Teprotumumab will help to cure bulging eyes and diplopia (double vision) in patients suffering from Graves disease
Horizon Therapeutics, a top-tier pharmaceutical company, got the approval from the USA Food and Drug Administration for their newly-minted medicine called Tepezza (teprotumumab) — the treatment of Thyroid Eye Disease (TED) — a rare, progressive, autoimmune disease that compromises eyesight causing proptosis (eye bulging), diplopia (double vision), blurring of vision, and horrible facial deformations.
Thyroid Eye Disease is also known as Grave’s ophthalmopathy, endocrine orbitopathy, thyroid ophthalmopathy, and autoimmune ophthalmopathy is an infrequent (affecting 16 women and 3 men out of 100 thousands of people) autoimmune inflammatory disease of the eyehole and periorbital tissues characterized with the retraction of the upper eyelid, swelling, erythema, conjunctivitis, and exophthalmos (eye protrusion, proptosis).
Generally, this pathology is a consequence of Graves’s disease or hyperthyreosis (the syndrome associated with an increased thyroid activity); however, it can also be of an independent nature. As the disease progresses, the symptoms get even worse: protrusion of the eyeballs intensifies followed with the manifestation of strabismus (crossed eyes), diplopia (double vision), and the increased risk of severe visual impairment.
Existing approaches to the treatment of Thyroid Eye Disease require the restoration of normal thyroid function and quitting smoking and other harmful habits. The symptomatic therapy of TED involves the use of artificial tears, selenium, glucocorticosteroids. In severe cases, a patient may be exposed to eyehole external irradiation and surgical interventions, including surgery on the eyelids, oculomotor muscles, orbital decompression accompanied by the removal of bone and/or fat tissue.
Tepezza is a revolutionary, non-surgical treatment for eye disease stemming from thyroid pathology (TED). The medicine was approved in January 2020 and presents a fully human monoclonal antibody (mAb) as well as a targeted inhibitor of the insulin-like growth factor-1 receptor (IGF-1R). The therapy is administered in a form of intravenous injections (once every 3 weeks for a total of 8 infusions) and works as effectively as surgery, still without those painful complications that often spring after surgical aggression.
Teprotumumab was approved by the FDA based on the results of 2 randomized, double-blind, placebo-controlled studies conducted by the department of surgery at Cedars-Sinai and other medical centers nationwide. The trial subjects were 170 patients plagued by active thyroid eye disease and receiving Teprotumumab in a form of injections once in three weeks during a 21-week clinical study. It was proved that:
- Patients had an effective response to the drug after two doses or six weeks of treatment;
- After 24 weeks, the experiment demonstrated that 83% of test persons had significant (greater than 2 millimeters) reduction in eye protrusion compared to 10% of those receiving a placebo.
- The overall positive effect was evident in 78% taking a genuine drug versus 7% of those taking a placebo.
Who generally suffer from TED?
Each year, nearly one million patients are diagnosed with TED in America. The disease most often affects people struggling from an overactive function of the thyroid gland (Graves’ disease). But TED can also occur in individuals without Graves’ disease.
Smokers, as well as women, have elevated risks than others in developing Thyroid Eye Disease. People with TED most often feel painful sensations when trying to move their eyes, as well as inflammation and swelling behind the eyes, which causes the eyes to push forward. These changes can lead to impaired vision, double vision, dryness, redness, and pain. In severe cases, TED leads to blindness, because swollen tissue in the eye sockets harms the optic nerve deteriorating its function.
Surgery can help change the deformed anatomy of the orbit, by removing excessive tissues, thus allowing some of the TED symptoms to go away. But it should be understood that is dangerous to constantly have surgical eye procedures, as well as that it is much more traumatic compared to nonsurgical therapy.
How does Tepezza work?
Tepezza (teprotumumab-trbw) works by relieving the inflammation underlying the biology of TED. During the active phase of TED, a special receptor called the insulin-like growth factor 1 receptor (IGF1R) gets activated, inducing the swelling of fat and muscle tissue in eyehole. As a result, the eyes get pushed forward, and a patient starts experiencing pain, redness, and double vision. Tepezza inhibits (blocks) the activity of this nasty receptor helping to fight TED at its source. Once the IGF1R receptor is blocked, the swelling of muscle and fat tissue subsides, TED symptoms disappear.
The price tag of your health
Teprotumumab is said to cost $14,900 per vial. Given the fact that the full treatment course will require approximately 23 vials, the price of your abolition of TED will gravitate toward whopping $343,000, which means that the majority of TED patients will simply not afford such a luxurious treatment.
In the USA, patients needing to purchase official prescription or OTC drugs, generally go to local pharmacies or scout their websites hoping to get the best deal and stay cost-wise. Sure, they may get across some special offers and discounts on prescription meds or supplements for general health and wellbeing, but expecting a really hefty discount or a fair price is too naively when living in the USA – the country plagued by monstrous capitalism and the overwhelming desire of businesses to make a client pay through the nose. Human health must never be the source of beneficiation of greedy companies and corporations. Fortunately, there is always a way to make healthcare affordable. A failproof approach is to consider online pharmacy Canada, a budget drug retailer that retrieves the assortment from nearby countries, which enables them to offer high-quality medicaments, supplements, and OTC medicaments at a significantly lower price, say twice as low as in most US retail drugstores. From wellbeing supplements to diabetic supplies, pain killers, cold remedies, antiallergic drugs, and anti-viral solutions among other things, the service gets all your pharmaceutical needs covered including professional real-time counseling from qualified pharmacists and options to obtain the required medicinal product that will fully fit the requirements of your insurance plan.
Safety concerns about Tepezza
Adverse reactions may become observable within 24 hours after the injection with teprotumumab and include:
- Blood pressure issues
- Rapid heartbeat
- Facial reddens, feeling hot
- Difficult breathing
- Muscle spasms
- Body aches
Patients diagnosed with Crohn’s disease, ulcerative colitis, or any other inflammatory bowel disease should take Tepezza with caution, as the medicine may worsen symptoms of these conditions following with abdominal pain, diarrhea, bloody stools.
Teprotumumab is also reported to increase a jump in blood sugar, meaning individuals with diabetes should carefully control their glucose level and adhere to an appropriate diet if they start curing their TED with Tepezza.
Clinical trials did not establish the ability of Tepezza to pass into human milk, which is why it is not known whether the drug may or may not harm the unborn or newborn baby. Female patients taking Tepezza should use effective birth control solutions to avoid pregnancy while on Tepezza therapy and, at least, 6 months after the final injection of the drug.