Current myositis clinical trials and tribulations.
Ann Rheum Dis
; 83(7): 826-829, 2024 Jun 12.
Article
en En
| MEDLINE
| ID: mdl-38216318
ABSTRACT
With improved understanding of disease pathogenesis and availability of outcome measures, there has been a remarkable increase in the number of therapeutic clinical trials in idiopathic inflammatory myopathies (myositis) over the last three years reaching as many as five trials per site. These trials share similar design and inclusion/exclusion criteria resulting in a competitive clinical trial landscape in myositis. While these are exciting times for the myositis field, we have a number of concerns about the design and conduct of the myositis trials. These include competitive landscape, lengthy placebo arms, underrepresentation of minority groups among participants, use of patient reported outcome measures with limited/no data on validity in myositis, antiquated disease classification criteria, and unclear performance of the ACR/EULAR Myositis Response Criteria in skin-predominant patients despite inclusion of these patients in trials. In this viewpoint, we further discuss these concerns and offer potential solutions such as including patient perspectives in the trial design and adoption of innovative frameworks.
Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Ensayos Clínicos como Asunto
/
Miositis
Tipo de estudio:
Clinical_trials
Límite:
Humans
Idioma:
En
Revista:
Ann Rheum Dis
Año:
2024
Tipo del documento:
Article