Evaluation of the efficacy and safety of sarilumab combination therapy in patients with rheumatoid arthritis with inadequate response to conventional disease-modifying antirheumatic drugs or tumour necrosis factor α inhibitors: systematic literature review and network meta-analyses.


Journal

RMD open
ISSN: 2056-5933
Titre abrégé: RMD Open
Pays: England
ID NLM: 101662038

Informations de publication

Date de publication:
2019
Historique:
received: 07 08 2018
revised: 08 11 2018
accepted: 03 12 2018
entrez: 20 3 2019
pubmed: 20 3 2019
medline: 20 3 2019
Statut: epublish

Résumé

To compare efficacy and safety of subcutaneous sarilumab 200 mg and 150 mg every 2 weeks plus conventional synthetic disease-modifying antirheumatic drugs (+csDMARDs) versus other targeted DMARDs+csDMARDs and placebo+csDMARDs, in inadequate responders to csDMARDs (csDMARD-IR) or tumour necrosis factor α inhibitors (TNFi-IR). Systematic literature review and network meta-analyses (NMA) conducted on 24 week efficacy and safety outcomes: Health Assessment Questionnaire Disability Index, modified total sharp score (mTSS, including 52 weeks), American College of Rheumatology (ACR) 20/50/70, European League Against Rheumatism Disease Activity Score 28-joint count erythrocyte sedimentation rate (DAS28)<2.6; serious infections/serious adverse events (including 52 weeks). 53 trials were selected for NMA. Results suggest that in csDMARD-IR and TNFi-IR (a smaller network), sarilumab+csDMARD had superior efficacy and similar safety versus placebo+csDMARDs and at least similar efficacy and safety versus other targeted DMARDs+csDMARDs.

Identifiants

pubmed: 30886733
doi: 10.1136/rmdopen-2018-000798
pii: rmdopen-2018-000798
pmc: PMC6397432
doi:

Substances chimiques

Antibodies, Monoclonal, Humanized 0
Antirheumatic Agents 0
Tumor Necrosis Factor-alpha 0
sarilumab NU90V55F8I

Types de publication

Journal Article Meta-Analysis Research Support, Non-U.S. Gov't Review

Langues

eng

Pagination

e000798

Déclaration de conflit d'intérêts

Competing interests: EC has received research grants, consultancy and speaker fees from Amgen, Biogen, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Chugai Pharma, Eli Lilly, Janssen, Novimmune, Novartis, Pfizer, Regeneron, Roche, R-Pharm, Sanofi, Tonix and UCB. T-M-TH, LP, HvH and PC are employees of Sanofi and hold stock and/or stock options in the company. CP is a former employee of and current shareholder in Sanofi and current employee of Novartis. C-IC, AK and EM are employees of Regeneron Pharmaceuticals, Inc. and hold stock and/or stock options in the company. NF has received consulting fees from Sanofi, Novo Nordisk, Ipsen, Allergan, Takeda, Biogen, Abbvie, Lifecell.

Références

Ann Rheum Dis. 2013 Sep 1;72(9):1524-35
pubmed: 23087184
Int J Rheum Dis. 2016 Nov;19(11):1143-1156
pubmed: 26259617
N Engl J Med. 2017 Feb 16;376(7):652-662
pubmed: 28199814
BMJ. 2010 Jul 16;341:c3515
pubmed: 20639294
BMJ. 2005 Oct 15;331(7521):897-900
pubmed: 16223826
Ann Rheum Dis. 2017 Jun;76(6):960-977
pubmed: 28264816
Arthritis Rheumatol. 2016 Jan;68(1):1-26
pubmed: 26545940
Stat Med. 1995 Dec 30;14(24):2685-99
pubmed: 8619108
J Rheumatol. 2011 May;38(5):855-62
pubmed: 21285171
Ann Rheum Dis. 2014 Jan;73(1):86-94
pubmed: 23962455
J Clin Rheumatol. 2014 Jan;20(1):25-33
pubmed: 24356474
GMS Health Technol Assess. 2009 Jul 21;5:Doc09
pubmed: 21289896
Med Decis Making. 2013 Jul;33(5):618-40
pubmed: 23804507
Arthritis Res Ther. 2016 Sep 06;18:198
pubmed: 27600829
N Engl J Med. 2012 Aug 9;367(6):508-19
pubmed: 22873531
Value Health. 2011 Jun;14(4):429-37
pubmed: 21669367
Lancet. 2013 May 4;381(9877):1541-50
pubmed: 23515142
Value Health. 2011 Jun;14(4):417-28
pubmed: 21669366
Int J Epidemiol. 2012 Jun;41(3):818-27
pubmed: 22461129
Arthritis Rheumatol. 2015 Jun;67(6):1424-37
pubmed: 25733246
Mod Rheumatol. 2016 Sep;26(5):651-61
pubmed: 26698929
Ann Rheum Dis. 2017 May;76(5):840-847
pubmed: 27856432
Arthritis Rheum. 2004 May;50(5):1400-11
pubmed: 15146409
J Clin Epidemiol. 1997 Jun;50(6):683-91
pubmed: 9250266
Dtsch Arztebl Int. 2015 Nov 20;112(47):803-8
pubmed: 26634940
Ann Intern Med. 2015 Jun 2;162(11):777-84
pubmed: 26030634
BMJ. 2011 Sep 06;343:d4849
pubmed: 21896610
Ann Rheum Dis. 2015 Mar;74(3):e24
pubmed: 25480886
Arthritis Rheum. 2013 Jan;65(1):28-38
pubmed: 23169319
Mod Rheumatol. 2014 Jul;24(4):552-60
pubmed: 24981319
Stat Med. 2004 Oct 30;23(20):3105-24
pubmed: 15449338
Mod Rheumatol. 2014 Sep;24(5):715-24
pubmed: 24313916
Arthritis Rheumatol. 2017 Feb;69(2):277-290
pubmed: 27860410
Ann Rheum Dis. 2012 Jun;71(6):817-24
pubmed: 22121129
Ann Rheum Dis. 2006 Oct;65(10):1357-62
pubmed: 16606651

Auteurs

Ernest Choy (E)

Division of Infection and Immunity, Cardiff University, Cardiff, UK.

Nick Freemantle (N)

Institute for Clinical Trials and Methodology, University College London, London, UK.

Clare Proudfoot (C)

Formerly, Health Economics and Outcomes Research, Sanofi, Guildford, UK.

Chieh-I Chen (CI)

Health Economics and Outcomes Research, Regeneron Pharmaceuticals, Inc, New York City, New York, USA.

Laurence Pollissard (L)

Global Health Economics & Value Assessment, Sanofi France, Chilly-Mazarin, France.

Andreas Kuznik (A)

Health Economics and Outcomes Research, Regeneron Pharmaceuticals, Inc, New York City, New York, USA.

Hubert Van Hoogstraten (H)

Global Medical Affairs, I&I, Sanofi, Bridgewater, New Jersey, USA.

Erin Mangan (E)

Medical Affairs, Regeneron Pharmaceuticals, Inc, New York City, New York, USA.

Paulo Carita (P)

Global Health Economics & Value Assessment, Sanofi France, Chilly-Mazarin, France.

Thi-Minh-Thao Huynh (TM)

Real World Evidence & Clinical Outcome Generation, Sanofi France, Chilly-Mazarin, France.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH