A DOUBLE BLIND RANDOMIZED CONTROL TRIAL TO ASSESS THE EFFICACY OF NAPROXEN AND SULFOSALAZINE IN ANKYLOSING SPONDYLITIS
Main Article Content
Keywords
Ankylosing spondylitis, inflammatory markers , Sulfosalazine, Naproxen
Abstract
Chronic inflammatory illness ankylosing spondylitis (AS) causes back discomfort and joint damage (Visvanathan S et al., 2008). It causes spinal inflammation and bone growth and is strongly linked to HLA-B27. The goal of our study was to assess the symptomatic progression of AS using advanced inflammatory indicators. We also concentrated on determining whether there was a relationship between the inflammatory markers and the disease's progression. This prospective, randomized, placebo-controlled trial of naproxen and sulfasalazine in AS patients examines inflammatory markers. 42 participants were separated into three groups. Group A has Placebo with AS (7 males and 3 females); Group B has AS (12 males and 4 females); and Group C has 11 males and 5 females. Group A received a placebo, Group B received 1000 mg/day naproxen, and Group C received 2000 mg/day salfosalazine. The study accepted BASFI, BASDAI, and BASGI scores of 4. AS was also linked to TNF-, IL-6, IL-17, ICAM-1, and MMP-3. So, inflammatory markers were accessed in AS patients to check AS prognosis. The correlation between biomarker levels and clinical response in well-established AS groups. Groups A, B, and C had baseline and sixth-week AS biomarker measurements. CRP, TNF-, IL-6, and MMP-3 levels were compared across groups A, B, and C. B and C had lower CRP levels than group A. ESR levels in all groups did not alter statistically. Drug response was substantially higher in group C than group B for TNF-α, IL-6, and MMP-3. IL-6 levels dropped threefold in group C from baseline (p 0.01) to the 6th week (p 0.001). Groups B and C had lower TNF- levels than group A (p 0.01, p 0.001). In conclusion, Cytokines like IL-6 and TNF-alpha may contribute to AS immunopathogenesis. We also think these cytokines can diagnose and test therapeutic efficacy. Sulfasalazine treats AS better than naproxen
Downloads
References
1. Anderson JJ, Baron G, van der Heijde D, Felson DT, Dougados M. Ankylosing Spondylitis Assessment Group preliminary definition of short-lerm improvement in ankylosing spondylitis. Arthritis Rheum 2001;44:1876-86. 2. Arends S, Lebbink HR, Spoorenberg A, et al. The formation of autoantibodies and antibodies to TNF-et blocking agents in relation to clinical response in patients with ankylosing spondylitis. Clin Exp Rheumatol 2010;28:661-8. 3. Bal A, Unlu E, Bahar G, et al. Comparison of serum IL-1 beta, slL-2R, IL-6, and TNF-alpha levels with disease activity parameters in ankylosing spondylitis. Clin Rheumatol 2007;26:211-15. 4. Baraliakos X, Listing J, Rudwaleit M, et al. The relationship between infiammation and new bone formation in patients with ankylosing spondylitis. Arthritis Res Ther 2008; 10:R104. 5. Brandt J, Listing J, Sieper J, Rudwaleit M, van der Heijde D, Braun J. Development and preselection of criteria for short term improvement after anti-TNFα treatment in ankylosing spondylitis .Ann Rheum Dis 2004;63:1438-44. 6. Calin A, Garrett S, Whitelock H, et al. A new approach to defining functional ability in ankylosing spondylitis: the development of the Bath Ankylosing Spondylicis Functional Index. J Rheumatol 1994;21(12):2281-2285. 7. Calin A, Nakache JP, Gueguen A, Zeidler H, Mielants H, Dougados M. Defining disease activity in ankylosing spondylitis: is c combination of variables (Bath Ankylosing Spondylitis Disease Activity Index) an appropriate instrument? Rheumatology (Oxford) 1999;38:878-82. 8. Chen J, Liu C. Sulfasalazine for ankylosing spondylitis. Cochrane Database Syst Rev 2005;(2):CD004800. 9. Conti F, Ceccarelli F, Marocchi E, Magrini L, Spinelli FR, Spadaro A, et al. Switching tumour necrosis factor α antagonists in patients with ankylosing spondylitis and psoriatic arthritis: an observational study over a 5-year period. Ann Rheum Dis 2007;66:1393-7. 10. de Vries MK, van Eijk IC, van der Horst-Eruinsma IE, et al. Erythrocyte sedimentation rate, C-reactive protein level, and serum amyloid a protein for patient selection and monitoring of anti-tumor necrosis factor treatment in ankylosing spondylitis. Arthritis Rheum 2009;61:1484-90. 11. Dougados M, Boumer P. Amor B. Sulphosalazine in ankylosing spondylitis: a double blind controlled study in 60 patients. BMJ 1986;293:911-14. 12. Dougados M, van der Linden S, Leirisalo-Repo M, Huitfeldt B, Juhlin R, Veys E, et al. Sulfasalazine in the treatment of spondyloarthropathy. A randomized, multicenter, double-blind, placebo-controlled study. Arthritis Rheum 1995;38:618-27. 13. Gossec L, van der Heijde D. Melian A, Krupa DA, James MK, Cavanaugh Jr PF, et al. The efficacy of cyclooxygenase-2 inhibition by etoricoxib and naproxen on the axial manifestations of ankylosing spondylitis in the presence of peripheral arthritis. Ann Rheum Dis 2005;62:1563-7. 14. Heuft-Dorenbosch L, van Tubergen A, Spoorenberg A, Landewe R, Dougados M, Mielants H, et al. The influence of peripheral arthritis on disease activity in ankylosing spondylitis patients as measured with the Bath Ankylosing Spondylitis Disease Activity Index. Arthritis Rheum2004;51:154-9. 15. Jenkinson TR, Mallorie PA, Whitelock HC, Kennedy LG, Garrett SL, Calin A. Defining spinal mobility in ankylosing spondylities (AS): the Bath AS Metrology Index. J Rheumatol 1994;21:1694-8. 16. Jones SD, Calin A, Steiner A. An update on the Bath Ankylosing Spondylitis Disease Activity and Functional Indices (BASDÁI, BASFI): excellent Cronbach's alpha scores. J Rheumatol 1996;23:407. 17. Maksymowych WP, Landewé R. Conner-Spady B, et al. Serum Matrix metalloproteinase 3 is an independent predictor of structural darnage progression in patients with ankylosing spondylitis. Arthritis Rheum 2007;56:1846-53. 18. Nissila M. Lehtinen K Leirisalo-Repo M, Luukkainen R, Mutru O, Yli-Kerttula U. MSulfasalazine in the treatment of ankylosing spondylitis. A twenty-six-week, placebo-controlled clinical trial. Arthritis Rheum 1988;31:1111-16. 19. Park MC, Lee SW, Choi ST, et al. Serum leptin levels correlate with interleukin-6 levels and disease activity in patients with ankylosing spondylitis. Scand J Rheumatol 2007;36:101-6. 20. Rudwaleit M, Schwarzlose S, Hilgert ES, Listing J, Sieper J. Magnetic resonance imaging (MRI) in predicting a major clinical responce to anti-TNF-treatment in ankylosing spondylitis.Ann Rheum Dis 2007.E-pub ahead of print. 21. Rudwaleit M. Schwarzlose S, Hilgert ES, Listing J, Braun ), Sieper J. MRI in predicting a major clinical response to anti-tumour necrosis factor treatment in ankylosing spondylitis. Ann Rheum Dis 2008;67:126-81. 22. Spoorenberg A, van der Heijde D, de Klerk E, Dougados M, de Vlam K, Mielants H et al. Relative value of erythrocyte sedimentation rate and C-reactive protein in assessment of disease activity in ankylosing spondylitis. J Rheumatol 1999;26:980-4. 23. Van der Heijde D, Landewe R, Feldtkeller E. Proposal of a linear definition of the Bath Ankylosing spondylitis Metrology Index (BASMI) and comparison with the 2-step and 10-step definitions.Ann Rheum Dis 2008;67:489-93. 24. Visvanathan S, Wagner C, Marini JC, et al. Inflammatory biomarkers, disease activity and spinal disease measures in patients with ankylosing spondylities after treatment with infliximab. Ann Rheum Dis 2008; 67:511-517. 25. Yang C, Gu J. Rihl M, et al. Serum levels of matrix metalloproteinase 3 and macrophage colony-stimulating factor 1 correlate with disease activity in ankylosing spondylitis. Arthritis Rheum 2004:51:691-9.
