Table 1.
Demographic and baseline characteristics (safety set)
| Variable | Canakinumab 25 mg n=55 | Canakinumab 50 mg n=54 | Canakinumab 100 mg n=54 | Canakinumab 200 mg n=54 | Canakinumab 300 mg n=53 | Canakinumab every 4 weeks n=53 | Colchicine 0.5 mg n=108 |
|---|---|---|---|---|---|---|---|
| Male, n (%) | 55 (100.0) | 51 (94.4) | 48 (88.9) | 50 (92.6) | 51 (96.2) | 49 (92.5) | 101 (93.5) |
| Age, years | |||||||
| Mean (SD) | 50.7 (9.72) | 54.4 (12.18) | 51.3 (12.41) | 52.6 (10.78) | 52.4 (11.30) | 52.8 (10.38) | 52.4 (10.69) |
| Median (range) | 52.0 (27–78) | 53.0 (32–78) | 51.0 (27–79) | 53.5 (29–74) | 51.0 (30–74) | 53.0 (23–72) | 54.0 (20–77) |
| Race, n (%) | |||||||
| Caucasian | 42 (76.4) | 43 (79.6) | 36 (66.7) | 39 (72.2) | 36 (67.9) | 41 (77.4) | 87 (80.6) |
| Black | 1 (1.8) | 1 (1.9) | 2 (3.7) | 2 (3.7) | 3 (5.7) | 3 (5.7) | 4 (3.7) |
| Asian | 4 (7.3) | 4 (7.4) | 10 (18.5) | 5 (9.3) | 4 (7.5) | 2 (3.8) | 5 (4.6) |
| Other | 8 (14.5) | 6 (11.1) | 6 (11.1) | 8 (14.8) | 10 (18.9) | 7 (13.2) | 12 (11.1) |
| BMI, kg/m2 | |||||||
| Mean (SD) | 31.03 (4.63) | 30.51 (4.35) | 29.88 (4.69) | 30.60 (4.12) | 30.63 (4.64) | 29.62 (4.32) | 30.30 (4.66) |
| Median (range) | 30.0 (22–40) | 29.9 (22–40) | 29.8 (21–40) | 30.4 (20–38) | 30.4 (17–40) | 29.7 (18–38) | 29.2 (22–40) |
| Classification of gouty arthritis, n (%)* | |||||||
| Acute monoarticular gouty arthritis | 15 (27.3) | 19 (35.2) | 20 (37.0) | 11 (20.4) | 17 (32.1) | 20 (37.7) | 37 (34.3) |
| Acute oligoarticular gouty arthritis | 27 (49.1) | 10 (18.5) | 22 (40.7) | 20 (37.0) | 14 (26.4) | 13 (24.5) | 28 (25.9) |
| Acute polyarticular gouty arthritis | 13 (23.6) | 25 (46.3) | 12 (22.2) | 23 (42.6) | 22 (41.5) | 20 (37.7) | 43 (39.8) |
| Duration of gouty arthritis, n (%) | |||||||
| <1 year | 3 (5.5) | 3 (5.6) | 2 (3.7) | 6 (11.1) | 4 (7.5) | 2 (3.8) | 9 (8.3) |
| 1–5 years | 13 (23.6) | 23 (42.6) | 25 (46.3) | 14 (25.9) | 20 (37.7) | 15 (28.3) | 39 (36.1) |
| 6–10 years | 15 (27.3) | 6 (11.1) | 12 (22.2) | 15 (27.8) | 10 (18.9) | 18 (34.0) | 27 (25.0) |
| >10 years | 24 (43.6) | 22 (40.7) | 15 (27.8) | 19 (35.2) | 19 (35.8) | 18 (34.0) | 33 (30.6) |
| Number of flares in previous year | |||||||
| Mean (SD) | 3.7 (2.27) | 4.3 (2.82) | 3.6 (2.26) | 4.7 (4.51) | 4.5 (3.68) | 4.4 (4.13) | 4.3 (3.82) |
| Median (range) | 3.0 (1–14) | 3.0 (2–14) | 3.0 (2–12) | 3.0 (1–25) | 4.0 (2–20) | 3.0 (2–24) | 3.0 (1–25) |
| Allopurinol dose at baseline, mg daily | |||||||
| Mean (SD) | 261.8 (65.2) | 263.0 (65.3) | 263.0 (65.3) | 257.4 (66.2) | 264.2 (65.3) | 258.5 (66.3) | 261.1 (65.3) |
| Median (range) | 300.0 (100–300) | 300.0 (100–300) | 300.0 (100–300) | 300.0 (100–300) | 300.0 (100–300) | 300.0 (100–300) | 300.0 (100–300) |
| Patients starting allopurinol before baseline, n (%) | 6 (10.9) | 8 (14.8) | 10 (18.5) | 8 (14.8) | 6 (11.3) | 8 (15.1) | 12 (11.1) |
| Creatinine clearance (ml/min),† n (%) | |||||||
| Low | 2 (3.6) | 2 (3.7) | 2 (3.7) | 4 (7.4) | 7 (13.2) | 2 (3.8) | 6 (5.6) |
| Normal | 31 (56.4) | 27 (50.0) | 27 (50.0) | 26 (48.1) | 19 (35.8) | 27 (50.9) | 58 (53.7) |
| High | 22 (40.0) | 25 (46.3) | 25 (46.3) | 24 (44.4) | 27 (50.9) | 24 (45.3) | 44 (40.7) |
| Serum urate, n (%) | |||||||
| ≥6 mg/dl | 50 (90.9) | 48 (88.9) | 49 (90.7) | 50 (92.6) | 49 (92.5) | 46 (85.2) | 96 (88.9) |
| ≥9 mg/dl | 30 (54.5) | 19 (35.2) | 20 (37.0) | 28 (51.9) | 25 (47.2) | 22 (41.5) | 51 (47.2) |
| CRP, mg/l | |||||||
| Mean (SD) | 5.9 (9.88) | 9.1 (18.84) | 4.5 (8.02) | 8.7 (15.40) | 7.8 (15.98) | 5.9 (6.59) | 5.9 (8.30) |
| Median (range) | 2.9 (0–70) | 3.4 (0–93) | 1.8 (0–51) | 3.7 (0–93) | 3.2 (0–81) | 3.1 (0–30) | 2.7 (0–49) |
| SAA, mg/l | |||||||
| Mean (SD) | 8.7 (11.90)‡ | 18.8 (53.89) | 8.2 (17.35)‡ | 18.3 (61.46)§ | 15.6 (61.90)‡ | 12.4 (22.47)‡ | 11.5 (28.71)¶ |
| Median (range) | 3.8 (1–61) | 4.9 (0–364) | 3.7 (0–120) | 5.5 (1–438) | 4.3 (1–446) | 4.8 (0–139) | 4.6 (0–270) |
| HAQ SDI score | |||||||
| Mean (SD) | 0.38 (0.47)‡ | 0.48 (0.60) | 0.39 (0.59) | 0.38 (0.55) | 0.35 (0.58)‡ | 0.42 (0.63) | 0.42 (0.66) |
| Median (range) | 0.25 (0–2.0) | 0.25 (0–2.1) | 0.06 (0–2.6) | 0 (0–2.5) | 0 (0–2.1) | 0.13 (0–2.1) | 0.06 (0–2.8) |
| Employment status | |||||||
| Working in paid, unpaid or voluntary employment | 40 (72.7) | 28 (51.9) | 35 (64.8) | 37 (68.5) | 37 (69.8) | 35 (66.0) | 73 (67.6) |
*
p=0.016 from χ2 test for comparability across all groups.
†
Creatinine clearance estimated using the Cockcroft–Gault formula. Normal range for women aged: 16–50 years, 65–110 ml/min; 51–70 years, 50–90 ml/min; 71–110 years, 35–60 ml/min. Normal range for men aged: 16–50 years, 80–125 ml/min; 51–70 years, 55–100 ml/min; 71–110 years, 40–75 ml/min.
‡
Data missing for one patient.
§
Data missing for two patients.
¶
Data missing for four patients.
BMI, body mass index; CRP, C reactive protein; HAQ SDI, Health Assessment Questionnaire Standard Disability Index; SAA, serum amyloid A; SD, standard deviation.