Table 1.
Patient demographics and baseline disease characteristics (safety analysis set*)
| Tofacitinib 5 mg BID (N=136) | Placebo→tofacitinib 5 mg BID (N=68) | Total (N=204) | |
| Patient demographics | |||
| Age (years), mean (SD) | 45.3 (11.6) | 43.9 (10.4) | 44.8 (11.2) |
| Aged ≥65 years, n (%) | 9 (6.6) | 1 (1.5) | 10 (4.9) |
| Male, n (%) | 79 (58.1) | 42 (61.8) | 121 (59.3) |
| BMI (kg/m2), mean (SD) | 24.6 (3.3) | 24.9 (3.9) | 24.7 (3.5) |
| Baseline disease characteristics | |||
| Duration of PsA (years), mean (SD) | 5.0 (6.0) | 3.5 (4.4) | 4.5 (5.5) |
| Swollen joint count (66), mean (SD) | 9.4 (7.7) | 9.9 (7.8) | 9.6 (7.7) |
| Tender/painful joint count (68), mean (SD) | 16.1 (12.1) | 14.9 (10.4) | 15.7 (11.5) |
| HAQ-DI, mean (SD) | 0.6 (0.5) | 0.6 (0.6) | 0.6 (0.5) |
| PGA-PsO, mean (SD)† | 2.2 (0.8) | 2.1 (0.8) | 2.2 (0.8) |
| PASI, median (range)‡ | 8.6 (1.4 to 58.6) | 8.0 (2.6 to 42.0) | 8.3 (1.4 to 58.6) |
| NAPSI, mean (SD)§ | 3.9 (2.1) | 4.0 (2.3) | 4.0 (2.2) |
| DAS28-3(CRP), mean (SD) | 4.1 (1.1) | 4.2 (1.0) | 4.1 (1.1) |
| Presence of enthesitis (LEI >0), n (%) | 71 (52.2) | 28 (41.2) | 99 (48.5) |
| Presence of dactylitis (DSS >0), n (%) | 93 (68.4) | 41 (60.3) | 134 (65.7) |
| CRP (mg/L), median (range) | 4.9 (0.2 to 115.0) | 8.2 (0.3 to 73.9) | 5.3 (0.2 to 115.0) |
| CRP >2.87 mg/L, n (%) | 89 (65.4) | 45 (66.2) | 134 (65.7) |
| SF-36v2 PCS, mean (SD) | 38.4 (8.2) | 38.5 (8.5) | 38.4 (8.3) |
| SF-36v2 MCS, mean (SD) | 42.0 (11.3) | 45.2 (11.1) | 43.1 (11.3) |
| Prior bDMARD use, n (%)¶ | 24 (17.6) | 6 (8.8) | 30 (14.7) |
| Concomitant medication use up to month 6, n (%) | |||
| Corticosteroids | 6 (4.4) | 5 (7.4) | 11 (5.4) |
| NSAIDs | 49 (36.0) | 41 (60.3) | 90 (44.1) |
| csDMARDs | 136 (100) | 68 (100) | 204 (100) |
| Methotrexate | 126 (92.6) | 62 (91.2) | 188 (92.2) |
| Sulfasalazine | 10 (7.4) | 6 (8.8) | 16 (7.8) |
*All patients who received ≥1 dose of study medication.
†Among patients with baseline PGA-PsO score >0: N=133 in the tofacitinib 5 mg BID group; N=66 in the placebo→tofacitinib 5 mg BID group.
‡Among patients with baseline psoriatic BSA ≥3% and PASI >0: N=75 in the tofacitinib 5 mg BID group; N=27 in the placebo→tofacitinib 5 mg BID group.
§Among patients with baseline NAPSI >0: N=99 in the tofacitinib 5 mg BID group; N=54 in the placebo→tofacitinib 5 mg BID group.
¶bDMARDs may have been used for psoriasis or other medical purposes. bDMARDs are not approved for the treatment of PsA in mainland China.
bDMARD, biological disease-modifying antirheumatic drug; BID, twice daily; BMI, body mass index; BSA, body surface area; CRP, C-reactive protein; csDMARD, conventional synthetic disease-modifying antirheumatic drug; DAS28-3(CRP), Disease Activity Score in 28 joints with CRP; DSS, Dactylitis Severity Score; HAQ-DI, Health Assessment Questionnaire-Disability Index; LEI, Leeds Enthesitis Index; MCS, Mental Component Summary; N, number of evaluable patients; n, number of patients with the specified characteristic; NAPSI, Nail Psoriasis Severity Index; NSAID, non-steroidal anti-inflammatory drug; PASI, Psoriasis Area and Severity Index; PCS, Physical Component Summary; PGA-PsO, Physician’s Global Assessment of Psoriasis; PsA, psoriatic arthritis; SD, standard deviation; SF-36v2, Short Form-36 Health Survey, version 2 acute.