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A randomized unblinded trial of cyclophosphamide versus azathioprine in the treatment of systemic sclerosis

O Nadashkevich1, P Davis, M Fritzler

  • 1Department of Internal Medicine/Rheumatology, L'viv Medical University, L'viv, Ukraine.

Clinical Rheumatology
|October 18, 2005
PubMed

Insights

Cyclophosphamide (CYC) shows promise in treating early diffuse systemic sclerosis (SSc), improving skin scores and Raynaud's phenomenon. This early intervention may modify disease progression, offering a new therapeutic avenue for SSc patients.

Area of Science:

  • Rheumatology
  • Immunology
  • Clinical Pharmacology

Background:

  • Systemic sclerosis (SSc) treatment options are limited, particularly for early-stage disease.
  • Early intervention during the inflammatory phase is crucial to prevent irreversible fibrosis and damage in SSc.
  • Cyclophosphamide (CYC) is a potential therapeutic agent for early SSc, but its efficacy and toxicity require further investigation.

Purpose of the Study:

  • To evaluate the efficacy and toxicity of cyclophosphamide (CYC) in patients with early diffuse systemic sclerosis (SSc).
  • To compare the effects of CYC with azathioprine (AZ) in managing early SSc.
  • To assess the impact of CYC on key disease markers and patient outcomes over 18 months.

Main Methods:

  • A randomized, unblinded, 18-month trial involving 60 patients with early diffuse SSc.
  • Patients were assigned to receive oral cyclophosphamide (CYC) or azathioprine (AZ) for 12 months, followed by maintenance doses.
  • All patients received a 6-month course of prednisolone, tapered to zero.

Main Results:

  • The CYC group showed statistically significant improvements in modified Rodnan skin score (MRSS), Raynaud's phenomenon (RP) attack frequency, and erythrocyte sedimentation rate (ESR).
  • The azathioprine (AZ) group did not demonstrate significant improvements in these markers.
  • Forced vital capacity (FVC) and diffusing capacity of the lungs for carbon monoxide (DLCO) remained stable in the CYC group but worsened in the AZ group.
  • No life-threatening adverse reactions were observed in either treatment group.

Conclusions:

  • Cyclophosphamide (CYC) demonstrates potential as a disease-modifying medication for early diffuse systemic sclerosis (SSc).
  • CYC positively influences the disease's evolution, showing benefits in skin involvement, vascular complications, and inflammatory markers.
  • CYC appears to be a promising therapeutic option for early SSc, warranting further investigation into its long-term effects and safety profile.

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