Efficacy and Safety of Etanercept for Patients with Ankylosing Spondylitis: A Systematic Review_Chinese Journal of Evidence-Based Medicine

Authors：

1. Evidence-based Medicine Center, Basic Medical Sciences School of Lanzhou University, Lanzhou 730000, China;2. Institute of Immunology, School of Basic Medical Science, Lanzhou University, Lanzhou 730000, China;

Corresponding author：

Keywords：

Etanercept; Ankylosing spondylitis; Efficacy; Safety; Systematic review

DOI：

10.7507/1672-2531.20090080

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Objective 　To assess the efficacy and safety of Etanercept for Ankylosing spondylitis.
Methods 　We searched The Cochrane Library (Issue 4. 2008), MEDLINE (1966 to September 2008), EMBASE (1974 to September 2008), CBM (1978 to 2008), CNKI (1994 to 2008), VIP (1989 to 2008), and Wanfang (1999 to 2008). The quality of included studies was critically evaluated. Data analyses were performed with The Cochrane Collaboration’s RevMan 5.0 software.
Results 　Seven randomized controlled trials with total of 949 patients met the included criteria. The metaanalysis showed the effective rate of ASAS 20 or ASAS 50 receiving Etanercept was significantly higher than in patients receiving placebo, while no significant differences were noted between the Etanercept and placebo group in other indices. There was no statistical significance among different dosages. Patient Injection-site reaction rate for Etanercept was higher than that for placebo. No significant differences were observed in other adverse effects.
Conclusions　 Etanercept is safe and effective for patients with Ankylosing spondylitis, however, some trials included in the review were of poor quality, so we needed the multi-center, large-scale randomized controlled trials of higher quality and the same course of treatment to confirm this.

Citation： LI Shaohong,MA Bin,TAN Jiying,YANG Kehu. Efficacy and Safety of Etanercept for Patients with Ankylosing Spondylitis: A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2009, 09(4): 423-429. doi: 10.7507/1672-2531.20090080 Copy

1.	donors. Arthritis Rheum, 1998, 41: 58-67.
2.	assessment group preliminary definition of short-term improvement in ankylosing spondylitis. Arthritis Rheum, 2001, 44: l876-1886.
3.	Sieper J, Braun J, Rudwaleit M, et al. Ankylosing spondylitis: an overview. Ann Rheum Dis, 2002, 61(Suppl 3): iii8–iii18.
4.	Br aun J , Bol low M, Remlinge r G, etal . Prevalenc e of spondylarthropathies in HLA-B27 positive and negative blood.
5.	Gran JT, Husby G, Hordvik M. Prevalence of ankylosing spondylitis in males and females in a young middle-aged population of Tromso, northern Norway. Ann Rheum Dis, 1985, 44: 359-67.
6.	Braun J, Listing J, Sieper J. Reply. Arthritis Rheum, 2005, 52: 4049-4059.
7.	Toussirot E, Wendling D. Current guidelines for the drug treatment of ankylosing spondylitis. Drugs, 1998, 56: 225-240.
8.	Immunex Corporation. Enbrel (etanercept) for subcutaneous injection (2006). Available from URL: http://www.amgen.com/pdfs/misc/enbrel_pi.pdf .
9.	Braun J, Heijde VD. Novel approaches in the treatment of ankylosing spondylitis and other spondyloarthritides. Expert Opin Investing Drugs, 2003, 12(7): 1097-1109.
10.	Linden S, Valkenburg HA, Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis. Arthritis Rheum, 1984, 27: 361-368.
11.	Heijde VD, Linden S, Ballamy N, et a1. Which domains should be included in a core set for endpoints in ankylosing spondylitis? Introduction to the ankylosing spondylitis module of omeractive. The Journal of Rheumatology, l999, 26(76): 495-497.
12.	Heijde VD, Braun J, McGonagle D, et a1.Treatment trials in ankylosing spondylitis: current and future considerations. Ann Rheum Dis, 2002, 6 l(Suppl 3): iii24-iii32.11 Anderson JJ, Baron G, Heijde VD, et a1．Ankylosing spondylitis.
13.	Millicent A, Stone SD, Robert D, et a1．Validation exercise of the ankylosing spondylitis assessment study (ASAS)group response criteria in ankylosing spondylitis patients treated with biologics. Arthritis Rheum, 2004, 51: 316-320.
14.	Heijde DV, Silva JC, Dougados M, et al. Etanercept 50 mg once weekly is as effective as 25 mg twice weekly in patients with ankylosing spondylitis. Ann Rheum Dis, 2006, 65(12): 1572-1577.
15.	Braun J, McHugh N, Singh A, et al. Improvement in patientreported outcomes for patients with ankylosing spondylitis treated with etan- ercept 50 mg once-weekly and 25 mg twice weekly. Rheumatology, 2007, 46: 999-1004.
16.	Davis JC, Heijde VD, Braun J, et al. Recombinant Human Tumor Necrosis Factor Receptor (Etanercept) for Treating Ankylosing Spondylitis. Arthritis Rheum, 2003, 48(11): 3230-3236.
17.	Davis JC, Heijde VD, Braun J, et al. Sustained durability and tolerability of etanercept in ankylosing spondylitis for 96 weeks. Ann Rheum Dis, 2005, 64(11): 1557-1562.
18.	Davis JC, Heijde VD, Braun J, et al. Efficacy and safety of up to 192 weeks of etanercept therapy in patients with ankylosing spondylitis. Ann Rheum Dis, 2008, 67: 346-352.
19.	Brandt J, Khariouzov A, Listing J, et al. Six-Month Results of a Double-Blind, Placebo-Controlled Trial of Etanercept Treatment in Patients With Active Ankylosing Spondylitis. Arthritis Rheum, 2003, 48(6): 1667-1675.
20.	Brandt J, Listing J, Haibel H, et al. Long-term efficacy and safety of etanercept after readministration in patients with active ankylosing spondylitis .Rheumatology, 2005, 44(3): 342-348.
21.	Jennifer D, Gorman, Kenneth E, et al. Treatment of ankylosing spondylitis by inhibition of tumor necrosis factors a. N Engl J Med, 2002, 346(18): 1349-1356.
22.	Calin A, Dijkmans B, Emery P, et al. Outcomes of a multicentre randomised clinical trial of etanercept to treat ankylosing spondylitis. Ann Rheum Dis, 2004, 63(12): 1594-1600.
23.	王莉莎, 黄烽, 张江林, 等. 肿瘤坏死因子拮抗剂在治疗强直性脊柱炎中的安全性分析. 中国新药杂志, 2007, 16(7): 556-561.
24.	郝慧琴, 黄烽, 邓小虎, 等. 依那西普不同用药方案治疗强直性脊柱炎疗效比较. 中国药物与临床, 2008, 8(6): 432-436.

1. donors. Arthritis Rheum, 1998, 41: 58-67.
2. assessment group preliminary definition of short-term improvement in ankylosing spondylitis. Arthritis Rheum, 2001, 44: l876-1886.
3. Sieper J, Braun J, Rudwaleit M, et al. Ankylosing spondylitis: an overview. Ann Rheum Dis, 2002, 61(Suppl 3): iii8–iii18.
4. Br aun J , Bol low M, Remlinge r G, etal . Prevalenc e of spondylarthropathies in HLA-B27 positive and negative blood.
5. Gran JT, Husby G, Hordvik M. Prevalence of ankylosing spondylitis in males and females in a young middle-aged population of Tromso, northern Norway. Ann Rheum Dis, 1985, 44: 359-67.
6. Braun J, Listing J, Sieper J. Reply. Arthritis Rheum, 2005, 52: 4049-4059.
7. Toussirot E, Wendling D. Current guidelines for the drug treatment of ankylosing spondylitis. Drugs, 1998, 56: 225-240.
8. Immunex Corporation. Enbrel (etanercept) for subcutaneous injection (2006). Available from URL: http://www.amgen.com/pdfs/misc/enbrel_pi.pdf .
9. Braun J, Heijde VD. Novel approaches in the treatment of ankylosing spondylitis and other spondyloarthritides. Expert Opin Investing Drugs, 2003, 12(7): 1097-1109.
10. Linden S, Valkenburg HA, Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis. Arthritis Rheum, 1984, 27: 361-368.
11. Heijde VD, Linden S, Ballamy N, et a1. Which domains should be included in a core set for endpoints in ankylosing spondylitis? Introduction to the ankylosing spondylitis module of omeractive. The Journal of Rheumatology, l999, 26(76): 495-497.
12. Heijde VD, Braun J, McGonagle D, et a1.Treatment trials in ankylosing spondylitis: current and future considerations. Ann Rheum Dis, 2002, 6 l(Suppl 3): iii24-iii32.11 Anderson JJ, Baron G, Heijde VD, et a1．Ankylosing spondylitis.
13. Millicent A, Stone SD, Robert D, et a1．Validation exercise of the ankylosing spondylitis assessment study (ASAS)group response criteria in ankylosing spondylitis patients treated with biologics. Arthritis Rheum, 2004, 51: 316-320.
14. Heijde DV, Silva JC, Dougados M, et al. Etanercept 50 mg once weekly is as effective as 25 mg twice weekly in patients with ankylosing spondylitis. Ann Rheum Dis, 2006, 65(12): 1572-1577.
15. Braun J, McHugh N, Singh A, et al. Improvement in patientreported outcomes for patients with ankylosing spondylitis treated with etan- ercept 50 mg once-weekly and 25 mg twice weekly. Rheumatology, 2007, 46: 999-1004.
16. Davis JC, Heijde VD, Braun J, et al. Recombinant Human Tumor Necrosis Factor Receptor (Etanercept) for Treating Ankylosing Spondylitis. Arthritis Rheum, 2003, 48(11): 3230-3236.
17. Davis JC, Heijde VD, Braun J, et al. Sustained durability and tolerability of etanercept in ankylosing spondylitis for 96 weeks. Ann Rheum Dis, 2005, 64(11): 1557-1562.
18. Davis JC, Heijde VD, Braun J, et al. Efficacy and safety of up to 192 weeks of etanercept therapy in patients with ankylosing spondylitis. Ann Rheum Dis, 2008, 67: 346-352.
19. Brandt J, Khariouzov A, Listing J, et al. Six-Month Results of a Double-Blind, Placebo-Controlled Trial of Etanercept Treatment in Patients With Active Ankylosing Spondylitis. Arthritis Rheum, 2003, 48(6): 1667-1675.
20. Brandt J, Listing J, Haibel H, et al. Long-term efficacy and safety of etanercept after readministration in patients with active ankylosing spondylitis .Rheumatology, 2005, 44(3): 342-348.
21. Jennifer D, Gorman, Kenneth E, et al. Treatment of ankylosing spondylitis by inhibition of tumor necrosis factors a. N Engl J Med, 2002, 346(18): 1349-1356.
22. Calin A, Dijkmans B, Emery P, et al. Outcomes of a multicentre randomised clinical trial of etanercept to treat ankylosing spondylitis. Ann Rheum Dis, 2004, 63(12): 1594-1600.
23. 王莉莎, 黄烽, 张江林, 等. 肿瘤坏死因子拮抗剂在治疗强直性脊柱炎中的安全性分析. 中国新药杂志, 2007, 16(7): 556-561.
24. 郝慧琴, 黄烽, 邓小虎, 等. 依那西普不同用药方案治疗强直性脊柱炎疗效比较. 中国药物与临床, 2008, 8(6): 432-436.

Chinese Journal of Evidence-Based Medicine

Efficacy and Safety of Etanercept for Patients with Ankylosing Spondylitis: A Systematic Review

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