Table 5.
Cases of tuberculosis (TB) in patients receiving IL-6 Inhibitors, abatacept, rituximab.
| IL-6 Inhibitors, abatacept, rituximab | ||||||||
|---|---|---|---|---|---|---|---|---|
| Drug | Disease | Study type | No~ | Pt-yrs | Active TB cases | Rate§ | Rate general population* | Reference |
| Tocilizumab | RA | RCT, LTE | 15,485 | NA | 0 | 0 | International | Cantini et al.106 |
| Tocilizumab | JIA | RCT | 205 | NA | 0 | 0 | International | Cantini et al.107 |
| Tocilizumab | RA | RCT | 3354 | NA | 0 | 0 | International | Souto et al.27 |
| Tocilizumab | RA | LTE | NA | 12,905.2 | 9 | 75.6 | International | Souto et al.27 |
| Tocilizumab | RA | RLS | 302 | NA | 0 | 0 | 14 (Japan) | Sakai et al.113 |
| Tocilizumab | JIA | RLS | 4 | 6.4 | 0 | 0 | 4.7 (Finland) | Tarkiainen et al.111 |
| Tocilizumab | Various ARD | RLS | 16 | NA | 0 | 0 | 199 (India) | Shobha et al.112 |
| Tocilizumab | RA, JIA | RLS | 17 | NA | 0 | 0 | 50 (UK-endemic region) | Nisar et al.110 |
| Tocilizumab | RA | RLS | 31 | 55.49 | 0 | 0 | 43 (Taiwan) | Lim et al.114 |
| Tocilizumab | RA | RLS | 114 | 141.38 | 0 | 0 | 43 (Taiwan) | Lin et al.115 |
| Tocilizumab, Abatacept, Rituximab | RA | RLS | 195 | NA | 0 | 0 | 45 (Brazil) | Yonekura et al.116 |
| Tocilizumab | RA | RLS | 2171 | 3861 | 1 | 26 | 8 (UK) | Rutherford et al.31 |
| Tocilizumab | RA | RLS | 68 | NA | 3 | NA | 92 (Malaysia) | Tan et al.118 |
| Tocilizumab | RA | RLS | 3881 | 1793.5 | 4 | 223 | 14 (Japan) | Koike et al.119 |
| Sarilumab | RA | RCT | 1348 | NA | 0 | 0 | International | Lee et al.120 |
| Sarilumab | AS | RCT | 251 | NA | 0 | 0 | International | Sieper et al.121 |
| Clazakizumab | RA | RCT | 298 | NA | 2 | NA | International | Weinblatt et al.122 |
| Clazakizumab | PsA | RCT | 124 | NA | 0 | 0 | International | Mease et al.123 |
| Sirukumab | RA | RCT | 2193 | NA | 1 | NA | International | Aletaha et al.124; Takeuchi et al.125,126; Taylor et al.127 |
| Abatacept | RA | RCT, LTE | 8539 | NA | 1 | NA | International | Cantini et al.106 |
| Abatacept | RA | RCT | 433 | 433 | 1 | 230 | International | Souto et al.27 |
| Abatacept | JIA, PsA, SLE | RCT | 535 | NA | 0 | 0 | International | Cantini et al.107 |
| Abatacept | RA | RCT, LTE | 4149 | 12,132 | 8 | 70 | International | Weinblatt et al.128 |
| Abatacept | RA, JIA, PsA | RLS | 1292 | NA | 0 | 0 | International | Nisar et al.110; Tarkiainen et al.111; Shobha et al.112; Lim et al.114; Takahashi et al129; Salmon et al.130 |
| Rituximab | Various ARD | RCT | 5233 | NA | 0 | 0 | International | Cantini et al.107 |
| Rituximab | RA | RCT, LTE | 3194 | 11,962 | 2 | 18 | International | Souto et al.27 |
| Rituximab | RA | RLS | 5072 | 17,154 | 2 | 12 | 8 (UK) | Rutherford et al.31 |
| Rituximab | RA | RLS | 39 | NA | 2 | NA | 92 (Malaysia) | Tan et al.118 |
| Rituximab | Various ARD | RLS | 33 | NA | 0 | 0 | 50 (UK-endemic region) | Nisar et al.110 |
| Rituximab | Various ARD | RLS | 42 | NA | 0 | 0 | 199 (India) | Shobha et al.112 |
| Rituximab | JIA | RLS | 9 | 8 | 0 | 0 | 4,7 (Finland) | Tarkiainen et al.111 |
| Rituximab | RA | RLS | 1303 | 1629 | 0 | 0 | 9.2 (France) | Gottenberg et al.131 |
| Rituximab | Various ARD | RLS | 370 | 299 | 0 | 0 | 7.3 (Germany) | Tony et al.132 |
| Rituximab | RA | RLS | 32 | NA | 0 | 0 | 7.3 (Germany) | Xanthouli et al.133 |
| Rituximab | RA | RLS | 2484 | NA | 1 | NA | 7.3 (Germany) | Wendler et al.134 |
| Rituximab | RA | RLS | 763 | 6179 | 2 | 32 | 43 (Taiwan) | Liao et al.135 |
~
Number of patients included in the study.
§
per 100,000 patient-years.
*
IR for TB infection in general population of certain country per 100,000 population.
ARD, autoimmune rheumatic diseases; AS, ankylosing spondylitis; JIA, juvenile idiopathic arthritis; LTE, long-term extension; NA, not applicable; PsA, psoriatic arthritis; Pt-yrs, patient-years; RA, rheumatoid arthritis; RCT, randomized control trial; RLS, real-life study; SLE, systematic lupus erythematosus; TCZ, tocilizumab.