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 2 OA pain intensity

	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	-20.1^b ± 21.97	-20.9^b ± 22.50	-20.2^b ± 21.86	-12.1 ± 19.92
Mean change from baseline at week 13 ± SD^a	-26.0^b ± 24.83	-26.0^b ± 24.92	-25.4^b ± 25.03	-19.8 ± 24.75
Response by MCII^a
Responders at week 2, n (%)	383 (47.2)	378 (47.0)	392 (48.3)	254 (31.6)
Odds ratio versus placebo^c (95% CI)	1.94^b (1.58–2.38)	1.92^b (1.57–2.35)	2.02^b (1.65–2.48)	NA
Odds ratio versus celecoxib^c (95% CI)	0.96^d (0.79–1.17)	0.95^d (0.78–1.15)	NA	NA
Responders at week 13, n (%)	484 (59.7)	489 (60.7)	463 (57.0)	393 (48.8)
Odds ratio versus placebo^c (95% CI)	1.55^b (1.27–1.89)	1.62^b (1.33–1.98)	1.39^b (1.14–1.69)	NA
Odds ratio versus celecoxib^c (95% CI)	1.12^d (0.92–1.36)	1.17^d (0.96–1.42)	NA	NA
Patients considering their current state as satisfactory by PASS^e
Satisfied patients at week 2, n (%)	251 (30.9)	270 (33.5)	242 (29.8)	137 (17.0)
Odds ratio versus placebo^c (95% CI)	2.19^b (1.73–2.77)	2.46^b (1.95–3.12)	2.07^b (1.63–2.62)	NA
Odds ratio versus celecoxib^c (95% CI)	1.06^d (0.86–1.31)	1.19^d (0.97–1.47)	NA	NA
Satisfied patients at week 13, n (%)	351 (43.3)	365 (45.3)	343 (42.2)	286 (35.5)
Odds ratio versus placebo^c (95% CI)	1.39^b (1.14–1.70)	1.51^b (1.23–1.84)	1.33^f (1.09–1.62)	NA
Odds ratio versus celecoxib^c (95% CI)	1.05^d (0.86–1.27)	1.14^d (0.93–1.38)	NA	NA

^aA patient was considered a responder by MCII if his/her change from baseline for OA pain intensity was decreased by greater than or equal to 19.9 mm. ^bp < 0.001 versus placebo. ^cMultiple logistic regression model with treatment as main effect. Pairwise comparisons were tested using two-sided significance unadjusted for multiple comparisons. ^dp value non-significant. ^eA patient was considered as achieving a satisfactory state according to PASS if his/her value for OA pain intensity was less than or equal to 32.3 mm. ^fp < 0.01 versus placebo. CI, confidence interval; MCII, Minimal Clinically Important Improvement; NA, not applicable; OA, osteoarthritis; od, once daily; PASS, Patient Acceptable Symptom State; SD, standard deviation.

ISSN: 1478-6362