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.
*Connecticut Children's Medical Center, Hartford, CT
†Cohen Children's Medical Center, New Hyde Park, NY
‡Children's Hospital of Eastern Ontario, Ottawa
§Hospital for Sick Children, Toronto, Ontario, Canada
||Children's Hospital, Boston, MA
¶Children's Hospital of Pittsburgh, Pittsburgh, PA
#Goryeb Children's Hospital, Morristown, NJ
**Nemours Children's Clinic, Jacksonville, FL
††University of North Carolina, Chapel Hill, NC
‡‡I.W.K. Health Center, Halifax, Nova Scotia, Canada
§§Cleveland Clinic Foundation, Cleveland, OH
||||Children's Hospital of Philadelphia, Philadelphia, PA
¶¶Cincinnati Children's Medical Center, Cincinnati
##Nationwide Children's Hospital, Columbus, OH
***Johns Hopkins Hospital, Baltimore, MD
†††Mayo Clinic, Rochester MN
‡‡‡University of Minnesota, Minneapolis, MN
§§§Riley Hospital for Children, Indianapolis, IN
||||||||||Children's Medical Center, Dayton, OH
¶¶¶Hasbro Children's Hospital, Providence, RI.
Address correspondence and reprint requests to Bella Zeisler, MD, Connecticut Children's Medical Center, 282 Washington St, Hartford, CT 06106 (e-mail: firstname.lastname@example.org).
Received 10 February, 2012
Accepted 18 July, 2012
Partial support for the present study came from a grant provided by Janssen Ortho-Biotech.
Bella Zeisler, Farhat Ashai-Khan, Neal LeLeiko, Marsha Kay, Andrew Grossman, Michael Kappelman, Jonathan Evans, Boris Sudel, Ryan Carvalho, and David Mack report no conflicts of interest. Trudy Lerer has the following disclosure: Janssen Ortho Biotech—research support. James Markowitz reports the following disclosures: Janssen Ortho Biotech—consultant, research support; Prometheus Laboratories—research support. Anne Griffiths reports the following disclosures: Abbott—consultant, speakers’ bureau; research support; Centocor—consultant, research support; Merck—consultant, speakers’ bureau; Janssen—consultant, speakers’ bureau, research support; Nestle—consultant; Shire—consultant. Athos Bousvaros reports the following disclosures: Warner Chilcott—consultant; Millennium—consultant; UCB (subinvestigator on a clinical trial)—research support; Abbott Nutrition—speaker for webinar (developed his content independently). David Keljo reports the following disclosure: Pfizer (manufacturer of Azulfidine)—a family member owns stock. Joel Rosh reports the following disclosures: Abbott, Centocor, UCB—grant/research funding; Abbott, Centocor, Soligenix—advisor/consultant; Abbott Nutrition—speakers’ bureau. Anthony Otley reports the following disclosures: Janssen Canada—advisory board, research support; Abbott Canada—advisory board; Abbott US—research support (site in multicenter trial); Mead Johnson Canada—speakers’ bureau; Nestle Canada—advisory board; UCB—research support (site in multicenter trial); AstraZeneca—research support (site in multicenter trial). Shehzad Saeed reports the following disclosures: Prometheus Laboratories, Given Imaging—speakers’ bureau; UCB—advisory board. Maria Oliva-Hemker reports the following disclosures: Abbott Immunology—research support. William Faubion reports the following disclosures: Centocor Ortho Biotech Services, Genentech Inc, Shire Pharmaceutical Development—consultant (no personal compensation received). Marian Pfefferkorn reports the following disclosures: UCB, Prometheus Laboratories—research support. Jeffrey Hyams reports the following disclosures: Janssen Ortho Biotech—research support, advisory board, speakers’ bureau; Abbott—research support; Shire—research support.