Table 1.
Demographics and baseline disease characteristics by treatment group and baseline MetS status; pooled data from OPAL Broaden and OPAL Beyond
|
Tofacitinib 5 mg BID a (N = 238) |
Tofacitinib 10 mg BID a (N = 236) |
Placebo a (N = 236) |
||||
|---|---|---|---|---|---|---|
|
With baseline MetS (N = 99) |
Without baseline MetS (N = 139) |
With baseline MetS (N = 101) |
Without baseline MetS (N = 135) |
With baseline MetS (N = 94) |
Without baseline MetS (N = 142) |
|
| OPAL Broaden b , N | 38 | 69 | 36 | 68 | 46 | 59 |
| OPAL Beyond c , N | 61 | 70 | 65 | 67 | 48 | 83 |
| Demographics | ||||||
| Age (y), mean (SD) | 53.0 (11.0) | 46.9 (12.8) | 53.2 (10.4) | 46.5 (11.9) | 53.2 (11.4) | 45.2 (12.2) |
| Female, n (%) | 51 (51.5) | 70 (50.4) | 59 (58.4) | 77 (57.0) | 48 (51.1) | 88 (62.0) |
| Race, n (%) | ||||||
| White | 95 (96.0) | 131 (94.2) | 98 (97.0) | 123 (91.1) | 90 (95.7) | 132 (93.0) |
| Other | 4 (4.0) | 8 (5.8) | 3 (3.0) | 12 (8.9) | 4 (4.3) | 10 (7.0) |
| BMI (kg/m2), mean (SD) | 33.3 (6.1) | 27.4 (5.4) | 33.4 (5.7) | 27.8 (5.5) | 32.9 (4.8) | 26.8 (4.8) |
| Abdominal obesity d , n (%) | 88 (88.9) | 63 (45.3) | 93 (92.1) | 54 (40.0) | 86 (91.5) | 54 (38.0) |
| Patients taking concomitant lipid‐lowering medications at baseline e , n (%) | 25 (25.3) | 4 (2.9) | 32 (31.7) | 7 (5.2) | 21 (22.3) | 5 (3.5) |
| Disease characteristics | ||||||
| Psoriatic arthritis duration (y), mean (SD) | 9.2 (7.9) | 8.2 (7.9) | 8.2 (6.5) | 6.9 (6.6) | 7.2 (6.3) | 8.7 (8.2) |
| SJC (66), mean (SD) | 13.6 (11.9) | 11.6 (8.9) | 14.2 (11.6) | 10.9 (8.0) | 11.8 (9.4) | 10.4 (8.5) |
| TJC (68), mean (SD) | 21.3 (13.4) | 20.0 (12.4) | 26.9 (17.5) | 20.5 (13.9) | 22.9 (14.9) | 18.3 (14.2) |
| CRP (mg/L) | ||||||
| > 2.87 f , n (%) | 69 (69.7) | 84 (60.4) | 68 (67.3) | 80 (59.3) | 62 (66.0) | 81 (57.0) |
| Mean (SD) | 11.1 (18.5) | 13.1 (21.9) | 10.1 (16.3) | 13.4 (25.2) | 11.9 (18.4) | 11.0 (21.4) |
| Median (range) | 5.2 (0.2‐126.0) | 5.8 (0.2‐115.0) | 5.0 (0.4‐100.0) | 5.0 (0.2‐163.0) | 5.3 (0.3‐100.0) | 4.0 (0.2‐164.0) |
| PASI, mean (SD) g | 9.5 (7.5) | 8.7 (8.1) | 10.6 (8.5) | 9.8 (7.4) | 12.0 (11.7) | 9.3 (8.5) |
| LEI, mean (SD) h | 2.9 (1.6) | 2.7 (1.5) | 3.5 (1.7) | 3.0 (1.7) | 2.7 (1.5) | 2.8 (1.5) |
| DSS, mean (SD) i | 8.6 (8.7) | 8.3 (9.3) | 10.3 (9.9) | 8.0 (6.4) | 7.9 (6.0) | 8.6 (8.0) |
| HAQ‐DI, mean (SD) | 1.3 (0.7) | 1.2 (0.6) | 1.4 (0.6) | 1.2 (0.6) | 1.3 (0.7) | 1.1 (0.7) |
| PtGA (mm), mean (SD) | 54.9 (22.8) | 57.1 (22.4) | 58.3 (21.2) | 54.9 (23.6) | 57.5 (23.7) | 53.2 (22.9) |
| PGA (mm), mean (SD) | 55.7 (20.0) | 52.8 (20.3) | 55.8 (20.1) | 55.3 (18.0) | 54.4 (19.0) | 53.3 (21.0) |
| Pain (mm), mean (SD) | 55.1 (22.7) | 56.7 (24.1) | 59.9 (19.0) | 55.3 (24.0) | 56.0 (24.7) | 52.9 (24.3) |
| FACIT‐F total score, mean (SD) | 26.0 (11.4) | 27.6 (11.5) | 26.2 (10.6) | 27.6 (10.3) | 27.8 (10.6) | 28.0 (10.8) |
| SF‐36v2 PCS, mean (SD) | 33.7 (7.8) | 34.8 (8.5) | 32.0 (8.7) | 35.1 (8.4) | 34.2 (8.4) | 36.0 (8.8) |
| SF‐36v2 MCS, mean (SD) | 41.1 (12.7) | 39.6 (11.1) | 40.3 (12.0) | 39.9 (12.3) | 40.2 (11.9) | 40.1 (11.7) |
| EQ‐VAS (mm), mean (SD) | 52.8 (21.7) | 50.8 (22.2) | 48.9 (21.6) | 51.7 (20.3) | 53.2 (22.8) | 51.6 (19.5) |
Abbreviations: BID, twice daily; BMI, body mass index; BSA, body surface area; CRP, C‐reactive protein; csDMARD, conventional synthetic disease‐modifying antirheumatic drug; DSS, Dactylitis Severity Score; EQ, EuroQol; FACIT‐F, Functional Assessment of Chronic Illness Therapy‐Fatigue; HAQ‐DI, Health Assessment Questionnaire‐Disability Index; LEI, Leeds Enthesitis Index; MCS, Mental Component Summary; MetS, metabolic syndrome; PASI, Psoriasis Area and Severity Index; PCS, Physical Component Summary; PGA, Physician’s Global Assessment of Arthritis; PtGA, Patient’s Global Assessment of Arthritis; SD, standard deviation; SF‐36v2, Short Form‐36 Health Survey Acute Version 2; SJC, swollen joint count (out of 66 joints); TJC, tender/painful joint count (out of 68 joints); TNFi, tumor necrosis factor inhibitor; VAS, Visual Analog Scale.
All patients received a stable dose of one background csDMARD.
All patients had not previously received a TNFi, except one patient randomized to placebo who received etanercept prior to enrollment.
All patients had an inadequate response to ≥ 1 TNFi.
Based on elevated waist circumference; waist circumference thresholds are population‐ and country‐specific (2).
Baseline concomitant lipid‐lowering medications were defined as drugs taken at baseline (Day 1).
Upper limit of normal.
PASI was assessed only in patients with baseline BSA ≥ 3% and PASI > 0.
Baseline LEI was summarized only for patients with baseline LEI > 0.
Baseline DSS was summarized only for patients with baseline DSS > 0.