Effect of disease duration in a randomized Phase III trial of rintatolimod, an immune modulator for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
| العنوان: | Effect of disease duration in a randomized Phase III trial of rintatolimod, an immune modulator for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome |
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| المؤلفون: | William M. Mitchell, Diane Young, David R. Strayer |
| المصدر: | PLoS ONE PLoS ONE, Vol 15, Iss 10, p e0240403 (2020) |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | 0301 basic medicine, Adult, Male, Poly U, medicine.medical_specialty, Time Factors, Rintatolimod, Science, Population, Placebo, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Double-Blind Method, law, Internal medicine, Chronic fatigue syndrome, medicine, Humans, Prospective Studies, education, Prospective cohort study, education.field_of_study, Multidisciplinary, Intention-to-treat analysis, Exercise Tolerance, Fatigue Syndrome, Chronic, business.industry, Middle Aged, medicine.disease, Clinical trial, 030104 developmental biology, Poly I-C, 030220 oncology & carcinogenesis, Medicine, Female, business, medicine.drug, Research Article |
| الوصف: | BackgroundRintatolimod is a selective TLR3 agonist, which has demonstrated clinical activity for ME/CFS in Phase II and Phase III double-blind, placebo-controlled, randomized, multi-site clinical trials.Methods and findingsA hypothesis-based post-hoc analysis of the Intent to Treat (ITT) population diagnosed with ME/CFS from 12 independent clinical sites of a Phase III trial was performed to evaluate the effect of rintatolimod therapy based on disease duration. The clinical activity of rintatolimod was evaluated by exercise treadmill tolerance (ETT) using a modified Bruce protocol. The ITT population (n = 208) was divided into two subsets of symptom duration. Patients with symptom duration of 2-8 years were identified as the Target Subset (n = 75); the remainder (8 year) were identified as the Non-Target Subset (n = 133). Placebo-adjusted percentage improvements in exercise duration and the vertical rise for the Target Subset (n = 75) were more than twice that of the ITT population. The Non-Target Subset (n = 133) failed to show any clinically significant ETT response to rintatolimod when compared to placebo. Within the Target Subset, 51.2% of rintatolimod-treated patients improved their exercise duration by ≥25% (p = 0.003) despite reduced statistical power from division of the original ITT population into two subsets.Conclusion/significanceAnalysis of ETT from a Phase III trial has identified within the ITT population, a subset of ME/CFS patients with ≥2 fold increased exercise response to rintatolimod. Substantial improvement in physical performance was seen for the majority (51.2%) of these severely debilitated patients who improved exercise duration by ≥25%. This magnitude of exercise improvement was associated with clinically significant enhancements in quality of life. The data indicate that ME/CFS patients have a relatively short disease duration window (Trial registrationClinicalTrials.gov: NCT00215800. |
| تدمد: | 1932-6203 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4ca9cccc6081207874db99997b2d5971 https://pubmed.ncbi.nlm.nih.gov/33119613 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....4ca9cccc6081207874db99997b2d5971 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 19326203 |
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