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Dose-loading with hydroxychloroquine improves the rate of response in early, active rheumatoid arthritis: A randomized, double-blind six-week trial with eighteen-week extension

✍ Scribed by Daniel E. Furst; Herbert Lindsley; Bruce Baethge; Gary R. Botstein; Jacques Caldwell; Fredrick Dietz; Robert Ettlinger; Harvey E. Golden; George E. McLaughlin; Larry W. Moreland; W. Neal Roberts; Theodore W. Rooney; Bruce Rothschild; Marshall Sack; Anthony I. Sebba; Michael Weisman; Kathryn E. Welch; David Yocum


Publisher
John Wiley and Sons
Year
1999
Tongue
English
Weight
182 KB
Volume
42
Category
Article
ISSN
0004-3591

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✦ Synopsis


Objective:

To investigate the usefulness of hydroxychloroquine (hcq) dose-loading to increase the percentage of responders or rate of response in treating rheumatoid arthritis (ra).

Methods:

Two hundred twelve patients with early ra (mean duration 1.5 years) were enrolled in a 24-week trial. patients were stabilized with 1,000 mg naproxen/day and then began a 6-week, double-blind trial comparing treatment with hcq at 400 mg/day (n = 71), 800 mg/day (n = 71), and 1,200 mg/day (n = 66), followed by 18 weeks of open-label hcq treatment at 400 mg/day.

Results:

All patients had mild, active disease at the time of initiation of hcq treatment (31-43% rheumatoid factor positive; no previous disease-modifying antirheumatic drugs; mean swollen joint count 8.6-10.4). based on the paulus criteria, response during the 6-week double-blind portion of the study was 47.97%, 57.7%, and 63.6% in the 400 mg/day, 800 mg/day, and 1,200 mg/day groups, respectively (p = 0.052). discontinuations for adverse events were dose related (3 in the 400 mg/day group, 5 in the 800 mg/day group, 6 in the 1,200 mg/day group). most involved the gastrointestinal (gi) system, with the background naproxen treatment possibly contributing. ocular abnormalities occurred in 17 of 212 patients (8%) but were not dose related.

Conclusion:

Dose-loading with hcq increased the degree of response at 6 weeks in this group of patients with early, predominantly seronegative ra. adverse gi events were dose related, while adverse ocular events were not.