Etanercept and tuberculosis (TB) risk: Reported cases of TB from postmarketing surveillance and national registries.
| Source/Year [Reference] | No. TB Cases/No. Patients | TB IR ETN/Country, No. Cases/100,000 Population/year | RR | Defective LTBI Screening/TB Prophylaxis, % | Host-related TB Risk Factors (%) |
|---|---|---|---|---|---|
| BIOBADASER, Spain 2003 [40] | 0/216 | 0 | NA | Pre-LTBI scr* | NA |
| ARTIS, Sweden, 2005 [41] | 6/NA | 80/NA | NA | Pre-LTBI scr* | NA |
| RABBIT, Germany, 2005 [42] | 0/512 | 0/8 | 0 | NA | NA |
| Pharmetrics, Canada, 2006 [43] | 32/2349 | NA | NA | Pre-LTBI scr* | NA |
| BIOBADASER, Spain, 2007 [44] | 2/1336 | 114/25 | 4.6 | 49% | NA |
| Japan 2009 [126] | 8/7091 | 112/25 | 4.5 | 0% | NA |
| LOHREN, Italy 2009 [46] | 1/242 | 233/8 | 29.1 | Pre-LTBI scr*, 15.3% | NA |
| RATIO, France, 2010 [47] | 5/NA | 9.3/8.7 | 1.1 | 80% | 66% |
| BSRBR, UK, 2010 [48] | 8/5521 | 53/14 | 3.8 | 5% | 70% |
| South Korea, 2011 [49] | 0/210 | 0/69.8 | 0 | 50% | NA |
| GISEA, Italy, 2012 [50] | 1/1130 | 88/8 | 11 | NA | NA |
| Northern California, USA, 2013 [51] | 8/2778 | 83/5 | 16.6 | NA | NA |
↵* Pre-LTBI screening included patients treated before 2001 recommendation for latent TB infection detection. NA: not available; LTBI: latent tuberculosis infection; RR: relative risk; IR ETN: incidence ratio in etanercept-treated patients.