Effect of golimumab on health-related quality of life, other patient-reported outcomes and healthcare resource utilization in patients with moderate-to-severe ulcerative colitis: a real-world multicenter, noninterventional, observational study in Greece
| Autor: | Spilios Manolakopoulos, Gregorios A. Paspatis, Anthia Gatopoulou, Marios Katsaros, Dimitris Moschovis, Gerassimos J. Mantzaris, Eleni Orfanoudaki, Konstantinos Thomopoulos, Ioannis A. Mouzas, Evangelia Petrikkou, Dimitrios Bakos, George Theocharis, Pantelis Karatzas, Achilleas Livieratos, Anastasia Kourikou, Evanthia Zampeli, Angeliki Theodoropoulou, Spyros Michopoulos, Maria Tzouvala, Dimitrios K. Christodoulou, Konstantinos Katsanos, Olga Giouleme |
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| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
MEDLINE Inflammatory bowel disease Severity of Illness Index Quality of life Internal medicine Health care Clinical endpoint Medicine Humans Patient Reported Outcome Measures Prospective Studies Hepatology Greece business.industry Gastroenterology Antibodies Monoclonal Patient Acceptance of Health Care medicine.disease Ulcerative colitis Golimumab Quality of Life Observational study Colitis Ulcerative business medicine.drug |
| Zdroj: | European journal of gastroenterologyhepatology. 33(1S Suppl 1) |
| ISSN: | 1473-5687 |
| Popis: | Background and aims This real-world study assessed the impact of golimumab on health-related quality of life (HRQoL) and other patient-reported outcomes (PROs) in patients with ulcerative colitis over 12 months in Greece. Methods GO-LIFE was a noninterventional, prospective, multicenter, 12-month study. Patients who had moderately-to-severely active ulcerative colitis were naive to antitumor necrosis factor (anti-TNFα) therapy and had failed previous conventional therapy. Patients received golimumab as per label. The primary endpoint was patients achieving inflammatory bowel disease questionnaire 32-item (IBDQ-32) remission at 12 months. Secondary endpoints, at 6 and 12 months, included patients achieving IBDQ-32 response; the mean change in the treatment satisfaction questionnaire for medication (TSQM) and the work productivity and activity impairment in ulcerative colitis (WPAI:UC) questionnaires; changes in healthcare utilization; patients achieving clinical response and remission; adherence rates and the percentage of patients who discontinued golimumab. Results IBDQ-32 remission was achieved by 76.9% of patients at 12 months. Mean changes in all TSQM and WPAI:UC domain scores at 12 months were statistically significant. Clinical remission was achieved by 49.4 and 50.6% of patients at 6 and 12 months, and clinical response by 59.3 and 56.8%, respectively. All patients but one (80/81) had high adherence (≥80%) to golimumab treatment over 12 months. Ulcerative colitis-related health care resource utilization was reduced during the follow-up period. Conclusions In real-world settings, treatment with golimumab resulted in meaningful improvements in HRQoL and other PROs, and in disease activity at 6 and 12 months in patients with moderately-to-severely active ulcerative colitis who were naive to anti-TNFa therapy. |
| Databáze: | OpenAIRE |
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