Assessment of effectiveness and safety of biosimilar infliximab (CT-P13) in a real-life setting for treatment of patients with active rheumatoid arthritis or ankylosing spondylitis

References

• Isaacs JD, Cutolo M, Keystone EC, et al. Biosimilars in immune-mediated inflammatory diseases: initial lessons from the first approved biosimilar anti-tumour necrosis factor monoclonal antibody. J Intern Med 2016;279:41-59
   PubMed Web of Science ®Google Scholar
• Yen JH. Treatment of early rheumatoid arthritis in developing countries. Biologics or disease-modifying anti-rheumatic drugs? Biomed Pharmacother 2006;60:688-92
   PubMed Web of Science ®Google Scholar
• Kelly CJ, Mir FA. Economics of biological therapies. BMJ 2009;339:b3276
   PubMed Web of Science ®Google Scholar
• Putrik P, Ramiro S, Kvien TK, et al. Inequities in access to biologic and synthetic DMARDs across 46 European countries. Ann Rheum Dis 2014;73:198-206
   PubMed Web of Science ®Google Scholar
• McCamish M, Woollett G. The state of the art in the development of biosimilars. Clin Pharmacol Ther 2012;91:405-17
   PubMed Web of Science ®Google Scholar
• Haustein R, de Millas C, Höer A, et al. Saving money in the European healthcare systems with biosimilars. GaBI J 2012;1:120-6
   Google Scholar
• Mulcahy AW, Predmore Z, Mattke S. The cost savings potential of biosimilar drugs in the United States. RAND Corporation; Santa Monica, CA, US. 2014. Available online at: http://www.rand.org/content/dam/rand/pubs/perspectives/PE100/PE127/RAND_PE127.pdf. Accessed May 2, 2017
   Google Scholar
• Dörner T, Strand V, Cornes P, et al. The changing landscape of biosimilars in rheumatology. Ann Rheum Dis 2016;75:974-82
   PubMed Web of Science ®Google Scholar
• Jacobs I, Petersel D, Isakov L, et al. Biosimilars for the treatment of chronic inflammatory diseases: a systematic review of published evidence. BioDrugs 2016;30:525-70
   PubMed Web of Science ®Google Scholar
• Braun J, Kudrin A. Switching to biosimilar infliximab (CT-P13): evidence of clinical safety, effectiveness and impact on public health. Biologicals 2016;44:257-66
   PubMed Web of Science ®Google Scholar
• Yoo DH, Hrycaj P, Miranda P, et al. 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 2013;72:1613-20
   PubMed Web of Science ®Google Scholar
• Yoo DH, Racewicz A, Brzezicki J, et al. A phase III randomized study to evaluate the efficacy and safety of CT-P13 compared with reference infliximab in patients with active rheumatoid arthritis: 54-week results from the PLANETRA study. Arthritis Res Ther 2016;18:82
   PubMed Web of Science ®Google Scholar
• Yoo DH, Prodanovic N, Jaworski J, et al. 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 2017;76:355-63
   PubMed Web of Science ®Google Scholar
• Park W, Hrycaj P, Jeka S, et al. 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 2013;72:1605-12
   PubMed Web of Science ®Google Scholar
• Park W, Yoo DH, Jaworski J, et al. Comparable long-term efficacy, as assessed by patient-reported outcomes, safety and pharmacokinetics, of CT-P13 and reference infliximab in patients with ankylosing spondylitis: 54-week results from the randomized, parallel-group PLANETAS study. Arthritis Res Ther 2016;18:25
   PubMed Web of Science ®Google Scholar
• Park W, Yoo DH, Miranda P, et al. 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 2017;76:346-54
   PubMed Web of Science ®Google Scholar
• Arnett FC, Edworthy SM, Bloch DA, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988;31:315-24
   PubMed Web of Science ®Google Scholar
• Aletaha D, Neogi T, Silman AJ, et al. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Ann Rheum Dis 2010;69:1580-8
   PubMed Web of Science ®Google Scholar
• van der Linden S, Valkenburg HA, Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis. A proposal for modification of the New York criteria. Arthritis Rheum 1984;27:361-8
   PubMed Web of Science ®Google Scholar
• Wells G, Becker JC, Teng J, et al. Validation of the 28-joint Disease Activity Score (DAS28) and European League Against Rheumatism response criteria based on C-reactive protein against disease progression in patients with rheumatoid arthritis, and comparison with the DAS28 based on erythrocyte sedimentation rate. Ann Rheum Dis 2009;68:954-60
   PubMed Web of Science ®Google Scholar
• Sieper J, Rudwaleit M, Baraliakos X, et al. The Assessment of SpondyloArthritis international Society (ASAS) handbook: a guide to assess spondyloarthritis. Ann Rheum Dis 2009;68(Suppl 2):ii1-44
   PubMed Web of Science ®Google Scholar
• Fransen J, van Riel PL. The disease activity score and the EULAR response criteria. Clin Exp Rheumatol 2005;23(5 Suppl 39):S93-S9
   PubMed Web of Science ®Google Scholar
• Anderson J, Caplan L, Yazdany J, et al. Rheumatoid arthritis disease activity measures: American College of Rheumatology recommendations for use in clinical practice. Arthritis Care Res (Hoboken) 2012;64:640-7
   PubMed Web of Science ®Google Scholar
• Mäkinen H, Hannonen P, Sokka T. Definitions of remission for rheumatoid arthritis and review of selected clinical cohorts and randomised clinical trials for the rate of remission. Clin Exp Rheumatol 2006;24(6 Suppl 43):S-22-8
   Web of Science ®Google Scholar
• Zochling J, Braun J. Remission in ankylosing spondylitis. Clin Exp Rheumatol 2006;24(6 Suppl 43):S-88-92
   Web of Science ®Google Scholar
• van der Heijde D, Lie E, Kvien TK, et al. ASDAS, a highly discriminatory ASAS-endorsed disease activity score in patients with ankylosing spondylitis. Ann Rheum Dis 2009;68:1811-8
   PubMed Web of Science ®Google Scholar
• Landewé R, van Tubergen A. Clinical tools to assess and monitor spondyloarthritis. Curr Rheumatol Rep 2015;17:47
   PubMed Web of Science ®Google Scholar
• Lukas C, Landewé R, Sieper J, et al. Development of an ASAS-endorsed disease activity score (ASDAS) in patients with ankylosing spondylitis. Ann Rheum Dis 2009;68:18–24
   PubMed Web of Science ®Google Scholar
• Sieper J. How to define remission in ankylosing spondylitis? Ann Rheum Dis 2012;71(Suppl 2):i93-5
   PubMed Web of Science ®Google Scholar
• Takeuchi T, Yamanaka H, Tanaka Y, et al. Evaluation of the pharmacokinetic equivalence and 54-week efficacy and safety of CT-P13 and innovator infliximab in Japanese patients with rheumatoid arthritis. Mod Rheumatol 2015;25:817-24
   PubMed Web of Science ®Google Scholar
• Tanaka Y, Yamanaka H, Takeuchi T, et al. Safety and efficacy of CT-P13 in Japanese patients with rheumatoid arthritis in an extension phase or after switching from infliximab. Mod Rheumatol 2017;27:237-45
   PubMed Web of Science ®Google Scholar
• Nikiphorou E, Kautiainen H, Hannonen P, et al. Clinical effectiveness of CT-P13 (infliximab biosimilar) used as a switch from remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data. Expert Opin Biol Ther 2015;15:1677-83
   PubMed Web of Science ®Google Scholar
• Gentileschi S, Barreca C, Bellisai F, et al. Switch from infliximab to infliximab biosimilar: efficacy and safety in a cohort of patients with different rheumatic diseases. Response to: Nikiphorou E, Kautiainen H, Hannonen P, et al. Clinical effectiveness of CT-P13 (infliximab biosimilar) used as a switch from remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data. Expert Opin Biol Ther 2015;15:1677–83. Expert Opin Biol Ther 2016;16:1311-2
   PubMed Web of Science ®Google Scholar
• Benucci M, Gobbi FL, Bandinelli F, et al. Safety, efficacy and immunogenicity of switching from innovator to biosimilar infliximab in patients with spondyloarthritis: a 6-month real-life observational study. Immunol Res 2017;65:419-22
   PubMed Web of Science ®Google Scholar
• Jørgensen KK, Olsen IC, Goll GL, et al.; NOR-SWITCH study group. 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. Lancet 2017;389:2304-16
   PubMed Web of Science ®Google Scholar
• Glintborg B, Sørensen IJ, Loft AG, et al. A nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis: 1-year clinical outcomes from the DANBIO registry. Ann Rheum Dis 2017;76:1426-31
   PubMed Web of Science ®Google Scholar