What is the Recently Popular ‘Stapokibart’? I Suggest You Learn About It



This spring, with the “visualization” of Beijing’s arborvitae pollen, the new drug “Stapokibart” has successfully become a hit beyond the medical community.

The author has received “targeted recommendations” on various platforms such as X Book and X Sound, and has encountered more and more customers coming to the clinic to inquire about this drug.

There are patients with rhinitis who have a lot of nasal discharge and tears, and even sneeze when spraying medicine; there are patients with atopic dermatitis who have skin rashes, ulcers, unbearable itching, and various treatments with little effect; there are also patients with chronic sinusitis, nasal polyps, and allergic rhinitis who are troubled by long-term nasal congestion, nasal discharge, and reduced sense of smell…

Everyone is very concerned: Is this new drug that has suddenly become popular really that miraculous? Is it suitable for me to use?



‘Pollen Allergy’ Can it be used?

Stapokibart is essentially a monoclonal antibody(short for “monoclonal antibody”).

Using monoclonal antibodies to treat pollen allergies is not a very new treatment method. Last spring, we published an article titled “Pollen Allergy to the Point of Despair? Learn about the ‘Rhinitis Shot’ That Works in One Dose”, which mentioned “rhinitis shot” – Omalizumab is a monoclonal antibody that can immediately improve the symptoms of pollen allergies and significantly enhance the quality of life for “pollen allergy sufferers”.

1. Why is Stapokibart so popular this year?

It may be because, on the one hand, this year Beijing’s pollen concentration has exploded, leading to a “concentrated outbreak” of a large number of people, and more people are troubled by pollen allergies, which may increase the heat of online discussions on this topic.

On the other hand, Stapokibart is the only monoclonal antibody approved in our country, and it has just been approved for the treatment of seasonal allergic rhinitis, while the Omalizumab mentioned above has not been approved in our country for the treatment of pollen allergies (The US FDA and Japan PMDA approved Omalizumab for the treatment of seasonal allergic rhinitis in 2014 and 2019, respectively).

That’s why it seems like everyone suddenly heard about “Stapokibart” this year. It can only be said that the favorable wind relies on strength, sending TA to the blue sky. In other words, pollen allergy patients are really suitable for using Stapokibart!

2. What’s the difference from Omalizumab?

In terms of effectiveness, there is no “head-to-head” study showing which one is better. The conclusion from the current clinical trials is that both monoclonal antibodies have good efficacy for pollen allergies.


Head-to-Head Study

Head-to-Head Study (head-to-head study) refers to an experiment that directly compares two effective treatment methods. For example, let two groups of patients use drug A and drug B respectively, and observe which one works better.

Unlike ordinary research (which only tests whether a single drug is effective), this kind of research is like a “competition”, which can clearly distinguish the advantages and disadvantages of the two plans and help doctors choose the best treatment method. Randomized controlled trial methods are often used to ensure fairness.

In terms of the onset time, Stapokibart can significantly improve symptoms in as fast as 2-4 days, and some people may take 1-2 weeks to take effect; Omalizumab is usually recommended to be used 2 weeks in advance before the pollen season.

In fact, both drugs are best used in advance, so that the effect will be more guaranteed.
If it is not used in advance, and the pollen season has already arrived and allergic symptoms have already appeared, it is still very effective.

The biggest difference between the two drugs lies in the dosage.


Dosage Comparison

Omalizumab requires blood testing to determine the dosage based on weight and total IgE levels for the best therapeutic effect.

That is to say, before using Omalizumab, blood needs to be drawn to test the serum total IgE, and then based on body weight, the doctor formulates the drug regimen, for example, some people need to use 4 vials each time (600mg), and then every 2 weeks for 1 time, 4 vials for maintenance treatment; while some only need 2 vials each time (300mg), and then every 4 weeks for 1 time, 2 vials for maintenance treatment.

While the dosage determination of Stapokibart is relatively simple –adults start with 600mg, and then 300mg every 2 weeks for maintenance treatment.
Whether using Omalizumab or Stapokibart, it is recommended to continue treatment until the end of the pollen season.



「Chronic Sinusitis」Can it be used?

Come on, friends, the first batch of clients who came to me for treatment and medication has already made it ashore, with pictures as proof.

Below are pairs of images, the left is before Stapokibart administration, and the right is after Stapokibart administration, trying to find similar parts, green dashed lines represent polyps (and nasal concha with polypoid changes), and green arrows represent nasal concha (treatment before and after shows improvement in swelling).

Scroll down to view

Aren’t you eager to get the shot right away?!

Stop🤚!
Not all chronic sinusitis patients are suitable for using biologics (also known as various “monoclonal antibodies”) !

In short, a sentence:

Only patients with chronic sinusitis complicated by nasal polyps with evidence of type 2 inflammation may benefit from monoclonal antibodies.

1. Why can only these patients benefit?

Chronic sinusitis may seem to be inflammation of the nasal cavity and sinuses, but the “causes of inflammation” are actually quite different. Just like water pipes leaking, some are due to loose connections, others are due to rust, requiring different repair methods.

Research has found that based on the “out-of-control links” of the human immune system, the immune inflammation mechanisms behind chronic sinusitis can be divided into three types (1, 2, 3).

The most common type 2 inflammation, driven byeosinophils, IL-4/IL-5/IL-13 as the main drivers, these inflammatory factors cause nasal mucosa swelling, increased secretion of nasal discharge, stimulate nasal mucosa edema, and even grow polyps.

Monoclonal antibodies developed for type 2 inflammation are like precise “fire extinguishers”, specifically targeting the drivers in type 2 inflammation, such as Dupilumab, Stapokibart can block both IL-4 and IL-13, and Mepolizumab acts on IL-5 and eosinophils.

However, these drugs are only effective against type 2 inflammation, just like keys can only open their corresponding locks.
Patients with chronic sinusitis, if assessed by a doctor to have clear evidence of type 2 inflammation, can achieve twice the result with half the effort with such drugs. Patients with other types of sinusitis need a doctor to choose another treatment plan.

Chronic sinusitis, due to different causes, can be chronic sinusitis without nasal polyps, or chronic sinusitis with nasal polyps.
Only in patients with chronic sinusitis complicated by nasal polyps, with clear evidence of type 2 inflammation (for example, patients with comorbid allergic diseases and/or increased eosinophils), is it more suitable to use monoclonal antibodies.

2. Chronic sinusitis complicated by nasal polyps, is Stapokibart the only choice?

After reading the explanation above, I think everyone may already have the answer: Stapokibart, Dupilumab, Omalizumab, and Mepolizumab on the market can be used for chronic sinusitis complicated by nasal polyps (Note: Some drugs have been proven to be effective, but have not yet been approved for the treatment of such diseases in China).

It’s just that different individual situations, doctors will consider different monoclonal antibodies. The reason why Stapokibart has been used more widely recently may be that the cost for the entire course of treatment is more cost-effective:


Advantages of Stapokibart

On the one hand, the dosage calculation is more uniform, and patients with larger body weight and higher total IgE only need to use the same dosage. On the other hand, the manufacturer is currently conducting a “buy two get one free” promotion
(Note: Patients need to apply to the manufacturer themselves)
, which is more cost-effective for patients who need long-term use.



「Atopic Dermatitis」Can it be used?

For atopic dermatitis, it is entirely within the “domain” of Stapokibart. Previously, Distinct Health has published an article titled “Eczema Itching, Severe Skin Damage? In addition to topical medication and endurance, there is this method”, which mentioned Dupilumab (trade name “Dupixent”) has given hope to many eczema patients.

Stapokibart and Dupilumab have the same target, both on the IL-4/IL-13 pathway of the immune response, so Stapokibart also has good specificity for the treatment of atopic dermatitis. “Adult moderate to severe atopic dermatitis” is actually the first indication approved for this drug after its launch in September 2024.

 

So for patients with atopic dermatitis, should they choose Stapokibart or Dupilumab?

Currently, there are no head-to-head studies to assess the difference in effectiveness of the two drugs in treating atopic dermatitis, there may be some individual differences in specific efficacy, for example, it is possible that Mr. A may feel better with Dupilumab, while Ms. B may feel better controlled after using Stapokibart.

Considerations of price and drug accessibility can also be factors in the choice. Which one to choose specifically can be discussed in detail with the attending physician.



Can adolescents under 18 use Stapokibart?

Indeed, with the high incidence of allergic diseases in recent years, more and more adolescents are troubled by such issues.

Stapokibart is currently only approved for adult patients aged 18 to 74, while Dupilumab can be used for patients with moderate to severe atopic dermatitis over 6 months old.

If under 18 years old and for various reasons want to try using Stapokibart?
The safest way is to consult a professional doctor and decide together whether to use off-label.

In general, Stapokibart, as a type of monoclonal antibody, is just a useful bullet in the hands of doctors.

For individuals, there are also two distinctly different clinical outcomes, “hitting the target” and “missing the target”. We can look at it objectively, without deifying or demonizing it. This is the practical and scientific attitude that medicine, as a science, should have.

At present, Distinct Health has introduced Stapokibart, providing patients with more individualized treatment options. If you are troubled by diseases such as pollen allergies, chronic sinusitis with nasal polyps, or atopic dermatitis, you can make an appointment with the following departments for professional assessment:

👉Otorhinolaryngology: For patients with allergic rhinitis, chronic sinusitis, and nasal polyps

👉Allergy Department: For patients with eczema and atopic dermatitis

Distinct Health physicians will combine your symptoms, medical history, and examination results to make a comprehensive judgment on whether to use Stapokibart or other biologics. Even if these drugs are not suitable, we will also formulate a scientific and targeted treatment plan for you to help you control the disease more effectively and improve your quality of life.

References

[1] Zhao Y, Zhang L, Wu L, et al. Long-term efficacy and safety of stapokibart for moderate-to-severe atopic dermatitis: 52-week results from a phase 3 trial. Allergy. Published online October 25, 2024. doi: 10.1111/all.16368

[2] Zhang Y, Yan B, Zhu Z, et al. Efficacy and safety of stapokibart (CM310) in uncontrolled seasonal allergic rhinitis (MERAK): an investigator-initiated, placebo-controlled, random

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