Hotline Archive - Treatment of Rheumatoid Arthritis with Methotrexate Alone, Sulfasalazine and Hydroxychloroquine, or a Combination of All Three Medications
May 1996
James R. O'Dell, MD, and associates reported in
the May 16, 1996, issue of the New England Journal of Medicine on the treatment
of rheumatoid arthritis with triple combination therapy.
These researchers conducted a two-year, double-blind
randomized study comparing methotrexate alone (7.5-17.5 mg/wk) with sulfasalazine
(500 mg twice a day) and hydroxychloroquine (200 mg twice a day), or all three
drugs. Methotrexate was adjusted to achieve remission. There was no difference
in the groups at entry.
The major end point was whether the patients'
conditions improved by 50 percent, as determined by whether three of the following
requirements had been fulfilled: morning stiffness of less than 30 minutes duration
or improved by 50 percent; joint tenderness improved by 50 percent; joint swelling
improved by 50 percent; and erythrocyte sedimentation rate of less than 30 mm
per hour in women and less than 20 mm in men. Patients that did not have this
degree of improvement were considered failures.
Fifty of 102 patients had 50 percent improvement
at nine months and maintained at least that for two years without major drug
toxicity. Twenty-four of 31 (77%) of these patients were in the group taking
all three drugs. Twelve of 36 patients (33%) were in the methotrexate group
and 14 of 35 (40%) were in the sulfasalazine/hydroxychloroquine group. Thirteen
patients discontinued the study because of drug toxicity. Seven patients were
in the methotrexate group, three were in the sulfasalazine/hydroxychloroquine
group, and three were in the three-drug group.
Disease modifying drugs currently available are
frequently disappointing when remission is the end point. There is little data
in the literature to suggest that combination therapy is better than a single
drug.
The present study demonstrates that in patients
with rheumatoid arthritis, the combination of methotrexate, sulfasalazine, and
hydroxychloroquine is better than either methotrexate alone or a combination
of sulfasalazine and hydroxychloroquine, and there is no increased toxicity
with the combination compared to methotrexate alone.
William Ginsburg, MD and Robert Thoburn, MD
Co-editors, ACR Hotline
May 15, 1996
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