RT Journal Article
SR Electronic
T1 Safety of synthetic and biological DMARDs: a systematic literature review informing the 2016 update of the EULAR recommendations for management of rheumatoid arthritis
JF Annals of the Rheumatic Diseases
JO Ann Rheum Dis
FD BMJ Publishing Group Ltd and European League Against Rheumatism
SP 1101
OP 1136
DO 10.1136/annrheumdis-2016-210708
VO 76
IS 6
A1 Sofia Ramiro
A1 Alexandre Sepriano
A1 Katerina Chatzidionysiou
A1 Jackie L Nam
A1 Josef S Smolen
A1 Désirée van der Heijde
A1 Maxime Dougados
A1 Ronald van Vollenhoven
A1 Johannes W Bijlsma
A1 Gerd R Burmester
A1 Marieke Scholte-Voshaar
A1 Louise Falzon
A1 Robert B M Landewé
YR 2017
UL http://ard.bmj.com/content/76/6/1101.abstract
AB 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-α inhibitor (TNFi) and non-TNFi, for the treatment of RA.