Table 1.
Baseline characteristics.*
| Cetrorelix (n = 48) | Placebo (n = 51) | |
|---|---|---|
| Demographics | ||
| Age (years) | 54.9 ± 11.4 | 55.0 ± 11.7 |
| Female sex (%) | 73 | 71 |
| Disease duration (years) | 11.5 ± 10.6 | 12.0 ± 12.9 |
| Anti-CCP antibody positive, n (%) | 28 (58) | 35 (69) |
| Current smoker, n (%) | 13 (27) | 20 (39) |
| Clinical and laboratory measures | ||
| DAS28-CRP | 5.0 ± 1.0 | 5.2 ± 1.0 |
| CRP (mg/L) | 18.9 ± 24.5 | 17.3 ± 22.5 |
| ESR (mm/h) | 22.0 ± 18.3 | 25.8 ± 27.0 |
| TNF-α (pg/mL)† | 21.2 ± 291 | 49.6 ± 290 |
| LH (IU/L) | 20.4 ± 16.3 | 19.6 ± 16.3 |
| FSH (IU/L)‡ | 36.9 ± 30.0 | 32.9 ± 31.1 |
| Cortisol (nmol/L) | 392 ± 151 | 401 ± 200 |
| Current medication | ||
| None, n (%) | 11 (23) | 12 (24) |
| Stable NSAIDs, n (%) | 9 (19) | 14 (27) |
| Stable prednisolone ≤ 7.5mg, n (%) | 24 (50) | 22 (43) |
| Stable DMARDs, n (%) | 19 (40) | 27 (53) |
| MTX | 16 (33) | 17 (33) |
| LEF | 2 (4) | 2 (4) |
| SSZ | 0 | 1 (2) |
| HCQ | 1 (2) | 2 (4) |
| MTX + SLZ | 0 | 3 (6) |
| MTX, SSZ, + HCQ | 0 | 2 (4) |
| Previous failure to DMARD and biologic therapy§ | ||
| Previous failure with DMARDs, n (%) | 40 (83) | 45 (88) |
| One previous DMARD | 13 (27) | 13 (25) |
| Two previous DMARDs | 10 (21) | 9 (18) |
| Three or more previous DMARDs | 17 (35) | 23 (45) |
| Previous failure with biologics, n (%) | 21 (44) | 23 (45) |
| One previous biologic | 9 (19) | 9 (18) |
| Two previous biologics | 6 (13) | 3 (6) |
| Three or more previous biologics | 6 (13) | 11 (22) |
CCP, Cyclic citrullinated peptide; DAS28-CRP, 28-joint Disease Activity Score calculated with C-reactive protein levels; ESR, erythrocyte sedimentation rate; TNF-α, tumour necrosis factor-α; LH, luteinizing hormone; FSH, follicle-stimulating hormone; NSAID, non-steroidal anti-inflammatory drug; DMARD, disease-modifying anti-rheumatic drug; MTX, methotrexate; SSZ, sulfasalazine; HCQ, hydroxychloroquine; LEF, leflunomide.
Values are given as mean ± standard deviation unless otherwise indicated.
Data are median (IQR), based on detectable TNF-α values > 0.5 pg/mL; n = 21 (cetrorelix), n = 30 (placebo).
Based on detectable FSH values < 256 IU/L; n = 48 (cetrorelix), n = 50 (placebo).
Previous failure includes inefficacy or intolerability.