Table 3 Improvements in patient-reported outcome measures during long-term adalimumab treatment
Patient-reported outcome measureDuration of adalimumab exposure, weeks
24, N48, N72, N104, N
HAQ DI*
    Change from baseline, mean (SD)−0.3 (0.5) 298−0.3 (0.5) 298−0.3 (0.5) 298−0.3 (0.5) 298
    Percentage change from baseline, mean (SD)−41.2 (55.7) 271−41.9 (58.5) 271−41.8 (53.1) 271−42.7 (56.1) 271
    Patients† achieving the MCID ⩾−0.3 points, %45.6, 28548.7, 27147.7, 26047.6, 231
    Patients† with complete resolution (HAQ DI  =  0), %31.9, 28535.8, 27138.5, 26038.5, 231
SF-36 PCS‡
    Change from baseline, mean (SD)9.0 (9.7) 28410.2 (10.2) 2859.7 (10.5) 2869.4 (10.5) 286
    Percentage change from baseline, mean (SD)33.8 (41.7) 28438.4 (44.5) 28536.7 (45.1) 28635.8 (44.4) 286
    Patients† achieving the MCID ⩾3 points, %75.0, 27276.4, 25974.6, 24878.6, 42
SF-36 MCS‡
    Change from baseline, mean (SD)2.5 (9.2) 2842.4 (9.8) 2852.3 (10.6) 2862.3 (10.8) 286
    Percentage change from baseline, mean (SD)8.8 (26.4) 2848.6 (27.7) 2859.1 (29.3) 2869.4 (30.5) 286
    Patients† achieving the MCID ⩾3 points, %43.8, 27242.5, 25945.2, 24850.0, 42
FACIT-F§
    Change from baseline, mean (SD)6.5 (10.0) 2886.7 (9.8) 2886.2 (10.4) 2886.1 (10.4) 288
    Percentage change from baseline, mean (SD)48.3 (170.6) 28753.5 (227.3) 28750.2 (195.4) 28750.6 (195.7) 287
    Patients† achieving the MCID ⩾3 points, %66.1, 28066.3, 26766.5, 25476.7, 43
DLQI¶
    Change from baseline, mean (SD)−6.6 (6.5) 126−6.1 (6.9) 126−5.8 (7.3) 126−5.8 (7.4) 126
    Percentage change from baseline, mean (SD)−61.4 (66.9) 122−59.4 (66.7) 122−50.8 (88.6) 122−49.3 (91.6) 122
    Patients† achieving the MCID ⩾−5.7 points, %52.9, 11949.5, 11148.1, 10456.3, 16
    Patients† achieving a score of 0 or 1, %58.8, 11968.5, 11157.7, 10468.8, 16
Patient’s assessment of pain**
    Change from baseline, mean (SD)−22.3 (26.8) 298−24.0 (26.9) 298−22.8 (27.2) 298−23.4 (27.6) 298
    Percentage change from baseline, mean (SD)−29.4 (100.3) 296−32.4 (113.5) 296−38.9 (61.9) 296−36.0 (95.6) 296
Patients global assessment of disease activity††
    Change from baseline, mean (SD)−21.2 (27.3) 298−22.4 (28.3) 298−21.1 (28.3) 298−21.6 (28.9) 298
    Percentage change from baseline, mean (SD), n−19.5 (131.4) 297−23.0 (139.9) 297−27.1 (99.5) 297−23.0 (165.2) 297

  • Values are by last-observation-carried-forward analysis unless otherwise noted.

  • *The health assessment questionnaire disability index (HAQ DI) is scored on a scale from 0 to 3 units, with a greater score indicating more functional limitations; 0 indicates complete resolution of functional loss.

  • †Observed data.

  • ‡For both the short form 36 physical component summary (SF-36 PCS) and mental component summary (MCS) scores, greater values indicate improvement.

  • §The functional assessment of chronic illness therapy–fatigue (FACIT–F) scale score has a range from 0 to 52, with a greater score indicating less fatigue; greater values indicate improvement.

  • ¶The dermatology life quality index (DLQI) score has a range from 0 to 30, with a greater score indicating a more impaired quality of life; lower values indicate improvement.

  • **Patient’s assessment of pain is based on a visual analogue scale with a range from 0 (no pain) to 100 (pain as bad as it could be).

  • ††Patient’s global assessment of disease activity is based on visual analogue scale range from 0 (very well) to 100 (very poorly).

  • MCID, minimum clinically important difference.