Summary: real-world evidenceClinical evidence of INFLECTRA® (CT-P13*/infliximab) is complemented by real-world studies1-46
Although randomised controlled trials are considered the gold standard for evaluating the efficacy and safety of a medication, observational studies conducted in a real-world setting are also useful in providing evidence of the effectiveness of a treatment in clinical practice47
However, it is important to be aware that real-world studies can be limited by several factors, including potential selection bias
- Observational studies are not powered and designed to detect differences between treatment arms
- Outcome definitions may differ between randomised controlled trials (RCTs) and real-world trials, and the generalisability of real-world study findings may be limited to source data populations
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CT-P13 is marketed under different brand names including INFLECTRA® and REMSIMA™.Remicade™ is a registered trademark of MSD.All published real-world studies evaluating CT-P13 in IBD identified through April 2020. The majority of studies were prospective. Although care has been taken to avoid counting errors arising from the publication of the same study on multiple occasions, errors of this nature may still be present.CD, Crohn’s disease; IBD, Inflammatory bowel disease; RCT, Randomised controlled trial; UC, Ulcerative colitis.References:Afonso J, et al. Therap Adv Gastroenterol 2017;10:661-71.Armuzzi A, et al. Inflamm Bowel Dis 2019;25:568-79. Balint A, et al. Expert Opin Biol Ther 2018;18:1181-7.Balint A, et al. Expert Opin Drug Saf 2017;16:885-90.Farkas K, et al. Expert Opin Biol Ther 2017;17:1325-32.Farkas K, et al. J Crohns Colitis 2016;10:1273-8.Fiorino G, et al. Inflamm Bowel Dis 2018;24:601-6.Gheorghe C, et al. J Drug Assess 2019;8(1):129-34. Goncalves J, et al. Aliment Pharmacol Ther 2018;48:507-22.Gonczi L, et al. Inflamm Bowel Dis 2017;23:1908-15.Harkin G, et al. J Crohns Colitis 2017;11:1400-1.Hlavaty T, et al. Gastroenterol Hepatol 2016;70:27-36.Ilias A, et al. Clin Gastroenterol Hepatol 2019;17(12):2506-13.Jahnsen J, et al. Expert Rev Gastroenterol Hepatol 2015;9(suppl 1):45-52.Kang Y-S, et al. Dig Dis Sci 2015;60:951-6.Kaniewska M, et al. Prz Gastroenterol 2017;12:169-74. Keil R, et al. Scand J Gastroenterol 2016;51:1062-8. Kennedy NA, et al. Lancet Gastroenterol Hepatol 2019;4:341-53.Kim NH, et al. J Gastroenterol Hepatol 2019. [pub ahead of print].Kolar M, et al. Dig Dis Sci 2017;35:91-100.Meyer A, et al. Aliment Pharmacol Ther 2019. [Epub ahead of print].Meyer A, et al. Ann Intern Med 2019;170:99-107. Park SH, et al. Expert Rev Gastroenterol Hepatol 2015;9(suppl 1):35-44. Richmond L, et al. Arch Dis Child 2018;103:89-91.Sieczkowska-Golub J, et al. J Pediatr Gastroenterol Nutr 2017;65:285-8.Tursi A, et al. Minerva Gastroenterol Dietol 2017;63:313-18.Yazici Y, et al. Biologics 2018;12:97-106.Avouac J, et al. Semin Arthritis Rheum 2018;47:741-8.Bergquvist V, et al. Therap Adv Gastroenterol 2018;11:1-13Bhat SB, et al. JMCP 2020;26:410-6.Boone NW, et al. Eur J Clin Pharmacol 2018;74:655-61.Buer LC, et al. J Crohns Colitis 2017;11:297-304.Chaparro M, et al. J Crohns Colitis 2019;13(11):1380-6.Eberl A, et al. Scand J Gastroenterol 2017;52:1348-53.Guerra Veloz MF, et al. Rev Esp Enferm Dig 2018;110:564-70.Guerra Veloz MF, et al. World J Gastroenterol 2018;24:5288-96.Guerrero Puente L, et al. Gastroenterol Hepatol 2017;40:595-604.Ho SL, et al. BioDrugs 2020;34:395-404.Hoivik ML, et al. Scand J Gastroenterol 2018;53:692-9.Kang B, et al. Inflamm Bowel Dis 2018;24:607-16.Plevris N, et al. Dig Dis Sci 2018:1-8.Razanskaite V, et al. J Crohns Colitis 2017;11:690-6.Schmitz EMH, et al. Aliment Pharmacol Ther 2018;47:356-63.Sieczkowska J, et al. J Crohns Colitis 2016;10:127-32.Smits LJT, et al. Inflamm Bowel Dis 2019;25:172-9.van Hoeve K, et al. Ther Drug Monit 2019;41:317-24.Tashkin DP, et al. Int J Chron Obstruct Pulmon Dis 2020;15:1225-43.Byong Duk Y, et al. Lancet 2019;393:1699-707.Jorgensen KK, et al. Lancet 2017;389:2304-16.Strik AS, et al. Lancet Gastroenterol Hepatol 2018;3:404-12.