New anti-inflammatory drugs! Sanofi/Regenerative Dupixent (Dabito®) significantly delays lung function decline in asthma patients: the efficacy is maintained for 3 years!

!-- webeditor: page s." -- September 09, 2020 / -- Sanofi and Regeneron recently in 2020 The results of a phase 3 open label expansion trial of the anti-inflammatory drug Dupixent (Chinese: Dabito, generic name: Dupiu monoanti, dupilumab) were presented at the International Conference of the European Respiratory Society (ERS).
trial showed that in adults and adolescents with moderate to severe asthma, previously observed Dupixent efficacy and safety can be maintained for up to three years.
Dr Michael Wechsler, lead investigator on the trial and director of the National Jewish Cohen Family Asthma Institute in Denver, Colorado, said: "These data suggest that Dupixent can slow the decline in lung function experienced by many people with moderate to severe asthma and continue to improve lung function for up to three years.
, patients treated with Dupixent maintained asthma control and reduced the risk of severe asthma attacks that could lead to hospitalization.
data reinforce Dupixent's importance as an ongoing long-term treatment that improves the patient's ability to breathe and maintains control over asthma, especially in patients with high potential type 2 inflammatory markers.
" phase 3 open label extension trial assessed the long-term safety and efficacy of Dupixent in 2,282 adult and adolescent patients with moderate to severe asthma who had previously participated in three key controlled clinical trials of Dupixent, including in patients with moderate to severe asthma Key phase 2b DRI (24 weeks) and phase 3 QUEST (52 weeks) trials were conducted, and phase 3 VENTURE (24 weeks) trials were conducted in patients with severe oral corticosteroid (OCS) dependent asthma.
patients who completed Dupixent or placebo therapy in these trials entered the development label extension trial and received up to 2 years of additional treatment, providing a total of up to 3 years of treatment data.
open-label extended trial, patients received 300mg Dupixent every other week for 96 weeks, in addition to standard care maintenance therapy.
safety analysis included patients from all 3 key trials, and efficacy and biomarker analysis included patients from key 2b stage DRI and phase 3 QUEST trials who did not rely on OCS.
long-term efficacy data from OCS-dependent patients will be presented at a future meeting.
end of the disease is the number and proportion of patients with adverse events within 96 weeks.
of the analysis of efficacy included the average change of FEV1 and the annualized severe aggravation rate.
type 2 inflammation is defined as baseline exhalation of nitric oxide (FeNO-25ppb) or blood-thymosinophils (-150 cells/microliers) at the start of the trial. The results presented at the
ERS conference were as follows: - Efficacy data: (1) Lung function: Patients continued to improve lung function by 13-22% during 96 weeks of treatment, as measured by an average change in maximum force exhalation capacity (FEV1) in the first second compared to the baseline of the initial asthma trial.
(2) asthma attacks: Patients maintained a low rate of severe asthma attacks (unaljusted annualized severe exacerbation rates) - an average of 0.31-0.35 incidents per year.
the year before the Dupixent trial began, the rate of severe asthma attacks was 2.09-2.17 per year.
type 2 inflammation: In patients with elevated type 2 inflammation markers at baseline, haemophilus acidophils or exhaled nitric oxide (FeNO), improvements in lung function and asthma attacks were more pronounced.
these long-term results, hemophilia (23-35%) and blood IgE (82%) were reduced in patients with the critical Phase 2b trial compared to the baseline of the initial asthma trial.
- Safety data: In open label extension trials, the proportion of patients with adverse events (AEs) was similar to the proportion in previous Dupixent asthma-critical trials.
during the 96-week treatment period, the overall rate of adverse reactions was 76-88%, with the most common adverse reactions being rhinitis (18-26%) and erythema at the injection site (2-23%).
serious adverse events in 9-13% of patients.
Dupixent, launched at the end of March 2017, has been approved to treat three diseases caused by type 2 inflammation: moderate to severe endexual dermatitis (in patients aged 6 years), moderate to severe asthma (in patients aged 12 years), and chronic nasal sinusitis (CRSwNP, adult patients).
Dupixent is an all-human monoclonal antibody that inhibits signaling of lecytolein-4 (IL-4) and lebinocyte mesotonin-13 (IL-13).
data from the Dupixent clinical trial show that IL-4 and IL-13 are key drivers of type 2 inflammation and play a key role in asthma, CRSwNP and endexual dermatitis.
more than 170,000 patients received Dupixent treatment for all approved adaptations worldwide.
, in June, Dupixent was approved by the State Drug Administration (NMPA) to treat moderate to severe endexual dermatitis (AD) in adults.
Dabito is the world's first and only approved target biologic agent for the treatment of severe specific dermatitis in adults, filling the unsuperfected needs of domestic clinics and rapidly, significantly and continuously improving the degree of dermatation and itching in patients with specific dermatitis.
the drug regulatory reform, Dabito was approved in China two years ahead of schedule, providing Chinese patients with new treatment options.
currently, Sanofi and Regeneratives are also conducting an extensive clinical project to assess Dupixent's treatment of diseases caused by allergies and other type 2 inflammations, including: childhood asthma (6-11 years, stage III), childhood endexual dermatitis (6 months to 5 months) age, Phase II/III), eosinophilic esophagealitis (Phase III), chronic obstructive pulmonary disease (Phase III), herpes-like herpes (Phase III), nodding itch (Phase III), chronic spontaneous urticaria (Phase III), food and environmental allergies (Phase II).
!--/ewebeditor:page--!--ewebeditor:page title"--Dupixent is another important product developed by Sanofi in collaboration with regeneratives following the PCSK9 inhibitor-type lipid-lowering drug Praluent, and is expected to be a game-changing drug.
, Dupixent's adaptive disorder is steadily increasing, with drug market research agency Evaluate Pharma predicting that global sales of the drug will reach $8 billion by 2024.
() Origin: Dupixent? (dupilumab) Long-term Data Show Sustained Development in Lung Function and Reduction in Severe Directorions in Adults and Adityans with Moderate-to-severe Asthma !--/ewebeditor: page.