Table 3:
Key findings of ustekinumab studies on specific subpopulations of patients with Crohn’s disease.
| First author | n of pts | Mean age [y] | Male n [%] | Study duration | UST-treated patients | Study aim | Primary endpoint | Main results |
|---|---|---|---|---|---|---|---|---|
| Mahadevan21 | 1490 | 32.0 | 0 [0.0%] | 21 months | 18 | To assess pregnancy outcomes in patients exposed to thiopurines and biologics | Rates of congenital malformations, SAB, preterm birth, LBW, and infections | Drug exposure did not increase the rate of congenital malformations, SAB, preterm birth, LBW, and infections over the first year of life |
| Wils22 | 73 | na | 0 [0.0%] | na | 29 | To assess maternal and neonatal complications of VDZ or UST in pregnant IBD pts | Rates of congenital malformations, SAB, preterm birth, LBW, and infections | No negative signal on maternal or neonatal outcomes |
| Chaparro23 | 433 | 34 | 0 [0.0%] | 5 years | 17 | To evaluate the risk of SAEs during pregnancy and the predictive factors of it | Rates of SAEs | Immunomodulators and biologics do not increase the risk of SAEs during pregnancy |
| Rosh24 | 44 | 13.0 | 18 [41.0%] | 16 weeks | 44 | To evaluate pharmacokinetics, safety/tolerability, and efficacy of UST in children with CD | To compare the pharmacokinetics of UST in paediatric and adult CD pts | The pharmacokinetics/safety profiles were generally consistent with those observed in adults with CD |
| Kim25 | 38 | 12.5 | na | 62 weeks | 38 | To analyse the long-term efficacy of UST in paediatric CD pts | Response to therapy | UST has long-term efficacy with no observed safety concerns. |
| Garg26 | 117 | 69.6 | 59 [50.5%] | 1.3 years | 117 | To assess the safety and efficacy of UST in elderly CD | To compare efficacy and safety of UST in elderly and young CD pts | UST is safe and effective in elderly CD |
| Asscher27 | 410 | 45.0 | 175 [42.7%] | 103.4 weeks | 207 | To evaluate the association between age and comorbidity with safety and efficacy outcomes of VDZ and UST in IBD | Infections, hospitalisations, treatment-related AEs, clinical response, and clinical remission | Comorbidity, but not age, is associated with an increased risk of hospitalisations on either treatment |
| Tursi28 | 15 | 42.0 | 9 [60.0%] | 12 months | 15 | To evaluate the efficacy of UST in operated CD patients | Clinical remission at 6 months | This is the first report on the use of ust in post-operative CD recurrence in patients previously refractory to biologics |
| Buisson29 | 63 | 37.0 | 15 [23.8%] | 6 months | 32 | To compare the efficacy of UST vs azathioprine in preventing endoscopic POR in CD | Endoscopic POR evaluated 6 months after intestinal resection | UST seems to be more effective than azathioprine in preventing endoscopic POR in this cohort of CD pts |
| Narula30 | 576 | 33.0 | 286 [49.6%] | na | 163 | To describe the clinical and endoscopic outcomes of CD pts with non-passable strictures | The likelihood that non-passable stenosis could be converted to passable stenosis | Pts with non-passable strictures can achieve symptomatic and endoscopic remission when receiving CD therapies |
| El Ouali31 | 21 | 44.0 | 11 [52.0%] | 8 months | 15 | To evaluate the outcomes of VDZ and UST in CD pts with symptomatic strictures | Time to recurrence of obstructive symptoms, time to surgical intervention | UST and VDZ may be initial options after failure of anti-TNF agents |
| Sands32 | na | na | na | 8 weeks | na | To report efficacy of UST in the treatment of perianal CD | Fistula response and complete fistula resolution | There is a consistent signal for efficacy in fistula healing that approached statistical significance in the combined analysis of fistula resolution, despite a relatively small number of pts |
| Chapuis-Biron33 | 207 | 37.7 | 75 [36.2%] | 48 weeks | 207 | To assess the efficacy of ust in perianal CD and predictors of clinical success | Clinical success at 6 months, with no need for medical or surgical treatment | UST appears as a potential effective therapeutic option in perianal refractory CD |
| Narula34 | 1398 | 38.6 | 445 [31.9%] | 52 weeks | 527 | To evaluate the efficacy of UST in treatment of EIMs | EIM resolution at Week 6 | UST did not lead to significant resolution of EIMs for CD compared with placebo at Weeks 6 and 52 |
| Tursi35 | 24 | 49.0 | 13 [54.2%] | 6 months | 24 | To report the efficacy of UST for the treatments of EIMs in CD | Remission | EIMs associated with CD respond well to UST |
| Phillips 36 |
28 | 37.0 | 8 [28.5] | na | 19 | To report the efficacy of UST to treat refractory cutaneous lesions | Remission | UST appears to be useful for different cutaneous lesions including metastatic CD, pyoderma gangrenosum, and erythema nodosum |
n, number; pts, patients; y, years; AEs, adverse events; SAEs, serious adverse events; SAB, spontaneous abortion; LBW, low birthweight;VDZ, vedolizumab; uUST, ustekinumab;IBD, inflammatory bowel disease; na, not available; CD, Crohn’s disease; POR, post-operative recurrence; EIMs, extraintestinal manifestasions.