New Injectable Drug Treats Moderate-To-Severe Plaque Psoriasis

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The Food and Drug Administration (FDA) has approved brodalumab (Siliq) for the treatment of moderate-to-severe plaque psoriasis, an autoimmune disease that causes patches of red and flaky skin.
Brodalumab is a human monoclonal antibody and an interleukin-17 receptor A antagonist. Blocking interleukin-17’s action inhibits the release of proinflammatory cytokines and chemokines, thus decreasing the immune response. Brodalumab is designed for patients who are candidates for systemic therapy or phototherapy but who have not responded or have stopped responding to other systemic treatments for plaque psoriasis. It is administered subcutaneously at weeks 0, 1, and 2, and then every two weeks thereafter. If an adequate response to drug therapy is not noted within 16 weeks of treatment, it is unlikely that brodalumab will be effective.
Brodalumab's safety and efficacy was established in three randomized, placebo-controlled clinical trials of 4,373 adults with moderate-to-severe plaque psoriasis. All three trials assessed the change from baseline to week 12 of use. More patients treated with brodalumab than placebo had skin that was clear or almost clear of psoriatic changes by the 12th week of treatment.
Unfortunately, suicidal ideation and behavior, including completed suicides, occurred during clinical trials of brodalumab. This risk appears to be greater if the patient has a history of suicidality or depression. For this reason, the drug's labeling carries a black box warning and the drug is only available via the FDA's Risk Evaluation and Mitigation Strategy program. This program requires the following: prescribers must be program certified and receive training concerning the risks of brodalumab therapy and must counsel patients about these risks; patients must sign an agreement stipulating that they recognize that mood changes are possible and that they must seek medical attention if these occur; and pharmacies must be program certified and dispense brodalumab only to patients who are authorized to receive it.
The most common adverse effects of brodalumab include arthralgia, myalgia, oropharyngeal pain, headache, fatigue, diarrhea, nausea, injection site reactions, neutropenia, influenza, and fungal infections. Brodalumab's label warns that it may cause serious infections, reactivate latent tuberculosis, and initiate or exacerbate Crohn's disease.
Brodalumab can alter the formation of cytochrome P-450 (CYP) enzymes, affecting the amount available for drug metabolism. Prior to initiation or discontinuation of brodalumab, nurses should assess patients for their use of drugs that are substrates of CYP isoenzymes (meaning they are metabolized via the same pathway). Drugs of special concern are those with a narrow therapeutic index, whose elevated circulating levels can produce serious and potentially lethal effects. If the patient taking brodalumab is also taking a CYP substrate, the nurse should notify the prescriber to monitor the therapeutic and adverse effects of the coadministered drugs. Dose adjustments of these drugs should be considered.
Nurses should carefully assess patients receiving brodalumab for new or worsening suicidal thoughts and behaviors, depression, anxiety, or other mood changes and teach them to contact their health care provider if any of these occur. NPs should refer patients with mood and behavioral changes to a mental health professional. Nurses should teach patients about all potential adverse effects. Because of immune suppression and the increased risk of infections, patients should not receive live virus vaccines while on brodalumab therapy. Nurses should teach patients to properly administer the prefilled single-use syringe of medication subcutaneously, following the instructions dispensed with each prescription.
For complete prescribing information, go to http://bit.ly/2os7Shz.

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