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REAL-WORLD DATA IN INFLAMMATORY BOWEL DISEASES ON VEDOLIZUMAB THERAPY: INTERIM ANALYSIS OF THE NON-INTERVENTIONAL LISTEN II STUDY

Hermann Schulze 1, Niels Teich 2, Andreas Stallmach 3, Taner Cavlar 4, Jana Knop 4, Sonja Henneberger 5

Affiliations

1 Agaplesion Markus-Hospital, Frankfurt am Main, Germany

2 Group Practice in Internal Medicine for Digestive and Metabolic Diseases, Leipzig, Germany

3 University Hospital Jena, Jena, Germany

4 Takeda Pharma Vertrieb GmbH & Co. KG, Berlin, Germany

5 Institut Dr. Schauerte GmbH, Munich, Germany

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Abstract

Introduction

Vedolizumab (VDZ) is a gut-selective anti-lymphocyte trafficking agent and is approved for treating patients with moderate to severe active UC (ulcerative colitis) and CD (Crohn’s disease) intravenously (IV) or subcutaneously (SC). The LISTEN II study determines patient characteristics and effectiveness in VDZ-treated patients in clinical routine with focus on patient reported outcomes (PROs).

Aims & Methods

LISTEN II is a multicentre, prospective, non-interventional study in Germany. Adult patients with UC or CD who either initiate VDZ IV or switch from IV to SC formulation, are enrolled. Data on patient characteristics, modalities of VDZ use and disease activity (pMayo and HBI) are followed up quarterly for up to one year per routine care. Electronic assessments of PROs are recorded weekly via a study-specific app (ePRO). Here, interim data up to 6 months follow-up are presented.

Results

Data of 242 UC (52% female, mean age 41 years) and 149 CD patients (60% female, mean age 40 years) were included in this analysis. VDZ treatment was newly initiated IV (start) in 206 UC and 127 CD patients and switched from IV to SC application (switch) by 36 UC and 22 CD patients at baseline. After 6-month's treatment, total mean pMayo score decreased in UC start-patients from 5.0±2.1 to 2.1±2.0 and remained at 1.0±1.3 in switch-patients. In CD-start patients HBI score decreased from 5.6±4.2 to 2.9±3.5 and from 3.0±3.5 to 2.5±2.9 in switch-patients.
The ePRO was initially used by 74% of UC and 73% of CD patients. The mean age was 39 years and the majority (84%) had newly started VDZ treatment. The initial high willingness to ePRO use declined to approx. 40% usage within the second quarter and to 30% during further follow-up. When looking at sustained usage per patient (percentage of patients who completed at least one question of ≥80% of all questionnaires available to them), 62% of UC and 55% of CD patients were sustained ePRO users. Most of UC patients (82%) and CD patients (88%) used a support program for the first time.
ePRO users with UC more frequently reported high burden of disease at study inclusion compared to those with CD (55% versus 25%; high burden of disease defined for UC as pMayo >4 and CD as HBI >7), with a mean pMayo score of 4.4±2.5 for UC and mean HBI score of 5.3±4.2 for CD patients. Overall, mean scores for ePRO symptoms declined within the follow-up period from baseline to 6 months. The absolute decline was most pronounced for symptoms impact on work productivity (3.9 to 1.9 points) in UC patients and sick leave (1.2 to 0.6 points) for CD patients (table).

Table: ePRO progression of UC and CD patients

UC patients Symptoms (Score range)	General wellbeing (0-4)	Impact on work productivity (0-10)	Sick leave (days per week) (0-7)	Rectal bleeding (0-3)
Baseline mean (SD)	N=180 1.7 (0.9)	N=171 3.9 (3.0)	N=177 1.1 (2.3)	N=175 1.3 (1.2)
3 Month mean (SD)	N=115 1.3 (0.8)	N=111 2.3 (2.6)	N=111 0.4 (1.5)	N=111 0.5 (0.9)
6 Month mean (SD)	N=78 1.2 (0.6)	N=76 1.9 (2.2)	N=76 0.2 (1.0)	N=76 0.3 (0.6)
CD patients Symptoms (Score range)	General wellbeing (0-4)	Impact on work productivity (0-4)	Sick leave (days per week) (0-7)	Abdominal pain (0-4)
Baseline mean (SD)	N=107 1.7 (0.9)	N=106 1.6 (1.1)	N=104 1.2 (2.5)	N=107 1.7 (1.1)
3 Month mean (SD)	N=70 1.5 (0.7)	N=70 1.1 (1.0)	N=69 1.0 (2.3)	N=70 1.2 (0.9)
6 Month mean (SD)	N=41 1.4 (0.7)	N=41 1.1 (1.0)	N=40 0.6 (1.9)	N=41 1.1 (0.7)

Conclusion

LISTEN II real-world data support the effectiveness of VDZ treatment in UC and CD patients. Patients, newly starting VDZ IV showed a decrease in disease activity under VDZ treatment, while for patients switching from existing VDZ IV to SC maintained therapeutic effectiveness was observed. UC and CD patients reported a steady improvement of relevant symptoms under VDZ treatment using the ePRO, however app adherence declined to 30% during follow-up.

Disclosure

Hermann Schulze, Andreas Stallmach and Niels Teich are involved in the data collection for this study and Andreas Stallmach is the Scientific Lead of the study. Hermann Schulze and Niels Teich receive payments from Takeda Pharma Vertrieb GmbH & Co. KG for their participation as advisory members of the study steering committee of this study. Sonja Henneberger participated in this study as a staff member of Institut Dr. Schauerte GmbH (IDS). The work of IDS was funded by Takeda Pharma Vertrieb GmbH & Co. KG. Taner Cavlar and Jana Knop are employees of Takeda Pharma Vertrieb GmbH & Co. KG. Taner Cavlar is owner of Takeda shares.

Conference

UEG Week Copenhagen 2023

Topics

IBD

Submission format

Abstract

Session

PP 05 IBD (Posters)

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

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VEDOLIZUMAB PERSISTENCE IN INFLAMMATORY BOWEL DISEASE PATIENTS AFTER SWITCHING FROM INTRAVENOUS TO SUBCUTANEOUS ADMINISTRATION: THE REAL-LIFE MULTICENTRE DOPER STUDY

Marianne Hupé 1, Nicolas Mathieu 2, Aurelien Amiot 3, Philippe Seksik 4, Maeva CHARKAOUI 5, Cyrielle Gilletta De Saint Joseph 6, Arnaud Bourreille 7, Mélanie Serrero 8, Yoram Bouhnik 9, Maria Nachury 10, Xavier Roblin 11, Stephane NANCEY 12, Vered Abitbol 13, Jean Marc Gornet 14, Celine Montuclard 15, Xavier Hebuterne 16, Thierry Paupard 17, Cléa Rouillon 18, Mehdi Kaassis 19, Pierre Andrau 20, Morgane Amil 21, Laurent Peyrin-Biroulet 22, Eric Vicaut 23, David Laharie 24

Affiliations

1 CHU Genoble Alpes, La Tronche, France

2 Clinique des Cèdres, Echorilles, France

3 Henri Mondor Hospital, APHP Dept. of Gastroenterology, Creteil, France

4 Gastroenterology & Nutrition Department, Paris, France

5 CHU Dijon, Paris Cedex 12, France

6 Hopital Rangueil, Toulouse, France

7 Hopital Hotel Dieu Et Hme - Hge Aile Sud, Nantes Cedex 1, France

8 Hopital Nord, Marseille, France

9 Groupe Hospitalier Privé Ambroise Paré Hartmann, Neuilly-sur-Seine, France

10 CHRU Lille, Courbevoie Cedex, France

11 University of St. Etienne Dept. de Gastroenterologie, Saint Etienne, France

12 CHU Lyon Sud, Pierre Benite, France

13 Hopital Cochin Gastroentérologie AP-HP, Paris Cedex 14, France

14 Hôpital Saint-Louis Gastroentérologie, Paris Cedex 10, France

15 CH DE VALENCE, Valence Cedex 9, France

16 Hospital Archet 2, Nice, Nice, France

17 CH de Dunkerque Gastroenterologie, Dunkerque Cedex 1, France

18 CHU Caen Normandie, Caen, France

19 CH DE CHOLET, Cholet Cedex, France

20 CH Bigorre, Tarbes, France

21 CH DPTAL LES OUDAIRIES, La Roche Sur Yon Cedex 9, France

22 Inserm U1256, Nancy University Hospital, Vandoeuvre-les-Nancy, France

23 Hôpital Lariboisière, APHP, Paris, France

24 CHU de Bordeaux Hopital Haut-Leveque Dept. de Gastroenterologie, Pessac cedex, France