Abstract
infliximab has changed the natural history of inflammatory bowel disease (IBD). The advent of biosimilar treatments such as CT-P13 will hopefully improve the availability of biological therapies. Data with regard to drug switching are currently limited. The objective of the study was to assess the effectiveness and safety of switching from the reference product (RP), infliximab, to CT-P13 in patients with IBD. this was a multicenter prospective observational study in patients with Crohn's disease (CD) and ulcerative colitis (UC). All patients had switched from infliximab RP (Remicade®) to CT-P13 treatment and were followed up for 12 months. The efficacy endpoint was the change in clinical remission assessed at 0 and 12 months, according to the Harvey-Bradshaw score and partial Mayo score for patients with CD and UC, respectively. Adverse events were monitored and recorded throughout the study. a total of 167 patients (116 CD/51 UC) were included; 88.8% (103/116) of patients with CD were in remission at the time of the drug switch and 69.7% were in remission at 12 months. The Harvey-Bradshaw (HB) score significantly changed at 12 months (p = 0.001); 84.3% (43/51) of patients with UC were in remission at the time of the drug switch and 76.7% were in remission at 12 months. No significant changes in the median partial Mayo score (p = 0.87) were observed at 12 months. Serious adverse events related to medication were reported in 12/167 (7.2%) cases. switching from infliximab RP to CT-P13 is safe and effective at 12 months. The loss of efficacy at 12 months was 15.7%.
Highlights
Over the past 20 years, the introduction of biological agents into the clinical practice is one of the major advancements in the treatment of inflammatory bowel diseases (IBD), such as Crohn’s disease (CD) and ulcerative colitis (UC) [1].Tumor necrosis factor alfa (TNF-α) antagonists such as infliximab [2], adalimumab [3] and golimumab [4] have changed the natural course of the disease [5]
All patients had switched from infliximab reference product (RP) (Remicade®) to CT-P13 and were treated according to the dosage and regime recommended by the Summary of Product Characteristics of Remsima® in Spain [30]
The baseline demographics and phenotypic characteristics of patients with CD and UC according to the Montreal Classification and prior to medication exposure are shown in table 1
Summary
Over the past 20 years, the introduction of biological agents into the clinical practice is one of the major advancements in the treatment of inflammatory bowel diseases (IBD), such as Crohn’s disease (CD) and ulcerative colitis (UC) [1].Tumor necrosis factor alfa (TNF-α) antagonists such as infliximab [2], adalimumab [3] and golimumab [4] have changed the natural course of the disease [5]. Despite the undoubted efficacy of biological therapy, these biological agents are much more expensive than traditional treatments. This imposes a considerable burden on the national healthcare system [6]. Many biological products have reached or are close to patent expiration. This has led to the development of biosimilar drugs.The biosimilar agents are highly similar in terms of quality, efficacy and safety to already licensed biologics [7] but can potentially result in a discounted cost of 20% to 70%. Offering considerable cost-savings to the healthcare systems [8]
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