Secukinumab improves physical function in subjects with plaque psoriasis and psoriatic arthritis: Results from two randomized, phase 3 trials

Journal of Drugs in Dermatology

Volumn 14, Issue 8, 2015, Pages 821-833

  Gottlieb, Alice B ^a   Langley, Richard G ^b   Philipp, Sandra ^c   Sigurgeirsson, Bardur ^d   Blauvelt, Andrew ^e   Martin, Ruvie ^f   Papavassilis, Charis ^f   Mpofu, Shephard ^f  

^a TUFTS MEDICAL CENTER   (United States)

^b DALHOUSIE UNIVERSITY   (Canada)

^c CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^d UNIVERSITY OF ICELAND   (Iceland)

^e OREGON MEDICAL RESEARCH CENTER   (United States)

^f NOVARTIS PHARMA AG   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

C REACTIVE PROTEIN; ETANERCEPT; SECUKINUMAB; DERMATOLOGICAL AGENT; INTERLEUKIN 17; MONOCLONAL ANTIBODY; NONSTEROID ANTIINFLAMMATORY AGENT;

ABSENCE OF SIDE EFFECTS; ADULT; ARTICLE; CONTROLLED STUDY; DISEASE SEVERITY; DRUG EFFICACY; FEMALE; FUNCTIONAL STATUS ASSESSMENT; HEALTH ASSESSMENT QUESTIONNAIRE; HEALTH ASSESSMENT QUESTIONNAIRE DISABILITY INDEX; HUMAN; MAJOR CLINICAL STUDY; MALE; PHASE 2 CLINICAL TRIAL; PROTEIN BLOOD LEVEL; PSORIASIS AREA AND SEVERITY INDEX; PSORIASIS VULGARIS; PSORIATIC ARTHRITIS; RANDOMIZED CONTROLLED TRIAL; TREATMENT RESPONSE; ANTAGONISTS AND INHIBITORS; ARTHRITIS, PSORIATIC; CLINICAL TRIAL; DAILY LIFE ACTIVITY; DOUBLE BLIND PROCEDURE; HEALTH STATUS; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; SEVERITY OF ILLNESS INDEX;

ACTIVITIES OF DAILY LIVING; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; ANTIBODIES, MONOCLONAL; ARTHRITIS, PSORIATIC; DERMATOLOGIC AGENTS; DOUBLE-BLIND METHOD; ETANERCEPT; HEALTH STATUS; HUMANS; INTERLEUKIN-17; SEVERITY OF ILLNESS INDEX;

EID: 84949759880     PISSN: 15459616     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (38)

1. Gottlieb A, Korman NJ, Gordon KB et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 2. Psoriatic arthritis: overview and guidelines of care for treatment with an emphasis on the biologies. J Am Acad Dermatol. 2008;58:851-864.
2. Catanoso M, Pipitone N, Salvarani C. Epidemiology of psoriatic arthritis. Reu- matismo. 2012;64:66-70.
3. Mease PJ, Gladman DD, Papp KA et al. Prevalence of rheumatologist-diag- nosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics. J Am Acad Dermatol. 2013;69:729-735.
4. Radtke MA, Reich K, Blome C et al. Prevalence and clinical features of psoriatic arthritis and joint complaints in 2009 patients with psoriasis: Results of a German national survey. J Eur Acad Dermatol Venereol. 2009:23:683- 691.
5. Christophers E, Barker JN, Griffiths CE et al. The risk of psoriatic arthritis remains constant following initial diagnosis of psoriasis among patients seen in European dermatology clinics. J Eur Acad Dermatol Venereol. 2010:24:548-554.
6. Wong K, Gladman DD, Husted J et al. Mortality studies in psoriatic arthritis: Results from a single outpatient clinic. I. Causes and risk of death. Arthritis Rheum. 1997;40:1868-1872.
7. All Y, Tom BD, Schentag CT et al. Improved survival in psoriatic arthritis with calendar time. Arthritis Rheum. 2007;56:2708-2714.
8. Velez NR, Wei-Passanese EX, Husni ME et al. Management of psoriasis and psoriatic arthritis in a combined dermatology and rheumatology clinic. Arch Dermatol Res. 2012;304:7-13.
9. Boehncke WH, Menter A. Burden of disease: psoriasis and psoriatic arthritis. Am J Clin Dermatol. 2013;14:377-388.
10. Frieta M, Siebert S, Mclnnes IB. The interleukin-17 pathway in psoriasis and psoriatic arthritis: disease pathogenesis and possibilities of treatment. Curr Rheumatol Rep. 2014:16:414.
11. Miossec P. IL-17 andTh17 cells in human inflammatory diseases. Microbes Infect. 2009;11:625-630.
12. Benham H, Norris R Goodall J et al. Th17 andTh22 cells in psoriatic arthritis and psoriasis. Arthritis Res Ther. 2013;15:R136.
13. Jandus C, Bioley G, Rivals JP et al. Increased numbers of circulating poly- functional Th17 memory cells in patients with seronegative spondylarthriti- des. Arthritis Rheum. 2008;58:2307-2317.
14. Kagami S, Rizzo HL, Lee JJ et al. Circulating Th17, Th22, andThl cells are increased in psoriasis. J Invest Dermatol. 2010;130:1373-1383.
15. Raychaudhuri SR Raychaudhuri SK, Genovese MC. IL-17 receptor and its functional significance in psoriatic arthritis. Mol Cell Biochem. 2012;359:419-429.
16. NoordenbosT, Yeremenko N, Gofita I et al. lnterleukin-17-positive mast cells contribute to synovial inflammation in spondylarthritis. Arthritis Rheum. 2012;64:99-109.
17. Lin AM, Rubin CJ, Khandpur R et al. Mast cells and neutrophils release IL-17 through extracellular trap formation in psoriasis. J Immunol. 2011;187:490- 500.
18. Lowes MA, Kikuchi T, Fuentes-Duculan J et al. Psoriasis vulgaris lesions contain discrete populations of Th1 and Th17 T cells. J Invest Dermatol. 2008:128:1207-1211.
19. van Baarsen LG, Lebre MC, van der Coelen D et al. Expression levels of IL-17A, IL-17F and their receptors in synovium of patients with rheumatoid arthritis, psoriatic arthritis and osteoarthritis: A target validation study. Ann Rheum Dis. 2011;70(Suppl 3):536.
20. Hwang SY, Kim JY Kim KW et al. IL-17 induces production of IL-6 and IL-8 in rheumatoid arthritis synovial fibroblasts via NRkappaB- And PI3-kinase/Akt- dependent pathways. Arthritis Res Ther. 2004;6:R120-R128.
21. Liang SC, Tan XY, Luxenberg DP et al. Interleukin (IL)-22 and IL-17 are coex- pressed byTh17 cells and cooperatively enhance expression of antimicrobial peptides. J Exp Med 2006;203:2271-2279.
22. Nograles KE, Zaba LC, Guttman-Yassky E et al. Th17 cytokines interleukin (IL)-17 and IL-22 modulate distinct inflammatory and keratinocyte-response pathways. Br J Dermatol. 2008;159:1092-1102.
23. Mclnnes IB. Sieper J, Braun J et al. Efficacy and safety of secukinumab, a fully human anti-interleukin-17A monoclonal antibody, in patients with moderate-to-severe psoriatic arthritis: A 24-week, randomised, double- blind, placebo-controlled, phase II proof-of-concept trial. Ann Rheum Dis. 2014;73:349-356.
24. Blauvelt A, Prinz JC, Gottlieb AB et al; The FEATURE Study Group. Secukinumab administration by pre-filled syringe: Efficacy, safety, and usability results from a randomized controlled trial in psoriasis (FEATURE). Br J Dermatol. 2014 Aug 16. [Epub ahead of print).
25. Langley RG, Elewski BE, Lebwohl M et al; for the ERASURE and FIXTURE Study Groups. Secukinumab in plaque psoriasis-results of two phase 3 trials. N Engl J Med. 2014;371:326-338.
26. Langley RGB, Feldman SR, Nyirady J et al.The 5-point Investigator's Global Assessment (IGA) Scale: A modified tool for evaluating plaque psoriasis severity in clinical trials. J Dermatolog Treat. 2015;26:23-31.
27. Fredriksson T, Pettersson U. Severe psoriasis - oral therapy with a new retinoid. Dermatologica. 1978;157:238-244.
28. Bruce B, Fries JF. The Health Assessment Questionnaire (HAQ). Clin Exp Rheumatol. 2005;23(5 Suppl 39):S14-S18.
29. Fries JR, Spitz R Kraines RG et al. Measurement of patient outcome in arthritis. Arthritis Rheum. 1980;23:137-145.
30. Mease PJ, Woolley JM, Bitman B et al. Minimally important difference of Health Assessment Questionnaire in psoriatic arthritis: Relating thresholds of improvement in functional ability to patient-rated importance and satisfaction. J Rheumatol. 2011;38:2461-2465.
31. Tezel N, YilmazTasdelen O, Bodur H et al. Is the health-related quality of life and functional status of patients with psoriatic arthritis worse than that of patients with psoriasis alone? Int J Rheum Dis. 2015;18:63-69.
32. Lebwohl M, Swensen AR, Nyirady J et al. The Psoriasis Symptom Diary: development and content validity of a novel patient-reported outcome instrument. Int J Dermatol. 2014;53:714-722.
33. LeungYY, Tam LS, Kun EW, Li EK. Impact of illness and variables associated with functional impairment in Chinese patients with psoriatic arthritis. Clin Exp Rheumatol. 2008;26:820-826.
34. Antoni CE, Kavanaugh A, Kirkham B et al. Sustained benefits of infliximab therapy for dermatologic and articular manifestations of psoriatic arthritis: Results from the infliximab multinational psoriatic arthritis controlled trial (IMPACT). Arthritis Rheum. 2005;52:1227-1236.
35. Mease PJ, Gladman DD, Ritchlin CT et al. Adalimumab Effectiveness in Psoriatic Arthritis Trial Study Group. Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: Results of a double- blind, randomized, placebo-controlled trial. Arthritis Rheum. 2005:52:3279- 3289.
36. Mease PJ, Fleischmann R, Deodhar AA et al. Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a Phase 3 double-blind randomised placebo-controlled study (RAPID-PsA). Ann Rheum Dis. 2014;73:48-55.
37. Kavanaugh A, Mclnnes I, Mease P et al. Golimumab, a new human tumor necrosis factor alpha antibody, administered every four weeks as a sub cutaneous injection in psoriatic arthritis: Twenty-four-week efficacy and safety results of a randomized, placebo-controlled study. Arthritis Rheum. 2009;60:976-986.
38. Enbrel® (etanercept). Prescribing Information. Thousand Oaks, CA; Amgen; November 2013.