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High-dose cyclophosphamide without stem cell rescue in scleroderma.

C V Tehlirian1, L K Hummers, B White

  • 1Department of Medicine, Johns Hopkins Medical Institution, Baltimore, Maryland, USA.

Annals of the Rheumatic Diseases
|November 3, 2007
PubMed
Summary
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High-dose cyclophosphamide without stem cell rescue showed significant skin score improvement in scleroderma patients. While generally safe, one patient died from infection, highlighting the need for careful monitoring.

Area of Science:

  • Rheumatology
  • Immunology
  • Pharmacology

Background:

  • Scleroderma is a chronic autoimmune disease characterized by skin thickening and potential organ damage.
  • Current treatments for diffuse cutaneous scleroderma have limitations, necessitating exploration of novel therapeutic approaches.

Purpose of the Study:

  • To evaluate the safety and efficacy of high-dose cyclophosphamide (CYC) without stem cell rescue in patients with active diffuse cutaneous scleroderma.
  • To assess the impact of this treatment on skin scores, functional status, and overall disease severity.

Main Methods:

  • An open-label, single-site study treated six patients with active diffuse cutaneous scleroderma using high-dose intravenous cyclophosphamide (200 mg/kg total) followed by granulocyte colony-stimulating factor.
  • Efficacy was measured by the modified Rodnan skin score (mRSS), Health Assessment Questionnaire-Disability Index (HAQ-DI), physician global assessment (PGA), and pulmonary function tests.

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Main Results:

  • Five of six patients showed significant improvement in mRSS within one month, with sustained benefits in three patients for up to 24 months.
  • Physician global assessment and HAQ-DI scores improved by 72% and 79% respectively at three months in five patients.
  • One patient died early due to infection after neutrophil recovery, representing the only serious adverse event.

Conclusions:

  • High-dose cyclophosphamide without stem cell rescue can induce clinically significant improvements in skin manifestations and disease severity in diffuse cutaneous scleroderma.
  • The treatment demonstrates potential as a therapeutic option, though careful monitoring for adverse events, including infection, is crucial.