Treatment of rheumatoid arthritis with methotrexate alone, sulfasalazine and hydroxychloroquine, or a combination of all three medications

James Robert O'Dell, Claire E. Haire, Nils Erikson, Walter Drymalski, William Palmer, P. James Eckhoff, Vernon Garwood, Pierre Maloley, Lynell Warren Klassen, Steven Wees, Harry Klein, Gerald Francis Moore

Research output: Contribution to journalArticle

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Abstract

Background. Rheumatoid arthritis is a common disease that causes substantial morbidity and mortality. The responses of patients with rheumatoid arthritis to treatment with a single so-called disease-modifying drug, such as methotrexate, are often suboptimal. Despite limited data, many patients are treated with combinations of these drugs. Methods. We enrolled 102 patients with rheumatoid arthritis and poor responses to at least one disease-modifying drug in a two-year, double-blind, randomized study of treatment with methotrexate alone (7.5 to 17.5 mg per week), the combination of sulfasalazine (500 mg twice daily) and hydroxychloroquine (200 mg twice daily), or all three drugs. The dose of methotrexate was adjusted in an attempt to achieve remission in all patients. The primary end point of the study was the successful completion of two years of treatment with 50 percent improvement in composite symptoms of arthritis and no evidence of drug toxicity. Results. Fifty of the 102 patients had 50 percent improvement at nine months and maintained at least that degree of improvement for two years without evidence of major drug toxicity. Among them were 24 of 31 patients treated with all three drugs (77 percent), 12 of 36 patients treated with methotrexate alone (33 percent, P<0.001 for the comparison with the three- drug group), and 14 of 35 patients treated with sulfasalazine and hydroxychloroquine (40 percent, P = 0.003 for the comparison with the three- drug group). Seven patients in the methotrexate group and three patients in each of the other two groups discontinued treatment because of drug toxicity. Conclusions. In patients with rheumatoid arthritis, combination therapy with methotrexate, sulfasalazine, and hydroxychloroquine is more effective than either methotrexate alone or a combination of sulfasalazine and hydroxychloroquine.

Original languageEnglish (US)
Pages (from-to)1287-1291
Number of pages5
JournalNew England Journal of Medicine
Volume334
Issue number20
DOIs
StatePublished - May 16 1996

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Hydroxychloroquine
Sulfasalazine
Methotrexate
Rheumatoid Arthritis
Drug-Related Side Effects and Adverse Reactions
Therapeutics
Pharmaceutical Preparations
Drug Combinations
Double-Blind Method
Arthritis

ASJC Scopus subject areas

  • Medicine(all)

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Treatment of rheumatoid arthritis with methotrexate alone, sulfasalazine and hydroxychloroquine, or a combination of all three medications. / O'Dell, James Robert; Haire, Claire E.; Erikson, Nils; Drymalski, Walter; Palmer, William; Eckhoff, P. James; Garwood, Vernon; Maloley, Pierre; Klassen, Lynell Warren; Wees, Steven; Klein, Harry; Moore, Gerald Francis.

In: New England Journal of Medicine, Vol. 334, No. 20, 16.05.1996, p. 1287-1291.

Research output: Contribution to journalArticle

O'Dell, James Robert ; Haire, Claire E. ; Erikson, Nils ; Drymalski, Walter ; Palmer, William ; Eckhoff, P. James ; Garwood, Vernon ; Maloley, Pierre ; Klassen, Lynell Warren ; Wees, Steven ; Klein, Harry ; Moore, Gerald Francis. / Treatment of rheumatoid arthritis with methotrexate alone, sulfasalazine and hydroxychloroquine, or a combination of all three medications. In: New England Journal of Medicine. 1996 ; Vol. 334, No. 20. pp. 1287-1291.
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title = "Treatment of rheumatoid arthritis with methotrexate alone, sulfasalazine and hydroxychloroquine, or a combination of all three medications",
abstract = "Background. Rheumatoid arthritis is a common disease that causes substantial morbidity and mortality. The responses of patients with rheumatoid arthritis to treatment with a single so-called disease-modifying drug, such as methotrexate, are often suboptimal. Despite limited data, many patients are treated with combinations of these drugs. Methods. We enrolled 102 patients with rheumatoid arthritis and poor responses to at least one disease-modifying drug in a two-year, double-blind, randomized study of treatment with methotrexate alone (7.5 to 17.5 mg per week), the combination of sulfasalazine (500 mg twice daily) and hydroxychloroquine (200 mg twice daily), or all three drugs. The dose of methotrexate was adjusted in an attempt to achieve remission in all patients. The primary end point of the study was the successful completion of two years of treatment with 50 percent improvement in composite symptoms of arthritis and no evidence of drug toxicity. Results. Fifty of the 102 patients had 50 percent improvement at nine months and maintained at least that degree of improvement for two years without evidence of major drug toxicity. Among them were 24 of 31 patients treated with all three drugs (77 percent), 12 of 36 patients treated with methotrexate alone (33 percent, P<0.001 for the comparison with the three- drug group), and 14 of 35 patients treated with sulfasalazine and hydroxychloroquine (40 percent, P = 0.003 for the comparison with the three- drug group). Seven patients in the methotrexate group and three patients in each of the other two groups discontinued treatment because of drug toxicity. Conclusions. In patients with rheumatoid arthritis, combination therapy with methotrexate, sulfasalazine, and hydroxychloroquine is more effective than either methotrexate alone or a combination of sulfasalazine and hydroxychloroquine.",
author = "O'Dell, {James Robert} and Haire, {Claire E.} and Nils Erikson and Walter Drymalski and William Palmer and Eckhoff, {P. James} and Vernon Garwood and Pierre Maloley and Klassen, {Lynell Warren} and Steven Wees and Harry Klein and Moore, {Gerald Francis}",
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T1 - Treatment of rheumatoid arthritis with methotrexate alone, sulfasalazine and hydroxychloroquine, or a combination of all three medications

AU - O'Dell, James Robert

AU - Haire, Claire E.

AU - Erikson, Nils

AU - Drymalski, Walter

AU - Palmer, William

AU - Eckhoff, P. James

AU - Garwood, Vernon

AU - Maloley, Pierre

AU - Klassen, Lynell Warren

AU - Wees, Steven

AU - Klein, Harry

AU - Moore, Gerald Francis

PY - 1996/5/16

Y1 - 1996/5/16

N2 - Background. Rheumatoid arthritis is a common disease that causes substantial morbidity and mortality. The responses of patients with rheumatoid arthritis to treatment with a single so-called disease-modifying drug, such as methotrexate, are often suboptimal. Despite limited data, many patients are treated with combinations of these drugs. Methods. We enrolled 102 patients with rheumatoid arthritis and poor responses to at least one disease-modifying drug in a two-year, double-blind, randomized study of treatment with methotrexate alone (7.5 to 17.5 mg per week), the combination of sulfasalazine (500 mg twice daily) and hydroxychloroquine (200 mg twice daily), or all three drugs. The dose of methotrexate was adjusted in an attempt to achieve remission in all patients. The primary end point of the study was the successful completion of two years of treatment with 50 percent improvement in composite symptoms of arthritis and no evidence of drug toxicity. Results. Fifty of the 102 patients had 50 percent improvement at nine months and maintained at least that degree of improvement for two years without evidence of major drug toxicity. Among them were 24 of 31 patients treated with all three drugs (77 percent), 12 of 36 patients treated with methotrexate alone (33 percent, P<0.001 for the comparison with the three- drug group), and 14 of 35 patients treated with sulfasalazine and hydroxychloroquine (40 percent, P = 0.003 for the comparison with the three- drug group). Seven patients in the methotrexate group and three patients in each of the other two groups discontinued treatment because of drug toxicity. Conclusions. In patients with rheumatoid arthritis, combination therapy with methotrexate, sulfasalazine, and hydroxychloroquine is more effective than either methotrexate alone or a combination of sulfasalazine and hydroxychloroquine.

AB - Background. Rheumatoid arthritis is a common disease that causes substantial morbidity and mortality. The responses of patients with rheumatoid arthritis to treatment with a single so-called disease-modifying drug, such as methotrexate, are often suboptimal. Despite limited data, many patients are treated with combinations of these drugs. Methods. We enrolled 102 patients with rheumatoid arthritis and poor responses to at least one disease-modifying drug in a two-year, double-blind, randomized study of treatment with methotrexate alone (7.5 to 17.5 mg per week), the combination of sulfasalazine (500 mg twice daily) and hydroxychloroquine (200 mg twice daily), or all three drugs. The dose of methotrexate was adjusted in an attempt to achieve remission in all patients. The primary end point of the study was the successful completion of two years of treatment with 50 percent improvement in composite symptoms of arthritis and no evidence of drug toxicity. Results. Fifty of the 102 patients had 50 percent improvement at nine months and maintained at least that degree of improvement for two years without evidence of major drug toxicity. Among them were 24 of 31 patients treated with all three drugs (77 percent), 12 of 36 patients treated with methotrexate alone (33 percent, P<0.001 for the comparison with the three- drug group), and 14 of 35 patients treated with sulfasalazine and hydroxychloroquine (40 percent, P = 0.003 for the comparison with the three- drug group). Seven patients in the methotrexate group and three patients in each of the other two groups discontinued treatment because of drug toxicity. Conclusions. In patients with rheumatoid arthritis, combination therapy with methotrexate, sulfasalazine, and hydroxychloroquine is more effective than either methotrexate alone or a combination of sulfasalazine and hydroxychloroquine.

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