OBJECTIVES: Despite a paucity of published supporting data, 5-aminosalicylate (5-ASA) use in pediatric ulcerative colitis (UC) is common. The present study describes the use and outcome of a large multicenter inception cohort of children with UC treated with 5-ASA. METHODS: Data were obtained from the Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry, a prospective North American observational study of children newly diagnosed as having inflammatory bowel disease ages 16 years or younger. Patient data are recorded at diagnosis, 30 days, and then quarterly. Patients are managed by physician dictate, not protocol. Disease activity is classified by physician global assessment. The primary outcome examined was corticosteroid (CS) free, inactive UC at 1 year following initiation of 5-ASA within 30 days of diagnosis (with or without concomitant CS use) without the need for rescue therapy (immunomodulators, biologics, or colectomy). RESULTS: Study subjects included 213 patients newly diagnosed as having UC who received oral 5-ASA compounds (115 of whom also received CS) during the first 30 days after diagnosis, and no other oral therapies for the treatment of UC. Of these 213 patients, 86 (40%) were CS free and physician global assessment inactive at 1 year without rescue. Outcome was not associated with disease severity at diagnosis, demographic or laboratory factors examined, or initial dose of 5-ASA used. CONCLUSIONS: Forty percent of children taking 5-ASA as primary maintenance therapy at diagnosis are in CS-free remission after 1 year of treatment. Further pediatric studies will be needed to address whether increased adherence and/or higher dosing schedules will improve outcomes.
OBJECTIVES: Despite a paucity of published supporting data, 5-aminosalicylate (5-ASA) use in pediatric ulcerative colitis (UC) is common. The present study describes the use and outcome of a large multicenter inception cohort of children with UC treated with 5-ASA. METHODS: Data were obtained from the Pediatric Inflammatory Bowel Disease Collaborative Research Group Registry, a prospective North American observational study of children newly diagnosed as having inflammatory bowel disease ages 16 years or younger. Patient data are recorded at diagnosis, 30 days, and then quarterly. Patients are managed by physician dictate, not protocol. Disease activity is classified by physician global assessment. The primary outcome examined was corticosteroid (CS) free, inactive UC at 1 year following initiation of 5-ASA within 30 days of diagnosis (with or without concomitant CS use) without the need for rescue therapy (immunomodulators, biologics, or colectomy). RESULTS: Study subjects included 213 patients newly diagnosed as having UC who received oral 5-ASA compounds (115 of whom also received CS) during the first 30 days after diagnosis, and no other oral therapies for the treatment of UC. Of these 213 patients, 86 (40%) were CS free and physician global assessment inactive at 1 year without rescue. Outcome was not associated with disease severity at diagnosis, demographic or laboratory factors examined, or initial dose of 5-ASA used. CONCLUSIONS: Forty percent of children taking 5-ASA as primary maintenance therapy at diagnosis are in CS-free remission after 1 year of treatment. Further pediatric studies will be needed to address whether increased adherence and/or higher dosing schedules will improve outcomes.
Authors: Jeffrey S Hyams; Sonia Davis Thomas; Nathan Gotman; Yael Haberman; Rebekah Karns; Melanie Schirmer; Angela Mo; David R Mack; Brendan Boyle; Anne M Griffiths; Neal S LeLeiko; Cary G Sauer; David J Keljo; James Markowitz; Susan S Baker; Joel Rosh; Robert N Baldassano; Ashish Patel; Marian Pfefferkorn; Anthony Otley; Melvin Heyman; Joshua Noe; Maria Oliva-Hemker; Paul A Rufo; Jennifer Strople; David Ziring; Stephen L Guthery; Boris Sudel; Keith Benkov; Prateek Wali; Dedrick Moulton; Jonathan Evans; Michael D Kappelman; M Alison Marquis; Francisco A Sylvester; Margaret H Collins; Suresh Venkateswaran; Marla Dubinsky; Vin Tangpricha; Krista L Spada; Bradley Saul; Jessie Wang; Jose Serrano; Kevin Hommel; Urko M Marigorta; Greg Gibson; Ramnik J Xavier; Subra Kugathasan; Thomas Walters; Lee A Denson Journal: Lancet Date: 2019-03-29 Impact factor: 79.321
Authors: Kevin A Hommel; Wendy N Gray; Elizabeth Hente; Katherine Loreaux; Richard F Ittenbach; Michele Maddux; Robert Baldassano; Francisco Sylvester; Wallace Crandall; Charles Doarn; Melvin B Heyman; David Keljo; Lee A Denson Journal: Contemp Clin Trials Date: 2015-05-21 Impact factor: 2.226
Authors: Andrea L Matthis; Bin Zhang; Lee A Denson; Bruce R Yacyshyn; Eitaro Aihara; Marshall H Montrose Journal: Inflamm Bowel Dis Date: 2016-08 Impact factor: 5.325
Authors: Carmen Cuffari; David Pierce; Bartosz Korczowski; Krzysztof Fyderek; Heather Van Heusen; Stuart Hossack; Hong Wan; Alena Y Z Edwards; Patrick Martin Journal: Drug Des Devel Ther Date: 2016-02-04 Impact factor: 4.162