annrheumdis-2018-January-77-1-55-inline-supplementary-material-1.doc - SUPPLEMENTARY MATERIAL 1 Inclusion criteria 2 Exclusion criteria 3 Criteria for

Annrheumdis-2018-January-77-1-55-inline-supplementary-material-1.doc

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SUPPLEMENTARY MATERIAL 1. Inclusion criteria 2. Exclusion criteria 3. Criteria for worsening (as preliminary proposed by the International Myositis Assessment and Clinical Studies Group (IMACS)) 4. Muscle biopsies and immunohistochemistry 5. Supplementary Table 1. Individual data on muscle biopsy features, autoantibody positivity and extramuscular manifestations at time of diagnosis, and responder/non-responder according to the International Myositis Assessment and Clinical Studies Group (IMACS) definition of improvement 6. Supplementary Table 2. Antibody panel for immunohistochemistry 7. Supplementary Table 3. Autoantibody data 8. Supplementary Table 4. Extramuscular disease activity assessed by Myositis intention to Treat Activity Index (MITAX) of the Myositis Disease Activity Assessment Tool (MDAAT) at start of treatment and after 6 months of active treatment, and worsening at time of primary endpoint according to the International Myositis Assessment and Clinical Studies Group (IMACS) preliminary criteria
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1. Inclusion criteria 1. Patients with definite or probable polymyositis or dermatomyositis diagnosed according to the diagnostic criteria by Bohan and Peter [13, 14]. 2. For polymyositis a muscle biopsy is required that confirmed this disease (performed at any time before the start of the study) and to exclude other conditions unless a patient is positive for myositis specific or myositis associated autoantibodies. 3. Polymyositis will be included after a judicial process by the three PIs. 4. Inflammatory active disease based on persisting or worsening muscle weakness, MMT < 150 or low endurance, FI -2 < 20% of upper value [15] together with at least one other sign of active disease: elevated serum levels of muscle enzymes (CK, LD, ASAT, ALAT, above upper limit and being explained by muscle involvement and not eg liver disease), inflammation in recent muscle biopsy (< 3 months) or on MRI scans or active extramuscular disease: skin rash, arthritis or interstitial lung disease (ILD) (as suggested by chest X-ray, high resolution computerized tomography (HRCT), or pulmonary function test). 5. Persisting disease activity after a minimum of 3 months treatment with prednisolone or equal drug. The treatment with prednisolone (or equal) should include the dose of at least 0.5 mg/kg/day for at least 1 month in the history and should be stable 1 month prior the baseline visit. Maximum dose of glucocorticoids should not exceed the equivalent of Prednisone 30 mg per day at the time of randomisation. 6. Combination with at least one other immunosuppressive drug, which includes methotrexate (minimum dose 15 mg/week) or azathioprine (minimum dose 100 mg/day) for at least 3 months. The dose of methotrexate or azathioprine should be stable for at least 1 month before the first administration of abatacept.
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