Background In blinded trials, transitioning from an innovator to a biosimilar has shown to be equivalent to maintenance on innovator biologic treatment in rheumatic diseases. However, data on open label transitioning to a biosimilar are scarce. Recently, we sequentially implemented two biosimilar transition projects (from innovator infliximab (REM) to biosimilar infliximab (CT-P13) and from innovator etanercept (ENB) to biosimilar etanercept (SB4)) in patients with a rheumatic disease using different communication strategies.
Objectives To investigate the impact of different communication strategies on the acceptance and persistence rates after transitioning from ENB to SB4 in 2016 and transitioning from REM to CT-P13 in 2015.
Methods Adult patients treated with REM or ENB were informed by letter about the request to transition to a biosimilar. Subsequently, patients were approached by telephone to ask whether they agreed. After the transition of REM to CT-P13 had finished, communication was enhanced for the transition of ENB to SB4 by 1) informing all patients at the same time directly followed by a national media item, 2) reporting that lower costs and fewer injection site reactions (demonstrated in a previous trial) were the reason for transitioning, 3) providing a “soft skills” training for rheumatology and pharmacy staff about how to assuage patient concerns regarding a biosimilar and how to act if a patient has objective or subjective health complaints (discuss possible nocebo response and incorrect causal attribution). Also, group think effects did not play a role during SB4 treatment (individual subcutaneous versus group intravenous administration). Transitioning patients were eligible for inclusion in the BIO-SWITCH study (switch REM to CT-P13) and BIO-SPAN study (switch ENB to SB4)1. Demographic, disease and treatment specific characteristics at baseline and disease activity and adverse events (AEs) during 6 months follow-up were collected.
Results 196 of 222 (88%) REM-treated patients and 636 of 643 (99%) ENB-treated patients transitioned to respectively CT-P13 and SB4 (delta 11%, 95% CI 7% to 16%). Until January 1st 2017, 479 of 636 (75%) patients gave informed consent for the BIO-SPAN study. Baseline characteristics were similar, except for disease duration and innovator treatment duration (both shorter in the BIO-SPAN cohort; p<0.01). Drug survival of patients on SB4 was adjusted for confounders greater than patients on CT-P13 (Figure 1; adjusted Hazard Rate 0.21, 95% CI 0.13 to 0.34). During 84 person-years of follow-up 47 patients discontinued CT-P13 (56/100 person-years; 26% due to inefficacy, 74% due to AEs). In contrast, 36 patients discontinued SB4 during 230 person-years of follow-up (16/100 person-years; 53% due to inefficacy, 42% due to AEs and 5% due to remission).
Conclusions Use of an enhanced communication strategy, together with more experience and absence of group think effects, resulted in much higher acceptance and persistence rates after open label shared decision making biosimilar transitioning in patients with a rheumatic disease.
Acknowledgements This study was funded by Biogen
Disclosure of Interest L. Tweehuysen: None declared, V. Huiskes: None declared, B. van den Bemt Speakers bureau: Pfizer, AbbVie, Mundipharma, F. van den Hoogen Consultant for: Biogen, Celltrion, Janssen, Mundipharma and Sandoz, A. A. den Broeder Consultant for: AMGEN