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Real-world data on switching of etanercept biosimilars Posted 09/08/2019

Real-world and clinical data from different studies involving switching to etanerept biosimilars were presented at the European Congress of Rheumatology 2019 (EULAR 2019) [1].

Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Etanercept is indicated for the treatment of rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.

Real-world data included results of a mandatory switch from originator to biosimilar etanercept (SB4) in 117 patients with inflammatory arthritis from a single centre in Spain [1]. The authors reported that the ‘biosimilar switch of SB4 was successful in over 74% of cases and was well tolerated’. 

A retrospective study in a Spanish hospital included 133 patients being treated with originator etanercept [2]. The authors concluded that the experience with the implementation of biosimilar switching was ‘positive’. They added that the switch in 55% of patients allowed ‘savings of Euros 3047.72 per patient/year’.

Real-world data from an Italian study where 82 patients were switched from originator to biosimilar etanercept also showed no significant differences in patients that switched or remained on originator etanercept in terms of efficacy [3].

A German study evaluated the safety and effectiveness of systematic non-medical switching from originator to biosimilar etanercept SB4 in 84 adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA) in a real-life setting [4]. The results led the authors to conclude that ‘systematic switch from innovator to biosimilar etanercept was not associated with changes in disease activity or function in all three indications within 12 weeks. This was independent of information on the switch transmitted to the patients’.

Finally, a pan-European observational study evaluated the real-world effectiveness of SB4 following the transition from originator etanercept in 533 patients with RA or axSpA [5]. Patients with stable RA or axSpA who transitioned from originator etanercept to SB4 maintained clinical response at six months post-transition. Most patients transitioned to the same dose regimen of biosimilar as they had received for the originator, remaining largely unchanged at six months, supporting ease and effectiveness of transition.

These results were presented at the European Congress of Rheumatology 2019, which took place on 12‒15 June 2019 in Madrid, Spain.

All of these studies add to the data on the safety, efficacy and economic advantage of switching to etanercept biosimilars.

Conflict of interest
The authors of the abstracts [1-5] reported conflict of interest, including being employees of pharmaceutical companies. For full details of the authors’ conflict of interest, see the abstracts [1-5].

Editor’s comment
It should be noted that data of the studies presented in this article were 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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References
1. Fernández S, Gonzalez S, Ordas-Calvo C, et al. AB0376 (2019): Results of a mandatory switching from originator to biosimilar etanercept in 117 patients with inflammatory arthritis from a single center. European Congress of Rheumatology 2019; 2019 Jun 12−15; Madrid, Spain.
2. Castillo Dayer PV, Ruiz Sara J, García Belando C, et al. AB1202 (2019): Switching of etanercept in a monographic consultation of biosimilar clinical practice and economic cost. European Congress of Rheumatology 2019; 2019 Jun 12−15; Madrid, Spain.
3. Ditto MC, Parisi S, Priora M. AB0401 (2019): switch from etanercept originator to etanercept biosimilar: data from real life. European Congress of Rheumatology 2019; 2019 Jun 12−15; Madrid, Spain.
4. Kiltz U, Tsiami S, Baraliakos X, Braun J. FRI0101 (2019): non-medical switching from originator to biosimilar etanercept – no evidence for a relevant nocebo effect – a retrospective analysis of real-life data. European Congress of Rheumatology 2019; 2019 Jun 12−15; Madrid, Spain.
5. Krueger K, Selmi C, Cantagrel A, et al. FRI0103 (2019): Benefit study: a pan-european observational study to evaluate real-world effectiveness of SB4 following transition from originator etanercept (ETN) in patients with rheumatoid arthritis (RA) or axial spondyloarthritis (AXSPA). European Congress of Rheumatology 2019; 2019 Jun 12−15; Madrid, Spain.

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