The effect of switching treatment from innovator infliximab to infliximab biosimilar on efficacy, safety and immunogenicity in patients with rheumatoid arthritis, spondyloarthritis or psoriatic arthritis in daily clinical care

Background: Taking into account the overall data from the PLANETRA and PLANETAS study, previous positive experiences with switching to a biosimilar, the viewpoint of relevant (inter)national stakeholders and the large cost difference, switching from Remicade to infliximab biosimilar in RA, SpA and PsA patients might be a sensible option. This should be done in shared decision making with the patient and should be monitored with caution. It is expected that in 2015 a substantial number of patients will switch from Remicade to infliximab biosimilar in daily clinical care. Since regulatory guidelines recommend close monitoring of patients who switch treatment to a biosimilar, we shall collect data on efficacy, safety and immunogenicity in daily clinical care.
Objective: To explore the effect of switching treatment from innovator infliximab (Remicade®) to infliximab biosimilar (Inflectra®, Remsima®) on efficacy, safety and immunogenicity in patients with RA, SpA or PsA in daily clinical care.

Study design: This is an exploratory observational controlled before after multicentre prospective cohort study.

Methods: Based on the treatment protocol of the hospitals, RA, SpA and PsA patients who are currently treated with Remicade will be informed about the option to switch to infliximab biosimilar. Both patients who will switch treatment to infliximab biosimilar (switch group) as patients who will not switch treatment (control group) will be asked to participate in this study. Data will be collected during the outpatient clinical visits performed in usual care during a 12 months follow-up. At baseline (day of the first infusion), patient characteristics and blood samples will be obtained. After 6 and 12 months (+/- 2 months) follow-up data on efficacy will be collected. Safety will be evaluated on the day of each infusion. After 6 and 12 months follow-up (+/- 2 months) a blood sample will be obtained on a scheduled infusion day.

To explore the effect of switching treatment from innovator infliximab (Remicade®) to infliximab biosimilar (Inflectra®, Remsima®) on efficacy, safety and immunogenicity in patients with rheumatoid arthritis (RA), spondyloarthritis (SpA) or psoriatic arthritis (PsA) in daily clinical care

Data will be recorded at baseline and after 6 and 12 months (+/- 2 months) of treatment.

Based on the treatment protocol of the hospitals, RA, SpA and PsA patients who are currently treated with Remicade will be informed about the option to switch to infliximab biosimilar. Both patients who will switch treatment to infliximab biosimilar (switch group) as patients who will not switch treatment (control group) will be asked to participate in this study. Data will be collected during the outpatient clinical visits performed in usual care during a 12 months follow-up. At baseline (day of the first infusion), patient characteristics and blood samples will be obtained. After 6 and 12 months (+/- 2 months) follow-up data on efficacy will be collected. Safety will be evaluated on the day of each infusion. After 6 and 12 months follow-up (+/- 2 months) a blood sample will be obtained on a scheduled infusion day.