Systematic Review With Network Meta-analysis

The Impact of Medical Interventions for Moderate-to-Severe Ulcerative Colitis on Health-Related Quality of Life

Paschalis Paschos; Anastasia Katsoula; Georgia Salanti; Olga Giouleme; Eleni Athanasiadou; Apostolos Tsapas

Disclosures

Aliment Pharmacol Ther. 2018;48(11-12):1174-1185. 

In This Article

Abstract and Introduction

Abstract

Background: Patient-reported outcomes are important in the assessment of efficacy of intervention for ulcerative colitis (UC).

Aim: To compare the impact of interventions for moderate-to-severe UC on health-related quality of life (HRQL).

Methods: We searched Medline, Embase, CENTRAL and grey literature sources through October 2017. We included randomised controlled trials (RCTs) that compared infliximab, adalimumab, golimumab, vedolizumab or tofacitinib to each other or placebo. Outcomes included the change in quality of life scores and the proportion of patients with improvement in quality of life. We performed random-effect pairwise and network meta-analysis. We assessed confidence in estimates using the CINeMA (Confidence in Network Meta-Analysis) framework.

Results: Fourteen RCTs assessed HRQL using the Inflammatory Bowel Disease Questionnaire (IBDQ) (14 trials), the Short Form questionnaire-36 (SF-36) (seven trials) or the European Quality of Life-5 Dimensions questionnaire (EQ-5D) (three trials). At induction (13 trials), low to very low confidence evidence suggested that all agents significantly improved both generic and disease-specific HRQL scores compared to placebo. However, only infliximab (MD 18.58; 95% CI 13.19–23.97) and vedolizumab (MD 18.00; 95% CI 11.08–24.92) showed clinically meaningful improvement in IBDQ score. Differences among individual interventions were imprecise. For maintenance (four trials), very low confidence evidence suggested that vedolizumab, tofacitinib and adalimumab maintained improvement in HRQL.

Conclusions: Induction treatment with infliximab, adalimumab, golimumab, vedolizumab or tofacitinib improves quality of life compared to placebo. Evidence on maintenance therapy is sparse and uncertain. Head-to-head comparisons could enhance confidence in conclusions about differences between drugs in terms of HRQL.

Introduction

Ulcerative colitis (UC) is a lifelong condition of unknown cause, with relapsing-remitting pattern.[1] The potential early presentation and lifelong course with episodes of bloody diarrhoea, urgency, tenesmus and abdominal pain can have a profound impact on health-related quality of life (HRQL). The Food and Drug Administration (FDA) proposed the inclusion of patient-reported outcomes (PROs) in clinical trials' endpoints.[2] The Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) initiative suggested the use of quality of life as the ultimate PRO.[3] Most trials assess quality of life with both generic and disease-specific questionnaires. A pairwise meta-analysis summarised available evidence from placebo-controlled trials on impact of licensed therapies on HRQL.[4] However, due to lack of head-to-head trials, existing evidence cannot inform comprehensive decision-making on comparative effectiveness. In addition, emerging novel treatment options further increase the uncertainty regarding selection of optimal therapy for ulcerative colitis. In the absence of direct comparisons, indirect comparisons from network meta-analyses[5,6] can be considered, under the assumption of transitivity. Existing network meta-analyses[7–11] on UC have only assessed efficacy and safety of interventions and did not explore their impact on quality of life. We therefore conducted a systematic review and network meta-analysis to compare the impact of established and emerging treatment options for patients with moderate-to-severe UC on quality of life.

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