Table 2 |.
Efficacy data of the included studies for the use of anti-TNF agents in Crohn’s disease
| Study | Drug | Endpoint | Study design | Follow-up (weeks) |
Results |
|
|---|---|---|---|---|---|---|
| Control (%) | Anti-TNF (%) | |||||
| Induction of clinical remission in Crohn’s disease | ||||||
| Hanaeur et al. 2006’4 (CLASSIC-1) | Adalimumab | Remission (CDAI) | All subjects included | 4 | 9/74 (12.2) | 27/76 (35.5) |
| Sandborn et al. 20077 (GAIN) | Adalimumab | Remission (CDAI) | All subjects included | 4 | 12/166 (7.2) | 34/159 (21.4) |
| Sandborn et al. 20075 (PRECISE-I) | Certolizumab Pegol | Remission (CDAI) | All subjects included | 6 | 57/329 (17.3) | 71/331 (21.4) |
| Sandborn et al. 201110 | Certolizumab Pegol | Remission (CDAI) | All subjects included | 6 | 53/215 (24.6) | 68/223 (30.5) |
| Schreiber et al. 20053 | Certolizumab Pegol | Remission (CDAI) | All subjects included | 12 | 17/73 (23.3) | 19/73 (26.0) |
| Targan et al. 19971 | Infliximab | Remission (CDAI) | All subjects included | 12 | 2/25 (8.0) | 8/27 (29.6) |
| Induction of clinical response in Crohn’s disease | ||||||
| Hanaeur et al. 20064 (CLASSIC-1) | Adalimumab | Response (CDAI Decrease by 100) | All subjects included | 4 | 18/74 (24.3) | 38/76 (50.0) |
| Sandborn et al. 20077 (GAIN) | Adalimumab | Response (CDAI Decrease by 100) | All subjects included | 4 | 41/166 (24.7) | 61/159 (38.4) |
| Sandborn et al. 20075 (PRECISE-I) | Certolizumab Pegol | Response (CDAI Decrease by 100) | All subjects included | 6 | 87/329 (26.4) | 115/331 (34.7) |
| Sandborn et al. 201110 | Certolizumab Pegol | Response (CDAI Decrease by 100) | All subjects included | 6 | 71/215 (33.0) | 87/223 (39.0) |
| Schreiber et al. 20053 | Certolizumab Pegol | Combined endpoint: response (CDAI decrease by 100)† remission (CDAI)* | All subjects included | 12 | 26/73 (35.5) | 32/73 (43.8) |
| Targan et al. 19971 | Infliximab | Response (CDAI Decrease by 70) | All subjects included | 12 | 3/25 (12.0) | 13/27 (48.1) |
| Maintenance of clinical remission in Crohn’s disease | ||||||
| Colombel et al. 20079 (CHARM) | Adalimumab | Remission (CDAI) | Responders only | 26 | 29/170 (17.1) | 68/172 (39.5) |
| Sandborn et al. 20076 (CLASSIC-II) | Adalimumab | Remission (CDAI) | Responders only | 24 | 9/18 (50.0) | 16/19 (84.2) |
| Sandborn et al. 20075 (PRECISE-I) | Certolizumab Pegol | Remission (CDAI) | All subjects included | 26 | 32/329 (9.7) | 47/331 (14.2) |
| Schreiber et al. 20078 (PRECISE-II) | Certolizumab Pegol | Remission (CDAI) | Responders only | 26 | 60/212 (28.3) | 103/216 (47.7) |
| Hanauer et al. 20022 (ACCENT-1) | Infliximab | Remission (CDAI) | Responders only | 30 | 23/110 (20.9) | 44/113 (38.9) |
| Maintenance of clinical response in Crohn’s disease | ||||||
| Colombel et al. 20079 (CHARM) | Adalimumab | Response (CDAI) | Responders only | 26 | 45/170 (26.5) | 89/172 (51.7) |
| Sandborn et al. 20076 (CLASSIC-II) | Adalimumab | Response (CDAI) | Responders only | 24 | 11/18 (61.1) | 16/19 (84.2) |
| Sandborn et al. 20075 (PRECISE-I) | Certolizumab Pegol | Response (CDAI) | All subjects included | 26 | 52/329 (15.8) | 75/331 (22.7) |
| Schreiber et al. 20078 (PRECISE-II) | Certolizumab Pegol | Response (CDAI) | Responders only | 26 | 76/212 (35.8) | 135/216 (62.5) |
Clinical remission by CDAI (Crohn's disease activity index) defined as score <150 points. Clinical response by CDAI defined as a reduction of ≥100 points, except in Targan et al. 1997, where response was defined by a decrease ≥70 points. For the study design column, 'All subjects included* means that the outcome of interest was measured among all trial participants. For the study design column, 'Responders only' means that the outcome of interest was measured only among those found to have had a positive response by CDAI score (reduction in CDAI by 70 points) within 4 weeks (people who did not achieve this, nonresponders, were not analysed in the outcome of interest). Acronyms of studies are provided in parentheses if available.
In Schreiber et al. 2005, this result was a combined endpoint of clinical response and clinical remission (response and remission defined as above).