Table 3. Incidence rates (IRs) and hazard ratios (HRs) of tuberculosis (TB) disease by biologic exposure with csDMARDs-exposed patients as reference group, and by isoniazid prophylaxis therapy (INHP) with the absence of INHP as reference group.
| TB cases/py | Crude IR per100000 py | Crude HR(95%CI) | Adjusted HR (95% CI) | |
|---|---|---|---|---|
| csDMARDs-exposed | 913/231,759 | 394 | 1.00 (reference) | 1.00 (reference) |
| INHP (-)(n = 36,148)# | 913/231,697 | 394 | 1.00 (reference) | 1.00 (reference) |
| INHP (+) (n = 14) | 0/62 | 0 | NA | NA |
| Adalimumab-exposed | 67/11,171 | 600 | 1.52(1.19–1.95)** | 1.52(1.18–1.96)* |
| INHP (-) (n = 1,615)# | 66/10,713 | 616 | 1.00 (reference) | 1.00 (reference) |
| INHP (+) (n = 63) | 1/459 | 218 | 0.35(0.05–2.50) | 0.45(0.06–3.24) |
| Etanercept-exposed | 121/27,367 | 442 | 1.14(0.94–1.37) | 1.16(0.95–1.41) |
| INHP (-) (n = 3,508)# | 121/26,880 | 450 | 1.00 (reference) | 1.00 (reference) |
| INHP (+) (n = 69) | 0/487 | 0 | NA | NA |
| Rituximab-exposed | 2/6,179 | 32 | 0.08(0.02–0.34)** | 0.08(0.02–0.31)** |
| INHP (-) (n = 755)# | 2/6,119 | 33 | 1.00 (reference) | 1.00 (reference) |
| INHP (+) (n = 8) | 0/60 | 0 | NA | NA |
# Not indicative of total number of patients without latent tuberculosis infection
csDMARDs: conventional synthetic disease-modifying anti-rheumatic drugs; py: person-years; IR: incidence rate; HR: hazard ratio; 95% CI: 95% confidence interval; NA: not applicable; INHP(+): with isoniazid prophylaxis; INHP(+): without isoniazid prophylaxis. Adjusted HR estimated from multivariate Cox proportional hazard models comparing each biologic to csDMARDspropensity score adjusted for age, sex, the use of corticosteroids (daily dose≧5mg), and Charlson comorbidity index.
* p<0.005,
** p<0.001, versus tsDMARDs-exposed patients