Table 1.
Demographics and baseline disease characteristics
| Characteristics | Placebo (n=67) | Lutikizumab (n=64) |
| Age, years, mean±SD | 66±7 | 66±8 |
| Female, n (%) | 58 (87) | 53 (83) |
| Race, n (%) | ||
| White | 66 (99) | 63 (98) |
| Black | 1 (1) | 0 |
| Asian | 0 | 1 (2) |
| BMI, kg/m2, mean±SD | 28±5 | 27±5 |
| OA duration, years | ||
| Mean±SD | 11±8 | 11±9 |
| Median (range) | 8.5 (0.4–37.5) | 7.4 (0.1–34.5) |
| Prior NSAID use, n (%) | 35 (52) | 36 (56) |
| Prior opioids use, n (%) | 1 (1) | 2 (3) |
| AUSCAN pain (full scale, 0–50), mean±SD* | 39±7 | 38±6 |
| AUSCAN function (full scale, 0–90), mean±SD* | 69±15 | 71±13 |
| Tender joints, both hands (full scale, 0–30), mean±SD* | 12±6 | 12±7 |
| Swollen joints, both hands (full scale, 0–30), mean±SD* | 6±5 | 6±5 |
| Verbruggen-Veys radiographic erosive joints, both hands (full scale, 0–16), mean±SD† | 2±2 | 3±2 |
| Kellgren-Lawrence score, both hands (full scale, 0–80), mean±SD‡ | 42±13 | 46±13 |
| OARSI JSN, both hands (full scale, 0–58), mean±SD§ | 29±10 | 32±9 |
| OARSI osteophytes, both hands (full scale, 0–58), mean±SD§ | 23±11 | 26±10 |
| HOAMRIS synovitis, index hand (sum score, 0–52.5), mean±SD¶** | 11±5 | 10±4 |
| HOAMRIS erosive damage, index hand (sum score, 0–52.5), mean±SD¶** | 18±10 | 18±9 |
| HOAMRIS BML, index hand (sum score, 0–52.5), mean±SD¶** | 7±6 | 5±5 |
| HOAMRIS cartilage space loss, index hand (sum score, 0–45), mean±SD¶** | 14±7 | 15±7 |
| Joints with synovitis by MRI, index hand (full scale, 0–15), mean±SD¶** | 9±3 | 8±3 |
| ANC, ×109/L, mean±SD | 3.8±1.0 | 4.1±1.6 |
| hsCRP, mg/L | ||
| Mean±SD | 4.1±6.6 | 4.4±8.0 |
| Median (range) | 1.8 (0.2–44.5) | 1.8 (0.3–53.7) |
*Placebo: n=66.
†Defined by Verbruggen et al,33 erosive phase+erosive with remodelling phase. Measured in DIP joints 2–5 and PIP joints 2–5.
‡Measured in DIP joints 2–5, PIP joints 2–5, CMC joint of the thumb and IP joint of the thumb.
§Measured in DIP joints 2–5, PIP joints 2–5, MCP joints 1–5, CMC joint of the thumb, IP joint of the thumb and STT joint.
¶Measured in DIP joints 2–5, PIP joints 2–5, MCP joints 1–5, CMC joint of the thumb and IP joint of the thumb.
**Placebo: n=63; lutikizumab: n=59.
STT, scaphotrapeziotrapezoid. ANC, absolute neutrophil count; AUSCAN, Australian/Canadian Osteoarthritis Hand Index; BMI, body mass index; BML, bone marrow lesions; CMC, carpometacarpal; DIP, distal interphalangeal; HOAMRIS, Hand Osteoarthritis MRI Scoring system; IP, interphalangeal; JSN, joint space narrowing; MCP, metacarpophalangeal; NSAID, non-steroidal anti-inflammatory drug; OA, osteoarthritis; OARSI, Osteoarthritis Research Society International; PIP, proximal interphalangeal; hsCRP, high-sensitivity C reactive protein.