Efficiency and safety of different etoricoxib regimens in patients with axial spondyloarthritis, including ankylosing spondylitis


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Aim. To study the clinical and laboratory efficiency and safety of different etoricoxib (ET) regimens in patients with axial spondyloarthritis (axSpA), including ankylosing spondylitis. Subjects and methods. Forty patients with high axSpA activity (Bath Ankylosing Disease Activity Index (BASDAI ≥4) were examined and randomized to 2 groups: 1) 30 patients who received ET 90 mg continuously every day; 2) 10 patients who took the drug in the same dose intermittently 1—3 times weekly. The activity of axSpA (BASDAI, Ankylosing Spondylitis Disease Activity Score (ASDAS), erythrocyte sedimentation rate (ESR), and high-sensitivity C-reactive protein (hs-CRP)) was evaluated at baseline, 2 and 12 weeks; adverse events were recorded at baseline, 2, 6, and 12 weeks. The number of patients who had achieved an ASAS40 response at 2 and 12 weeks were taken into consideration. Results. At 12 weeks, the continuous administration group displayed decreases in BASDAI from 8 to 4, in ASDAS from 3.8 to 2.6, and in hs-CRP levels from 9.5 to 3.9 mg/l; the intermittent administration group exhibited decreases in BASDAI from 7.6 to 6.0, in ASDAS from 3.5 to 3.1, and hs-CRP from 8.8 to 4.5 mg/l (p<0.05). At this time, an AS40 response was achieved by 22 (73.3%) and 2 (20%) patients in Groups 1 and 2, respectively (p<0.05 for all). No serious adverse events were recorded. Conclusion. The efficacy of ET given in a daily dose of 90 mg was much higher than that of the drug used thrice or less weekly in the patients with axSpA.

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I Z Gaydukova

A P Rebrov

References

  1. Каратеев А.Е. Нестероидные противовоспалительные препараты в современной клинической практике: «за» больше, чем «против». Совр ревматол 2008; 1: 70—77.
  2. Poddubnyy D., van der Heijde D. Therapeutic controversies in spondyloarthritis: nonsteroidal anti-inflammatory drugs. Rheum Dis Clin North Am 2012; 38 (3): 601—611.
  3. Barkhuizen A., Steinfeld S., Robbins J. et al. Celecoxib is efficacious and well tolerated in treating signs and symptoms of ankylosing spondylitis. J Rheumatol 2006; 33: 1805—1812.
  4. Wanders A., van der Heijde D., Landewe R. et al. Nonsteroidal antiinflammatory drugs reduce radiographic progression in patients with ankylosing spondylitis: a randomized clinical trial. Arthritis Rheum 2005; 52: 1756—1765.
  5. Poddubnyy D., Rudwaleit M., Haibel H. et al. Effect of non-steroidal anti-inflammatory drugs on radiographic spinal progression in patients with axial spondyloarthritis: results from the German Spondyloarthritis Inception Cohort. Ann Rheum Dis 2012; 71 (10): 1616—1622.
  6. Poddubnyy D., Haibel H., Listing J. et al. Baseline radiographic damage, elevated acute-phase reactant levels, and cigarette smoking status predict spinal radiographic progression in early axial spondylarthritis. Arthritis Rheum 2012; 64 (5): 1388—1398.
  7. Poddubnyy D., Rudwaleit M., Haibel H. et al. Rates and predictors of radiographic sacroiliitis progression over 2 years in patients with axial spondyloarthritis. Ann Rheum Dis 2011; 70 (8): 1369—1374.
  8. Song I.H., Poddubnyy D.A., Rudwaleit M., Sieper J. Benefits and risks of ankylosing spondylitis treatment with nonsteroidal antiinflammatory drugs. Arthritis Rheum 2008; 58 (4): 929—938.
  9. Mallen S.R., Essex M.N., Zhang R. Gastrointestinal tolerability of NSAIDs in elderly patients: a pooled analysis of 21 randomized clinical trials with celecoxib and nonselective NSAIDs. Curr Med Res Opin 2011; 27 (7): 1359—1366.
  10. Dougados M., Gueguen A., Nakache J.P. et al. Ankylosing spondylitis: what is the optimum duration of a clinical study? A one year versus a 6 weeks non-steroidal anti-inflammatory drug trial. Rheumatology (Oxford) 1999; 38: 235—244.
  11. Rudwaleit M., Landewe R., van der Heijde D. et al. The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part I): classification of paper patients by expert opinion including uncertainty appraisal. Ann Rheum Dis 2009; 68 (6): 770—776.
  12. Bennett P.H., Burch T.A. Population studies of the rheumatic diseases. Amsterdam: Excerpta Medica Foundation International Congress Series 148. 1966: 456—457.
  13. van der Linden S., Valkenburg H.A., Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis. A proposal for modification of the New York criteria. Arthritis Rheum 1984; 27 (4): 361—368.
  14. Rudwaleit M., Jurik A.G., Hermann K.G. et al. Defining active sacroiliitis on magnetic resonance imaging (MRI) for classification of axial spondyloarthritis: a consensual approach by the ASAS/OMERACT MRI group. Ann Rheum Dis 2009; 68 (10): 1520—1527.
  15. Lee Y.C., Chang C.H., Lin J.W. et al. Non-steroidal anti-inflammatory drugs use and risk of upper gastrointestinal adverse events in cirrhotic patients. Liver Int 2012; 32 (5): 859—866.
  16. Laine L., Curtis S.P., Cryer B. et al. Assessment of upper gastrointestinal safety of etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac. Arthritis Long-term (MEDAL) programme: a randomized comparison. Lancet 2007; 369: 465—473.
  17. Chang C.H., Chen H.C., Lin J.W. et al. Risk of hospitalization for upper gastrointestinal adverse events associated with nonsteroidal anti-inflammatory drugs: a nationwide case-crossover study in Taiwan. Pharmacoepidemiol Drug Saf 2011; 20 (7): 763—771.
  18. Martina S.D., Vesta K.S., Ripley T.L. Etoricoxib: a highly selective COX-2 inhibitor. Ann Pharmacother 2005; 39 (5): 854—862.
  19. Van der Heijde D., Baraf H.S., Ramos-Remus C. et al. Evaluation of the efficacy of etoricoxib in ankylosing spondylitis: results of a fifty-two-week, randomized, controlled study. Arthritis Rheum 2005; 52: 1205—1215.
  20. Garrett S., Jenkinson T., Kennedy L.G. et al. New approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activity Index. J Rheumatol 1994; 21: 2286—2291.
  21. Lukas C., Landewe R., Sieper J. et al. Development of an ASAS-endorsed disease activity score (ASDAS) in patients with ankylosing spondylitis. Ann rheum dis 2009; 68 (1): 18—24.
  22. Braun J., van den Berg R., Baraliakos X. et al. 2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis 2011; 70 (6): 896—904.
  23. Tubach F., Ravaud P., Beaton D. et al. Minimal clinically important improvement and patient acceptable symptom state for subjective outcome measures in rheumatic disorders. J Rheumatol 2007; 34 (5): 1188—1193.
  24. Wolfe F., Michaud K., Pincus T. A composite disease activity scale for clinical practice, observational studies, and clinical trials: the patient activity scale (PAS/PAS-II). J Rheumatol 2005; 32 (12): 2410—2415.
  25. Реброва О.Ю. Статистический анализ медицинских данных. Применение пакета прикладных программ STATISTICA. М: Медиа-Сфера 2002.
  26. Amor B., Dougados M., Khan M.A. Management of refractory ankylosing spondylitis and related spondyloarthropathies. Rheum Dis Clin North Am 1995; 2 1(1): 117—128.
  27. Lories R.J. Etoricoxib and the treatment of ankylosing spondylitis. Expert Opin Drug Metab Toxicol 2012; 12: 1599—608.
  28. Maquirriain J., Kokalj A. Management of acute Achilles tendinopathy: effect of etoricoxib on pain control and leg stiffness. Georgian Med News 2013; 222: 36—43.
  29. Hunt R.H., Harper S., Watson D.J. et al. The gastrointestinal safety of the COX-2 selective inhibitor etoricoxib assessed by both endoscopy and analysis of upper gastrointestinal events. Am J Gastroenterol 2003; 98 (8): 1725—1733.
  30. Patrignani P., Capone M.L., Tacconelli S. Clinical pharmacology of etoricoxib: a novel selective COX2 inhibitor. Expert Opin Pharmacother 2003; 4 (2): 265—284.
  31. Hur C., Chan A.T., Tramontano A.C., Gazelle G.S. Coxibs versus combination NSAID and PPI therapy for chronic pain: an exploration of the risks, benefits, and costs. Ann Pharmacother 2006; 40 (6): 1052—1063.
  32. Brown T.J., Hooper L., Elliott R.A. et al. A comparison of the cost-effectiveness of five strategies for the prevention of non-steroidal anti-inflammatory drug-induced gastrointestinal toxicity: a systematic review with economic modeling. Health Technol Assess 2006; 10 (38): iii-iv, xi-xiii, 1—183.
  33. Sieper J., Klopsch T., Richter M. et al. Comparison of two different dosages of celecoxib with diclofenac for the treatment of active ankylosing spondylitis: results of a 12-week randomized, double-blind, controlled study. Ann Rheum Dis 2008; 67: 323—329.
  34. Barkhuizen A., Steinfeld S., Robbins J. et al. Celecoxib is efficacious and well tolerated in treating signs and symptoms of ankylosing spondylitis. J Rheumatol 2006; 33: 1805—1812.
  35. Sieper J., Lenaerts J., Wollenhaupt J. et al. Efficacy and safety of infliximab plus naproxen versus naproxen alone in patients with early, active axial spondyloarthritis: results from the double-blind, placebo-controlled INFAST study, Part 1. Ann Rheum Dis 2014; 73 (1): 101—107.
  36. Sieper J., Lenaerts J., Wollenhaupt J. et al. Maintenance of biologic-free remission with naproxen or no treatment in patients with early, active axial spondyloarthritis: results from a 6-month, randomised, open-label follow-up study, INFAST Part 2. Ann Rheum Dis 2014; 73 (1): 108—113.

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