Ultrasound of metacarpophalangeal joints is a sensitive and reliable endpoint for drug therapies in rheumatoid arthritis: results of a randomized, two-center placebo-controlled study

Table 4 Performance of exploratory composite endpoints.

Endpoint	Scan	Day 15 Effect size (90% CI)	Day 8 Effect size (90% CI)	Day 2 Effect size (90% CI)
Z-score(DAS28+Trans VASCi+Long STi)	1	1.96 (0.97; 2.90)	1.41 (0.46; 2.32))	1.28 (0.40; 2.13)
Z-score(DAS28+Trans VASCi+Long STA)	1	2.05 (1.05; 3.01)	1.53 (0.56; 2.46)	1.14 (0.28; 1.98)
Z-score(DAS28+TransPDA +Long STA)	1	2.14 (1.12; 3.10)	1.17 (0.25; 2.05)	1.14 (0.28; 1.98)
Z-score(DAS28+TransPDA +Long STi)	1	1.93 (0.95; 2.87)	0.98 (0.09; 1.84)	0.95 (0.11; 1.76)
DAS28(CRP)		0.95 (0.11; 1.76)	0.75 (-0.12; 1.59)	0.67 (-0.15; 1.46)

Panel A (Prednisone 15mg versus Placebo) effect sizes for composite endpoints at Day 15, Day 8 and Day 2 compared with DAS28(CRP). The sum of the standardized score of DAS28(CRP), 10 MCP Trans VASCi, 10MCP Long STi (Z-score(DAS28+Trans VASCi+Long STi)); the sum of the standardized score of DAS28(CRP), 10 MCP Trans VASCi, 10 MCP Long STA (Z-score(DAS28+Trans VASCi+Long STA)); the sum of the standardized score of DAS28(CRP), 10 MCP Trans PDA, 10 MCP Long STA (Z-score(DAS28+Trans PDA+Long STA)); and the sum of the standardized score of DAS28(CRP), 10 MCP Trans PDA, 10 MCP Long STi (Z-score(DAS28+Trans PDA +Long STi)). Note: If the 90% confidence interval excludes zero (or values less than zero) then the value is significant at the <0.05 level for a one-sided comparison. We have prior information giving us the directionality of change and are only interested in change in one direction. Therefore, all the above effect sizes for composite endpoints were significant at all post dose time points and for DAS28(CRP) at Day 15 only. CI, confidence interval; CRP, C-reactive protein; DAS28, Disease Activity Score in 28 Joints; PDA; Power Doppler Area; STA, synovial thickness area; STi, synovial thickness index; VASCi, vascularity index.

ISSN: 1478-6362