Table 2.
Improvements from baseline to weeks 14, 24, 52, and 104 in physical function, health-related quality of life, and impact of disease on productivity*
| Placebo (n = 113) | Golimumab | |||
|---|---|---|---|---|
| 50 mg (n = 146) | 100 mg (n = 146) | Combined (n = 292) | ||
| HAQ DI score | ||||
| Week 14 | 0.04 ± 0.44 | 0.31 ± 0.50† | 0.38 ± 0.51† | 0.35 ± 0.50† |
| Week 24‡ | −0.01 ± 0.49 | 0.33 ± 0.55† | 0.39 ± 0.50† | 0.36 ± 0.53† |
| Week 52§ | 0.37 ± 0.56 | 0.41 ± 0.53 | 0.43 ± 0.53 | 0.42 ± 0.53 |
| Week 104§ | 0.36 ± 0.58 | 0.43 ± 0.56 | 0.45 ± 0.55 | 0.44 ± 0.55 |
| SF-36 PCS score | ||||
| Week 14 | 0.63 ± 7.68 | 6.53 ± 8.88† | 7.85 ± 9.55† | 7.19 ± 9.23† |
| Week 24‡ | 0.67 ± 8.72 | 7.42 ± 9.17† | 8.22 ± 9.64† | 7.83 ± 9.41† |
| Week 52§ | 8.25 ± 10.50 | 9.87 ± 9.51 | 9.19 ± 10.29 | 9.53 ± 9.90 |
| Week 104§ | 8.76 ± 11.41 | 8.70 ± 9.56 | 8.50 ± 10.45 | 8.60 ± 10.00 |
| SF-36 MCS score | ||||
| Week 14 | 0.40 ± 11.39 | 2.79 ± 10.27¶ | 3.56 ± 12.06¶ | 3.18 ± 11.20¶ |
| Week 24‡ | −0.60 ± 12.13 | 3.37 ± 10.55# | 4.29 ± 11.03# | 3.84 ± 10.79† |
| Week 52§ | 3.69 ± 11.23 | 3.95 ± 11.73 | 4.84 ± 11.60 | 4.40 ± 11.65 |
| Week 104§ | 2.99 ± 11.08 | 4.71 ± 11.35 | 4.69 ± 12.21 | 4.70 ± 11.77 |
| Impact of disease on productivity | ||||
| Week 16‡ | 0.01 ± 2.56 | 1.69 ± 2.77† | 2.43 ± 2.98† | 2.06 ± 2.90† |
| Week 24‡ | 0.08 ± 2.62 | 1.86 ± 2.74† | 2.63 ± 2.99† | 2.24 ± 2.89† |
| Week 52§ | 2.81 ± 3.23 | 2.58 ± 2.65 | 2.88 ± 3.06 | 2.74 ± 2.87 |
| Week 104§ | 2.80 ± 3.20 | 2.50 ± 2.83 | 3.12 ± 3.11 | 2.82 ± 2.99 |
Values are the mean ± SD. HAQ = Health Assessment Questionnaire; DI = disability index; SF-36 = 36-item Short Form health survey; PCS = physical component summary; MCS = mental component summary.
P <0.001 vs. placebo.
Week 16 and week 24 data were analyzed using the intent-to-treat method; the last observation carried forward method was employed to impute missing data. For patients in the placebo or golimumab 50 mg group who entered early escape, the last observation before their dose adjustment at week 16 was used for week 24 analyses. Patients in the 100 mg group were not eligible to receive a dose adjustment according to the protocol; therefore, no adjustment of week 24 data was made for patients who met the early escape criteria.
For all week 52 and week 104 analyses, a completer analysis utilizing observed data was employed.
P <0.05 vs. placebo.
P <0.01 vs. placebo.