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    Biologic holiday a question of risk management

    Administering methotrexate reduces potential for loss of response with reduced biologic use

    Clinicians need to consider that taking patients off a biologic agent may decrease the possibility of response when the patient is put back on biologic therapy, one expert says. Patients can develop antibodies while they are off the drug that can nullify the impact of the biologic therapy down the road, according to Kim A. Papp, M.D., Ph.D., F.R.C.P.C., president of Probity Medical Research Inc., in Waterloo, Ontario, Canada.

    “Why is it an issue to go off the drugs (biologics)?” Dr. Papp asks. “It is (because of) the formation of antibodies. Not everyone forms antibodies in sufficient volume to abrogate the effect of the drug, but it’s a real effect,” he explained to colleagues during a presentation Dermatology Update 2015. A dermatologist and leader in clinical trial research in Canada, Dr. Papp discussed the risks of taking patients off biologic therapy.

    For the time being, sufficiently sensitive assays do not exist to detect the extent of antibody formation in a patient who has discontinued biologic therapy, according to Dr. Papp.

    READ: Biologic use beyond psoriasis

    Because biologic agents are very large molecules, their immunogenicity is pretty wide, Dr. Papp notes. “The worst thing you can do is to give intermittent dosing because when the level (of drug) decreases, that is when the compound is more immunogenic,” Dr. Papp says.

    When serum levels of a drug in the body are decreased, it increases the likelihood that the body recognizes the biologic agent as foreign, Dr. Papp explains.

    “Serum levels drop, efficacy drops, and antibodies go up,” he says. “Sometimes the (level of) antibodies stay up, meaning the next time you put someone on the drug, they won’t respond.”

    The route of administration of biologic agents is typically subcutaneous, which contributes to the immunogenicity of the therapies. “That is the most immunogenic way to deliver a drug,” Dr. Papp says. “That is why it is critical to make sure you and your patients store the drug properly.”

    NEXT: Curbing loss of response


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