Table 1.
Pivotal clinical trials of the three anti-TNF drugs approved for CD patients.
| Drug | Trials (Ref) | Patients | End-Points | Results |
|---|---|---|---|---|
| Infliximab (IFX) | ACCENT I (72) ACCENT II (73) SONIC (74) |
335/573 responders at week 2 282 222 |
Remission at week 30 Fistulas’ healing at week 54 Steroid-free remission and mucosal healing at week 26 |
IFX 5 mg/Kg: 44/113 (39%) IFX 10 mg/Kg: 50/112 (45%) Placebo: 23/110 (21%) IFX induction + 8 week maintenance: 50/138 (36%) IFX induction + placebo: 27/144 (19%) Remission—IFX + AZA: 96/169 (57%) IFX: 75/169 (44%) AZA: 51/170 (30%) Mucosal healing—IFX + AZA: 47/107 (44%) IFX: 28/93 (30%) AZA 18/109 (17%) |
| Adalimumab (ADA) | CLASSIC I (75) CLASSIC II(76) CHARM (77) GAIN (78) Extend (79) |
299 259 499/854 responders at week 4 325 135 |
Remission at week 4 Remission at week 56 Remission at week 26 and 56 Fistulas healing at week 56 Remission rate at week 4 in patients IFX non responders Mucosal healing at week 12 and 52 |
ADA 160/80 mg: 27/76 (36%) ADA 80/40 mg: 18/75 (24%) ADA 40/20 mg: 13/74 (18%) Placebo: 9/74 (12%) ADA 40 mg/2 week: 15/19 (79%) ADA 40 mg/week: 15/18 (83%) Placebo: 8/18 (44%) ADA with dose optimization: 93/204 (46%) Week 26—ADA 40 mg/2 week: 68/172 (40%) ADA 40 mg/week: 75/157 (47%) Placebo: 29/170 (17%) Week 56—ADA 40 mg/2 week: 62/172 (36%) ADA 40 mg/week: 65/157 (41%) Placebo: 20/170 (12%) ADA 40 mg/2 week: 10/30 (33%) ADA 40 mg/week: 11/40 (28%) Placebo: 6/47 (13%) ADA: 34/159 (21%) Placebo: 12/166 (7%) Week 12—ADA 40 mg/2 week: 17/62 (27%) Placebo: 8/61 (13%) Week 52—ADA 40 mg/2 week: 15/62 (24%) Placebo: 0/61 (0%) |
| Certolizumab pegol (CZP) | PRECISE1 (80) PRECISE2 (81) PRECISE3 (82) |
655 425 241 from PRECISE2 |
Remission at week 6 and 26 Remission at week 26 Remission at week 52 and 80 |
Week 6—CZP: 71/329 (22%) Placebo: 57/326 (17%) Week 6 and 26—CZP: 47/327 (14%) Placebo: 32/326 (10%) CZP: 103/215 (48%) Placebo: 61/210 (29%) Week 52—CZP continuous group: 58/141 (41%) Drug-interruption group *: 30/100 (30%) Week 80—CZP continuous group: 51/141 (36%) Drug-interruption group *: 23/100 (23%) |
* Patients who had CZP from week 0 to 6, then placebo from week 6 to 26 (from PRECISE2), then CZP to week 80 (in PRECISE3).