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

Abstract

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<0.001)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’ behavior2/Using an open design, the percentage of patients complaining of a lower efficiency and/or a worse safety profile of the biosimilar was high3/Ther...

Real-World Evidence on Etanercept Biosimilar SB4 in Etanercept-Naïve or Switching Patients: A Systematic Review

“…A study done in a single hospital in France with a relatively low switch acceptance rate (51.6% of eligible patients) found that physicians’ behaviour rather than patients’ characteristics were associated with switching. Older clinicians and those with full-time academic posts were more likely to switch patients, but there were no independent patient characteristics associated with switching [35].…”

“…Most of the congress reports with data on SB4 effectiveness found no clinically meaningful differences between pre- and post-switch disease activity or changes over time in historic and switching cohorts of patients (Table S1) [8, 31, 35–42]. In one study of 120 switchers, 39.1% (47/120) of patients had increases in DAS28 resulting in 22.5% (27/120) of patients moving to a higher disease state [43].…”

The Efficacy, Safety, and Immunogenicity of Switching Between Reference Biopharmaceuticals and Biosimilars: A Systematic Review

“…59 This need was echoed in a single switch from etanercept RP to SB4 in patients with rheumatic disease in a single center in France. 60 Approximately 17% of patients discontinued the biosimilar, whereas no objective parameter concluded a lower efficacy or a REVIEW decreased safety profile. The authors suggested that this could be explained by the open study design (i.e., patients were aware of the switch).…”

“…The authors suggested that this could be explained by the open study design (i.e., patients were aware of the switch). 60 The study parameters and results of the switch studies for etanercept can be consulted in Table S9 in the online Supplementary Information.…”

<p>Real-World Patient Experience of Switching Biologic Treatment in Inflammatory Arthritis and Ulcerative Colitis – A Systematic Literature Review</p>

“…36 Furthermore, Al Tabaa et al conclude that the likelihood of patients transitioning to a biosimilar treatment was mainly related to the behavior of the physicians; and that, when using an open study design, a larger proportion of patients transitioning to a biosimilar treatment complained of lower efficiency and/or a worse safety profile. 34 Scherlinger et al also suggest that negative patient perceptions of biosimilars impact the persistence with biosimilar treatment, as shown by the lack of objective clinical disease activity among a large proportion of patients who requested to be transitioned back to the originator treatment. 26 Taken together, this points to the importance of considering a nocebo effect when investigating patient satisfaction with treatment transition.…”