Etanercept in combination with sulfasalazine, hydroxychloroquine, or gold in the treatment of rheumatoid arthritis.
OBJECTIVE
To prospectively determine the efficacy and safety of etanercept in combination with sulfasalazine (SSZ), hydroxychloroquine (HCQ), and gold in the treatment of rheumatoid arthritis (RA).


METHODS
A prospective open-label study enrolled 119 patients with RA who had active disease despite stable therapy with SSZ (n = 50), HCQ (n = 50), or intramuscular gold (n = 19). Primary efficacy endpoints consisted of American College of Rheumatology responses at 24 and 48 weeks. Safety was established at regularly scheduled visits.


RESULTS
Patients in each etanercept combination showed significant improvement at both 24 and 48 weeks. Toxicity withdrawals by 48 weeks included gold (n = 1): proteinuria; HCQ (n = 5): septic wrist and bilateral pneumonia, rash, optic neuritis, breast cancer, squamous cancer of the tongue; and SSZ (n = 5): otitis media, elevated liver function indicators, pericarditis, rash, and gastroenteritis. The most common adverse events not requiring discontinuation from the study were injection site reactions (43% of patients) and upper respiratory type infections (34%).


CONCLUSIONS
This study is the first to prospectively evaluate the safety of etanercept in combination with SSZ, HCQ, and gold in patients with RA. Etanercept in combination with SSZ, HCQ, or gold was efficacious and well tolerated, with a discontinuation rate of 9% (11/119) for adverse events at 48 weeks.
O'Dell
James R
JR
Department of Internal Medicine, University of Nebraska Medical Center, Omaha, 983025, USA. jrodell@unmc.edu
Petersen
Kara
K
Leff
Robert
R
Palmer
William
W
Schned
Eric
E
Blakely
Kent
K
Haire
Claire
C
Fernandez
Ana
A
D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000503:physiopathology; D004359:Drug Therapy, Combination; D000068800:Etanercept; D005260:Female; D006046:Gold / Q000627:therapeutic use*; D006304:Health Status; D006801:Humans; D006886:Hydroxychloroquine / Q000627:therapeutic use*; D007074:Immunoglobulin G / Q000009:adverse effects*; D007273:Injections, Intramuscular; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D018124:Receptors, Tumor Necrosis Factor; D011993:Recombinant Fusion Proteins / Q000009:adverse effects*; D012720:Severity of Illness Index; D012460:Sulfasalazine / Q000627:therapeutic use*; D016896:Treatment Outcome
D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D011993:Recombinant Fusion Proteins; D012460:Sulfasalazine; D006886:Hydroxychloroquine; D006046:Gold; D000068800:Etanercept