FRI0200 Higher acceptance and persistence rates after biosimilar transitioning in patients with a rheumatic disease after employing an enhanced communication strategy

Abstract

BackgroundIn 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.ObjectivesTo 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.MethodsAdult 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.Results196 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).ConclusionsUse 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 transitio...

Open‐Label, Non‐Mandatory Transitioning From Originator Etanercept to Biosimilar SB4

“…The rate of acceptance of SB4 in this study was higher than that reported previously for CT‐P13 in our first transitioning study (the BIO‐SWITCH study, with an acceptance rate of 88%) . The rate of SB4 treatment persistence was also higher than that in previously published studies on non‐mandatory transitioning from REM to CT‐P13 (persistence rates varying from 76% at month 6 , 74% at week 34 , and 72% at month 12 ).…”

Treatment Outcomes with Biosimilars: Be Aware of the Nocebo Effect

“…The authors concluded a nocebo effect was likely; however, they recommended further investigation to fully understand this phenomenon with regard to biosimilar use. The discontinuation rates stated in these publications are higher than those seen in registries and clinical center studies in patients treated with the etanercept biosimilar, with some reporting B 9% discontinuation rate following C 5 months of treatment [16,17,[19][20][21]. Interestingly, these are far lower than those seen in Turkey, where medical billing records from patients with rheumatoid arthritis were analyzed, and 63 and 82% of biologic-naïve and switch patients (from INF to CT-P13), respectively, discontinued biosimilar treatment [37,38].…”

“…Furthermore, to assure patient safety, approved biosimilars are under strict pharmacovigilance (the monitoring and tracking of drug safety over time). HCP healthcare professional, PD pharmacodynamics, PK pharmacokinetics, RCT randomized clinical trials, RWE real-world evidence possible nocebo effects [20]. They found that this led to higher patient acceptance and persistence rates compared with patients who did not receive this enhanced communication strategy [20].…”

“…At least one phase III, randomized clinical trial is then performed in a sensitive patient population representative of those included in an approved indication for the reference biologic, to demonstrate equivalent efficacy and comparable safety and immunogenicity of the biosimilar and its reference biologic. Post-marketing authorization studies, together with real-world data from registries and clinical centers, provide additional confirmation for the long-term effectiveness, safety, and immunogenicity of approved biosimilars [2,[15][16][17][18][19][20][21]. All this taken together comprises the totality of evidence for a biosimilar, highlighting the rigorous process in which biosimilars are developed and monitored [2].…”

“…HCP healthcare professional, PD pharmacodynamics, PK pharmacokinetics, RCT randomized clinical trials, RWE real-world evidence possible nocebo effects [20]. They found that this led to higher patient acceptance and persistence rates compared with patients who did not receive this enhanced communication strategy [20]. Further real-world data also show that comprehensive patient education and support (including face-to-face discussions; provision of patient information sheets on drug switch and biosimilars; access to a helpline number and regular clinical reviews) during the switch to a biosimilar product resulted in higher acceptance of these agents by patients, which may also help reduce the nocebo effect [30,41].…”