Complete remission at 8 weeks with high-dose adrenomedullin in UC
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Complete remission at 8 weeks was observed in patients with steroid-resistant ulcerative colitis who received a high dose of adrenomedullin, according to study published in The Journal of Gastroenterology.
“[Despite] the limited number of patients in this double-blind randomized trial, we observed the successful complete remission at 8 weeks in patients with steroid-resistant UC receiving a high dose of [adrenomedullin(AM)],” Toshihiro Kita, MD, from the division of circulatory and body fluid regulation, department of internal medicine, faculty of medicine at the University of Miyazaki, Japan, and colleagues, said “Hence, AM could serve as candidate potent therapeutic agent for complete remission in refractory UC.”
Kita and colleagues performed a phase 2a trial assessing 28 patients in Japan with steroid-resistant UC. Investigators randomly assigned patients to four groups. They were given an infusion of 5, 10 and 15 ng/kg per minute of AM or placebo for 8 hours per day for 14 days. The change in Mayo scores at 2 weeks served as the study’s primary endpoint. Other endpoints include the change in Mayo scores and the rate of clinical remission at 8 weeks.
At 2 weeks, no differences were observed among the four groups with regard to the primary and secondary endpoints, according to researchers.
“Despite the insufficient tracking rate, the Mayo score at 8weeks was only significantly decreased in the high-dose AM group (15 ng/kg per minute) compared with the placebo group (–9.3 ± 1.2 vs. –3.0 ± 2.8, P = .035), with its rate of clinical remission at 8 weeks being significantly higher (3/3, 100% vs. 0/2, 0%, P = .025),” the authors wrote.
Investigators noted mild adverse events caused by the vasodilatory effect of AM; however, no serious adverse events were observed.
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