(HealthDay News) – Thalidomide is associated with improved clinical remission at eight weeks of treatment for children with refractory Crohn’s disease, according to a study published in the Nov. 27 issue of the Journal of the American Medical Association.
Marzia Lazzerini, PhD, from the Institute for Maternal and Child Health IRCCS “Burlo Garofolo” in Trieste, Italy, and colleagues conducted a multicenter placebo-controlled trial involving children with active Crohn’s disease despite immunosuppressive treatment. Participants were randomized to receive thalidomide (n=28) or placebo (n=26) once daily for eight weeks. Non-responders to placebo received thalidomide for an additional eight weeks in an open-label extension.
The researchers found that significantly more thalidomide-treated than placebo-treated children achieved clinical remission (46.4 vs.11.5%; risk ratio, 4.0; P=0.01). At four weeks, the responses were not different, but greater improvement was seen at eight weeks in the thalidomide group (75% response: 46.4 vs. 11.5%; 25% response: 64.2 vs. 30.8%; both P=0.01). More than half (52.4%) of the non-responders who received thalidomide subsequently reached remission at week eight. Overall, 65.3% of children achieved 75% esponse and 63.3% achieved clinical remission. The mean remission duration was 181.1 weeks in the thalidomide group vs. 6.3 weeks in the placebo group (P<0.001).
“These findings require replication to definitively determine clinical utility of this treatment,” the authors write.