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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.
Arthritis Rheum. 2002 May; 46(5):1164-70.AR

Abstract

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.

Authors+Show Affiliations

University of Nebraska Medical Center, Omaha 68198, USA. jrodell@unmc.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

12115219

Citation

O'Dell, James R., et al. "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." Arthritis and Rheumatism, vol. 46, no. 5, 2002, pp. 1164-70.
O'Dell JR, Leff R, Paulsen G, et al. 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. Arthritis Rheum. 2002;46(5):1164-70.
O'Dell, J. R., Leff, R., Paulsen, G., Haire, C., Mallek, J., Eckhoff, P. J., Fernandez, A., Blakely, K., Wees, S., Stoner, J., Hadley, S., Felt, J., Palmer, W., Waytz, P., Churchill, M., Klassen, L., & Moore, G. (2002). 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. Arthritis and Rheumatism, 46(5), 1164-70.
O'Dell JR, et al. 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. Arthritis Rheum. 2002;46(5):1164-70. PubMed PMID: 12115219.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - O'Dell,James R, AU - Leff,Robert, AU - Paulsen,Gail, AU - Haire,Claire, AU - Mallek,Jack, AU - Eckhoff,P James, AU - Fernandez,Ana, AU - Blakely,Kent, AU - Wees,Steven, AU - Stoner,Julie, AU - Hadley,Stephen, AU - Felt,Jeffrey, AU - Palmer,William, AU - Waytz,Paul, AU - Churchill,Melvin, AU - Klassen,Lynell, AU - Moore,Gerald, PY - 2002/7/13/pubmed PY - 2002/8/1/medline PY - 2002/7/13/entrez SP - 1164 EP - 70 JF - Arthritis and rheumatism JO - Arthritis Rheum VL - 46 IS - 5 N2 - 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. SN - 0004-3591 UR - https://www.unboundmedicine.com/medline/citation/12115219/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_ L2 - https://doi.org/10.1002/art.10228 DB - PRIME DP - Unbound Medicine ER -