Long-term efficacy of leflunomide on disease activity and inhibition of joint damage: retrospective comparison with methotrexate for Japanese rheumatoid arthritis patients

References

• American College of Rheumatology Subcommittee on Rheuma-toid Arthritis Guidelines. Guidelines for the Management of Rheumatoid Arthritis. Arthritis Rheum. 2002;46:328–46.
   PubMed Web of Science ®Google Scholar
• Maini R, Clair EWS, Breedveld F, Furst D, Kalden J, Weisman M, et al. Infliximab (chimeric anti-tumour necrosis factor a monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomized phase III trial. Lancet. 1999;354:1932–9.
   PubMed Web of Science ®Google Scholar
• Study Group of the Ministry of Health, Labor and Welfare (2004) Diagnosis and therapeutic manual of rheumatoid arthritis. Diagnostic manual and evidence-based treatment guidelines (in Japanese). Japan Rheumatology Foundation.
   Google Scholar
• Kashiwazaki S, Ichikawa Y, Sugawara S, Nagaya I, Kawai S, Hakota M, et al. Determination of the clinical optimal dose of L-377 (methotrexate capsule) for the treatment of rheumatoid arthritis (in Japanese). Jpn J Inflamm. 1996;16:437–58.
   Google Scholar
• Fox RI, Herrmann ML, Frangou CG, Wahl GM, Morris RE, Kirschbaum BJ. How does leflunomide modulate the immune response in rheumatoid arthritis? Bio Drugs. 1999;12:301–15.
   Google Scholar
• Mladenovic V, Domljan Z, Roman B, Jajic I, Mihallovic D, Dordevic J, 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;11:1595–603.
   Google Scholar
• Smolen JS, Kalden JR, Scott DL, Rozman B, Kvien TK, Larsen A, et al. Efficacy and safety of leflunomide compared with pla-cebo and sulphasalazine in active rheumatoid arthritis: a double-blind randomised multicentre trial. Lancet. 1999;353:259–66.
   PubMed Web of Science ®Google Scholar
• Strand V, Cohen S, Schiff M, Weaver A, Fleischmann R, Cannon G, et al. Treatment of active rheumatoid arthritis with lefluno-mide compared with placebo and methotrexate. Arch Intern Med. 1999;159:2542–50.
   PubMed Web of Science ®Google Scholar
• Emery P, Breedveld FC, Lemmel EM, Kaltwasser JP, Dawes PT, Gömör B, et al. A comparison of the efficacy and safety of le-flunomide and methotrexate for the treatment rheumatoid arthri-tis. Rheumatology. 2000;39:655–65.
   Google Scholar
• Ichikawa Y, Kamatani N, Goto M, Kondo H, Saito T, Torikai K, et al. Phase II dose ranging study of leflunomide in Japan. Investigation of efficacy, safety and pharmacokinetics. J New Rem Clin. 2003;52:891–931.
   Google Scholar
• Tateishi H, Ogawa R, Nakamura T, Murata N, Tanaka S. Investigation of safety and efficacy of leflunomide in long term treatment for Japanese patients of rheumatoid arthritis. J New Rem Clin. 2003;52:932–58.
   Google Scholar
• Ito S, Sumida T. Interstitial lung disease associated with leflun-omide. Intern Med. 2004;43:1103–4.
   PubMed Web of Science ®Google Scholar
• Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum. 1998;31:315–24.
   Web of Science ®Google Scholar
• Prevoo ML, van't Hof MA, Kuper HH, van Leeuwen MA, van de Putte LB, van Riel PL. Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum. 1995;38:44–8.
   Google Scholar
• van Gestel AM, Prevoo ML, van 't Hof MA, van Rijswijk MH, van de Putte LB, van Riel PL. Development and validation of the European League Against Rheumatism response criteria for rheumatoid arthritis. Comparison with the preliminary American College of Rheumatology and the World Health Organization/ International League Against Rheumatism Criteria. Arthritis Rheum. 1996;39:34–40.
   Google Scholar
• Larsen A. How to apply Larsen score in evaluating radiographs of rheumatoid arthritis in long term studies? J Rheumatol. 1995;22:10–11.
   Google Scholar
• Larsen A, Dale K, Eek M. Radiographic evaluation of rheumatoid arthritis and related conditions by standard reference films. Acta Radiol Diagn. 1977;18:481–91.
   Google Scholar
• Kuper HH, van Leeuwen MA, van Riel PLCM, Prevoo MLL, Houtman PM, Lolkema WF, et al. Radiographic damage in large joints in early rheumatoid arthritis: relationship with radiographic damage in hands and feet, disease activity, and physical dis-ability. Br J Rheum. 1997;36:855–60.
   PubMedGoogle Scholar
• Landewé R, van der Heijde D. Radiographic progression depicted by probability plots. Presenting data with optimal use of indi-vidual values. Arthritis Rheum. 2004;50:699–706.
   Google Scholar
• Ochi T, Iwase R, Yonemasu K. Natural course of joint destruc-tion and fluctuation of serum C lq levels in patients with rheu-matoid arthritis. Arthritis Rheum. 1988;31:37–43.
   Google Scholar
• Cutolo M, Sulfi A, Ghiorzo P, Pizzorni C, Craviot TOC, Villaggio B. Anti-inflammatory effects of leflunomide on cultured synovial macrophages from patients with rheumatoid arthritis. Ann Rheum Dis. 2003;62:297–302.
   PubMed Web of Science ®Google Scholar
• Urushibara M, Takayanagi H, Koga T, Kim S, Isobe M, Morishita Y, et al. The antirheumatic drug leflunomide inhibits osteo-clastogenesis by interfering with receptor activator of NF-kB figand- stimulated induction of nuclear factor of activated T cell c. Arthrits Rheum. 2004;50:794–804.
   PubMedGoogle Scholar
• Strand V, Scott DL, Emery P, Kalden JR, Smolen JS, Cannon GW, et al. Physical function and health related quality of life: analysis of 2-year data from randomized, controlled studies of leflunomide, sulfasalazine or methotrexate in patients with active rheumatoid arthritis. J Rheumatol. 2005;32:590–601.
   PubMed Web of Science ®Google Scholar
• van der Heijde D, Kalden JR, Scott DL, Smolen JS, Strand V. Long term evaluation of radiographic disease progression in a subset of patients with rheumatoid arthritis treated with lefluno-mide beyond 2 years. Ann Rheum Dis. 2004;63:737–9.
   Google Scholar
• Larsen A, Kvien TK, Schattenkirchner M, Rau R, Scott DL, Smolen JS, et al. Slowing of joint progression in rheumatoid arthritis patients during long-term treatment with leflunomide or sulfasalazine. Scand J Rheumatol. 2001;30:135–42.
   PubMed Web of Science ®Google Scholar
• Dougados M, Emery P, Lemmell EM, Serna R, Zerbini C, Brin S, et al. Efficacy and safety of leflunomide and predisposing factor for treatment response in patients with active rheumatoid arthri-tis: RELIEF 6-month data. J Rheumtol. 2003;30:2572–9.
   PubMed Web of Science ®Google Scholar
• van der Heijde DM, van Lie PL, Nuver-Zwart IH, Gribnau FW, van de Putte LB. Effects of hydroxychloroquine and sulphasal-azine on progression of joint damage in rheumatoid arthritis. Lancet 1989;1:1036–9.
   PubMed Web of Science ®Google Scholar
• Bruynesteyn K, van der Heijde D, Boers M, van der Linden S, Lassere M, van der Vleuten C. The Sharp/van der Heijde method outperformed the Larsen/Scott method on the individual patient level in assessing radiographs in early rheumatoid arthritis. J Clin Epidemiol. 2004;57:502–12.
   PubMed Web of Science ®Google Scholar
• Saag KG, Teng GG, Patkar NM, Anuntiyo J, Finney C, Curtis JR, et al. American college of rheumatology 2008 Recommendations for the use of nonbiologic and biologic disease-modifying anti-rheumatic drugs in rheumatoid arthritis. Arthritis Care Res. 2008;59:762–84.
   Web of Science ®Google Scholar
• Inokuma S, Sato T, Sagawa A, Matsuda T, Takemura T, Ohtsuka T, et al. Proposals for leflunomide use to avoid lung injury in patients with rheumatoid arthritis. Mod Rheumatol. 2008;18:442–6.
   PubMed Web of Science ®Google Scholar