Recommendations for incorporating biologicals into management of moderate to severe plaque psoriasis: individualized patient approaches

Abstract

Psoriasis is a T-cell mediated skin disease that affects approximately 2% of the population worldwide. Despite the prevalence of the disease and long-standing efforts to develop strategies to treat it, there is a need for safe and effective therapies to treat psoriasis, particularly the more severe forms. Biological agents such as alefacept, efalizumab, etanercept, and infliximab have been recognized as a class of treatment distinct from other forms of therapy in the treatment algorithm of psoriasis. Recent national and international consensus meetings have developed statements that position biological agents as an important addition to the treatment armamentarium for moderate to severe psoriasis, along with phototherapy and traditional systemic agents. There has been consensus that treatment should be individualized to each patient's needs and circumstances. Biological agents offer the hope of safe, effective, long-term management of moderate to severe psoriasis. As new agents receive approval from Health Canada, the available range of therapeutic options for treating this chronic disease will broaden. A Canadian Psoriasis Expert Panel recently convened in February 2005 to analyze, based on a series of clinical case scenarios, the indications, contraindications, and considerations for and against each of the four biological agents, derived from product labelling, where available, and from the efficacy and safety data from phase 3 and earlier clinical trials, as well as post-marketing reports. The Panel has formulated a set of recommendations for incorporating these biological agents into the current treatment paradigm of moderate to severe plaque psoriasis and has identified the preferred biological agents for each patient based on individual needs and circumstances.

Efalizumab, a reversible T-cell modulator for psoriasis

“…15 Deduced trough values by the end of the Sun et al 23 study ranged from 6 to 12 lg/ml. 4 Another recent study of efalizumab pharmacokinetics and pharmacodynamics reached similar conclusions. 16 In an open-label, monotherapeutic study involving 70 adults with moderate to severe plaque psoriasis, Mortensen and colleagues monitored efalizumab levels, leukocyte counts, and LFA-1 expression, as well as severity of psoriasis over the course of 12 weeks of treatment and 12 weeks of posttreatment washout.…”

“…The humanized IgG 1 MAb efalizumab is one of several such agents. 4 Efalizumab is directed against the CD11a subunit of LFA-1, a lymphocyte surface protein that binds intracellular adhesion molecule-1 (ICAM-1) and other ICAMs. T cells and other leukocytes use their surface LFA-1 to bind stably to ICAM-bearing cell types, including APCs, endothelial cells, and keratinocytes.…”

Efficacy and safety of adalimumab in patients with plaque psoriasis who have shown an unsatisfactory response to etanercept

“…In addition to topical therapy, phototherapy, and the oral systemic agents, there are, at the time of this writing, 5 biologics approved in various countries for the treatment of psoriasis with at least one more pending approval. 7,8 Choosing the best treatment for moderate to severe psoriasis becomes more complex both for patients and clinicians. Biologics targeting TNF-alfa are among the most frequently prescribed systemic treatments for psoriasis in the United States and Canada.…”

Strategies for optimizing treatment with efalizumab in moderate to severe psoriasis

“…As with phototherapy and traditional systemic agents, biologicals may be used as a first-line therapy in the treatment of moderate to severe psoriasis. 10,11 The patientÕs severity of disease and suitability profile for a biological must be assessed to ensure that the patient meets all the criteria for therapy and that there are no contraindications. Efalizumab is appropriate to use in adult patients who:…”