Biologics
Modern advances in our understanding of immunologic processes, along with discoveries in disease pathophysiology, have led to the development of innovative therapeutic tools. In several fields of medicine, biologic response modifiers, selective immunoregu
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Biologics Panoglotis Mitropoulos and Robert A. Norman
Modern advances in our understanding of immunologic processes, along with discoveries in disease pathophysiology, have led to the development of innovative therapeutic tools. In several fields of medicine, biologic response modifiers, selective immunoregulatory drugs, or simply biologics are now being used in the treatment of conditions for which either no other effective therapies exist or the existing therapies provide substandard therapeutic results. Biologic agents comprise a variety of medicinal products already in use, such as vaccines, human cells and tissues, recombinant therapeutic proteins, allergenic products, blood components, and human gene therapy products. The term biologics, however, is more commonly used to describe a class of medications produced by means of biological processes involving recombinant DNA technology. These are immunoregulators and bioengineered proteins, such as fusion proteins, chimeric or fully humanized monoclonal antibodies, or recombinant cytokines that directly interfere with the pathological effects of T cells.
10.1 Indications Currently, the only US Food and Drug Administrationapproved indication of biologics in dermatology is for the treatment of psoriasis (Table 10.1).1–5 Nonetheless, the treatment potential of these medications has led to their off-label use for several other conditions in dermatology. Some of these include
P. Mitropoulos (*) Camp Long Troop Medical Clinic, South Korea e-mail: [email protected]
pemphigus vulgaris, paraneoplastic pemphigus, epidermolysis bullosa acquisita, primary cutaneous B-cell lymphoma, dermatomyositis, atopic dermatitis, chronic urticaria, sarcoidosis, granuloma annulare, Sweet’s syndrome, lupus erythematosus, and several other granulomatous, autoimmune, inflammatory, and neutrophilic dermatoses.1 For psoriasis, biologics do not constitute first-line treatment. Biologic therapy should be reserved for moderate-to-severe plaque psoriasis, and in cases where traditional treatments do not appear to be adequate or are contraindicated. Current initial therapies for psoriasis include topical agents (corticosteroids, coal tar, anthralins, vitamin A and D derivatives) and systemic agents (methotrexate, cyclosporine, retinoids) as well as phototherapy. Biologic therapy may be reasonable for patients who fall in two or more of the following categories: • Age ³18 year old • Chronic (³6 months) moderate/severe plaque psoriasis • Psoriasis-area severity index (PASI) score of ten or more (or body surface area (BSA) of 10% or greater if PASI score not applicable), and a dermatology quality life index (DQLI) of less than ten • Inadequate response or intolerance to standard therapy • Higher than average risk of developing clinically important drug-related toxicity with the standard treatments • Significant coexistent unrelated morbidity (i.e., unstable congestive heart failure [CHF], liver disease) which precludes the use of systemic agents like cyclosporine or methotrexate
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