Table 2.
Cross‐classification of predicted responses using the RAPID‐3 versus the CDAI in the 658 patients with an assessment at week 12 (full analysis set)a
| RAPID‐3–based classificationb | Total no. (%) of patients | CDAI‐based classificationc | ||
|---|---|---|---|---|
| Predicted responder (n = 557) | Predicted nonresponder (n = 79) | Treatment failure (n = 22) | ||
| Predicted responder | 475 (100) | 440 (92.6) | 29 (6.1) | 6 (1.2) |
| Predicted nonresponder | 103 (100) | 79 (76.7) | 19 (18.4) | 5 (4.9) |
| Treatment failure | 80 (100) | 38 (47.5) | 31 (38.8) | 11 (13.8) |
Two patients (1 in each assessment arm) were excluded because of missing baseline data; none were excluded because of missing week 12 data. Those who could be classified both as a responder (based on a low absolute value) and as a treatment failure (based on poor improvement from baseline) were considered treatment failures (n = 3). Values are the number of patients (% of the row total). Unweighted κ for agreement = 0.22 (95% confidence interval 0.16–0.28).
For the Routine Assessment of Patient Index Data 3 (RAPID‐3) assessment arm, responders were those who had improvement of >3.6 from baseline or had a RAPID‐3 score of ≤6, treatment failures were those who had improvement of ≤0 from baseline, and nonresponders were those who could not be classified as either a responder or a treatment failure.
For the Clinical Disease Activity Index (CDAI) assessment arm, responders were those who had improvement of >11 from baseline or had a CDAI score of ≤10, treatment failures were those who had improvement of <1 from baseline, and nonresponders were those who could not be classified as either a responder or a treatment failure.