This article is more than 5 years old. Information may no longer be current.
Anti-TNF-a superior to routine therapy at inducing remission in pediatric Crohn's disease
Click Here to Manage Email Alerts
Anti-tumor necrosis factor-alpha therapy administered in routine gastroenterology practice settings was more effective at inducing clinical and corticosteroid-free remission in pediatric Crohn’s disease patients than usual care, according to recent study data.
Michael D. Kappelman, MD, associate professor of pediatrics, University of North Carolina, and colleagues conducted a series of non-randomized trials based on ImproveCareNow (ICN) registry data on 4,130 patients with moderate to severe Crohn’s disease (CD) treated at 35 pediatric gastroenterology practices from April 2007 to March 2012. Patients were classified and compared as either initiators or noninitiators of anti-tumor necrosis factor-alpha therapy. (anti-TNF-a).
Michael D. Kappelman
Of 1,814 patients who received anti-TNF-a during the study period, 603 previously had never used anti-TNF-a, and 1,211 were receiving it upon entry into the ICN. Probability of achieving remission was calculated and compared with the results of a controlled trial of anti-TNF-a efficacy in children (REACH) and a comparative study of anti-TNF-a vs. thiopurines in adults (SONIC).
After a 26-week follow-up period, initiators had a 54.4% chance (95% CI, 47.7-61.1) of remission and a 47.3% chance (95% CI, 40.6-53.9) of corticosteroid-free remission; noninitiators had rates of 41.2% (95% CI, 38.2-44.2) and 31.2% (95% CI, 28.4-34), respectively. Remission rate ratios adjusted for patient and disease characteristics and medications were 1.53 (95% CI, 1.2-1.96) for clinical remission and 1.74 (95% CI, 1.33-2.29) for corticosteroid-free remission. Clinical remission rates for ICN compared with REACH were 49% (95% CI, 38%-61%) and 59% (95% CI, 50%-68%), respectively. Unadjusted corticosteroid-free remission rate ratios for ICN and SONIC were 1.73 (95% CI, 1.38-2.16) vs. 1.69 (95% CI, 1.31-2.17).
“Our findings suggest that anti-TNF-a agents are comparatively more effective than usual care for treating children who have moderate to severe CD who are managed in routine clinical practice settings,” the investigators concluded. “Our results are remarkably consistent with those of single-group efficacy studies among children and comparative controlled clinical trials done among adults, but they expand the evidence base by providing new information on the comparative effectives of anti-TNF-a for CD managed in routine pediatric gastroenterology settings.”
The researchers also observed that using data from ICN for observational research was efficacious. "ICN is a learning health system comprised of over 60 hospitals and practices committed to improving the care and outcomes of children with IBD," Kappelman told Healio.com. "Practices collect standardized health data in the context of routine clinical practice, and these data can be used to answer important clinical questions rapidly and efficiently, without some of the practical or ethical challenges in randomized controlled clinical trials."
Disclosure: See the study for a full list of relevant financial disclosures.
Click Here to Manage Email Alerts