Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: Results from the CLEAR study

Journal of the American Academy of Dermatology

Volumn 76, Issue 1, 2017, Pages 60-69.e9

  Blauvelt, Andrew ^a   Reich, Kristian ^b   Tsai, Tsen Fang ^c   Tyring, Stephen ^d   Vanaclocha, Francisco ^e   Kingo, Külli ^f   Ziv, Michael ^g   Pinter, Andreas ^h   Vender, Ronald ⁱ   Hugot, Sophie ^j   You, Ruquan ^k   Milutinovic, Marina ^j   Thaçi, Diamant ^l  

^a OREGON MEDICAL RESEARCH CENTER   (United States)

^b SCIderm Clinical Research and Dermatologikum   (Germany)

^c NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

^d UNIVERSITY OF TEXAS   (United States)

^e HOSPITAL UNIVERSITARIO 12 DE OCTUBRE   (Spain)

^f TARTU UNIVERSITY HOSPITAL   (Estonia)

^g HAEMEK MEDICAL CENTER   (Israel)

^h GOETHE UNIVERSITY   (Germany)

ⁱ MCMASTER UNIVERSITY   (Canada)

^j NOVARTIS PHARMA AG   (Switzerland)

^k Novartis Beijing Novartis Pharma Co Ltd   (China)

^l UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

more..

Author keywords

clinical trial; efficacy; psoriasis; Psoriasis Area and Severity Index (PASI); safety; secukinumab; ustekinumab

Indexed keywords

SECUKINUMAB; USTEKINUMAB; DERMATOLOGICAL AGENT; MONOCLONAL ANTIBODY;

ADULT; ARTHRALGIA; ARTICLE; BACKACHE; CEREBROVASCULAR ACCIDENT; DIARRHEA; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; HEADACHE; HEART INFARCTION; HUMAN; INFECTION; INFESTATION; MAJOR CLINICAL STUDY; MALE; PAIN; PHASE 3 CLINICAL TRIAL; PIGMENTED NEVUS; PRIORITY JOURNAL; PRURITUS; PSORIASIS AREA AND SEVERITY INDEX; PSORIASIS VULGARIS; QUALITY OF LIFE; QUESTIONNAIRE; RHINOPHARYNGITIS; TREATMENT DURATION; TREATMENT RESPONSE; UPPER RESPIRATORY TRACT INFECTION; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED STUDY; MIDDLE AGED; PSORIASIS; RANDOMIZED CONTROLLED TRIAL; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

ADULT; ANTIBODIES, MONOCLONAL; DERMATOLOGIC AGENTS; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; PSORIASIS; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; USTEKINUMAB;

EID: 84994735189     PISSN: 01909622     EISSN: 10976787     Source Type: Journal    
DOI: 10.1016/j.jaad.2016.08.008     Document Type: Article

References (28)

1. 1 Langley, R.G., Elewski, B.E., Lebwohl, M., et al., ERASURE Study Group; FIXTURE Study Group. Secukinumab in plaque psoriasis: results of two phase 3 trials. N Engl J Med 371 (2014), 326–338.
2. 2 Blauvelt, A., Prinz, J.C., Gottlieb, A.B., 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 172 (2015), 484–493.
3. 3 Paul, C., Lacour, J.P., Tedremets, L., et al., the JUNCTURE Study Group. Efficacy, safety, and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomized, controlled trial (JUNCTURE). J Eur Acad Dermatol Venereol 29 (2015), 1082–1090.
4. 4 Mease, P.J., McInnes, I.B., Kirkham, B., et al., FUTURE 1 Study Group. Secukinumab inhibition of interleukin-17A in patients with psoriatic arthritis. N Engl J Med 373 (2015), 1329–1339.
5. 5 McInnes, I.B., Mease, P.J., Kirkham, B., et al., FUTURE 2 Study Group. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 386 (2015), 1137–1146.
6. 6 Baeten, D., Sieper, J., Braun, J., et al., MEASURE 1 Study Group; MEASURE 2 Study Group. Secukinumab, an interleukin-17A inhibitor, in ankylosing spondylitis. N Engl J Med 373 (2015), 2534–2548.
7. 7 Cosentyx [US prescribing information], 2015, Novartis Pharmaceuticals Corporation, East Hanover, NJ.
8. 8 Cosentyx [EU prescribing information], 2016, Novartis Europharm Limited, Camberley, United Kingdom.
9. 9 Thaçi, D., Blauvelt, A., Reich, 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 73 (2015), 400–409.
10. 10 Stelara [US prescribing information], 2012, Janssen Biotech, Horsham; PA.
11. 11 Stelara [EU prescribing information], 2015, Janssen-Cilag International NV, Beerse; Belgium.
12. 12 European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP). Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003329.pdf. Accessed on May 1, 2016.
13. 13 Ryan, C., Korman, N.J., Gelfand, J.M., et al. Research gaps in psoriasis: opportunities for future studies. J Am Acad Dermatol 70 (2014), 146–167.
14. 14 Papoutsaki, M., Talamonti, M., Giunta, A., et al. The impact of methodological approaches for presenting long-term clinical data on estimates of efficacy in psoriasis illustrated by three-year treatment data on infliximab. Dermatology 221:Suppl 1 (2010), 43–47.
15. 15 Rubin, D.R., An overview of multiple imputation. Proceedings of the Section on Survey Research Methods of the Annual Meeting of the American Statistical Association, 1988, American Statistical Organization, New Orleans, LA, 79–84 Available at: https://www.amstat.org/Sections/Srms/Proceedings/papers/1988_016.pdf Accessed May 1, 2016.
16. 16 Langley, R.G., Feldman, S.R., 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 26 (2015), 23–31.
17. 17 Kagami, S., Rizzo, H.L., Kurtz, S.E., et al. IL-23 and IL-17A, but not IL-12 and IL-22, are required for optimal skin host defense against Candida albicans. J Immunol 185 (2010), 5453–5462.
18. 18 Puel, A., Cypowyj, S., Bustamante, J., et al. Chronic mucocutaneous candidiasis in humans with inborn errors of interleukin-17 immunity. Science 332 (2011), 65–68.
19. 19 Blauvelt, A., Lebwohl, M.G., Bissonnette, R., IL-23/IL-17A dysfunction phenotypes inform possible clinical effects from anti-IL-17A therapies. J Invest Dermatol 135 (2015), 1946–1953.
20. 20 van de Kerkhof, P.C.M., Griffiths, C.E.M., Reich, K., et al. Secukinumab long-term safety experience: a pooled analysis of ten phase 2 and 3 clinical studies in moderate-to-severe plaque psoriasis. J Am Acad Dermatol 75 (2016), 83–98.e4.
21. 21 Leonardi, C.L., Kimball, A.B., Papp, K.A., 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 371 (2008), 1665–1674.
22. 22 Papp, K.A., Langley, R.G., 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 371 (2008), 1675–1684.
23. Weisman, S., Pollack, C.R., Gottschalk, R.W., Psoriasis disease severity measures: comparing efficacy of treatments for severe psoriasis. J Dermatolog Treat 14 (2003), 158–165.
24. Langley, R.G., Feldman, S.R., 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 26 (2015), 23–31.
25. Bruce, B., Fries, J.F., The Stanford Health Assessment Questionnaire: dimensions and practical applications. Health Qual Life Outcomes, 1, 2003, 20.
26. Finlay, A.Y., Khan, G.K., Dermatology Life Quality Index (DLQI)—a simple practical measure for routine clinical use. Clin Exp Dermatol 19 (1994), 210–216.
27. EuroQol Group. EuroQol—a new facility for the measurement of health-related quality of life. Health Policy 16 (1990), 199–208.
28. Reilly, M.C., Zbrozek, A.S., Dukes, E.M., The validity and reproducibility of a work productivity and activity impairment instrument. PharmacoEconomics 4 (1993), 353–365.