Mesalamine enemas may be helpful in pediatric ulcerative colitis

Last Updated: 2017-04-19

By David Douglas

NEW YORK (Reuters Health) - Following failure of high-dose oral mesalamine (5-aminosalicylic acid), topical enemas containing the agent may be effective in many children with mild to moderate ulcerative colitis (UC), according to Israeli and Finnish researchers.

As Dr. Dan Turner told Reuters Health by email, “Pediatric gastroenterologists have been reluctant in using enemas in children given the perceived invasiveness. Our study shows that not only is this intervention effective in many children who were resistant to oral 5-aminosalicylic acid, and could be an alternative to stepping up to steroids in some children, most of the participants tolerated the enemas very well."

In a paper online March 23 in the Journal of Crohn's and Colitis, Dr. Turner of the The Hebrew University in Jerusalem and colleagues note that pediatric disease is more extensive than that in adults and more often refractory to mesalamine. However, there have been no prospective trials of mesalamine enemas in children.

To investigate further, the team examined outcomes in a three-week prospective, open-label, extension enema arm of a previously reported single-blinded randomized controlled trial; 38 children aged 4 to 18 years were enrolled after failing at least three weeks of full-dose oral mesalamine. None had been treated with steroids or enemas in the previous month and those with isolated proctitis were excluded.

Their Paediatric Ulcerative Colitis Activity Index (PUCAI) score ranged from 10 to 55. They went on to receive Pentasa mesalamine enemas (Ferring Pharmaceuticals) at 25 mg/kg with a maximum of 1 g daily, along with their previous oral dose of mesalamine.

After three weeks, clinical remission, defined as PUCAI below 10 and a change of at least 10 points from baseline was achieved in 16 children (42%), and a response was seen 27 (71%).

However, eight children deteriorated and needed steroids, three of whom required hospitalization in order to have intravenous steroids.

In the earlier randomized trial, the researchers note, “oral mesalamine leads to remission in only 35% of children with mild to moderate UC, without significant difference between the drug being prescribed once or twice daily.”

"Our finding here," they write, "adds that topical therapy may play an important role in inducing remission and as a steroid-sparing agent in those refractory to oral mesalamine."

Dr. Turner concluded, "I think that physicians should consider using enemas more freely for treating children with mild to moderate UC."

Dr. Nadeem Ahmad Afzal, a consultant in pediatric gastroenterology at Southampton Children's Hospital in the U.K., told Reuters Health by email, "While we continue to seek new treatments for use in children with ulcerative colitis, it is as important to explore more effective ways for using well-known established treatments."

Dr. Afzal, who was not involved in the new work, said the study’s authors, who include world-leading pediatric gastroenterologists, "have demonstrated short-term effectiveness with use of mesalazine (mesalamine) enemas in children with extensive colitis, in a novel multi-center randomized controlled trial. This new evidence gives pediatric GI clinicians another very useful, non-steroid treatment option for treatment of extensive colitis in children."

The study was funded by Ferring Pharmaceuticals. Dr. Turner and other authors reported relationships with the company.

SOURCE: http://bit.ly/2nLZpGZ

J Crohns Colitis 2017.