Infliximab Clinical Trial Updates

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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.”

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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