimumab.
Sustained clinical benefit, defined as continued MTX use or intentional cessation of successful treatment before study completion, was observed in 86% of patients at 6 months, 63% at 12 months, 47% at 24 months and 20% at 60 months. After follow-up, 35 patients were still receiving MTX monotherapy, and 18 patients intentionally had stopped treatment.
Fifty-six percent of the 62 patients who discontinued MTX during follow-up experienced adverse events, while 38% discontinued due to loss of response and 5% due to primary nonresponse. Multivariate analysis indicated no significant associations between MTX failure and any assessed variables.
Adverse events were mild, the most common being GI issues (9%), malaise (6%) and asymptomatic rise in liver enzymes (6%). One patient required hospital admission due to cytomegalovirus infection. No treatment-related deaths were observed within the cohort. Investigators noted a significant association between adverse events during MTX use and having been intolerant to initial treatment with thiopurine.
“This large cohort study regarding monotherapy MTX in CD patients after thiopurine therapy showed that approximately half of the CD patients have clinically sustained therapeutic benefit from MTX therapy over 2 years, decreasing to one-fifth over 5 years,” the researchers concluded. “Long-term use of MTX was well tolerated and relatively safe; the first months of therapy in particular when the first months of therapy were uneventful.”
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