A promising biological drug for chronic sinusitis

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Grandmother: Dr. Abdul Hafeez Yahya Khoja

At the beginning of this week, on July 10 this year, “Sanofi”, the company specializing in the field of health care, organized a medical scientific symposium through virtual videoconferencing technology, in which it launched a new biological drug under the name “Dupixent / Dupilumab”. As an additional treatment with corticosteroids, for the treatment of adults with chronic sinusitis and nasal polyposis (Chronic Rhinosinusitis with Nasal Polyposis, CRSwNP), especially those for whom corticosteroid treatment or surgery does not provide the desired disease control.
The new drug has been approved by the Saudi Food and Drug Authority. It was jointly developed by Sanofi and Regeneron under a global cooperation agreement.
Although opinions and perspectives on the pathophysiology of chronic sinusitis have expanded greatly over the past two decades, the exact etiology and stabilization mechanism remains unknown. The disease has many factors, and the evidence for it also varies.
In this symposium, the pathological mechanisms of this disease were better understood, and the way the new drug works compared to the previous treatment method. The symposium was moderated by Professor Saree Al-Dossary, Professor of Medicine and Rhinology and Director of the Department of Sinus and the Bottom of the Skull at King Saud University in Riyadh, and was attended by Professor Osama Marghalani, Professor at the College of Medicine, Umm Al-Qura University in Makkah Al-Mukarramah and the Consultant of Otolaryngology, Head and Neck Surgery at King Faisal Specialist Hospital and Research Center In Jeddah, Professor Klaus Bachert, Professor and Head of the Department of Upper Airway Research Laboratory at Ghent University Hospital in Belgium, and Prof. Martin Wagenmann, Head of the Department of Nose, Allergy and Laparoscopic Skull Bottom Surgery at the University Hospital Düsseldorf, Germany. The “Your Health” supplement in the Middle East attended the conference at a special invitation, as an exclusive representative of the Saudi media.
– Sinusitis
Sinus congestion and polyps. Prof. Osama Marghalani spoke at the conference, explaining that chronic sinusitis is a disease that affects the nose and the mucous membrane of the sinuses adjacent to the nose, which leads to congestion in the sinus area and the growth of polyps in the nose as a result of the enlargement of the mucous membranes of the nose, which are known as nasal polyps, for a period of time More than 12 weeks.
According to Professor Marghalani, the incidence of chronic sinusitis increases in middle age, especially over the age of 42 years, and the incidence of men is more than that of women. Chronic sinusitis is considered one of the most common diseases worldwide, with an incidence of 12 percent in America, 10 percent in Europe, and 7 percent in Korea.
Symptoms. Symptoms of chronic sinusitis with nasal polyps (CRSwNP) include anterior or posterior runny nose, nasal congestion, obstruction, and difficulty breathing through the nose, facial pressure and pain, with loss of smell and taste. Nasal polyps or polyps are defined by the inflammatory lesions that appear in the nasal airways, and are usually bilateral, i.e. on either side of the nose.
The reasons. Sinusitis is caused by several reasons, such as allergies or infection with some types of bacteria, viruses, or fungi. There are no specific genetic or environmental factors strongly associated with the development of this disease. Defects and abnormalities in the cells of the nasal septum, increased exposure to disease-causing bacteria and impaired immune systems may play prominent roles in the disease.
Nasal polyps. Nasal polyposis is frequently associated with asthma and allergic rhinitis, but the cellular and molecular mechanisms that contribute to clinical symptoms are not yet fully understood. More studies are still needed to further explore the clinical and pathophysiological features of nasal polyposis so that biomarkers can be identified and new advances made to improve treatment and management of this disease.
– Inflammation and the emergence of polyps,
Professor Osama Marghalani classified sinusitis as the second type of inflammation that comes as a result of exposure to allergens in some people or as a result of some types of fungi.
He added that when exposure to the allergen occurs, the stem cells present the antigen to the immature T lymphocytes, which develop and are distinguished into transforming into type II helper T lymphocytes, where they secrete many chemicals known as cytokines, especially Interleukin 4 and Interleukin 13. Interlaken 5.
As for the modus operandi of Interleukin 4 and Interleukin 13 and their binding to receptors on the surface of B cells that secrete antibodies into the blood, these bodies bind to the receptors on the surface of mast cells and then secrete histamine that stimulates the growth of goblet cells, which are cells present In the nose, they secrete mucus, and upon stimulation of a large amount, they in turn secrete a large amount of mucus, which results in a runny nose.
As for Interlaken 5, Professor Marghalani states that it stimulates the bone marrow to form a large number of eosinophil cells and release them through the blood, which contribute to the defense process against the allergen, which leads to the secretion of a large amount of mucus through the nose, and this may be accompanied by congestion The mucous membranes of the sinuses that lead to the growth of the adenoids on both sides of the nose with constriction of the lung muscles leading to difficulty breathing and disturbance of the epithelium, which works to protect the nasal membranes from the passage of harmful substances through them.
– Methods of Treatment
The role of steroid drugs. Prof. Claus Bachert, Professor and Head of the Upper Airway Research Laboratory Department at Ghent University Hospital in Belgium, spoke at the conference about the interpretation of type II infections, stating that there are mutual and rare roles between the second type of proteins that regulate the immune response (interleukin). 4. 13, 5) that are secreted by T cells with chronic nasal polyposis, indicating that 76% of patients require taking steroid drugs regularly during week 52. While 83% of them require surgery during week 52.
The role of surgery. Prof. Martin Wagenmann, Head of the Department of Nose, Allergy and Laparoscopic Skull Bottom Surgery at the University Hospital Düsseldorf in Germany also spoke at the conference that resorting to surgery comes as a result of several factors such as insufficient improvement of the disease after taking medical treatments, and the existence of a relationship between Symptoms of disease, results of endoscopic surgery and radiological findings, as well as benign tumors, disease complications, and myeloma.
He added that the nasal polyposis disease results in exorbitant direct and indirect economic burdens, and the direct burdens fall under the need to mobilize all health care resources, while the indirect burdens affect academic achievement, work and productivity, and the increase in these burdens is linked to the increase in the spread of type II inflammatory diseases. .
A new biological drug
Efforts to treat benign neoplasms associated with chronic sinusitis have resulted in the adoption of the first drug approved by the US Food and Drug Administration and recently by the Saudi Food and Drug Authority, called Dupixent. The nasal route, as it reduces the need for surgical removal of tumors.
The new drug was tested in two studies involving patients over the age of 18 years, and it contributed to significantly reducing the size of nasal tumors, and it also helped restore the sense of smell. In less than 4 weeks, when added to other nasal polyps drugs, it has been clinically proven that the new drug reduces nasal congestion and reduces nasal polyps, in addition to being safe and effective. As for the side effects, the most important ones are allergies, keratitis, eye swelling, and blepharitis.
On the mechanism of action of the new drug, Dupixent, Professor Marghalani explained that this drug is classified within the category of human monoclonal antibody, and works to block the signals released from Interleukin 4 and Interleukin 13 by preventing them from binding to the receptors that are on the surface of cells. The B assigned to interleukin 4 and interleukin 13. As a result, Dupixent binds to these receptors on the surface of B cells, thus preventing the occurrence of inflammation resulting from interleukin 4 and interleukin 13, and accordingly, the number of eosinophil decreases by 70 percent.
The sense of smell improves by 71 percent during the second week of starting treatment in most cases, and the nasal congestion and blockage improves by 54 percent during week 52, and the process of shrinking the size of adenoids and eliminating them improves by 37 percent during week 52. The need to use steroid medications is reduced by 76 percent, while the need for surgery is reduced by 83 percent. And this treatment is given by injection under the skin in the abdomen or thigh area, taking into account that the skin is intact and avoiding injection in areas of the skin that contain scars, bruises or redness, and the drug is given at a dose of 300 mg every two weeks.
DUPIXENT is the first and only alternative biological treatment for nasal tumor surgery, and it is used with other drugs for the continued treatment of chronic sinusitis with nasal polyposis in adults whose disease is not controlled.
Sinuses … Anxiety and Depression
> Prof. Dr. “Dong Kyu Kim,” see Prof. Dong Kyu Kim of the College of Medicine at Halim University in Shancheon, South Korea, said that sinusitis is among the common human diseases, and despite receiving optimal medical and surgical treatment, some patients have persistently recurring symptoms, causing them anxiety and depression.
It was found from the results of a recent scientific study that I supervised with other Korean researchers and published in JAMA Otolaryngology and Head and Neck Surgery on March 8, 2019. People who suffer from chronic sinusitis are more prone to depression and anxiety, as well. The total incidence of depression during the 11-year follow-up period was 1.51 times higher for those with sinusitis, and the incidence of anxiety was 1.57 times higher than for people without sinus problems.

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