NEW YORK (Reuters Health) – Most children and adolescents starting treatment for ulcerative colitis (UC) with standardized therapy will not achieve steroid-free remission at 12 weeks, according to findings published in Lancet Gastroenterology and Hepatology.
“Our data reveal a sobering early course for children with new-onset ulcerative colitis,” Dr. Jeffrey Hyams of Connecticut Children’s Medical Center in Hartford and colleagues write in their September 20 online report. Given the findings, they suggest, additional interventions may be needed to improve early outcomes in pediatric UC patients, especially those who are severely ill and require intravenous corticosteroids as first-line treatment.
Current initial treatment for children with UC is based on evidence from clinical trials in adults, Dr Hyams and his team note. They launched the PROTECT study in 2012 to study how 428 children (mean age, 13) with newly diagnosed UC responded to standardized treatment with mesalazine (136 patients), oral corticosteroids (144), or intravenous corticosteroids (148).
At 12 weeks, 48% of patients on mesalazine, 33% on oral corticosteroids, and 21% on IV corticosteroids had achieved corticosteroid-free remission. Seven percent of the mesalazine group, 15% of the oral corticosteroid group, and 36% of the IV corticosteroid group required treatment escalation. Eight patients initially receiving IV corticosteroids underwent colectomy.
Factors predicting remission at 12 weeks included a Pediatric Ulcerative Colitis Activity Index (PUCAI) score below 35 (odds ratio 2.44), higher baseline albumin per 1-g/dL increase in children younger than 12 (OR, 4.05), and remission at 4 weeks (OR, 6.26).
Patients who started on IV corticosteroids were significantly more likely to require treatment escalation by week 12 if they had a baseline total Mayo score of 11 or higher (OR, 2.59), a rectal biopsy eosinophil count of 32 cells per high-power field or less (OR, 4.55), rectal biopsy surface villiform changes (OR, 3.05), or were not in remission at week 4 (OR, 30.28).
“Our results show that clinical activity indices, including PUCAI and Mayo score, can be combined with serum albumin and specific histological features of rectal biopsies to judge the likelihood of success for first-line therapies, and that week 4 remission is a crucial juncture to guide additional therapies,” Dr. Hyams and colleagues write. “These data suggest that additional therapeutic interventions could be warranted to improve early outcomes, especially in children presenting with severe disease and requiring treatment with intravenous corticosteroids.”
The findings suggest that using a “systematic approach” will help clinicians make decisions on early treatment in pediatric UC patients, Dr. James Ashton of Southampton Children’s Hospital and Dr. R. Mark Beattie of the University of Southhampton, UK, write in a comment accompanying the study. In adults, they add, treatment has shifted toward starting patients on anti-TNF therapy or immunomodulating drugs, but pediatric practitioners have raised concerns about the toxicity of these treatments.
“While current evidence is not yet adequate to provide a firm answer to whether we should be adopting a ubiquitous top-down approach in paediatric ulcerative colitis, this study does offer intriguing data indicating that there is significant room for improvement in early remission rates, and that earlier treatment escalation, especially in moderate to severe disease, should be considered,” they conclude.
Dr. Hyams was not available for an interview by press time.
SOURCES: http://bit.ly/2wkJ38x and http://bit.ly/2fQYxLb
Lancet Gastroenterol Hepatol 2017.
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