Effectiveness and Safety of Thalidomide for Ankylosing Spondylitis: A Systematic Review_Chinese Journal of Evidence-Based Medicine

Authors：

 CHENJing , ZHENGQing , ZENGZhi-yong ,  CHENJun-min

Department of Rheumatology Immunology, First Affiliated Hospital, Fujian Medical University, Fuzhou 350005, China;

Corresponding author：

CHENJun-min, Email: drjunminchen@hotmail.com

Keywords：

Thalidomide; Ankylosing spondylitis; Systematic review; Meta-analysis; Randomized controlled trial

DOI：

10.7507/1672-2531.20150014

Video：

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Objective To systematically review the effectiveness and safety of thalidomide for ankylosing spondylitis (AS). Methods Databases including Ovid MEDLINE (1946 to 2014.2.1), EMbase (1947 to 2014.2.1), CENTRAL (Issue 1, 2014), CBM (1978 to 2014.2.1), CNKI (1994 to 2014.2.1), WanFang Data (1980 to 2014.2.1) and VIP (1989 to 2014.2.1) were searched for randomized controlled trials about the effectiveness and safety of thalidomide for AS. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data, and assessed methodological quality of included studies. Meta-analysis was then conducted using RevMan 5.2 software. Results Seven RCTs were included involving 544 patients. The results of meta-analysis showed that, compared with the blank group, thalidomide increased clinical remission, but it showed no obvious advantage in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), and secondary outcome index, with an increased total rate of withdrawal/drop-out. Compared with SSZ, thalidomide increased the rate of maintaining remission when it was used in the maintenance treatment after the patients attained ASAS20; and for other outcomes it was similar to SSZ. Compared with NSAIDs, thalidomide increased the rate of maintaining remission when it was used in the maintenance treatment after the patients attained ASAS20; it increased clinical remission; for secondary outcomes it was similar to NSAIDs; and it had a higher incidence of adverse reaction as well as an increased total rate of withdrawal/drop-out. Conclusion Compared with the blank group, thalidomide increases clinical remission, with an obviously-increased total rate of withdrawal/drop-out. Compared with SSZ, thalidomide increases the rate of maintaining remission when it is used in the maintenance treatment after patients attain ASAS20. Compared with NSAIDs, thalidomide increases the rate of maintaining remission when it is used in the maintenance treatment after patients attain ASAS20; it also increases clinical remission; but it has a higher incidence of adverse reaction as well as an increased total rate of withdrawal/drop-out. Due to limited quantity and quality of the included studies, the above conclusion needs to be verified by conducting more high quality studies.

Citation： CHENJing, ZHENGQing, ZENGZhi-yong, CHENJun-min. Effectiveness and Safety of Thalidomide for Ankylosing Spondylitis: A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2015, 15(1): 75-82. doi: 10.7507/1672-2531.20150014 Copy

1.	曾庆馀. 重视强直性脊柱炎的临床研究. 实用医学杂志, 2002, 18(1):111-112.
2.	黄烽. 应重视非甾体抗炎药对早期强直性脊柱炎的治疗价值. 中国药物应用与监测, 2006, (6):1-4.
3.	Kwoh CK, Simms R, Anderson L, et al. Guidelines for the management of rheumatoid arthritis:2002 Update. Arthritis Rheum, 2002, 46(2):328-346.
4.	林珺芳, 陈君敏, 刘超. 甲氨喋呤治疗强直性脊柱炎的系统评价. 中国循证医学杂志, 2007, 7(4):260-266.
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6.	李少红, 马彬, 谭继英, 等. 依那西普治疗强直性脊柱炎的系统评价. 中国循证医学杂志, 2009, 9(4):423-429.
7.	朱珂, 刘卓刚, 杨威, 等. 国内沙利度胺治疗多发性骨髓瘤疗效与安全性的Meta分析. 中国循证医学杂志, 2009, 9(8):899-903.
8.	Moll JM, Wright V. New York clinical criteria for ankylosing spondylitis. A statistical evaluation. Ann Rheum Dis, 1973, 32(4):354-363.
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10.	Olivieri I, van Tubergen A, Salvarani C, et al. Seronegative spondyloarthritides. Best Pract Res Clin Rheumatol, 2002, 16(5):723-739.
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12.	Anderson JJ, Baron G, van der Heijde D, et al. Ankylosing spondylitis assessment group preliminary definition of short-term improvement in ankylosing spondylitis. Arthritis Rheum, 2001, 44(8):1876-1886.
13.	Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions version 5.1.0. The Cochrane Collaboration, 2011. Available at:http://www.cochrane-handbook.org.
14.	Deng X, Zhang J, Huang F. Thalidomide reduces recurrence of ankylosing spondylitis in patients following discontinuation of etanercept. Rheumatol Int, 2013, 33(6):1409-1413.
15.	林志翔. 沙利度胺治疗强直性脊柱炎疗效观察. 实用医学杂志, 2007, 23(13):2079-2080.
16.	宋纯, 王华杰, 范秀珍. 沙利度胺治疗活动型强直性脊柱炎临床疗效观察. 中国药业, 2006, 15(16):53-54.
17.	吴建红. 沙利度胺治疗强直性脊柱炎65例临床观察. 临床合理用药杂志, 2009, 2(15):11-12.
18.	张怀明. 沙利度胺治疗强直性脊柱炎疗效观察. 中国基层医药, 2009, 16(8):1480-1481.
19.	张羽, 杨静, 田岚, 等. 停英夫利昔单抗后用沙利度胺对维持强直性脊柱炎病情缓解效果观察. 浙江临床医学, 2012, 14(8):909-911.
20.	庄俊汉, 叶志中, 张丽君, 等. 反应停治疗强直性脊柱炎的临床研究. 中国药物与临床, 2002, 2(6):363-366.
21.	Tam LS, Gu J, Yu D. Pathogenesis of ankylosing spondylitis. Nat Rev Rheumatol, 2010, 6(7):399-405.
22.	Keifer JA, Guttridge DC, Ashburner BP, et al. Inhibition of NF-kappa B activity by thalidomide through suppression of IkappaB kinase activity. J Biol Chem, 2001, 276(25):22382-22387.
23.	Sampaio EP, Sarno EN, Galilly R, et al. Thalidomide selectively inhibits tumor necrosis factor alpha production by stimulated human monocytes. J Exp Med, 1991, 173(3):699-703.
24.	Corral LG, Haslett PA, Muller GW, et al. Differential cytokine modulation and T cell activation by two distinct classes of thalidomide analogues that are potent inhibitors of TNF-alpha. J Immunol, 1999, 163(1):380-386.
25.	Breban M, Gombert B, Amor B, et al. Efficacy of thalidomide in the treatment of refractory ankylosing spondylitis. Arthritis Rheum, 1999, 42(3):580-581.
26.	Huang F, Gu J, Zhao W, et al. One-year open-label trial of thalidomide in ankylosing spondylitis. Arthritis Rheum, 2002, 47(3):249-254.
27.	Wei JC, Chan TW, Lin HS, et al. Thalidomide for severe refractory ankylosing spondylitis:a 6-month open-label trial. J Rheumatol, 2003, 30(12):2627-2631.
28.	Schafer P. Apremilast mechanism of action and application to psoriasis and psoriatic arthritis. Biochem Pharmacol, 2012, 83(12):1583-1590.

1. 曾庆馀. 重视强直性脊柱炎的临床研究. 实用医学杂志, 2002, 18(1):111-112.
2. 黄烽. 应重视非甾体抗炎药对早期强直性脊柱炎的治疗价值. 中国药物应用与监测, 2006, (6):1-4.
3. Kwoh CK, Simms R, Anderson L, et al. Guidelines for the management of rheumatoid arthritis:2002 Update. Arthritis Rheum, 2002, 46(2):328-346.
4. 林珺芳, 陈君敏, 刘超. 甲氨喋呤治疗强直性脊柱炎的系统评价. 中国循证医学杂志, 2007, 7(4):260-266.
5. Chen J, Liu C. Sulfasalazine for ankylosing spondylitis. Cochrane Database Syst Rev, 2005, 2.
6. 李少红, 马彬, 谭继英, 等. 依那西普治疗强直性脊柱炎的系统评价. 中国循证医学杂志, 2009, 9(4):423-429.
7. 朱珂, 刘卓刚, 杨威, 等. 国内沙利度胺治疗多发性骨髓瘤疗效与安全性的Meta分析. 中国循证医学杂志, 2009, 9(8):899-903.
8. Moll JM, Wright V. New York clinical criteria for ankylosing spondylitis. A statistical evaluation. Ann Rheum Dis, 1973, 32(4):354-363.
9. 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(4):361-368.
10. Olivieri I, van Tubergen A, Salvarani C, et al. Seronegative spondyloarthritides. Best Pract Res Clin Rheumatol, 2002, 16(5):723-739.
11. Rudwaleit M, van der Heijde D, Landewe R, et al. The development of Assessment of SpondyloArthritis International Society classification criteria for axial spondyloarthritis (part II):validation and final selection. Ann Rheum Dis, 2009, 68(6):777-783.
12. Anderson JJ, Baron G, van der Heijde D, et al. Ankylosing spondylitis assessment group preliminary definition of short-term improvement in ankylosing spondylitis. Arthritis Rheum, 2001, 44(8):1876-1886.
13. Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions version 5.1.0. The Cochrane Collaboration, 2011. Available at:http://www.cochrane-handbook.org.
14. Deng X, Zhang J, Huang F. Thalidomide reduces recurrence of ankylosing spondylitis in patients following discontinuation of etanercept. Rheumatol Int, 2013, 33(6):1409-1413.
15. 林志翔. 沙利度胺治疗强直性脊柱炎疗效观察. 实用医学杂志, 2007, 23(13):2079-2080.
16. 宋纯, 王华杰, 范秀珍. 沙利度胺治疗活动型强直性脊柱炎临床疗效观察. 中国药业, 2006, 15(16):53-54.
17. 吴建红. 沙利度胺治疗强直性脊柱炎65例临床观察. 临床合理用药杂志, 2009, 2(15):11-12.
18. 张怀明. 沙利度胺治疗强直性脊柱炎疗效观察. 中国基层医药, 2009, 16(8):1480-1481.
19. 张羽, 杨静, 田岚, 等. 停英夫利昔单抗后用沙利度胺对维持强直性脊柱炎病情缓解效果观察. 浙江临床医学, 2012, 14(8):909-911.
20. 庄俊汉, 叶志中, 张丽君, 等. 反应停治疗强直性脊柱炎的临床研究. 中国药物与临床, 2002, 2(6):363-366.
21. Tam LS, Gu J, Yu D. Pathogenesis of ankylosing spondylitis. Nat Rev Rheumatol, 2010, 6(7):399-405.
22. Keifer JA, Guttridge DC, Ashburner BP, et al. Inhibition of NF-kappa B activity by thalidomide through suppression of IkappaB kinase activity. J Biol Chem, 2001, 276(25):22382-22387.
23. Sampaio EP, Sarno EN, Galilly R, et al. Thalidomide selectively inhibits tumor necrosis factor alpha production by stimulated human monocytes. J Exp Med, 1991, 173(3):699-703.
24. Corral LG, Haslett PA, Muller GW, et al. Differential cytokine modulation and T cell activation by two distinct classes of thalidomide analogues that are potent inhibitors of TNF-alpha. J Immunol, 1999, 163(1):380-386.
25. Breban M, Gombert B, Amor B, et al. Efficacy of thalidomide in the treatment of refractory ankylosing spondylitis. Arthritis Rheum, 1999, 42(3):580-581.
26. Huang F, Gu J, Zhao W, et al. One-year open-label trial of thalidomide in ankylosing spondylitis. Arthritis Rheum, 2002, 47(3):249-254.
27. Wei JC, Chan TW, Lin HS, et al. Thalidomide for severe refractory ankylosing spondylitis:a 6-month open-label trial. J Rheumatol, 2003, 30(12):2627-2631.
28. Schafer P. Apremilast mechanism of action and application to psoriasis and psoriatic arthritis. Biochem Pharmacol, 2012, 83(12):1583-1590.

Chinese Journal of Evidence-Based Medicine

Effectiveness and Safety of Thalidomide for Ankylosing Spondylitis: A Systematic Review

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