Secukinumab for Long-Term Treatment of Psoriatic Arthritis: A Two-Year Followup From a Phase III, Randomized, Double-Blind Placebo-Controlled Study

Arthritis Care and Research

Volumn 69, Issue 3, 2017, Pages 347-355

  Kavanaugh, Arthur ^a   Mease, Philip J ^b   Reimold, Andreas M ^c   Tahir, Hasan ^d   Rech, Jürgen ^e   Hall, Stephen ^f   Geusens, Piet ^g   Wang, Zailong ^h   Pricop, Luminita ^h   Mpofu, Shephard ^h  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^d WHIPPS CROSS UNIVERSITY HOSPITAL   (United Kingdom)

^e UNIVERSITY HOSPITAL ERLANGEN   (Germany)

^f CABRINI INSTITUTE   (Australia)

^g MAASTRICHT UNIVERSITY MEDICAL CENTER   (Netherlands)

^h NOVARTIS PHARMA AG   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

METHOTREXATE; PLACEBO; SECUKINUMAB; IMMUNOLOGIC FACTOR; MONOCLONAL ANTIBODY;

ADENOMA; ADULT; AMERICAN COLLEGE OF RHEUMATOLOGY CRITERIA; ARTICLE; BACKACHE; BASAL CELL CARCINOMA; BONE METASTASIS; CEREBROVASCULAR ACCIDENT; CONTROLLED STUDY; CROHN DISEASE; DACTYLITIS; DIARRHEA; DISEASE ACTIVITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; ENTHESITIS; ESOPHAGUS CANDIDIASIS; FOLLOW UP; HEADACHE; HEALTH ASSESSMENT QUESTIONNAIRE DISABILITY INDEX; HEART INFARCTION; HUMAN; HYPERCHOLESTEROLEMIA; HYPERTENSION; IMMUNOGENICITY; INFECTION; INFESTATION; LOADING DRUG DOSE; LONG TERM CARE; MAJOR CLINICAL STUDY; NAUSEA; NEUTROPENIA; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL; PROSTATE CANCER; PSORIASIS AREA AND SEVERITY INDEX; PSORIATIC ARTHRITIS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SALIVARY GLAND ADENOMA; SHORT FORM 36; SKIN CANCER; SKIN CANDIDIASIS; THRUSH; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION; VAGINA CANDIDIASIS; ARTHRITIS, PSORIATIC; CLINICAL TRIAL; DRUG ADMINISTRATION; IMMUNOLOGY; MULTICENTER STUDY; PHASE 2 CLINICAL TRIAL; REMISSION; TIME FACTOR; TREATMENT OUTCOME;

ANTIBODIES, MONOCLONAL; ARTHRITIS, PSORIATIC; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; HUMANS; IMMUNOLOGIC FACTORS; REMISSION INDUCTION; TIME FACTORS; TREATMENT OUTCOME;

EID: 85013898012     PISSN: 2151464X     EISSN: 21514658     Source Type: Journal    
DOI: 10.1002/acr.23111     Document Type: Article

References (29)

1. Gottlieb A, Korman NJ, Gordon KB, Feldman SR, Lebwohl M, Koo JY, 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 biologics. J Am Acad Dermatol 2008;58:851–64.
2. Coates L, Tillett W, Chandler D, Helliwell PS, Korendowych E, Kyle S, et al. The 2012 BSR and BHPR guideline for the treatment of psoriatic arthritis with biologics. Rheumatology (Oxford) 2013;52:1754–7.
3. Gossec L, Smolen JS, Ramiro S, de Wit M, Cutolo M, Dougados M, et al. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis 2016;75:499–510.
4. Ritchlin CT, Kavanaugh A, Gladman DD, Mease PJ, Helliwell P, Boehncke WH, et al. Treatment recommendations for psoriatic arthritis. Ann Rheum Dis 2009;68:1387–94.
5. Mrowietz U, Leonardi CL, Girolomoni G, Toth D, Morita A, Balki SA, et al. Secukinumab retreatment-as-needed versus fixed-interval maintenance regimen for moderate to severe plaque psoriasis: a randomized, double-blind, non-inferiority trial (SCULPTURE). J Am Acad Dermatol 2015;73:27–36.
6. Langley RG, Elewski BE, Lebwohl M, Reich K, Griffiths CE, Papp K, et al. Secukinumab in plaque psoriasis: results of two phase 3 trials. N Engl J Med 2014;371:326–38.
7. Thaci D, Blauvelt A, Reich K, Tsai TF, Vanaclocha F, Kingo K, et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate to severe plaque psoriasis: CLEAR, a randomized controlled trial. J Am Acad Dermatol 2015;73:400–9.
8. Blauvelt A, Prinz JC, Gottlieb AB, Kinko K, Sofen H, Ruer-Mulard M, et al. Secukinumab administration by pre-filled syringe: efficacy, safety and useability results from a randomized controlled trial in psoriasis (FEATURE). Br J Dermatol 2015;172:484–93.
9. Gottlieb AB, Langley RG, Philipp S, Sigurgeirsson B, Blauvelt A, Martin R, et al. Secukinumab improves physical function in subjects with plaque psoriasis and psoriatic arthritis: results from two randomized, phase 3 trials. J Drugs Dermatol 2015;14:821–33.
10. Baeten D, Sieper J, Braun J, Baraliakos X, Dougados M, Emery P, et al. Secukinumab, an interleukin-17A inhibitor, in ankylosing spondylitis. N Engl J Med 2015;373:2534–48.
11. McInnes IB, Sieper J, Braun J, Emery P, van der Heijde D, Isaacs JD, et al. Efficacy and safety of secukinumab, a fully human anti-interleukin-ILA 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;73:349–56.
12. McInnes IB, Mease PJ, Kirkham B, Kavanaugh A, Ritchlin CT, Rahman P, et al. Secukinumab, a human anti-interleukin-ILA monoclonal antibody, in patients with psoriatic arthritis (FUTURE-2): a randomized, double-blind, placebo-controlled, phase 3 trial. Lancet 2015;386:1137–46.
13. Mease PJ, McInnes IB, Kirkham B, Kavanaugh A, Rahman P, van der Heijde D, et al. Secukinumab inhibition of interleukin-17A in patients with psoriatic arthritis. N Engl J Med 2015;373:1329–39.
14. Taylor W, Gladman D, Helliwell P, Marchesoni A, Mease O, Mielants H, for the CASPAR group. Classification criteria for psoriatic arthritis: development of new criteria from a large international study. Arthritis Rheum 2006;54:2665–73.
15. US Department of Health and Human Services. Common terminology criteria for adverse events (CTCAE). Ver. 4. 2010. URL: www.evs.nci.nih.gov.
16. Klein U, Liang E, Vogel B, Kolbinger F, Bruin G, Lloyd P. Immunogenicity of the novel anti-IL-17a antibody, secukinumab, with intravenous and subcutaneous dosing regimens in healthy subjects and patients. Ann Rheum Dis 2013;72 Suppl 3:630.
17. Coates LC, Kavanaugh A, Mease RL, Soriano ER, Acosta-Felquer ML, Armstrong AW, et al. Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA): treatment recommendations for psoriatic arthritis. 2015. Arthritis Rheumatol 2016;68:1060–71.
18. Ranganath VK, Khanna D, Paulus HE. ACR remission criteria and response [review]. Clin Exp Rheumatol 2006;24 Suppl 43:S14–21.
19. Lebwohl MG, Bachelez H, Barker J, Girolomoni G, Kavanaugh A, Langley RG, et al. Patient perspectives in the management of psoriasis: results from the population-based Multinational Assessment of Psoriasis and Psoriatic Arthritis Survey. J Am Acad Dermatol 2014;70:871–81.
20. Fagerli KM, Lie E, van der Heijde D, Heiberg MS, Kaistad S, Rødevand E, et al. Switching between TNF inhibitors in psoriatic arthritis: data from the NOR-DMARD study. Ann Rheum Dis 2013;72:1840–4.
21. 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;149:1180–5.
22. Behrens F, Koehm M, Arndt U, Wittig BM, Greger G, Thaci D, et al. Does concomitant methotrexate with adalimumab influence treatment outcomes in patients with psoriatic arthritis? Data from a large observational study. J Rheumatol 2016;43:632–9.
23. Fagerli KM, Lie E, van der Heijde D, Heiberg MS, Lexberg AS, Rødevand E, et al. The role of methotrexate co-medication in TNF-inhibitor treatment in patients with psoriatic arthritis: results from 440 patients included in the NOR-DMARD study. Ann Rheum Dis 2014;73:132–7.
24. Mease PJ. A short history of biological therapy for psoriatic arthritis. Clin Exp Rheumatol 2015;33 Suppl 93:S104–8.
25. Mease PJ, Armstrong AW. Managing patients with psoriatic arthritis: the diagnosis and pharmacologic treatment of psoriatic arthritis in patients with psoriasis. Drugs 2014;74:423–41.
26. Saad AA, Ashcroft DM, Watson KD, Hyrich KL, Noyce PR, Symmons DP, et al. Persistence with anti-tumour necrosis factor therapies in patients with psoriatic arthritis: observational study from the British Society of Rheumatology Biologics Register. Arthritis Res Ther 2009;11:R52.
27. Mease PJ. Biologic therapy for psoriatic arthritis. Rheum Dis Clin North Am 2015;41:723–38.
28. Rich P, Sigurgeirsson B, Thaci D, Ortonne JP, Paul C, Schopf RE, et al. Secukinumab induction and maintenance therapy in moderate-to-severe plaque psoriasis: a randomized, double-blind, placebo-controlled, phase II regimen-finding study. Br J Dermatol 2013;168:402–11.
29. Van der Heijde D, Landewe RB, Mease PJ, McInnes IB, Conaghan PG, Pricop L, et al. Secukinumab provides significant and sustained inhibition of joint structural damage in a phase III study of active psoriatic arthritis. Arthritis Rheumatol 2016;68:1914–21.