The randomized, double-blind, placebo-controlled study (N=331) achieved its primary endpoint and key secondary endpoints in the intent-to-treat (ITT) population.
For this study, researchers identified randomized controlled trials that included adults with moderate-to-severe CD treated with various biologic agents (i.e., infliximab, adalimumab, certolizumab pegol, vedolizumab, ustekinumab) as first- or second-line therapies compared with placebo or an active comparator.
The new analysis pooled patients from the UNITI-1 and UNITI-2 trials who had clinical response after a single intravenous (IV) dose of ustekinumab and entered a 5-year follow-up period.
Data added to the labeling includes first-of-their-kind pharmacokinetic studies demonstrating negligible to low transfer of CIMZIA through placenta and minimal transfer to breast milk from mother to infant.
The authors point out how, unlike other autoinflammatory conditions, "IBD has the benefit of effective and safe gut specific anti-integrin therapies which can provide a platform off of which combinations can be employed."
Cx601 is a first-in-class allogeneic cell therapy intended for patients who have had an inadequate response to at least one conventional or biologic therapy.