Golimumab improves health-related quality of life of patients with moderate-to-severe ulcerative colitis: Results of the go-care study.

Golimumab Inflammatory bowel disease questionnaire Ulcerative colitis

Journal

Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
ISSN: 1878-3562
Titre abrégé: Dig Liver Dis
Pays: Netherlands
ID NLM: 100958385

Informations de publication

Date de publication:
12 Aug 2023
Historique:
received: 24 02 2023
revised: 25 07 2023
accepted: 28 07 2023
pubmed: 14 8 2023
medline: 14 8 2023
entrez: 13 8 2023
Statut: aheadofprint

Résumé

In recent years, improvement of Health-Related Quality of Life (HRQoL) in Ulcerative colitis (UC) has become a relevant measure for treatment efficacy. We report results from a multicenter prospective study in Italy investigating HRQoL in adult patients with UC treated with golimumab (GLM). Patients who had shown clinical response after a 6-week induction phase (w0), were followed for an additional 48 weeks (w48) (total 54-week treatment). Of the 159 patients enrolled 90 completed the study. Compared to values at the beginning of treatment (n = 137), significant improvements were observed for mean total Inflammatory Bowel Disease Questionnaire (IBDQ) scores at w0 (168.5) and w48 (181.7). Patients with baseline PMS above the median tended to have greater improvements in IBDQ at w0 (OR 2.037, p = 0.033) and w48 (OR 3.292, p = 0.027). Compared to beginning of GLM treatment, the mean Full Mayo Score (FMS) decreased by 5.9 points at w48, while mean Partial Mayo Score (PMS) decreased by 3.9 points at w0 and by 4.9 points at w48. GLM improved HRQoL, disease activity and inflammatory biomarkers in UC patients with moderate-to-severely active disease. The greater the burden of disease activity at baseline, the greater the improvement of HRQoL after 24 and 48 weeks of treatment.

Sections du résumé

BACKGROUND BACKGROUND
In recent years, improvement of Health-Related Quality of Life (HRQoL) in Ulcerative colitis (UC) has become a relevant measure for treatment efficacy.
METHODS METHODS
We report results from a multicenter prospective study in Italy investigating HRQoL in adult patients with UC treated with golimumab (GLM). Patients who had shown clinical response after a 6-week induction phase (w0), were followed for an additional 48 weeks (w48) (total 54-week treatment).
RESULTS RESULTS
Of the 159 patients enrolled 90 completed the study. Compared to values at the beginning of treatment (n = 137), significant improvements were observed for mean total Inflammatory Bowel Disease Questionnaire (IBDQ) scores at w0 (168.5) and w48 (181.7). Patients with baseline PMS above the median tended to have greater improvements in IBDQ at w0 (OR 2.037, p = 0.033) and w48 (OR 3.292, p = 0.027). Compared to beginning of GLM treatment, the mean Full Mayo Score (FMS) decreased by 5.9 points at w48, while mean Partial Mayo Score (PMS) decreased by 3.9 points at w0 and by 4.9 points at w48.
CONCLUSIONS CONCLUSIONS
GLM improved HRQoL, disease activity and inflammatory biomarkers in UC patients with moderate-to-severely active disease. The greater the burden of disease activity at baseline, the greater the improvement of HRQoL after 24 and 48 weeks of treatment.

Identifiants

DOI: 10.1016/j.dld.2023.07.031 PMID: 37574431
pubmed: 37574431
pii: S1590-8658(23)00783-1
doi: 10.1016/j.dld.2023.07.031
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © 2023. Published by Elsevier Ltd.

Déclaration de conflit d'intérêts

Conflict of interest Armuzzi A.: Consultant: AbbVie, Allergan, Amgen, Arena, Biogen, Bristol-Myers Squibb, Celgene, Celltrion, Eli-Lilly, Ferring, Galapagos, Gilead, Janssen, MSD, Mylan, Pfizer, Protagonist Therapeutics, Roche, Samsung Bioepis, Sandoz, Takeda. Lecture fees: AbbVie, Amgen, Arena, Biogen, Bristol-Myers Squibb, Eli-Lilly, Falk, Ferring, Galapagos, Gilead, Janssen, MSD, Novartis, Pfizer, Roche, Samsung Bioepis, Sandoz, Takeda, Tigenix Research grants: MSD, Takeda, Pfizer, Biogen Saibeni S.: Advisory board, lecture fees, consultancy for: AbbVie, Arena, Janssen, Ferring, Gilead, MSD, Takeda Scaldaferri F.: MSD, Jansen, Takeda, Sandoz, Ferring, Pfizer Geccherle A.: Served as a speaker, and/or advisory board member for the following organisations: AbbVie, Takeda, Janssen. Soriano A.: served as speaker and/or consultant and/or advisory board member and/or received fees from Janssen, Takeda, Pfizer, Novartis. Orlando A.: AO received lecture grants and/or served as an advisory board member for: AbbVie, Biogen, Chiesi, Janssen-Cilag MSD, Galapagos, Pfizer, Samsung Bioepis, Sofar, and Takeda Pharmaceuticals. Principi M.B.: Advisory boards, lectures fee, for Abbvie, Janssen, Pfizer, MDS,Takeda. Sarpi L.: MSD Cappello M: consultant for Takeda, Janssen-Cilag, Galapagos, Ferring, Biogen, speaker for Takeda, Biogen, Janssen-Cilag, Galapagos, Ferring D'Incà R.: Advisor for MSD, Takeda, Janssen, Biogen Lecture fees: Galapagos Bossa F.: Advisory board per Janssen; Pfizer; Celgene; Galapagos; Takeda Bezzio C.: received lecture fees and served as a consultant for Takeda, MSD, Ferring, Galapagos and Janssen.

Auteurs

S Saibeni (S)

Gastroenterology Unit, Rho Hospital, ASST Rhodense, Milan, Italy.

C Bezzio (C)

IBD Unit, Gastroenterology IBD Unit, Rho Hospital, ASST Rhodense, Milan, Italy.

F Bossa (F)

Foudation Casa della Sofferenza, UOC Gastroenterology and Digestive Endoscopy, San Giovanni Rotondo, Foggia, Italy.

A C Privitera (AC)

IBD Unit A.O. "Cannizzaro", Catania, Italy.

S Marchi (S)

Department of Translational Research, University of Pisa, Italy.

J Roselli (J)

Gastroenterology, Biomedical and Experimental and Clinical Sciences, "Mario Serio" University of Florence, Italy.

S Mazzuoli (S)

IBD Unit U.O.C. of Gastroenterology "Monsignor Raffaele Dimiccoli" Hospital, ASL Barletta, Italy.

A Geccherle (A)

IBD Unit IRCCS "Sacro Cuore-Don Calabria" Negrar di Valpolicella, Verona, Italy.

A Soriano (A)

Department of Internal Medicine, Gastroenterology Division and IBD Center, Azienda Unità Sanitaria Locale - IRCCS of Reggio Emilia Arcispedale S. Maria Nuova, 42121 Reggio Emilia, Italy.

M B Principi (MB)

U.O.C. of Gastroenterology, "Azienda Policlinico- Universitaria", Bari, Italy.

A Viola (A)

Department of Clinical and Experimental Medicine, University of Messina, Italy.

L Sarpi (L)

Gastroenterology and Digestive Endoscpy, Hospital "Media Valle del Tevere" Pantalla -Todi, Perugia, Italy.

M Cappello (M)

Gastroenterology and Hepatology Section, Promise, University of Palermo, Italy.

R D'Incà (R)

U.O.C of Gastroenterology, "University Azienda", Padua, Italy.

M Mastronardi (M)

U.O.S IBD IRCCS "S. De Bellis" Castellana Grotte, Bari Italy.

G Bodini (G)

Policlinico San Martino, University of Genoa, Italy.

M Guerra (M)

Foudation Casa della Sofferenza, UOC Gastroenterology and Digestive Endoscopy, San Giovanni Rotondo, Foggia, Italy.

A Benedetti (A)

Clinic of Gastroenterology, Hepatology and Digestive Endoscopy, Università Politecnica delle Marche-Ospedali Riuniti, Ancona, Italy.

M Romano (M)

Precision Medicine Department, University "l. Vanvitelli" Naples, Italy.

M Cicala (M)

U.O.C. of Gastroenterology and Digestive Endoscopy, "Campus Bio Medico" University, Rome, Italy.

A Di Sabatino (A)

Department of Internal Medicine and Medical Therapeutics, University of Pavia, Pavia Italy; First Department of Internal Medicine, IRCCS San Matteo Hospital Foundation, Pavia, Italy.

F Scaldaferri (F)

CEMAD (Digestive Disease Center) - UOS IBD UNIT, Fondazione Policlinico Universitario ‟A Gemelli" IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.

T De Rosa (T)

Medical Affairs MSD Italy, Rome, Italy.

A M Giardino (AM)

Medical Affairs MSD Italy, Rome, Italy.

V Germano (V)

Medical Affairs MSD Italy, Rome, Italy.

A Orlando (A)

IBD Unit A.O. Ospedali Riuniti "Villa Sofia Cervello", Palermo, Italy.

A Armuzzi (A)

IBD Center, IRCCS Humanitas Research Hospital, Rozzano, 20089 Milan, Italy; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, 20090 Milan, Italy. Electronic address: alearmuzzi@yahoo.com.

Classifications MeSH