An Efficacy Study of Secukinumab in Plaque Psoriasis Patients With Subclinical Psoriatic Arthritis as Measured by Musculoskeletal Ultrasound

Summary

Given the role of IL-17 in the development of entheseal-driven pathology, a therapeutic strategy aimed at blocking IL-17 would be a logical option for the treatment of subclinical enthesitis in psoriasis patients. This study will be the first randomized trial of a biologic therapy versus placebo in participants with plaque psoriasis and subclinical psoriatic arthritis, using musculoskeletal ultrasound.

Timeline

Start

2020-11-02

Primary completion

2021-03-24

Completion

2021-03-24

Publications

• Background Acquitter M, Misery L, Saraux A, Bressollette L, Jousse-Joulin S. Detection of subclinical ultrasound enthesopathy and nail disease in patients at risk of psoriatic arthritis. Joint Bone Spine. 2017 Dec;84(6):703-707. doi: 10.1016/j.jbspin.2016.10.005. Epub 2016 Dec 5.
• Background Armstrong AW, Robertson AD, Wu J, Schupp C, Lebwohl MG. Undertreatment, treatment trends, and treatment dissatisfaction among patients with psoriasis and psoriatic arthritis in the United States: findings from the National Psoriasis Foundation surveys, 2003-2011. JAMA Dermatol. 2013 Oct;149(10):1180-5. doi: 10.1001/jamadermatol.2013.5264.
• Background Basra MK, Fenech R, Gatt RM, Salek MS, Finlay AY. The Dermatology Life Quality Index 1994-2007: a comprehensive review of validation data and clinical results. Br J Dermatol. 2008 Nov;159(5):997-1035. doi: 10.1111/j.1365-2133.2008.08832.x. Epub 2008 Sep 15.
• Background Cassell SE, Bieber JD, Rich P, Tutuncu ZN, Lee SJ, Kalunian KC, Wu CW, Kavanaugh A. The modified Nail Psoriasis Severity Index: validation of an instrument to assess psoriatic nail involvement in patients with psoriatic arthritis. J Rheumatol. 2007 Jan;34(1):123-9.
• Background Chen M, Kianifard F. A nonparametric procedure associated with a clinically meaningful efficacy measure. Biostatistics. 2000 Sep;1(3):293-8. doi: 10.1093/biostatistics/1.3.293.
• Background Doherty SD, Van Voorhees A, Lebwohl MG, Korman NJ, Young MS, Hsu S, National Psoriasis Foundation. National Psoriasis Foundation consensus statement on screening for latent tuberculosis infection in patients with psoriasis treated with systemic and biologic agents. J Am Acad Dermatol. 2008 Aug;59(2):209-17. doi: 10.1016/j.jaad.2008.03.023. Epub 2008 May 15.
• Background El Miedany Y, El Gaafary M, Youssef S, Ahmed I, Nasr A. Tailored approach to early psoriatic arthritis patients: clinical and ultrasonographic predictors for structural joint damage. Clin Rheumatol. 2015 Feb;34(2):307-13. doi: 10.1007/s10067-014-2630-2. Epub 2014 May 3.
• Background Elnady B, El Shaarawy NK, Dawoud NM, Elkhouly T, Desouky DE, ElShafey EN, El Husseiny MS, Rasker JJ. Subclinical synovitis and enthesitis in psoriasis patients and controls by ultrasonography in Saudi Arabia; incidence of psoriatic arthritis during two years. Clin Rheumatol. 2019 Jun;38(6):1627-1635. doi: 10.1007/s10067-019-04445-0. Epub 2019 Feb 12.
• Background Faustini F, Simon D, Oliveira I, Kleyer A, Haschka J, Englbrecht M, Cavalcante AR, Kraus S, Tabosa TP, Figueiredo C, Hueber AJ, Kocijan R, Cavallaro A, Schett G, Sticherling M, Rech J. Subclinical joint inflammation in patients with psoriasis without concomitant psoriatic arthritis: a cross-sectional and longitudinal analysis. Ann Rheum Dis. 2016 Dec;75(12):2068-2074. doi: 10.1136/annrheumdis-2015-208821. Epub 2016 Feb 25.
• Background Feldman SR, Zhao Y, Shi L, Tran MH. Economic and Comorbidity Burden Among Patients with Moderate-to-Severe Psoriasis. J Manag Care Spec Pharm. 2015 Oct;21(10):874-88. doi: 10.18553/jmcp.2015.21.10.874.
• Background Ficjan A, Husic R, Gretler J, Lackner A, Graninger WB, Gutierrez M, Duftner C, Hermann J, Dejaco C. Ultrasound composite scores for the assessment of inflammatory and structural pathologies in Psoriatic Arthritis (PsASon-Score). Arthritis Res Ther. 2014 Oct 31;16(5):476. doi: 10.1186/s13075-014-0476-2.
• Background Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. doi: 10.1111/j.1365-2230.1994.tb01167.x.
• Background Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. Dermatologica. 1978;157(4):238-44. doi: 10.1159/000250839.
• Background Gladman DD, Antoni C, Mease P, Clegg DO, Nash P. Psoriatic arthritis: epidemiology, clinical features, course, and outcome. Ann Rheum Dis. 2005 Mar;64 Suppl 2(Suppl 2):ii14-7. doi: 10.1136/ard.2004.032482.
• Background Gottlieb AB, Griffiths CE, Ho VC, Lahfa M, Mrowietz U, Murrell DF, Ortonne JP, Todd G, Cherill R, Marks I, Emady-Azar S, Paul CF; Multi-Centre Investigator Group. Oral pimecrolimus in the treatment of moderate to severe chronic plaque-type psoriasis: a double-blind, multicentre, randomized, dose-finding trial. Br J Dermatol. 2005 Jun;152(6):1219-27. doi: 10.1111/j.1365-2133.2005.06661.x.
• Background Gutierrez M, Filippucci E, De Angelis R, Salaffi F, Filosa G, Ruta S, Bertolazzi C, Grassi W. Subclinical entheseal involvement in patients with psoriasis: an ultrasound study. Semin Arthritis Rheum. 2011 Apr;40(5):407-12. doi: 10.1016/j.semarthrit.2010.05.009. Epub 2010 Aug 5.
• Background Kampylafka E, d'Oliveira I, Linz C, Lerchen V, Stemmler F, Simon D, Englbrecht M, Sticherling M, Rech J, Kleyer A, Schett G, Hueber AJ. Resolution of synovitis and arrest of catabolic and anabolic bone changes in patients with psoriatic arthritis by IL-17A blockade with secukinumab: results from the prospective PSARTROS study. Arthritis Res Ther. 2018 Jul 27;20(1):153. doi: 10.1186/s13075-018-1653-5.
• Background King MT, Fayers PM. Making quality-of-life results more meaningful for clinicians. Lancet. 2008 Mar 1;371(9614):709-10. doi: 10.1016/S0140-6736(08)60324-4. No abstract available.
• Background Manuel O, Kumar D. QuantiFERON-TB Gold assay for the diagnosis of latent tuberculosis infection. Expert Rev Mol Diagn. 2008 May;8(3):247-56. doi: 10.1586/14737159.8.3.247.
• Background Mathew AJ, Bird P, Gupta A, George R, Danda D. Magnetic resonance imaging (MRI) of feet demonstrates subclinical inflammatory joint disease in cutaneous psoriasis patients without clinical arthritis. Clin Rheumatol. 2018 Feb;37(2):383-388. doi: 10.1007/s10067-017-3895-z. Epub 2017 Dec 4.
• Background Naredo E, Moller I, de Miguel E, Batlle-Gualda E, Acebes C, Brito E, Mayordomo L, Moragues C, Uson J, de Agustin JJ, Martinez A, Rejon E, Rodriguez A, Dauden E; Ultrasound School of the Spanish Society of Rheumatology and Spanish ECO-APs Group. High prevalence of ultrasonographic synovitis and enthesopathy in patients with psoriasis without psoriatic arthritis: a prospective case-control study. Rheumatology (Oxford). 2011 Oct;50(10):1838-48. doi: 10.1093/rheumatology/ker078. Epub 2011 Jun 23.
• Background Savage L, Goodfield M, Horton L, Watad A, Hensor E, Emery P, Wakefield R, Wittmann M, McGonagle D. Regression of Peripheral Subclinical Enthesopathy in Therapy-Naive Patients Treated With Ustekinumab for Moderate-to-Severe Chronic Plaque Psoriasis: A Fifty-Two-Week, Prospective, Open-Label Feasibility Study. Arthritis Rheumatol. 2019 Apr;71(4):626-631. doi: 10.1002/art.40778. Epub 2019 Mar 4.
• Background Scher JU, Ogdie A, Merola JF, Ritchlin C. Preventing psoriatic arthritis: focusing on patients with psoriasis at increased risk of transition. Nat Rev Rheumatol. 2019 Mar;15(3):153-166. doi: 10.1038/s41584-019-0175-0.
• Background Tinazzi I, McGonagle D, Biasi D, Confente S, Caimmi C, Girolomoni G, Gisondi P. Preliminary evidence that subclinical enthesopathy may predict psoriatic arthritis in patients with psoriasis. J Rheumatol. 2011 Dec;38(12):2691-2. doi: 10.3899/jrheum.110505. No abstract available.
• Background Villani AP, Rouzaud M, Sevrain M, Barnetche T, Paul C, Richard MA, Beylot-Barry M, Misery L, Joly P, Le Maitre M, Aractingi S, Aubin F, Cantagrel A, Ortonne JP, Jullien D. Prevalence of undiagnosed psoriatic arthritis among psoriasis patients: Systematic review and meta-analysis. J Am Acad Dermatol. 2015 Aug;73(2):242-8. doi: 10.1016/j.jaad.2015.05.001. Epub 2015 Jun 6.
• Background Weisman S, Pollack CR, Gottschalk RW. Psoriasis disease severity measures: comparing efficacy of treatments for severe psoriasis. J Dermatolog Treat. 2003 Sep;14(3):158-65. doi: 10.1080/09546630310013360.
• Background Zabotti A, McGonagle DG, Giovannini I, Errichetti E, Zuliani F, Zanetti A, Tinazzi I, De Lucia O, Batticciotto A, Idolazzi L, Sakellariou G, Zandonella Callegher S, Sacco S, Quartuccio L, Iagnocco A, De Vita S. Transition phase towards psoriatic arthritis: clinical and ultrasonographic characterisation of psoriatic arthralgia. RMD Open. 2019 Oct 23;5(2):e001067. doi: 10.1136/rmdopen-2019-001067. eCollection 2019.
• Results Acquacalda E, Albert C, Montaudie H, Fontas E, Danre A, Roux CH, Breuil V, Lacour JP, Passeron T, Ziegler LE. Ultrasound study of entheses in psoriasis patients with or without musculoskeletal symptoms: A prospective study. Joint Bone Spine. 2015 Jul;82(4):267-71. doi: 10.1016/j.jbspin.2015.01.016. Epub 2015 Apr 13.

Drugs

Indications