Table 2.
The summary of findings for the SONIC [31] study. Results of the SONIC trials. All values are in means (SD).
Study Id and Registration Number | Intervention and Comparator |
Dosage and Frequency | Results for | Intervention | Azathioprine | p Value | Conclusion |
---|---|---|---|---|---|---|---|
SONIC [31] NCT00094458 |
Infliximab (IV) and azathioprine (oral) |
Infliximab 5mg/kg given at week 2,4,6 and then every 8 weeks OR azathioprine 2.5 mg/kg |
Mean IBDQ at baseline | 126.7 (30.3) | 128 (29) | - | Non-inferiority trial favoured infliximab over azathioprine in improving HRQoL. |
Change at week 2 | 27.2 (26.1) | 20.1 (24.3) | 0.007 | ||||
Change at week 6 | 34.8 (31.8) | 28.3 (31.3) | 0.10 | ||||
Change at week 10 | 37.8 (35.6) | 31.0 (31.7) | 0.10 | ||||
Change at week 18 | 39.9 (34.2) | 30.3 (33.9) | 0.01 | ||||
Change at week 26 | 39.9 (36.6) | 31.4 (35.4) | 0.05 | ||||
Change at week 32 * | 55.8 (33.6) | 39.1 (32.9) | 0.001 | ||||
Change at week 42 * | 51.4 (32.8) | 40.3 (32.1) | 0.04 | ||||
Change at week 50 * | 51.6 (32.9) | 43.0 (33.4) | 0.09 |
* SONIC extension for maintenance therapy.