SAT0199 Switch from innovator etanercept to biosimilar etanercept in inflammatory rheumatic diseases: the experience of cochin university hospital paris-france

Autor: A. Etcheto, C. Miceli-Richard, M. Anna, Maxime Dougados, O. Al Tabaa
Rok vydání: 2018
Předmět:
Zdroj: Saturday, 16 JUNE 2018.
DOI: 10.1136/annrheumdis-2018-eular.5157
Popis: Background: Etanercept biosimilar (bETN) is available for treatment of spondyloarthritis (SpA) and rheumatoid arthritis (RA) since 2016 in France. Data showing effectiveness and safety of bETN are still limited. Objectives: 1/To evaluate the RA and SpA patients’ and treating rheumatologists’ characteristics associated with the switch 2/To evaluate the safety and efficiency of bETN. Methods: Patients: All the patients receiving innovator etanercept for at least 3 months on October 2016 and monitored in the department of rheumatology B of Cochin hospital. Physicians: All the 9 physicians in charge of at least one patient. Study design: After information (one hour session) on the biosimilars, all the physicians were invited to propose a switch from innovator etanercept to bETN. Data collected: physicians’ characteristics, patients’ characteristics (demographics, diagnosis of the rheumatic disease, disease activity parameters). Results: Of the 435 outpatients who had received etanercept; 304 were receiving etanercept in 2016 and 183 were eligible for a potential switch (the remaining 121 patients did not attend any out-patient-clinic between October 1st 2016 and April 1st 2017). The percentage of patients who switched to bETN was 51.6% (94 patients). This switch was more frequently performed in patients monitored by older physicians (mean age: 50.4±14.3 vs 44.8±11.3, p=0.005) and by physicians with a full-time academical position (56.4 % vs 13.5 %, p The patients’ characteristics were similar: % RA (51.1% vs 44.9%), age (52.1±15 vs 50.5±15), female gender (57.4% vs 51.6%), disease duration (16.8±11.9 vs 14.8±11.3) except for the NSAID intake (28.3 % vs 12.3 %, p=0.014) and the global evaluation (25.2±19.4 vs 19.1±21.8, p=0.02) in the switchers vs non-switchers, respectively. However, no independent factors were associated with the switch in the multivariate analysis. The bETN retention rate was 83 % [0.76–0.92] after a 6 month follow-up period. The bETN was discontinued in 26 patients with the following reasons: inefficiency 13 patients, adverse event 13 patients (painful injection site n = 4, fatigue = 2, pruritus n = 2, “allergic reaction” n =1, headache n = 1, pollakiuria n = 1, dizziness n = 1, supply problem n = 1). The univariate analysis aimed at evaluating the baseline predisposing factors of bETN discontinuation overtime picked up the baseline objective sign of inflammation (defined by CRP≥6 mg/L or ESA ≥28 mm) (OR=4.18 [1.19 – 14.66] p=0.0256), p=0.002) and global disease activity score (OR = 1.57 [1.04 – 2.36], p=0.03). Nevertheless, no independent factors were associated with the switch in the multivariate analysis. There was no difference in the changes in the disease activity parameters in both the completer and ITT population. Conclusions: This study suggests that: 1/The probability to switch from etanercept innovator to bETN was mainly related to physicians’ behavior 2/Using an open design, the percentage of patients complaining of a lower efficiency and/or a worse safety profile of the biosimilar was high 3/There was no objective parameter permitting to conclude at a lower efficiency and/or a worse safety profile of the bETN in comparison to the innovator etanercept. Disclosure of Interest: None declared
Databáze: OpenAIRE
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