Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial

The Lancet - Tập 389 Số 10086 - Trang 2304-2316 - 2017
Kristin Kaasen Jørgensen1, Inge Christoffer Olsen2, Guro Løvik Goll2, M Lorentzen3, Nils Bolstad4, Espen A. Haavardsholm2,5, Knut E.A. Lundin6,7,5, Cato Mørk8, Jørgen Jahnsen1,5, Tore K Kvien2,5, Ingrid Prytz Berset, Bjørg TS Fevang, Jon Florholmen, S. Kalstad, N.J. Mørk8, K Ryggen1, K.M. Tveit, Sigrun K Sæther, Bjørn Gulbrandsen, Jon Hagfors, Kenneth Waksvik, David J. Warren, Karoline J. Henanger, Øivind Asak, Somyeh Baigh, Ingrid Marianne Blomgren, Trude Jannecke Bruun, Katrine Dvergsnes, Svein Oskar Frigstad, Clara Gram Gjesdal, Berit Grandaunet, Inger Marie Jensen Hansen, Ingvild S H Hatten, Gert Huppertz‐Hauss, Magne Henriksen, Sunniva S Hoie, Jan Krogh, Julia R Kruse, Maud-Kristine Aga Ljoså, Irina P Midtgard, Paweł Mielnik, Bjørn Moum, Geir Noraberg, Armin Poyan, Ulf Prestegård, Haroon Rashid, Jan Henrik Rydning, Liv Sagatun, Kathrine Aglen Seeberg, Kristine Skjetne, Eldri Kveine Strand, Hilde Stray, Njaal Stray, Roald Torp, Cecilia Vold, Carl Magnus Ystrøm, Camilla Zettel
1Department of Gastroenterology, Akershus University Hospital, Lørenskog, Norway
2Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway
3Department of Dermatology, Oslo University Hospital – Rikshospitalet, Oslo, Norway
4Department of Medical Biochemistry, Oslo University Hospital, Radiumhospitalet, Oslo, Norway
5Faculty of Medicine, University of Oslo, Oslo, Norway
6Centre for Immune Regulation, University of Oslo, Oslo, Norway
7Department of Gastroenterology, Oslo University Hospital–Rikshospitalet, Oslo, Norway
8Institute of Cancer Research and Molecular Medicine, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim, Norway

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Kuek, 2007, Immune-mediated inflammatory diseases (IMIDs) and biologic therapy: a medical revolution, Postgrad Med J, 83, 251, 10.1136/pgmj.2006.052688

Putrik, 2014, Inequities in access to biologic and synthetic DMARDs across 46 European countries, Ann Rheum Dis, 73, 198, 10.1136/annrheumdis-2012-202603

Park, 2013, A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study, Ann Rheum Dis, 72, 1605, 10.1136/annrheumdis-2012-203091

Yoo, 2013, A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study, Ann Rheum Dis, 72, 1613, 10.1136/annrheumdis-2012-203090

Schneider, 2013, Biosimilars in rheumatology: the wind of change, Ann Rheum Dis, 72, 315, 10.1136/annrheumdis-2012-202941

Dorner, 2016, The changing landscape of biosimilars in rheumatology, Ann Rheum Dis, 75, 974, 10.1136/annrheumdis-2016-209166

Weise, 2014, Biosimilars: the science of extrapolation, Blood, 124, 3191, 10.1182/blood-2014-06-583617

Danese, 2013, ECCO position statement: the use of biosimilar medicines in the treatment of inflammatory bowel disease (IBD), J Crohns Colitis, 7, 586, 10.1016/j.crohns.2013.03.011

Ben-Horin, 2016, Biosimilars in inflammatory bowel disease: facts and fears of extrapolation, Clin Gastroenterol Hepatol, 14, 1685, 10.1016/j.cgh.2016.05.023

Blauvelt, 2016, Biosimilars for psoriasis: clinical studies to determine similarity, Br J Dermatol, 10.1111/bjd.14267

Feagan, 2014, The challenge of indication extrapolation for infliximab biosimilars, Biologicals, 42, 177, 10.1016/j.biologicals.2014.05.005

Gecse, 2016, Biosimilar monoclonal antibodies for inflammatory bowel disease: current comfort and future prospects, Drugs, 76, 1413, 10.1007/s40265-016-0638-4

Dorner, 2015, Biosimilars in rheumatology: current perspectives and lessons learnt, Nat Rev Rheumatol, 11, 713, 10.1038/nrrheum.2015.110

Braun, 2016, Switching to biosimilar infliximab (CT-P13): evidence of clinical safety, effectiveness and impact on public health, Biologicals, 44, 257, 10.1016/j.biologicals.2016.03.006

Buer, 2016, Switching from Remicade(R) to Remsima(R) is safe and feasible: a prospective, open-label study, J Crohns Colitis, 10.1093/ecco-jcc/jjw166

Smits, 2016, Clinical outcomes following a switch from Remicade(R) to the biosimilar CT-P13 in inflammatory bowel disease patients: a prospective observational cohort study, J Crohns Colitis, 10, 1287, 10.1093/ecco-jcc/jjw087

Dapavo, 2016, The infliximab biosimilar in the treatment of moderate to severe plaque psoriasis, J Am Acad Dermatol, 75, 736, 10.1016/j.jaad.2016.04.068

Glintborg, 2016, Three months' clinical outcomes from a nationwide non-medical switch from originator to biosimilar infliximab in patients with inflammatory arthritis, results from the DANBIO registry, Ann Rheum Dis, 75, 142

Park, 2016, Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study, Ann Rheum Dis

Yoo, 2016, Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study, Ann Rheum Dis

Harvey, 1980, Measuring Crohn's disease activity, Lancet, 315, 1134, 10.1016/S0140-6736(80)91577-9

Schroeder, 1987, Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis: a randomized study, N Engl J Med, 317, 1625, 10.1056/NEJM198712243172603

Machado, 2011, Ankylosing Spondylitis Disease Activity Score (ASDAS): defining cut-off values for disease activity states and improvement scores, Ann Rheum Dis, 70, 47, 10.1136/ard.2010.138594

Prevoo, 1995, Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis, Arthritis Rheum, 38, 44, 10.1002/art.1780380107

Fredriksson, 1978, Severe psoriasis—oral therapy with a new retinoid, Dermatologica, 157, 238, 10.1159/000250839

Schaeverbeke, 2016, Immunogenicity of biologic agents in rheumatoid arthritis patients: lessons for clinical practice, Rheumatology, 55, 210, 10.1093/rheumatology/kev277

Choe, 2017, A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy, Ann Rheum Dis, 76, 58, 10.1136/annrheumdis-2015-207764

Emery, 2017, A phase III randomised, doubleblind, parallel-group study comparing SB4 with etanercept reference product in patients with active rheumatoid arthritis despite methotrexate therapy, Ann Rheum Dis, 76, 51, 10.1136/annrheumdis-2015-207588

Griffiths, 2016, The EGALITY study: a confirmatory, randomised, double-blind study comparing the efficacy, safety and immunogenicity of GP2015, a proposed etanercept biosimilar, versus the originator product in patients with moderate to severe chronic plaque-type psoriasis, Br J Dermatol

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The Lancet

Tập 389 Số 10086

2304-2316

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