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

Abstract

BackgroundIn Denmark, patients (pts) treated with originator etanercept (ETA) 50 mg SC conducted a mandatory non-medical switch to biosimilar SB4 in April 2016 (switchers). Pts treated with 25 mg ETA or 50 mg powder-solution were not mandated to switch (non-switchers). Some switchers resumed ETA during follow-up (back-switchers).ObjectivesTo investigate the frequency of back-switching after the non-medical switch from ETA to SB4, and in back-switchers to study, 1) baseline characteristics at the time of initial switch (ETA->SB4), 2) reasons for SB4 withdrawal, 3) changes in disease activity during treatment with SB4 and after back-switching.MethodsPatient 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.Results1641 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died (n=9), were lost to follow-up (n=1) or did not re-start bDMARDs (n=65).Among the 120 back-switchers, SB4 was withdrawn due to LOE (52%), AE (39%), or other/unknown reasons (9%).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 11–1 days. Baseline characteristics of back-switchers vs the rest of the switch population were similar (all p>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).Abstract FRI0103 – Table 1Description of ETA-SB4-ETA back-switchers (n=120)ConclusionsIn 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.References[1] Glintborg, et al. Arthritis Rheum2017;69(suppl 10).[2] Glintborg, et al. Abstract, EULAR2018.AcknowledgementsPartly sponsored by BiogenDisclosure of InterestB. Glintborg Grant/research support from: Abbvie, Biogen, Pfizer, I. Sørensen: None declared, E. Omerovic: None declared, F. Mehnert: Non...

Multidisciplinary team intervention to reduce the nocebo effect when switching from the originator infliximab to a biosimilar

“…However, conclusions could not be drawn because the RFs identified were markers of higher disease activity and treatment failure (online supplemental material, table 1). 11–13 25–27…”

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

“…Notably, the least common reason for switching or discontinuing treatment was patient preference, which is in line with the finding that numerous studies included in this review state that the initial switch, in which patients cycle from originator to biosimilar products, was due to non-medical reasons and mandated by healthcare payers. 18,31,32,43,44,49,50,54,55,62,80 This is in contrast to switching to a treatment with another MoA, which generally occurs due to medical reasons 2 and is less related to mandates issued by payers. In this context, it is of interest to note that an overall originator-to-biosimilar switching strategy has been recommended by several healthcare authorities 3,85 and that this review found that the most commonly cited reason for switching back to the originator drug from biosimilar treatment was adverse events.…”

“…It is also worth noting that the three studies by Glintborg et al all use the DANBIO registry and that the overlap of patients is therefore likely to be considerable. 18,49,50 This is especially pertinent for the two conference abstracts, both of which focus on patients treated with etanercept. However, as the population size, patient baseline characteristics, and number of treatment switches differ between the two publications, both were included as it was not possible to discern the amount of overlap.…”

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

“…Immuno-Rheumatology research group; 2 Immunology, University Hospital La Paz, Madrid, Spain Background: Rituximab (Rtx), a monoclonal antibody against CD20+, induces transient depletion of B cells and was approved for the treatment of patients with active rheumatoid arthritis (RA). Previous data 1 showed that Rtx is particularly effective on autoimmune diseases in which auto-antibodies (auto-Ab) are produced.…”