Etanercept switching study investigates non-mandatory transitioning

Biosimilars/Research | Posted 23/02/2018 post-comment0 Post your comment

A study carried out by researchers from The Netherlands investigated whether non-mandatory transitioning from originator to biosimilar etanercept improves retention rates [1]. V13H09

Blinded transitioning from originator to biosimilar infliximab (CT‑P13) has been found to be not inferior to continuing with the originator infliximab. On the other hand, open-label mandatory transitioning resulted in a slightly lower 1-year retention rate in the switched patients compared to those that continued with the originator infliximab. The authors of this study therefore investigated whether this was also the case for etanercept and whether non-mandatory transitioning might be preferred above mandatory.

In 2016, 642 patients treated with originator etanercept (Enbrel) were asked to transition to biosimilar etanercept (SB4) by a structured implementation strategy with opt-out option. A total of 635 (99%) agreed to transition. Of these patients, 625 patients (433 RA, 128 PsA, 64 AS) were included in the transition cohort. In addition, 600 patients treated with Enbrel in 2014 were included in the historical cohort.

Crude 6-months retention rates of SB4 in the transition cohort and Enbrel in the historical cohort were: 90% (95%CI 88%–93%) vs 92% (95%CI 90%–94%). The transition cohort had a significantly higher relative risk of discontinuation than the historical cohort (adjusted HR 1.57, 95%CI 1.05–2.36). Reasons for discontinuing SB4 (n = 60, 10%) and Enbrel (n = 46, 8%) were: lack of effect (43% vs 61%), adverse events (47% vs 28%), malignancy (3% vs 4%), pregnancy (4% vs 4%) and other (3% vs 3%). In the transition cohort, 17 patients restarted Enbrel, 32 patients switched to another biological and 11 patients maintained biological-free. The Disease Activity Score for 28 joints – C-Reactive Protein (DAS28‑CRP), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and CRP were not statistically different between baseline and month 6 in the transition cohort. Due to a slightly lower baseline CRP (1 [0-5] vs 3 [1-5], p < 0.001) and DAS28‑CRP (1.9 [1.5−2.6] vs 2.1 [1.6−2.9], p < 0.001) changes in CRP (0.5 (12) vs -1.5 (14), p = 0.01) and DAS28-CRP (-0.01 (0.93) vs -0.26 (-0.99), p < 0.001) at month 6 favoured the historical cohort.

These data were presented at the American College of Rheumatology’s (ACR) 2017 Annual Meeting, which was held on 19−24 October 2017 in San Diego, CA, USA.

The authors concluded that ‘open label non-mandatory transitioning from Enbrel to SB4 showed a statistically significantly but clinically not relevant lower retention rate compared to a historical cohort, similar to retention seen after mandatory infliximab transitioning. Non-mandatory transitioning, when executed optimally, might therefore be an attractive alternative to mandatory transitioning’.

Conflict of interest
The authors of the abstract [1] did not provide any conflict of interest statement.

Editor’s comment
It should be noted that data of the study presented in this article was published as an abstract and presented at a conference. These data and conclusions should be considered as preliminary until published in a peer-reviewed journal.

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1. Tweehuysen L, et al. Open label transitioning from originator etanercept to biosimilar SB4 compared to continuing treatment with originator etanercept in a historical cohort in rheumatic diseases in daily practice. American College of Rheumatology’s (ACR) 2017 Annual Meeting; 19-24 October 2017: CA, USA.

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Source: ACR

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