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▎The content team editor of WuXi AppTec recently, a drug suitable for the treatment of adult patients with eosinophilic granulomatous polyangiitis (EGPA)-mepolizumab injection (English common name: mepolizumab; trade name: new Available), approved by China National Medical Products Administration (NMPA) for marketing
.
Public information shows that Mepolizumab is the world's first monoclonal antibody biologics targeting human interleukin-5 (IL-5) approved for marketing
.
The drug has been approved for marketing in China, which is expected to bring more effective and safe treatment options for patients
.
Screenshot source: Rare autoimmune disease on NMPA official website Eosinophilic granulomatous polyangiitis is a rare autoimmune disease.
The peak age of onset is 30-40 years old, and both men and women may suffer from the disease
.
Relevant data show that the annual incidence of eosinophilic granulomatous polyangiitis is 0.
5 to 6.
8 per million
.
Patients with bronchial asthma belong to the high-risk group of the disease, with an annual incidence rate of 64.
4 per million
.
Unlike other vasculitis, eosinophilic granulomatosis with polyangiitis is the earliest and most easily affected parts of the respiratory tract and lungs.
However, as the disease progresses, multiple systems in the patient's body may be affected and cause irreversible organ damage.
Seriously threaten the lives of patients
.
According to the natural course of the disease, eosinophilic granulomatous polyangiitis can be divided into prodromal phase, tissue eosinophil infiltration phase and vasculitis phase
.
It should be noted that not all patients will go through these three stages, and there is no clear boundary between the three stages
.
Image source: 123RF symptoms vary greatly due to different organs involved.
Different organs are affected, and patients will also have different symptoms
.
Respiratory system involvement: Most patients develop wheezing.
More than 95% of patients have a history of wheezing and coughing.
75% of patients have allergic rhinitis.
These are typical initial symptoms of eosinophilic granulomatous polyangiitis.
Patients may also have recurrent rhinitis or nasal polyps
.
Heart involvement: Patients with severe heart involvement have a poor prognosis and are also the main cause of death of patients, accounting for about 50%
.
About 27% to 47% of patients may have heart involvement and show corresponding symptoms, such as dilated cardiomyopathy, eosinophilic endocarditis, eosinophilic myocarditis, coronary vasculitis, and heart valves Disease, congestive heart failure, pericarditis and pericardial effusion
.
Gastrointestinal involvement: The incidence is 37% to 62%.
Patients may experience gastrointestinal symptoms such as abdominal pain, diarrhea, gastrointestinal bleeding and even intestinal perforation
.
Nervous system involvement: Approximately 70% of patients will have multiple mononeuritis or mixed sensorimotor peripheral neuropathy
.
A typical polyneuritis is manifested as a drop of the wrist or foot
.
25% of patients have central nervous system involvement, manifested as diffuse brain lesions and cerebrovascular events
.
Kidney involvement: Although there are fewer people (about 1/3) of renal vasculitis, and the severity is low, it can quickly develop from a simple urine test abnormality to acute progressive glomerulonephritis
.
Skin involvement: 70% of patients may have skin involvement.
This is one of the main manifestations of vasculitis.
Patients may have purpura, nodules and papules distributed on the limbs and scalp
.
Multiple maculopapular rashes, erythema multiforme, lively reticularis, blisters, sterile pustules, petechiae, ecchymosis and urticaria can all appear at different stages of the disease, and papules and nodular lesions may occur Necrosis or rupture
.
Image source: 123RF, the world's first approved anti-IL-5 monoclonal antibody, mepolizumab.
The therapeutic target of mepolizumab is the cytokine-interleukin-5 (IL-5)
.
IL-5 is the main cytokine for the maturation, activation and survival of eosinophils
.
Mepolizumab binds to IL-5 and blocks the binding of IL-5 to the surface receptors of eosinophils, inhibits the biological activity of eosinophils and reduces the number of eosinophils to a normal level, thereby reducing eosinophilia The growth of granulocytes, as well as inflammation and tissue damage mediated by eosinophils, maintain a healthy state
.
Mepolizumab is the world's first anti-IL-5 monoclonal antibody approved for marketing
.
In the United States, the FDA has approved a number of indications for mepolizumab, including severe asthma, adult patients with eosinophilic granulomatous vasculitis, adults and children over 12 years of age with eosinophilia (HES) patients , accompanied by nasal polyps and chronic sinusitis (CRSwNP) patients, and so on
.
Image source: 123RF's effectiveness and safety have been verified.
In an international multicenter, randomized, double-blind, placebo-controlled study called MIRRA, 136 patients diagnosed with relapsed or refractory eosinophilic granulomatosis were included Patients with polyangiitis, at least 6 months old (age ≥18 years)
.
The patients who participated in the trial were injected with 300 mg of mepolizumab, or the control drug, every four weeks; a total of 52 weeks of treatment and 8 weeks of follow-up were used to evaluate the effectiveness and safety of this drug
.
The results of the study showed that compared with placebo, the remission period of the mepolizumab group was prolonged, the long-term remission rate increased by 12 times, and the annual recurrence rate was reduced by 50%
.
In addition, the oral corticosteroid (OCS) dose in the mepolizumab group was lower, and 60% of the patients fell below 7.
5 mg/day
.
Safety analysis shows that mepolizumab is safe.
The most common adverse reactions are headache, nasopharyngitis, arthralgia, sinusitis and upper respiratory tract infection.
The incidence of serious adverse reactions related to treatment is low (4%)
.
Image source: 123RF We expect that the approval of mepolizumab injection will bring new treatment options for patients with eosinophilic granulomatous polyangiitis and help patients better control this refractory disease Autoimmune diseases and thus a better life
.
It is recommended to read once a day to effectively control blood sugar throughout the day! The basal insulin GLP-1RA injection was approved for marketing! New choice for diabetes treatment! The new generation of insulin sensitizer "siglita sodium" was approved to be marketed for the treatment of malignant pleural mesothelioma, and dual immunotherapy was approved! The patient assistance project was launched simultaneously, China ushered in the second CAR-T product! Recommendations for the treatment of relapsed or refractory large B-cell lymphoma! For the treatment of classic Hodgkin’s lymphoma, another new anti-PD-1 antibody drug was approved.
Reference materials [1] Multidisciplinary Expert Consensus Compilation Group on the Diagnosis and Treatment of Eosinophilic Granulomatous Polyangiitis, (2018).
Eosinophilic Granuloma Multidisciplinary expert consensus on the diagnosis and treatment of polyangiitis.
Chinese Journal of Tuberculosis and Respiratory Diseases, DOI:10.
3760/cma.
j.
issn.
1001-0939．2018.
07.
002.
[3] Release of drug approval certificate pending information on November 19, 2021.
Retrieved Nov 24 2021, from https:// yppjfb/20211119085349161.
html[3] The world's first biologic agent for the treatment of adult eosinophilic granulomatous polyangiitis, Xin Kolai, was officially approved in China.
Retrieved Nov 24 2021, from https://mp.
weixin .
qq.
com/s/xi79GxayOIg90S0QQAyE4w Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.
This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a treatment recommendation either
.
If you need guidance on treatment plans, please go to a regular hospital for treatment
.
.
Public information shows that Mepolizumab is the world's first monoclonal antibody biologics targeting human interleukin-5 (IL-5) approved for marketing
.
The drug has been approved for marketing in China, which is expected to bring more effective and safe treatment options for patients
.
Screenshot source: Rare autoimmune disease on NMPA official website Eosinophilic granulomatous polyangiitis is a rare autoimmune disease.
The peak age of onset is 30-40 years old, and both men and women may suffer from the disease
.
Relevant data show that the annual incidence of eosinophilic granulomatous polyangiitis is 0.
5 to 6.
8 per million
.
Patients with bronchial asthma belong to the high-risk group of the disease, with an annual incidence rate of 64.
4 per million
.
Unlike other vasculitis, eosinophilic granulomatosis with polyangiitis is the earliest and most easily affected parts of the respiratory tract and lungs.
However, as the disease progresses, multiple systems in the patient's body may be affected and cause irreversible organ damage.
Seriously threaten the lives of patients
.
According to the natural course of the disease, eosinophilic granulomatous polyangiitis can be divided into prodromal phase, tissue eosinophil infiltration phase and vasculitis phase
.
It should be noted that not all patients will go through these three stages, and there is no clear boundary between the three stages
.
Image source: 123RF symptoms vary greatly due to different organs involved.
Different organs are affected, and patients will also have different symptoms
.
Respiratory system involvement: Most patients develop wheezing.
More than 95% of patients have a history of wheezing and coughing.
75% of patients have allergic rhinitis.
These are typical initial symptoms of eosinophilic granulomatous polyangiitis.
Patients may also have recurrent rhinitis or nasal polyps
.
Heart involvement: Patients with severe heart involvement have a poor prognosis and are also the main cause of death of patients, accounting for about 50%
.
About 27% to 47% of patients may have heart involvement and show corresponding symptoms, such as dilated cardiomyopathy, eosinophilic endocarditis, eosinophilic myocarditis, coronary vasculitis, and heart valves Disease, congestive heart failure, pericarditis and pericardial effusion
.
Gastrointestinal involvement: The incidence is 37% to 62%.
Patients may experience gastrointestinal symptoms such as abdominal pain, diarrhea, gastrointestinal bleeding and even intestinal perforation
.
Nervous system involvement: Approximately 70% of patients will have multiple mononeuritis or mixed sensorimotor peripheral neuropathy
.
A typical polyneuritis is manifested as a drop of the wrist or foot
.
25% of patients have central nervous system involvement, manifested as diffuse brain lesions and cerebrovascular events
.
Kidney involvement: Although there are fewer people (about 1/3) of renal vasculitis, and the severity is low, it can quickly develop from a simple urine test abnormality to acute progressive glomerulonephritis
.
Skin involvement: 70% of patients may have skin involvement.
This is one of the main manifestations of vasculitis.
Patients may have purpura, nodules and papules distributed on the limbs and scalp
.
Multiple maculopapular rashes, erythema multiforme, lively reticularis, blisters, sterile pustules, petechiae, ecchymosis and urticaria can all appear at different stages of the disease, and papules and nodular lesions may occur Necrosis or rupture
.
Image source: 123RF, the world's first approved anti-IL-5 monoclonal antibody, mepolizumab.
The therapeutic target of mepolizumab is the cytokine-interleukin-5 (IL-5)
.
IL-5 is the main cytokine for the maturation, activation and survival of eosinophils
.
Mepolizumab binds to IL-5 and blocks the binding of IL-5 to the surface receptors of eosinophils, inhibits the biological activity of eosinophils and reduces the number of eosinophils to a normal level, thereby reducing eosinophilia The growth of granulocytes, as well as inflammation and tissue damage mediated by eosinophils, maintain a healthy state
.
Mepolizumab is the world's first anti-IL-5 monoclonal antibody approved for marketing
.
In the United States, the FDA has approved a number of indications for mepolizumab, including severe asthma, adult patients with eosinophilic granulomatous vasculitis, adults and children over 12 years of age with eosinophilia (HES) patients , accompanied by nasal polyps and chronic sinusitis (CRSwNP) patients, and so on
.
Image source: 123RF's effectiveness and safety have been verified.
In an international multicenter, randomized, double-blind, placebo-controlled study called MIRRA, 136 patients diagnosed with relapsed or refractory eosinophilic granulomatosis were included Patients with polyangiitis, at least 6 months old (age ≥18 years)
.
The patients who participated in the trial were injected with 300 mg of mepolizumab, or the control drug, every four weeks; a total of 52 weeks of treatment and 8 weeks of follow-up were used to evaluate the effectiveness and safety of this drug
.
The results of the study showed that compared with placebo, the remission period of the mepolizumab group was prolonged, the long-term remission rate increased by 12 times, and the annual recurrence rate was reduced by 50%
.
In addition, the oral corticosteroid (OCS) dose in the mepolizumab group was lower, and 60% of the patients fell below 7.
5 mg/day
.
Safety analysis shows that mepolizumab is safe.
The most common adverse reactions are headache, nasopharyngitis, arthralgia, sinusitis and upper respiratory tract infection.
The incidence of serious adverse reactions related to treatment is low (4%)
.
Image source: 123RF We expect that the approval of mepolizumab injection will bring new treatment options for patients with eosinophilic granulomatous polyangiitis and help patients better control this refractory disease Autoimmune diseases and thus a better life
.
It is recommended to read once a day to effectively control blood sugar throughout the day! The basal insulin GLP-1RA injection was approved for marketing! New choice for diabetes treatment! The new generation of insulin sensitizer "siglita sodium" was approved to be marketed for the treatment of malignant pleural mesothelioma, and dual immunotherapy was approved! The patient assistance project was launched simultaneously, China ushered in the second CAR-T product! Recommendations for the treatment of relapsed or refractory large B-cell lymphoma! For the treatment of classic Hodgkin’s lymphoma, another new anti-PD-1 antibody drug was approved.
Reference materials [1] Multidisciplinary Expert Consensus Compilation Group on the Diagnosis and Treatment of Eosinophilic Granulomatous Polyangiitis, (2018).
Eosinophilic Granuloma Multidisciplinary expert consensus on the diagnosis and treatment of polyangiitis.
Chinese Journal of Tuberculosis and Respiratory Diseases, DOI:10.
3760/cma.
j.
issn.
1001-0939．2018.
07.
002.
[3] Release of drug approval certificate pending information on November 19, 2021.
Retrieved Nov 24 2021, from https:// yppjfb/20211119085349161.
html[3] The world's first biologic agent for the treatment of adult eosinophilic granulomatous polyangiitis, Xin Kolai, was officially approved in China.
Retrieved Nov 24 2021, from https://mp.
weixin .
qq.
com/s/xi79GxayOIg90S0QQAyE4w Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.
This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a treatment recommendation either
.
If you need guidance on treatment plans, please go to a regular hospital for treatment
.
