Table 3. Subgroup analysis, by trial design.
Rates of clinical remission, response and mucosal healing in biologic-treated patients in trials of induction therapy and maintenance therapy, by exposure or non-exposure to concomitant 5-ASA [variables adjusted for: sex, smoking status, baseline disease activity, disease extent, concomitant corticosteroids, concomitant immunomodulators, baseline laboratory variables including C-reactive protein, albumin and hemoglobin]
| Outcome | Concomitant 5-ASA: No | Concomitant 5-ASA: Yes | p-value |
|---|---|---|---|
| INDUCTION PHASE (Range 6–10 weeks) | |||
| Clinical remission | |||
| • Proportion (n/N) | 58 / 240 (24.2%) | 200 / 905 (22.1%) | |
| • Unadjusted OR (95% CI) | 1.0 | 0.97 (0.69, 1.37) | 0.86 |
| • Adjusted OR (95% CI) | 1.0 | 0.64 (0.38, 1.11) | 0.10 |
| Clinical Response | |||
| • Proportion (n/N) | 137 / 235 (58.3%) | 469 / 893 (52.5%) | |
| • Unadjusted OR (95% CI) | 1.0 | 0.91 (0.67, 1.26) | 0.52 |
| • Adjusted OR (95% CI) | 1.0 | 0.77 (0.47, 1.24) | 0.28 |
| Mucosal Healing | |||
| • Proportion (n/N) | 134 / 257 (52.1%) | 486 / 959 (50.7%) | |
| • Unadjusted OR (95% CI) | 1.0 | 1.05 (0.79, 1.39) | 0.75 |
| • Adjusted OR (95% CI) | 1.0 | 0.99 (0.70, 1.55) | 0.70 |
| MAINTENANCE PHASE (Range 26–54 weeks) | |||
| Clinical remission | |||
| • Proportion (n/N) | 72 / 159 (45.3%) | 281 / 685 (41.0%) | |
| • Unadjusted OR (95% CI) | 1.0 | 0.79 (0.55, 1.13) | 0.20 |
| • Adjusted OR (95% CI) | 1.0 | 0.62 (0.37, 1.06) | 0.08 |
| Clinical Response | |||
| • Proportion (n/N) | 83 / 158 (52.5%) | 319 / 687 (46.4%) | |
| • Unadjusted OR (95% CI) | 1.0 | 0.87 (0.61, 1.25) | 0.46 |
| • Adjusted OR (95% CI) | 1.0 | 1.01 (0.58, 1.76) | 0.97 |
| Mucosal Healing | |||
| • Proportion (n/N) | 98 / 245 (40.0%) | 361 / 844 (42.8%) | |
| • Unadjusted OR (95% CI) | 1.0 | 1.17 (0.87, 1.58) | 0.31 |
| • Adjusted OR (95% CI) | 1.0 | 1.18 (0.75, 1.84) | 0.48 |