Table 3.
Main baseline characteristics of patients who developed severe infections in comparison with those who did not
| Severe infection n = 37 |
No severe infection n = 307 |
Bilateral P value | |
|---|---|---|---|
| Females | 32 (86%) | 238 (77%) | 0.289 |
| Mean age (years) | 49.14 ± 2.77 | 41.97 ± 0.86 | 0.008* |
| Autoimmune diseases | |||
| - Systemic lupus erythematosus | 11 (30%) | 129 (42%) | |
| - Systemic vasculitis | 8 (22%) | 42 (14%) | |
| - Inflammatory myopathies | 6 (16%) | 32 (16%) | 0.459 |
| - Behçet disease | 2 (5%) | 29 (9%) | |
| - Primary Sjögren's syndrome | 2 (5%) | 21 (7%) | |
| - Other diseases | 8 (22%) | 54 (18%) | |
| Previous therapies (ever exposed) | |||
| - Oral corticosteroids | 35 (95%) | 297 (97%) | 0.377 |
| - Methylprednisolone pulses | 4 (11%) | 82 (27%) | 0.043 |
| - Cyclophosphamide | 23 (62%) | 149 (48%) | 0.163 |
| - Mycophenolate | 12 (32%) | 86 (28%) | 0.567 |
| - Azathioprine | 6 (16%) | 91 (30%) | 0.120 |
| - Methotrexate | 12 (32%) | 97 (32%) | 1.000 |
| - Intravenous immunoglobulins | 6 (16%) | 83 (27%) | 0.171 |
| Cumulated dose/length of previous therapies | |||
| - Mean length of prednisone therapy (years) | 9.50 ± 2.89 | 7.93 ± 0.67 | 0.540 |
| - Cumulated dose of cyclophosphamide (gr) | 9.00 | 7.00 ± 1.20 | 0.629 |
| - Mean length of mycophenolate (years) | 0.96 ± 0.79 | 2.39 ± 0.44 | 0.236 |
| - Mean length of azathioprine (years) | 0.38 ± 0.28 | 1.56 ± 0.39 | 0.324 |
| - Number of previous immunosuppressants | |||
| > = 3 | 5 (13%) | 68 (22%) | 0.289 |
| > = 4 | 2 (5%) | 23 (7%) | 1.000 |
| Biological agent | |||
| - Rituximab | 29 (78%) | 235 (76%) | |
| - Infliximab | 4 (11%) | 33 (11%) | |
| - Etanercept | 2 (5%) | 19 (6%) | 0.982 |
| - Adalimumab | 2 (5%) | 17 (5%) | |
| - Other | 0 (0%) | 3 (1%) | |
| Therapies administered concomitantly | |||
| - Corticosteroids | 35 (95%) | 277 (90%) | 0.554 |
| - Cyclophosphamide | 8 (22%) | 95 (31%) | 0.342 |
| - Mycophenolate | 5 (13%) | 17 (5%) | 0.073 |
| - Azathioprine | 0 (0%) | 16 (5%) | 0.235 |
| - Methotrexate | 5 (13%) | 36 (12%) | 0.788 |
| - Cyclosporin A/Tacrolimus | 5 (13%) | 14 (5%) | 0.041 |
| - Intravenous immunoglobulins | 2 (5%) | 12 (4%) | 0.653 |
| Time of exposure to biological (person-years) | |||
| - Total time | 17.59 ± 2.16 | 17.23 ± 0.75 | 0.873 |
| - Exposure to rituximab | 15.13 ± 1.63 | 14.07 ± 0.47 | 0.471 |
| - Exposure to infliximab | 26.25 ± 15.4 | 15.27 ± 1.74 | 0.124 |
| - Exposure to etanercept | 12.50 ± 8.50 | 29.35 ± 3.84 | 0.246 |
| - Exposure to adalimumab | 26.00 ± 9.00 | 13.95 ± 2.52 | 0.183 |
*Statistically significant in the Cox regression multivariate model (hazard ratio 1.026, 95% confidence interval 1.005 to 1.047, P = 0.014).