Table 2.
Baseline demographics and disease characteristics of patients with lymphoma events and age‐ and sex‐matched controls from the tofacitinib RA clinical development programa
| Lymphoma (n = 19) | Controls (n = 76) | |
|---|---|---|
| Median age, years (range) | 60 (42–76) | 60 (42–78) |
| Sex, % female | 78.9 | 78.9 |
| Race, % white | 78.9 | 72.4 |
| Average tofacitinib dose, mg/day | 16.2 ± 4.6 | 16.9 ± 3.9 |
| Tofacitinib treatment duration, years | 2.2 ± 1.7 | 2.6 ± 1.5 |
| Body mass index, kg/m2 | 28.2 ± 6.8 | 28.0 ± 5.5 |
| RA disease duration, years | 8.1 ± 6.5 | 8.3 ± 7.6 |
| HAQ DI score | ||
| At baseline | 1.2 ± 0.6 | 1.5 ± 0.7 |
| At time lymphoma was reported | 0.9 ± 0.6 | 0.8 ± 0.7 |
| Four‐variable DAS28‐ESR score | ||
| At baseline | 6.1 ± 1.3 | 6.3 ± 1.1 |
| At time lymphoma was reported | 3.6 ± 1.0 | 3.5 ± 1.1 |
| Concomitant methotrexate, % | 84.2 | 65.8 |
| Weekly dose, mg | 16.0 | 15.0 |
| Corticosteroid daily dose, mg | 7.3 | 5.1 |
| Anti‐CCP positivity, % | 52.6 | 44.7 |
| RF positivity, % | 87.5 | 73.1 |
| History of Sjögren's syndrome, %b | 15.8 | 6.6 |
| No. DMARDs used previously, % | ||
| 0 | 5.3 | 11.8 |
| 1 | 36.8 | 39.5 |
| 2 | 31.6 | 15.8 |
| >2 | 26.3 | 32.9 |
| Prior biologic DMARD use, % | 21.1 | 21.1 |
a
Values are the mean ± SD unless otherwise indicated. RA = rheumatoid arthritis; HAQ DI = Health Assessment Questionnaire disability index; DAS28‐ESR = Disease Activity Score in 28 joints using the erythrocyte sedimentation rate; CCP = cyclic citrullinated peptide; RF = rheumatoid factor; DMARDs = disease‐modifying antirheumatic drugs.
b
For patients with lymphoma, history of Sjögren's syndrome was specifically queried at the time of lymphoma event. Collection of Sjögren's syndrome history was not systematically performed for patients in the matched control group.