Table 1.
Univariate and multivariate analyses of the baseline factors assessed for associations with HZ among tofacitinib-treated patients in the phase II, phase III, and long-term extension studies*
| HZ cases (n = 239) | Non-HZ cases (n = 4,550) | Univariate OR (95% CI) | Multivariate OR (95% CI) | |
|---|---|---|---|---|
| Age, median (range) years | 57 (21–75) | 54 (18–86) | 1.7 (1.3–2.3)† | 1.9 (1.5–2.6) |
| Female, no. (%) | 208 (87) | 3,795 (84) | 1.3 (0.9–1.9) | – |
| Race, no. (%) | ||||
| White | 114 (48) | 2,756 (61) | – | – |
| Black | 3 (1) | 136 (3) | – | – |
| Asian | 107 (45) | 1,217 (27) | 2.2 (1.7–2.9) | 2.4 (1.9–3.2) |
| Duration of RA, mean years | 9.9 | 8.9 | 1.2 (1.0–1.6)† | – |
| Diabetes mellitus, no. (%) | 21 (9) | 351 (8) | 1.1 (0.7–1.8) | – |
| COPD, no. (%) | 18 (7.5) | 341 (7.5) | 1.0 (0.6–1.6) | – |
| Smoking, no. (%) | 77 (32) | 1,530 (34) | 0.7 (0.5–1.1) | – |
| BMI, mean kg/m2 | 25.8 | 26.8 | 0.7 (0.5–1.0)† | – |
| Absolute lymphocyte count, mean | 1.5 | 1.7 | 1.3 (1.0–1.7)† | – |
| Severity of RA, mean DAS28-ESR | 5.2 | 5.3 | 0.8 (0.6–1.1)† | – |
| Concomitant DMARDs, no. (%) | ||||
| Methotrexate | 144 (60) | 2,900 (64) | 0.9 (0.7–1.1) | – |
| Leflunomide | 7 (3) | 202 (4.5) | 0.6 (0.3–1.4) | – |
| Hydroxychloroquine | 19 (8) | 309 (7) | 1.2 (0.7–1.9) | – |
| Baseline corticosteroids‡ | 140 (59) | 2,419 (53) | 1.2 (1.0–1.6) | – |
95% CI = 95% confidence interval; RA = rheumatoid arthritis; COPD = chronic obstructive pulmonary disease; BMI = body mass index; DAS28-ESR = Disease Activity Score in 28 joints (4-variable) using the erythrocyte sedimentation rate; DMARDs = disease-modifying antirheumatic drugs.
Odds ratios (ORs) calculated for continuous variables were the factor by which the odds of herpes zoster (HZ) being present increased in response to an increase of 2 standard deviations in a given variable.
Per protocol, patients were allowed to take corticosteroids with a prednisone or equivalent dosage of ≤10 mg daily.