Table 3 |
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|
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). |
|||
|
Díaz-Lagares et al. Arthritis Research & Therapy 2011 13:R112 doi:10.1186/ar3397 |
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