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.
In AWARD-7, eligible patients (N=577) were randomized to receive dulaglutide 1.5mg once-weekly (N=193), dulaglutide 0.75mg (N=190) once-weekly, or insulin glargine daily (N=194), all in combination with insulin lispro, for 52 weeks. HbA1c at 26 weeks with a 0.4% non-inferiority margin was designated as the primary outcome, while secondary outcomes included eGFR and urine albumin-to-creatinine ratio.
ACX-362E is a targeted, narrow spectrum oral antibiotic that blocks the DNA replication process through inhibition of polymerase III, which has been shown to be bactericidal.
The update is based on data from the Phase 3 FUTURE 5 study (N=996) which evaluated Cosentyx versus placebo in patients with active psoriatic arthritis.