title: Effects of administration of an anti-CD5 plus immunoconjugate in rheumatoid arthritis. Results of two phase II studies. The CD5 Plus Rheumatoid Arthritis Investigators Group.
abstract: OBJECTIVE
  To evaluate the safety and activity of an immunoconjugate of ricin A chain and anti-CD5 monoclonal antibody (anti-CD5 IC), with and without concomitant methotrexate and/or azathioprine, in the treatment of rheumatoid arthritis (RA).
  
  
  METHODS
  Seventy-nine patients with active RA were enrolled in 2 prospective open-label protocols.
  
  
  RESULTS
  Using composite criteria, response rates were 50-68% at 1 month and 22-25% at 6 months. Transient depletion of CD3/CD5 T cells was observed on days 2 and 5 of treatment, with reconstitution on day 15 or day 29. Treatment-associated adverse effects were common but resolved rapidly without sequelae.
  
  
  CONCLUSIONS
  These findings suggest activity of anti-CD5 IC in active RA and warrant confirmation in a multicenter randomized study (currently underway).
authors.forename: V
authors.initials: V
authors.lastname: Strand
authors.forename: P E
authors.initials: PE
authors.lastname: Lipsky
authors.forename: G W
authors.initials: GW
authors.lastname: Cannon
authors.forename: L H
authors.initials: LH
authors.lastname: Calabrese
authors.forename: C
authors.initials: C
authors.lastname: Wiesenhutter
authors.forename: S B
authors.initials: SB
authors.lastname: Cohen
authors.forename: N J
authors.initials: NJ
authors.lastname: Olsen
authors.forename: M L
authors.initials: ML
authors.lastname: Lee
authors.forename: T J
authors.initials: TJ
authors.lastname: Lorenz
authors.forename: B
authors.initials: B
authors.lastname: Nelson
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D015703:Antigens, CD / Q000032:analysis* / Q000276:immunology*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000276:immunology; D001379:Azathioprine / Q000009:adverse effects / Q000627:therapeutic use*; D018956:CD5 Antigens; D002452:Cell Count; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D000922:Immunotoxins / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008727:Methotrexate / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D011446:Prospective Studies; D012276:Ricin; D013601:T-Lymphocytes / Q000276:immunology*; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D015703:Antigens, CD; D018956:CD5 Antigens; D000922:Immunotoxins; D012276:Ricin; D001379:Azathioprine; D008727:Methotrexate