Table 2.
Characteristics of included studies
Study; publication type | Study design | Country | Data source | Study years | Study population | Sample size | Advanced therapy | Follow-up duration, months | Outcomes reported |
---|---|---|---|---|---|---|---|---|---|
USA | |||||||||
Bornheimer 2019 [45]; abstract | Retrospective cohort | USA | IQVIA RWD Adjudicated Claims Database | 01/2011 to 12/2017 | Patients with UC receiving ≥ 1 IBD-related biologic | 4832 | Not specified | 60 | Costs |
Borren 2020 [46]; article | Prospective cohort | USA | Prospective Registry for IBD Study | 12/2014 to 06/2018 | Patients with moderate-to-severe UC initiating biologic therapy | 308 | ADA, IFX, UST, or VDZ | 12.4 | HRQoL |
Cai 2020 [47]; abstract | Retrospective cohort | USA | IBM MarketScan Commercial Claims Database | 01/2017 to 12/2017 | Adults with UC and ≥ 1 medical or pharmacy claim for a biologic | 6414 | Not specified | 12 | Costs, HCRU |
Carter 2011 [30]; article | Retrospective cohort | USA | IMS LifeLink database | 09/2004 to 03/2009 | Patients with UC newly initiating IFX | 420 | IFX | 12–14 | Costs, HCRU |
Chapman 2019 [48]; abstract | Retrospective cohort | USA | PharMetrics Plus claims data | 01/2013 to 10/2017 | Patients with UC newly initiating biologic therapy | 3595 | ADA, GOL, IFX, or VDZ | 12 | HCRU |
Chen 2021 [49]; abstract | Retrospective cohort | USA | Optum Research Database | 2016 to 2019 | Patients with UC treated with biologic therapy | NR | Anti-TNF or VDZ | NR | HCRU |
Chiorean 2020 [50]; article | Retrospective cohort | USA | IBM MarketScan databases | 01/2000 to 09/2017 | Patients with UC who switched from an initial anti-TNF to another anti-TNF or VDZ | 1348 | ADA, GOL, IFX, or VDZ | 6 | Costs, HCRU |
Cross 2020 [51]; abstract | Retrospective cohort | USA | Corrona IBD registry | 5/2017 to 9/2019 | Patients with UC on biologics/JAK inhibitors | 315 | Not specified | NR | Costs |
Hunter 2019 [52]; abstract | Cross-sectional | USA | Truven Health MarketScan Commercial and Medicare Supplemental Databases | 01/2007 to 12/2017 | Patients with UC currently receiving biologics | NR | Not specified | NA | HCRU |
Kirchgesner 2021 [44]; article | Retrospective cohort | USA | IBM MarketScan and Optum’s Clinformatics Data Mart Database |
MarketScan (2004 to 2018); Optum (2005 to 2019) |
Anti-TNF-naïve patients with moderate-to-severe UC initiating biologic therapy | 878 | IFX | 9.3 | HCRU |
Kochar 2018 [53]; abstract | Retrospective cohort | USA | Truven Health MarketScan database | 05/2014 to 12/2015 | Patients with UC who are new users of VDZ | 249 | VDZ | 6 | HCRU |
Long 2019 [28]; article | Retrospective cohort | USA | IQVIA RWD Adjudicated Claims Database | 07/2011 to 07/2014 | Patients with UC who were new and chronic users (≥ 60 days) of anti-TNFs | 2851 | ADA, CZP, GOL, or IFX | 2 | Costs, HCRU |
Long 2020 [29]; article | Retrospective cohort | USA | IBM MarketScan Research Databases | 01/2012 to 03/2017 | Patients with UC initiating biologic therapy | 2331 | ADA, GOL, IFX, or VDZ | 12 | Costs, HCRU |
Naegeli 2019 [54]; abstract | Cross-sectional | USA | IBM MarketScan Commercial, Medicaid, and Medicare Supplemental Claims database | 01/2017 to 12/2017 | Patients with UC receiving biologics | 7705 | Not specified | NA | HCRU |
Nguyen 2020 [55]; abstract | Cross-sectional | USA | IBM Watson Health MarketScan database | 2010 to 2017 | Patients with UC initiating biologic therapy | 7331 | Not specified | NA | HCRU |
Null 2017 [56]; article | Retrospective cohort | USA | Humana Research Database | 01/2007 to 12/2014 | Patients with UC initiating biologic therapy | 295 | ADA or IFX | 12 | Costs, HCRU |
Patel 2018 [57]; abstract | Retrospective cohort | USA | Explorys Universe database | 05/2014 to 10/2017 | Biologic-naïve patients with UC initiating treatment with IFX or VDZ | 150 | IFX or VDZ | 12 | HCRU |
Perera 2018 [58]; article | Retrospective cohort | USA | Truven Health MarketScan Commercial and Medicare Supplemental Databases | 04/2010 to 03/2015 | Patients with UC initiating biologics | 2195 | ADA, CZP, GOL, IFX, NAT, UST, or VDZ | 12 | Costs, HCRU |
Pilon 2020 [59]; article | Retrospective cohort | USA | Optum Healthcare Solutions, Inc employer claims database | 01/1999 to 03/2017 | Patients with moderate-to-severe UC receiving biologics | 889 | ADA, CZP, GOL, IFX, NAT, or VDZ | 58.8 | Costs |
Rubin 2020 [60]; article | Retrospective cohort | USA | IBM MarketScan Commercial Claims & Encounters and Medicare Supplemental & Coordination of Benefits databases | 01/2001 to 12/2014 | Patients with UC and ≥ 1 anti-TNF drug claim | 4451 | Anti-TNF (not specified) | 12 | Costs |
Stewart 2021 [61]; article | Retrospective cohort | USA | Optimum Clinformatics Data Mart | 01/2013 to 12/2018 | Patients with UC initiating an anti-TNF agent | 492 | ADA or GOL | 12 | HCRU |
Wolf 2021 [62]; abstract | Retrospective cohort | USA | MarketScan Commercial Claims data | 01/2012 to 12/2016 | Patients with UC initiating biologic therapy | 2972 | ADA, IFX, GOL, or VDZ | 24 | Costs, HCRU |
Europe | |||||||||
Armuzzi 2021 [63]; abstract Armuzzi 2018 [32]; article |
Prospective cohort | Italy | GO-CARE study | NR | Patients with UC treated with GOL | 83 | GOL | 12.4 | HRQoL |
Bamias 2021 [64]; article Bamias 2019 [65]; abstract |
Prospective cohort | Greece | Greek tertiary GI-IBD centers | 11/2015 to 05/2019 | Patients with UC initiating therapy with VDZ | 96 | VDZ | 12.4 | HRQoL |
Black 2016 [66]; article | Retrospective cohort | UK | Hospital Treatment Insights database (IMS Health Ltd, UK) | 01/2010 to 03/2014 | Patients with UC treated with ADA | 191 | ADA | 12 | Costs |
Campbell-Hill 2018 [31]; abstract | Retrospective cohort | Germany | Patient charts from 15 German centers | 07/2014 to 10/2015 | Patients with UC initiating VDZ or an anti-TNF agent | 140 | ADA, GOL, IFX, or IFX biosimilar | 12 | Costs |
Casellas 2012 [67]; article | Retrospective cohort | Spain | Crohn-Colitis Care Unit (UACC) at Hospital Universitario Valle de Hebrón | NR | Patients with UC treated with anti-TNFs | 11 | ADA or IFX | 12 | HRQoL |
Desmond 2012 [68]; article | Prospective cohort | Ireland | IBD database of a tertiary referral center, Cork University Hospital | 01/1991 to 01/2009 | Patients with UC admitted to the Cork University Hospital | 25 | ADA or IFX | Median: 14.2 | HCRU |
Dignass 2020 [69]; article |
Retrospective cohort | Germany | German statutory health insurance database | 01/2013 to 12/2015 | Patients with UC newly initiating biologic therapy | 304 | ADA, GOL, IFX, or VDZ | 24 | Costs, HCRU |
Eriksson 2021 [72]; article | Prospective cohort | Sweden | Swedish National Quality Register for IBD (SWIBREG); SVEAH Study | 06/2015 to 11/2018 | Patients with active UC at the onset of biologic treatment | 117 | VDZ | 12 | HRQoL |
Gatopoulou 2021 [73]; article | Prospective cohort | Greece | GO-LIFE study | 2015 to 2018 | Anti-TNF-naïve patients with moderately to severely active UC and inadequate response, intolerability, or contraindication to conventional therapies | 81 | GOL | 12 | HRQoL |
Khalili 2020 [74]; article | Retrospective cohort | Sweden | Swedish National Patient Register | 2014 | Patients with UC on anti-TNF therapy | 862 | Anti-TNF (not specified) | 12 | Costs |
Kirchgesner 2021 [44]; article | Retrospective cohort | France | SNDS | 2009 to 2018 | Anti-TNF-naïve patients with moderate-to-severe UC initiating biologic therapy | 620 | IFX | 9.3 | HCRU |
Lawton 2019 [75]; article | Retrospective cohort | France | Outpatient clinic at the Nancy University hospital | 11/2016 to 02/2017 | Patients with UC treated with ADA or IFX | 25 | ADA, IFX, or IFX biosimilar | 12 | Costs |
Lo 2020 [76]; article | Prospective cohort | Denmark | Danish national registries | 01/2003 to 12/2004 | Patients with UC receiving biologics | 28 | Not specified | 144 | Costs |
Lowenberg 2014 [77]; article | Retrospective cohort | Netherlands | Local hospital database | 11/2003 to 08/2012 | Patients hospitalized for severe corticosteroid-refractory UC and treated with IFX | 16 | IFX | Median: 34.5 | Costs, HCRU |
Mandel 2014 [78]; article | Retrospective cohort | Hungary | Patients’ medical charts | 01/2008 to NR | Patients with steroid-refractory UC receiving at least one maintenance anti-TNF therapy | 42 | ADA or IFX | Median: 102 | HCRU |
Mantzaris 2019 [79]; abstract | Prospective cohort | Greece | GO-LIFE study | NR | Anti-TNF-naïve patients with moderate-to-severe UC and inadequate response to conventional therapies | 50 | GOL | 6 | HCRU |
Oussalah 2010 [80]; article | Retrospective cohort | France | Medical records of patients from five academic centers in France | 12/2007 to 12/2014 | Patients with UC initiating first-line anti-TNF therapy | 191 | ADA or IFX | Median: 18 | HCRU |
Picker 2021 [81] |
Retrospective cohort | Germany | AOK PLUS | 01/2015 to 06/2019 | Patients with UC undergoing advanced therapies | 574 | Anti-TNFs (not specified), TOF, or VDZ | 48 | Costs, HCRU |
Pöllinger 2019 [84]; article | Retrospective cohort | Germany | Arvato Health Analytics GmbH database in cooperation with Gesundheitsforen Leipzig GmbH | 2007 to 2015 | Patients with moderate-to-severe UC treated with biologics | 154 | ADA | 12 | Costs |
Sebastian 2019 [85]; article | Retrospective cohort | UK | 11 acute hospitals | 05/2016 to 05/2018 | Hospitalized, steroid-refractory patients with ASUC | 131 | IFX | 12 | HCRU |
Singh 2017 [86]; article | Retrospective cohort | Denmark | Danish National Patient Registry | 2005 to 2014 | Biologic-naïve patients with UC | 275 | ADA or IFX |
Median: ADA 15.6 Median: IFX 27.6 |
HCRU |
Teich 2021 [39]; article Teich 2020 [40]; article Teich 2019 [42]; abstract |
Prospective cohort | Germany | GO CUTE study | 03/2014 to 08/2019 | Patients with UC who were suitable for GOL therapy | 282 | GOL | 24 | Costs, HCRU, HRQoL |
van der Valk 2015 [41]; article | Prospective cohort | Netherlands | COIN study | 10/2010 to 10/2011 | Patients with UC on anti-TNF therapy | 34 | ADA or IFX | 24 | Costs, HRQoL |
van Gennep 2017 [43]; article | Retrospective cohort | Netherlands, Belgium | Academic Medical Center in Amsterdam, the Netherlands, and the University Hospitals in Leuven, Belgium | 2010 to 01/2015 | Patients with moderate-to-severe UC starting treatment with an anti-TNF agent | 59 | ADA, GOL, or IFX | Median: 29 | HRQoL |
Wilke 2020 [87]; article | Retrospective cohort | Germany | Regional German Sickness Fund | 01/2011 to 12/2015 | Patients newly diagnosed with UC initiating anti-TNF therapies | 131 | ADA, CZP, IFX, or GOL | Median: 51 | Costs |
Ylisaukko-Oja 2019 [88]; article Torvinen 2018 [89]; abstract |
Retrospective cohort | Finland | The Hospital District of Southwest Finland | 2014 to 2016 | Anti-TNF-naïve patients with UC initiating treatment with IFX | 110 | IFX | 12 | Costs, HCRU |
ADA adalimumab, CZP certolizumab pegol, GI gastrointestinal, GOL golimumab, HCRU healthcare resource utilization, HRQoL health-related quality of life, IBD inflammatory bowel disease, IFX infliximab, JAK Janus kinase, NA not applicable, NAT natalizumab, NR not reported, RWD real-world data, SNDS Système National des Données de Santé (French nationwide health insurance database), TNF tumor necrosis factor, UC ulcerative colitis, UST ustekinumab, VDZ vedolizumab