High-dose etanercept in ankylosing spondylitis: Results of a 12-week randomized, double blind, controlled multicentre study (LOADET study)

Rheumatology

Volumn 50, Issue 10, 2011, Pages 1828-1837

  Navarro Sarabia, Federico ^a   Fernández Sueiro, José L ^b   Torre Alonso, Juan C ^c   Gratacos, Jordi ^d   Queiro, Rubén ^e   Gonzalez, Carlos ^f   Loza, Eduardo ^g   Linares, Luis ^h   Zarco, Pedro ⁱ   Juanola, Xavier ^j   Román Ivorra, José ^k   Martín Mola, Emilio ^l   Sanmartí, Raimon ^m   Mulero, Juan ⁿ   Diaz, Gema ^o   Armendáriz, Yolanda ^o   Collantes, Eduardo ^p  

^a HOSPITAL UNIVERSITARIO VIRGEN MACARENA   (Spain)

^b University Hospital of la CoruñA Spain   (Spain)

^c HOSPITAL MONTE NARANCO   (Spain)

^d HOSPITAL DE SABADELL   (Spain)

^e HOSPITAL UNIVERSITARIO CENTRAL DE ASTURIAS   (Spain)

^f HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑÓN   (Spain)

^g Universidad Pública de Navarra   (Spain)

^h HOSPITAL UNIVERSITARIO VIRGEN DE LA ARRIXACA   (Spain)

ⁱ HOSPITAL UNIVERSITARIO FUNDACIÓN ALCORCÓN   (Spain)

^j HOSPITAL UNIVERSITARI DE BELLVITGE   (Spain)

^k HOSPITAL UNIVERSITARIO DR PESET   (Spain)

^l HOSPITAL UNIVERSITARIO LA PAZ   (Spain)

^m HOSPITAL CLÍNIC   (Spain)

ⁿ HOSPITAL UNIVERSITARIO PUERTA DE HIERRO   (Spain)

^o PFIZER INC   (United States)

^p HOSPITAL UNIVERSITARIO REINA SOFÍA   (Spain)

more..

Author keywords

Ankylosing spondylitis; Efficacy; Etanercept; Safety

Indexed keywords

DISEASE MODIFYING ANTIRHEUMATIC DRUG; ETANERCEPT; NONSTEROID ANTIINFLAMMATORY AGENT;

ABDOMINAL PAIN; ANKYLOSING SPONDYLITIS; ARTICLE; CLINICAL ASSESSMENT; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG MEGADOSE; DRUG RESPONSE; DRUG SAFETY; FEMALE; HUMAN; HYPERTRANSAMINASEMIA; INJECTION SITE REACTION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PHARYNGITIS; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; REMISSION; RHINOPHARYNGITIS; UPPER RESPIRATORY TRACT INFECTION;

EID: 80053143369     PISSN: 14620324     EISSN: 14620332     Source Type: Journal    
DOI: 10.1093/rheumatology/ker083     Document Type: Article

References (34)

1. Braun J, Sieper J. Ankylosing spondylitis. Lancet 2007; 369:1379-90.
2. Sieper J, Rudwaleit M, Khan MA, Braun J. Concepts and epidemiology of spondyloarthritis. Best Pract Res Clin Rheumatol 2006;20:401-17.
3. Sieper J. Developments in the scientific and clinical understanding of the spondyloarthritides. Arthritis Res Ther 2009;11:208.
4. Zochling J, van der Heijde D, Burgos-Vargas R et al. ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis 2006;65:442-52.
5. Song IH, Poddubnyy DA, Rudwaleit M, Sieper J. Benefits and risks of ankylosing spondylitis treatment with nonsteroidal antiinflammatory drugs. Arthritis Rheum 2008;58: 929-38.
6. Kirwan J, Edwards A, Huitfeldt B, Thompson P, Currey H. The course of established ankylosing spondylitis and the effects of sulphasalazine over 3 years. Br J Rheumatol 1993;32:729-33.
7. Clegg DO, Reda DJ, Abdellatif M. Comparison of sulfasalazine and placebo for the treatment of axial and peripheral articular manifestations of the seronegative spondylarthropathies: a Department of Veterans Affairs cooperative study. Arthritis Rheum 1999;42:2325-9.
8. Braun J, Baraliakos X, Brandt J et al. Persistent clinical response to the anti-TNF-alpha antibody infliximab in patients with ankylosing spondylitis over 3 years. Rheumatology 2005;44:670-6.
9. Davis JC Jr, van der Heijde DM, 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: 346-52.
10. Dijkmans B, Emery P, Hakala M et al. Etanercept in the longterm treatment of patients with ankylosing spondylitis. J Rheumatol 2009;36:1256-64.
11. Goldenberg MM. Etanercept, a novel drug for the treatment of patients with severe, active rheumatoid arthritis. Clin Ther 1999;21:75-87.
12. 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;48:1667-75.
13. Davis JC Jr, Van Der Heijde D, Braun J et al. Recombinant human tumor necrosis factor receptor (etanercept) for treating ankylosing spondylitis: a randomized, controlled trial. Arthritis Rheum 2003;48:3230-6.
14. Calin A, Dijkmans BA, Emery P et al. Outcomes of a multicentre randomised clinical trial of etanercept to treat ankylosing spondylitis. Ann Rheum Dis 2004;63:1594-600.
15. van der Heijde D, Landewé R, Einstein S et al. Radiographic progression of ankylosing spondylitis after up to two years of treatment with etanercept. Arthritis Rheum 2008;58:1324-31.
16. Leonardi CL, Powers JL, Matheson RT et al. Etanercept as monotherapy in patients with psoriasis. N Engl J Med 2003;349:2014-22.
17. De Felice C, Mazzotta A, Esposito M, Bianchi L, Chimenti S. High-dose initiation of etanercept in psoriatic arthritis and plaque psoriasis: efficacy, safety and impact on patients' quality of life. J Dermatolog Treat 2006;17: 355-8.
18. Sterry W, Ortonne JP, Kirkham B et al. Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTA randomised double blind multicentre trial. Br Med J 2010;340:c147.
19. Weinblatt ME, Schiff MH, Ruderman EM et al. Efficacy and safety of etanercept 50mg twice a week in patients with rheumatoid arthritis who had a suboptimal response to etanercept 50mg once a week: results of a multicenter, randomized, double-blind, active drug-controlled study. Arthritis Rheum 2008;58:1921-30.
20. Johnsen AK, Schiff MH, Mease PJ et al. Comparison of doses of etanercept (50 vs 100 mg) in active rheumatoid arthritis: a randomized double blind study. J Rheumatol 2006;33:659-64.
21. Van der Linden S, Valkenburg H, Cats A. Evaluation of diagnostic criteria for ankylosing spondylitis. A proposal for modification of the New York criteria. Arthritis Rheum 1984;27:361-8.
22. Anderson JJ, Baron G, van der Heijde D, Felson DT, Dougados M. Ankylosing spondylitis assessment group preliminary definition of short-term improvement in ankylosing spondylitis. Arthritis Rheum 2001;44:1876-86.
23. Calin A, Garrett S, Whitelock H et al. A new approach to defining functional ability in ankylosing spondylitis: the development of the Bath Ankylosing Spondylitis Functional Index. J Rheumatol 1994;21:2281-5.
24. Garrett S, Jenkinson T, Kennedy LG, Whitelock H, Gaisford P, Calin A. A new approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activity Index. J Rheumatol 1994;21: 2286-91.
25. Stone MA, Inman RD, Wright JG, Maetzel A. Validation exercise of the Ankylosing Spondylitis Assessment Study (ASAS) group response criteria in ankylosing spondylitis patients treated with biologics. Arthritis Rheum 2004;51: 316-20.
26. 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-TNF alpha treatment in ankylosing spondylitis. Ann Rheum Dis 2004; 63:1438-44.
27. van der Heijde D, Landewé 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.
28. Heuft-Dorenbosch L, Spoorenberg A, van Tubergen A. Assessment of enthesitis in ankylosing spondylitis. Ann Rheum Dis 2003;62:127-32.
29. EuroQol Group. EuroQol-a new facility for the measurement of health-related quality of life. Health Policy 1990; 16:199-208.
30. Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992;30:473-83.
31. van der Heijde D, Dijkmans B, Geusens P et al. Ankylosing spondylitis study for the evaluation of Recombinant Infliximab Therapy Study Group. Efficacy and safety of infliximab in patients with ankylosing spondylitis: results of a randomized, placebo-controlled trial (ASSERT). Arthritis Rheum 2005;52:582-91.
32. Rudwaleit M, Claudepierre P, Wordsworth P et al. Effectiveness, safety, and predictors of good clinical response in 1250 patients treated with adalimumab for active ankylosing spondylitis. J Rheumatol 2009;36:801-8.
33. Inman RD, Davis JC Jr, Heijde D et al. Efficacy and safety of golimumab in patients with ankylosing spondylitis: results of a randomized, double-blind, placebo-controlled, phase III trial. Arthritis Rheum 2008; 58:3402-12.
34. van der Heijde D, Kivitz A, Schiff MH et al. Efficacy and safety of adalimumab in patients with ankylosing spondylitis: results of a multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheum 2006;54:2136-46.