Long-term efficacy of ustekinumab in patients with moderate-to-severe psoriasis treated for up to 5 years in the PHOENIX 1 study

Journal of the European Academy of Dermatology and Venereology

Volumn 27, Issue 12, 2013, Pages 1535-1545

  Kimball, A B ^a   Papp, K A ^b   Wasfi, Y ^c   Chan, D ^c   Bissonnette, R ^d   Sofen, H ^e   Yeilding, N ^c   Li, S ^c   Szapary, P ^c   Gordon, K B ^f  

^a MASSACHUSETTS GENERAL HOSPITAL   (United States)

^b PROBITY MEDICAL RESEARCH   (Canada)

^c JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^d INNOVADERM RESEARCH   (Canada)

^e Dermatology Research Associates   (United States)

^f NORTHWESTERN UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; USTEKINUMAB;

ADULT; ANAPHYLAXIS; ARTICLE; BASAL CELL CARCINOMA; CLINICAL EVALUATION; CONTROLLED STUDY; CROSSOVER PROCEDURE; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; HUMAN; INFECTION; INJECTION SITE REACTION; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NON MELANOMA SKIN CANCER; OPPORTUNISTIC INFECTION; OUTCOME ASSESSMENT; PNEUMONIA; PRIORITY JOURNAL; PSORIASIS; PSORIASIS AREA AND SEVERITY INDEX; RANDOMIZED CONTROLLED TRIAL; SERUM SICKNESS; SLEEP DISORDERED BREATHING; SQUAMOUS CELL CARCINOMA; TREATMENT DURATION; TREATMENT RESPONSE; TUBERCULOSIS;

ADULT; ANTIBODIES, MONOCLONAL, HUMANIZED; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; PLACEBOS; PSORIASIS; TREATMENT OUTCOME;

EID: 84888205088     PISSN: 09269959     EISSN: 14683083     Source Type: Journal    
DOI: 10.1111/jdv.12046     Document Type: Article

References (17)

1. Gordon K, Papp K, Poulin Y, Gu Y, Rozzo S, Sasso EH, for the Canadian Psoriasis Guidelines Committee. Long-term efficacy and safety of adalimumab in patients with moderate to severe psoriasis treated continuously over 3 years: results from an open-label extension study for patients from REVEAL. J Am Acad Dermatol 2012; 16: 241-251.
2. Kimball AB, Gordon KB, Fakharzadeh S, et al. Long-term efficacy of ustekinumab in patients with moderate-to-severe psoriasis: results from the PHOENIX 1 trial through up to 3 years. Br J Dermatol 2012; 166: 861-872.
3. Leonardi C, Kimball AB, Papp KA, et al., for the PHOENIX 1 study investigators. 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 2008; 371: 1665-1674.
4. Fredriksson T, Pettersson U,. Severe psoriasis-oral therapy with a new retinoid. Dermatologica 1978; 157: 238-244.
5. Finlay AY, Khan GK,. Dermatology Life Quality Index (DLQI)-a simple practical measure for routine clinical use. Clin Exp Dermatol 1994; 19: 210-216.
6. Geng D, Shankar G, Schantz A, Rajadhyakshe M, Davis H, Wagner C,. Validation of immunoassays used to assess immunogenicity to therapeutic monoclonal antibodies. J Pharm Biomed Anal 2005; 39: 364-375.
7. C5 Research. C5 Research, Cleveland Clinic Coordinating Center for Clinical Research. [WWW document] URL http://c5research.clevelandclinic.org/ home.aspx (last accessed: 25 July 2012).
8. Papp K, Crowley J, Ortonne J-P, et al. Adalimumab for moderate to severe chronic plaque psoriasis: efficacy and safety of retreatment and disease recurrence following withdrawal from therapy. Br J Dermatol 2011; 164: 434-441.
9. Reich K, Nestle FO, Papp K, et al., for the EXPRESS study investigators. (period) Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial. Lancet 2005; 366: 1367-1374.
10. Tyring S, Gottlieb A, Papp K, et al. Etanercept and clinical outcomes, fatigue, and depression in psoriasis: double-blind placebo-controlled randomised phase III trial. Lancet 2006; 367: 29-35.
11. Reich K, Burden AD, Eaton JN, Hawkins NS,. Efficacy of biologics in the treatment of moderate to severe psoriasis: a network meta-analysis of randomized controlled trials. Br J Dermatol 2012; 166: 179-188.
12. Lucka TC, Pathirana D, Sammain A, et al. Efficacy of systemic therapies for moderate-to-severe psoriasis: a systemic review and meta-analysis of long-term treatment. J Eur Acad Dermatol Venereol 2012; 26: 1331- 1334.
13. Patel RV, Shelling ML, Prodanovich S, Federman DG, Kirsner RS,. Psoriasis and vascular disease-risk factors and outcomes: a systemic review of the literature. J Gen Intern Med 2011; 26: 1036-1049.
14. Reich K, Langley RG, Lebwohl M, et al. Cardiovascular safety of ustekinumab in patients with moderate to severe psoriasis: results of integrated analyses of data from phase II and III clinical studies. Br J Dermatol 2011; 164: 862-872.
15. Ryan C, Leonardi CL, Krueger JG, et al. Association between biologic therapies for chronic plaque psoriasis and cardiovascular events: a meta-analysis of randomize d controlled trials. JAMA 2011; 306: 864-871.
16. Tzellos T, Kyrgidis A, Zouboulis CC,. Re-evaluation of the risk for major adverse cardiovascular events in patients treated with anti-IL-12/23 biological agents for chronic plaque psoriasis: a meta-analysis of randomized controlled trials. J Eur Acad Dermatol Venereol 2012; doi: 10.1111/j.1468-3083.2012.04500. x. [Epub ahead of print].
17. Papp KA, Strober B, Augustin M, Calabro S, Londhe A, Chevrier M,. on behalf of the PSOLAR investigators and Steering Committee. PSOLAR: design, utility, and preliminary results of a prospective, international, disease-based registry of patients with psoriasis who are receiving, or are candidates for, conventional systemic treatments or biologic agents. J Drugs Dermatol 2012; 11: 1210-1217.