Open-label phase 3 study of diclofenac conjugated to hyaluronate (diclofenac etalhyaluronate: ONO-5704/SI-613) for treatment of osteoarthritis: 1-year follow-up

Table 4 Summary statistics of efficacy outcomes at baseline, weeks 2, 12, 24, and 52

	Baseline Mean ± SD	Week 2 Mean ± SD	Week 12 Mean ± SD	Week 24 Mean ± SD	Week 52 Mean ± SD
	N = 166	N = 166	N = 162	N = 158	N = 157
Pain score	5.9 ± 1.2	4.9 ± 1.9	4.3 ± 2.2	3.9 ± 2.3	3.1 ± 2.3
Patient global assessment (mm)	54.8 ± 19.3	43.4 ± 21.7	36.3 ± 23.7	33.0 ± 22.7	24.9 ± 23.0
Physician global assessment (mm)	54.2 ± 15.5	41.6 ± 19.8	32.8 ± 20.7	31.2 ± 22.1	23.7 ± 21.6
SF-36^a
MCS	53.0 ± 8.4	NA	53.1 ± 9.5	53.7 ± 9.4	52.8 ± 9.2
RCS	47.5 ± 13.3	NA	49.0 ± 11.7	49.8 ± 12.1	47.9 ± 12.5
PCS	31.9 ± 11.1	NA	33.0 ± 12.1	33.9 ± 13.0	36.3 ± 12.4
EQ-5D^a
QOL score	0.73 ± 0.13	NA	0.77 ± 0.13	0.78 ± 0.14	0.78 ± 0.14
VAS score	68.4 ± 15.6	NA	68.8 ± 18.0	70.9 ± 18.3	71.1 ± 18.6
Responder^b, n (%)	NA	49 (29.5)	76 (46.9)	91 (57.6)	108 (68.8)

SF-36 Medical Outcomes Study Short-Form 36-Item Health Survey, MCS mental component summary, NA not applicable, RCS role/social component summary, PCS physical component summary, EQ-5D EuroQol 5 dimension, QOL quality of life, VAS visual analogue scale
^aLower score indicates more pain or functional disability, and higher score indicates less pain or functional disability. QOL assessment was not conducted at week 2
^bPatients with improvement in joint pain score from baseline of at least 30%

ISSN: 1471-2474