May 01, 2014
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Long-term infliximab therapy safe, effective for pediatric IBD patients

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Pediatric patients with Crohn’s disease and ulcerative colitis safely tolerated infliximab, some requiring dose escalation to maximize treatment response, for an extended time, according to recent data.

Researchers at Cedars Sinai Pediatric IBD Center in Los Angeles conducted a retrospective 10-year review of 188 patients (aged 21 years or younger; 51.6% female) with inflammatory bowel disease (IBD). For study inclusion, all patients had to have received at least one dose of infliximab (IFX) and at least 1 year of follow-up.

Sixteen percent of the patients had ulcerative colitis (UC) and 84% had Crohn’s disease (CD). The UC and CD groups were divided into patients who achieved sustained durable response (SDR) and those who did not. SDR was considered remission that involved standard maintenance dosing of 5 mg/kg IFX once every 7 or 8 weeks.

At the last follow-up, 41% of the 150 patients with CD who responded to IFX achieved SDR, while 41% of the 22 patients with UC who responded to IFX also met SDR status. Among CD patients, 88% continued to receive IFX at 1 year and 82% at 5 years. Seventy percent of UC patients avoided colectomy at 1 year.

For the 65 CD patients who did not achieve SDR, 37 required IFX dose intensification to 10 mg/kg, and in the UC arm, seven of the 13 non-SDR patients underwent IFX escalation.

Less than 1% of patients were affected by recurrent infections that restricted IFX therapy. Infusion reactions were the most commonly cited reasons for ceasing IFX therapy, with 25% of CD patients and 11% of UC patients developing anti-infliximab antibodies that caused IFX failures.

“Our study demonstrates that IFX is safe and effective for long-term maintenance therapy in pediatric patients with IBD,” the researchers concluded. “IFX dose intensification can optimize durability and overcome loss of response.”

Disclosure: Researcher Marla C. Dubinsky, MD, reports receiving an independent investigator scientific grant from and is a consultant for Janssen.