SONIC trial data "could challenge treatment protocol" for CD

Data from the Phase IIIb SONIC trial show that a significantly greater proportion of patients with moderate to severe Crohn's disease receiving Johnson & Johnson's Remicade (infliximab), either with azathioprine or alone, experienced steroid-free remission and mucosal healing compared with those given azathioprine alone.

Azathioprine is not approved by the US Food and Drug Administration for the treatment of CD. However, the off-patent immunosuppressant is widely used by gastroenterologists and other physicians in the USA to treat patients with the bowel condition.

Findings presented at the American College of Gastroenterology annual meeting in Orlando, Florida, demonstrate that, at week 26, 57% of patients on the Remicade combination and 44% of those receiving monotherapy achieved steroid-free remission, the primary endpoint of the study, compared with 31% of subjects getting azathioprine alone (p<0.001 Remicade with azathioprine versus azathioprine monotherapy; p=0.009 Remicade monotherapy vs azathioprine monotherapy; p=0.022 Remicade with azathioprine vs monotherapy).