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. 2021 Nov 1;12:746396. doi: 10.3389/fphar.2021.746396

TABLE 1.

Demographic Details of Included Studies.

Studies with year Place Study design Sample size Anti-TNF agent Inflammatory condition Follow-up Mean age (yrs) Sample size in anti TNF-α v/s controlled or placebo Adverse events reported Sample size with adverse events Odds ratio (95% CI)
Anti TNF-α Without anti TNF-α Anti TNF-α Without anti TNF-α
Galloway et al. (2011) United Kingdom Prospective Observational Study 15,396 Adalimumab, etanercept, infliximab RA 6 months 58 years 11,798 3598 Serious Infection 1,512 296 1.64 (1.44–1.87)
Curtis et al. (2007) United States Retrospective Cohort Study 5,326 Adalimumab, etanercept, infliximab RA 17 months 52.5 ± 12.5 2,393 2,933 Serious bacterial Infection 65 58 1.38 (0.97–1.98)
Dixon et al. (2006) United Kingdom Prospective Observational Study 9,018 Adalimumab, etanercept, infliximab RA 6 months 58 years 7,664 1,354 Serious Infection 525 56 1.70 (1.29–2.26)
Carmona et al. (2007) Spain Registry For Active Long-Term Follow-Up 1,578 Infliximab, etanercept RA 2 years 60 789 789 Serious Infection 114 63 1.54 (1.15–2.07)
Malignancies 11 23 0.47 (0.23–0.97)
Bejarano et al. (2008) United Kingdom Multicenter, Randomized, Controlled Trial 148 Adalimumab RA 1 year 47 ± 9 75 73 Serious Infection 13 11 1.18 (0.49–2.84)
Breedveld et al. (2006) United States Multicenter, Randomized, Double-Blind Clinical Trial 799 Adalimumab RA 2 years 52 ± 14 274 257 Serious Infection 3 7 0.40 (0.10–1.55)
Malignancies 2 4 0.47 (0.08–2.56)
TB 1 0 2.82 (0.11–69.65)
Chen et al. (2009) Taiwan Randomized Double-Blind, Placebo-Controlled, Comparative Study 47 Adalimumab RA 12 weeks 53 35 12 Adverse events 28 11 0.36 (0.04–3.31)
Detert et al. (2013) Germany Comparative Study 172 Adalimumab RA 48 weeks 59.5 87 85 Serious Infection 3 4 0.72 (0.16–3.33)
Malignancies 0 3 0.13 (0.01–2.65)
Kavanaugh et al. (2013) United States Randomised, Controlled Study 1,032 Adalimumab RA 20 months 50.5 515 517 Serious Infection 13 6 2.21 (0.83–5.85)
Malignancies 1 0 3.02 (0.12–74.24)
TB 1 0 3.02 (0.12–74.24)
Huang et al. (2014) China Randomised, Controlled Trial 344 Adalimumab AS 12 weeks 29.8 229 115 Serious Infection 1 0 1.52 (0.06–37.52)
Miyasaka (2008) Japan MulticenterDouble-Blind Study 352 Adalimumab RA 24 weeks 54.4 265 87 Serious Infection 13 4 1.07 (0.34–3.37)
Malignancies 0 2 0.06 (0.00–1.35)
Takeuchi et al. (2014) Japan Randomised, Double-Blind, Placebo-Controlled, Multicentre Study 334 Adalimumab RA 70 days 54.0 ± 13.1 171 163 Serious Infection 2 1 1.92 (0.17–21.35)
Choy et al. (2012) United Kingdom Randomized, Double-Blind Study 247 Certolizumab pegol RA 24 weeks 54.4 126 121 Serious Infection 3 2 -1.45 (0.24–8.84)
Fleischmann et al. (2009) 2009 Randomised Double-Blind Study 220 Certolizumab pegol RA 24 weeks 53.8 111 109 Serious Infection 4 0 -9.17 (0.49–172.34)
Landewé et al. (2014) Netherlands A Double-Blind Randomised Placebo-Controlled phase 3 Study 325 Certolizumab pegol AS 24 weeks 39.4 218 107 Serious Infection 2 0 -2.48 (0.12–52.17)
Mease et al. (2014) United States Double-Blind Randomised Placebo-Controlled Study 409 Certolizumab pegol PsA 24 weeks 47.5 273 136 Serious Infection 4 1 2.01 (0.22–18.14)
Smolen et al. (2009) United States Multicentre, Randomised, Double-Blind, Placebo-Controlled, phase III Trial 461 Golimumab RA 24 weeks 54.5 306 155 Serious Infection 4 3 0.67 (0.15–3.04)
Malignancies 1 0 1.53 (0.06–37.70)
Weinblatt et al. (2003) United States Randomised Double-Blind Study 271 Adalimumab RA 24 weeks 55.5 209 62 Serious Infection 2 0 1.51 (0.07–31.78)
Malignancy 1 0 0.90 (0.04–22.35)
Galloway et al. (2013) United Kingdom Cohort Study 15,554 Etanercept, adalimumab, infliximab RA - 58 11,881 3673 Skin And Soft Tissue Infection 275 45 2.1428
Listing et al. (2005) Germany Case Control Study 1,529 Etanercept and infliximab RA 12 months 55 928 601 Serious infections 200 39 3.96 (2.76–5.68)
TB 1 0 1.95 (0.08–47.84)
Mercer et al. (2015) United Kingdom Prospective Cohort Study 15,016 Adalimumab, etanercept, infliximab RA 3 years 58 11,767 3249 Cancer 239 93 -0.70 (0.55–0.90)
Axelrad et al. (2016) United States Retrospective Cohort Study 255 - - - 33 106 149 Cancer 22 46 -0.59 (0.33–1.05)
Scott et al. (2014) United States Cohort Study 6,841 Adalimumab, etanercept, infliximab, golimumab, certolizumab pegol RA 12 months - 932 5,909 Cancer 367 1,465 -1.97 (1.71–2.28)