Table 2

LS mean change from baseline to week 26 in scores for secondary or exploratory efficacy endpoints

Endpoint (full scale), mean (95% CI)	Placebo	Lutikizumab	LS mean (95% CI) difference Lutikizumab–placebo	P values Lutikizumab vs placebo*
Tender joints, both hands (0–30)	−4.7 (−7.1 to −2.3) n=65	−5.8 (−8.2 to −3.3) n=59	−1.07 (−3.19 to 1.06)	0.32
Swollen joints, both hands (0–30)	−1.8 (−3.5 to −0.2) n=65	−2.2 (−3.9 to 0.5) n=59	−0.35 (−1.82 to 1.13)	0.64
Verbruggen-Veys new radiographic erosive joints vs baseline, both hands (0–16)†	0.26 (0.10 to 0.42) n=61	0.18 (0.02 to 0.35) n=52	−0.07 (0.22 to 0.08)	0.33
Kellgren-Lawrence score, both hands (0–80)‡	0.13 (−0.25 to 0.50) n=61	0.10 (−0.28 to 0.48) n=52	−0.03 (−0.38 to 0.32)	0.87
OARSI JSN, both hands (0–58)§	0.14 (−0.23 to 0.51) n=61	0.03 (−0.35 to 0.40) n=52	−0.11 (−0.46 to 0.23)	0.51
OARSI osteophytes, both hands (0–58)§	0.25 (−0.05 to 0.55) n=61	0.14 (−0.17 to 0.45) n=52	−0.11 (−0.39 to 0.17)	0.45
HOAMRIS synovitis, index hand (sum score; 0–52.5)¶	0.92 (−0.05 to 1.88) n=55	0.85 (−0.16 to 1.86) n=47	−0.07 (−1.01 to 0.87)	0.89
HOAMRIS erosive damage, index hand (sum score; 0–52.5)¶	0.26 (−1.01 to 1.53) n=55	0.10 (−1.22 to 1.43) n=47	−0.16 (−1.39 to 1.08)	0.80
HOAMRIS BML, index hand (sum score; 0–52.5)¶	0.11 (−1.61 to 1.38) n=55	0.44 (−0.87 to 1.76) n=48	0.33 (−0.92 to 1.58)	0.60
HOAMRIS cartilage space loss, index hand (0–45)¶	0.29 (−0.30 to 0.89) n=55	0.46 (−0.16 to 1.09) n=47	0.17 (−0.41 to 0.75)	0.56
Joints with synovitis by MRI, index hand (0–15)¶	0.46 (−0.20 to 1.11) n=55	0.54 (−0.14 to 1.23) n=47	0.09 (−0.55 to 0.73)	0.79

*P values are from an ANCOVA adjusted for treatment group and country as factors, and including baseline value as a covariate.
†Defined by Verbruggen et al 33 as joints that entered the erosive, erosive with remodelling or remodelling phase but were normal, stationary or only starting to lose joint space at baseline. 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.
ANCOVA, analysis of covariance model; BML, bone marrow lesions; CMC, carpometacarpal; DIP, distal interphalangeal; HOAMRIS, Hand Osteoarthritis MRI Scoring system; IP, interphalangeal; JSN, joint space narrowing; LS, least squares; MCP, metacarpophalangeal; OARSI, Osteoarthritis Research Society International; PIP, proximal interphalangeal; STT, scaphotrapeziotrapezoid.