Comparative Acceptability of Therapeutic Maintenance Regimens in Patients With Inflammatory Bowel Disease: Results From the Nationwide ACCEPT2 Study.


Journal

Inflammatory bowel diseases
ISSN: 1536-4844
Titre abrégé: Inflamm Bowel Dis
Pays: England
ID NLM: 9508162

Informations de publication

Date de publication:
03 04 2023
Historique:
received: 11 02 2022
medline: 5 4 2023
pubmed: 12 7 2022
entrez: 11 7 2022
Statut: ppublish

Résumé

Owing to growing number of therapeutic options with similar efficacy and safety, we compared the acceptability of therapeutic maintenance regimens in inflammatory bowel disease (IBD). From a nationwide study (24 public or private centers), IBD patients were consecutively included for 6 weeks. A dedicated questionnaire including acceptability numerical scales (ANS) ranging from 0 to 10 (highest acceptability) was administered to both patients and related physicians. Among 1850 included patients (65.9% with Crohn's disease), the ANS were 8.68 ± 2.52 for oral route (first choice in 65.8%), 7.67 ± 2.94 for subcutaneous injections (first choice in 21.4%), and 6.79 ± 3.31 for intravenous infusions (first choice in 12.8%; P < .001 for each comparison). In biologic-naïve patients (n = 315), the most accepted maintenance regimens were oral intake once (ANS = 8.8 ± 2.2) or twice (ANS = 6.9 ± 3.4) daily and subcutaneous injections every 12 or 8 weeks (ANS = 7.9 ± 3.0 and ANS = 7.2 ± 3.2, respectively). Among 342 patients with prior exposure to subcutaneous biologics, the preferred regimens were subcutaneous injections (≥2 week-intervals; ANS between 9.1 ± 2.3 and 8.1 ± 2.7) and oral intake once daily (ANS = 7.7 ± 3.2); although it was subcutaneous injections every 12 or 8 weeks (ANS = 8.4 ± 3.0 and ANS = 8.1 ± 3.0, respectively) and oral intake once daily (ANS = 7.6 ± 3.1) in case of prior exposure to intravenous biologics (n = 1181). The impact of usual therapeutic escalation or de-escalation was mild (effect size <0.5). From patients' acceptability perspective, superiority and noninferiority cutoff values should be 15% and 5%, respectively. Although oral intake is overall preferred, acceptability is highly impacted by the rhythm of administration and prior medication exposures. However, SC treatment with long intervals between 2 injections (≥8 weeks) and oral intake once daily seems to be the most accepted modalities. Considering both the route of medication delivery and the interval between 2 administrations, we observed a strong impact of patients’ experience regarding previous treatments. The most accepted maintenance regimens were subcutaneous injections with interval ≥8 weeks and oral intake.

Sections du résumé

BACKGROUND
Owing to growing number of therapeutic options with similar efficacy and safety, we compared the acceptability of therapeutic maintenance regimens in inflammatory bowel disease (IBD).
METHODS
From a nationwide study (24 public or private centers), IBD patients were consecutively included for 6 weeks. A dedicated questionnaire including acceptability numerical scales (ANS) ranging from 0 to 10 (highest acceptability) was administered to both patients and related physicians.
RESULTS
Among 1850 included patients (65.9% with Crohn's disease), the ANS were 8.68 ± 2.52 for oral route (first choice in 65.8%), 7.67 ± 2.94 for subcutaneous injections (first choice in 21.4%), and 6.79 ± 3.31 for intravenous infusions (first choice in 12.8%; P < .001 for each comparison). In biologic-naïve patients (n = 315), the most accepted maintenance regimens were oral intake once (ANS = 8.8 ± 2.2) or twice (ANS = 6.9 ± 3.4) daily and subcutaneous injections every 12 or 8 weeks (ANS = 7.9 ± 3.0 and ANS = 7.2 ± 3.2, respectively). Among 342 patients with prior exposure to subcutaneous biologics, the preferred regimens were subcutaneous injections (≥2 week-intervals; ANS between 9.1 ± 2.3 and 8.1 ± 2.7) and oral intake once daily (ANS = 7.7 ± 3.2); although it was subcutaneous injections every 12 or 8 weeks (ANS = 8.4 ± 3.0 and ANS = 8.1 ± 3.0, respectively) and oral intake once daily (ANS = 7.6 ± 3.1) in case of prior exposure to intravenous biologics (n = 1181). The impact of usual therapeutic escalation or de-escalation was mild (effect size <0.5). From patients' acceptability perspective, superiority and noninferiority cutoff values should be 15% and 5%, respectively.
CONCLUSIONS
Although oral intake is overall preferred, acceptability is highly impacted by the rhythm of administration and prior medication exposures. However, SC treatment with long intervals between 2 injections (≥8 weeks) and oral intake once daily seems to be the most accepted modalities.
Considering both the route of medication delivery and the interval between 2 administrations, we observed a strong impact of patients’ experience regarding previous treatments. The most accepted maintenance regimens were subcutaneous injections with interval ≥8 weeks and oral intake.

Autres résumés

Type: plain-language-summary (eng)
Considering both the route of medication delivery and the interval between 2 administrations, we observed a strong impact of patients’ experience regarding previous treatments. The most accepted maintenance regimens were subcutaneous injections with interval ≥8 weeks and oral intake.

Identifiants

pubmed: 35815744
pii: 6639655
doi: 10.1093/ibd/izac119
doi:

Substances chimiques

Biological Products 0

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

579-588

Informations de copyright

© The Author(s) 2022. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Auteurs

Anthony Buisson (A)

Université Clermont Auvergne, Inserm, Centre Hospitalier Universitaire Clermont-Ferrand, 3iHP, Service d'Hépato-Gastro Entérologie, Clermont-Ferrand, France.
Université Clermont Auvergne, 3iHP, Inserm U1071, M2iSH, USC-INRA 2018, F-63000 Clermont-Ferrand, France.

Mélanie Serrero (M)

Department of Gastroenterology, University Hospital of Marseille Nord, Aix-Marseille, Marseille University, Marseille, France.

Laurie Orsat (L)

Université Clermont Auvergne, Inserm, Centre Hospitalier Universitaire Clermont-Ferrand, 3iHP, Service d'Hépato-Gastro Entérologie, Clermont-Ferrand, France.

Stéphane Nancey (S)

French Institute of Health and Medical Research U1111-CIRI, Department of Gastroenterology, Lyon-Sud University Hospital, Hospices Civils de Lyon, Pierre Bénite, France.

Pauline Rivière (P)

Service d'Hépato-gastroentérologie et oncologie digestive, Hôpital Haut-Lévêque, Centre Hospitalier Universitaire de Bordeaux, Université de Bordeaux, Bordeaux, France.

Romain Altwegg (R)

Department of Hepatogastroenterology, Centre Hospitalier Universitaire St Eloi Montpellier, Montpellier, France.

Laurent Peyrin-Biroulet (L)

French Institute of Health and Medical Research Nutrition-Genetics and Exposure to Environmental Risks U1256, Department of Gastroenterology, University Hospital of Nancy, University of Lorraine, Vandœuvre-lès-Nancy, France.

Maria Nachury (M)

Université Lille, Inserm, Centre Hospitalier Universitaire Lille, U1286-INFINITE-Institute for Translational Research in Inflammation, F-59000 Lille, France.

Xavier Hébuterne (X)

Gastroenterology and Clinical Nutrition, Centre Hospitalier Universitaire Nice and University Côte d'Azur, Nice, France.

Cyrielle Gilletta (C)

Centre Hospitalier Universitaire de Toulouse, Toulouse, France.

Mathurin Flamant (M)

Private practice, Clinique Jules Verne, Nantes, France.

Stéphanie Viennot (S)

Private practice, La Clinique de l'Alma, Paris, France.

Guillaume Bouguen (G)

Centre Hospitalier Universitaire Rennes, Univ Rennes, INSERM, CIC1414, Institut NUMECAN (Nutrition Metabolism and Cancer), F-35000 Rennes, France.

Aurélien Amiot (A)

EC2M3-EA7375, Department of Gastroenterology, Groupe Hospitalier Henri Mondor-Albert Chennevier, Assistance Publique-Hôpitaux de Paris, University of Paris Est Créteil, Créteil, France.

Stéphane Mathieu (S)

Private practice, Elsan group, Clermont-Ferrand, France.

Lucine Vuitton (L)

Centre Hospitalier Universitaire Besançon, Besançon, France.

Laurianne Plastaras (L)

Centre Hospitalier Colmar, Colmar, France.

Arnaud Bourreille (A)

Centre Hospitalier Universitaire Nantes, Nantes, France.

Ludovic Caillo (L)

Service d'hépato-gastro-entérologie, Centre Hospitalier Universitaire Nimes, Univ Montpellier, Nimes, France.

Félix Goutorbe (F)

Department of Gastroenterology, Hospital of Bayonne, Bayonne, France.

Guillaume Pineton De Chambrun (G)

Private practice, Clinique du Parc, Castelnau-le-Lez, France.

Alain Attar (A)

Private practice, Clinique Monceau, Paris, France.

Xavier Roblin (X)

Centre Hospitalier Universitaire Saint-Etienne, Saint-Etienne, France.

Bruno Pereira (B)

Université Clermont Auvergne, Centre Hospitalier Universitaire Clermont-Ferrand, DRCI, Unité de Biostatistiques, Clermont-Ferrand, France.

Mathurin Fumery (M)

Centre Hospitalier Universitaire Amiens, Université de Picardie Jules Verne, Unité Peritox, Amiens, France.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH