Focus on biosimilar etanercept – bioequivalence and interchangeability

Figures & data

Table 1 Reported studies on non-medical switching from re-ETN to SB4 biosimilar in real-life clinical studies

Author, year, reference	Disease	Patient number	Discontinuations N (%)	LOE or AEs; N (%)	Follow-up; months
Tweehuysen et al, 2018^Citation39	RA, PsA, AS	Overall: 635 RA: 433 PsA: 128 AS: 64	60 (9.4) RA: NA PsA: NA AS: 64	LOE: 26 (43) AEs: 28 (47) Malignancy: 2 (3)	6
Glintborg et al, 2017^Citation40	RA, PsA, SpA	Overall: 1,623 RA: 937 PsA: 351 SpA: 335	Overall: 276 (17) RA: 177 (18.9) PsA: 52 (14.8) SpA: 47 (14)	LOE: 124 (45) AEs: 77 (28) Malignancy: 8 (3)	12
Hendricks et al, 2017^Citation41	RA, SpA	Overall 85 RA: NA SpA: NA	9 (10.6) RA: NA RA: NA	LOE: 5 (55.5) AEs: 4 (44.4)	4
Dyball et al, 2017^Citation42	RA	Overall: 38	6 (15.7)	LOE: 4 (66.7) AEs: 2 (33.3)	7
Alten et al, 2017^Citation43	RA	Overall: 2,938	323 (11)	NA	2
Holroyd et al, 2017^Citation44	RA, PsA, SpA	Overall: 93 RA: 58 PsA: 16 SpA: 19	14 (15) RA: NA PsA: NA SpA: NA	NA	6
Sigurdardottir et al, 2017^Citation45	RA, PsA, SpA, other arthritis, JIA	Overall: 147 RA: 76 PsA: 28 SpA: 25 Other arthritis: 10 JIA: 8	Overall: 21 (14.3) RA: NA PsA: NA SpA: NA Other arthritis: NA JIA: NA	LOE: 14 (66.6) AEs: NA	8
Haugeberg et al, 2018^Citation46	RA	191	28 (14.7)	LOE: 18 (64.2) AEs: 10 (35.7)	12

Abbreviations: AEs, adverse events; AS, ankylosing spondylitis; JIA, juvenile idiopathic arthritis; LOE, loss of efficacy; NA, not available; PsA, psoriatic arthritis; RA, rheumatoid arthritis; re-ETN, reference etanercept; SpA, spondyloarthritis.

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