Are Patients at Risk for Recurrent Disease Activity After Switching From Remicade ® to Remsima ® ? An Observational Study.

Background:Since the late '90s, infliximab (Remicade(R)) is being used successfully to treat patients with several non-infectious immune mediated inflammatory diseases (IMIDs). In recent years, infliximab biosimilars, including Remsima(R)were introduced in clinical practice. Aim:To investigate the interchangeability of Remicade(R)(originator infliximab) and its biosimilar Remsima(R)in patients with rare immune-mediated inflammatory diseases (IMIDs). Methods:This two-phased prospective open label observational study was designed to monitor the transition from Remicade(R)to Remsima(R)in patients with rare IMIDs. All included patients were followed during the first 2 years. The primary endpoint was the demonstration of non-difference in quality of life and therapeutic efficacy, as measured by parameters including a safety monitoring program, physicians perception of disease activity (PPDA) and patient self-reported outcomes (PSROs). Secondary outcomes included routine blood analysis, pre-infusion serum drug concentration values and anti-drug antibody formation. Results:Forty eight patients treated with Remicade(R)were switched to Remsima(R)in June-July 2016 and subsequently monitored during the first 2 years. The group consisted of patients with sarcoidosis (n= 17), Behcet's disease (n= 12), non-infectious uveitis (n= 11), and other diagnoses (n= 8). There were no significant differences in PPDA, PSROs, clinical and laboratory assessments and pre-infusion serum drug concentrations between the groups. De novo anti-drug antibodies were observed in two patients. Seven patients with sarcoidosis and five with another diagnosis developed a significant disease relapse (n= 7) or adverse events (n= 5) within 2 years; 10 of these patients discontinued Remsima(R)treatment, one withdrew from the study and one received additional corticosteroid therapy. Conclusions:We observed no significant differences in PSROs, PPDA and laboratory parameters after treatment was switched from Remicade(R)to Remsima(R). However, disease relapse or serious events were observed in 12 out of 48 patients when treatment was switched from Remicade(R)to Remsima(R). The choice to switch anti-TNF alpha biologics in patients with rare IMIDs, particularly in sarcoidosis, requires well-considered decision-making and accurate monitoring due to a possibly higher incidence of disease worsening.