P187 Clinical follow-up of patients with Crohn's disease treated with ustekinumab in our hospital
T. Valdes Delgado*1, C. A. Moreno Márquez1, M. F. Guerra Veloz1, L. Castro Laria1, B. Maldonado Pérez1, V. Merino Bohórquez2, F. Argüelles Arias1
1Hospital Universitario Virgen Macarena, Gastroenterology Unit, Seville, Spain, 2Hospital Universitario Virgen Macarena, Pharmacology, Seville, Spain
Background
Major advances of knowledge in the immunology and pathophysiology of the intestinal inflammatory processes have helped to identify novel molecular targets for drugs and potential new therapeutic approaches fot the treatment of Inflammatory Bowel Intestinal (IBD), one of those target is Anti-Interleukin pathway. Currently, highlighting ustekinumab for moderate–severe Crohn’s disease (CD) and previous anti-TNF failure. The aim of our study was to evaluate, according to clinical practice, the characteristics and evolution of CD in patients receiving Ustekinumab in our hospital.
Methods
This is an observational and prospective study about a cohort of patients with long-standing CD and failures to other biologic drugs, in treatment with Ustekinumab from November 2017 to November 2018. We assessed characteristics of the disease in each patient, based on the Montreal Classification, activity scores (CDAI and Harvey–Bradshaw) and clinical patients’ evolution at 12 and 24 weeks after the beginning of Ustekinumab.
Results
We included 23 patients with CD, 43.5% (10/23) were men with an average age of 41.9 ± 11.3 years. In 65.2% (15/23) the location was ileocolic (L3), 21.7% (5/23) presented ileal involvement (L1), and 8.7% (2/23) colonic location (L2). The disease had an inflammatory behaviour (B1) in 39.1% (9/23), fistulizing (B3) in 34.8% (8/23), and the remaining 26.1% (6/23) presented a stenosing behaviour (B2) (Table 1).
Table 1. Demographic characteristics
| Demographic characteristics | |
|---|---|
| Sex | |
| Men | 10 (43.5) |
| Women | 13 (56.5) |
| Montreal classification | |
| Age | A1: 1 (4.3) A2: 19 (82.6) A3: 3 (13) |
| Location | L1: 5 (21.7) L2: 2 (8.7) L3: 15 (65.2) |
| Behaviour | B1: 9 (39.1) B2: 6 (26.1) B3: 8 (34.8) |
| Perianal affectation | 12 (52.2) |
| > 2 previous biologics | 23 (100) |
Perianal involvement was present in 52.2% (12/23) of patients and 30.4% (7/23) had extraintestinal manifestations. The most common reported were polyarthralgias, followed by dermatological involvement. In the first visit, the CDAI average score of 176 and the Harvey–Bradshaw index of 10.6. At the second visit (at 12 weeks) both showed a decrease to 88.5 points and 6 points, respectively. The third visit (at 24 weeks) was completed by 11 patients, maintaining all of them clinical remission, with a CDAI average score of 46.5 and Harvey–Bradshaw index of 4 (Table 2).
Table 2. Disease activity indices
| Visit 1 (Week 0) | Visit 2 (Week 12) | Visit 3 (Week 24) | |
|---|---|---|---|
| CDAI | 176 | 88.5 | 46.5 |
| Harvey–Bradshaw | 10.6 | 6 | 4 |
Conclusion
Treatment with ustekinumab seems to be an effective alternative in patients with advanced CD and previous anti-TNF or vedolizumab failure, warranting further evaluation with a larger cohort and a longer term follow-up.