P328 Ustekinumab is an effective and safe therapy in anti-TNF refractory Crohn’s Disease: a two year real-life observational study from Spain
Rueda Sanchez, J.(1);Cabello Ramirez, M.(1);Camara Baena, S.(1);Keco Huerga, A.(1);Garcia de la Borbolla Serres, J.(1);Castro Fernandez, M.(1);Grande Santamaria, L.(1);
(1)Virgen de Valme Universitary Hospital, CGU Gastroenterology, Sevilla, Spain
Ustekinumab is a monoclonal antibody targeting IL-12/23 and was proved efficacious during the registration clinical trials. However real-world data in a day to day setting is still scarce. The aim of our study was to evaluate the effectiveness, durability and safety of ustekinumab in our real-life cohort.
We present a retrospective, observational study from a single tertiary center. We included adult CD patients that had received the standard ustekinumab intravenous induction and with at least 12-month follow-up. We assessed clinical (HBI) and biomarker (CRP, calprotectin) response at 3, 6, 12, 18 and 24 months. Adverse events, perianal disease response and corticosteroid (CS) use were also recorded.
We observed a significant decrease in median HBI in all visits. Clinical response was observed in 72.7% of patients at 12 months and 66.7% at 24 months. Clinical remission was achieved in 57.6% and 58.3% of patients at 12 and 24 months respectively. CS-free clinical remission rates were 45.5% at 12 months and 54.2% at 24 months. The most frequent maintenance dose interval was q8w, with only 6/35 patients (17,14%) requiring dose escalation due to inefficacy of standard q8w interval. Drug survival at 2 years was 93.9%. Perianal disease clinical improvement was noted in 16 out of 17 patients with perianal disease at baseline. Fecal calprotectin decreased significantly from baseline, with a median change of -66 ug/g at 12 months and -253 ug/g at 24 months.
Ustekinumab was generally well-tolerated. Two adverse events were recorded during the follow-up period, an herpes zoster and an uveitis, none of them required Ustekinumab discontinuation.
According to our results, Ustekinumab was effective, durable, and safe for moderate-severe CD in a real-life clinical setting, with more than half of patients achieving CS-free clinical remission at 24 months in an anti-TNF refractory cohort.
|N = 35|
|Age (Median, IQR)||44 (33-55)|
|Sex (M/F); n,%||15(43%) / 20 (57%)|
|Age at diagnosis; n,% |
- 17-40 y (A2)
- >40 y (A3)
|Disease location; n,% |
- Ileal (L1)
- Colonic (L2)
- Ileocolonic (L3)
- Upper digestive (L4)
|Disease phenotype; n,% |
- Inflammatory (B1)
- Stricturing (B2)
- Penetrating (B3)
|Intestinal resection; n,%||8 (22,86%)|
|Clinical activity |
- H. Bradshaw Index; median, IQR
- CDAI; median, IQR
|Laboratory markers |
- CRP (mg/l); median,IQR
- Calprotectin (mg/Kg); median,IQR
|Previous treatment |
33 (94,28%) * ≥2 AntiTNF: 24 (68,57%)