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Table 4 WOMAC™ LK 3.1 Function subscale score response

From: 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

 

Lumiracoxib 100 mg od

(n = 811)

100 mg od with initial dose

(n = 805)

Celecoxib 200 mg od

(n = 813)

Placebo

(n = 806)

Mean change from baseline at week 2 ± SDa

-8.7b ± 10.71

-8.9b ± 11.19

-8.7b ± 10.61

-4.1 ± 9.41

Mean change from baseline at week 13 ± SDa

-11.2b ± 12.65

-11.2b ± 12.71

-10.5b ± 12.41

-7.2 ± 12.62

Response by MCIIc

Responders at week 2, n (%)

425 (52.7)

413 (51.7)

422 (52.1)

264 (32.9)

Odds ratio versus placebod (95% CI)

2.27b (1.86–2.78)

2.18b (1.78–2.67)

2.22b (1.81–2.72)

NA

Odds ratio versus celecoxibd (95% CI)

1.02e (0.84–1.24)

0.98e (0.81–1.20)

NA

NA

Responders at week 13, n (%)

506 (62.7)

495 (62.0)

490 (60.5)

378 (47.1)

Odds ratio versus placebod (95% CI)

1.89b (1.55–2.31)

1.83b (1.50–2.23)

1.72b (1.41–2.10)

NA

Odds ratio versus celecoxibd (95% CI)

1.10e (0.90–1.34)

1.06e (0.87–1.30)

NA

NA

Patients considering their current state as satisfactory by PASSf

Satisfied patients at week 2, n (%)

262 (32.3)

271 (33.7)

259 (31.9)

154 (19.1)

Odds ratio versus placebod (95% CI)

2.02b (1.61–2.54)

2.15b (1.71–2.71)

1.98b (1.57–2.49)

NA

Odds ratio versus celecoxibd (95% CI)

1.02e (0.83–1.26)

1.09e (0.88–1.34)

NA

NA

Satisfied patients at week 13, n (%)

337 (41.6)

333 (41.4)

315 (38.7)

238 (29.5)

Odds ratio versus placebod

1.70b (1.38–2.09)

1.69b (1.37–2.07)

1.51b (1.23–1.86)

NA

Odds ratio versus celecoxibd

1.12e (0.92–1.37)

1.12e (0.92–1.36)

NA

NA

  1. 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 WOMAC™ LK 3.1 Function was decreased by greater than or equal to 6.19 (converted from VAS). 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 WOMAC™ LK 3.1 Function was less than or equal to 21.08 (converted from VAS). CI, confidence interval; MCII, Minimal Clinically Important Improvement; NA, not applicable; od, once daily; PASS, Patient Acceptable Symptom State; SD, standard deviation; VAS, visual-analogue scale; WOMAC™ LK 3.1, Western Ontario and McMaster Universities Osteoarthritis Index Likert version 3.1.