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Erschienen in: Drugs 6/2017

01.04.2017 | AdisInsight Report

Sarilumab: First Global Approval

verfasst von: Lesley J. Scott

Erschienen in: Drugs | Ausgabe 6/2017

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Abstract

Sarilumab (Kevzara™) is a fully human IgG1 monoclonal antibody that binds specifically to both soluble and membrane-bound interleukin (IL)-6 receptors (sIL-6Rα and mIL-6Rα) and thereby inhibits IL-6-mediated signalling through these receptors. Subcutaneous sarilumab is approved in Canada for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more biological or non-biological disease-modifying anti-rheumatic drugs. It is under regulatory review for use in rheumatoid arthritis in other countries, including in the EU, USA and Japan. Sarilumab is also under phase II investigation for the treatment of juvenile idiopathic arthritis. This article summarizes the milestones in the development of sarilumab leading to its first global approval for the treatment of rheumatoid arthritis.
Literatur
2.
Zurück zum Zitat Srirangan S, Choy EH. The role of interleukin 6 in the pathophysiology of rheumatois arthritis. Ther Adv Musculoskel Dis. 2010;2(5):247–56.CrossRef Srirangan S, Choy EH. The role of interleukin 6 in the pathophysiology of rheumatois arthritis. Ther Adv Musculoskel Dis. 2010;2(5):247–56.CrossRef
3.
Zurück zum Zitat Smolen JS, Aletaha D, McInnes IA. Rheumatoid arthritis. Lancet. 2016;388:23–38. Smolen JS, Aletaha D, McInnes IA. Rheumatoid arthritis. Lancet. 2016;388:23–38.
4.
Zurück zum Zitat Sanofi, Regeneron Pharmaceuticals. Sanofi and Regeneron announce EMA acceptance for review of Marketing Authorisation Application for sarilumab. 2016. http://www.sanofi.com. Accessed 15 Feb 2017. Sanofi, Regeneron Pharmaceuticals. Sanofi and Regeneron announce EMA acceptance for review of Marketing Authorisation Application for sarilumab. 2016. http://​www.​sanofi.​com. Accessed 15 Feb 2017.
5.
Zurück zum Zitat Sanofi, Regeneron Pharmaceuticals Inc. Sanofi and Regeneron announce first approval of KevzaraTM (sarilumab) for the treatment of moderately to severely active rheumatoid arthritis in adult patients by Health Canada. 2017. http://www.sanofi-aventis.com. Accessed 1 Feb 2017. Sanofi, Regeneron Pharmaceuticals Inc. Sanofi and Regeneron announce first approval of KevzaraTM (sarilumab) for the treatment of moderately to severely active rheumatoid arthritis in adult patients by Health Canada. 2017. http://​www.​sanofi-aventis.​com. Accessed 1 Feb 2017.
9.
Zurück zum Zitat Mangan EK, Parrino J, Wu R, et al. Pharmacodynamic effect and safety of single-dose administration of subcutaneous sarilumab or intravenous tocilizumab in patients with rheumatoid arthritis [abstract no. APL16-0768]. Int J Rheum Dis. 2016;19(Suppl 2):196. Mangan EK, Parrino J, Wu R, et al. Pharmacodynamic effect and safety of single-dose administration of subcutaneous sarilumab or intravenous tocilizumab in patients with rheumatoid arthritis [abstract no. APL16-0768]. Int J Rheum Dis. 2016;19(Suppl 2):196.
10.
Zurück zum Zitat Boyapati A, Msihid J, Fiore S, et al. Sarilumab plus methotrexate suppresses circulating biomarkers of bone resorption and synovial damage in patients with rheumatoid arthritis and inadequate response to methotrexate: a biomarker study of MOBILITY. Arthritis Res Ther. 2016;18(1):225.CrossRefPubMedPubMedCentral Boyapati A, Msihid J, Fiore S, et al. Sarilumab plus methotrexate suppresses circulating biomarkers of bone resorption and synovial damage in patients with rheumatoid arthritis and inadequate response to methotrexate: a biomarker study of MOBILITY. Arthritis Res Ther. 2016;18(1):225.CrossRefPubMedPubMedCentral
11.
Zurück zum Zitat Huizinga TW, Fleischmann RM, Jasson M, et al. Sarilumab, a fully human monoclonal antibody against IL-6Rα in patients with rheumatoid arthritis and an inadequate response to methotrexate: efficacy and safety results from the randomised SARIL-RA-MOBILITY Part A trial. Ann Rheum Dis. 2014;73:1626–34.CrossRefPubMed Huizinga TW, Fleischmann RM, Jasson M, et al. Sarilumab, a fully human monoclonal antibody against IL-6Rα in patients with rheumatoid arthritis and an inadequate response to methotrexate: efficacy and safety results from the randomised SARIL-RA-MOBILITY Part A trial. Ann Rheum Dis. 2014;73:1626–34.CrossRefPubMed
12.
Zurück zum Zitat Genovese MC, Fleischmann R, Kivitz AJ, et al. Sarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate: results of a phase III study. Arthritis Rheumatol. 2015;67(6):1424–37.CrossRefPubMed Genovese MC, Fleischmann R, Kivitz AJ, et al. Sarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate: results of a phase III study. Arthritis Rheumatol. 2015;67(6):1424–37.CrossRefPubMed
13.
Zurück zum Zitat Strand V, Kosinski M, Chen CI, et al. Sarilumab plus methotrexate improves patient-reported outcomes in patients with active rheumatoid arthritis and inadequate responses to methotrexate: results of a phase III trial. Arthritis Res Ther. 2016;18:198.CrossRefPubMedPubMedCentral Strand V, Kosinski M, Chen CI, et al. Sarilumab plus methotrexate improves patient-reported outcomes in patients with active rheumatoid arthritis and inadequate responses to methotrexate: results of a phase III trial. Arthritis Res Ther. 2016;18:198.CrossRefPubMedPubMedCentral
14.
Zurück zum Zitat van der Heijde D, Fan C, van Hoogstraten H, et al. Consistency of radiographic responses with sarilumab plus methotrexate across subpopulations of patients with rheumatoid arthritis in a phase 3 study [abstract no. SAT0058]. Ann Rheum Dis. 2016;75(Suppl 2):685. van der Heijde D, Fan C, van Hoogstraten H, et al. Consistency of radiographic responses with sarilumab plus methotrexate across subpopulations of patients with rheumatoid arthritis in a phase 3 study [abstract no. SAT0058]. Ann Rheum Dis. 2016;75(Suppl 2):685.
15.
Zurück zum Zitat Fleischmann R, Mangan EK, van Adelsberg J, et al. Onset of action of sarilumab in patients with rheumatoid arthritis in 2 phase 3 studies [abstract no. SAT0180]. Ann Rheum Dis. 2016;75(Suppl 2):733.CrossRef Fleischmann R, Mangan EK, van Adelsberg J, et al. Onset of action of sarilumab in patients with rheumatoid arthritis in 2 phase 3 studies [abstract no. SAT0180]. Ann Rheum Dis. 2016;75(Suppl 2):733.CrossRef
16.
Zurück zum Zitat Strand V, Chen C, Mahajan P, et al. Early onset of benefit by patient-reported outcomes (PROs) with sarilumab treatment in RA [abstract no. AB0251]. Ann Rheum Dis. 2016;75(Suppl 2):984–5. Strand V, Chen C, Mahajan P, et al. Early onset of benefit by patient-reported outcomes (PROs) with sarilumab treatment in RA [abstract no. AB0251]. Ann Rheum Dis. 2016;75(Suppl 2):984–5.
17.
Zurück zum Zitat Fleischmann R, van Adelsberg J, Lin Y, et al. Sarilumab and nonbiologic disease-modifying antirheumatic drugs in patients with active RA and inadequate response or intolerance to tumour necrosis factor inhibitors. Arthritis Rheumatol. 2016;69(2):277–90.CrossRef Fleischmann R, van Adelsberg J, Lin Y, et al. Sarilumab and nonbiologic disease-modifying antirheumatic drugs in patients with active RA and inadequate response or intolerance to tumour necrosis factor inhibitors. Arthritis Rheumatol. 2016;69(2):277–90.CrossRef
18.
Zurück zum Zitat Strand V, Mahajan P, Chen C, et al. Benefit of sarilumab with csDMARDs on patient productivity in work, household work and family, social, leisure activities in TNF-IR RA patients [abstract no. AB0252]. Ann Rheum Dis. 2016;75(Suppl 2):985. Strand V, Mahajan P, Chen C, et al. Benefit of sarilumab with csDMARDs on patient productivity in work, household work and family, social, leisure activities in TNF-IR RA patients [abstract no. AB0252]. Ann Rheum Dis. 2016;75(Suppl 2):985.
19.
Zurück zum Zitat Burmester GR, Lin Y, Patel R, et al. Efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy for the treatment of patients with active rheumatoid arthritis (MONARCH): a randomised, double-blind, parallel-group phase III trial. Ann Rheum Dis. 2016. doi:10.1136/annrheumdis-2016-210310. Burmester GR, Lin Y, Patel R, et al. Efficacy and safety of sarilumab monotherapy versus adalimumab monotherapy for the treatment of patients with active rheumatoid arthritis (MONARCH): a randomised, double-blind, parallel-group phase III trial. Ann Rheum Dis. 2016. doi:10.​1136/​annrheumdis-2016-210310.
20.
Zurück zum Zitat Genovese MC, Fay J, Parrino J, et al. Sarilumab dose reduction to manage laboratory abnormalities in an open-label extension study in RA patients [abstract no. FRI0228]. Ann Rheum Dis. 2016;75(Suppl 2):515–6. Genovese MC, Fay J, Parrino J, et al. Sarilumab dose reduction to manage laboratory abnormalities in an open-label extension study in RA patients [abstract no. FRI0228]. Ann Rheum Dis. 2016;75(Suppl 2):515–6.
21.
Zurück zum Zitat Fleischmann R, Genovese MC, van Adelsberg J, et al. Pooled safety and efficacy of sarilumab in rheumatoid arthritis patients 65 years of age and older [abstract no. 1605]. Arthritis Rheumatol. 2016;68(Suppl 10). Fleischmann R, Genovese MC, van Adelsberg J, et al. Pooled safety and efficacy of sarilumab in rheumatoid arthritis patients 65 years of age and older [abstract no. 1605]. Arthritis Rheumatol. 2016;68(Suppl 10).
Metadaten
Titel
Sarilumab: First Global Approval
verfasst von
Lesley J. Scott
Publikationsdatum
01.04.2017
Verlag
Springer International Publishing
Erschienen in
Drugs / Ausgabe 6/2017
Print ISSN: 0012-6667
Elektronische ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-017-0724-2

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