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Improved functional ability in patients with rheumatoid arthritis--longterm treatment with leflunomide versus sulfasalazine. European Leflunomide Study Group.
J Rheumatol. 2001 Sep; 28(9):1983-91.JR

Abstract

OBJECTIVE

We previously reported that the new disease modifying antirheumatic drug leflunomide resulted in significant improvement in functional ability compared with placebo and sulfasalazine in a 6 month double blind, randomized, Phase III trial in rheumatoid arthritis (RA). The current study compared functional disability in cohorts of patients with RA from the initial study who volunteered to continue treatment with leflunomide or sulfasalazine.

METHODS

The Health Assessment Questionnaire (HAQ) was used to assess functional ability in patients completing 6 months of therapy who chose to continue in double blinded 12 and 24 month extensions. Patients on active regimens continued taking leflunomide 20 mg/day or sulfasalazine 2 g/day; those taking placebo were switched at Month 6 to sulfasalazine.

RESULTS

Leflunomide significantly improved patients' functional ability compared to placebo (p < or = 0.0001) and sulfasalazine (p < or = 0.01) at 6 months. These changes were seen as early as Month 1, and continued improvements were seen in 12 and 24 month cohorts. Mean HAQ scores were significantly improved with leflunomide compared with sulfasalazine at 24 months (-0.65 vs -0.36; p = 0.0149); corresponding changes in HAQ Disability Index (DI) were -0.73 vs -0.56 and were not statistically different. Leflunomide is safe and well tolerated and no unexpected adverse events were noted during the 2 year period; diarrhea, nausea, and alopecia were less frequent with continued treatment.

CONCLUSION

These longterm data confirm leflunomide improves functional ability as shown by reductions in HAQ scores. The benefit of leflunomide is reflected in other efficacy criteria, such as global assessments and the American College of Rheumatology response rates, all of which showed significantly more improvement with leflunomide than sulfasalazine at 24 months.

Authors+Show Affiliations

Department of Internal Medicine III, University of Erlangen-Nuremberg, Germany. joachim.kalden@med3.med.uni-erlangen.deNo 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
Clinical Trial, Phase III
Comparative Study
Guideline
Journal Article
Practice Guideline
Randomized Controlled Trial

Language

eng

PubMed ID

11550964

Citation

Kalden, J R., et al. "Improved Functional Ability in Patients With Rheumatoid Arthritis--longterm Treatment With Leflunomide Versus Sulfasalazine. European Leflunomide Study Group." The Journal of Rheumatology, vol. 28, no. 9, 2001, pp. 1983-91.
Kalden JR, Scott DL, Smolen JS, et al. Improved functional ability in patients with rheumatoid arthritis--longterm treatment with leflunomide versus sulfasalazine. European Leflunomide Study Group. J Rheumatol. 2001;28(9):1983-91.
Kalden, J. R., Scott, D. L., Smolen, J. S., Schattenkirchner, M., Rozman, B., Williams, B. D., Kvien, T. K., Jones, P., Williams, R. B., Oed, C., & Rosenburg, R. (2001). Improved functional ability in patients with rheumatoid arthritis--longterm treatment with leflunomide versus sulfasalazine. European Leflunomide Study Group. The Journal of Rheumatology, 28(9), 1983-91.
Kalden JR, et al. Improved Functional Ability in Patients With Rheumatoid Arthritis--longterm Treatment With Leflunomide Versus Sulfasalazine. European Leflunomide Study Group. J Rheumatol. 2001;28(9):1983-91. PubMed PMID: 11550964.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Improved functional ability in patients with rheumatoid arthritis--longterm treatment with leflunomide versus sulfasalazine. European Leflunomide Study Group. AU - Kalden,J R, AU - Scott,D L, AU - Smolen,J S, AU - Schattenkirchner,M, AU - Rozman,B, AU - Williams,B D, AU - Kvien,T K, AU - Jones,P, AU - Williams,R B, AU - Oed,C, AU - Rosenburg,R, AU - ,, PY - 2001/9/12/pubmed PY - 2002/1/31/medline PY - 2001/9/12/entrez SP - 1983 EP - 91 JF - The Journal of rheumatology JO - J Rheumatol VL - 28 IS - 9 N2 - OBJECTIVE: We previously reported that the new disease modifying antirheumatic drug leflunomide resulted in significant improvement in functional ability compared with placebo and sulfasalazine in a 6 month double blind, randomized, Phase III trial in rheumatoid arthritis (RA). The current study compared functional disability in cohorts of patients with RA from the initial study who volunteered to continue treatment with leflunomide or sulfasalazine. METHODS: The Health Assessment Questionnaire (HAQ) was used to assess functional ability in patients completing 6 months of therapy who chose to continue in double blinded 12 and 24 month extensions. Patients on active regimens continued taking leflunomide 20 mg/day or sulfasalazine 2 g/day; those taking placebo were switched at Month 6 to sulfasalazine. RESULTS: Leflunomide significantly improved patients' functional ability compared to placebo (p < or = 0.0001) and sulfasalazine (p < or = 0.01) at 6 months. These changes were seen as early as Month 1, and continued improvements were seen in 12 and 24 month cohorts. Mean HAQ scores were significantly improved with leflunomide compared with sulfasalazine at 24 months (-0.65 vs -0.36; p = 0.0149); corresponding changes in HAQ Disability Index (DI) were -0.73 vs -0.56 and were not statistically different. Leflunomide is safe and well tolerated and no unexpected adverse events were noted during the 2 year period; diarrhea, nausea, and alopecia were less frequent with continued treatment. CONCLUSION: These longterm data confirm leflunomide improves functional ability as shown by reductions in HAQ scores. The benefit of leflunomide is reflected in other efficacy criteria, such as global assessments and the American College of Rheumatology response rates, all of which showed significantly more improvement with leflunomide than sulfasalazine at 24 months. SN - 0315-162X UR - https://www.unboundmedicine.com/medline/citation/11550964/Improved_functional_ability_in_patients_with_rheumatoid_arthritis__longterm_treatment_with_leflunomide_versus_sulfasalazine__European_Leflunomide_Study_Group_ L2 - http://www.jrheum.org/cgi/pmidlookup?view=long&amp;pmid=11550964 DB - PRIME DP - Unbound Medicine ER -