Role of biologics: ustekinumab
receiving ustekinumab 45mg versus 60.3% in the 90mg group)(Figure 1).33 Of the patients with dactylitis at baseline, 60.8% in the 45mg ustekinumab group and 53.8% in the 90mg group showed a complete improvement at week 52. The corresponding percentages of patients with enthesitis at baseline who showed improvement at week 52 were 44.4% and 45.8%.33
For plaque psoriasis, ustekinumab is approved for administration as a 45mg injection followed by a 45mg dose four weeks later, and then every 12 weeks thereafter. For patients with a body weight >100kg, the initial dose is 90mg, followed by a 90mg dose four weeks later, and then every 12 weeks thereafter.12
these patients, 45mg was also shown to be efficacious. However, 90mg resulted in greater efficacy.21–23,35
arthritis, ustekinumab is approved as an initial dose of 45mg, followed by a 45mg dose four weeks later, and then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight >100kg.12
Ustekinumab is administered by SC injection. Its half-life is approximately three weeks (range: 15–32 days).32 l
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2. Benson JM et al. Therapeutic targeting of the IL-12/23 pathways: generation and characterization of ustekinumab. Nat Biotechnol 2011;29(7):615–24.
3. Benson JM et al. Discovery and mechanism of ustekinumab: a human monoclonal antibody targeting interleukin-12 and interleukin-23 for treatment of immune-mediated disorders. MAbs 2011;3(6):535–45.
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11. Stelara Full Prescribing Information. http://www. accessdata.fda.gov/spl/data/69e4e4b9-e2da-
4113-963d-623665a5102a/69e4e4b9-e2da-4113- 963d-623665a5102a.xml#section-1.2. Accessed January 2014.
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22. Leonardi CL et al. PHOENIX1 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;17:1665–74.
23. Papp KA et al. PHOENIX 2 study investigators. Efficacy and safety of ustekinumab, a human
interleukin-12/23 monoclonal antibody, inpatients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2). Lancet 2008;17:1675–84.
24. Papp KA et al. Long-term Safety of Ustekinumab in Patients With Moderate-to-Severe Psoriasis. Final Results From 5 Years of Follow-Up. Br J Dermatol 2013;168(4):844–54.
25. Kimball AB et al. Long-term efficacy of ustekinumab in patients with moderate-to-severe psoriasis treated for up to 5 years in the PHOENIX 1 study. J Eur Acad Dermatol Venereol 2013;27(12):1535–45.
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33. McInnes IB et al. PSUMMIT 1 Study Group. Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo- controlled PSUMMIT 1 trial. Lancet 2013;382(9894):780–9.
34. Ritchlin CT et al. Ustekinumab in active psoriatic arthritis including patients previously treated with anti-TNF agents: results of a phase 3, multicentre, double-blind, placebo-controlled study. Arthritis Rheum 2012;64(Suppl 10):S1080–1.
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