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Controlled clinical trial of IV cyclophosphamide versus IV methylprednisolone in severe neurological manifestations in systemic lupus erythematosus . 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 .
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Intervention_Pharmacological
cyclophosphamide
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Intervention_Pharmacological
methylprednisolone
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Intervention_Pharmacological
methylprednisolone
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Intervention_Pharmacological
cyclophosphamide
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Intervention_Pharmacological
IV MP bimonthly
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Outcome_Other
response to treatment
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Outcome_Physical
20 % improvement from basal conditions
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Outcome_Physical
clinical , laboratory , or specific neurological testing variables
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Outcome_Other
response rate
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Outcome_Other
effective