Clinical effectiveness of CT-P13 (Infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data

Abstract

The clinical effectiveness of INB in both PROs and disease-activity measures was comparable to INX during the first year of switching, with no immediate safety signals. Subjective reasons (negative expectations) may play a role among discontinuations of biosimilars. Larger patient numbers and longer follow-up are necessary for confirming this clinical experience.

The infliximab biosimilar in the treatment of moderate to severe plaque psoriasis

“…9,10 About 50% of patients with psoriasis who start infliximab have to discontinue treatment within the first year because of loss of efficacy attributed to antiinfliximab antibodies and a faster drug clearance.…”

Patients with Rheumatoid Arthritis Identified as Potentially Suitable for Biosimilar Infliximabin Europe

“…Clinical evidence is evolving in favor of switching patients from infliximab-biologic to its biosimilar [15][16][17][18]. In this context, patients currently on infliximab-biologic could all be considered for biosimilar-infliximab.…”

Treatment Outcomes with Biosimilars: Be Aware of the Nocebo Effect

“…At least one phase III, randomized clinical trial is then performed in a sensitive patient population representative of those included in an approved indication for the reference biologic, to demonstrate equivalent efficacy and comparable safety and immunogenicity of the biosimilar and its reference biologic. Post-marketing authorization studies, together with real-world data from registries and clinical centers, provide additional confirmation for the long-term effectiveness, safety, and immunogenicity of approved biosimilars [2,[15][16][17][18][19][20][21]. All this taken together comprises the totality of evidence for a biosimilar, highlighting the rigorous process in which biosimilars are developed and monitored [2].…”

“…Recently, this nocebo effect has also been considered in patients switching from reference biologics to biosimilars [15,18,36]. In observational studies, 16-28% of patients were found to discontinue CT-P13 biosimilar following C 3 months of treatment [15,18,36].…”

“…In observational studies, 16-28% of patients were found to discontinue CT-P13 biosimilar following C 3 months of treatment [15,18,36]. Additionally, it was suggested that these discontinuation rates might have been slightly higher than those historically reported with the reference biologic and that this difference could be partially explained by perceived loss of efficacy and minor adverse events (such as fatigue, malaise, and headache), despite no changes in efficacy, safety, or immunogenicity being observed [15,18,36]. The authors concluded a nocebo effect was likely; however, they recommended further investigation to fully understand this phenomenon with regard to biosimilar use.…”