Table 3.
Endpoints for Dual Biologic Therapy (DBT)
| Baseline | Post-Treatment | |
|---|---|---|
| PRO-2 score (median) † | 24.1 | 13.4 |
| Clinical Remission | 0/22 (0%) | 9/22 (41%) |
| Mild | 2/22 (9%) | 2/22 (9%) |
| Moderate | 20/22 (91%) | 9/22 (41%) |
| Severe | 0/22 (0%) | 2/22 (9%) |
| Clinical Response | n/a | 11/22 (50%) |
| Endoscopic ‡ | ||
| Remission | 0/23 (0%) | 6/23 (26%) |
| Improvement | n/a | 10/23 (43%) |
| C-reactive protein (median) | 17 mg/L | 9 mg/L |
| Albumin (median) | 36 g/L | 37 g/L |
| Perianal fistula present | 12/24 (50%) | 8/24 (33%) |
| Required surgery | n/a | 8/24 (33%) |
| Adverse event | n/a | 3/24 (13%) |
| Serious adverse event | n/a | 2/24 (8%) |
PRO-2 (Crohn’s disease-patient reported outcome-2 score) unable to be calculated in two trials due to presence of an ostomy.
Endoscopic endpoint data not yet available in four trials; three were consideredfailure of DBT due to surgery or entering a clinical trial - one was awaiting follow-up but achieved clinical response.