PMID- 10075615
OWN - NLM
STAT- MEDLINE
DCOM- 19990311
LR  - 20220409
IS  - 0003-4819 (Print)
IS  - 0003-4819 (Linking)
VI  - 130
IP  - 6
DP  - 1999 Mar 16
TI  - Etanercept therapy in rheumatoid arthritis. A randomized, controlled trial.
PG  - 478-86
AB  - BACKGROUND: In a phase II study, etanercept (recombinant human tumor necrosis 
      factor receptor [p75]:Fc fusion protein) safely produced rapid, dose-dependent 
      improvement in rheumatoid arthritis over 3 months. OBJECTIVE: To confirm the 
      benefit of etanercept therapy of longer duration and simplified dosing in 
      patients with rheumatoid arthritis. DESIGN: Randomized, double-blind, 
      placebo-controlled trial with blinded joint assessors. SETTING: 13 North American 
      centers. PATIENTS: 234 patients with active rheumatoid arthritis who had an 
      inadequate response to disease-modifying antirheumatic drugs. INTERVENTION: 
      Twice-weekly subcutaneous injections of etanercept, 10 or 25 mg, or placebo for 6 
      months. MEASUREMENTS: The primary end points were 20% and 50% improvement in 
      disease activity according to American College of Rheumatology (ACR) responses at 
      3 and 6 months. Other end points were 70% ACR responses at 3 and 6 months and 
      other measures of disease activity at 3 and 6 months. RESULTS: Etanercept 
      significantly reduced disease activity in a dose-related fashion. At 3 months, 
      62% of the patients receiving 25 mg of etanercept and 23% of the placebo 
      recipients achieved 20% ACR response (P < 0.001). At 6 months, 59% of the 25-mg 
      group and 11% of the placebo group achieved a 20% ACR response (P < 0.001); 40% 
      and 5%, respectively, achieved a 50% ACR response (P < 0.01). The respective mean 
      percentage reduction in the number of tender and swollen joints at 6 months was 
      56% and 47% in the 25-mg group and 6% and -7% in the placebo group (P < 0.05). 
      Significantly more etanercept recipients achieved a 70% ACR response, minimal 
      disease status (0 to 5 affected joints), and improved quality of life. Etanercept 
      was well tolerated, with no dose-limiting toxic effects. CONCLUSIONS: Etanercept 
      can safely provide rapid, significant, and sustained benefit in patients with 
      active rheumatoid arthritis.
FAU - Moreland, L W
AU  - Moreland LW
AD  - Division of Clinical Immunology and Rheumatology, University of Alabama at 
      Birmingham, 35294-7201, USA.
FAU - Schiff, M H
AU  - Schiff MH
FAU - Baumgartner, S W
AU  - Baumgartner SW
FAU - Tindall, E A
AU  - Tindall EA
FAU - Fleischmann, R M
AU  - Fleischmann RM
FAU - Bulpitt, K J
AU  - Bulpitt KJ
FAU - Weaver, A L
AU  - Weaver AL
FAU - Keystone, E C
AU  - Keystone EC
FAU - Furst, D E
AU  - Furst DE
FAU - Mease, P J
AU  - Mease PJ
FAU - Ruderman, E M
AU  - Ruderman EM
FAU - Horwitz, D A
AU  - Horwitz DA
FAU - Arkfeld, D G
AU  - Arkfeld DG
FAU - Garrison, L
AU  - Garrison L
FAU - Burge, D J
AU  - Burge DJ
FAU - Blosch, C M
AU  - Blosch CM
FAU - Lange, M L
AU  - Lange ML
FAU - McDonnell, N D
AU  - McDonnell ND
FAU - Weinblatt, M E
AU  - Weinblatt ME
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Ann Intern Med
JT  - Annals of internal medicine
JID - 0372351
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Immunoglobulin G)
RN  - 0 (Receptors, Tumor Necrosis Factor)
RN  - 0 (Recombinant Proteins)
RN  - OP401G7OJC (Etanercept)
SB  - IM
MH  - Algorithms
MH  - Anti-Inflammatory Agents, Non-Steroidal/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Etanercept
MH  - Female
MH  - Humans
MH  - Immunoglobulin G/administration & dosage/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Patient Dropouts
MH  - Quality of Life
MH  - Receptors, Tumor Necrosis Factor/administration & dosage/*therapeutic use
MH  - Recombinant Proteins/administration & dosage/adverse effects/therapeutic use
MH  - Statistics as Topic
EDAT- 1999/03/13 03:11
MHDA- 2000/09/08 11:01
CRDT- 1999/03/13 03:11
PHST- 1999/03/13 03:11 [pubmed]
PHST- 2000/09/08 11:01 [medline]
PHST- 1999/03/13 03:11 [entrez]
AID - 199903160-00004 [pii]
AID - 10.7326/0003-4819-130-6-199903160-00004 [doi]
PST - ppublish
SO  - Ann Intern Med. 1999 Mar 16;130(6):478-86. doi: 
      10.7326/0003-4819-130-6-199903160-00004.