Anti-TNF-alpha therapy helps achieve remission in pediatric Crohn's disease

By Will Boggs MD

NEW YORK (Reuters Health) - Anti-TNF-alpha therapy is more effective than usual care for achieving remission of Crohn's disease in children, according to data from ImproveCareNow (ICN).

Usual care in this study could include any combination of thiopurines, methotrexate, corticosteroids, 5-aminosalicylates, nutrition therapy, and surgery.

"Our study demonstrated that antiTNFa is more effective than conventional treatments, like thiopurines and steroids, at achieving remission," Dr. Christopher B. Forrest from The Children's Hospital of Philadelphia told Reuters Health by email. "This finding, though, does not mean that antiTNFa should be the standard of care for all children, because that would also involve an evaluation of maintenance of remission and side effects and more direct comparisons of treatment options."

Studies in adults have shown anti-TNF-alpha therapy to be superior to placebo and thiopurines, but similar studies are lacking in children.

Dr. Forrest and colleagues used data from ICN to compare initiation of biologic therapy with anti-TNF-alpha to usual care among pediatric patients who had moderate to severe Crohn's disease. Overall, 1814 children received anti-TNF-alpha therapy and 2316 children did not.

At 26 weeks, children receiving anti-TNF-alpha therapy ("initiators") had a 54.4% chance of achieving remission, compared with 41.2% in children who did not receive anti-TNF-alpha therapy ("non-initiators"), according to the June 16th Pediatrics online report.

At the same time, initiators had a 47.3% chance of achieving corticosteroid-free remission, compared with only 31.2% for non-initiators.

Results were similar at 26 and 52 weeks of follow-up: initiators were about 50% more likely than non-initiators to achieve clinical remission and 70% more likely to achieve corticosteroid-free remission.

Differences in favor of initiation emerged as early as six weeks of follow-up, the researchers say.

These results were comparable to single-group, open-label clinical trials, such as REACH, with pediatric patients and comparative controlled trials done with adults, such as SONIC.

"Some clinicians like to reserve use of biologics because of their cost and side effects, and in fact conventional treatment can be used to achieve remission," Dr. Forrest explained. "Timing of use of biologics is a next step in this research program. There are some physicians who use antiTNFa at diagnosis and others who step up to the therapy after other treatments have failed. The comparative effectiveness of these two strategies is unknown."

"In addition to the clinical message, I think the study's use of a learning health system is one of the most interesting parts of the work," Dr. Forrest said. "The study was done in ImproveCareNow, which is a learning health system comprised of over 60 hospitals and practices committed to improving the care and outcomes of children with inflammatory bowel disease (IBD). Practices collect standardized health data in the context of routine clinical practice."

"Our study showed that data collected routinely for the purposes of clinical practice and quality improvement can be repurposed to answer important clinical questions rapidly and efficiently, without some of the practical or ethical challenges in randomized controlled clinical trials," Dr. Forrest said.

SOURCE: http://bit.ly/1yt0ZtJ

Pediatrics 2014;134:37-44.

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