Table 1.
Summary of RCTs on ustekinumab in Crohn’s disease
| Name of the study | Type of RCT | Number of patients | Primary endpoint | Relevant secondary endpoints | Results | Serious adverse eventsa |
|---|---|---|---|---|---|---|
| Sandborn et al14 | Phase IIa, (crossover), moderate-to-severe Crohn’s | 104 | Clinical response at week 8 | USTb: 49% PBO: 40% | USTb: 4% | |
| Clinical response at week 4 and 6 | USTb: 53% PBO: 30% | PBO: 6% | ||||
| 49 (subgroup: previous exposure to IFX) | Clinical response at week 8 | USTb: 59% PBO: 26% | ||||
| CERTIFI13 | Phase IIb, moderate- to-severe Crohn’s: resistant to anti-TNF | 526 | Clinical response at week 6 | UST: 39.7% (6 mg/kg dose IV) PBO: 23.5% | USTc: 5.8% | |
| PBO: 8.3% | ||||||
| 145 (subgroup: responders put on maintenance) | Clinical response at week 22 | UST: 69.4% (90 mg SC) PBO: 42.5% | UST: 12.5%d | |||
| Clinical remission at weeks 22 | UST: 41.7% (90 mg SC) PBO: 27.4% | PBO:16.4% | ||||
| UNITI-138,39 | Phase III, moderate-to- severe Crohn’s: failed/intolerant to anti-TNF | 741 | Clinical response at week 6 | UST: 33.7% (6 mg/kg IV), 34.3% (130 mg IV) PBO: 21.5% | UST: 7.2% (6 mg/kg IV), 4.9% (130 mg IV) | |
| Clinical remission at week 8 | UST: 20.9% (6 mg/kg IV), 15.9% (130 mg IV) PBO: 7.3% | |||||
| Clinical response at week 8 | UST: 37.8% (6 mg/kg IV), 33.5% (130 mg IV) PBO: 20.2% | |||||
| PBO: 6.1% | ||||||
| UNITI-238,40 | Phase III, moderate-to- severe Crohn’s | 628 | Clinical response at 6 weeks | UST: 55.5% (6 mg/kg IV), 51.7% (130 mg IV) PBO: 28.7% | UST: 2.9% (6 mg/kg IV), 4.7% (130 mg IV) | |
| Clinical remission at week 8 | UST: 40.2% (6 mg/kg IV), 30.6% (130 mg IV) PBO: 19.6% | |||||
| Clinical response at week 8 | UST: 57.9% (6 mg/kg IV), 47.4% (130 mg IV) PBO: 32.1% | |||||
| PBO: 5.8% | ||||||
| IM-UNITI38,41 | Phase III maintenance, UNITI-1 and UNITI-2 responders | 397 | Clinical remission at week 44 | UST: 53.1% (90 mg SC q8w), 48.8% (90 mg SC q12w) | UST: 9.9% (q8w), 12.2% (q12w) | |
| PBO: 35.9% | ||||||
| Clinical response at week 44 | UST: 59.4% (90 mg SC q8w), 58.1% (90 mg SC q12w) | PBO: 15.0% | ||||
| PBO: 44.3% | ||||||
| Corticosteroid-free remission at week 44 | UST: 46.9% (90 mg SC q8w), 42.6% (90 mg SC q12w) | |||||
| PBO: 29.8% | ||||||
| Continued remission at week 44 among those in remission at inclusion | UST: 66.7% (90 mg SC q8w), 56.4% (90 mg SC q12w) | |||||
| PBO: 45.6% | ||||||
| Clinical remission at 44 anti-TNF refractory/intolerant | UST: 41.1% (90 mg SC q8w), 38.6% (90 mg SC q12w) | |||||
| PBO: 26.2% | ||||||
| Clinical remission at 44 conventional therapy failures | UST: 62.5% (90 mg SC q8w), 56.9% (90 mg SC q12w) | |||||
| PBO: 44.2% | ||||||
| Clinical remission at 44 anti-TNF naïve | UST: 65.4% (90 mg SC q8w), 56.6% (90 mg SC q12w) | |||||
| PBO: 49.0% |
Notes:
a
Through week 8 unless specified.
b
Combined subcutaneous and intravenous group.
c
Combined data for 1, 3, and 6 mg/kg IV induction groups.
d
Through week 22.
Abbreviations: IFX, infliximab; PBO, placebo; TNF, tumor necrosis factor; UST, ustekinumab; RCTs, randomized control trials; IV, intravenous; SC, subcutaneous; q8w, every 8 weeks; q12w, every 12 weeks.