Abstract
Objectives:
We aimed to assess the long-term safety and tolerability of imatinib in diffuse cutaneous systemic sclerosis (dcSSc).
Methods:
In this open-label, single-arm, extension-phase clinical trial, patients continued imatinib for 24 months following 12 months of initial treatment.
Results:
Seventeen patients were enrolled. Forty of 92 adverse events (AE) and 0/6 serious (S) AEs were possibly related to medication. The MRSS decreased from a median of 21 to 16, (p=0.002).
Conclusions:
This study demonstrates long-term safety and tolerability of imatinib in a substantial proportion of patients with dcSSc. This is important in evaluating the relevance of this therapy in a chronic disease such as SSc.
Publication types
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Clinical Trial, Phase II
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Research Support, Non-U.S. Gov't
MeSH terms
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Adult
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Antirheumatic Agents / therapeutic use
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Benzamides / therapeutic use*
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Calcium Channel Blockers / therapeutic use
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Drug Therapy, Combination
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Female
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Glucocorticoids / therapeutic use
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Humans
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Hydroxychloroquine / therapeutic use
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Imatinib Mesylate
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Lung Diseases, Interstitial / drug therapy*
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Lung Diseases, Interstitial / etiology
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Male
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Middle Aged
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Piperazines / therapeutic use*
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Prednisone / therapeutic use
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Protein Kinase Inhibitors / therapeutic use*
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Proton Pump Inhibitors / therapeutic use
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Pyrimidines / therapeutic use*
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Respiratory Function Tests
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Scleroderma, Diffuse / complications
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Scleroderma, Diffuse / drug therapy*
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Treatment Outcome
Substances
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Antirheumatic Agents
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Benzamides
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Calcium Channel Blockers
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Glucocorticoids
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Piperazines
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Protein Kinase Inhibitors
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Proton Pump Inhibitors
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Pyrimidines
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Hydroxychloroquine
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Imatinib Mesylate
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Prednisone