Safety, efficacy, and drug survival of the infliximab biosimilar <scp>CT‐P13</scp> in post‐marketing surveillance of Japanese patients with psoriasis

Morita, Akimichi; Nishikawa, Kiyohiro; Yamada, Fumika; Yamanaka, Keiichi; Nakajima, Hideki; Ohtsuki, Mamitaro

doi:10.1111/1346-8138.16508

Cited by 11 publications

(8 citation statements)

References 34 publications

(69 reference statements)

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“…Over the 3-year observation period, the development of ADA was detected in 20 patients of cohort 1 (8.5%) vs. 11 patients of cohort 2 (25%). The risk of treatment discontinuation was significantly higher in patients with positive ADA in both cohorts Morita A, 2022 [45] Efficacy (PASI, DLQI, DAS28-CRP) and safety (AEs)…”

Section: Main Outcomes Main Resultsmentioning

confidence: 96%

“…Twelve studies [36][37][38][39][40][41][42][43][44][45]47,48] evaluated the effects in terms of the efficacy and safety derived from the switch among infliximab products. Eleven studies were carried out in Europe, while one study was conducted in Japan.…”

Section: Infliximab Switching Studiesmentioning

confidence: 99%

“…Lastly, the only study performed outside European countries (the study location was Japan) was the one carried out by Morita A et al [45]. The authors carried out a prospective post-marketing surveillance with the aim to evaluate the safety, efficacy, and drug survival after non-medical switching from the infliximab originator among 165 patients with psoriasis (105 switchers).…”

Section: Infliximab Switching Studiesmentioning

confidence: 99%

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Switching between Originators and Biosimilars in Dermatology: A Systematic Review of Real-World Clinical Studies

Nicoletti

Pentella

et al. 2023

Biologics

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Background. Although biosimilars have been increasingly used over recent years, some concerns about a potential loss of efficacy and altered safety profile when switching from an originator to a biosimilar still exist. Interchangeability can be a challenge for dermatologists too. An extensive systematic review of published switching studies among originators and biosimilars was carried out in order to provide evidence regarding the effects derived from the switch in terms of efficacy and safety outcomes in real-life contexts. Results. Thirty-seven articles were included in this systematic review (14 studies related to adalimumab, 10 to etanercept, 12 to infliximab, and 1 each to adalimumab, etanercept, and infliximab). Studies were mainly carried out among European countries. Most of them were observational studies or register-based studies. The majority of studies enrolled patients diagnosed with psoriasis or psoriatic arthritis who underwent a single switch from the originator to the biosimilar. Overall, the studies’ results demonstrated that switching between adalimumab, etanercept, and infliximab originators and biosimilars is safe and effective in a real-life setting of patients with dermatological conditions. Only a few studies highlighted an increase in the risk of loss of efficacy as well as an increased rate of AEs, both of which were identified as the main causes of biosimilar discontinuation, probably associated with the well-known phenomenon of the nocebo effect. Conclusion. Switching from a biologic originator to its biosimilar is safe and effective. Only a few studies have evaluated the switch among biosimilars; thus, no firm conclusion can be drawn for this type of switch in terms of the efficacy and safety outcomes. Based on our results, we believe that biosimilars can be considered interchangeable with their reference products and that no additional switch studies are necessary to support switching among originators and biosimilars in clinical practice. However, the continuous monitoring of all biologics (both originators and biosimilars) in routine clinical practice is strongly needed given their peculiar safety profile.

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Section: Main Outcomes Main Resultsmentioning

confidence: 96%

Section: Infliximab Switching Studiesmentioning

confidence: 99%

Section: Infliximab Switching Studiesmentioning

confidence: 99%

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Switching between Originators and Biosimilars in Dermatology: A Systematic Review of Real-World Clinical Studies

Nicoletti

Pentella

et al. 2023

Biologics

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“…There have been >90 switching studies performed with biosimilars which have not revealed any significant issues. 13,[16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33] This continued surveillance must remain a focus of pharmacovigilance programs to monitor biosimilars as they are on the market. 34…”

Section: Introductionmentioning

confidence: 99%

“…There have been >90 switching studies performed with biosimilars which have not revealed any significant issues. 13,16-33…”

Section: Introductionmentioning

confidence: 99%

Biosimilars in Dermatology Review

Baker,

Kalb

2023

Journal of Psoriasis and Psoriatic Arthritis

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Background Safe and effective biosimilar medications have the potential to significantly increase access to these valuable drugs. The two current biosimilars available in dermatology in the United States (US) are infliximab and rituximab which were Food and Drug Administration (FDA) approved in 2016 and 2018 respectively. There has been significant interest in this topic as a number of biosimilar versions of adalimumab will be available in 2023. Objective This review will discuss biosimilar basics and the experience with biosimilars used in dermatology in the US, Asia, and Europe. Methods All articles in Ovid/Medline from 2015 to Feb 2023 on biosimilars were reviewed with a particular emphasis on medications used in dermatology. Other reports from pharmaceutical manufacturers and blogs following the development of the biosimilar industry provided key insights. Results Biosimilars have been able to produce significant savings and market share increases, particularly in Europe, where there has been a longer experience. The specifics depend on drug prescribing practices and incentives in the individual country. This degree of savings and market share increases have not been realized with the current biosimilars available in the US. Conclusion While biosimilars have resulted in significant savings compared to originator drugs, it is clear that prescribing incentives and physician education are crucial in achieving these savings. To what degree biosimilar market share will increase in the US remains to be determined.

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Real-World Safety and Efficacy of Biosimilar CT-P13 in Patients with Immune-Mediated Inflammatory Diseases: Integrated Analysis of Three Japanese Prospective Observational Studies

Takeuchi,

Nishikawa,

Yamada

et al. 2023

Drug Saf

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Introduction Biosimilar CT-P13 was approved with limited data from clinical trials compared to the originator infliximab in biologic-naïve patients with rheumatoid arthritis. Three prospective post-marketing surveillance studies have been conducted in Japanese biologic-naïve patients and switched patients from biologics including the originator infliximab. Objective We performed an integrated analysis of final data from three post-marketing studies to provide long-term safety and efficacy data of CT-P13 in a real-world clinical setting. Methods A total of 1816 patients consisting of 987 patients with rheumatoid arthritis, 342 patients with Crohn’s disease, 322 patients with ulcerative colitis, and 165 patients with psoriasis were evaluated for safety. Efficacy was assessed in 1150 patients whose disease parameter values were serially collected. Results Adverse drug reactions were reported in 24.2% of all patients. The incidence of adverse drug reactions differed by the prior treatment status with biologics: 30.5% in patients naïve to biologics, 17.0% in patients switched from the originator infliximab, and 33.5% in patients switched from other biologics. Infusion reactions were the most frequent adverse drug reactions (8.2%), and its incidence was significantly higher in patients with ulcerative colitis and an allergy history in a multivariable Cox regression analysis. Infection was the second most frequent (6.1%), but tuberculosis only occurred in four patients (0.2%). The incidence of infection was low in patients with Crohn’s disease and psoriasis, and significant risk factors were an allergy history, comorbidities, and concomitant steroid use. Interstitial lung disease occurred in 16 patients (0.9%), including 11 patients with rheumatoid arthritis. With CT-P13 therapy, disease activity parameters decreased similarly in all four diseases, although long-term drug discontinuation rates because of inefficacy varied by disease. In naïve patients, the disease activity parameters decreased rapidly and the proportion of patients in remission increased. Patients switched from infliximab maintained lowered parameter levels with infliximab pretreatment. Decreases were also observed in patients switched from other biologics, but discontinuations were most often because of insufficient efficacy. Conclusions The integrated analysis of a large number of patients detected no new safety signals with long-term CT-P13 treatment. Efficacy in rheumatoid arthritis, psoriasis, Crohn’s disease, and ulcerative colitis cases was confirmed in biologic-naïve patients and switched patients from the originator infliximab or other biologics. Supplementary Information The online version contains supplementary material available at 10.1007/s40264-023-01340-1.

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Safety, efficacy, and drug survival of the infliximab biosimilar CT‐P13 in post‐marketing surveillance of Japanese patients with psoriasis

Cited by 11 publications

References 34 publications

Switching between Originators and Biosimilars in Dermatology: A Systematic Review of Real-World Clinical Studies

Switching between Originators and Biosimilars in Dermatology: A Systematic Review of Real-World Clinical Studies

Biosimilars in Dermatology Review

Real-World Safety and Efficacy of Biosimilar CT-P13 in Patients with Immune-Mediated Inflammatory Diseases: Integrated Analysis of Three Japanese Prospective Observational Studies

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