A real-world analysis from Japan confirmed that CT-P13, an intravenous infliximab biosimilar, had comparable safety and efficacy to the reference product (Remicade; infliximab) in patients with immune-mediated inflammatory diseases.
A real-world study found that CT-P13 (Remsima, Inflectra), Celltrion’s intravenous infliximab biosimilar, is just as safe and effective as the originator (Remicade; reference infliximab) for people with immune-related inflammatory diseases.
The Japanese analysis, published in Drug Safety, reviewed data from 3 prospective post-marketing surveillance (PMS) studies conducted in patients who were biologic-naïve and those who were switched from the originator to the biosimilar. The study provided valuable long-term data on the safety and efficacy of biosimilar CT-P13 and identify risk factors for frequent adverse drug reactions (ADRs), which can help providers with clinical decision-making.
Researchers pooled data from studies assessing CT-P13 in patients with rheumatoid arthritis (RA), Crohn disease (CD) and ulcerative colitis (UC), and psoriasis. Patients with RA received the first dose of CT-P13 between January 2015 and November 2020, with a surveillance period of 1 year. Patients with CD or UC started CT-P13 therapy between January 2015 and April 2018, with a 2-year follow-up period. The study on psoriasis enrolled patients from May 2015 to January 2020 and had a 1-year follow-up period. All 3 studies were conducted by Nippon Kayaku after CT-P13 was approved in Japan.
During the present analysis, the patients were categorized into 3 categories: biologic-naïve patients, patients switching from originator infliximab to CT-P13, and patients switching to CT-P13 from another biologic for medical reasons (adverse events or inadequate response).
Overall, 1816 patients (RA: n = 987, 54%; CD: n = 342, 19%; UC: n = 322, 18%; psoriasis: n = 165, 9%) were evaluated for CT-P13 safety, and 1150 patients who had pre-treatment and post-treatment data for disease activity parameters were assessed for efficacy. Of those patients, 735 (40%) were biologic-naïve, 894 (49%) switched from originator infliximab to CT-P13, and 197 (11%) switched to CT-P13 from another biologic.
In the safety analysis, adverse reactions were reported in 24.2% of all patients (biologic-naïve: 30.5%; originator to CT-P13: 17.0%; other biologic to CT-P13: 33.5%). Infusion reactions were the most common adverse reaction (8.2%), and the incidence was highest in patients with UC and those with an allergy history. Infection was the second most common reaction (6.1%); however, tuberculosis only occurred in 4 (0.2%) patients.
Infection incidence was low in the CD and psoriasis cohorts, and the significant risk factors were allergy history, comorbidities, and concomitant steroid use. Sixteen (0.4%) patients experienced interstitial lung disease, including 11 patients with RA.
In the efficacy analysis, CT-P13 therapy resulted in similar decreases in disease activity parameters across all 4 diseases. Treatment discontinuation varied by disease. Discontinuations due to efficacy issues were most common in UC and psoriasis (19% for both). Adverse reactions as the reason for discontinuation were higher among patients with UC (14%). Sixty-four (4%) patients who switched from the originator switched back.
Additionally, disease activity parameters decreased quickly and the proportion of patients in remission increased in naïve patients. Those who switched from the originator maintained lowered parameter levels that were achieved prior to switching. Decreases observed in patients who switched from another biologic were found, but they were mostly because of insufficient efficacy, suggesting that the patients did not respond to infliximab therapy generally rather than complications with the biosimilar.
The analysis had some limitations. Patient data varies due to different diseases, and the use of previously reported data for comparisons in single-arm post-marketing studies makes the results less conclusive. Real-world post-marketing data is scarcer than clinical trial data, but it still provides valuable insights into real clinical practice.
The authors concluded, “as a cost-effective biosimilar, CT-P13 could be useful for the treatment of immune-mediate inflammatory diseases in biologic-naïve patients and switched patients from biologics.”
Takeuchi T, Nishikawa K, Yamada F, et al. Real‐world safety and efficacy of biosimilar CT‐P13 in patients with immune‐mediated inflammatory diseases: Integrated analysis of three Japanese prospective observational studies. Drug Saf. 2023;46:991-1005. doi:10.1007/s40264-023-01340-1