Observational study of switching from Etanercept reference product to a biosimilar in a population of patients with rheumatoid arthritis in a tertiary hospital

Abstract

Objective.- T he p rimary o bjective w as t o e valuate disease activity in a population of patients with a diagnosis of Rheumatoid Arthritis (RA) on biological treatment with Etanercept reference product (ETN-PR) who switched to Etanercept biosimilar (ETN-BS). The secondary objective was to evaluate the use of corticosteroids and adverse events (AEs) before and after the switch to the biosimilar (BS). 

Materials and methods.- A longitudinal, retrospective study was carried out in patients diagnosed with RA according to the 2010 classification criteria of the American College of Rheumatology (ACR) who were undergoing controls in the outpatient clinic of a tertiary hospital. The medical records were reviewed in the hospital's computer system. Disease activity was evaluated using the serological marker CRP (C-reactive protein) measured in mg/dl (reference value ≤5) and the Clinical Disease Activity Index (CDAI) score. Both were collected 1 month before and 6 months after the BS change. Information was also collected on the use of disease-modifying drugs (DMARDs), corticosteroids and NSAIDs 1 month before and 6 months after the change due to BS and seropositivity for antibodies against rheumatoid factor and citrullinated peptide. 

Conclusion.– Patients with RA maintained remission and low disease activity during the switch from ETN-PR to ETN-BS. There was no increase in the dose of corticosteroids and no adverse effects occurred during the use of BS.