Role of Quality of Life as Endpoint for Inflammatory Bowel Disease Treatment

Abstract

Inflammatory bowel diseases (IBDs) are chronic disabling conditions, characterized by an unpredictable course with flare-ups and periods of remission, that frequently affect young people and require lifelong medical follow-up and treatment. For years, the main endpoints of IBD treatment had been clinical remission and response, followed by biomarker normalization and mucosal healing. In the last decades, different therapies have been proved to be effective to treat IBD and the use of patient reported outcome (PRO) have become more relevant. Therefore, health-related quality of life (HRQoL) that has been defined as the value assigned to the duration of life influenced by physical and mental health, has been suggested as an important endpoint for IBD management since multiple studies have shown that IBD impairs it, both physically and psychologically. Thus, HRQoL has been included as an outcome in numerous studies evaluating different IBD therapies, both clinical trials and real-life studies. It has been assessed by using both generic and specific disease tools, and most treatments used in clinical practice have been demonstrated to improve HRQoL. The relevance of HRQoL as an endpoint for new drugs is going to increase and its management and improvement will also improve the prognosis of IBD patients.

Daily life difficulties among patients with ulcerative colitis in Japan and the United Kingdom: A comparative study

“…Previous studies have reported an association between worse abdominal symptoms and poor quality of life, and the results of our study support this. [ 22 , 23 ] Among them, the presence of visible bleeding has a significant impact on the patient’s daily life. Bloody stool is a more accurate predictor of UC activity than frequency of bowel movements [ 24 ] and may have a greater impact on DLS scores.…”

The personality traits activity, self-reproach, and negative affect jointly predict clinical recurrence, depressive symptoms, and low quality of life in inflammatory bowel disease patients

“…IBD can have a prolonged impact on daily functioning and earlier studies have reported lower quality of life amongst IBD patients when compared to healthy controls [ 37 ]. Further, low quality of life has been shown to be a marker of clinical[ 38 , 39 ] and mucosal disease activity [ 39 ]. Thus, the association between personality and disease-related quality of life is highly relevant for IBD patients [ 38 ].…”

Disease clearance in ulcerative colitis: Setting the therapeutic goals for future in the treatment of ulcerative colitis

“…Several studies have reported that UC impairs QoL and clinical activity (increased bowel frequency, urgency, and rectal bleeding) was pointed out as the factor with the most negative impact on HRQoL ( 22 – 24 ). Moreover, treatments usually used in trials and clinical practice (as aminosalicylates, biologics, and small molecules) are able to improve de QoL in patients with UC ( 25 ). The Inflammatory Bowel Disease Questionnaire 32 (IBDQ-32) [a 32-item questionnaire that includes four aspects of the patient’s life and the main domains are intestinal symptoms (10 items), systemic symptoms (five items), and social (12 items) and emotional domains (five items)] and Inflammatory Bowel Disease Questionnaire 36 (IBDQ-36) [a 36-item questionnaire that comprises these points: intestinal symptoms (eight items), systemic symptoms (seven items), social (six items) and emotional domains (eight items), and functional impairment (seven items)] are the most commonly disease-specific tools used and have been demonstrated to be reliable and valid ( 26 ).…”