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Table 2 Improvements in health-related quality of life at weeks 12, 24 and 52 (ITT population, LOCF)*

From: Rapid and sustained improvements in health-related quality of life, fatigue, and other patient-reported outcomes in rheumatoid arthritis patients treated with certolizumab pegol plus methotrexate over 1 year: results from the RAPID 1 randomized controlled trial

  Week 12 Week 24 Week 52
  CZP 200 mg
+ MTX
(n = 393)
CZP 400 mg
+ MTX
(n = 390)
PBO
+ MTX
(n = 199)
CZP 200 mg
+ MTX
(n = 393)
CZP 400 mg
+ MTX
(n = 390)
PBO
+ MTX
(n = 199)
CZP 200 mg
+ MTX
(n = 393)
CZP 400 mg
+ MTX
(n = 390)
PBO
+ MTX
(n = 199)
PCS          
   Mean score (SD) 36.1 (8.9) 36.8 (8.4) 30.7 (7.1) 37.8 (9.5) 38.4 (8.8) 31.4 (7.3) 38.1 (9.5) 38.9 (8.9) 31.5 (7.4)
   Mean change from BL 5.8 (0.5)† 6.4 (0.6)† 0.7 (0.6) 7.7 (0.4)† 8.3 (0.4)† 1.8 (0.6) 7.8 (0.4)† 8.6 (0.4)† 1.7 (0.6)
% MCID 38.2† 36.5† 21.4 46.6† 51.7† 10.9 42.2† 46.1† 11.5
MCS          
   Mean score (SD) 45.5 (11.5) 45.7 (11.6) 41.4 (10.8) 45.6 (11.5) 45.6 (11.6) 41.3 (10.7) 45.8 (11.4) 45.4 (11.5) 41.1 (10.8)
   Mean change from BL 5.6 (0.7)† 5.5 (0.7)† 2.0 (0.8) 6.3 (0.6)† 6.5 (0.6)† 2.3 (0.8) 6.4 (0.6)† 6.4 (0.6)† 2.1 (0.8)
% MCID 36.0‡ 33.3 28.1 41.1† 41.9† 13.0 39.2† 38.1† 9.9
Physical Functioning          
   Mean score (SD) 45.1 (25.8) 46.1 (24.6) 31.2 (21.0) 47.6 (26.5) 48.8 (24.7) 33.3 (22.2) 49.3 (26.9) 50.3 (24.9) 33.1 (22.3)
   Mean change from BL 11.4 (1.4)† 12.2 (1.4)† -1.0 (1.7) 15.6 (1.2)† 16.5 (1.2)† 1.9 (1.6) 16.7 (1.2)† 17.9 (1.2)† 1.7 (1.6)
% MCID 32.1† 33.6† 18.4 42.0† 46.6† 10.7 38.0† 44.3† 9.7
Role Physical          
   Mean score (SD) 34.1 (38.3) 33.9 (38.5) 15.0 (28.0) 37.2 (40.4) 38.6 (40.2) 18.0 (30.2) 37.7 (40.3) 39.2 (41.8) 17.3 (30.2)
   Mean change from BL 24.8 (2.4)† 24.2 (2.5)† 6.4 (2.9) 27.8 (2.0)† 29.1 (2.0)† 9.4 (2.8) 26.9 (2.1)† 29.1 (2.0)† 8.1 (2.9)
% MCID 24.9† 24.5‡ 13.9 33.0† 36.8† 10.3 32.2† 31.1† 8.2
Bodily Pain          
   Mean score (SD) 47.8 (20.1) 49.6 (20.4) 33.1 (18.5) 51.4 (22.3) 53.4 (20.8) 33.2 (19.4) 52.0 (22.8) 53.9 (22.2) 34.0 (20.1)
   Mean change from BL 18.0 (1.3)† 20.2 (1.4)† 4.5 (1.6) 23.3 (1.1)† 25.8 (1.1)† 6.3 (1.5) 23.5 (1.1)† 26.2 (1.1)† 6.8 (1.6)
% MCID 45.9‡ 43.3‡ 33.3 52.5† 58.2† 15.9 48.8† 50.7† 14.9
General Health          
   Mean score (SD) 44.0 (18.9) 48.4 (19.6) 36.9 (18.0) 47.4 (19.6) 48.5 (19.7) 37.2 (17.1) 47.5 (20.3) 47.6 (19.2) 36.9 (16.6)
   Mean change from BL 8.9 (1.1)† 11.1 (1.1)† 2.4 (1.3) 13.2 (0.9)† 14.0 (0.9)† 3.7 (1.2) 13.0 (0.9)† 13.0 (0.9)† 3.1 (1.3)
% MCID 31.1 32.7‡ 24.2 44.3† 45.7† 11.3 40.3† 40.6† 10.3
Vitality          
   Mean score (SD) 48.2 (21.4) 50.0 (21.3) 37.0 (19.1) 50.9 (21.6) 51.4 (21.3) 38.3 (19.9) 50.7 (21.7) 51.1 (20.9) 38.4 (20.0)
   Mean change from BL 12.9 (1.3)† 14.4 (1.4)† 2.8 (1.6) 15.5 (1.1)† 16.2 (1.1)† 4.7 (1.5) 15.1 (1.0)† 15.6 (1.0)† 4.5 (1.5)
% MCID 35.5‡ 35.3‡ 27.0 45.1† 45.7† 12.2 40.8† 42.8† 11.2
Social Functioning          
   Mean score (SD) 64.8 (25.2) 64.0 (24.4) 50.6 (25.1) 66.6 (25.7) 65.7 (24.4) 50.8 (25.7) 67.2 (25.9) 66.2 (25.3) 50.6 (25.4)
   Mean change from BL 15.6 (1.6)† 14.7 (1.6)† 2.6 (1.9) 18.3 (1.3)† 18.1 (1.3)† 3.4 (1.8) 18.5 (1.3)† 18.6 (1.3)† 3.2 (1.8)
% MCID 39.5‡ 36.8 30.1 45.3† 48.3† 11.7 43.5† 44.4† 11.2
Role Emotional          
   Mean score (SD) 50.4 (43.0) 50.8 (43.9) 37.4 (41.2) 50.2 (42.9) 54.1 (43.4) 36.3 (40.9) 52.8 (43.0) 53.9 (43.5) 35.7 (40.6)
   Mean change from BL 19.2 (2.8)‡ 19.3 (2.9)‡ 6.6 (3.3) 22.2 (2.2)† 26.4 (2.2)† 7.8 (3.1) 23.9 (2.3)† 26.1 (2.2)† 7.1 (3.1)
% MCID 25.5‡ 22.4 17.4 31.7† 33.2† 10.8 29.0† 29.7† 9.2
Mental Health          
   Mean score (SD) 64.1 (19.4) 64.5 (20.2) 56.1 (19.7) 64.3 (20.1) 63.8 (20.2) 56.3 (21.1) 64.3 (20.4) 63.3 (19.9) 55.8 (21.1)
   Mean change from BL 9.3 (1.2)† 8.9 (1.2)† 2.1 (1.4) 11.0 (1.0)† 10.5 (1.0)† 3.7 (1.3) 10.7 (1.0)† 9.9 (1.0)† 3.0 (1.4)
% MCID 33.3‡ 27.4 27.0 40.8† 37.1† 14.3 37.3† 33.9† 11.2
  1. *SF-36 PCS, MCS and domain scores, adjusted mean change from baseline, and percentage of patients reporting improvements meeting or exceeding MCID. Changes from baseline were analyzed using ANCOVA with region and treatment as factors, and baseline as covariate (using LOCF imputation of missing data).
  2. P < 0.001; ‡P < 0.05.
  3. BL = baseline; CZP = certolizumab pegol; ITT = intent to treat; LOCF = last observation carried forward; MCID = minimal clinically important difference; MCS = mental component summary; MTX = methotrexate; PBO = placebo; PCS = physical component summary; SD = standard deviation; SF-36 = short-form 36-item health survey.