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Treatment with Interleukin-1 Receptor Antagonist (IL-1ra) in Patients with Chronic Inflammatory Myopathies

Principal Investigator:

Ingrid E. Lundberg

Study Design:

Open label

Types & Number of IIM Studied:

Polymyositis, dermatomyositis and inclusion body myositis in adult patients (n = 15)

Entry Criteria:

Treatment resistant myositis: (1) Men/women age: 18- 80 years (2) Diagnosis of polymyositis, dermatomyositis or inclusion body myositis based on clinical, biochemical, histopathological and electrophysiological criteria of Bohan & Peter (3) Adequate immunosuppressive treatment for at least 2 months including corticosteroids > 0,75mg/kg (for at least one month) and treatment with azathioprine or methotrexate (4) Muscle strength and/or function reduced at least 20 % below predicted values (5) The patients must be capable of giving informed consent and consent must have been obtained prior to any screening procedures

IMACS Core Set Measures Included:

(1) Disease activity by the IMACS score: a) Patients global assessment on an visual analogue scale b) Physicians global assessment on an visual analogue scale c) Function in daily activities by the Health assessment questionnaire (HAQ) d) Serum levels of creatine phosphokinase e) Extramuscular disease activity by Myositis Disease Activity Assessment Tool (MYOACT, MYOVAS) f) Muscle strength by the Manual Muscle Test (MMT-8) (2) Tolerability to anakinra (3) Function in daily activities by the myositis specific questionnaire: Myositis activity profile (MAP) (4) Health related quality of life by the self administrated questionnaire SF-36

Other Measures Included:

Myositis Functional Index

Primary Outcome:

Improvement assessed by the Myositis Functional index (Josefsson et al) 1996) at 12 months.

Study Status:

Enrollment Completed

Funding:

Swedish Research Council, Swedish Rheumatism Association

Comments:

None.

Publications:

Zong M, Dorph C, Dastmalchi M, Alexanderson H, Pieper J, Amoudruz P, Barbasso Helmers S, Nennesmo I, Malmström V, Lundberg IE. Anakinra treatment in patients with refractory inflammatory myopathies and possible predictive response biomarkers: a mechanistic study with 12 months follow-up., Ann Rheum Dis, 2014 May;73(5):913-20.[Abstract ]

Contact:

Ingrid Lundberg, M.D., Ph.D.
Rheumatology Unit
Department of Medicine
Karolinska University Hospital
Solna, Karolinska Institutet
SE- 171 76 Stockholm, Sweden
Tel +46-8-5177-3080
Fax +46-8-5177-3080
Ingrid.Lundberg@medks.ki.se


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