An analysis of number needed to treat to obtain clinically important improvement† in PRO with golimumab treatment.
| Proportion of Patients Achieving Clinically Important Improvement† | ||||
|---|---|---|---|---|
| Visit/PRO | Placebo + MTX (%) | Golimumab, 2 mg/kg + MTX (%) | P value vs Placebo + MTX | Number Needed to Treat |
| Week 12 | ||||
| SF-36 PCS | 32.0 | 52.9 | < 0.001 | 4.8 |
| SF-36 MCS | 33.5 | 47.9 | < 0.001 | 7.0 |
| EQ-5D VAS | 29.8 | 46.5 | < 0.001 | 6.0 |
| FACIT-Fatigue | 42.8 | 57.5 | < 0.001 | 6.8 |
| Week 16 | ||||
| SF-36 PCS | 36.6 | 60.8 | < 0.001 | 4.1 |
| SF-36 MCS | 35.0 | 58.2 | < 0.001 | 4.3 |
| EQ-5D VAS | 31.4 | 54.6 | < 0.001 | 4.3 |
| FACIT-Fatigue | 39.2 | 64.4 | < 0.001 | 4.0 |
| Week 24 | ||||
| SF-36 PCS | 37.6 | 65.6 | < 0.001 | 3.6 |
| SF-36 MCS | 35.0 | 57.2 | < 0.001 | 4.5 |
| EQ-5D VAS | 39.0 | 60.4 | < 0.001 | 4.7 |
| FACIT-Fatigue | 40.3 | 65.8 | < 0.001 | 3.9 |
↵† Clinically important improvements were defined as change ≥ 5 points for SF-36 PCS and MCS, change ≥ 1/2 SD for EQ-5D VAS, and change ≥ 4 points for FACIT-Fatigue. FACIT-Fatigue: Functional Assessment of Chronic Illness Therapy-Fatigue; MTX: methotrexate; SF-36 PCS/MCS: Medical Outcomes Study Short Form-36 questionnaire physical/mental component summary; PRO: patient-reported outcome: VAS: visual analog scale.