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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.
Rheumatology (Oxford) 2002; 41(8):892-8R

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.

Authors+Show Affiliations

Division of Rheumatology, Department of Internal Medicine, School of Medicine, DPMSC, University of Udine, 33100 Udine, Italy.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

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 -