Real-world evidence

Stadig mer dokumentasjon av real-world evidence fortsetter å underbygge bruken av Inflectra1-11

Figuren viser alle publiserte studier, rapporter og abstracts som evaluerer CT-P13 i IBD identifisert til og med april 2017‡§.

 

Real-world evidence

Fotnoter
CT-P13 markedsføres under forskjellige merkenavn som Inflectra og Remsima.
Ikke alle studier evaluerte effekten og/eller sikkerheten til CT-P13.
§Flertallet av studiene var enten retrospektive eller prospektive/observerende, og i de fleste tilfeller ble CT-P13-resultatene sammenlignet med baselineparametre eller tidligere evidens for Remicade.
ECCO, European Crohn’s and Colitis Organisation; IBD, inflammatorisk tarmsykdom; TNF-α, Tumour necrosis factor-alpha.

 

Relaterte terapiområder

Referanser:

1. Fiorino G, Manetti N, Armuzzi A et al, The PROSIT-BIO Cohort: A Prospective Observational Study of Patients with Inflammatory Bowel Disease Treated with Infliximab Biosimilar, Inflamm Bowel Dis 2017;23:233-43
2. Gonczi L, Gesce KB, Vegh Z et al. Long-term Efficacy, Safety, and Immunogenicity of Biosimilar Infliximab After One Year in a Prospective Nationwide Cohort, Inflamm Bowel Dis 2017;23(11):1908-15.
3. Afonso J, Tavares de Sousa H, Rosa I et al, Therapeutic drug monitoring of CT-P13: a comparison of four different immunoassays, Ther Adv Gastroenterol 2017;10(9):661-71.
4. Arguelles-Arias F, Veloz MFG, Amarillo RP et al, Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: 12 months results, Eur J Gastroenterol Hepatol 2017;29(11):1290-5. 
5. Avouac J, Moltó A, Abitbol V et al. Systematic switch from Innovator Infliximab to Biosimilar Infliximab in Inflammatory Chronic Diseases in Daily Clinical Practice: The Experience of Cochin University Hospital, Paris, France, Semin Arthritis Rheum 2017. [Epub ahead of print.]
6. Balint A, Rutka M, Végh Z et al. Frequency and Characteristics of Infusion Reactions during Biosimilar Infliximab Treatment in Inflammatory Bowel Diseases: results from Central European nationwide cohort, Expert Opin Drug Saf 2017;16(8):885-90.
7. Boone NW, Liu L, Romberg-Camps MJ et al, The nocebo effect challenges the non-medical infliximab switch in practice, Eur J Clin Pharmacol 2018;74 (5), 655-661.
8. Eberl A, Huoponen S, Pahikkala T et al, Switching maintenance infliximab therapy to biosimilar infliximab in inflammatory bowel disease patients, Scand J Gastroenterol 2017;52(12):1348-53.
9. Farkas K, Rutka M, Golovics PA et al, Efficacy of Infliximab Biosimilar CT-P13 Induction Therapy on Mucosal Healing in Ulcerative Colitis,  J Crohns Colitis  2016;10:1273-1278. 
10. Farkas K, Rutka M, Ferenci T et al, Infliximab biosimilar CT-P13 therapy is effective and safe in maintaining remission in Crohn’s disease and ulcerative colitis – experiences from a single center, Expert Opin Biol Ther 2017;17(11):1325-32.
11. Guerrero Puente L, Iglesias F, Benitez JM et al, Evolution after switching to biosimilar infliximab in inflammatory bowel disease patients in clinical remission, Gastroenterol Hepatol 2017;40(9):595-604.
12. Hlavaty T, Krajcovicova A, Sturdik I et al. Biosimilar infl iximab CT-P􀍷􀍹 treatment in patients with infl am matory bowel diseases – a one-year, single-centre retrospective study, Gastroenterol Hepatol 2016;70:27-32. 
13. Jahnsen J, Detlie TE, Vatn S et al, Biosimilar infliximab (CT-P13) in the treatment of inflammatory bowel disease: A Norwegian observational study, Expert Rev Gastroenterol Hepatol. 2015;9(S1):S45-52. 
14. Kang B, Lee Y, Lee K et al, Long-term Outcomes After Switching to CT-P13 in Pediatric- Onset Inflammatory Bowel Disease: A Single-Center Prospective Observational Study, Inflamm Bowel Dis 2018.
15. Keil R, Wasserbauer M, Zádorova Z et al, Clinical monitoring: infliximab biosimilar CT-P13 in the treatment of Crohn’s disease and ulcerative colitis, Scand J Gastroenterol 2016; 51:1062-1068. 
16. Razanskaite V, Bettey M, Downey L et al,  Biosimilar Infliximab in Inflammatory Bowel Disease: Outcomes of a Managed Switching Programme, Journal of Crohn's and Colitis, 2017, 690–696 
17. Richmond L, Curtis L, Garrick V et al, Biosimilar infliximab use in paediatric IBD, Arch Dis Child 2018;103(1):89-91.
18. Schmitz EMH, Boekema PJ, Straathof JWA et al,  Switching from infliximab innovator to biosimilar in patients with inflammatory bowel disease: a 12-month multicenter observational prospective cohort study, Aliment Pharacol Ther 2018;47(3):356-63.
19. Smits L, Grelack A, Derokx LAAP et al,  Long-Term Clinical Outcomes After Switching from Remicade[1] to Biosimilar CT-P13 in Inflammatory Bowel Disease, Dig Dis Sci 2017;62(11):3117-22.
20. UK inflammatory bowel disease (IBD) programme steering group. Royal College of Physicians, UK. IBD Biological Therapy Audit 2016 . Available at: https://www.rcplondon.ac.uk/projects/outputs/national-clinical-audit-biological-therapies-annual-report-2016. Lest mai 2018

PP-IFA-NOR-0027