Z Gastroenterol 2020; 58(08): e116
DOI: 10.1055/s-0040-1716048
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Etrolizumab induction therapy improves patient-reported outcomes, endoscopic activity and histologic severity in patients with moderate-severe Ulcerative colitis after failure of anti-TNF therapy: results from the HICKORY open label induction trial

P Hasselblatt
1   Universitätsklinik Freiburg, Innere Medizin II/Gastroenterologie, Freiburg, Deutschland
,
L Peyrin-Biroulet
2   Universite de Lorraine, Vanoeuvre-les-Nancy, Frankreich
,
DT Rubin
3   University of Chicago Medicine, Chicago, Vereinigte Staaten von Amerika
,
B Feagan
4   University of Western Ontario, London, Kanada
,
YS Oh
5   Genentech, Inc., South San Francisco, Vereinigte Staaten von Amerika
,
H Tyrrell
6   Roche Products Limited, Welwyn Garden City, Vereinigtes Königreich
,
RK Pai
7   Mayo Clinic, Scottsdale, Vereinigte Staaten von Amerika
,
A Boruvka
8   F. Hoffmann La-Roche, Mississauga, Kanada
,
A Scherl
5   Genentech, Inc., South San Francisco, Vereinigte Staaten von Amerika
,
S Williams
6   Roche Products Limited, Welwyn Garden City, Vereinigtes Königreich
,
S Tole
5   Genentech, Inc., South San Francisco, Vereinigte Staaten von Amerika
,
J Thommes
5   Genentech, Inc., South San Francisco, Vereinigte Staaten von Amerika
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    Introduction Ulcerative colitis (UC) patients intolerant/refractory (IR) to anti-TNFs are difficult to treat. Several objective markers for clinical, endoscopic and histological response are currently being assessed in clinical trials The HICKORY open label induction (OLI) trial evaluated the safety and efficacy of etrolizumab in patients I/R to anti-TNF. Here we assessed patient reported outcomes (PRO), centrally read endoscopy and histology in this population.

    Methods All patients (n=130) received Etrolizumab (ETRO) 105 mg s.c. every 4 weeks (wk) for 14 wk. Mayo Scores (MCS, incl. Subscores for endoscopy [ES], rectal bleeding [RB] and stool frequency [SF]) were assessed at baseline and wk 14. Established criteria of clinical response and remission according to the Mayo score were used. Sigmoid biopsies were taken at baseline and wk 14 (n=98) and assessed by 4 central readers using the validated Robarts (RHI) and Nancy (NHI) histology indices.

    Results Median MCS at baseline was 9.4 (n=130). After 14 wk of ETRO therapy clinical response and remission were observed in 51 % and 12 % of patients, respectively. Endoscopic remission (ES ≤ 1) occurred in 24 %; and 44 % of pts had a ≥ 1-point improvement in ES. Improved ES was also associated with increased remission rates in RB and SF. All patients with ES = 0 reported RB ≤ 1 while 90 % reported SF ≤ 1. Histology at 14 wk revealed a decrease in NHI/RHI scores by a mean of 0.7/6.3. A ≥ 2-point improvement in NHI was achieved in 36 % of all pts, 48 % of clinical responders, and 85 % of clinical remitters. A NHI score ≤ 1 was achieved in 20 %, 33 %, and 69 %, respectively. A ≥ 50 % decrease in RHI was achieved in 43 % (all pts), 54 % (responders) and 85 % (remitters). A RHI score ≤ 3 was achieved in 22 %, 37 %, and 77 %, respectively.

    Conclusions aTNF-I/R patients with moderate-severe UC and high disease burden treated with open label ETRO for 14 wk achieved clinically meaningful response and remission rates as well as endoscopic and histological improvement. These results demonstrate that centrally read histological analysis using RHI or NHI correlated with MCS-based clinical outcomes.


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    Publication History

    Article published online:
    08 September 2020

    © Georg Thieme Verlag KG
    Stuttgart · New York