FRI0103 One-year follow-up of a nationwide cohort of patients with inflammatory arthritis, who switched from originator to biosimilar etanercept, focusing on patients who switched back to originator. an observational danbio study
Authors: B. Glintborg, I.J. Sørensen, E. Omerovic, F. Mehnert, N. Manilo, K. Danebod, D.V. Jensen, H. Nordin, A.G. Loft, O. Hendricks, S. Chrysidis, B.L. Andersen, J.L. Raun, H. Lindegaard, J. Espesen, S.H. Jakobsen, I.M.J. Hansen, E.B. Dalsgaard, D.D. Pedersen, S. Kristensen, A. Linauskas, L.S. Andersen, J. Grydehøj, N.S. Krogh, M.L. Hetland
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> In Denmark, patients (pts) treated with originator etanercept (ETA) 50 mg SC conducted a mandatory non-medical switch to biosimilar SB4 in April 2016 (<i>switchers).</i> Pts treated with 25 mg ETA or 50 mg powder-solution were not mandated to switch (<i>non-switchers).</i> Some switchers resumed ETA during follow-up (<i>back-switchers)</i>. <h3>Objectives</h3> To investigate the frequency of <i>back-switching</i> after the non-medical switch from ETA to SB4, and in back-switchers to study<i>,</i> 1) baseline characteristics at the time of initial switch (ETA-&gt;SB4), 2) reasons for SB4 withdrawal, 3) changes in disease activity during treatment with SB4 and after back-switching. <h3>Methods</h3> Patient data were retrieved from the DANBIO registry (censored August 2017). For back-switchers, disease activity at the start of SB4 (=baseline) and at the time of back-switching to ETA were compared, and changes in disease activity between the two time points were calculated (=delta values), stratified by indication (RA/PsA/AxSpA). Baseline characteristics of back-switchers were compared to the rest of the switch population (Chi-sq, Mann-Whitney U-test). Abbreviations are shown in table 1. <h3>Results</h3> 1641 pts switched from ETA to SB4. Of these, 299 (18%) withdrew SB4 therapy during 1 year follow-up and either switched back to ETA (n=120, 7%), started another bDMARD (n=104), died (n=9), were lost to follow-up (n=1) or did not re-start bDMARDs (n=65). Among the 120 back-switchers, SB4 was withdrawn due to LOE (52%), AE (39%), or other/unknown reasons (9%). The reasons for withdrawal of SB4 in back-switchers are listed in table 1. No major safety events occurred. The median time on SB4 before back-switching was 120 (IQR 73–193) days, and the time between stop of SB4 and re-start of ETA was 1<sup>1–1</sup> days. Baseline characteristics of back-switchers vs the rest of the switch population were similar (all p&gt;0.05). Among back-switchers who stopped SB4 due to LOE, PGA increased during SB4 treatment, whereas CRP and SJC were largely unchanged (table 1). At the date of censoring, 104/120 back-switchers (87%) were still treated with originator ETA (median treatment duration 236 (155–302) days). <h3>Conclusions</h3> In a nationwide cohort of 1621 arthritis patients that were switched from ETA to SB4, 7% switched back to ETA. Back-switchers had no distinct clinical or disease characteristics upon start of SB4. AEs prior to back-switching were largely unspecific. In pts who withdrew SB4 due to LOE, PGA had increased. Reasons for back-switching appeared to be predominantly subjective rather than objective (nocebo effect). Originator drug was still available (25 mg or 50 mg powder-solution), which may have encouraged back-switching. <h3>References</h3> [1] Glintborg, et al. Arthritis Rheum2017;69(suppl 10). [2] Glintborg, et al. Abstract, EULAR2018. <h3>Acknowledgements</h3> Partly sponsored by Biogen <h3>Disclosure of Interest</h3> B. Glintborg Grant/research support from: Abbvie, Biogen, Pfizer, I. Sørensen: None declared, E. Omerovic: None declared, F. Mehnert: None declared, N. Manilo: None declared, K. Danebod: None declared, D. Jensen: None declared, H. Nordin: None declared, A. G. Loft Grant/research support from: AbbVie, MSD, Novartis, Pfizer, Roche, UCB, O. Hendricks Grant/research support from: Abbvie, Roche, Novartis, S. Chrysidis: None declared, B. Andersen: None declared, J. Raun: None declared, H. Lindegaard: None declared, J. Espesen: None declared, S. Jakobsen: None declared, I. M. Hansen Grant/research support from: Roche, E. Dalsgaard: None declared, D. Pedersen: None declared, S. Kristensen: None declared, A. Linauskas: None declared, L. Andersen: None declared, J. Grydehøj: None declared, N. Krogh: None declared, M. Hetland Grant/research support from: Abbvie, Biogen, BMS, CellTrion, MSD, Novartis, Orion, Pfizer, Samsung, UCB