The need for comparative data in spondyloarthritis

Arthritis Research & Therapy

Frank Behrens¹  Ernest Choy²  Mikkel Østergaard³  Kurt de Vlam⁴  Georg A. Schett⁵  Bruce W. Kirkham⁶  Michael Rissler⁷  Chiara Perella⁷  Kamel Chaouche-Teyara⁷  Salvatore D’Angelo⁸  Xenofon Baraliakos⁹ 

[1] CIRI/Rheumatology and Fraunhofer TMP, Goethe-University;CREATE Centre, Division of Infection and Immunity, Cardiff University School of Medicine;Copenhagen Center for Arthritis Research (COPECARE), Center for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup, and Department of Clinical Medicine, University of Copenhagen;Division of Rheumatology, University Hospitals Leuven, and Skeletal Biology and Engineering Research Center, Department of Development and Regeneration, KU Leuven;Friedrich-Alexander University Erlangen-Nurnberg and Universitätsklinikum Erlangen;Guy’s and St Thomas’ NHS Foundation Trust;Novartis Pharma AG;Rheumatology Department of Lucania and Rheumatology Institute of Lucania (IRel), San Carlo Hospital of Potenza;Rheumazentrum Ruhrgebiet, Ruhr-University Bochum;

关键词: Biological therapy;    Clinical trials;    Psoriatic arthritis;    Radiography;    Spondyloarthropathy;   

DOI  :  10.1186/s13075-019-1812-3

来源: DOAJ

【 摘 要 】

Abstract Spondyloarthritis comprises a group of inflammatory diseases, characterised by inflammation within axial joints and/or peripheral arthritis, enthesitis and dactylitis. An increasing number of biologic treatments, including biosimilars, are available for the treatment of spondyloarthritis. Although there are a growing number of randomised controlled trials assessing treatments in spondyloarthritis, there is a paucity of data from head-to-head studies. Comparative data are required so that clinicians and payers have the level of evidence required to inform clinical decision-making and health economic assessments. In the absence of head-to-head studies, statistical methods such as network meta-analyses and matching-adjusted indirect comparisons (MAICs) are used for assessing comparative effectiveness. Network meta-analysis can be used to compare treatments for trials using a common comparator (e.g. placebo); however, for those without a common comparator or where considerable heterogeneity exists between the study populations, a MAIC that controls for differences in study design and baseline patient characteristics may be used. MAICs, unlike network meta-analyses, are of value for longer-term comparisons beyond the placebo-controlled phase of clinical trials, which is important for chronic diseases requiring long-term treatment, like spondyloarthritis. At present, there are a number of limitations that restrict the effectiveness of MAIC, such as the poor availability of individual patient-level data from trials, which results in patient-level data from one trial being compared with published whole-population data from another. Despite these limitations, drug reimbursement agencies are increasingly accepting MAIC as a means of comparative effectiveness and greater methodological guidance is needed. This report highlights a number of challenges that are specific to conducting comparative studies like MAIC in spondyloarthritis, including disease heterogeneity, the paucity of biomarkers and the duration of studies required for radiographic endpoints in this slow-progressing disease.

【 授权许可】

Unknown