New Indications for Biological Medications
Most of the medications used for treating diseases are chemically synthesized in a laboratory. Some newer medications, however, are derived from a variety of natural sources such as humans, animals, or microorganisms. These newer medications, often referred to as “biologicals,” are typically produced by using biotechnology and/or other cutting-edge methodologies. Biologicals represent a breakthrough advance in therapeutics as they may offer the most effective means to treat a variety of medical illnesses and conditions that presently have no other treatments available.
Most allergic and immunological disorders have chronic uncontrolled inflammation as the primary underlying mechanism of the disease. This chronic inflammation often leads to organ dysfunction and the unwanted symptoms associated with such inflammation. The inflammatory process is mediated by various chemical substances such as antibodies and cytokines. The biological medications (i.e., biologicals) target these inflammatory mediators and suppress or block their actions resulting in better control of the disease.
- XOLAIR (i.e., omalizumab) was the first biological approved by the FDA for the treatment of asthma. It was initially approved for adults in 2003 and later approved for children in 2006. Xolair acts by blocking the “allergy” antibody, commonly called IgE, which acts as a mediator of many disorders of immediate hypersensitivity.
Xolair is used for adult and pediatric patients who are 6 years of age and older with moderate to severe persistent asthma, whose symptoms are inadequately controlled with inhaled corticosteroids, who have a positive allergy skin test or an in vitro (i.e., in the test tube) reactivity to a perennial aeroallergen such as dust mites. It is administered by subcutaneous (SQ) injections on a regular basis (i.e., every 4 weeks). The dose and frequency of administration depend on the IgE level and the weight of the patient. The IgE level is determined by a blood test.
After getting the approval for the treatment of moderate to severe persistent asthma, Xolair subsequently was also approved for the treatment of chronic idiopathic urticaria (i.e., chronic hives) in patients ≥ 12 years of age who remain symptomatic despite H1 antihistamine (e.g., Clarinex, Claritin, Allegra, Zyrtec, Xyzal, Benadryl) treatment. Xolair has helped numerous individuals suffering from chronic hives.
More recently, Xolair has received an additional indication for the add-on maintenance treatment of nasal polyps in adult patients ≥ 18 years of age who have an inadequate response to nasal corticosteroids (e.g., Flonase, Nasonex, Nasacort AQ, Rhinocort AQ, Qnasl)
- NUCALA (i.e., mepolizumab) is a biological drug that blocks a cytokine called IL-5. It was approved in 2015 as an add-on maintenance treatment for patients with severe eosinophilic asthma aged 6 years and older. The approved recommended dosage is 100 mg once every 4 weeks given as a subcutaneous (SQ) injection.
Later, Nucala also was approved for:
- Add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (i.e., CRSwNP) in adult patients 18 years of age and older with an inadequate response to nasal corticosteroids
- Treatment of adult patients with eosinophilic granulomatosis with polyangiitis (i.e., EGPA)
- Treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (i.e., HES)
- FASENRA (i.e., benralizumab) is indicated for the add-on maintenance treatment in patients with severe eosinophilic asthma aged 12 years and older. It acts by rapidly depleting eosinophils which cause tissue damage when excessively activated and accumulated. The maintenance dose is 30 mg. injected subcutaneously (SQ) under the skin every 8 weeks.
- DUPIXENT (i.e., dupilumab) acts by blocking 2 pro-inflammatory cytokines called IL-4 and IL-13. It is administered every 2 weeks as a subcutaneous (SQ) injection under the skin.
It is used to treat:
- Adults and children 6 months of age and older with moderate to severe eczema (i.e., atopic dermatitis) that is not well controlled with prescription therapies used on the skin (i.e., topical), or who cannot use topical therapies
- With other asthma medications for the maintenance treatment of moderate to severe eosinophilic or oral steroid-dependent asthma in adults and children 6 years of age and older whose asthma is not controlled with their current asthma medications
- With other medications for the maintenance treatment of chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults whose disease is not controlled
- Adults and children 12 years of age and older, who weigh at least 88 pounds (i.e., 40 kg), with eosinophilic esophagitis (EoE)
- Adults with prurigo nodularis (PN)
- TEZSPIRE (i.e., tezepelumab) is the most recent biological medication that was approved by the FDA for treatment of asthma. It is a medication that blocks the cytokine TSLP, a cytokine which plays a prominent role at the top of the inflammatory pathway. It is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.
Tezspire can be used without checking for any biomarker levels such as IgE. It can also be used in most phenotypes of asthma and is not restricted to only be used in eosinophilic asthma as with some other biologicals. It is administered as an injection subcutaneously (SQ) under the skin in a single dose of 210 mg. every 4 weeks.
The board certified allergy doctors at Black & Kletz Allergy see both adult and pediatric patients and have over 50 decades of experience in the field of allergy, asthma, and immunology. Black & Kletz Allergy has 3 convenient locations with on-site parking located in Washington, DC, McLean, VA (Tysons Corner, VA), and Manassas, VA. The Washington, DC and McLean, VA offices are Metro accessible and we offer a free shuttle that runs between the McLean, VA office and the Spring Hill metro station on the silver line. To schedule an appointment, please call any of our offices or you may click Request an Appointment and we will respond within 24 hours by the next business day. We have been servicing the greater Washington, DC metropolitan area for over 50 years and we look forward to providing you with the highest state-of-the-art allergy care in a friendly and approachable environment.