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Update on Outcome Assessment in Myositis

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Update on Outcome Assessment in Myositis FOCUS ON MYOSITISREVIEWS Update on outcome assessment in myositis Lisa G. Rider1*, Rohit Aggarwal2, Pedro M. Machado3, Jean-Yves Hogrel4, Ann M. Reed5, Lisa Christopher-Stine6 and Nicolino Ruperto7 Abstract | The adult and juvenile myositis syndromes, commonly referred to collectively as idiopathic inflammatory myopathies (IIMs), are systemic autoimmune diseases with the hallmarks of muscle weakness and inflammation. Validated, well-standardized measures to assess disease activity, known as core set measures, were developed by international networks of myositis researchers for use in clinical trials. Composite response criteria using weighted changes in the core set measures of disease activity were developed and validated for adult and juvenile patients with dermatomyositis and adult patients with polymyositis, with different thresholds for minimal, moderate and major improvement in adults and juveniles. Additional measures of muscle strength and function are being validated to improve content validity and sensitivity to change. A health-related quality of life measure, which incorporates patient input, is being developed for adult patients with IIM. Disease state criteria, including criteria for inactive disease and remission, are being used as secondary end points in clinical trials. MRI of muscle and immunological biomarkers are promising approaches to discriminate between disease activity and damage and might provide much-needed objective outcome measures. These advances in the assessment of outcomes for myositis treatment, along with collaborations between international networks, should facilitate further development of new therapies for patients with IIM. Patient-reported outcome The idiopathic inflammatory myopathies (IIMs), comprising clinicians and researchers with a special measures also known as myositis, are a diverse group of auto­ interest in IIM, which include the International Myositis (PROMs). Measurements based immune diseases that are characterized by chronic Assessment and Clinical Studies Group (IMACS) and on information provided muscle inflammation and associated muscle weak­ the Paediatric Rheumatology International Trials directly by the patient (that is, ness. However, the IIMs are complex, systemic diseases Organisation (PRINTO)2, have developed standardized, the study subject) about the status of his or her health with skeletal muscle involvement and frequent mani­ well­validated assessment measures to evaluate these condition, without amendment festations in other organ systems, including the skin, constructs. In this Review, we discuss developments or interpretation of the patient’s joints and cardiopulmonary, gastrointestinal and con­ in the past few years in the assessment of IIM outcomes response by a clinician or stitutional systems. The most common forms of IIM and summarize the major tools available to clinicians and anyone else. are dermatomyositis, polymyositis and inclusion body researchers to evaluate the outcome of IIM treatment. Health-related quality of life myositis (IBM) in adults and dermatomyositis in chil­ (HRQoL). A multidimensional dren (juvenile dermatomyositis). To adequately evaluate Core set measures assessment of a subject’s health patients, assess their responses to therapies and track Core set measures (CSMs) are the minimum set of meas­ that includes domains related long­term outcomes, IIM researchers must assess the ures that are required to comprehensively assess disease to physical, mental, emotional and social functioning. HRQoL following constructs: disease activity, that is, the type, and that should be carried out and reported in all clinical goes beyond direct measures of extent and severity of reversible pathological manifes­ studies and therapeutic trials. International consortia of health, life expectancy and tations of IIM; disease damage, which includes persis­ collaborating IIM investigators have developed and val­ causes of death and focuses on tent changes from previously active disease (related to idated CSMs (TABLE 1) to assess disease activity in adult the effect that health status has on quality of life. scarring, atrophy or fibrosis), long­term complications patients with dermatomyositis or polymyositis (IMACS) of therapy or comorbid conditions; patient-reported and in children with juvenile dermatomyositis (IMACS outcome measures (PROMs), including patient reports and PRINTO)3. These measures are practical, well stand­ *e-mail: [email protected] about physical function and health-related quality of life ardized and reliable; they are easy to use in multicentre doi:10.1038/nrrheum.2018.33 (HRQoL); and objective measures, such as imaging international studies, they are applicable to all forms of Published online 12 Apr 2018 and biomarkers1. International collaborative groups IIMs, and they are well validated. The PRINTO CSMs NATURE REVIEWS | RHEUMATOLOGY VOLUME 14 | MAY 2018 | 303 ©2018 Mac millan Publishers Li mited, part of Spri nger Nature. All ri ghts reserved. REVIEWS Key points damage on growth and development, is also recom­ mended by the PRINTO for the assessment of damage • The primary assessment of myositis includes core set measures of disease activity and in patients with juvenile dermatomyositis4. disease damage and measures of patient-reported outcomes. The CSMs of disease activity and damage have been • A new composite myositis response criterion, which combines and differentially widely adopted not only by the IMACS and the PRINTO weights core set activity measures to determine minimal, moderate and major clinical but also by other groups12,13. Limitations of the CSMs response, has been developed and validated. include a lack of validation in patients with IBM and • Measures of muscle strength and function are being refined for myositis subgroups variations between specialists in assessments of strength and are being used as primary or secondary outcome measures in studies and clinical and function, as discussed below. trials in patients with myositis. • Disease-specific patient-reported outcomes, including health-related quality of life IIM response criteria measures that reflect patient perspectives, are being developed. Response criteria provide standardized measurements of • Imaging and immunological biomarkers provide objective measures that can changes in disease activity in response to a therapeutic discriminate disease activity from disease damage, but they still require validation in clinical trials. intervention and of the therapeutic efficacy of a treat­ ment14. The initial partially validated response criteria that were established for juvenile dermatomyositis and adult dermatomyositis or polymyositis included the pre­ Author addresses liminary definitions of improvement, which required 1Environmental Autoimmunity Group, National Institute of Environmental Health ≥20% improvement in a minimum of three of six CSMs Sciences, US National Institutes of Health, Bethesda, MD, USA. of disease activity to establish that patients showed a 2Department of Medicine, Division of Rheumatology and Clinical Immunology, minimal clinically meaningful improvement15,16. These University of Pittsburgh, Pittsburgh, PA, USA. preliminary response criteria were used successfully 3Centre for Rheumatology and MRC Centre for Neuromuscular Diseases, as primary end points in several therapeutic trials, University College London, London, UK. but they define only the minimal clinical improvement, 4 Institut de Myologie, GH Pitié-Salpêtrière, Paris, France. they were only partially validated, and they lacked 5Department of Pediatrics, Duke University School of Medicine, Durham, NC, USA. 6 sufficient sensitivity and discriminatory validity in Division of Rheumatology, Department of Medicine, Johns Hopkins University School 6–10 of Medicine, Baltimore, MD, USA. randomized trials . 7Istituto Giannina Gaslini, Clinica Pediatria e Reumatologia, PRINTO, Genoa, Italy. The development of data-driven and consensus-​ driven conjoint analysis-based hybrid response criteria for adult patients with dermatomyositis or poly­myositis of disease activity for juvenile dermatomyositis received and children with juvenile dermatomyositis, including provisional acceptance by both the ACR and EULAR3,4. quantitative assessment of improvement on a contin­ The IMACS CSMs have been recommended for use in uous scale and different thresholds for minimal, mod­ patients with IBM, although supporting validation stud­ erate and major improvement, marks a major advance ies are lacking, and therefore they are not universally in assessing the response to treatment in clinical trials 5 11 Biomarkers accepted for this subgroup . and studies of patients with IIMs . These composite Measurable indicators of The CSMs of disease activity are also responsive response criteria are based on weighted scores that are normal biological processes, to changes in disease activity, as demonstrated in sev­ applied to absolute percentage improvement in the six pathogenic processes or eral therapeutic trials in children with juvenile der­ CSMs (TABLE 2). The criteria were developed using data responses to an exposure or matomyositis and in adults with dermatomyositis or sets with many patients, novel conjoint analysis method­ intervention, including 6–10 17–21 therapeutic interventions. poly­myositis . The minimal clinically meaningful ology , clinical trial validation and consensus among change in each disease activity measure has also been experts in adult and paediatric myositis who specialize in
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