title: Clinical and biologic effects of anti-interleukin-10 monoclonal antibody administration in systemic lupus erythematosus.
abstract: OBJECTIVE
  To evaluate the safety and clinical efficacy of administering an anti-interleukin-10 (anti-IL-10) monoclonal antibody (mAb) to systemic lupus erythematosus (SLE) patients with active and steroid-dependent disease. In addition, we sought to assess the effects of in vivo IL-10 neutralization on biologic markers of SLE.
  
  
  METHODS
  Treatment consisted of 20 mg/day intravenous administration of an anti-IL-10 murine mAb (B-N10) for 21 consecutive days, with a followup period of 6 months. Six patients were studied.
  
  
  RESULTS
  Treatment was safe and well tolerated. All patients developed antibodies against B-N10. Cutaneous lesions and joint symptoms improved in all patients beginning during B-N10 administration and continuing to month 6. The SLE Disease Activity Index decreased from a mean +/- SEM of 8.83+/-0.91 on day 1 to 3.67+/-0.67 on day 21 (P = 0.001), 1.50+/-0.84 at month 2, and 1.33+/-0.80 at month 6 (P<0.001). At the end of followup, the disease was clinically inactive in 5 of the 6 patients. Prednisone administration was decreased from a mean +/- SEM of 27.9+/-5.7 mg/day on day 1 to 9.6+/-2.0 mg/day at month 6 (P<0.005). Activity of immune and endothelial cells rapidly decreased, as assessed by the early evolution of several biologic markers.
  
  
  CONCLUSIONS
  This is the first report of IL-10 antagonist administration to humans. The study shows the involvement of IL-10 in the pathogenesis of SLE, and indicates that the use of IL-10 antagonists may be beneficial in the management of refractory SLE.
authors.affiliation: Instituto Nacional de la Nutrición Salador Zubrinán, Mexico City, Mexico.
authors.forename: L
authors.initials: L
authors.lastname: Llorente
authors.forename: Y
authors.initials: Y
authors.lastname: Richaud-Patin
authors.forename: C
authors.initials: C
authors.lastname: García-Padilla
authors.forename: E
authors.initials: E
authors.lastname: Claret
authors.forename: J
authors.initials: J
authors.lastname: Jakez-Ocampo
authors.forename: M H
authors.initials: MH
authors.lastname: Cardiel
authors.forename: J
authors.initials: J
authors.lastname: Alcocer-Varela
authors.forename: L
authors.initials: L
authors.lastname: Grangeot-Keros
authors.forename: D
authors.initials: D
authors.lastname: Alarcón-Segovia
authors.forename: J
authors.initials: J
authors.lastname: Wijdenes
authors.forename: P
authors.initials: P
authors.lastname: Galanaud
authors.forename: D
authors.initials: D
authors.lastname: Emilie
mesh_terms: D000293:Adolescent; D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000097:blood; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016753:Interleukin-10 / Q000097:blood / Q000276:immunology*; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy*; D008297:Male; D010865:Pilot Projects
chemical_list: D000911:Antibodies, Monoclonal; D016753:Interleukin-10