Научно-практическая ревматология (Apr 2013)

Evaluation of the short-term efficacy and safety of biological agents in different rheumatic diseases: a multidisciplinary therapeutic hospital"s experience

  • N A Mukhin,
  • P I Novikov,
  • Sergey Valentinovich Moiseev,
  • T M Ignatova,
  • L V Kozlovskaya,
  • E N Semenkova,
  • V V Fomin,
  • S V Gulyaev,
  • T N Krasnova,
  • L A Strizhakov,
  • T N Yanushkevich,
  • V V Panasyuk,
  • N V Nikiforova,
  • S V Roshchupkina,
  • Yu D Sorokin,
  • A D Meshkov,
  • L V Dubrovskaya,
  • E S Zhabina,
  • S A Parfenova,
  • E I Kuznetsova,
  • I A Lopatina

DOI
https://doi.org/10.14412/1995-4484-2013-640
Journal volume & issue
Vol. 51, no. 2
pp. 138 – 144

Abstract

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There has been a substantial expansion in the possibilities of current therapy for rheumatic diseases (RD) primarily due to the use of genetically engineered biological agents (GEBA). Objective: to evaluate the short-term efficacy and safety of GEBA in patients with different RD. Subjects and methods. The trial included all RD patients receiving GEBA: rituximab (RTM), infliximab (INF), adalimumab, etanercept, tocilizumab, abatacept in 2009-2012. Therapeutic efficiency and safety were evaluated 6 months later. The effect of GEBA was determined as “remission”, “improvement”, and “no response”, by using the parameters peculiar to specific diseases (such as BVAS, DAS28, BASDAI). Results. The trial enrolled 107 patients (49 men and 58 women; mean age 41.5 years) with rheumatoid arthritis (n=34), ANCA-associated vasculitis (n = 34), systemic lupus erythematosus (n=16), cryoglobulinemic vasculitis (n=11), ankylosing spondyloarthritis (n = 8), systemic vasculitis with large artery involvement (n=6), and other RD. All the cases showed severe systemic autoimmune disease refractory to standard immunosuppressive therapy. RTM (n=66) and INF (n = 31) were most frequently used. The high rate of RTM prescription was due to the fact that this drug was given to all patients with ANCA-associated vasculitis, systemic lupus erythematosus, and cryoglobulinemic vasculitis who totaled more than half of the patients included into the trial. The vast majority of them received GEBA for the first time. After the treatment, there was remission in 62 (57.9%) and improvement in 42 (39.3%) cases. Mild or moderate adverse reactions were observed in 22 (20.6%) patients and severe ones were seen in 6 (5.6%). Conclusion. GEBA therapy ensures a significant improvement in a substantial proportion of patients with different RD refractory to standard immunosuppressive therapy.

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