Overview

Anakinra in Myositis

Status:
Completed

Trial end date:
2008-09-01

Target enrollment:
0

Participant gender:
All

Summary

To investigate the effect of the interleukin-1 (IL-1) blocking agent, anakinra, in patients with treatment-resistant inflammatory myopathies. Patients and methods: Fifteen patients with refractory polymyositis (PM), dermatomyositis (DM), or inclusion body myositis (IBM) were treated with 100 mg anakinra subcutaneously per day during 12 months. Outcome measures included myositis disease activity score with improvement defined according to The International Myositis Assessment and Clinical Studies Group (IMACS) and for muscle performance the functional index of myositis (FI). In addition repeat muscle biopsies were performed

Phase:

Phase 2/Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Karolinska Institutet

Treatments:

Interleukin 1 Receptor Antagonist Protein

Criteria

Inclusion Criteria:

Men and women aged 18 to 80 years with diagnosis of PM, DM or IBM based Peter and Bohan's
and Grigg's criteria. All patients had to be capable of giving informed consent. Other
inclusion criteria were muscle strength and/or function reduced at least 20 % below
predicted values as measured by functional index (FI) [45-47] and failure to respond to
treatment with high-dose glucocorticoids (0.75 mg/kg/day for at least one month) in
combination with azathioprine and/or methotrexate for at least two months.

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Exclusion Criteria:

serious infections such as hepatitis, pneumonia, pyelonephritis in the previous 3 months;
history of opportunistic infections such as tuberculosis, drug resistant atypical
mycobacterium, active pneumocystis carinii, active cytomegalovirus infection; documented
HIV infection; alcoholism, alcoholic liver disease or other chronic liver disease; chest
x-ray suggestive of active tuberculosis; and pregnant, nursing mothers or patients with
planned pregnancy within one and a half years of enrolment.

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