Univariate and multivariate analysis of risk factors of serious infections that occurred during treatment with ABA or within 3 months of its discontinuation
| Patients with severe infection (n=69) | Patients without severe infection (n=907) | HR univariate analysis (95% CI) | p Value, univariate analysis | HR multivariate analysis (95% CI) | p Values, multivariate analysis | |
|---|---|---|---|---|---|---|
| Age, mean±SD years* | 64.6±12.1 | 57.5±13.6 | 1.48 (1.22 to 1.79) | <0.001 | 1.44 (1.17 to 1.76) | 0.001 |
| Female | 53 (76.8) | 718 (79.2) | 1.15 (0.66 to 2.02) | 0.616 | ||
| Disease duration, mean±SD months | 18.7±10.3 | 17.4±9.5 | 1.01 (0.99 to 1.04) | 0.358 | ||
| RA-related extra-articular involvement | 8 (11.8) | 90 (10.1) | 1.19 (0.57 to 2.48) | 0.648 | ||
| Ever smoking | 4 (5.9) | 94 (10.5) | 0.54 (0.20 to 1.48) | 0.231 | ||
| Record of cancer | 5 (7.4) | 48 (5.3) | 1.53 (0.62 to 3.81) | 0.359 | ||
| Cardiac insufficiency | 2 (2.9) | 11 (1.2) | 2.69 (0.66 to 10.98) | 0.169 | ||
| Diabetes | 13 (20.6) | 93 (10.9) | 2.08 (1.13 to 3.83) | 0.019 | 1.67 (0.90 to 3.09) | 0.105 |
| Previous serious or recurrent infection | 37 (53.6) | 298 (33.4) | 2.30 (1.43 to 3.70) | 0.001 | 1.94 (1.18 to 3.20) | 0.009 |
| Previous DMARDs, mean±SD | 3±1.6 | 2.8±1.5 | 1.07 (0.91 to 1.26) | 0.404 | ||
| Previous anti-TNF | 0.55 (0.30 to 0.98) | 0.044 | ||||
| 0 anti-TNF | 14 (20.3) | 112 (12.4) | ||||
| 1 anti-TNF | 20 (29) | 212 (23.4) | ||||
| 2 anti-TNF | 16 (23.2) | 340 (37.5) | ||||
| 3 anti-TNF | 19 (27.5) | 242 (26.7) | ||||
| Previous rituximab | 14 (20.3) | 276 (30.5) | 0.62 (0.34 to 1.11) | 0.110 | ||
| RF positive | 52 (82.5) | 570 (72.2) | 1.78 (0.93 to 3.42) | 0.081 | ||
| Anti-CCP positive | 46 (80.7) | 508 (70.2) | 1.79 (0.92 to 3.45) | 0.084 | ||
| Initial DAS28-ESR, mean±SD | 5.5±1.4 | 5.3±1.3 | 1.11 (0.91 to 1.37) | 0.304 | ||
| IgG <6 g/L | 2 (7.1) | 19 (6.2) | 1.28 (0.30 to 5.4) | 0.737 | ||
| Hypogammaglobulinemia <6/L | 3 (7.1) | 28 (6.2) | 1.29 (0.40 to 4.18) | 0.671 | ||
| Concomitant DMARDs† | 41 (59) | 589 (65) | 0.88 (0.53 to 1.45) | 0.608 | ||
| Methotrexate alone | 30 (73.2) | 447 (75.9) | ||||
| Leflunomide alone | 10 (24.4) | 81 (13.8) | ||||
| Other/combinations | 1 (2.4) | 61 (10,3) | ||||
| Concomitant corticosteroids† Dosage in patients treated with corticosteroids, mean±SD (mg/day) | 54 (83.1) 9.5±7.9 | 678 (75.8) 8.6±9.0 | 1.57 (0.82 to 3.00) 1.01 (0.99 to 1.03) | 0.175 0.406 |
Except where indicated otherwise, values are number of patients (%).
*HR is given for an increase of 10 years.
†Defined as the dose on the day of ABA first infusion.
ABA, abatacept; CCP, cyclic citrullinated peptide; DAS28, disease activity score in 28 joints; DMARDs, disease-modifying antirheumatic drugs; ESR, erythrocyte sedimentation rate; RA, rheumatoid arthritis; RF, rheumatoid factor.