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P611 A real-world assessment of golimumab effect on quality of life, healthcare resource utilisation and work productivity in patients with ulcerative colitis in Greece: interim results from the GO-LIFE study

G. Mantzaris*1, A. Gatopoulou2, D. Christodoulou3, K. Katsanos3, I. Mouzas4, M. Tzouvala5, G. Paspatis6, K. Thomopoulos7, S. Michopoulos8, G. Koujlakis9, I. Pachiadakis10, K. Triantafyllou11, P. Karatzas12, D. Moschovis13, G. Theocharis7, M. Tampaki14

1Evangelismos-Ophthalmiatreion Athinon-Polykliniki Hospital, Gastroenterology, Athens, Greece, 2University Hospital of Alexandroupoli, Democritus University of Thrace, 2nd Department of Internal Medicine, Alexandroupoli, Greece, 3University Hospital of Ioannina, Gastroenterology, Ioannina, Greece, 4University of Crete, Medical School, Gastroenterology, Heraklion, Greece, 5General Hospital of Nikea and Piraeus, Agios Panteleimon – Agia Varvara., Gastroenterology, Nicea, Greece, 6Venizeleio Pananeio General Hospital of Heraklion, Gastroenterology, Heraklion, Greece, 7University Hospital of Patras, Medical School, Gastroenterology, Patras, Greece, 8Alexandra General Hospital of Athens, Gastroenterology, Athens, Greece, 9Democritus University of Thrace, Digestive System Endoscopy Unit, Alexandroupoli, Greece, 10424 Military General Hospital, Gastroenterology and Hepatology, Thessaloniki, Greece, 11Second Department of Internal Medicine - Propaedeutic, Research Institute and Diabetes Center, Department of Internal Medicine, Medical School, National and Kapodistrian University of Athens, Hepatogastroenterology Unit, Athens, Greece, 12Evangelismos Hospital, Gastroenterology, Athens, Greece, 13General Hospital of Nikea and Piraeus, Agios Panteleimon – Agia Varvara, Gastroenterology, Nicea, Greece, 14Merck Sharp and Dohme Pharmaceutical, Industrial and Commercial S.A, Athens, Greece

Background

GO-LIFE is an observational, prospective study assessing the impact of golimumab (GLM) on health-related quality of life (HRQoL) and other patient-reported outcomes in patients with ulcerative colitis (UC) in real-world clinical practice. This interim analysis presents the 6-month results.

Methods

Eligible patients had moderate-to-severe UC (total Mayo score 6–12, endoscopy subscore ≥2), inadequate response to conventional therapy and were anti-TNFa naïve. GLM was administered per label (no dose optimisation applied). Primary objective was the assessment of the clinically meaningful HRQoL improvement rate, defined as ≥16-point increase in Inflammatory Bowel Disease Questionnaire (IBDQ-32) score from baseline (BL) to 6 months. Other endpoints included assessments of the impact of GLM on: treatment satisfaction, with the Treatment Satisfaction Questionnaire for Medication (TSQM-14); UC-related healthcare resource utilisation (HCRU) during the 6-month period prior to BL vs. 6-month follow-up period; work productivity with the Work Productivity and Activity Impairment (WPAI:UC) questionnaire; and disease activity with the total/partial Mayo score (for patients without endoscopy at 6 months, only the partial Mayo score was used).

Results

Fifty patients with mean ± SD UC duration of 8.1 ± 8.1 years were included in the interim analysis; 37 (74%) patients completed the 6-month follow-up. Clinically meaningful HRQoL improvement from BL to 6 months was achieved by 27/50 patients (54%; 95% CI: 39%–68%). All TSQM-14 dimensions improved at 6 months vs. BL; mean ± SD change was significant for effectiveness: 18.0 ± 28.9 (p < 0.001) and convenience: 10.2 ± 21.8 (p = 0.002), and nonsignificant for side effects and global satisfaction:6.8 ± 24.9 (p = 0.142) and 6.2 ± 30.7 (p = 0.182), respectively. HCRU was reduced during the follow-up period vs. the 6-month period prior to BL (table). All WPAI:UC domain scores improved at 6 months vs. BL; improvement was significant for absenteeism (p = 0.039), work productivity loss (p = 0.025) and activity impairment (p = 0.044). For 28 patients, total Mayo score was not available (no endoscopy done) at 6 months (13 patients did not reach the 6 month visit and for 15 patients endoscopy was not available at 6 months). Clinical response was achieved by 32 (64%) patients and clinical remission by 27 (54%) patients, using the partial Mayo score.

6-month period prior to baselineFollow-up period (baseline to 6 months)p-value
Hospitalisations, n235
Hospitalisation duration (days), median (min, max)7.0 (1.0, 12.0)5.0 (3.0, 7.0)0.33
Emergency room visits (patients), n53
Emergency room visits per patient, median (min, max)1.0 (1.0, 3.0)1.0 (1.0, 4.0)0.86
Outpatient admissions (patients), n63
Outpatient admissions per patient, median (min, max)2.5 (2.0, 6.0)2.0 (1.0, 3.0)0.34

HCRU data comparison.

Conclusion

In real-world practice GLM improved HRQoL, treatment satisfaction, HCRU, work productivity and disease activity in patients with moderate to severe UC. The study was funded by Merck Sharp and Dohme S.A., Greece.