Endoscopy 2020; 52(S 01): S15-S16
DOI: 10.1055/s-0040-1704054
ESGE Days 2020 oral presentations
Friday, April 24, 2020 08:30 – 10:30 Endoscopy in flames Liffey Hall 1
© Georg Thieme Verlag KG Stuttgart · New York

INTRALESIONAL INJECTION OF ADALIMUMAB IN INTESTINAL STRICTURES OF PATIENTS WITH CROHN’S DISEASE: A RANDOMIZED, MULTICENTER, PROSPECTIVE CLINICAL TRIAL

B González-Suárez
1   Hospital Clínic Barcelona, Endoscopy Unit, Gastroenterology Department, Barcelona, Spain
,
A Giordano
1   Hospital Clínic Barcelona, Endoscopy Unit, Gastroenterology Department, Barcelona, Spain
,
C Romero
1   Hospital Clínic Barcelona, Endoscopy Unit, Gastroenterology Department, Barcelona, Spain
,
S Khorrami
2   Hospital Universitario Son Espases, Instituto de Investigación Sanitaria de Palma, Palma de Mallorca, Spain
,
A Gutierrez
3   Hospital General Universitario de Alicante, IBD Unit, Digestive Disease Department, Alicante, Spain
,
MD Martín Arranz
4   Hospital Universitario La Paz, IBD Unit, Digestive Disease Department, Madrid, Spain
,
L Argüello
5   Hospital Universitari i Politècnic La Fe, Digestive Endoscopy Unit, Valencia, Spain
,
L Marquez
6   Hospital del Mar, Department of Gastroenterology, Barcelona, Spain
,
CH Nadal
7   Hospital Universitari de Girona, Department of Gastroenterology, Girona, Spain
,
A Echarri
8   Hospital Arquitecto Marcide, IBD Unit, A, Digestive Disease Department, Coruña, Spain
,
YG Lama
9   Hospital Universitario Puerta de Hierro, IBD Unit, Digestive Disease Department, Madrid, Spain
,
J Panés
10   Hospital Clínic Barcelona, IBD Unit, Gastroenterology Department, Barcelona, Spain
,
E Ricart
10   Hospital Clínic Barcelona, IBD Unit, Gastroenterology Department, Barcelona, Spain
› Author Affiliations
Further Information

Publication History

Publication Date:
23 April 2020 (online)

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    Aims Intestinal strictures in patients with Crohn’s disease (CD) represent a challenge due to their low response rate to medical therapy and high recurrence after endoscopic or surgical treatment. The intralesional injection of anti-TNF drugs is an option not fully investigated.

    The primary endpoint was to evaluate response rate to endoscopic dilation (ED) and intralesional injection of adalimumab (ADA) or placebo in patients with CD and intestinal strictures. The secondary endpoint was to evaluate serum ADA levels and anti-ADA antibodies concentration in our cohort.

    Methods A multicenter clinical trial was conducted in 14 hospitals. Patients with CD and intestinal strictures amenable to ED without previous anti-TNF treatment were enrolled. Patients were randomized to placebo or intralesional ADA, associated to ED and received a 52-week clinical follow-up. A second endoscopy was performed at week 8; the passage of the endoscope through the stricture was considered endoscopic response to treatment.

    Results Of 102 patients enrolled, 26 met the inclusion criteria and 5 of them were screening failure. Twenty-one patients were finally included in the analysis (43% females; mean age 49.8±12.9 years). After randomization, 9 patients received intralesional placebo + ED and 12 patients intralesional ADA + ED resulting in an endoscopic response rate at week 8 of 66% and 50%, respectively (p=0.4). After one injection, ADA serum levels increased from 4 hours to one week after the injection and decreased at week 8. Two patients (9.5%) developed anti-ADA antibodies during follow-up.

    Conclusions A single intralesional injection of ADA associated to ED is not more effective than ED alone. Prospective studies with a larger sample size and, probably, repeated injections of ADA might be useful to clarify the real role of this therapeutic strategy.


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