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    Systemic medications for psoriasis therapy must be prescribed with caution

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    Wailea, Hawaii — New and emerging systemic medications (such as the biologics) can be very useful in the treatment of patients suffering from moderate to severe psoriasis, particularly in those patients recalcitrant to other tried therapies. These potent medications can be associated with severe adverse events (AEs), however, and it is up to the clinician to carefully weigh the pros and cons of each medication before making decisions on therapy.

    "Considering the potential AEs when choosing systemic therapy is important. However, we must remember that many of these medications are new, and not all have the same track record as some of the more established drugs, which also have been used in other specialties outside of dermatology," says Craig Leonardi, M.D., clinical professor of dermatology, St. Louis University, St. Louis.

    Dr. Leonardi recently addressed the evolving issues with the IL12/23 p40 antibodies, namely ustekinumab (Stelara, Centocor Ortho Biotech) and briakinumab (Abbott) at MauiDerm 2011. (See also "from the podium," page 18, May 2011 Dermatology Times).

    FDA withdrawal

    Available on the market since 2009, ustekinumab has been shown to be effective for the treatment of moderate-to-severe psoriasis. Briakinumab is an experimental medication in the pipeline that has been undergoing studies for more than two-and-a-half years and works very similar to ustekinumab. Abbott withdrew its Food and Drug Administration (FDA) application for briakinumab in mid-January 2011, however.

    According to Dr. Leonardi, briakinumab was withdrawn because the experimental drug had significant safety issues involving three types of events, the most serious of which was MACE (major cardiovascular events). In the context of a study, MACE events are heart attacks or strokes.

    Within the first 12 weeks of treatment in the latest trial with briakinumab, there were five MACE events in the study arm (n=981) and none in the placebo arm (n=484) of the trial. Additionally, six patients who were blinded to briakinumab developed squamous cell carcinoma (four cutaneous and two extracutaneous), compared to none in the placebo group.

    The third event seen in the trial was the development of serious infection in five study patients that required hospitalization and/or IV antibiotics. Dr. Leonardi says to the best of his knowledge, none of these patients died as a result of infection. One patient developed serious infection, cytomegalovirus, in the placebo-controlled arm of the study.

    The fact that the cancers that had developed were all squamous cell carcinoma is significant, Dr. Leonardi says, because in general, basal cell carcinomas are much more common in the general population — except in the presence of immunosuppression.

    "This is very concerning, because we would usually expect more severe AEs such as cancer and MACE events to show up months or years after a treatment, and yet, these appeared after only 12 weeks into treatment," Dr. Leonardi says. "Blinded placebo-controlled trials are of great value and must be respected, and therefore, these results are considerably unsettling."

    Though it may be disconcerting that a new experimental drug did not make the grade and achieve FDA approval, the main problem for physicians and their patients is that briakinumab has the exact same mechanism of action as the already approved ustekinumab drug. This may be a cause of worry for physicians who prescribe this biologic to their patients with psoriasis.

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