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Controlled clinical trial of IV cyclophosphamide versus IV methylprednisolone in severe neurological manifestations in systemic lupus erythematosus
  1. L Barile-Fabris1,
  2. R Ariza-Andraca2,
  3. L Olguín-Ortega3,
  4. L J Jara1,
  5. A Fraga-Mouret5,
  6. J M Miranda-Limón3,
  7. J Fuentes de la Mata5,
  8. P Clark4,
  9. F Vargas4,
  10. J Alocer-Varela4
  1. 1Clinical Epidemiology Research Unit, Hospital Especialidades, Centro Médico Nacional Instituto Mexicano del Seguro Social, Mexico
  2. 2Internal Medicine Department, Centro Médico Nacional Instituto Mexicano del Seguro Social, Mexico
  3. 3Rheumatology Department, Hospital de Especialidades, Centro Médico La Raza, Instituto Mexicano del Seguro Social, Mexico
  4. 4Clinical Epidemiology Postgraduate Program, Universidad Nacional Autónoma de México, Mexico
  5. 5Rheumatology Department, HECMN, SXXI, IMSS, Mexico
  1. Correspondence to:
    Dr L Barile-Fabris
    Avenida San Bernabé 712 bis casa 3, San Jerónimo Lídice, Mexico City 10200 Mexico;


Background: Severe neurological involvement in systemic lupus erythematosus (NPSLE) is one of the most dreadful complications of the disease.

Objective: To identify the best drug, dose, and treatment.

Patients and methods: The study was a controlled clinical trial at two tertiary care centres of patients with SLE according to the ACR criteria, with incident (no more than 15 days) onset of severe NP manifestations such as seizures, optic neuritis, peripheral or cranial neuropathy, coma, brainstem disease, or transverse myelitis. Induction treatment with 3 g of IV methylprednisolone (MP) followed by either IV monthly cyclophosphamide (Cy) versus IV MP bimonthly every 4 months for 1 year and then IV Cy or IV MP every 3 months for another year. The primary end point was response to treatment: at least 20% improvement from basal conditions on clinical, laboratory, or specific neurological testing variables.

Results: Overall, a response rate of 75% was observed. Of the 32 patients studied, 18/19 receiving Cy and 7/13 receiving MP responded to treatment (p<0.03).

Conclusions: Cy seems to be more effective than MP in the treatment of acute, severe NPSLE.

  • CNS, central nervous system
  • CSF, cerebrospinal fluid
  • Cy, cyclophosphamide
  • IV, intravenous
  • MP, methyl prednisolone
  • MRI, magnetic resonance imaging
  • NPSLE, neuropsychiatric systemic lupus erythematosus
  • SLE, systemic lupus erythematosus
  • SLEDAI, SLE Disease Activity Index
  • SLICC, Systemic Lupus International Collaborating Clinics
  • neurological involvement
  • systemic lupus erythematosus
  • treatment
  • controlled clinical trials
  • methylprednisolone
  • cyclophosphamide
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