Study | Observation period | Dataset | tDMARD | Patients | Control | TB IR in the general population | Crude IR (95% CI) | Adj IR (95% CI) |
Gomez-Reino1 | 1999–2002 | BIOBADASER | IFX | RA, AS, PsA | General population | 21 | 2000: 1893 (NR) 2001: 1113 (NR) | 2000: 90.1 (58.8 to 146.0) 2001: 53.0 (34.5 to 89.0) |
Carmona3 | 2000–2004 | BIOBADASER | IFX, (ADA, ETA) | RA, AS, PsA, JIA, other | General population | Prescreening: 522 (369–738) Postscreening: 117 (29–470) | Prescreening: 20.9 (12.0 to 36.8) Postscreening: 4.7 (0.5 to 18.9) | |
Dixon4 | <April 2008 | BSRBR | ETA, ADA, IFX | RA | csDMARDs | (14) | TNFi 118 (84–160)* ETA 53 (23–105) ADA 217 (132–335) IFX 123 (64–215) | NR |
Tam5 | 2004–2008 | Hong Kong cohort | ETA, ADA, IFX | RA | General population csDMARDs | 60–84.5 | TNFi 2162 (NR) | 34.9 (8.9 to 137) 12.5 (3.5 to 44.7) |
Tubach6 | 2004–2007 | RATIO, France | ETA, ADA, IFX | RA (58%), AS, PsA, PsO, IBD, Behçet disease | General population | 8.7 | TNFi 117 (11–223) ETA 9.3 (0.0 to 9.4) ADA 215.0 (0.0 to 521.7) IFX 187.5 (0.1 to 375) | 12.2 (9.7 to 16) 1.8 (0.7 to 4.3) 29.3 (20 to 42) 18.6 (13.4 to 26) |
Winthorp7 | 2000–2008 | Kaiser Permanente Northern California (KPNC) insurance dataset | ETA, ADA, IFX | RA | KPNC general population | 2.8 | TNFi 56 (24–111) | NR |
Baddley8 | 1998–2007 | Four US insurance datasets—SABER study | ETA, ADA, IFX, new users | RA, PsO, PsA, AS, IBD | csDMARDs | TNFi 40 (20–70) | 4.2 (0.5 to 33.5) | |
Arkema9 | 2002–2011 | Pooled Swedish registries | ETA, ADA, IFX, GOL, CZP, ANA, ABA, TCZ, RTX | RA | csDMARDs | 6.8 | All tDMARD: 39.4 (23.7 to 61.5) 2002 to 06: 89.9 (NR) 2007 to 11: 24.2 (NR) By tDMARD: ETA 15.7 (3.2 to 46)* ADA 52.4 (19.2 to 114.1) IFX 67.2 (29 to 132.4) GOL 0 (0 to 1074) CZP 0 (0 to 1218) RTX 29 (0.7 to 161.7) | 4.4 (2.3 to 8.5) 7.9 (3.3 to 18.9) 2.4 (0.9 to 6.1) NR |
de Vries10 | 2002–2013 | Pooled Swedish registries | TNFi pooled | PsA, SpA, AS pooled | tDMARD naïve | 6.8 | TNFi: 22 (8.3 to 59) | 7.5 (1.9 to 29) |
Yonekura11 | 2009–2013 | BiobadaBrasil | ETA, ADA, IFX | RA | csDMARDs | 37.2 | TNFi 286 (NR) ETA 192 ADA 443 IFX 182 | NR |
Wang12 | 2006–2016 | Hong Kong Hospital Authority database | ETA, ADA, IFX | RA, AS, PsA pooled | General population | 60–84.5 | TNFi: 784 (NR) | 11 (7.8 to 14.1) |
Kay13 | RCTs+OLEs | GOL | RA, AS, PsA pooled | Placebo | Endemic and non-endemic TB populations | GOL 230 (140–350) | NR | |
Bykerk14 | RCTs+OLEs | CZP | RA | Placebo | Endemic and non-endemic TB populations | CZP 470 (340–640) | NR |
*Most recent TNFis, switchers included. % calculated from the provided data for KPNC population.
ADA, adalimumab; AS, ankylosing spondylitis ; csDMARD, conventional synthetic disease-modifying antirheumatic drug; CZP, certolizmab; ETA, etanercept; GOL, golimumab; IFX, infliximab; IR, incidence rate per 100 000 person-years; NR, not reported; OLE, open label extension of the RCT; PsA, psoriatic arthriti; RA, rheumatoid arthritis; RCT, randomised controlled trial; TB, tuberculosis ; tDMARD, targeted disease-modifying antirheumatic drug ; TNFi, tumour necrosis factor inhibitor.