Impact of biological agents and tofacitinib for moderate-to-severe ulcerative colitis on health-related quality of life: a protocol for a network meta-analysis

• Published in: BMJ open 2021-12, Vol.11 (12), p.e055182-e055182
• Main Authors: Ma, Xueni, Xu, Huimei, Zhang, Dekui
• Format: Article
• Language: English
• Subjects: adult gastroenterology; Bias; Clinical trials; Decision making; gastroenterology; Gastroenterology and Hepatology; Health care policy; Inflammatory bowel disease; Meta-analysis; Monoclonal antibodies; Quality of life; Questionnaires; Systematic review; Tumor necrosis factor-TNF
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2021-055182

IntroductionIn the past few years, several options have been proposed as alternative and more effective therapeutic drugs for moderate-to-severe ulcerative colitis (UC), such as biological agents and tofacitinib. Most of the clinical studies related to UC aimed to evaluate the efficacy of the drugs on clinical outcomes such as disease activity and side effects. This review aims to compare the impact of infliximab, adalimumab, golimumab, ustekinumab, vedolizumab and tofacitinib for moderate-to-severe UC on health-related quality of life (HRQoL), thereby guiding clinical treatment and scientific research of this disease.Methods and analysisWe will search PubMed, Embase and Cochrane Library from inception until July 2021 for all randomised controlled trials (RCTs) reported in English as double-blind comparing infliximab, adalimumab, golimumab, ustekinumab, vedolizumab or tofacitinib as induction or maintenance therapies with another or with placebo in moderate-to-severe UC on HRQoL. The primary outcome of this study is changes in the mean difference in HRQoL scores. Data of each pairwise comparison will be synthesised to obtain summary standardised mean differences for continuous outcomes and ORs for dichotomous outcomes. Then, a network meta-analysis (NMA) will be performed, and a common-effects Mantel-Haenszel NMA will be conducted for dichotomous outcomes, while a random-effects NMA will be used for all other outcomes. Finally, we will follow the Grading of Recommendations, Assessment, Development and Evaluations approach to assess the confidence in estimates derived from NMA of the main outcomes.Ethics and disseminationOnly published secondary data will be used in this study, and therefore ethics approval is not required. The findings will be published in a peer-reviewed medical journal.PROSPERO registration numberCRD42021225048.