title: Short-term effect of leflunomide in patients with Takayasu arteritis: an observational study.
abstract: OBJECTIVE
  To evaluate the efficacy of leflunomide in controlling disease activity in patients with Takayasu arteritis (TA) refractory or intolerant to conventional treatment.
  
  
  METHODS
  We conducted a prospective open-label study of 15 TA patients (mean age 36.2 years) with active disease based on clinical assessment, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and magnetic resonance angiography (MRA). Patients received leflunomide 20 mg/day for at least 6 months and were followed up for a mean of 9.1 months. Adverse events attributable to leflunomide were recorded.
  
  
  RESULTS
  At baseline, 14 TA patients had active disease despite therapy with corticosteroids and immunosuppressive agents, while one patient had intolerance to current treatment. In the follow-up visit, we found a significant decrease in the frequency of patients with active TA (93% vs. 20%, p = 0.002), in the mean daily dose of prednisone (34.2 vs. 13.9 mg, p < 0.001) and in the median values of ESR (29.0 vs. 27.0 mm/h, p = 0.012) and CRP (10.3 vs. 5.3 mg/L, p = 0.012). Two patients (13.3%) developed new angiographic lesions in the follow-up MRA. Three patients (20%) experienced mild adverse events during the study and none discontinued therapy.
  
  
  CONCLUSIONS
  This is the first open-label study to demonstrate improvement in disease activity and acute phase reactants with 20 mg/day of leflunomide in TA patients who were refractory or intolerant to conventional therapy with corticosteroids and immunosuppressive agents. Leflunomide was safe and a steroid-sparing effect was observed. A double-blind controlled study is desirable to confirm this finding.
authors.affiliation: Rheumatology Division, Federal University of São Paulo-Unifesp/EPM, Brazil. alexandre_wagner@uol.com.br
authors.forename: A W S
authors.initials: AW
authors.lastname: de Souza
authors.forename: M D
authors.initials: MD
authors.lastname: da Silva
authors.forename: L S G
authors.initials: LS
authors.lastname: Machado
authors.forename: A C D
authors.initials: AC
authors.lastname: Oliveira
authors.forename: F A G
authors.initials: FA
authors.lastname: Pinheiro
authors.forename: E I
authors.initials: EI
authors.lastname: Sato
mesh_terms: D000328:Adult; D001799:Blood Sedimentation; D002097:C-Reactive Protein / Q000378:metabolism; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000008:administration & dosage; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007555:Isoxazoles / Q000009:adverse effects / Q000627:therapeutic use*; D000077339:Leflunomide; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage; D011446:Prospective Studies; D013625:Takayasu Arteritis / Q000097:blood / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D007555:Isoxazoles; D002097:C-Reactive Protein; D000077339:Leflunomide; D011241:Prednisone