Multivariable analysis of PRO measures as predictors of treatment failure
| OR | 95% CI | P value | |
| SF-36 PCS (per 10-point decrease) | |||
| All patients | 1.8 | 1.2 to 2.6 | 0.0023 |
| TCZ/PDN group | 1.8 | 1.1 to 2.9 | 0.023 |
| PBO/PDN group | 1.6 | 0.9 to 2.8 | 0.15 |
| FACIT-Fatigue scale (per 10-point decrease) | |||
| All patients | 1.6 | 1.2 to 2.2 | 0.00081 |
| TCZ/PDN group | 1.8 | 1.2 to 2.6 | 0.0028 |
| PBO/PDN group | 1.3 | 0.8 to 2.1 | 0.27 |
| PtGA (per 10-point increase) | |||
| All patients | 1.2 | 1.0 to 1.3 | 0.028 |
| TCZ/PDN group | 1.3 | 1.1 to 1.5 | 0.0078 |
| PBO/PDN group | 1.0 | 0.8 to 1.2 | 0.99 |
| SF-36 MCS (per 10-point decrease) | |||
| All patients | 1.3 | 1.0 to 1.7 | 0.040 |
| TCZ/PDN group | 1.3 | 1.0 to 1.8 | 0.090 |
| PBO/PDN group | 1.2 | 0.8 to 1.9 | 0.42 |
| EQ-5D score (per 0.1-point decrease) | |||
| All patients | 1.2 | 1.0 to 1.4 | 0.063 |
| TCZ/PDN group | 1.2 | 1.0 to 1.5 | 0.038 |
| PBO/PDN group | 1.0 | 0.8 to 1.3 | 0.85 |
Each model included a single PRO and the following predictor variables: duration of disease at baseline, prednisone dose at baseline, new-onset vs relapsing disease at baseline, sex, PMR symptoms at GCA diagnosis, jaw claudication at GCA diagnosis and (for analysis of all patients) PBO/PDN vs TCZ/PDN treatment.
EQ-5D, EuroQol-5D; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue scale; GCA, giant cell arteritis; MCS, Mental Component Summary; PBO/PDN, placebo+prednisone; PCS, physical component summary; PMR, polymyalgia rheumatica; PRO, patient-reported outcome; PtGA, Patient Global Assessment of Disease Activity; SF-36, 36-Item Short Form Survey; TCZ/PDN, tocilizumab+prednisone.