A pilot study of mycophenolate mofetil combined to intravenous methylprednisolone pulses and oral low-dose glucocorticoids in severe early systemic sclerosis

Clin Exp Rheumatol. 2007 Mar-Apr;25(2):287-92.


Objective: This pilot study was aimed at evaluating the efficacy and safety of a protocol-based treatment strategy combining mycophenolate mofetil (MMF), intravenous (IV) methylprednisolone (MP) pulses and low-dose glucocorticoids (GC) in early systemic sclerosis (SSc) patients suffering from either active interstitial lung disease (ILD) or extensive skin disease.

Patients and methods: Sixteen SSc patients were recruited in the study, 9 based on the severity of their skin involvement (modified Rodnan total skin score [TSS] >or= 15) and 7 based on the presence of active ILD. Patients received 3 consecutive daily IV MP pulses, followed by 5 additional monthly IV MP pulses. MMF (0.5 g bid for one week; then, 1 g bid) and low-dose (5-10 mg/day) oral prednisolone were prescribed for one year. Patients were assessed at baseline, month 6 and 12. Statistics were by ANOVA.

Results: TSS and Health Assessment Questionnaire significantly improved over time. In ILD patients, the vital capacity, forced expiratory volume in one second and carbon monoxide diffusing capacity significantly improved. Although the difference was not statistically significant, ground glass lesions decreased, based on semi-quantitative planimetry analyses performed on chest high-resolution computerized tomography. Toxicity was low and none of the patients suffered from renal crisis.

Conclusion: The results of this pilot study suggest that the combination of MMF, IV MP and low-dose GC might achieve good clinical, functional and radiological results in patients suffering from severe early SSc.

Publication types

  • Clinical Trial

MeSH terms

  • Administration, Oral
  • Adult
  • Dose-Response Relationship, Drug
  • Drug Therapy, Combination
  • Female
  • Glucocorticoids / administration & dosage
  • Glucocorticoids / adverse effects
  • Glucocorticoids / therapeutic use*
  • Health Surveys
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Immunosuppressive Agents / adverse effects
  • Immunosuppressive Agents / therapeutic use*
  • Injections, Intravenous
  • Lung Diseases, Interstitial / drug therapy
  • Lung Diseases, Interstitial / etiology
  • Male
  • Methylprednisolone / administration & dosage
  • Methylprednisolone / adverse effects
  • Methylprednisolone / therapeutic use*
  • Middle Aged
  • Mycophenolic Acid / administration & dosage
  • Mycophenolic Acid / adverse effects
  • Mycophenolic Acid / analogs & derivatives*
  • Mycophenolic Acid / therapeutic use
  • Pilot Projects
  • Pulse Therapy, Drug
  • Scleroderma, Systemic / complications
  • Scleroderma, Systemic / drug therapy*
  • Skin Diseases / drug therapy
  • Skin Diseases / etiology
  • Treatment Outcome


  • Glucocorticoids
  • Immunosuppressive Agents
  • Mycophenolic Acid
  • Methylprednisolone