PMID- 11111818
OWN - NLM
STAT- MEDLINE
DCOM- 20010531
LR  - 20191104
IS  - 1091-6660 (Print)
IS  - 1091-6660 (Linking)
VI  - 4
IP  - 5
DP  - 2000 Oct
TI  - Immunoadsorption for the treatment of rheumatoid arthritis: final results of a 
      randomized trial. Prosorba Trial Investigators.
PG  - 363-73
AB  - A double-blind, randomized, placebo controlled study was conducted to determine 
      the efficacy of a promising immunoadsorption treatment device containing 
      staphylococcal protein A (Prosorba Immunoadsorption Column, Cypress Bioscience, 
      Inc., San Diego, CA, U.S.A.) in patients with refractory rheumatoid arthritis 
      (RA). Eligibility criteria required adult RA patients who had failed either 
      methotrexate or 2 other disease modifying antirheumatic drugs (DMARD) and who had 
      predefined active disease. All disease-modifying agents were discontinued at 
      least 30 days prior to entry. Patients received 12 weekly procedures after being 
      randomized to the active treatment arm or to the sham treatment arm (apheresis 
      only). Evaluations were double-blinded and occurred at baseline and periodically 
      for 24 weeks thereafter. Primary efficacy was assessed at 7 and 8 weeks after the 
      completion of 12 treatments (at trial Weeks 19 and 20) using the American College 
      of Rheumatology (ACR) definition of improvement (1,2), and results from the 
      assessments at Weeks 19 and 20 were averaged. Ninety-nine randomized patients had 
      a mean disease duration of 15.4 years and received an average of greater than 5 
      DMARD regimens prior to entry. Analysis of patients who completed all treatments 
      and follow-up indicated that 15 of 36 (41.7%) column-treated patients responded 
      compared to 5 of 32 (15.6%) sham-treated patients (p < or = 0.003). Intent to 
      treat analysis of all patients who were randomized in the study indicated 15 of 
      52 (28.9%) column-treated patients responded compared to only 5 of 47 (10.6%) 
      patients who received sham treatments (p = .005). Common adverse events (AEs) 
      included joint pain, fatigue, joint swelling, and hypotension. Central line usage 
      was clearly associated with significant AEs during this trial and is not 
      recommended. Hemoglobin, hematocrit, and mean corpuscular volume values decreased 
      similarly in both treatment arms, attributed to phlebotomy for laboratory and 
      scientific studies and to small, repetitive (normal) apheresis losses. Other AEs 
      such as nausea, rash, pruritus, flushing, and fever occurred in 1 to 6% of 
      treatments in each arm (NS). There was no significant increase in AEs in 
      column-treated patients compared to sham-treated patients. Protein A 
      immunoadsorption was proven to be a new therapeutic alternative in patients with 
      severe, refractory disease.
FAU - Furst, D
AU  - Furst D
AD  - Virginia Mason Research Center and University of Washington, Seattle 98101, USA.
FAU - Felson, D
AU  - Felson D
FAU - Thoren, G
AU  - Thoren G
FAU - Gendreau, R M
AU  - Gendreau RM
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Ther Apher
JT  - Therapeutic apheresis : official journal of the International Society for 
      Apheresis and the Japanese Society for Apheresis
JID - 9706703
RN  - 0 (Placebos)
SB  - IM
EIN - Ther Apher 2002 Feb;6(1):99
MH  - Adult
MH  - Arthritis, Rheumatoid/diagnosis/*therapy
MH  - Double-Blind Method
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - *Immunosorbent Techniques
MH  - Male
MH  - Middle Aged
MH  - Placebos
MH  - Safety
MH  - Time Factors
EDAT- 2000/12/09 11:00
MHDA- 2001/06/02 10:01
CRDT- 2000/12/09 11:00
PHST- 2000/12/09 11:00 [pubmed]
PHST- 2001/06/02 10:01 [medline]
PHST- 2000/12/09 11:00 [entrez]
AID - 10.1046/j.1526-0968.2000.004005363.x [doi]
PST - ppublish
SO  - Ther Apher. 2000 Oct;4(5):363-73. doi: 10.1046/j.1526-0968.2000.004005363.x.