Table 1

Serious infections in patients on biologics (observational studies)

Study IDRegistryInterventionControlaHR (Intervention vs comparator/control)Risk of bias
Serious infections
 Galloway (2011) Rheumatology (a)11BSRBR3 TNFicsDMARDs1.2 (1.1, 1.5)Low
 Greenberg (2010) ARD12CORRONA3 TNFi+MTXMTX1.1 (1.0, 1.3)Low
 Grijalva (2011) JAMA13Claim database3 TNFicsDMARDs1.1 (0.9, 1.2)Moderate
 Grijalva (2010) Rheumatology14Claim database3 TNFiMTX1.3 (0.8, 2.2)Moderate
 Komano (2011) J Rheum15REALETA/IFXcsDMARDsRR 2.4 (1.1, 5.1)Moderate
 Sakai (2012) AC&R16REALETA/IFXcsDMARDsRR 2.0 (1.3, 3.2)Moderate
 Strangfeld (2011) ARD17RABBIT3 TNFicsDMARDs1.8 (1.2, 2.7)Low
 Lane (2011) Medicine (Baltimore)18Claim database3 TNFicsDMARDs1.2 (1.0, 1.5) vs HCQ, SSZ, goldModerate
 Galloway (2011) Rheumatology (b)19BSRBRAnakinracsDMARDs1.6 (0.9, 2.7)Low
Herpes zoster
 Galloway (2013) ARD20BSRBR3 TNFicsDMARDs1.7 (1.1, 2.7); adjusted for drop-outs 1.5 (1.0, 2.4)Low
 McDonald (2009) Clin Inf Diseases21Claim Database3 TNFicsDMARDs1.4 (1.1, 1.8)Moderate
 Strangfeld (2009) JAMA22RABBIT3 TNFicsDMARDs1.6 (1.0, 2.7)Low
 Garcia-Doval (2010) ARD23BIOBADASERTNFi (3?)General population10 (3, 26)Low
 Winthrop (2013) JAMA24Claim Dabatase3 TNFicsDMARDs1.0 (0.8, 1.3)Moderate
 Dixon (2010) ARD (a)25BSRBR3 TNFicsDMARDsNALow
 Tam (2010) Clin Exp Rheumatol26Hong Kong Cohort3 TNFiGeneral population
34.9 (8.9, 137.2)
12.5 (3.5, 44.7)
 Tubach (2009) A&R27RATIO3 TNFiGeneral population12.4 (9.1, 16.9)Low
 Winthrop ARD28Claim database3 TNFiGeneral populationNAModerate
  • More details are found in online supplementary tables S1–S20.

  • aHR, adjusted HR; BIOBADASER, Spanish Biologics Register; BSRBR, British Society of Rheumatology Biologics Register; CORRONA, Consortium of Rheumatology Researchers of North America; csDMARDs, conventional synthetic disease-modifying antirheumatic drugs; ETA, etanercept; HCQ, hydroxychloroquine; IFX, infliximab; MTX, methotrexate; NA, not available (not mentioned in the original article); RABBIT, Rheumatoid Arthritis Observation of Biologic Therapy (RABBIT (in German)); RATIO, French Biologics Register; REAL, Registry of Japanese Rheumatoid Arthritis Patients for Longterm Safety; SSZ, sulfasalazine; TNFi, tumour necrosis factor α inhibitor.