Table 1

Baseline demographics and characteristics

FosdagrocoratPrednisonePlacebo
1 mg
(n=45)
5 mg
(n=47)
10 mg
(n=45)
15 mg
(n=48)
5 mg
(n=45)
10 mg
(n=46)
(n=47)
Age (years), mean (range)50 (18–78)55 (29–77)55 (25–80)54 (27–84)53 (20–78)57 (34–75)55 (23–79)
Race (white), n (%)38 (84.4)41 (87.2)43 (95.6)42 (87.5)39 (86.7)38 (82.6)41 (87.2)
Gender (female), n (%)33 (73.3)38 (80.9)34 (75.6)37 (77.1)39 (86.7)41 (89.1)37 (78.7)
Disease duration (years), mean (range)7.9 (0.3–33.0)8.1 (0.3–42.0)6.6 (0.3–27.0)8.2 (0.3–35.0)7.4 (0.3–34.9)5.2 (0.3–17.0)6.7 (0.3–33.0)
Postmenopausal, n (%)*15 (33.3)17 (36.2)22 (48.9)17 (35.4)18 (40.0)26 (56.5)23 (48.9)
DAS28-4(CRP), mean (SD)†5.82 (0.85)5.96 (0.80)5.98 (0.73)5.92 (0.70)5.95 (0.84)5.99 (0.67)6.00 (0.84)
SJC, mean (SD)13.7 (5.9)15.7 (5.4)14.6 (5.8)14.5 (5.6)14.9 (6.4)14.9 (4.5)15.9 (5.5)
TJC, mean (SD)11.6 (5.2)11.6 (4.6)11.0 (4.9)10.9 (4.8)11.6 (4.5)11.3 (3.8)12.1 (3.8)
CRP (mg/L), mean (SD)†23.2 (21.9)25.5 (23.7)26.9 (20.7)26.3 (26.1)24.6 (23.8)27.0 (38.1)22.4 (24.0)
IGT, n (%)1 (2.2)01 (2.2)0000
DM, n (%)3 (6.7)01 (2.2)1 (2.1)1 (2.2)1 (2.2)0
P1NP (ng/mL), mean (SD)‡58.4 (28.4)51.3 (25.6)50.5 (28.5)50.1 (25.2)52.9 (28.6)48.7 (18.4)58.0 (30.9)
 Median (Q1–Q3)57.2 (37.0–66.3)46.2 (32.7–63.2)43.1 (30.3–64.4)46.2 (34.0–62.4)47.8 (34.9–59.9)49.2 (31.9–60.5)52.2 (33.4–79.5)
uNTx:uCr (nM BCE/mM), mean (SD)§58.5 (38.6)60.5 (39.3)54.6 (35.7)48.7 (22.4)67.0 (51.6)53.0 (25.0)64.9 (30.8)
 Median (Q1–Q3)53.1 (34.3–63.7)49.1 (30.1–80.6)47.9 (30.8–65.3)44.3 (33.0–59.1)50.7 (38.2–73.9)46.1 (33.7–72.0)60.0 (44.7–86.3)
OC (ng/mL), mean (SD)‡27.6 (13.9)26.4 (13.8)24.2 (12.6)21.3 (8.5)24.5 (11.9)22.9 (7.5)26.1 (12.3)
 Median (Q1–Q3)26.6 (18.7–31.4)22.4 (14.5–36.5)21.1 (14.3–32.8)20.1 (15.8–25.2)23.3 (15.2–30.7)21.2 (18.3–28.6)25.3 (17.6–32.7)
CTx (ng/mL), mean (SD)‡0.50 (0.25)0.49 (0.30)0.43 (0.26)0.43 (0.24)0.50 (0.27)0.43 (0.21)0.49 (0.25)
 Median (Q1–Q3)0.48 (0.37–0.60)0.48 (0.25–0.60)0.43 (0.21–0.57)0.37 (0.23–0.65)0.45 (0.33–0.58)0.38 (0.27–0.60)0.48 (0.27–0.65)
Cortisol (ng/mL), mean (SD)¶104.4 (53.4)117.9 (57.2)108.6 (48.9)109.4 (58.1)115.3 (48.5)120.1 (54.5)113.7 (60.1)
HAQ-DI, mean (SD)1.40 (0.71)1.60 (0.64)1.47 (0.60)1.61 (0.63)1.62 (0.55)1.63 (0.58)1.65 (0.56)
SF-36 PCS, mean (SD)33.24 (7.29)31.49 (6.21)30.44 (6.53)31.87 (7.41)31.86 (6.46)30.52 (7.18)31.68 (6.08)
SF-36 MCS, mean (SD)38.28 (10.34)38.08 (10.62)42.41 (12.08)37.61 (10.79)40.05 (11.55)37.30 (10.07)38.74 (9.56)
  • All study treatments were administered once daily.

  • *Menopause was assessed by study investigator at week 2.

  • †n=45 for prednisone 10 mg.

  • ‡n=45, 47, 45, 47, 44, 45 and 47 for fosdagrocorat 1 mg, 5 mg, 10 mg and 15 mg, prednisone 5 mg and 10 mg, and placebo, respectively.

  • §n=45, 47, 44, 48, 44, 45 and 47 for fosdagrocorat 1 mg, 5 mg, 10 mg, and 15 mg, prednisone 5 mg and 10 mg, and placebo, respectively.

  • ¶n=45, 47, 43, 48, 43, 43 and 45 for fosdagrocorat 1 mg, 5 mg, 10 mg, and 15 mg, prednisone 5 mg and 10 mg, and placebo, respectively.

  • BCE, bone collagen equivalent;CRP, C reactive protein;CTx, C-terminal telopeptide;DAS28-4(CRP), Disease Activity Score in 28 joints (CRP);DM, diabetes mellitus;HAQ-DI, Health Assessment Questionnaire-Disability Index;IGT, impaired glucose tolerance;MCS, mental component summary;n, number of patients with observations;OC, osteocalcin;PCS, physical component summary;P1NP, procollagen type 1 N-terminal propeptide;Q, quartile;SF-36, Short-Form 36 Health Survey;SJC, swollen joint count;TJC, tender joint count;uNTx:uCr, urinary N-telopeptide to urinary creatinine ratio.