Ankilozan Spondilitli Hastalarda Etanercept Tedavisinin Etkinliği ve Güvenilirliği+

Amaç: Bu çalışmanın amacı; ankilozan spondilit (AS)'li hastalarda etanercept tedavisinin etkinliğini ve güvenilirliğini araştırmaktır. Gereç ve Yöntem: 21 AS'li hasta tedavi öncesi ve 6 aylık tedaviden sonra klinik ve laboratuvar parametrelerle değerlendirildi. Tedavinin etkinliği ayrıca Uluslararası AS Çalışma Grubu (ASAS)'nun AS'te tedaviye yanıt kriterleri olan ASAS-20, ASAS-40, ASAS-5/6, ASAS parsiyel remisyon ve BASDAI-50 yanıtı ile belirlendi. Bulgular: 6 aylık etanercept tedavisinden sonra klinik ve laboratuvar değerlendirme parametrelerinin tümünde istatistiksel olarak anlamlı iyileşme görüldü. Ayrıca 18 hastada ASAS-20, 16 hastada ASAS-40, 14 hastada ASAS-5/6, 10 hastada ASAS parsiyel remisyon ve 16 hastada BASDAI-50 yanıtları elde edildi. Ciddi yan etki nedeni ile tedaviyi bırakmak zorunda kalan hasta olmadı. 4 hastada enjeksiyon yeri reaksiyonu, 1 hastada eritem, 1 hastada bulantı-kusma şikayeti tespit edildi. Sonuç: Bulgularımız, etanercept tedavisinin AS'li hastalarda etkili olduğunu ve güvenle kullanılabileceğini göstermektedir. Anahtar kelimeler: Etanercept, Ankilozan Spondilit, Etkinlik, Güvenilirlik

Efficacy and Safety of Etanercept in Patients with Ankylosing Spondylitis

Objective: The aim of this study was to evaluate efficacy and safety of etanercept in patients with ankylosing spondylitis (AS). Material and Methods: 21 patients with AS were evaluated before and after 6 months of etanercept treatment based on the clinical and laboratory parameters. Clinical efficacy was determined using criteria defined by the asessment in AS (ASAS) International Working Group (ASAS-20 ASAS-40, ASAS-5/6, and ASAS partial remission) and BASDAI-50 responses. Results: There were statistically significant improvements in all clinical and laboratory parameters after the six months of etanercept treatment (p <0.001). Additionally, ASAS-20 was achieved in 18 of 21 patients. ASAS-40, ASAS-5/6, ASAS partial remission and BASDAI-50 were achieved in 16, 13, 10 and 16 patients, respectively. None of the patients withdrew from etanercept treatment because of serious adverse effect. Injection site reaction in 4, erythema in 1, and nausea and vomiting in 1 patients were observed throughout of the study. Conclusion: Our results demonstrated that etanercept treatment was safe and effective in AS patients. Key words: Etanercept, Ankylosing Spondylitis, Efficacy, Safety

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  • Davis JC, van der Heijde D, Dougados M, et al. Reductions in health-related quality of life in patients with ankylosing spondylitis and improvements with etanercept therapy. Arthritis Rheum 2005;53:494-501.
  • Davis JC, Jr., Van Der Heijde D, Braun J, et al. Recombinant human tumor necrosis factor receptor (etanercept) for treating ankylosing spondylitis: a randomized, controlled trial. Arthritis Rheum 2003;48:3230-6.
  • van der Linden S, Valkenburg HA, Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis. A proposal for modification of the New York criteria. Arthritis Rheum 1984;27:361-8.
  • Temekonidis TI, Alamanos Y, Nikas SN, et al. Infliximab therapy in patients with ankylosing spondylitis: an open label 12 month study. Ann Rheum Dis 2003;62:1218-20.
  • Akkoc Y, Karatepe AG, Akar S, et. al. A Turkish version of the Bath Ankylosing Spondylitis Disease Activity Index: reliability and validity. Rheumatol Int 2005;25 280-4.
  • Karatepe AG, Akkoc Y, Akar S, et al. The Turkish versions of the Bath Ankylosing Spondylitis and Dougados Functional Indices: reliability and validity. Rheumatol Int 2005;25:612-8.
  • Daltroy LH, Larson MG, Roberts NW, et al. A modification of the spondyloarthropathies. J Rheumatol 1990;17:946-50. Questionnaire for the
  • Jenkinson TR, Mallorie PA, Whitelock HC, et al. Defining spinal mobility in ankylosing spondylitis (AS). The Bath AS Metrology Index. J Rheumatol 1994;21:1694-8.
  • Doward LC, Spoorenberg A, Cook SA, et al. Development of the ASQoL: a quality of life instrument specific to ankylosing spondylitis. Ann Rheum Dis 2003;62:20-6.
  • Heuft-Dorenbosch L, Spoorenberg A, van Tubergen A, et al. Assessment of enthesitis in ankylosing spondylitis. Ann Rheum Dis 2003;62:127-32.
  • van der Heijde D, Pangan AL, Schiff MH, et al. Adalimumab effectively reduces the signs and symptoms of active ankylosing spondylitis in patients with total spinal ankylosis. Ann Rheum Dis 2008;67:1218-21.
  • Cohen JS. Clinical and laboratory improvement in ankylosing spondylitis after treatment with etanercept: a case report. J Clin Rheumatol 2000;6:221-4.
  • Choi CB, Kim TJ, Park HJ, et. al. Safety and clinical responses in ankylosing spondylitis after three months of etanercept therapy. J Korean Med Sci 2008;23:852-6.
  • Konttinen L, Tuompo R, Uusitalo T, et al. Anti-TNF therapy in the treatment of ankylosing spondylitis: the Finnish experience. Clin Rheumatol 2007;26:1693-700.
  • Bodur H, Ataman S, Akbulut L, et al. Characteristics and medical management of patients with rheumatoid arthritis and ankylosing spondylitis. Clin Rheumatol 2008;27:1119-25.
  • Gorman JD, Sack KE, Davis JC, Jr. Treatment of ankylosing spondylitis by inhibition of tumor necrosis factor alpha. N Engl J Med 2002;346:1349-56.
  • Lee SH, Lee YA, Hong SJ, et. al. Etanercept 25 mg/week is effective enough to maintain remission for ankylosing spondylitis among Korean patients. Clin Rheumatol 2008;27:179-81.
  • Braun J, McHugh N, Singh A, et al. Improvement in patient- reported outcomes for patients with ankylosing spondylitis treated with etanercept 50 mg once-weekly and 25 mg twice- weekly. Rheumatology (Oxford) 2007;46:999-1004.
  • Bresnihan B, Cunnane G. Infection complications associated with the use of biologic agents. Rheum Dis Clin North Am 2003;29:185-202.
  • Weisman MH. What are the risks of biologic therapy in rheumatoid arthritis? An update on safety. J Rheumatol Suppl 2002;65:33-8.
  • Calin A, Dijkmans BA, Emery P, et al. Outcomes of a multicentre randomised clinical trial of etanercept to treat ankylosing spondylitis. Ann Rheum Dis 2004;63:1594-600.