Idiopathic Inflammatory Myopathies (IIMs)
Conditions
Brief summary
This study aims to explore the clinical characteristics and mechanism of Deucravacitinib in the treatment of idiopathic inflammatory myopathies.Detailed Description: The investigators designed a single center, open-label, prospective study. Adults with active idiopathic inflammatory myopathies will be enrolled, meeting the Bohan & Peter Dermatomyositis/Polymyositis(DM/PM) or Rheumatology(ACR) & European allance of associations for rheumatology(EULAR)(2017) diagnostic criteria. Deucravacitinib 6 mg once a day was administered for 6 months to explore its efficacy and safety, which could help to evaluate Deucravacitinib clinical characteristics and mechanism. Patients would be evaluated the improvement of clinical and laboratory indexes. Changes of symptoms, immune cell subsets and cytokines were monitored. Symptoms were evaluated by Visual Analogue Scale (VAS) of patient global and physician global, manual muscle testing(MMT-8), the Health Assessment Questionnaire(HAQ), Creatine kinase, Myositis Disease Activity Assessment Tool(MDAAT).
Interventions
Deucravacitinib 6mg once a day for 6 months.
Sponsors
Peking University People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Inclusion criteria
* Adults between 18 years and 75 years of age. * Adults with active idiopathic inflammatory myopathies will be enrolled, meeting the Bohan \& Peter DM/PM or American College of Rheumatology(ACR) \& European allance of associations for rheumatology(EULAR)(2017) diagnostic criteria. * Active disease: MDAAT skin VAS ≥ 3 cm, with at least 3 core indicators abnormal; * Inadequate response to or intolerance of conventional treatments (such as glucocorticoids, immunosuppressants).
Exclusion criteria
* Any subject meeting either of the following criteria should be excluded: * Combined with other systemic autoimmune diseases; * Severe hepatic and renal dysfunction; * Active infections (such as tuberculosis, hepatitis B, HIV); * Pregnant or lactating women; * Previous use of JAK inhibitors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IMACS-defined improvement | week 24 | The International Myositis Assessment and Clinical Studies (IMACS) definition of improvement (DOI) criteria require improvement of ≥20% in at least three of the six Core Symptom Metrics (CSMs), with no more than two CSMs showing a worsening of ≥25% (excluding MMT-8); |
Countries
China
Outcome results
None listed