2012, Number 2
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Med Cutan Iber Lat Am 2012; 40 (2)
Ustekinumab within the hospital terapeutic
González-Guerra E
Language: Spanish
References: 29
Page: 49-57
PDF size: 93.23 Kb.
ABSTRACT
The incorporation of drugs to clinical practice has numerous economic, clinical and administration consequences. Thus, before starting any treatment it is necessary a preliminary evaluation of the drug according to evidence-based medicine criteria. The present article discusses the main characteristics of ustekinumab, a biologic drug prescribed for the treatment of moderate to severe plaque psoriasis. Although there is no justification for this strategy a number of hospitals use this agent as second-line treatment in anti-TNF monoclonal antibody unresponsive patients. The responsibility to include ustekinumab in the hospital pharmacy belongs to the Pharmacy and Therapeutics Committee. However, the person who knows best the drug is the referring clinician and in turn he is the responsible of making the relevant data available to the committee.
Ustekinumab is a monoclonal antibody that specifically targets the cytokines interleukin 12 (IL-12) and interleukin 23 (IL-23). The main advantages of ustekinumab are its rapid onset of action and short-term clinical effectiveness. The effect of ustekinumab can be found three years after the end of treatment and the rates of adverse effects of ustekinumab are similar to placebo. Compared to other prescribed medications to treat psoriasis, as anti-TNF, it is not contraindicated in patients with moderate or severe congestive heart failure (NYHA III/IV) neither in demyelinating diseases. The main advantage of ustekinumab is its easy administration and dosage in comparison with other treatments. For all this reasons, ustekinumab is a useful therapeutic agent for the treatment of patients with chronic plaque psoriasis. Due to ethical and equity reasons, all biologic agents that have been approved for the treatment of psoriasis must be available for all patients who are candidates for the treatment, without limitations that may involve inequality for the patient. This is the primary objective of this paper.
REFERENCES
Nickoloff BJ, Stevens SR. What have we learned in dermatology from the biologic therapies? J Am Acad Dermatol 2006; 54: S143-51.
Sterry W, Barker J, Boehncke WH, Bos JD, Chimenti S, Christophers E et al. Biological therapies in the systemic management of psoriasis. Br J Dermatol 2004; 151: 3-17.
Cargill M, Schrodi SJ, Chang M, Garcia VE, Brandon R, Callis KP et al. A large-scale genetic association study confirms IL12B and leads to the identification of IL23R as psoriasis-risk genes. Am J Hum Genet 2007; 80: 273-90.
Capon F, Di Meglio P, Szaub J, Prescott NJ, Dunster C, Baumber L,et al. Sequence variants in the genes for the interleukin-23 receptor (IL23R) and its ligand (IL12B) confer protection against psoriasis. Hum Genet 2007; 122: 201-06.
Hong K, Chu A, Ludviksson BR, Berg EL, Ehrhardt RO. IL-12, independently of IFN-γ, plays a crucial role in the pathogenesis of a murine psoriasis-like skin disorder. J Immunol 1999; 162: 7480-91.
Puig L, Dauden E, Carrascosa JM. Comentarios a las directrices europeas y británicas sobre el tratamiento de la psoriasis. Actas Dermosifiliogr 2010; 101: 285-90.
Gordon K, Leonardi C, Griffiths C,Szapary P, Yeilding N, Hsu M et al. Ustekinumab safety update: cumulative experience from longer term follow up of patients treated in the ustekinumab psoriasis clinical development program. Poster presentado en Psoriasis 2010: Congress of The Psoriasis International Network, 1-4 julio 2010. Paris. P 047.
Hawkins N, Huntley A, Eaton J. Metaanalysis weight-based of biologic therapies of biologic therapies for the treatment of moderate to severe psoriasis. CPES. Sao Paulo, 27-29 Abril 2010.
Clemmensen A, Spon M, Skov L, Zachariae C, Gniadecki R.Responses to ustekinumab in the anti-TNF agent-naïve vs. anti-TNF agentexposed patients with psoriasis vulgaris. J Eur Acad Dermatol Venereol 2010 Nov 25. doi:10.1111/j.1468-3083.2010.03914.x. [Epub ahead of print].
Papp KA, Langley RG, Lebwohl M et al. Effi cacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, doubleblind, placebo-controlled trial (PHOENIX 2). Lancet 2008; 371: 1675-84.
Leonardi CL, Kimball AB, Papp KA, Yeilding N, Guzzo C, Wang Y, Li S, Dooley LT, Gordon KB; 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).
Sobell et al. Póster presentado en Psoriasis 2010. Congress of The Psoriasis International Network, 1-4 julio 2010. Paris. P045.
Kimball et al. Efficacy of ustekinumab is sustained through 3 years of treatment for patients with moderate-to-severe psoriasis maintained on q12 week dosing based on body weight. Poster 044. Psoriasis 2010, Congress of the International Psoriasis Network. Paris, 1-4 de Julio de 2010.
Reich K, Leonardi C, Griffiths CEM, Szapari PO, Wasi Y, Hsu MC, et al. Update on the cumulative safety experience of ustekinumab: Results from the ustekinumab psoriasis clinical development program with up to 4 years of follow-up. Póster FC07-03 presentado en el World Congress of Dermatology 2011, Seoul.
GordonK, Baker D,Yeilding N, Guenther L. Sustained Efficacy of ustekinumab for the treatment of moderate to severe psoriasis in initial responders continuing with manteinance therapy through year 3. Póster presentado en el congreso AAD2010 Congress, febrero de 2011, New Orleans (USA). P3345.
Griffiths CEM, Strober BE, Van de Kerkof P, Ho V, Fidelus-Gort R, Yeilding N et al. Comparison of ustekinumab and etanercept for moderate to severe psoriasis. N Engl J Med 2010; 36 (2): 118-28.
Fieschi C, Casanova JL. The role of interleukin- 12 in human infectious diseases: only a faint signature. Eur J Immunol 2003; 33: 1461-64.
De Jong R, Altare F, Haagen IA et al. Severe mycobacterial and salmonella infections in interleukin-12 receptor-deficient patients. Science 1998; 280: 1435-8.
Kimball AB, Bissonnette R, Leonardi C, Menter A, Szapary P, Wasfi Y et al. Tasas de infecciones en el programa de desarrollo clínico de ustekinumab en psoriasis: actualización con hasta 4 años de seguimiento. Póster P01151 presentado en el Congreso Europeo de Dermatología y Venereología 2011, Lisboa.
Leonardi C et al. Póster presentado en Psoriasis 2010. Congress ofTthe Psoriasis International Network, 1-4 julio 2010. Paris. P049.
Segal et al. Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsingremitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study. Lancet Neurol 2008; 7: 796-804.
Schon MP, Boehncke W-H. Psoriasis. New Engl J Med 2005; 354: 1899-912.
Wakkee M. Psoriasis may not be an independent risk factor for acute ischemic heart disease hospitalizations: results of a large population-based Dutch cohort. J Invest Dermatol 2010; 130: 962-7.
Gordon K, Szapary P, Langley RG, Reich K, Lebwohl M, Guzzo C et al. Efecto de ustekinumab en los acontecimientos cardiovasculares: Resultados de los ensayos agrupados de psoriasis de fase 2 y 3. Póster presentado en el congreso AAD2010 Congress, febrero de 2011, New Orleans (USA). P3305.
Reich K et al. Update on the cardiovascular safety of ustekinumab in pooled phase 2 & 3 psoriasis clinical trials with up to 4 years of follow-up. Póster P01153 presentado en el EADV 2011, Lisboa.
Krueger GG, Langley RG, Leonardi C, et al. A human interleukin-12/23 monoclonal antibody for the treatment of psoriasis. N Engl J Med 2007; 356: 580-92.
Stern RS, Nijsten T, Feldman SR, Margolis DJ, Rolstad T. Psoriasis is common, carries a substantial burden even when not extensive, and is associated with widespread treatment dissatisfaction. Invest Dermatol Symp Proc 2004; 9: 136-39.
Richards HL, Fortune DG, Griffi ths CE. Adherence to treatment in patients with psoriasis. J Eur Acad Dermatol Venereol 2006; 20: 370-79.
Schmitt-Rau K, Rosenbach T, Radtke MA, Augustin M. Cost-Effectiveness of Biological Therapy in Remission Induction of Moderate to Severe Plaque Psoriasis. Dermatology 2010. [Epub ahead of print].