Table 4.
Clinically important difference (CID) and responder definition (RD) estimations for FACIT-Fatigue in patients with PsA
| Model | Analysis | Anchor | Study data | Experience domain | Impact domain | Total score |
|---|---|---|---|---|---|---|
| Clinically important difference (SE) [95% CI] | ||||||
| Repeated measures model-CID | Main analysis | PtGA | Pooled | 1.45 (0.04) | 1.73 (0.05) | 3.12 (0.08) |
| [1.38, 1.52] | [1.63, 1.82] | [2.97, 3.27] | ||||
| Sensitivity analysis | PtGA | OPAL Broaden | 1.39 (0.05) | 1.66 (0.06) | 3.00 (0.10) | |
| [1.30, 1.48] | [1.53, 1.78] | [2.80, 3.19] | ||||
| OPAL Beyond | 1.53 (0.06) | 1.82 (0.08) | 3.29 (0.12) | |||
| [1.42, 1.64] | [1.67, 1.97] | [3.04, 3.53] | ||||
| SF-36 Vitality | Pooled | 1.06 (0.01) | 1.21 (0.02) | 2.25 (0.03) | ||
| [1.03, 1.08] | [1.17, 1.25] | [2.18, 2.31] | ||||
| Effect size (SD) | ||||||
| Repeated measures model-CID | Main analysis | PtGA | Pooled | 8.73 (4.54) | 18.93 (6.88) | 27.66 (10.95) |
| Sensitivity analysis | PtGA | OPAL Broaden | 9.13 (4.34) | 19.56 (6.57) | 28.69 (10.47) | |
| OPAL Beyond | 8.30 (4.72) | 18.25 (7.14) | 26.54 (11.35) | |||
| Responder definition (SE) [95% CI] | ||||||
| Repeated measures model-RD | Main analysis | SGIC | Pooled | 1.67 (0.09) | 2.12 (0.12) | 3.76 (0.20) |
| [1.49, 1.86] | [1.88, 2.37] | [3.37, 4.15] | ||||
| Sensitivity analysis | OPAL Broaden | 1.54 (0.12) | 2.02 (0.15) | 3.52 (0.25) | ||
| [1.31, 1.77] | [1.72, 2.33] | [3.03, 4.01] | ||||
| OPAL Beyond | 1.91 (0.16) | 2.30 (0.20) | 4.19 (0.33) | |||
| [1.60, 2.23] | [1.90, 2.70] | [3.54, 4.85] | ||||
Pooled data: OPAL Broaden and OPAL Beyond
CI confidence interval, CID clinically important difference; FACIT-Fatigue Functional Assessment of Chronic Illness Therapy–Fatigue; PsA psoriatic arthritis, PtGA Patient’s Global Assessment of Psoriasis and Arthritis, RD responder definition, RMM repeated measures model, SD standard deviation, SE standard error, SF-36 Short Form Survey-36, SGIC Subject Global Impression of Change