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Thalidomide improved clinical remission of Crohn's disease
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Treatment with thalidomide improved clinical remission after 8 weeks in children and adolescents with Crohn's disease not responding to treatment, according to recent study findings published in JAMA.
Marzia Lazzerini, PhD, of the Institute for Maternal and Child Health IRCCS Burlo Garofolo in Italy and colleagues evaluated 56 children with active Crohn's disease between August 2008 and September 2012 to determine whether thalidomide (Thalomid, Celgene) is effective in inducing and maintaining remission. Patients were randomly assigned thalidomide (1.5-2.5 mg/kg per day) or placebo (once daily) for 8 weeks. Patients not responding to placebo received thalidomide for an additional 8 weeks.
Patients treated with thalidomide achieved remission significantly more often compared with patients on placebo (RR=4; 95% CI, 1.2-12.5). Most secondary outcomes were significantly improved at 8 weeks in the thalidomide group compared with the placebo group (RR=4; 95% CI, 1.2-12.5).
Among patients who received thalidomide after not responding to placebo, 52.4% achieved remission at 8 weeks (RR=4.5; 95% CI, 1.4-14.1).
Overall, 63.3% of patients who received thalidomide achieved remission. Mean duration of clinical remission was 181.1 weeks in the thalidomide group versus 6.3 weeks in the placebo group (P<.0001).
“Among children and adolescents with refractory Crohn disease, the use of thalidomide compared with placebo resulted in improved clinical remission at 8 weeks of treatment and longer-term maintenance of remission in an open-label follow-up,” the researchers wrote. “These findings require replication to definitively determine the utility of this treatment.”
Disclosure: The study was funded in part by the Italian Medicines Agency. Celgene provided the study drug.
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