Roeland Vis1, Ewoudt M W van de Garde2, Jan C Grutters3,4, Ingrid H E Korenromp3. 1. Dept of Clinical Pharmacy, St Antonius Hospital, Nieuwegein, The Netherlands r.vis@antoniusziekenhuis.nl. 2. Dept of Clinical Pharmacy, St Antonius Hospital, Nieuwegein, The Netherlands. 3. Interstitial Lung Diseases Centre of Excellence, Dept of Pulmonology, St Antonius Hospital, Nieuwegein, The Netherlands. 4. Division of Heart & Lungs, University Medical Center Utrecht, Utrecht, The Netherlands.
Abstract
AIMS: Many sarcoidosis patients experience a reduction in health-related quality of life (HRQoL) and a majority of patients report fatigue. Historically, drug trials in sarcoidosis have focused on changes in chest radiographs, lung function parameters and biomarkers, while HRQoL and fatigue have not been the main outcomes examined. We performed a systematic review of the literature to evaluate the existing evidence on the effects of pharmacological interventions on HRQoL and fatigue outcomes. METHODS: The systematic search was performed in Medline and Embase and yielded 15 records covering seven randomised controlled trials and seven single-arm open label studies, which were included in a qualitative synthesis (the results of one study were included in two publications). 12 studies evaluated immunosuppressive and/or immunomodulatory therapies and two studies evaluated stimulants. RESULTS: Nine out of the 14 studies observed positive treatment effects from the interventions on HRQoL and/or fatigue, exceeding the minimal important difference. The risk of bias was generally high with only three studies rated as having a low risk of bias. The results suggest a potential for improvement in HRQoL and/or fatigue in patients with active disease who are either untreated or treated but not yet fully stabilised or therapy refractory. CONCLUSION: More randomised, double-blind and placebo-controlled trials are needed to expand the evidence base on these important outcome parameters.
AIMS: Many sarcoidosispatients experience a reduction in health-related quality of life (HRQoL) and a majority of patients report fatigue. Historically, drug trials in sarcoidosis have focused on changes in chest radiographs, lung function parameters and biomarkers, while HRQoL and fatigue have not been the main outcomes examined. We performed a systematic review of the literature to evaluate the existing evidence on the effects of pharmacological interventions on HRQoL and fatigue outcomes. METHODS: The systematic search was performed in Medline and Embase and yielded 15 records covering seven randomised controlled trials and seven single-arm open label studies, which were included in a qualitative synthesis (the results of one study were included in two publications). 12 studies evaluated immunosuppressive and/or immunomodulatory therapies and two studies evaluated stimulants. RESULTS: Nine out of the 14 studies observed positive treatment effects from the interventions on HRQoL and/or fatigue, exceeding the minimal important difference. The risk of bias was generally high with only three studies rated as having a low risk of bias. The results suggest a potential for improvement in HRQoL and/or fatigue in patients with active disease who are either untreated or treated but not yet fully stabilised or therapy refractory. CONCLUSION: More randomised, double-blind and placebo-controlled trials are needed to expand the evidence base on these important outcome parameters.
Authors: Daniel Soriano; Caroline Quartucci; Prerana Agarwal; Joachim Müller-Quernheim; Björn Christian Frye Journal: Internist (Berl) Date: 2022-04-09 Impact factor: 0.743