Definitions of non-response and of predictability indices used in the study
| Definitions of non-response 9 | |||
| Outcome at M3* | CDAI | ∆ DAS28(ESR) | ∆ HAQ-DI |
| Early non-response | Score >22 | Decrease of ≤1.2 compared with baseline value | Decrease of <0.22 compared with baseline value |
| Outcome at M12* | CDAI | DAS28(ESR) | HAQ-DI |
| Treatment failure | Score >10 | Score >3.2 | Score >0.5 |
| Definitions of indices of predictability | |||
| Sensitivity | In all patients in treatment failure at M12, the proportion with early non-response observed at M3 | ||
| Specificity | In all patients with treatment success at M12, the proportion with early response observed at M3 | ||
| Predictability of non-response | In all patients identified as non-responders by M3, the proportion with treatment failure at M12 | ||
| Predictability of response | In all patients identified as responders by M3, the proportion with treatment success at M12 | ||
| Accuracy | In all patients, the proportion for whom treatment outcome (response or non-response) at M3 is the same as at M12 (either failure or success) | ||
*The CDAI criterion assessed at M3 and M12 was the absolute value of the score. For the DAS28(ESR) and the HAQ-DI, the criterion was the change in score since baseline at M3 and the absolute value of the score at M12.
CDAI, Clinical Disease Activity Index; CZP, certolizumab pegol; DAS28, 28-joint Disease Activity Score; ESR, erythrocyte sedimentation rate; HAQ-DI, Health Assessment Questionnaire Disability Index; M3, 3 months; M12, 12 months.