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Meta-analysis finds once-daily mesalamine comparable to standard dose for UC
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Mesalamine administered once a day was found to be as safe and effective as the standard dose for treating ulcerative colitis across multiple studies in a recent review.
Researchers evaluated 11 randomized trials involving 4,070 patients who were assigned mesalamine orally to treat ulcerative colitis (UC) in determining the effectiveness of a once-daily dosage compared with conventional dosing of two or three times daily. This included three studies with induction of remission and eight on maintenance of remission as primary endpoints.
Brian G. Feagan
“The research was initiated because a number of relatively small studies had suggested there was ‘no difference’ in efficacy between conventional regimens and the reduced frequency regimens, and a meta-analysis seemed like a good way to increase the statistical power and fully evaluate the question,” researcher Brian G. Feagan, MD, director of clinical trials at the Robarts Research Institute at the University of Western Ontario in London, Canada, told Healio.com.
Proportions of patients who did not achieve clinical remission (42.0% of once-daily vs. 44.3% of standard-dose patients, RR=0.95, 0.82-1.10), or clinical improvement (39.7% vs. 45.8%, RR=0.87, 0.68-1.10) were similar between the two dosing strategies. Relapse incidence after 6 months (16.2% vs. 14.8%, RR=1.10, 0.83-1.46) and 12 months (28.7% vs. 31.1%, RR=0.92, 0.83-1.03) also was similar (95% CI for all).
Investigators found no differences between dosages in patients’ adherence to treatment or incidence of adverse events (41.2% of once-daily patients vs. 42.5% receiving standard dosage, RR=0.97; 95% CI, 0.88-1.07), serious events (3.2% vs. 2.3%, RR=1.38; 95% CI, 0.92-2.07) or study withdrawal due to adverse events (1.7% vs. 1.8%, RR=0.96; 95% CI, 0.58-1.58).
The data regarding failure to achieve clinical improvement, achieve or maintain remission, or adhere to the regimen was rated of moderate quality according to the GRADE criteria.
“5-ASA [mesalamine] can be dosed once or twice daily, which should improve compliance and drug efficacy,” Feagan said. “The standard multidose regimens that are currently labeled were not based on sound pharmacokinetic data, but were a legacy of the need to dose the parent compound, sulfasalazine, several times a day to minimize side effects. … Although compliance rates to multidose regimens reported in clinical trials are in fact quite high, this is not likely to be the case in real-world clinical practice.”
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