TABLE 2.
Characteristics of 18 Biosimilar Studies in the Real-World Setting
| Author, year | Country | Study design | Study center | Data source | Study period a | Biosimilar sample size | Outcomes (DC/SW) |
|---|---|---|---|---|---|---|---|
| Avouac et al,201818 | France | Prospective | Single hospital | Medical records | October 2015 to July 2016 (subgroup: up to December 2016 for RP reinitiators) | RA = 31 AxSpA = 131 Crohn’s = 41 UC = 23 Other rheumatic diseases (PsA, juvenile arthritis, undifferentiated inflammatory arthritis) = 20 |
DC, SW |
| Bansback et al,202026 | United States | Retrospective | Multicenter | Registry | January 2017 to September 2018 | RA = 536 PsA = 177 AS = 51 |
DC, SW |
| Boone et al,201817 | Netherlands | Retrospective, pragmatic study | Single center | Medical records, other | July 2016 to April 2017 | Crohn’s = 73 UC = 28 RA = 9 PsA = 5b AS = 10b |
DC |
| Codreanu et al,201833 | Bulgaria, the Czech Republic, Romania | Prospective | Multicenter | Clinical data | December 2014 to October 2016 (enrollment period) | RA = 81 AS = 70 |
DC |
| Fisher et al,202034 | Canada | Retrospective (historical cohort), prospective (policy cohort) | Multicenter | Claims | November 2015 to August 2019 (covering 4 cohorts) | Combined (RA, AS, PsA, unknown) = 75 | SW |
| Glintborg et al,201727 | Denmark | Prospective data collection | Multicenter | Registries, other (records from 2 hospitals) | 2000 to September 2016 | RA = 403 PsA = 120 AxSpA = 279 |
DC, SW |
| Grøn et al,201928 | Denmark | Prospective data; emulating RCT using ITT analysis | Multicenter | Registries | January 2013 to January 2018 (covering 3 calendar periods) | RA: cohort 2 = 7 cohort 3 = 225 |
DC |
| Kim et al,201635 | South Korea | Retrospective | Single database covering all populations (multicenter) | Medical claims | April 2009 to March 2014 | All indications, including RA = 983 | SW |
| Kim et al,202036 | Republic of Korea | Retrospective | Multicenter | Medical records | September 2012 to December 2017 | RA = 154 AS = 337 |
DC, SW |
| Layegh et al,201937 | Netherlands | Retrospective | Single center | Medical records, other | September 2015 to January 2018 | RA = 41 PsA = 4 |
DC, SW |
| Nikiphorou et al,201538 | Finland | Prospective | Single hospital | Clinical data, pro | NR | RA = 15 AS = 14 PsA = 7 JIA = 2 chronic reactive arthritis = 1 |
DC, SW |
| Nikiphorou et al,201939 | Finland | Retrospective | Single center | Clinical data, pro | NR (2008 onwards) | RA = 18 AS/SpA = 31 PsA = 21 adult JIA = 4 IBD/REA = 6 Other = 19 |
DC, SW |
| Sung et al,201716 | South Korea | Retrospective | Multicenter | Registry, medical records | October 2011 to September 2015 (enrollment period) | RA = 55 | DC |
| Tweehuysen et al,201840 | Netherlands | Prospective | Multicenter | Medical records, clinical data | July 2015 to May 2016 | RA = 75 PsA = 50 AS = 67 |
DC, SW |
| Valido et al,201941 | Portugal | Prospective | Single center | Registry (clinical data) | November 2015 to November 2017 | RA = 16 PsA = 8 SpA = 36 |
DC, SW |
| Vergara-Dangond et al,201742 | Spain | Retrospective | Single center | Clinical data | June 2015 to January 2016 (SW period) | RA = 2 PsA = 2 AS = 3 |
DC |
| Yazici et al,201815 | Turkey | Retrospective | Multicenter | Claims | December 2010 to June 2016 (enrollment period) | RA = 92 | DC, SW |
| Yazici et al,201814 | Turkey | Retrospective | Multicenter | Claims | October 2014 to May 2015 (enrollment period) | RA = 204 IBD = 77 |
DC, SW |
a Study periods are not specific to IFX biosimilars.
b We noted discrepancy in sample size for PsA and AS and reported data based on table results.
AS = ankylosing spondylitis; AxSpA = axial spondyloarthritis; biosim = biosimilar; Crohn’s = Crohn’s disease; DC = discontinuation; IBD = inflammatory bowel disease; ITT = intention-to-treat; JIA = juvenile idiopathic arthritis; NR = not reported; PsA = psoriasis or psoriatic arthritis; PRO = patient-reported outcome; RCT = randomized controlled trial; REA = reactive arthritis; RP = reference product; SpA = spondyloarthritis; SW = switching; UC = ulcerative colitis.