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Review

Impact of Secukinumab on Patient-Reported Outcomes in the Treatment of Ankylosing Spondylitis: Current Perspectives

, ORCID Icon &
Pages 277-292 | Published online: 26 Nov 2020

References

  • 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. doi:10.1002/art.17802704016231933
  • van der Heijde D, Ramiro S, Landewe R, et al. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis. 2017;76(6):978–991. doi:10.1136/annrheumdis-2016-21077028087505
  • Braun J, Kiltz U, Heldmann F, Baraliakos X. Emerging drugs for the treatment of axial and peripheral spondyloarthritis. Expert Opin Emerg Drugs. 2015;20(1):1–14. doi:10.1517/14728214.2015.99337825575936
  • Glatigny S, Fert I, Blaton MA, et al. Proinflammatory Th17 cells are expanded and induced by dendritic cells in spondylarthritis-prone HLA-B27-transgenic rats. Arthritis Rheum. 2012;64(1):110–120. doi:10.1002/art.3332121905004
  • Shen H, Goodall JC, Hill Gaston JS. Frequency and phenotype of peripheral blood Th17 cells in ankylosing spondylitis and rheumatoid arthritis. Arthritis Rheum. 2009;60(6):1647–1656. doi:10.1002/art.2456819479869
  • Kenna TJ, Davidson SI, Duan R, et al. Enrichment of circulating interleukin-17-secreting interleukin-23 receptor-positive gamma/delta T cells in patients with active ankylosing spondylitis. Arthritis Rheum. 2012;64(5):1420–1429. doi:10.1002/art.3350722144400
  • McGonagle DG, McInnes IB, Kirkham BW, Sherlock J, Moots R. The role of IL-17A in axial spondyloarthritis and psoriatic arthritis: recent advances and controversies. Ann Rheum Dis. 2019;78(9):1167–1178. doi:10.1136/annrheumdis-2019-21535631278139
  • Smith JA, Colbert RA. The interleukin-23/interleukin-17 axis in spondyloarthritis pathogenesis: Th17 and beyond. Arthritis Rheumatol. 2014;66(2):231–241. doi:10.1002/art.3829124504793
  • Gravallese EM, Schett G. Effects of the IL-23-IL-17 pathway on bone in spondyloarthritis. Nat Rev Rheumatol. 2018;14(11):631–640. doi:10.1038/s41584-018-0091-830266977
  • Jo S, Wang SE, Lee YL, et al. IL-17A induces osteoblast differentiation by activating JAK2/STAT3 in ankylosing spondylitis. Arthritis Res Ther. 2018;20(1):115. doi:10.1186/s13075-018-1582-329880011
  • Pinto LG, Cunha TM, Vieira SM, et al. IL-17 mediates articular hypernociception in antigen-induced arthritis in mice. Pain. 2010;148(2):247–256. doi:10.1016/j.pain.2009.11.00619969421
  • McNamee KE, Alzabin S, Hughes JP, et al. IL-17 induces hyperalgesia via TNF-dependent neutrophil infiltration. Pain. 2011;152(8):1838–1845. doi:10.1016/j.pain.2011.03.03521507574
  • U.S. Food and Drug Administration (FDA). Secukinumab prescribing information. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125504s035lbl.pdf. Accessed 1020, 2020.
  • European Medicines Agency (EMA). Secukinumab summary of product characteristics. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003729/WC500183129.pdf. Accessed 920, 2020.
  • Baeten D, Sieper J, Braun J, et al. Secukinumab, an interleukin-17A inhibitor, in ankylosing spondylitis. N Engl J Med. 2015;373(26):2534–2548. doi:10.1056/NEJMoa150506626699169
  • Pavelka K, Kivitz A, Dokoupilova E, et al. Efficacy, safety, and tolerability of secukinumab in patients with active ankylosing spondylitis: a randomized, double-blind phase 3 study, MEASURE 3. Arthritis Res Ther. 2017;19(1):285. doi:10.1186/s13075-017-1490-y29273067
  • Kivitz AJ, Wagner U, Dokoupilova E, et al. Efficacy and safety of secukinumab 150 mg with and without loading regimen in ankylosing spondylitis: 104-week results from MEASURE 4 Study. Rheumatology Therapy. 2018;5(2):447–462. doi:10.1007/s40744-018-0123-530121827
  • Huang F, Sun F, Wan W, et al. Secukinumab provided significant and sustained improvement in the signs and symptoms of ankylosing spondylitis: results from the 52-week, Phase III China-centric study, MEASURE 5. Clin Med J. 2020. doi:10.1097/CM9.0000000000001099
  • Kishimoto M, Taniguchi A, Fujishige A, et al. Efficacy and safety of secukinumab in Japanese patients with active ankylosing spondylitis: 24-week results from an open-label phase 3 study (MEASURE 2-J). Modern Rheumatology. 2020;30(1):132–140. doi:10.1080/14397595.2018.153800430334633
  • ClinicalTrials.gov. NCT03259074: effect of secukinumab on radiographic progression in ankylosing spondylitis as compared to GP2017 (Adalimumab Biosimilar) (SURPASS). Available from: https://clinicaltrials.gov/ct2/show/NCT03259074. Accessed 103, 2020.
  • Cohen SB, Strand V, Aguilar D, Ofman JJ. Patient- versus physician-reported outcomes in rheumatoid arthritis patients treated with recombinant interleukin-1 receptor antagonist (anakinra) therapy. Rheumatol. 2004;43(6):704–711. doi:10.1093/rheumatology/keh152
  • Strand V, Cohen S, Crawford B, Scott DL. Patient-reported outcomes better discriminate active treatment from placebo in randomized controlled trials in rheumatoid arthritis. Rheumatol. 2004;43(5):640–647. doi:10.1093/rheumatology/keh140
  • Ward MM, Deodhar A, Akl EA, et al. American College of Rheumatology/Spondylitis association of america/spondyloarthritis research and treatment network 2015 recommendations for the treatment of ankylosing spondylitis and nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2016;68(2):282–298. doi:10.1002/art.3929826401991
  • Landewé R, van Tubergen A. Clinical tools to assess and monitor spondyloarthritis. Curr Rheumatol Rep. 2015;17(7):47. doi:10.1007/s11926-015-0522-326063534
  • Yellen SB, Cella DF, Webster K, Blendowski C, Kaplan E. Measuring fatigue and other anemia-related symptoms with the Functional Assessment of Cancer Therapy (FACT) measurement system. J Pain Symptom Manage. 1997;13(2):63–74. doi:10.1016/S0885-3924(96)00274-69095563
  • Deodhar A, Conaghan PG, Kvien TK, et al. Secukinumab provides rapid and persistent relief in pain and fatigue symptoms in patients with ankylosing spondylitis irrespective of baseline C-reactive protein levels or prior tumour necrosis factor inhibitor therapy: 2-year data from the MEASURE 2 study. Clin Exp Rheumatol. 2019;37(2):260–269.30148436
  • Sieper J, Rudwaleit M, Baraliakos X, et al. The Assessment of SpondyloArthritis international Society (ASAS) handbook: a guide to assess spondyloarthritis. Ann Rheum Dis. 2009;68(Suppl 2):ii144. doi:10.1136/ard.2008.104018
  • Doward LC, Spoorenberg A, Cook SA, et al. Development of the ASQoL: a quality of life instrument specific to ankylosing spondylitis. Ann Rheum Dis. 2003;62(1):20–26. doi:10.1136/ard.62.1.2012480664
  • Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001;33:337–343. doi:10.3109/0785389010900208711491192
  • 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(6):473–483. doi:10.1097/00005650-199206000-000021593914
  • Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. PharmacoEconomics. 1993;4(5):353–365. doi:10.2165/00019053-199304050-0000610146874
  • 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(12):2286–2291.7699630
  • 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(12):2281–2285.7699629
  • Jenkinson TR, Mallorie PA, Whitelock HC, Kennedy LG, Garrett SL, Calin A. Defining spinal mobility in ankylosing spondylitis (AS). The Bath AS Metrology Index. J Rheumatol. 1994;21(9):1694–1698.7799351
  • Aissaoui N, Rostom S, Hakkou J, et al. Fatigue in patients with ankylosing spondylitis: prevalence and relationships with disease-specific variables, psychological status, and sleep disturbance. Rheumatol Int. 2012;32(7):2117–2124. doi:10.1007/s00296-011-1928-521516494
  • Heiberg T, Lie E, van der Heijde D, Kvien TK. Sleep problems are of higher priority for improvement for patients with ankylosing spondylitis than for patients with other inflammatory arthropathies. Ann Rheum Dis. 2011;70(5):872–873. doi:10.1136/ard.2010.13379321109522
  • Baraliakos X, Braun J, Deodhar A, et al. Long-term efficacy and safety of secukinumab 150 mg in ankylosing spondylitis: 5-year results from the phase III MEASURE 1 extension study. RMD Open. 2019;5(2):e001005. doi:10.1136/rmdopen-2019-00100531565244
  • Deodhar AA, Dougados M, Baeten DL, et al. Effect of secukinumab on patient-reported outcomes in patients with active ankylosing spondylitis: a phase III randomized trial (MEASURE 1). Arthritis Rheumatol. 2016;68(12):2901-–2910. doi:10.1002/art.39805
  • Cella D, Yount S, Sorensen M, Chartash E, Sengupta N, Grober J. Validation of the functional assessment of chronic illness therapy fatigue scale relative to other instrumentation in patients with rheumatoid arthritis. J Rheumatol. 2005;32(5):811–819.15868614
  • Kvien T, Conaghan PG, Deodhar A, et al. Reduction in fatigue in patients with active ankylosing spondylitis: results of two phase 3 studies of secukinumab. Poster SAT0421 presented at the European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology; 8–116 2016; London, UK 2016.
  • Bodur H, Ataman S, Rezvani A, et al. Quality of life and related variables in patients with ankylosing spondylitis. Qual Life Res. 2011;20(4):543–549. doi:10.1007/s11136-010-9771-920978859
  • Marzo-Ortega H, Miceli-Richard C, Gill S, et al. Subcutaneous secukinumab 150 mg provides rapid and sustained relief in total and nocturnal back pains, morning stiffness, and fatigue in patients with active ankylosing spondylitis over 4 years. Arthritis Rheumatol. 2019;71.
  • Ward MM. Health-related quality of life in ankylosing spondylitis: a survey of 175 patients. Arthritis Care Res (Hoboken). 1999;12(4):247–255. doi:10.1002/1529-0131(199908)12:4<247::AID-ART3>3.0.CO;2-H
  • Emery P, Baeten D, Deodhar A, et al. Secukinumab improves physical function and quality of life in patients with active ankyloising spondylitis: 2-year data from MEASURE 1, a Phase 3 randomised trial. Ann Rheum Dis. 2016;75:818. doi:10.1136/annrheumdis-2016-eular.2308
  • Deodhar A, Boonen A, Ferraccioli G, et al. Secukinumab provides early and sustained improvements in health-related quality of life in patients with ankylosing spondylitis: a pooled analysis from the secukinumab phase 3 trial program. Arthritis Rheumatol. 2018;70.
  • Boonen A, Chorus A, Miedema H, et al. Withdrawal from labour force due to work disability in patients with ankylosing spondylitis. Ann Rheum Dis. 2001;60(11):1033–1039. doi:10.1136/ard.60.11.103311602474
  • Rudwaleit M, Haibel H, Baraliakos X, et al. The early disease stage in axial spondylarthritis: results from the German Spondyloarthritis Inception Cohort. Arthritis Rheum. 2009;60(3):717–727. doi:10.1002/art.2448319248087
  • Boonen A. van der Linden SM. The burden of ankylosing spondylitis. J Rheumatol Suppl. 2006;78:4–11.17042055
  • Deodhar A, Conaghan PG, Strand V, et al. Secukinumab provides sustained improvements in work productivity and health related quality of life in patients with ankylosing spondylitis: long-term results from MEASURE 1 and MEASURE 2. Ann Rheum Dis. 2017;76:1293.
  • Rudwaleit M, Listing J, Brandt J, Braun J, Sieper J. Prediction of a major clinical response (BASDAI 50) to tumour necrosis factor alpha blockers in ankylosing spondylitis. Ann Rheum Dis. 2004;63(6):665–670. doi:10.1136/ard.2003.01638615037444
  • Marzo-Ortega H, Sieper J, Kivitz A, et al. Long-term evaluation of secukinumab 150 mg in ankylosing sponylitis: 5-year end-of-study efficacy and safety results from a phase 3 trial. Ann Rheum Dis. 2019;78:873.
  • Pavelka K, Kivitz AJ, Dokoupilova E, et al. Secukinumab 150/300 mg provides sustained improvements in the signs and symptoms of active ankylosing spondylitis: 3-year results from the phase 3 MEASURE 3 Study. ACR Open Rheumatology. 2020;1–9.
  • Zochling J. Measures of symptoms and disease status in ankylosing spondylitis: ankylosing Spondylitis Disease Activity Score (ASDAS), Ankylosing Spondylitis Quality of Life Scale (ASQoL), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Global Score (BAS‐G), Bath Ankylosing Spondylitis Metrology Index (BASMI), Dougados Functional Index (DFI), and Health Assessment Questionnaire for the Spondylarthropathies (HAQ‐S). Arth Care Res. 2011;63:S47S58.
  • Wei JCC, Baeten D, Geusens P, Porter B, Martin R, Richards H. Intravenous loading and subcutaneous maintenance with secukinumab provides sustained improvement in multiple measures of disease activity in subjects with active ankyloisng spondylitis: 52-week data from the randomized, double-blind, placebo-controlled, phase 3 measure 1 study. Ann Rheum Dis. 2015;74:1146–1147.
  • 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(8):1876–1886. doi:10.1002/1529-0131(200108)44:8<1876::AID-ART326>3.0.CO;2-F11508441
  • 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-TNFa treatment in ankylosing spondylitis. Ann Rheum Dis. 2004;63:1438–1444. doi:10.1136/ard.2003.01671715044211
  • Zochling J, Braun J. Remission in ankylosing spondylitis. Clin Exp Rheumatol. 2006;24(6 Suppl 43):S-88–92.
  • Deodhar A, Boonen A, Ferraccioli G, et al. Secukinumab improves health-related quality of life in patients with ankylosing spondylitis, irrespective of time since first diagnosis: pooled results from the secukinumab phase 3 trial program. Ann Rheum Dis. 2019;78:878–879.
  • Vastesaeger N, van der Heijde D, Inman R, et al. Predicting the outcome of ankylosing spondylitis therapy. Ann Rheum Dis. 2011;70:973–981. doi:10.1136/ard.2010.14774421402563
  • Arends S, Brouwer E, Van der Veer E, et al. Baseline predictors of response and discontinuation of tumor necrosis factor-alpha blocking therapy in ankylosing spondylitis: a prospective longitudinal observational cohort study. Arthritis Res Ther. 2011;13:R94. doi:10.1186/ar336921689401
  • 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(4):801–808. doi:10.3899/jrheum.08104819273449
  • Deodhar A, Mease P, Machado P, Meng X, Strand V, Magrey M. Impact of age and disease duration on the response to IL-17A inhibitor (secukinumab) treatment in ankylosing spondylitis: pooled results from the phase 3 MEASURE studies. Arthritis Rheumatol. 2019;71.
  • Braun J, Deodhar A, Landewe R, et al. Impact of baseline C-reactive protein levels on the response to secukinumab in ankylosing spondylitis: 3-year pooled data from two phase III studies. RMD Open. 2018;4(2):e000749. doi:10.1136/rmdopen-2018-00074930564451
  • Kiltz U, Peterlik D, Winkelmann V, Tony HP. Aquila study in German - real world data on secukinumab’s effectiveness in ankylosing spondylitis patients - results from an interim analysis. Ann Rheum Dis. 2019;78:890.31040122
  • Kiltz U, Van der Heijde D, Boonen A, Braun J. The ASAS Health Index (ASAS HI) - a new tool to assess the health status of patients with spondyloarthritis. Clin Exp Rheum. 2014;32(5):S-105–108.
  • Stewart AL, Hays RD, Ware JE. The MOS short-form general health survey: reliability and validity in a patient population. Med Care. 1988;26:724–732. doi:10.1097/00005650-198807000-000073393032
  • Beck AT, Steer RA, Brown GK. Beck Depression Inventory. second edition manual San Antonio (TX): The Psychological Corporation; 1996.
  • Michelson B, Brahe CH, Askling J, et al. Pooled 6-month treatment outcomes and drug retention rates in 1556 patients with axial spondyloarthritis treated with secukinumab in routine clinical practice in 12 European countries in the EuroSpa research collaboration. Ann Rheum Dis. 2019;78:888–889.
  • 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(1):18–24. doi:10.1136/ard.2008.09487018625618
  • Ogdie A, Liu M, Rebello S, et al. Clinical characteristics and treatment profiles of patients with ankylosing spondylitis who initiated secukinumab and other biologics: results from the corona psoriatic arthritis/spondyloarthritis (PsA/SpA) registry. Ann Rheum Dis. 2019;78:484–486.
  • Augustin M, Von Kiedrowski R, Rigopoulos D, et al. Effectiveness and safety of secukinumab treatment in real-world clinical settings in European countries confirms its efficacy and safety from clinical trials: data from an interim analysis of SERENA study. J Am Acad Dermatol. 2019;81(4):AB50.
  • Alkoky H, Khan Z, Tahir H. Long-term efficacy of secukinumab in the management of ankylosing spondylitis in clinical practice: real world data (Abstract E095). Rheumatol. 2019;58:kez110.093. doi:10.1093/rheumatology/kez110.093
  • Argumánez CM, Emperiale V, Martín M, et al. Secukinumab for axial spondyloarthritis: drug survival in real-world setting and response factors (Abstract FRI0402). Ann Rheum Dis. 2019;78(Suppl2):887.881–887.
  • Elliott A, Wright G. Real-world data on secukinumab use for psoriatic arthritis and ankylosing spondylitis. Ther Adv Musculoskelet Dis. 2019;11:1759720X19858510. doi:10.1177/1759720X19858510
  • Magrey M, Bozyczko M, Wolin D, et al. Treatment experience and satisfaction in ankylosing spondylitis patients treated with secukinumab: results from a us web-based survey. Ann Rheum Dis. 2018;77:1014.
  • Martinis F, Caimmi A, Carletto A, Fracassi E, Rossini M. Real-world efficacy and safety of secukinumab: data from verona’s cohort. Ann Rheum Dis. 2018;77:1544–1545.29490979
  • Flouri I, Repa A, Avgustidis N, et al. Comparable clinical responses but higher treatment adherence of secukinumab compared to TNF inhibitors in spondyloarthritis patients: long term prospective observational study in a tertiary hospital of Greece. Ann Rheum Dis. 2019;78:893.
  • Deodhar A, Blanco R, Dokoupilová E, et al. Secukinumab improves signs and symptoms of non-radiographic axial spondyloarthritis: primary results of a randomized controlled phase III study. Arthritis Rheumatol. 2020. doi:10.1002/art.41477
  • Baraliakos X, Gossec L, Pournara E, et al. Secukinumab improves clinical and imaging outcomes in patients with psoriatic arthritis and axial manifestations with inadequate response to NSAIDs: week 52 results from the MAXIMISE trial. Ann Rheum Dis. 2020;79(Suppl1): Abstract OPOO53.
  • Marzo-Ortega H, Sieper J, Kivitz AJ, et al. Secukinumab 150 mg provides sustained improvements in the signs and symptoms of active ankylosing spondylitis with consistent safety profile and high retention rate: 4-Year results from a phase III trial [abstract]. Arthritis Rheumatol. 2018;70.
  • Marzo-Ortega H, Sieper J, Kivitz A, et al. Secukinumab provides sustained improvements in the signs and symptoms of active ankylosing spondylitis with high retention rate: 3-year results from the phase III trial, MEASURE 2. RMD Open. 2017;3(2):3:e000592. doi:10.1136/rmdopen-2017-000592
  • Marzo-Ortega H, Sieper J, Kivitz A, et al. Secukinumab and sustained improvement in signs and symptoms of patients with active ankylosing spondylitis through two years: results from a phase III study. Arthritis Care Res (Hoboken). 2017;69(7):1020–1029. doi:10.1002/acr.2323328235249
  • Braun J, Sieper J, Aelion J, et al. Secukinumab improves multiple parameters of disease activity in subjects with active ankylosing spondylitis through 52 weeks of subcutaneous therapy: data from the phase 3 MEASURE 2 study. Ann Rheum Dis. 2015;74(Suppl2):1147. doi:10.1136/annrheumdis-2015-eular.3031