In 2016, a Canadian public policy group called The Fraser Institute (TFI) issued a report on a groundbreaking suite of medicines. The title? "The Biologic Revolution in the Production of Drugs."
Biologics for asthma are now part of this suite.
Most drugs on the market are synthetic. Developers make synthetic drugs by compounding non-living chemicals into small molecules. The chemical reaction in the body produces the drugs' therapeutic effects.
In contrast, scientists derive biologic drugs from living, organic cells.
The very first biologic drug was created in 1921. Scientists at the University of Toronto purified insulin from the E.coli bacteria.
This was the first effective diabetes treatment. Researches estimate biologic insulin has saved almost a billion lives since its discovery a century ago. TFI's 2016 report explores how far biologic pharmacology has come since then.
Today, biologic drugs make up 14% of the Canadian drug market. Much of this segment is medications that can address treatment-resistant illnesses.
Where small-molecule drugs falter, new biologic drugs often succeed. Biologics for asthma make up some of these success stories. If you struggle with managing your asthma symptoms, one of these medications might be right for you.
What Are Biologics for Severe Asthma?
Biologic drugs can prove challenging. Living organisms react to subtle changes in their environments.
The same organism may produce different hormones and proteins in different contexts. This happens despite apparently similar conditions.
But, new technology enables scientists to stabilize organisms' environments with increased precision. As a result, the past decade has seen incredible strides in biologic development.
New biologics for asthma are the result of these strides. For instance, pharmaceutical labs can now clone cell lines consistently. This lets them develop monoclonal antibodies.
Monoclonal Antibodies for Asthma
Monoclonal antibodies are typically hyper-specialized white blood cells. They are virtually identical to one another.
This enables hyper-specificity. Some monoclonal antibody cells only bind to one end of one specific antigen molecule. An antigen part of a particle (like dust) triggers an immune system response.
Asthma is largely a disorder of an over-reactive immune system. Certain cells overreact when processing an antigen. Instead of producing a cough, an asthma patient's immune system severely constricts airways.
The antibody binds to certain cells in the system. There are multiple ways this can circumvent the extreme reaction.
Monoclonal Antibodies vs. Small-Molecule Drugs
Monoclonal antibodies treat overactive immune systems. Yet, they avoid many of the side effects common to small-molecule drug treatments.
This is because cells can act with precision, while chemical reactions are inevitably generalized. Monoclonal antibodies generally have no impact on molecules (or cells) they don't bind with.
Moreover, monoclonal antibodies live inside the human body for some time. They can prevent or subdue an asthma attack before it reaches critical levels.
In contrast, acute inhalants only stay in the body briefly. Patients must use these immediately during an attack.
FDA Approved Biologics
To let Canadian patients get biologics for asthma, Canada partners with the United States. Here, drugs must be approved by Health Canada before doctors can prescribe them. The Food and Drugs Act (FDA) sets safety regulations.
In 2016, Health Canada signed an agreement with the USA's Food and Drug Administration (U.S. FDA). Both agencies recognize one another's safety standards as "comparable."
Thus, drugs approved by the U.S. FDA can be prescribed in Canada. Likewise, drugs approved by Health Canada may be prescribed in the United States.
Currently, Health Canada has approved a few biologics to treat severe asthma. All are monoclonal antibodies. These drugs treat different types of asthma.
Types of Asthma
There are two severe types of asthma. A patient may consider biologics for asthma (meaning eosinophilic asthma) if his current treatment isn't effective.
Eosinophilic Asthma - When a person's body produces too many inflammatory cells (eosinophils), they experience frequent asthma attacks. Often, they also get hives. This is eosinophilic asthma.
Allergic (IgE-mediated) Asthma - IgE-mediated asthma is a different dysfunction. A person's Immunoglobulin E (IgE) cells overreact to trigger particles.
Typical IgE cells modulate the immune system's response. But, with IgE-mediated asthma, these cells don't modulate correctly.
Instead, certain triggers provoke these cells to release too much histamine. Histamine causes extreme swelling.
Types of Biologic Therapy Drugs
What are the types of biologic therapy drugs for treating asthma?
If you're choosing biologic drugs for asthma, get specific about your condition. Different drugs address different underlying causes of asthma.
All biologic asthma medicines are monoclonal antibodies. But, different cell lines bind to different molecules.
This piece explores five biologic asthma-control drugs. Learn the source and purpose of each drug.
Then, examine the efficacy and known side effects. And, discover whether you can take it at home.
Xolair® (omalizumab) is a biomodulator. It treats IgE-mediated asthma.
Specifically, omalizumab is a monoclonal antibody with prophylaxis effects. This means it opens the airways. It also reduces swelling in bronchial tubes.
Genetech collaborated with Novartis Pharmaceuticals Corporation to make Xolair®. The drug earned FDA approval in 2020.
Scientists derived this monoclonal antibody from an ovarian cell line. The original line belonged to a Chinese hamster. These cells have the unique tendency to subvert IgE reaction.
The chief symptom of IgE-mediated asthma is recurring asthma attacks. These attacks are triggered by particles in the patient's environment.
During an asthma attack, the immune system releases an extreme amount of histamine. This hormone causes swelling. Swelling can cut off the windpipe.
This airway restriction can be lethal. The World Health Organization (WHO) notes that roughly 461,000 people die of asthma attacks every year.
Omalizumab prevents the histamine release and subsequent swelling. In patients with IgE-mediated asthma, IgE cells kickstart a dangerous chain reaction.
When triggered, these cells command mast cells and basophils. These cells then release a dangerous amount of hormones. In turn, these hormones cause extreme swelling.
Omalizumab cells bind to receptors in the immune system cells' chain. This disrupts the chain reaction that causes the attack.
It also binds to receptors on the triggering molecule. This prevents the IgE cells from "noticing" the trigger.
Dispensing Xolair® (Dosage and Method)
Omalizumab is injected. It's an asthma biologic shot. In most cases, physicians dispense Xolair® at a doctor's office or clinic.
Dosage varies. A patient may only need one shot every four weeks. But, a doctor can prescribe up to two shots every week.
Xolair® at Home
In 2020, Xolair® developers applied for a new FDA approval. They designed syringes pre-filled with one Xolair® dose.
Patients can take these pre-measured shots at home. In 2021, the U.S. FDA approved the pre-filled shots. The regulatory group signed-off on at-home Xolair® use.
Doctors may only prescribe at-home Xolair® to appropriate patients. Appropriate patients have no history of anaphylaxis or allergic reactions.
They must also administer the shot correctly three times. The doctor must observe the patient administering the dose before he prescribes the at-home shot.
Omalizumab rarely causes side effects. The most common side effects include:
- Muscle aches
- Joint pain
- Injection site irritation or reaction
It's important to talk to your doctor about a drug's potential side effects. They can run down the most likely issues. They can also suggest how to deal with them.
Nucala (mepolizumab) is a monoclonal antibody drug. It treats eosinophilic asthma.
Eosinophilic asthma doesn't stem from IgE dysfunction. Instead, a person's immune system over-produces eosinophil cells.
Eosinophilic asthma is a severe form of asthma. It often resists steroid treatments.
Immune responses follow different "chains of command" in different bodies. Some patients have a Th-2 dominant inflammatory response.
The Th-2 cell is usually adaptive. It targets immune system responses and helps repair tissue.
But, the response depends on cytokines to deliver messages correctly. Cytokines are proteins and amino acids. One cytokine in this system is Il-5.
When Il-5 is dysfunctional, it doesn't properly relay messages from Th-2. This error causes bone marrow to produce too many eosinophils. Then, too many eosinophil cells are "recruited" to swarm the antigen.
Other command dysfunctions in this chain exacerbate the problem. Airways become hyper-responsive and the system produces too much mucous.
Then, down-the-line cells release too many histamines and other fluids. This causes:
- Acute allergic reactions
- Vasodilation (blood vessels widen)
- Edema (tissues swell due to trapped fluids)
- Bronchospasms (airways narrow)
Eosinophilic asthma attacks cause harm even after they end. Eosinophilic cells hover near the tissue surface, ready for action.
A new antigen can trigger these leftover cells. This is, in part, why eosinophilic asthma resists steroid treatment.
GlaxoSmithKline developed Nucala® (mepolizumab). Like omalizumab, mepolizumab is derived from hamster cells.
Mepolizumab is a monoclonal antibody. Specifically, it's an IL-5 antagonist. GSK engineered Nucala® to mend dysfunctional inflammatory response chains.
Mepolizumab binds to IL-5 proteins. Then, it alters the proteins' signals. This prevents the downstream effects of the faulty signal.
As a result, bone marrow does not overproduce eosinophils. There's no eosinophil swarm.
GSK notes that doctors should prescribe Nucala® alongside corticosteroids. The antibody makes these steroids more effective.
Nucala® earned FDA approval in 2015. The FDA approved later formulations in 2020 and 2021. Nucala® can treat some blood vessel disorders as well as asthma.
Dispensing Nucala® (Dosage and Method)
Nucala® is a shot. Someone must inject the medicine under the patient's skin.
Initially, only medical professionals could dispense mepolizumab. Also, they had to give the shot in a clinical setting.
Now, patients can inject themselves at home. Patients take one dose every four weeks.
Mepolizumab has no known drug interactions. But, there are a few potential side effects to be aware of. These include:
- Injection site reaction
Studies note other side effects that are incredibly rare. Talk to your doctor about what to do in the case of an extreme effect.
Cinqair® (reslizumab) is a monoclonal antibody. This biologic treats eosinophilic asthma. It earned FDA approval in 2016.
Like mepolizumab, reslizumab alters the TH-2 inflammatory response. But, Nucala® binds to Il-5 proteins.
In contrast, Cinqair binds to the Il-5 receptors on eosinophil cells. It prevents overproduction by disrupting the signal.
Teva Pharmaceuticals makes Cinqair®. Scientists used recombinant DNA technology to create the cell line.
They developed Cinqair® from murine myeloma NS0 cells. These cells are used often in biomedicine.
Dispensing Cinqair® (Dosage and Method)
Doctors dispense Cinqair® through an intravenous (IV) infusion. You cannot administer Cinqair® through an IV push or bolus.
Dosages vary. Patients take Cinqair® once every four weeks. Only a medical professional in a healthcare setting can administer this drug.
Cinquair® has more frequent and significant side effects than Nucala and Xolair. The FDA labels Cinqair with its strongest warning. 3.3% of patients have experienced anaphylaxis on this drug.
Cinqair® increases patients' risk of developing cancer. Patients also risk throat pain.
Faserna® (benralizumab) is a monoclonal antibody. The FDA approved Faserna to treat eosinophilic asthma in 2018.
Faserna® interfaces with eosinophils and Il-5 proteins. It reduces eosinophil production. But, its mechanism is unclear.
AstraZeneca developed Faserna®. Scientists altered this biologic to be lightweight.
Faserna® is an afucosylated antibody. Engineers created previous afucosylated antibodies as anti-cancer agents.
Dispensing Fasenra® (Dosage and Method)
Faserna® is a shot. Someone must inject Faserna® under the patient's skin.
Patients may also self-administer Faserna®. The Faserna® Pen earned FDA approval in 2019.
Initially, patients must take Faserna every four weeks. Then, patients only need a dose once every eight weeks.
Patients who take Faserna risk anaphylaxis. However, that is not common. Common side effects include:
- Injection-site reactions
Talk to your doctor about potential side effects. Learn what to do in the case of adverse reactions.
Dupixent (dupilumab) is a monoclonal antibody. It binds to Il-4 and Il-13 cytokine proteins.
Dupilumab alters or interrupts these proteins signals to other cells in an immune response chain. The FDA approves this drug to treat asthma, eczema, and chronic sinusitis.
Doctors can prescribe Dupixent for moderate and severe asthma.
Dupixent can treat multiple types of asthma. It can treat eosinophilic asthma. It can also treat IgE-mediated asthma and other sub-types.
Sanofi and Regeneron Pharmaceuticals developed Dupixent®.
They specifically developed dupilumab to reduce dependency on oral steroids. Some patients can reduce or eliminate oral steroids with this biologic.
Dispensing Dupixent® (Dosage and Method)
Dupixent® is an injection. It's either a shot or a pen. Adult patients can inject themselves at home. Patients take Dupixent® once every two weeks.
Patients do not risk anaphylaxis with Dupixent®. Side effects are uncommon and mild.
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