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    Pearls to optimize safety, success with biologics

    Safety issues top priority for therapeutic selection and follow-up

    In the experience of Jeffrey Sobell, M.D., treatment of moderate-to-severe plaque psoriasis with biologics has been extremely rewarding and has produced some of the happiest and most satisfied patients he sees. Optimizing safety and success, however, requires knowledge of the warnings and precautions pertaining to each agent, careful patient follow-up, and ongoing counseling.

    Speaking at the Fall Clinical Dermatology Conference, Dr. Sobell discussed how he tailors his selection of a biologic agent to the individual’s medical history along with his approaches for treatment initiation and follow-up.

    Dr. Sobell“There are now six biologics with an FDA-approved indication for treatment of moderate-to-severe psoriasis representing three different mechanistic categories. Maximizing safety is paramount for all treatment decisions, and while the available biologics share many attributes, there are some important differences in their safety profiles,” says Dr. Sobell, assistant professor of dermatology, Tufts University School of Medicine, Boston.

    The biologics approved for the treatment of moderate-to-severe psoriasis include three tumor necrosis factor-α (TNF-α) antagonists — etanercept (Enbrel, Amgen), infliximab (Remicade, Janssen Biotech), and adalimumab (Humira, AbbVie); one interleukin (IL)-12/23 antagonist —ustekinumab (Stelara, Janssen Biotech), and two IL-17A antagonists — ixekizumab (Taltz, Eli Lilly) and secukinumab (Cosentyx, Novartis).

    Considerations for biologic use

    Dr. Sobell says that no biologic should be used in a patient with an active serious infection. In addition, screening for tuberculosis (TB) and viral hepatitis is mandatory.

    “TNF-α antagonists should be used with caution in anyone with a history of hepatitis B infection because the virus can be reactivated, but these biologics are probably the systemic treatment of choice in anyone with concomitant hepatitis C infection,” he explains.

    Dr. Sobell also considers the use of any biologic very carefully in patients with a history of malignancy, although a warning about increased risk of malignancy appears only in the labeling for the TNF-α antagonists and the IL-12/23 inhibitor.

    “We know that the TNF-α antagonists are associated with an increased risk of squamous cell carcinoma of the skin, but there is not solid evidence to guide treatment decisions for patients with a history of any malignancy. My decision in patients with a history of a solid tumor is individualized based on a discussion with the patient and the oncologist,” Dr. Sobell says.

    In addition, based on warnings and precautions in the product information, he does not use TNF-α antagonists in anyone with a demyelinating disease (eg., multiple sclerosis), moderate-to-severe congestive heart failure, or chronic carriers of hepatitis B. And, Dr. Sobell says he tends to avoid etanercept in patients who are obese because of evidence that individuals weighing more than 200 pounds are less likely to achieve a good response.

    NEXT: Considerations with common comorbidites



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