title: Daclizumab-induced adverse events in multiple organ systems in multiple sclerosis.
abstract: OBJECTIVE
  To report 3 patients with multiple sclerosis (MS) who presented with daclizumab-related adverse events (AEs) in multiple organ systems.
  
  
  METHODS
  A retrospective chart review was performed of patients with MS who had clinical and histopathologic findings suggestive of daclizumab-induced AEs between 2004 and 2010 at the Johns Hopkins MS Clinic. This study met criteria for exemption from review from the institutional review board.
  
  
  RESULTS
  Of 20 total patients with MS who had been treated with daclizumab, 3 patients with clinical and histopathologic findings suggestive of daclizumab-induced AEs were identified. All patients were treated with Zenapax (1 mg/kg monthly IV infusions) outside of a clinical trial setting. Clinical manifestations after a mean treatment duration of 20 months consisted of diffuse rash and alopecia, diffuse lymphadenopathy, and breast nodules. Tissue histopathology demonstrated lymphocytic infiltrates with CD56-expressing cells in 2 patients (lymph node, breast nodule). On daclizumab discontinuation, the rash/alopecia and diffuse lymphadenopathy resolved, while the breast nodules stabilized.
  
  
  CONCLUSIONS
  Daclizumab-induced AEs can occur in various organ systems after a relatively prolonged duration of exposure and require clinician awareness. Future studies are needed to better understand the relationship between natural killer cells and daclizumab-related AEs.
authors: From the Department of Neurology (J. Oh, S.S., P.A.C., S.D.N.), Johns Hopkins University, Baltimore; and Neuroimmunology Branch (I.C., J. Ohayon, B.B.), National Institute of Neurological Disorders and Stroke, Bethesda, MD.
authors: Jiwon
authors: J
authors: Oh
authors: Shiv
authors: S
authors: Saidha
authors: Irene
authors: I
authors: Cortese
authors: Joan
authors: J
authors: Ohayon
authors: Bibiana
authors: B
authors: Bielekova
authors: Peter A
authors: PA
authors: Calabresi
authors: Scott D
authors: SD
authors: Newsome
mesh_terms: D000386:AIDS-Related Complex / Q000139:chemically induced*; D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects*; D015703:Antigens, CD / Q000378:metabolism; D001940:Breast / Q000187:drug effects / Q000473:pathology; D000077561:Daclizumab; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000009:adverse effects*; D007166:Immunosuppressive Agents / Q000009:adverse effects*; D017254:Leukemic Infiltration / Q000139:chemically induced; D008198:Lymph Nodes / Q000187:drug effects / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy; D012189:Retrospective Studies
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D015703:Antigens, CD; D007074:Immunoglobulin G; D007166:Immunosuppressive Agents; D000077561:Daclizumab