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)

13 (37,14%)
22 (62,85%)
Disease location; n,%
-  Ileal (L1)
-  Colonic (L2)
-  Ileocolonic (L3)
-  Upper digestive (L4)

5 (14%)
4 (11,43%)
26 (74,29%)
2 (5,71%)
Disease phenotype; n,%
-  Inflammatory (B1)
-  Stricturing (B2)
-  Penetrating (B3)
-  Perianal

15 (42,86%)
11 (31,43%)
9 (25,71%)
17 (48.57%)
Intestinal resection; n,%8 (22,86%)
Clinical activity
- H. Bradshaw Index; median, IQR
- CDAI; median, IQR

8 (6-10)
217 (171-247)
Laboratory markers
- CRP (mg/l); median,IQR
- Calprotectin (mg/Kg); median,IQR

5.3 (2-13.4)
670 (232-1336)
Previous treatment
- Corticosteroids
- Immunomodulators
- AntiTNF

31 (88,57%)
32 (91,42%)
33 (94,28%)  * ≥2 AntiTNF: 24 (68,57%)