1. American College of Rheumatology-Hotline (2003) FDA Meeting March
2003: Update on the safety of new drugs for rheumatoid arthritis- Part III: Safety and efficacy update on leflunomide (Arava®). www.fda.gov/ohrms/dockets/ac/acmenu.htm
2. Reinhold-Keller E, Gross WL (2001)
Leflunomid zur Behandlung der rheumatoiden Arthritis.
Deutsches Ärzteblatt 98:A1881–1887
3. Bundesausschuß der Ärzte und Krankenkassen
(2002) Änderungen der Arzneimittelrichtlinien: Leflunomid.
Deutsches Ärzteblatt 99:A 2734
4. Prakash A, Jarvis B (1999) Leflunomide.
Drugs 58:1137–1164
5. Breedveld FC, Dayer J-M (2000) Leflunomide:
mode of action in the treatment of rheumatoid arthritis.
Ann Rheum Dis 59:841–849
6. Mladenovic V, Domljan Z, Rozman B, Jajic I, Mihailovic D, Dordevic J
(1995) 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 38:1595–1603
7. Smolen JS, Kalden JR, Scott DL, Rozman B, Kvien TK, Larsen A, Loew-Friedrich I, Oed C, Rosenburg R
(1999) Efficacy and safety of leflunomide compared with placebo and sulphasalazine in active rheumatoid arthritis: a double-blind, randomised, multicentre trial. Lancet 353:259–266
8. Scott DL, Smolen JS, Kalden JR, van de Putte LBA, Larsen A, Kvien TK, Schattenkirchner M, Nash P, Oed C, Loew-Friedrich I
(2001) Treatment of active rheumatoid arthritis with leflunomide: two year follow up of a double blind, placebo contolled trial versus sulfasalazine.
Ann Rheum Dis 60:913–923
9. Strand V, Cohen S, Schiff M, Weaver A, Fleischmann R, Cannon G, Fox R, Moreland L, Olsen N, Furst D, Caldwell J, Kaine J, Sharp J, Hurley F, Loew-Friedrich I
(1999) Treatment of active rheumatoid arthritis with leflunomide compared with placebo and methotrexate.
Arch Intern Med 159: 2542–2550
10. Cohen S, Cannon GW, Schiff M, Weaver A, Fox R, Olsen N, Furst D, Sharp J, Moreland L, Caldwell J, Kaine J, Strand V
(2001) Two-year, blinded, randomized, controlled trial of treatment of active rheumatoid arthritis with leflunomide compared with methotrexate.
Arthritis Rheum 44: 1984–1992
11. Emery P, Breedveld FC, Lemmel EM, Kaltwasser JP, Dawes PT, Gomor B, Van Den Bosch F, Nordstrom D, Bjorneboe O, Dahl R, Horslev-Petersen K, Rodriguez De La Serna A, Molloy M, Tikly M, Oed C, Rosenburg R, Loew-Friedrich I
(2000) A comparison of the efficacy and safety of leflunomide and methotrexate for the treatment of rheumatoid arthritis.
Rheumatology 39:655–665
12. Kalden JR, Scott DL, Smolen JS, Schattenkirchner M, Rozman B, Williams BD, Kvien TK, Jones P, Williams RB, Oed C, Rosenburg R
(2001) Improved functional ability in patients with rheumatoid arthritis – longterm treatment with leflunomide versus sulfasalazine.
J Rheumatol 28:1983–1991
13. Sharp JT, Strand V, Leunh H, HurleyF, Loew-Friedrich I
(2000) Treatment with leflunomide slows radiographic progression of rheumatoid arthritis. Results from three randomized controlled trials of leflunomide in patients with active rheumatoid arthritis.
Arthritis Rheum 43:495–505
14. Larsen A, Kvien TK, Schattenkirchner M et al
(2001) Slowing of disease progression in rheumatoid arthritis patients during long-term treatment with leflunomide or sulfasalazine.
Scand J Rheumatol 30:135–142
15. Furst DE, Cohen S, Emery P, Dorrier K, Simpson K (2001) Does folic acid decrease the efficacy as well as the toxicity of methotrexate in rheumatoid arthritis?
Arthritis Rheum 44,Suppl, Abstract 1921
16. Kalden JR, Schattenkirchner M, Sörensen H, Emery P, Deighton C, Rozman B, Breedveld F
(2003) Efficacy and safety of leflunomide in patients with active rheumatoid arthritis – five years follow-up.
Arthritis Rheum 46:1513–1520
17. Weinblatt ME, Kremer JM, Coblyn JS, Maier AL, Helfgott SM, Morrell M
(1999) Pharmakokinetics, safety and efficacy of combination treatment with methotrexate and leflunomide in patients with active rheumatoid arthritis.
Arthritis Rheum 42:1322–1328
18. Kremer JM, Genovese MC, Cannon GW, Caldwell JR, Cush JJ, Furst DE, Luggen ME, Keystone E, Weisman MH, Bensen WM, Kaine JL, Ruderman EM, Coleman P, Curtis DL, Kopp EJ, Kantor SM, Waltuck J, Lindsley HB, Markenson JA, Strand V, Crawford B, Fernando I, Simpson K, Bathon
JM (2002) Concomitant leflunomide therapy in patients with active rheumatoid arthritis despite stable doses of methotrexate.
Ann Intern Med 137:726–733
19. Kremer JM, Genovese MC, Cannon GW, Caldwell JR, Cush JJ, Furst DE, Luggen ME, Keystone E, Bathon JM, Kavanaugh A, Ruderman EM, Coleman P, Curtis DL, Kopp EJ, Kantor SM, Weisman M, Waltuck J, Lindsley HB, Markenson JA, Crawford B, Fernando I, Simpson K, Strand V
(2004) Combination leflunomide and methotrexate (MTX) therapy for patients with active rheumatoid arthritis failing MTX monotherapy: Open-label extension of a randomized, doubleblind, placebo controlled trial.
J Rheumatol 31:1521–1531
20. Fachinformation Arava, Stand Oktober 2003