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Analysis of improvements, full responses, remission and toxicity in rheumatoid patients treated with step-up combination therapy (methotrexate, cyclosporin A, sulphasalazine) or monotherapy for three years.

Abstract

OBJECTIVE

To evaluate two monotherapies followed by step-up combination therapy with two or three complementary drugs in active rheumatoid arthritis (RA) in comparison with sulphasalazine (SSZ) alone.

METHODS

One hundred and twenty-six consecutive patients with early active RA were enrolled in this open controlled clinical trial. The primary end-point was 50% improvement according to the ACR criteria (ACR50) at 6, 12 or 18 months. The secondary end-points were a full response (Magnusson criteria) and/or remission (ACR criteria) at 3 yr. Methotrexate (MTX) (group 1), cyclosporin A (CsA) (group 2) or SSZ (group 3) was used first. After 6 months, a combination of two drugs (CsA and MTX) was employed in groups 1 and 2. SSZ was added after 12 months if improvement was less than ACR50 with the combination. Group 3 continued with SSZ alone.

RESULTS

After 6 months, 57% of patients in group 1, 31% of group 2 (MTX vs CsA, P=0.002) and 33% of group 3 (MTX vs SSZ, P=0.01) had reached ACR50 improvement according to intention-to-treat analysis. At month 12 after starting a drug combination, 67% of group 1 and 76% of group 2 had reached ACR50 compared with 24% of group 3. At the 18-month follow-up, 90% of group 1 and 88% of group 2 but only 24% of group 3 had reached ACR50. After 18 months, 62% of group 1, 60% of group 2 and 48% of group 3 showed side-effects and three, five and eight patients in the three groups respectively had dropped out of the study. At the 3-yr follow-up, 9% of the patients in groups 1 and 2 and 7% of group 3 were in remission according to the ACR criteria; according to the Magnusson criteria, 40% showed a full response in groups 1 and 2 but only 21% did so in group 3.

CONCLUSION

MTX appears to be the fastest-acting agent. A step-up approach with MTX plus CsA plus SSZ led to a 50% improvement according to the ACR criteria in most patients. After 3 yr, 40% of patients receiving combination therapy and 21% of patients receiving monotherapy showed a full response, while 9 and 7% respectively attained remission.

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  • Authors+Show Affiliations

    ,

    Division of Rheumatology, Department of Internal Medicine, School of Medicine, DPMSC, University of Udine, 33100 Udine, Italy.

    , , , ,

    Source

    Rheumatology (Oxford, England) 41:8 2002 Aug pg 892-8

    MeSH

    Acetaminophen
    Anti-Inflammatory Agents, Non-Steroidal
    Antirheumatic Agents
    Arthritis, Rheumatoid
    Cyclosporine
    Disease-Free Survival
    Drug Therapy, Combination
    Female
    HLA-DR1 Antigen
    Humans
    Male
    Methotrexate
    Middle Aged
    Pain
    Sulfasalazine

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    12154206

    Citation

    Ferraccioli, G F., et al. "Analysis of Improvements, Full Responses, Remission and Toxicity in Rheumatoid Patients Treated With Step-up Combination Therapy (methotrexate, Cyclosporin A, Sulphasalazine) or Monotherapy for Three Years." Rheumatology (Oxford, England), vol. 41, no. 8, 2002, pp. 892-8.
    Ferraccioli GF, Gremese E, Tomietto P, et al. Analysis of improvements, full responses, remission and toxicity in rheumatoid patients treated with step-up combination therapy (methotrexate, cyclosporin A, sulphasalazine) or monotherapy for three years. Rheumatology (Oxford). 2002;41(8):892-8.
    Ferraccioli, G. F., Gremese, E., Tomietto, P., Favret, G., Damato, R., & Di Poi, E. (2002). Analysis of improvements, full responses, remission and toxicity in rheumatoid patients treated with step-up combination therapy (methotrexate, cyclosporin A, sulphasalazine) or monotherapy for three years. Rheumatology (Oxford, England), 41(8), pp. 892-8.
    Ferraccioli GF, et al. Analysis of Improvements, Full Responses, Remission and Toxicity in Rheumatoid Patients Treated With Step-up Combination Therapy (methotrexate, Cyclosporin A, Sulphasalazine) or Monotherapy for Three Years. Rheumatology (Oxford). 2002;41(8):892-8. PubMed PMID: 12154206.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Analysis of improvements, full responses, remission and toxicity in rheumatoid patients treated with step-up combination therapy (methotrexate, cyclosporin A, sulphasalazine) or monotherapy for three years. AU - Ferraccioli,G F, AU - Gremese,E, AU - Tomietto,P, AU - Favret,G, AU - Damato,R, AU - Di Poi,E, PY - 2002/8/3/pubmed PY - 2002/9/6/medline PY - 2002/8/3/entrez SP - 892 EP - 8 JF - Rheumatology (Oxford, England) JO - Rheumatology (Oxford) VL - 41 IS - 8 N2 - OBJECTIVE: To evaluate two monotherapies followed by step-up combination therapy with two or three complementary drugs in active rheumatoid arthritis (RA) in comparison with sulphasalazine (SSZ) alone. METHODS: One hundred and twenty-six consecutive patients with early active RA were enrolled in this open controlled clinical trial. The primary end-point was 50% improvement according to the ACR criteria (ACR50) at 6, 12 or 18 months. The secondary end-points were a full response (Magnusson criteria) and/or remission (ACR criteria) at 3 yr. Methotrexate (MTX) (group 1), cyclosporin A (CsA) (group 2) or SSZ (group 3) was used first. After 6 months, a combination of two drugs (CsA and MTX) was employed in groups 1 and 2. SSZ was added after 12 months if improvement was less than ACR50 with the combination. Group 3 continued with SSZ alone. RESULTS: After 6 months, 57% of patients in group 1, 31% of group 2 (MTX vs CsA, P=0.002) and 33% of group 3 (MTX vs SSZ, P=0.01) had reached ACR50 improvement according to intention-to-treat analysis. At month 12 after starting a drug combination, 67% of group 1 and 76% of group 2 had reached ACR50 compared with 24% of group 3. At the 18-month follow-up, 90% of group 1 and 88% of group 2 but only 24% of group 3 had reached ACR50. After 18 months, 62% of group 1, 60% of group 2 and 48% of group 3 showed side-effects and three, five and eight patients in the three groups respectively had dropped out of the study. At the 3-yr follow-up, 9% of the patients in groups 1 and 2 and 7% of group 3 were in remission according to the ACR criteria; according to the Magnusson criteria, 40% showed a full response in groups 1 and 2 but only 21% did so in group 3. CONCLUSION: MTX appears to be the fastest-acting agent. A step-up approach with MTX plus CsA plus SSZ led to a 50% improvement according to the ACR criteria in most patients. After 3 yr, 40% of patients receiving combination therapy and 21% of patients receiving monotherapy showed a full response, while 9 and 7% respectively attained remission. SN - 1462-0324 UR - https://www.unboundmedicine.com/medline/citation/12154206/Analysis_of_improvements_full_responses_remission_and_toxicity_in_rheumatoid_patients_treated_with_step_up_combination_therapy__methotrexate_cyclosporin_A_sulphasalazine__or_monotherapy_for_three_years_ L2 - https://academic.oup.com/rheumatology/article-lookup/doi/10.1093/rheumatology/41.8.892 DB - PRIME DP - Unbound Medicine ER -