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‘To switch or not to switch’: the missing piece in the puzzle of biosimilar literature?

Published on Jan 4, 2019in Annals of the Rheumatic Diseases14.299
· DOI :10.1136/annrheumdis-2018-214908
Marc Scherlinger6
Estimated H-index: 6
,
Thierry Schaeverbeke12
Estimated H-index: 12
(University of Bordeaux)
Abstract
We read with great interest the paper from Glintborg and coauthors ‘To switch or not to switch’ reporting biosimilar etanercept switching in Denmark.1 In the Danish Biologic (DANBIO) cohort, patient treated with originator etanercept (Enbrel) were informed of a mandatory switch to SB4. However, the 25 mg pen or a powder-based preparation of original etanercept (OE) were still available. At 1 year after this decision, the authors reported that only 79% of patients had switched to SB4 and 21% remained treated with the originator biologic. In westernised countries, biologics therapies …
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  • Citations (3)
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We are grateful to Scherlinger and Schaeverbeke for their reply to our letter.1 We would like to remind that in our letter we raised several concerns regarding the low grade of evidence supporting recommendation 6 on the switching procedure, as reported in the recently published recommendations for the use of biosimilars in rheumatology practice.2 3 We believe that international recommendations should be based on solid bases, and, as underlined in our letter, by analysis of the existing literatu...
5 CitationsSource
In their correspondence, Cantini and Benucci1 express their concern about the lack of real-life data supporting the switch from originator to biosimilar biological disease-modifying antirheumatic drugs, as recommended in the recently issued consensus-based recommendations.2 They argue that the Danish Nationwide Biologic (DANBIO) registry reporting real-life data showed a lower than expected retention rate after the switch to biosimilar infliximab (bio-IFX) and etanercept.3 4 Concerning bio-IFX, ...
2 CitationsSource
We read with interest the recently published recommendations for the use of biosimilars in rheumatology practice.1 However, we have some concerns regarding recommendation 6 on the efficacy and safety of switching from the originator biologic to the respective biosimilar. Considering the strong impact of the European League Against Rheumatism recommendations on real-life clinical decisions, such recommendation seems not sufficiently supported by the evidence because available data do not allow to...
13 CitationsSource
#1Marc Scherlinger (University of Bordeaux)H-Index: 6
#2Emmanuel Langlois (University of Bordeaux)H-Index: 2
Last. Thierry Schaeverbeke (University of Bordeaux)H-Index: 12
view all 4 authors...
Abstract Objective To study acceptance rate and factors influencing acceptance of the switch from originator etanercept (Enbrel©) to biosimilar etanercept (SB4, Benepali©) in patients with rheumatic disease. Methods Patients with a well-controlled rheumatic disease consulting in our rheumatology department were offered the switch for SB4. After oral and written information concerning biosimilar, free choice to accept the switch was left to the patients. The main outcome was primary switch accept...
12 CitationsSource
We read with great interest Cantini and Benucci’s response to our letter.1 However, we would like to add some points to the debate. To date and to our knowledge, every single clinical trial investigating efficacy and safety of biosimilars in rheumatology using a double-blinded design has failed to report any clinical difference with the original biologic. The double-blinded controlled trial NOR-SWITCH as well as open-label extension studies such as PLANETRA investigating efficacy and safety of t...
3 CitationsSource
#1Bente Glintborg (Gentofte Hospital)H-Index: 12
#2Anne Loft (AU: Aarhus University)H-Index: 32
Last. Merete Lund Hetland (UCPH: University of Copenhagen)H-Index: 44
view all 24 authors...
Objectives Real-world evidence on effectiveness of switching to biosimila r etanercept is scarce. In Denmark, a nationwide guideline of mandatory switch from 50 mg originator (ETA) to biosimilar (SB4) etanercept was issued for patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (AxSpA) in 2016. Clinical characteristics and treatment outcomes were studied in ETA-treated patients, who switched to SB4 (switchers) or maintained ETA (non-switchers). Retentio...
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#1Evrydiki Kravvariti (UoA: National and Kapodistrian University of Athens)H-Index: 4
#2George D. Kitas (University of Manchester)H-Index: 58
Last. Petros P. Sfikakis (UoA: National and Kapodistrian University of Athens)H-Index: 46
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Nocebo effects are noxious reactions to therapeutic interventions that occur because of negative expectations of the patient. In the past decade, neurobiological data have revealed specific neural pathways induced by nocebos (that is, interventions that cause nocebo effects), as well as the associated mechanisms and predisposing factors of nocebo effects. Epidemiological data suggest that nocebos can have a notable effect on medication adherence, clinical outcomes and health-care policy. Meta-an...
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#1L TweehuysenH-Index: 6
#2V.J.B. HuiskesH-Index: 2
Last. A.A. den Broeder (Radboud University Nijmegen)H-Index: 32
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#1Sunil NagpalH-Index: 7
#2Vinod Krishna (Janssen Pharmaceutica)H-Index: 1
Last. Loui MadakamutilH-Index: 2
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Background Rheumatoid arthritis (RA) is a chronic autoimmune disease characterised by infiltration of immune cells into the synovium and hyperplasia of the synovial lining, resulting in the formation of pannus that degrades cartilage and bone. Fibroblast-like synoviocytes (FLS) are the main cell types of the rheumatoid synovium and possess phenotypic and molecular characteristics of transformed cells. JQ1, an inhibitor of the bromodomain and extra terminal domain (BET) family that includes BRD2,...
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#2Thao PhamH-Index: 32
Last. Daniel WendlingH-Index: 47
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Joint Bone Spine - In Press.Proof corrected by the author Available online since jeudi 26 avril 2018
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Cited By3
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#1B. Glintborg (Copenhagen University Hospital)H-Index: 7
#2Anne Loft (AU: Aarhus University)H-Index: 32
Last. Merete Lund Hetland (UCPH: University of Copenhagen)H-Index: 44
view all 24 authors...
1 CitationsSource
#1Bente GlintborgH-Index: 12
#2Rikke Ibsen (iMinds)H-Index: 14
Last. Jakob KjellbergH-Index: 18
view all 5 authors...
Objectives In year 2016, Danish national guidelines included a mandatory switch of patients with inflammatory rheumatic diseases treated with originator etanercept (ETA) to biosimilar SB4 in routine care. We aimed to explore if switching lead to increased healthcare utilisation and costs. Methods Observational cohort study. Adult patients who switched from ETA to SB4 were identified in the Danish nationwide DANBIO registry. In the National Patient Registry, we identified health utilisation (hosp...
2 CitationsSource
#1Josef S. Smolen (University of Vienna)H-Index: 114
#2João Gonçalves (University of Lisbon)H-Index: 35
Last. Jake Yongkwon Lee (Samsung)H-Index: 1
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Compared with the original approved biological drug on which it is based, a biosimilar has highly similar physicochemical characteristics and biological activity, as well as equivalent efficacy and no clinically meaningful differences in safety and immunogenicity. Before they are approved, biosimilars must undergo a rigorous development process using state-of-the-art technologies to establish biosimilarity to the reference biological product. After approval, biosimilars must comply with good pha...
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