Safety of synthetic and biological DMARDs: a systematic literature review informing the 2016 update of the EULAR recommendations for management of rheumatoid arthritis

被引：263

作者：

Ramiro, Sofia ^{[1
]}

Sepriano, Alexandre ^{[2
]}

Chatzidionysiou, Katerina ^{[3
]}

Nam, Jackie L. ^{[4
,5
,6
]}

Smolen, Josef S. ^{[7
]}

van der Heijde, Desiree

Dougados, Maxime ^{[8
]}

van Vollenhoven, Ronald ^{[9
]}

Bijlsma, Johannes W. ^{[10
]}

Burmester, Gerd R. ^{[11
]}

Scholte-Voshaar, Marieke ^{[12
,13
]}

Falzon, Louise ^{[14
]}

Landewe, Robert B. M. ^{[15
]}

机构：

[1] Leiden Univ, Med Ctr, Dept Rheumatol, Albinusdreef 2,POB 9600, NL-2300 RC Leiden, Netherlands

[2] Univ Nova Lisboa, Nova Med Sch, CEDOC, Lisbon, Portugal

[3] Karolinska Inst, Unit Clin Therapy Res, Inflammatory Dis ClinTRID, Stockholm, Sweden

[4] Univ Leeds, Leeds Inst Rheumat & Musculoskeletal Med, Chapel Allerton Hosp Leeds, Leeds, W Yorkshire, England

[5] Leeds Teaching Hosp NHS Trust, NIHR Leeds Musculoskeletal Biomed Res Unit, Leeds, W Yorkshire, England

[6] Med Univ Vienna, Div Rheumatol, Dept Med, Vienna, Austria

[7] Hietzing Hosp, Dept Med, Vienna, Austria

[8] Paris Descartes Univ, Cochin Hosp, Dept Rheumatol, INSERM U1153 Clin Epidemiol & Biostat, Paris, France

[9] Amsterdam Rheumatol Ctr, Dept Clin Immunol Rheumatol, Amsterdam, Netherlands

[10] Univ Med Ctr Utrecht, Dept Rheumatol, Utrecht, Netherlands

[11] Charite, Dept Rheumatol & Clin Immunol, Berlin, Germany

[12] Univ Twente, Dept Psychol Hlth & Technol, Enschede, Netherlands

[13] EULAR Standing Comm People Arthritis Rheumatism, Rheumatism, Egypt

[14] Columbia Univ, Ctr Behav Cardiovasc Hlth, New York, NY USA

[15] Zuyderland Med Ctr, Dept Rheumatol, Heerlen, Netherlands

来源：

ANNALS OF THE RHEUMATIC DISEASES | 2017年 / 76卷 / 06期

关键词：

ANTITUMOR NECROSIS FACTOR; ANTI-TNF THERAPY; SOFT-TISSUE INFECTIONS; LONG-TERM SAFETY; BRITISH SOCIETY; SERIOUS INFECTIONS; FACTOR INHIBITORS; CANCER-RISK; OPPORTUNISTIC INFECTIONS; CARDIOVASCULAR EVENTS;

D O I：

10.1136/annrheumdis-2016-210708

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Objectives To assess the safety of synthetic (s) and biological (b) disease-modifying antirheumatic drugs (DMARDs) for the management of rheumatoid arthritis (RA) to inform the European League Against Rheumatism recommendations for the management of RA. Methods Systematic literature review (SLR) of observational studies comparing any DMARD with another intervention for the management of patients with RA. All safety outcomes were included. A comparator group was required for the study to be included. Risk of bias was assessed with the Hayden's tool. Results Twenty-six observational studies addressing diverse safety outcomes of therapy with bDMARDs met eligibility criteria (15 on serious infections, 4 on malignancies). Substantial heterogeneity precluded meta-analysis. Together with the evidence from the 2013 SLR, based on 15 studies, 7 at low risk of bias, patients on bDMARDs compared with patients on conventional sDMARDs had a higher risk of serious infections (adjusted HR (aHR) 1.1 to 1.8)-without differences across bDMARDs-a higher risk of tuberculosis (aHR 2.7 to 12.5), but no increased risk of infection by herpes zoster. Patients on bDMARDs did not have an increased risk of malignancies in general, lymphoma or non-melanoma skin cancer, but the risk of melanoma may be slightly increased (aHR 1.5). Conclusions These findings confirm the known safety pattern of bDMARDs, including both tumour necrosis factor-a inhibitor (TNFi) and non-TNFi, for the treatment of RA.

引用

页码：1093 / 1101

页数：9

共 72 条

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