Summary of disease-activity and quality-of-life clinical endpoints at week 24 for patients receiving ofatumumab or placebo
| Ofatumumab 700 mg (n=129) | Placebo (n=131) | OR (95% CI) | p Value | |
|---|---|---|---|---|
| ACR20 | 64/129 (50%) | 35/131 (27%) | 2.86 (1.67 to 4.91) | <0.001 |
| ACR50 | 35/129 (27%) | 14/131 (11%) | 3.29 (1.63 to 6.62) | <0.001 |
| ACR70 | 17/129 (13%) | 3/131 (2%) | 6.63 (1.87 to 23.51) | 0.001 |
| EULAR response* | 87/129 (67%) | 54/131 (41%) | 3.07 (1.82 to 5.18) | <0.001 |
| Clinical remission† | 13/129 (10%) | 7/131 (5%) | 2.09 (0.76 to 5.77) | 0.152 |
| HAQ–DI response‡ | 74/129 (57%) | 59/131 (45%) | 1.65 (1.01 to 2.70) | 0.046 |
| Ofatumumab 700 mg (n=129) | Placebo (n=131) | Adjusted mean difference (95% CI) | p Value | |
| DAS28–CRP§ | ||||
| Baseline, mean (SD) | 5.83 (0.794) | 5.63 (0.800) | ||
| Week 24, mean (SD) | 4.12 (1.270) | 4.98 (1.437) | ||
| Adjusted mean (SE) change | −1.77 (0.151) | −0.77 (0.154) | −1.00 (−1.29 to −0.72) | <0.001 |
| DAS28–ESR§ | ||||
| Baseline, mean (SD) | 6.59 (0.828) | 6.41 (0.782) | ||
| Week 24, mean (SD) | 4.84 (1.360) | 5.67 (1.439) | ||
| Adjusted mean (SE) change | −1.79 (0.157) | −0.80 (0.161) | −0.99 (−1.29 to −0.69) | <0.001 |
| HAQ–DI§ | ||||
| Baseline, mean (SD) | 1.7 (0.67) | 1.5 (0.65) | ||
| Week 24, mean (SD) | 1.2 (0.79) | 1.3 (0.74) | ||
| Adjusted mean (SE) change | −0.53 (0.077) | −0.32 (0.078) | −0.22 (−0.37 to −0.07) | 0.004 |
| FACIT–F¶ | ||||
| Baseline, mean (SD) | 25.2 (10.00) | 29.5 (9.54) | ||
| Week 24, mean (SD) | 32.0 (11.52) | 30.2 (10.86) | ||
| Adjusted mean (SE) change | 7.29 (1.353) | 3.55 (1.394) | 3.75 (1.11 to 6.39) | 0.006 |
| SF-36 physical component summary score** | ||||
| Baseline, mean (SD) | 29.9 (6.73) | 31.9 (7.32) | ||
| Week 24, mean (SD) | 35.9 (9.28) | 34.8 (8.79) | ||
| Adjusted mean (SE) change | 6.69 (1.031) | 4.21 (1.048) | 2.48 (0.51 to 4.45) | 0.014 |
| SF-36 mental component summary score** | ||||
| Baseline, mean (SD) | 38.2 (11.77) | 40.1 (11.84) | ||
| Week 24, mean (SD) | 42.2 (11.38) | 40.2 (11.95) | ||
| Adjusted mean (SE) change | 4.60 (1.272) | 1.57 (1.308) | 3.03 (0.61 to 5.46) | 0.014 |
ACR20/50/70, 20%/50%/70% improvement as per American College of Rheumatology (ACR) criteria.
* EULAR response of moderate or good, based on DAS28–CRP.
† DAS28–CRP score less than 2.6.
‡ Change from baseline HAQ–DI score of 0.22 or greater.
§ Negative change represents an improvement. Patient numbers assessed: placebo (n=130); ofatumumab (n=126).
** Patient numbers assessed: placebo (n=117); ofatumumab (n=116).
¶ Patient numbers assessed: placebo (n=111); ofatumumab (n=114).
Results are reported in accordance with EULAR/ACR collaborative recommendations.33
CRP, C-reactive protein; DAS28, disease activity score based on 28 joints; EULAR, European League Against Rheumatism; ESR, erythrocyte sedimentation rate; FACIT–F, functional assessment of chronic illness therapy–fatigue; HAQ–DI, health assessment questionnaire disability index; SF-36, short-form health survey.