The primary endpoint was disease activity at week 16 after switching to CT-P13 relative to baseline. Secondary endpoints included additional inflammatory, pharmacokinetic and immunogenicity parameters, as well as quality of life and safety. All markers were assessed at Week 0 and 16.
“Switching did not result in significant changes of disease activity as corroborated by relevant and validated biomarkers,” Dr. Smits and colleagues report. “Pharmacokinetic parameters such as [trough level] of CT-P13 were maintained during the study. Two patients developed new detectable [antidrug antibodies] and [five] patients discontinued CT-P13.” There were no unexpected safety signals.
The design of the study, which did not include a control group that allowed patients to continue brand name infliximab, is a limitation of the study, they note. “Therefore, it is difficult to interpret changes in efficacy, safety and pharmacokinetics that may be due to either the switch to CT-P13 or may be coincident with the natural course. The ongoing NOR-SWITCH study (estimated completion date January 2017) might be able to provide answers to some of the issues,” they write.
They note that the cohort was heterogeneous in terms of diagnosis, infusion schedule and disease activity. “As such our cohort reflects real world practice outside the strict in- and exclusion criteria of randomized controlled trials, which allows immediate translation of results to clinical care. However, the duration of follow-up was relatively short and longer follow-up is required to determine long-term efficacy, safety and immunogenicity of CT-P13.
Despite these limitations, the authors say their study shows that switching from brand name infliximab to CT-P13 had no marked impact on short-term clinical outcomes, suggesting that making the switch to CT-P13 for the treatment of IBD is “feasible.”
None of the studies had commercial funding and the authors did not report relevant conflicts of interest.
