Gert Van Assche1, Laurent Peyrin-Biroulet2, Andreas Sturm3, Javier P Gisbert4, Daniel R Gaya5, Bern Bokemeyer6, Gerassimos J Mantzaris7, Alessandro Armuzzi8, Shaji Sebastian9, Nuria Lara10, Mark Lynam10, Sonia Rojas-Farreras10, Tao Fan11, Qian Ding11, Christopher M Black11, Sumesh Kachroo11. 1. Division of Gastroenterology, University Hospitals Leuven, Leuven, Belgium. Electronic address: gert.vanassche@uzleuven.be. 2. Department of Hepato-Gastroenterology and Inserm U954, University Hospital of Nancy, Lorraine University, Vandoeuvre-lès-Nancy, France. 3. Department of Gastroenterology, DRK Kliniken Berlin I Westend, Berlin, Germany. 4. Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP) and Centro de Investigación Biomédica and Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain. 5. Gastroenterology Unit, Glasgow Royal Infirmary, Glasgow, UK. 6. Gastroenterology Practice, Minden, Germany. 7. Department of Gastroenterology, Evangelismos Hospital, Athens, Greece. 8. IBD Unit, Complesso Integrato Columbus, Catholic University, Rome, Italy. 9. Gastroenterology and IBD Unit, Hull and East Yorkshire Hospitals NHS Trust, Hull, UK. 10. IMS Health, Real World Evidence Solutions, Barcelona, Spain. 11. Merck & Co., Inc., Rahway, NJ, United States.
Abstract
BACKGROUND: Treatment of ulcerative colitis (UC) is aimed at maintaining corticosteroid-free remission and improving quality of life (QoL). AIM: Assess patients' perception of disease burden and unmet clinical needs in moderate/severe UC patients. METHODS: Adults surgery-free conventionally treated patients with Mayo score ≥6 were enrolled in an observational, cross-sectional, retrospective study in 11 European countries. Disease control was defined as Mayo score ≤2 with no sub-score >1. No corticosteroid was used the previous two months. Unmet clinical needs were defined as: non-controlled disease, self-perception of 'moderate'/'severe' disease, and dissatisfaction with treatments. Disease burden on QoL and work productivity were assessed (EuroQol-5D-5L, Short Inflammatory Bowel Disease Questionnaire (SIBDQ) and Work Productivity and Activity Impairment (WPAI) in UC questionnaire). RESULTS: UC patients (n=253) with mean Mayo score at enrolment of 4.9, 44.3% of patients had Mayo score ≥6. Main treatment was 5-ASA (75%). Overall, 25% met the composite endpoint for unmet clinical needs. Mean (SD) questionnaire scores were: EQ-5D-5L-VAS, 71 (19.1), EQ-5D-5L utility, 0.77 (0.19), SIBDQ, 4.8 (1.3), and WPAI, 26% (32%). CONCLUSIONS: Patients with moderate/severe UC in the last 12 months treated with conventional therapies felt that their disease was not controlled and 25% reported unmet clinical needs. QoL and work productivity were seriously impaired.
BACKGROUND: Treatment of ulcerative colitis (UC) is aimed at maintaining corticosteroid-free remission and improving quality of life (QoL). AIM: Assess patients' perception of disease burden and unmet clinical needs in moderate/severe UC patients. METHODS: Adults surgery-free conventionally treated patients with Mayo score ≥6 were enrolled in an observational, cross-sectional, retrospective study in 11 European countries. Disease control was defined as Mayo score ≤2 with no sub-score >1. No corticosteroid was used the previous two months. Unmet clinical needs were defined as: non-controlled disease, self-perception of 'moderate'/'severe' disease, and dissatisfaction with treatments. Disease burden on QoL and work productivity were assessed (EuroQol-5D-5L, Short Inflammatory Bowel Disease Questionnaire (SIBDQ) and Work Productivity and Activity Impairment (WPAI) in UC questionnaire). RESULTS: UC patients (n=253) with mean Mayo score at enrolment of 4.9, 44.3% of patients had Mayo score ≥6. Main treatment was 5-ASA (75%). Overall, 25% met the composite endpoint for unmet clinical needs. Mean (SD) questionnaire scores were: EQ-5D-5L-VAS, 71 (19.1), EQ-5D-5L utility, 0.77 (0.19), SIBDQ, 4.8 (1.3), and WPAI, 26% (32%). CONCLUSIONS:Patients with moderate/severe UC in the last 12 months treated with conventional therapies felt that their disease was not controlled and 25% reported unmet clinical needs. QoL and work productivity were seriously impaired.
Authors: Rogerio S Parra; Julio M F Chebli; Heda M B S Amarante; Cristina Flores; Jose M L Parente; Odery Ramos; Milene Fernandes; Jose J R Rocha; Marley R Feitosa; Omar Feres; Antonio S Scotton; Rodrigo B Nones; Murilo M Lima; Cyrla Zaltman; Carolina D Goncalves; Isabella M Guimaraes; Genoile O Santana; Ligia Y Sassaki; Rogerio S Hossne; Mauro Bafutto; Roberto L K Junior; Mikaell A G Faria; Sender J Miszputen; Tarcia N F Gomes; Wilson R Catapani; Anderson A Faria; Stella C S Souza; Rosana F Caratin; Juliana T Senra; Maria L A Ferrari Journal: World J Gastroenterol Date: 2019-10-14 Impact factor: 5.742
Authors: Alessandro Armuzzi; Miriam Tarallo; James Lucas; Daniel Bluff; Benjamin Hoskin; Danielle Bargo; Joseph C Cappelleri; Leonardo Salese; Marco daCosta DiBonaventura Journal: BMC Gastroenterol Date: 2020-01-21 Impact factor: 3.067
Authors: Matthew J Brookes; John Waller; Joseph C Cappelleri; Irene Modesto; Marco D DiBonaventura; Natalie Bohm; Ruth Mokgokong; Olivia Massey; Robert Wood; Danielle Bargo Journal: BMJ Open Gastroenterol Date: 2020-09