1. Golimumab improves health-related quality of life of patients with moderate-to-severe ulcerative colitis: Results of the go-care study.
- Author
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Saibeni S, Bezzio C, Bossa F, Privitera AC, Marchi S, Roselli J, Mazzuoli S, Geccherle A, Soriano A, Principi MB, Viola A, Sarpi L, Cappello M, D'Incà R, Mastronardi M, Bodini G, Guerra M, Benedetti A, Romano M, Cicala M, Di Sabatino A, Scaldaferri F, De Rosa T, Giardino AM, Germano V, Orlando A, and Armuzzi A
- Subjects
- Adult, Humans, Quality of Life, Prospective Studies, Antibodies, Monoclonal therapeutic use, Treatment Outcome, Severity of Illness Index, Colitis, Ulcerative drug therapy, Inflammatory Bowel Diseases drug therapy
- Abstract
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: 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: 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: 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., Competing Interests: 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., (Copyright © 2023. Published by Elsevier Ltd.)
- Published
- 2024
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