medwireNews: Montelukast reduces the risk for relapse in patients with ulcerative colitis in the steroid-tapering phase of therapy, concludes a study in Iran.
“Although different treatments such as mesalamine, steroids, and anti-TNF drugs were administered in this regard, due to their limited effectiveness, price, and potential side effects, there is a need to study the novel approaches to keep remission in patients with [ulcerative colitis],” write Zeinab Nikniaz (Imam Reza Hospital, Tabriz University of Medical Sciences) and colleagues in BMC Gastroenterology.
The researchers enrolled 222 patients with ulcerative colitis into a trial to assess the effect of the anti-inflammatory montelukast, which blocks the leukotriene receptor, on remission maintenance during the tapering phase of corticosteroids.
Eligible patients were 18 to 75 years old and had been diagnosed based on endoscopic and histologic findings. They had endoscopically confirmed pancolitis, acute severe ulcerative colitis based on Truelove and Witt’s severity index criteria, and had achieved clinical remission with prednisolone 1 mg/kg and oral mesalamine 3 g/day.
The patients were randomly assigned to receive daily doses of montelukast 10 mg (n=98) or placebo (n=124) for 22 weeks with an additional 8 weeks of follow-up. During this period, patients tapered their prednisolone to a dose of 20 mg/day before slowing the tapering to 2.5 mg/week until the drug was discontinued at 14 weeks.
For the primary trial outcome, the researchers monitored the patients for clinical relapse of ulcerative colitis. This was defined as a flare of acute symptoms scoring 3 or more on the partial Mayo score, a measure combining rectal bleeding, stool frequency, and the physician’s rating of the disease that ranges from 0 to 12, where a higher score indicates more severe ulcerative colitis. Relapse was also signaled by the need to increase the dose of medications or add steroids, tacrolimus, azathioprine, topical formulations, or tumor necrosis factor-α inhibitors.
The patients were a mean of 42 years old, 51.4% were women, and they had a mean disease duration of 5.7 years. The baseline characteristics were similar between the groups except for fecal calprotectin, which was significantly higher in the montelukast group, at 39.1 µg/g compared with 20.7 µg/g in the placebo group. Other exceptions were the erythrocyte sedimentation rate (ESR), and high sensitive C-reactive protein (hs-CRP) levels, which were significantly lower in the montelukast than the placebo group, with corresponding values of 10.6 versus 14.8 mm/hr and 1.2 versus 1.7 mg/L.
Nikniaz et al found that fewer patients in the montelukast than the placebo group relapsed during the study, with rates of 33.0% and 61.3%, respectively. They note that patients given montelukast had significantly longer relapse-free periods than those given placebo, with corresponding lengths of 27.2 and 20.8 weeks.
At the end of prednisolone tapering, 94% of patients in the montelukast group were relapse free, compared with 73% of patients on placebo. After ceasing prednisolone, an additional 16% of patients on montelukast relapsed compared with a further 57% in the placebo group. This trend held up after discontinuing montelukast in the follow-up period, with 65% and 25% of the montelukast and placebo groups relapse free, respectively.
By the end of the follow-up period, Nikniaz and colleagues observed that the montelukast group also had a significantly lower mean partial Mayo score than the placebo group of 2.2 versus 3.2. This was also the case for serum ESR, hs-CRP levels, and fecal calprotectin with respective values of 21.9 versus 37.1 mm/hour, 9.2 versus 12.3 mg/L, and 237.2 versus 406.2 µg/g. However, there were no differences in terms of white blood cells and hemoglobin.
Meanwhile, consistently fewer patients given montelukast than placebo had fecal calprotectin levels equal to or higher than 200 µg/g, an indicator of inflammation, at months 2 and 3, as well as 6 weeks after the intervention, at which point 32.7% versus 62.9% of patients met this criterion.
The investigators found no serious side effects, with no participants needing colectomy, and no patient leaving the study due to side effects.
The authors acknowledge limitations with the study, including imbalanced baseline measurements, a short follow-up period, and the lack of assessment of endoscopic remission, which is the most accurate way to evaluate mucosal healing. However, they opted to use fecal calprotectin levels as an indicator as it was less invasive, they say.
“Although these findings were clinically significant, owing to the limitations of the study, more studies with longer follow-up periods, using endoscopy with biopsy for evaluating mucosal healing, including patients with other subtypes of [ulcerative colitis] who use biologics and assessment of endoscopic healing of mucus [are] needed to confirm the result of this study,” Nikniaz et al write.
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