Document Detail

Treatment of rheumatoid arthritis with methotrexate and hydroxychloroquine, methotrexate and sulfasalazine, or a combination of the three medications: results of a two-year, randomized, double-blind, placebo-controlled trial.
MedLine Citation:
PMID:  12115219     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To compare the efficacy of combination therapy with methotrexate (MTX) and hydroxychloroquine (HCQ), MTX and sulfasalazine (SSZ), and MTX, HCQ, and SSZ in patients with rheumatoid arthritis (RA). METHODS: RA patients (n = 171) who had not previously been treated with combinations of the study medications were randomized to receive 1 of the 3 treatment combinations in this 2-year, double-blind, placebo-controlled protocol. HCQ was given at a dosage of 200 mg twice a day. The dosage of MTX was accelerated from 7.5 mg/week to 17.5 mg/week in all patients who were not in remission. Similarly, the dosage of SSZ was escalated from 500 mg twice a day to 1 gm twice a day in patients who were not in remission. The primary end point of the study was the percentage of patients who had a 20% response to therapy according to the American College of Rheumatology (ACR) criteria at 2 years. RESULTS: Intent-to-treat analysis revealed that patients receiving the triple combination responded best, with 78% achieving an ACR 20% response at 2 years, compared with 60% of those treated with MTX and HCQ (P = 0.05) and 49% of those treated with MTX and SSZ (P = 0.002). Similar trends were seen for the ACR 50% response, with 55%, 40%, and 29% of patients in the 3 treatment groups, respectively, achieving these results at 2 years (P = 0.005 for the triple combination group versus the MTX and SSZ group). All combination treatments were well-tolerated. Fourteen patients (evenly distributed among the 3 groups) withdrew from the protocol because of symptoms that were potentially related to the study medication. CONCLUSION: The triple combination of MTX, SSZ, and HCQ is well-tolerated, and its efficacy is superior to that of the double combination of MTX and SSZ and is marginally superior to that of the double combination of MTX and HCQ.
James R O'Dell; Robert Leff; Gail Paulsen; Claire Haire; Jack Mallek; P James Eckhoff; Ana Fernandez; Kent Blakely; Steven Wees; Julie Stoner; Stephen Hadley; Jeffrey Felt; William Palmer; Paul Waytz; Melvin Churchill; Lynell Klassen; Gerald Moore
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Arthritis and rheumatism     Volume:  46     ISSN:  0004-3591     ISO Abbreviation:  Arthritis Rheum.     Publication Date:  2002 May 
Date Detail:
Created Date:  2002-07-12     Completed Date:  2002-07-31     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0370605     Medline TA:  Arthritis Rheum     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1164-70     Citation Subset:  AIM; IM    
University of Nebraska Medical Center, Omaha 68198, USA.
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MeSH Terms
Antirheumatic Agents / administration & dosage*,  adverse effects
Arthritis, Rheumatoid / drug therapy*
Double-Blind Method
Drug Therapy, Combination
Hydroxychloroquine / administration & dosage*,  adverse effects
Methotrexate / administration & dosage*,  adverse effects
Middle Aged
Sulfasalazine / administration & dosage*,  adverse effects
Treatment Outcome
Reg. No./Substance:
0/Antirheumatic Agents; 118-42-3/Hydroxychloroquine; 59-05-2/Methotrexate; 599-79-1/Sulfasalazine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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