A recent double-blind randomized controlled trial has revealed that montelukast, an antileukotriene medication, could improve remission maintenance in patients with ulcerative colitis undergoing corticosteroid tapering.
In the study, published in BMC Gastroenterology, researchers led by Kourosh Masnadi Shirazi, of the Tabriz University of Medical Sciences in Iran, recruited 222 patients with ulcerative colitis who were administered either 10 mg of montelukast or placebo for 22 weeks, with follow-up extending 8 weeks postintervention.
Relapse occurred in 108 patients, with 32 in the montelukast group and 76 in the placebo group. The relapse-free period was longer in the montelukast group, averaging 27.25 weeks compared with 20.88 weeks in the placebo group. At the end of the intervention, 94% of the patients in the montelukast group remained relapse free compared with 73% of those in the placebo group.
Statistically significant differences in inflammatory biomarkers were also reported. The mean partial Mayo score, serum erythrocyte sedimentation rate, high-sensitive C-reactive protein levels, and fecal calprotectin were all lower in the montelukast group at the end of the intervention and 6 weeks postintervention. Notably, the frequency of patients with fecal calprotectin levels exceeding 200 μg/g was higher in the placebo group.
"Compared with placebo, montelukast had a significant positive effect on remission maintenance in patients [with ulcerative colitis] who were in the steroid-tapering phase of therapy," reported the study authors. The study represents one of the first human trials to assess montelukast's effect on steroid-sparing remission maintenance in patients with ulcerative colitis.
The trial included patients aged 18 to 75 years with confirmed pancolitis and acute severe ulcerative colitis, excluding those with cardiovascular diseases, kidney or lung failure, and recent use of anti–tumor necrosis factor–alpha drugs or azathioprine.
Statistical analysis employed intention-to-treat methods, utilizing independent sample t-tests and chi-square tests for baseline comparisons, and one-way analysis of covariance for follow-up comparisons, adjusting for age, gender, disease duration, and baseline values.
Montelukast could be a valuable addition to the therapeutic arsenal for managing ulcerative colitis, particularly during corticosteroid tapering. However, the researchers acknowledged limitations, including the lack of endoscopic remission assessment and the short follow-up duration postmontelukast discontinuation.
They reported no conflicts of interest.
