Infliximab Clinical Trial Updates

The Big Molecule Watch is monitoring clinical trial activities involving infliximab.  Here we report on recent studies with Celltrion’s INFLECTRA (infliximab-dyyb).

Earlier this year, clinical trial data was published from an observational real-world study of patients with inflammatory bowel disease, including Crohn’s disease (“CD”) and ulcerative colitis (“UC”) in the United States and Canada.  A total of 67 CD and 48 UC patients were enrolled in the study.  The study found that clinical outcomes among biologic-naïve users of Celltrion’s infliximab-dyyb improved for UC and were maintained for CD patients.  Similarly, biologic-naïve users of infliximab-dyyb showed significant improvements in patient reported outcomes.

More recently, results were published from a real-world post-marketing surveillance clinical study in Japan of 165 psoriasis patients treated with Celltrion’s INFLECTRA (also known as CT-P13).  According to the study, the response rate was high (78%) in patients with psoriatic arthritis, and 40% and 20% in those in plaque psoriasis and pustular psoriasis, respectively.  Adverse drug reactions (“ADRs”) occurred in 29 patients (17.6%), with infusion reaction reported as the most frequent ADR (6.7%).  The study authors concluded that “CT-P13 showed excellent effectiveness as a first-line therapy, no clinical difficulties in switching from [IFX, the originator’s infliximab], and usefulness in patients who failed other biologics,” and that “CT-P13 could be a cost-effective alternative to IFX for the treatment of psoriasis.”