Post‐marketing analysis for biosimilar CT‐P13 in inflammatory bowel disease compared with external data of originator infliximab in Japan

Abstract

Background and Aim: CT-P13, an infliximab (IFX) biosimilar, was approved for treatment of inflammatory bowel disease. However, no comparison with the originator IFX in this indication has been conducted in Japan where endemic levels of tuberculosis and hepatitis virus infection are not low. We evaluated the safety and efficacy in real-world data of CT-P13 and compared with originator IFX data in Japan. Methods: In a prospective post-marketing surveillance (PMS) study, patients who received CT-P13 in a 28-month period from January 2015 were followed up for 2 years. By conducting Japanese administrative database search (DBS) for the same period of PMS, data of the originator IFX including treatment persistence, tuberculosis incidence, and liver injury were analyzed retrospectively and compared with the corresponding PMS data of CT-P13. Results: CT-P13 persistence in PMS (n = 640) and IFX persistence in DBS (n = 4113) were almost similar between patients who switched from the originator and patients who continued on the originator, and also between the biologics-naïve patient groups. There were no differences in the incidences of tuberculosis and hepatic injury (Tuberculosis: 2 patients [0.31%] with CT-P13, 10 patients [0.24%] with the originator, P = 0.75; Hepatic injury: 18.5% with CT-P13, 15.4% with the originator, P = 0.22). Most of the patients with hepatic injury continued treatment in PMS and DBS at similar rates (80.8% vs 83.6%, P = 0.65). Conclusion:The results of long-term PMS of CT-P13 compared with external reference data from an administrative database suggested that the biosimilar and its originator were comparably useful in real-world clinical practice.

Research on Liver Damage Caused by the Treatment of Rheumatoid Arthritis with Novel Biological Agents or Targeted Agents

“…Infliximab biosimilars CT-P13 and SB2 were approved in 2016 and 2017, respectively, and both have similar therapeutic efficacy and safety profiles compared to infliximab and induced comparable liver injury compared to infliximab. 62 Other biologics such as levilimab (targeting interleukins or the receptors), satralizumab and cytokine or chemokine-targeted biologics such as mavrilimumab and otilimab are still used in clinical trials. Although different biosimilars have demonstrated efficacy and safety compared to the reference product, serious adverse reactions may not have been fully identified and confidence in their use is still lacking.…”

Experiencia mundial en el uso de biocomparables en enfermedad inflamatoria intestinal

“…En otro estudio japonés sobre la vigilancia poscomercialización, los pacientes que recibieron infliximab CT-P13 en un periodo de 28 meses a partir de enero de 2015 fueron seguidos durante 2 años. No hubo diferencias en la incidencia de tuberculosis y de lesión hepática al comparar con el biológico original (tuberculosis: 2 pacientes [0.31%] con CT-P13 y 10 pacientes [0.24%] con el biológico original, p = 0.75; lesión hepática: 18.5% con CT-P13 y 15.4% con el biológico original, p = 0.22) 22 .…”

Impact of Infliximab-dyyb (Infliximab Biosimilar) on Clinical and Patient-Reported Outcomes: 1-Year Follow-up Results from an Observational Real-World Study Among Patients with Inflammatory Bowel Disease in the US and Canada (the ONWARD Study)

“…Recently, a few studies outside North America have compared safety outcomes, such as hepatitis and tuberculosis infections, and the pharmacokinetic profile of infliximab biosimilar and the originator in the real-world IBD population. These studies found that infliximab biosimilar had similar safety and pharmacokinetic profile in real-world settings [9,10]. Additional real-world studies from outside North America, where approval for infliximabdyyb for IBD occurred before 2016, suggest no clinically meaningful differences in safety and effectiveness when patients either remain on RP infliximab or switch to an infliximab biosimilar [11][12][13][14][15][16][17].…”