title: The Prosorba column for treatment of refractory rheumatoid arthritis: a randomized, double-blind, sham-controlled trial.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of the Prosorba column as a treatment for rheumatoid arthritis (RA) in patients with active and treatment-resistant (refractory) disease.
  
  
  METHODS
  A sham-controlled, randomized, double-blind, multicenter trial of Prosorba versus sham apheresis was performed in patients with RA who had failed to respond to treatment with methotrexate or at least 2 other second-line drugs. Patients received 12 weekly treatments with Prosorba or sham apheresis, with efficacy evaluated 7-8 weeks after treatment ended. Patients were characterized as responders if they experienced improvement according to the American College of Rheumatology (ACR) response criteria at the efficacy time point. A data safety monitoring board (DSMB) evaluated interim analyses for the possibility of early completion of the trial.
  
  
  RESULTS
  Patients in the trial had RA for an average of 15.5 years (range 1.7-50.6) and had failed an average of 4.2 second-line drug treatments prior to entry. After the completion of treatment of 91 randomized patients, the DSMB stopped the trial early due to successful outcomes. Of the 47 patients in the Prosorba arm, 31.9% experienced ACR-defined improvement versus 11.4% of the 44 patients in the sham-treated arm (P = 0.019 after adjustment for interim analysis). When results from 8 additional patients, who had completed blinded treatments at the time of DSMB action, were added to the analysis (n = 99), results were unchanged. The most common adverse events were a short-term flare in joint pain and swelling following treatment, a side effect that occurred in most subjects at least once in both treatment arms. Other side effects, although common, occurred equally as frequently in both treatment groups.
  
  
  CONCLUSIONS
  Apheresis with the Prosorba column is an efficacious treatment for RA in patients with active disease who have failed other treatments.
authors.affiliation: Boston University School of Medicine, Massachusetts, USA.
authors.forename: D T
authors.initials: DT
authors.lastname: Felson
authors.forename: M P
authors.initials: MP
authors.lastname: LaValley
authors.forename: A R
authors.initials: AR
authors.lastname: Baldassare
authors.forename: J A
authors.initials: JA
authors.lastname: Block
authors.forename: J R
authors.initials: JR
authors.lastname: Caldwell
authors.forename: G W
authors.initials: GW
authors.lastname: Cannon
authors.forename: C
authors.initials: C
authors.lastname: Deal
authors.forename: S
authors.initials: S
authors.lastname: Evans
authors.forename: R
authors.initials: R
authors.lastname: Fleischmann
authors.forename: R M
authors.initials: RM
authors.lastname: Gendreau
authors.forename: E R
authors.initials: ER
authors.lastname: Harris
authors.forename: E L
authors.initials: EL
authors.lastname: Matteson
authors.forename: S H
authors.initials: SH
authors.lastname: Roth
authors.forename: H R
authors.initials: HR
authors.lastname: Schumacher
authors.forename: M H
authors.initials: MH
authors.lastname: Weisman
authors.forename: D E
authors.initials: DE
authors.lastname: Furst
mesh_terms: D000328:Adult; D001172:Arthritis, Rheumatoid / Q000503:physiopathology / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010956:Plasmapheresis; D013205:Staphylococcal Protein A / Q000494:pharmacology*; D016896:Treatment Outcome
chemical_list: D013205:Staphylococcal Protein A