Evaluation of the Patient Acceptable Symptom State in a pooled analysis of two multicentre, randomised, double-blind, placebo-controlled studies evaluating lumiracoxib and celecoxib in patients with osteoarthritis

Table 3 Patient's global assessment of disease activity

	Lumiracoxib 100 mg od (n = 811)	Lumiracoxib 100 mg od with initial dose (n = 805)	Celecoxib 200 mg od (n = 813)	Placebo (n = 806)
Mean change from baseline at week 2 ± SD^a	-18.4^b ± 23.62	-19.0^b ± 23.83	-17.1^b ± 23.72	-9.5 ± 20.81
Mean change from baseline at week 13 ± SD^a	-24.2^b ± 25.83	-23.2^b ± 25.57	-21.3^b ± 26.78	-16.3^b ± 25.19
Response by MCII^c at week 13
Responders at week 2, n (%)	359 (44.3)	369 (45.8)	352 (43.3)	242 (30.1)
Odds ratio versus placebo^d (95% CI)	1.85^b (1.51–2.27)	1.97^b (1.60–2.42)	1.78^b (1.45–2.18)	NA
Odds ratio versus celecoxib^d (95% CI)	1.04^e (0.85–1.27)	1.11^e (0.91–1.35)	NA	NA
Responders at week 13, n (%)	465 (57.3)	456 (56.6)	432 (53.1)	357 (44.3)
Odds ratio versus placebo^d (95% CI)	1.69^b (1.39–2.05)	1.64^b (1.35–2.00)	1.42^b (1.17–1.73)	NA
Odds ratio versus celecoxib^d (95% CI)	1.19^e (0.97–1.44)	1.15^e (0.95–1.40)	NA	NA
Satisfaction with treatment by PASS^f
Satisfied patients at week 2, n (%)	240 (29.6)	255 (31.7)	234 (28.8)	140 (17.4)
Odds ratio versus placebo^d (95% CI)	2.00^b (1.58–2.53)	2.21^b (1.74–2.79)	1.92^b (1.52–2.44)	NA
Odds ratio versus celecoxib^d (95% CI)	1.04^e (0.84–1.29)	1.15^e (0.93–1.42)	NA	NA
Satisfied patients at week 13, n (%)	347 (42.8)	353 (43.9)	321(39.5)	255 (31.6)
Odds ratio versus placebo^d (95% CI)	1.62^b (1.32–1.98)	1.69^b (1.38–2.07)	1.41^b (1.15–1.73)	NA
Odds ratio versus celecoxib^d (95% CI)	1.15^e (0.94–1.40)	1.20^e (0.98–1.46)	NA	NA

^ap values for comparison with placebo in analysis of covariance adjusting for study and baseline. ^bp < 0.001 versus placebo. ^cA patient was considered a responder by MCII if his/her change from baseline for patient's global assessment was decreased by greater than or equal to 18.3 mm. ^dMultiple logistic regression model with treatment as main effect. Pairwise comparisons were tested using two-sided significance unadjusted for multiple comparisons. ^ep value non-significant. ^fA patient was considered as achieving a satisfactory state according to PASS if his/her value for patient's global assessment was less than or equal to 32.0 mm. CI, confidence interval; MCII, Minimal Clinically Important Improvement; NA, not applicable; od, once daily; PASS, Patient Acceptable Symptom State; SD, standard deviation.

ISSN: 1478-6362