Ustekinumab for the treatment of patients with active ankylosing spondylitis: Results of a 28-week, prospective, open-label, proof-of-concept study (TOPAS)

Annals of the Rheumatic Diseases

Volumn 73, Issue 5, 2014, Pages 817-823

  Poddubnyy, Denis ^a   Hermann, Kay Geert A ^a   Callhoff, Johanna ^b   Listing, Joachim ^b   Sieper, Joachim ^a  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b German Rheumatism Research Centre   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

C REACTIVE PROTEIN; METHOTREXATE; PLACEBO; PREDNISONE; USTEKINUMAB;

ABDOMINAL DISCOMFORT; ABDOMINAL PAIN; ADULT; ANKYLOSING SPONDYLITIS; ARTICLE; BACKACHE; BATH ANKYLOSING SPONDYLITIS DISEASE ACTIVITY INDEX; CLINICAL ARTICLE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; HEADACHE; HUMAN; MALE; NUCLEAR MAGNETIC RESONANCE IMAGING; OPEN STUDY; PRIORITY JOURNAL; PROSPECTIVE STUDY; PROTEIN BLOOD LEVEL;

ANKYLOSING SPONDYLITIS; SPONDYLOARTHRITIS; TREATMENT;

ADULT; ANTIBODIES, MONOCLONAL, HUMANIZED; FEMALE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; MALE; PROSPECTIVE STUDIES; SPONDYLITIS, ANKYLOSING; TIME FACTORS; TREATMENT OUTCOME;

EID: 84897980960     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2013-204248     Document Type: Article

References (49)

1. 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;70:896-904.
2. van der Heijde D, Sieper J, Maksymowych WP, et al. 2010 Update of the international ASAS recommendations for the use of anti-TNF agents in patients with axial spondyloarthritis. Ann Rheum Dis 2011;70:905-8.
3. Braun J, Zochling J, Baraliakos X, et al. Efficacy of sulfasalazine in patients with inflammatory back pain due to undifferentiated spondyloarthritis and early ankylosing spondylitis: a multicentre randomised controlled trial. Ann Rheum Dis 2006;65:1147-53. (Pubitemid 44277387)
4. Haibel H, Brandt HC, Song IH, et al. No efficacy of subcutaneous methotrexate in active ankylosing spondylitis: a 16-week open-label trial. Ann Rheum Dis 2007;66:419-21. (Pubitemid 46579648)
5. Haibel H, Rudwaleit M, Braun J, et al. Six months open label trial of leflunomide in active ankylosing spondylitis. Ann Rheum Dis 2005;64:124-6. (Pubitemid 40075288)
6. Haibel H, Rudwaleit M, Listing J, et al. Open label trial of anakinra in active ankylosing spondylitis over 24 weeks. Ann Rheum Dis 2005;64:296-8. (Pubitemid 40193630)
7. Song IH, Heldmann F, Rudwaleit M, et al. Treatment of active ankylosing spondylitis with abatacept: an open-label, 24-week pilot study. Ann Rheum Dis 2011;70:1108-10.
8. Sieper J, Inman R, Badalamenti S, et al. Sarilumab for the treatment of ankylosing spondylitis: results of a phase 2, randomized, double-blind, placebo-controlled, international study (ALIGN). Ann Rheum Dis 2012;71(Suppl 3):111.
9. Sieper J, Porter-Brown B, Thompson L, et al. Assessment of short-term symptomatic efficacy of tocilizumab in ankylosing spondylitis: results of randomised, placebo-controlled trials. Ann Rheum Dis 2014;73:95-100.
10. van der Heijde D, Dijkmans B, Geusens P, et al. Efficacy and safety of infliximab in patients with ankylosing spondylitis: results of a randomized, placebo-controlled trial (ASSERT). Arthritis Rheum 2005;52:582-91. (Pubitemid 40216323)
11. 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. (Pubitemid 44051069)
12. Davis JC, van der Heijde DM, Braun J, et al. Sustained durability and tolerability of etanercept in ankylosing spondylitis for 96 weeks. Ann Rheum Dis 2005; 64:1557-62. (Pubitemid 41532037)
13. 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.
14. Lie E, van der Heijde D, Uhlig T, et al. Effectiveness of switching between TNF inhibitors in ankylosing spondylitis: data from the NOR-DMARD register. Ann Rheum Dis 2011;70:157-63.
15. Burton PR, Clayton DG, Cardon LR, et al. Association scan of 14,500 nonsynonymous SNPs in four diseases identifies autoimmunity variants. Nat Genet 2007;39:1329-37. (Pubitemid 350041542)
16. Rahman P, Inman RD, Gladman DD, et al. Association of interleukin-23 receptor variants with ankylosing spondylitis. Arthritis Rheum 2008;58:1020-5. (Pubitemid 351564003)
17. Nair RP, Duffin KC, Helms C, et al. Genome-wide scan reveals association of psoriasis with IL-23 and NF-kappaB pathways. Nat Genet 2009;41:199-204.
18. Duerr RH, Taylor KD, Brant SR, et al. A genome-wide association study identifies IL23R as an inflammatory bowel disease gene. Science 2006;314:1461-3. (Pubitemid 44871953)
19. Appel H, Maier R, Bleil J, et al. In situ analysis of interleukin-23- and interleukin-12-positive cells in the spine of patients with ankylosing spondylitis. Arthritis Rheum 2013;65:1522-9.
20. Mei Y, Pan F, Gao J, et al. Increased serum IL-17 and IL-23 in the patient with ankylosing spondylitis. Clin Rheumatol 2011;30:269-73.
21. Romero-Sanchez C, Jaimes DA, Londono J, et al. Association between Th-17 cytokine profile and clinical features in patients with spondyloarthritis. Clin Exp Rheumatol 2011;29:828-34.
22. Weaver CT, Hatton RD, Mangan PR, et al. IL-17 family cytokines and the expanding diversity of effector T cell lineages. Annu Rev Immunol 2007;25:821-52. (Pubitemid 46697925)
23. Dardalhon V, Korn T, Kuchroo VK, et al. Role of Th1 and Th17 cells in organ-specific autoimmunity. J Autoimmun 2008;31:252-6.
24. Baeten D, Baraliakos X, Braun J, et al. Anti-interleukin-17A monoclonal antibody secukinumab in treatment of ankylosing spondylitis: a randomised, double-blind, placebo-controlled trial. Lancet 2013;382:1705-13.
25. Sherlock JP, Joyce-Shaikh B, Turner SP, et al. IL-23 induces spondyloarthropathy by acting on ROR-gammat+ CD3+CD4-CD8- entheseal resident T cells. Nat Med 2012;18:1069-76.
26. Leonardi CL, Kimball AB, Papp KA, et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1). Lancet 2008;371:1665-74. (Pubitemid 351671883)
27. Papp KA, Langley RG, Lebwohl M, et al. Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet 2008;371:1675-84. (Pubitemid 351671884)
28. Griffiths CE, Strober BE, van de Kerkhof P, et al. Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis. N Engl J Med 2010;362:118-28.
29. Gottlieb A, Menter A, Mendelsohn A, et al. Ustekinumab, a human interleukin 12/ 23 monoclonal antibody, for psoriatic arthritis: randomised, double-blind, placebo-controlled, crossover trial. Lancet 2009;373:633-40.
30. McInnes IB, Kavanaugh A, Gottlieb AB, et al. Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial. Lancet 2013;382:780-9.
31. Sandborn WJ, Feagan BG, Fedorak RN, et al. A randomized trial of Ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with moderate-to-severe Crohn's disease. Gastroenterology 2008;135:1130-41.
32. 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;27:361-8. (Pubitemid 14134775)
33. Garrett S, Jenkinson T, Kennedy LG, et al. A new approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activity Index. J Rheumatol 1994;21:2286-91.
34. Brandt J, Listing J, Sieper J, et al. Development and preselection of criteria for short term improvement after anti-TNF alpha treatment in ankylosing spondylitis. Ann Rheum Dis 2004;63:1438-44. (Pubitemid 39433948)
35. 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;44:1876-86. (Pubitemid 32758236)
36. 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;68:18-24.
37. Machado P, Landewe R, Lie E, et al. Ankylosing Spondylitis Disease Activity Score (ASDAS): defining cut-off values for disease activity states and improvement scores. Ann Rheum Dis 2010;70:47-53.
38. 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 unctional Index. J Rheumatol 1994;21:2281-5.
39. Jenkinson TR, Mallorie PA, Whitelock HC, et al. Defining spinal mobility in ankylosing spondylitis (AS). The Bath AS Metrology Index. J Rheumatol 1994;21:1694-8. (Pubitemid 24285485)
40. The EuroQol Group. EuroQol-A new facility for the measurement of health-related quality of life. Health Policy 1990;16:199-208.
41. Doward LC, McKenna SP, Meads DM, et al. Translation and validation of non-English versions of the Ankylosing Spondylitis Quality of Life (ASQOL) questionnaire. Health Qual Life Outcomes 2007;5:7.
42. Kvien TK, Heiberg T, Hagen KB. Minimal clinically important improvement/difference (MCII/MCID) and patient acceptable symptom state (PASS): what do these concepts mean? Ann Rheum Dis 2007;66(Suppl 3):iii40-1. (Pubitemid 350032631)
43. Heuft-Dorenbosch L, Spoorenberg A, van Tubergen A, et al. Assessment of enthesitis in ankylosing spondylitis. Ann Rheum Dis 2003;62:127-32. (Pubitemid 36135387)
44. Maksymowych WP, Mallon C, Morrow S, et al. Development and validation of the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index. Ann Rheum Dis 2009;68:948-53.
45. Dougados M, Simon P, Braun J, et al. ASAS recommendations for collecting, analysing and reporting NSAID intake in clinical trials/epidemiological studies in axial spondyloarthritis. Ann Rheum Dis 2011;70:249-51.
46. Althoff CE, Sieper J, Song IH, et al. Active inflammation and structural change in early active axial spondyloarthritis as detected by whole-body MRI. Ann Rheum Dis 013;72:967-73.
47. Sandborn WJ, Gasink C, Gao LL, et al. Ustekinumab induction and maintenance therapy in refractory Crohn's disease. N Engl J Med 2012;367:1519-28.
48. Rahman P, Puig L, Gottlieb A, et al. Ustekinumab improves physical function, quality of life and work productivity of patients with active psoriatic arthritis who were naïve to MTX, despite MTX therapy or previously treated with anti-TNFa: results from PSUMMIT I and PSUMMIT II. Ann Rheum Dis 2013;72(Suppls3):671.
49. 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;68:777-83.