Efficacy and safety of leflunomide 10 mg versus 20 mg once daily in patients with active rheumatoid arthritis: Multinational double-blind, randomized trial

Rheumatology

Volumn 43, Issue 6, 2004, Pages 744-749

  Poor G ^b   Strand, V ^a  

^a STANFORD UNIVERSITY   (United States)

^b NATIONAL INSTITUTE OF RHEUMATOLOGY AND PHYSIOTHERAPY   (Hungary)

Author keywords

Leflunomide; Non inferiority study; Randomized clinical trial; Rheumatoid arthritis

Indexed keywords

CORTICOSTEROID; LEFLUNOMIDE; NONSTEROID ANTIINFLAMMATORY AGENT;

ADULT; AGED; ALOPECIA; ANEMIA; ARTICLE; CALCULATION; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISABILITY; DISEASE EXACERBATION; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG ERUPTION; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; HUMAN; HYPERTENSION; HYPOTHESIS; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; NAUSEA; PRIORITY JOURNAL; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RHEUMATOID ARTHRITIS;

ADRENAL CORTEX HORMONES; ADULT; AGED; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; ARTHRITIS, RHEUMATOID; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; ISOXAZOLES; MALE; MIDDLE AGED; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 3042591318     PISSN: 14620324     EISSN: None     Source Type: Journal    
DOI: 10.1093/rheumatology/keh168     Document Type: Article

References (23)

1. American College of Rheamatology ad hoc committee on clinical guidelines. Guidelines for the management of rheumatoid arthritis. Arthritis Rheum 1996;1996:713-22.
2. Pincus T, Callahan L. What is the natural history of rheumatoid arthritis? Rheum Dis Clin North Am 1993;19:123-51.
3. Singh G. Recent considerations in nonsteroidal anti-inflammatory drug gastropathy. Am J Med 1998;105:31S-38S.
4. Felson DT, Anderson JJ, Meenan RF. Use of short-term efficacy/toxicity tradeoffs to select second-line drugs in rheumatoid arthritis. A metaanalysis of published clinical trials. Arthritis Rheum 1992;35: 1117-25.
5. Prakash A, Jarvis B. Leflunomide: a review of its use in active rheumatoid arthritis. Drugs 1999;58:1137-64.
6. Alldred A, Emery P. Leflunomide: a novel DMARD for the treatment of rheumatoid arthritis. Expert Opin Pharmacother 2001;2:125-37.
7. Fox RI. Mechanism of action of leflunomide in rheumatoid arthritis. J Rheumatol Suppl 1998;53:20-6.
8. Sharp JT, Strand V, Leung H, Hurley F, Loew-Friedrich I. Treatment with leflunomide slows radiographic progression of rheumatoid arthritis: results from three randomized controlled trials of leflunomide in patients with active rheumatoid arthritis. Leflunomide Rheumatoid Arthritis Investigators Group. Arthritis Rheum 2000; 43:495-505.
9. Smolen JS, Kalden JR, Scott DL et al. Efficacy and safety of leflunomide compared with placebo and sulphasalazine in active rheumatoid arthritis: a double-blind, randomised, multicenter trial. European Leflunomide Study Group. Lancet 1999;353:259-66.
10. Strand V, Cohen S, Schiff M et al. Treatment of active rheumatoid arthritis with leflunomide compared with placebo and methotrexate. Leflunomide Rheumatoid Arthritis Investigators Group. Arch Intern Med 1999;159:2542-50.
11. Emery P, Breedveld FC, Lemmel EM et al. A comparison of the efficacy and safety of leflunomide and methotrexate for the treatment of rheumatoid arthritis. Rheumatology 2000;39:655-65.
12. Mladenovic V, Domljan Z, Rozman B et al. Safety and effectiveness of leflunomide in the treatment of patients with active rheumatoid arthritis. Results of a randomized, placebo-controlled, phase II study. Arthritis Rheum 1995;38:1595-603.
13. Arnett FC, Edworthy SM, Bloch DA et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988;31:315-24.
14. Smolen JS, Breedveld FC, Eberl G et al. Validity and reliability of the twenty-eight-joint count for the assessment of rheumatoid arthritis activity. Arthritis Rheum 1995;38:38-43.
15. Fries JF, Spitz P, Kraines RG, Holman HR. Measurement of patient outcome in arthritis. Arthritis Rheum 1980;23:137-45.
16. Felson D, Anderson J, Boers M et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995;38:727-35.
17. Ortiz Z, Shea B, Garcia Dieguez M et al. The responsiveness of generic quality of life instruments in rheumatic diseases. A systematic review of randomized controlled trials. J Rheumatol 1999;26:210-6.
18. Committee for Proprietary Medicinal Products. Points to consider on switching between superiority and non-inferiority. Br J Clin Pharmacol 2001;52:223-8.
19. Laster LL, Johnson MF. Non-inferiority trials: the 'at least as good as' criterion. Stat Med 2003;22:187-200.
20. ICH Expert Working Group. ICH harmonised tripartite guideline. Choice of control group and related issues in clinical trials. Federal Register, 2000;66:24390-1.
21. Scott DL, Smolen JS, Kalden JR et al. Treatment of active rheumatoid arthritis with leflunomide: two year follow up of a double blind, placebo controlled trial versus sulfasalazine. Ann Rheum Dis 2001;60:913-23.
22. Cohen S, Cannon GW, Schiff M et al. Two-year, blinded, randomized, controlled trial of treatment of active rheumatoid arthritis with leflunomide compared with methotrexate. Utilization of Leflunomide in the Treatment of Rheumatoid Arthritis Trial Investigator Group. Arthritis Rheum 2001;44:1984-92.
23. Osiri M, Shea B, Robinson V et al. Leflunomide for treating rheumatoid arthritis (Cochrane Review). Cochrane Database Syst Rev 2003:CD002047.