Journal
ANNALS OF THE RHEUMATIC DISEASES
Volume 73, Issue 3, Pages 529-535Publisher
BMJ PUBLISHING GROUP
DOI: 10.1136/annrheumdis-2013-204575
Keywords
Rheumatoid arthritis; DMARDs (biologic); DMARDs (synthetic); anti-TNF; outcomes research
Categories
Funding
- Fundacao para a Ciencia e Tecnologia
- Abbvie
- BMS
- MSD
- Pfizer
- Roche-Chugai
- UCB
- Expanscience
- Nordic Pharma
- Abbott/Abbvie
- Amgen
- Astra-Zeneka
- Celgene
- Glaxo
- Infinity
- Janssen
- Lilly
- Medimmune
- Menarini
- Novo-Nordisk
- Roche
- Samsung
- Sandoz
- Sanofi-Aventis
- Vertex
- Abbott
- Bristol Myers-Squibb
- Chugai
- Centocor
- AstraZeneca
- Daiichi
- Eli-Lilly
- GSK
- Janssen Biologics
- Merck
- Novartis
- Otsuka
- Genentech
- Ablynx
- Astra-Zeneca
- Glaxo-Smith-Kline
- Schering-Plough
- Wyeth
- Imaging Rheumatology bv
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Objectives To update the evidence for the safety of synthetic disease-modifying antirheumatic drugs (sDMARDs), glucocorticoids (GC) and biological DMARDs (bDMARDs) in patients with rheumatoid arthritis (RA) to inform the European League Against Rheumatism (EULAR) recommendations for the management of RA. Methods Systematic literature review (SLR) of observational studies (including registries). Interventions were any bDMARD (anakinra, infliximab, etanercept, adalimumab, rituximab, abatacept, tocilizumab, golimumab or certolizumab pegol) or sDMARD (methotrexate, leflunomide, hydroxychloroquine, sulfasalazine, gold/auranofin, azathioprine, chlorambucil, chloroquine, cyclosporin, cyclophosphamide, mycophenolate, minocycline, penicillamine, tacrolimus or tofacitinib) and a comparator was required. Information on GCs was collected from the included studies. All safety outcomes were included. Results Forty-nine observational studies addressing diverse safety outcomes of therapy with bDMARDs met eligibility criteria. Substantial heterogeneity precluded meta-analysis of any of the outcomes. Patients on tumour necrosis factor inhibitors (TNFi) compared to patients on conventional sDMARDs had a higher risk of serious infections (adjusted HR (aHR) 1.1-1.8), a higher risk of tuberculosis, and an increased risk of infection by herpes zoster cannot be excluded. Patients on TNFi did not have an increased risk for malignancies in general, lymphoma or non-melanoma skin cancer, but the risk of melanoma may be slightly increased (aHR 1.5). From the studies identified on conventional sDMARDs, no new safety signals were found. Conclusions The findings from this SLR confirm the known safety pattern of sDMARDs and bDMARDs for the treatment of RA.
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