Skip To Main Content

Det finns mer bakom okontrollerad astma

DUPIXENT går längre än att bara påverka EOS genom att angripa typ 2-inflammation1-3

MER PRECISION
Den enda biologiska behandlingen som specifikt riktar in sig på både IL-4 och IL-13 för att stoppa lokal och systemisk typ 2-inflammation vid källan1-3,a
MER MÖJLIGHETER
Förbättringar som dina patienter kan känna, och varaktigt skydd mot sjukdomsprogression som du kan se1,4,b
Utforska mer Lär mer

up to

up to

up to

up to

SE bifogad annons1

Dupixent är indicerat för vuxna och ungdomar (12 år och äldre), som tillägg till underhållsbehandling vid svår astma med typ 2 inflammation, som kännetecknas av förhöjda nivåer av eosinofiler och/eller förhöjd kväveoxidhalt i utandningsluften (FeNO), se avsnitt Farmakodynamik, som är otillräckligt kontrollerad trots hög dos inhalerad kortikosteroid (ICS) i kombination med ett annat läkemedel för underhållsbehandling.

Dupixent är indicerat för barn 6 till 11 år, som tillägg till underhållsbehandling vid svår astma med typ 2 inflammation, som kännetecknas av förhöjda nivåer av blod eosinofiler och/eller förhöjd kväveoxidhalt i utandningsluften (FeNO), se avsnitt Farmakodynamik, som är otillräckligt kontrollerad trots medel till hög dos inhalerad kortikosteroid (ICS) i kombination med ett annat läkemedel för underhållsbehandling.

Se övriga indikationer i den obligatoriska informationen.

SmPC

Verkningsmekanism

MOD

IL-4 OCH IL-13 ÄR CENTRALA DRIVKRAFTER BAKOM TYP 2-INFLAMMATION2,11

MOD

IL-4 och IL-13 bidrar till systemisk eosinofil och allergisk inflammation samt lokala inflammatoriska effekter2,11

MOA

ÖKAD PRECISION FÖR ATT RIKTA IN SIG PÅ BÅDE IL-4 OCH IL-13 FÖR ATT PÅVERKA TYP 2-INFLAMMATION VID KÄLLAN1,3

lungs

SYSTEMIC INFLAMMATION

Reduces Type 2 Biomarkers1,2,11-17

Airways

SYSTEMIC INFLAMMATION

Improves Airway Structures1,2,11-17

Allergic inflammationa

  • B-cell class switching and IgE production
  • Mast cell IgE-dependent and -independent activation

Eosinophilic inflammationa

  • Eosinophil trafficking
  • Airway smooth muscle hypertrophy
  • Airway remodeling
  • Epithelial barrier dysfunction
  • Elevated FeNO levels
  • Mucus hypersecretion
  • Collagen production and fibrosis
MOA_Cells

DUPIXENT går längre än att bara påverka EOS genom att specifikt rikta in sig på IL-4 och IL-13 för att skydda mot strukturella luftvägsskador och sjukdomsprogression1-3

Patient typer

FLER MÖJLIGHETER FÖR PATIENTER MED TYP 2-ASTMA1

DUPIXENT GÅR LÄNGRE ÄN EOS FÖR ATT GÖRA MER FÖR PATIENTER MED TYP 2-ASTMA3,n

Type 2 Asthma

Patient | Ålder 35

EOS 370 cells/μL, IgE 270 IU, FeNO 15 ppb

FeNO

IDENTIFIERA TYP 2-ASTMA: FÖRHÖJDA EOS OCH/ELLER FÖRHÖJT FeNO, OAVSETT ALLERGISTATUS5

up to

icon

75% reduction in annualized severe exacerbations5,a

icon

IMPROVED LUNG FUNCTION, WHICH WAS STRONGLY CORRELATED WITH A REDUCTION OF MUCUS PLUGGING related to the anti-inflammatory effect of Dupixent7,m

~3 years

of sustained breathing relief patients can feel18,b

90%

of patients experienced zero exacerbations19,c

Typ 2 biomarkörer

59%

av patienter med typ 2-astma har mer än en förhöjd typ 2-biomarkör10,*

Biomarkers

Förhöjda EOS förekommer utan andra biomarkörer hos ~8% av patienter med typ 2-astma10*

DUPIXENT GÖR MER FÖR TYP 2-ASTMAPATIENTER SOM ANVÄNDER OCS19

Christina

Patient | Ålder 41

EOS 110 cells/μL; IgE 72 IU; FeNO 20 ppb

FeNO

DEN FÖRSTA OCS-KUREN ÄR DET FÖRSTA TECKNET PÅ ATT UTVÄRDERA FÖR TYP 2-ASTMA1,3,19-21

icon

94% of patients maintained complete elimination19,d

up to

icon

250 mL improvement in lung function19,e

icon

90% were exacerbation-free19,f

DUPIXENT GÖR MER FÖR PATIENTER MED ALLERGISK STATUS5

Allergic Status

Patient | Ålder 38

EOS 140 cells/μL; IgE 325 IU; FeNO 33 ppb

FeNO

DUPIXENT ÄR EFFEKTIVT HOS PATIENTER MED ALLERGISK STATUS SOM HAR FÖRHÖJDA EOS OCH/ELLER FÖRHÖJT FeNO5

EOS + Allergic

icon

470 mL improvement in lung function5,g

FeNO + Allergic

icon

470 mL improvement in lung function5,h

EOS + FeNO + Allergic

icon

550 mL improvement in lung function5,i

DUPIXENT HOS BARN MED TYP 2-ASTMA20,21

Children

Patient | Ålder 10

EOS 305 cells/μL; IgE 22 IU; FeNO 30 ppb

FeNO

IDENTIFIERA TYP 2-ASTMA: FÖRHÖJDA EOS OCH/ELLER FÖRHÖJT FeNO, OAVSETT ALLERGISTATUS

up to

icon

470 mL improvement in lung function20,j

icon

66% reduction in exacerbation20,k

ZERO

exacerbations in 91% of children21,l

Effekt

Lung funktion (>1 biomarkörer, FeNO, EOS)

>1 Biomarkör

BÄTTRE ANDNING INNEBÄR FLER MÖJLIGHETER FÖR PATIENTER MED TYP 2-ASTMA5

I en post hoc-analys uppvisade patienter med mer än en förhöjd biomarkör signifikant förbättring av FEV1 vid vecka 525

EOS + Allergic

icon

440 mL improvement5,a

EOS + FeNO

icon

530 mL improvement5,b

FeNO + Allergic

icon

440 mL improvement5,c

EOS + FeNO + Allergic

icon

500 mL improvement5,d

>1 biomarker

icon

VISSA PATIENTER UPPNÅDDE MER ÄN EN HALV LITERS FÖRBÄTTRING AV LUNGFUNKTIONEN5

Förhöjd FeNO

BÄTTRE ANDNING INNEBÄR FLER MÖJLIGHETER FÖR TYP 2-ASTMAPATIENTER MED FÖRHÖJT FeNO18,22

Elevated FeNO_Improvement

~3 YEARS OF SUSTAINED RELIEF was seen in the OLE study18,c

Nitric-Oxide

ENLIGT GINA ÄR FÖRHÖJT FeNO STARKT PREDIKTIVT FÖR BEHANDLINGSSVAR MED DUPIXENT23

Förhöjd EOS

BÄTTRE ANDNING INNEBÄR FLER MÖJLIGHETER FÖR PATIENTER MED FÖRHÖJDA EOS22

Elevated EOS_Improvement

~3 YEARS OF SUSTAINED RELIEF was seen in the OLE study18,c

OCS

ENLIGT GINA ÄR FÖRHÖJDA EOS STARKT PREDIKTIVA FÖR BEHANDLINGSSVAR MED DUPIXENT23

In patients with EOS ≥500 cells/μL

icon

490 mL improvement in FEV1 at Week 525,a

Exacerbations (>1 biomarker, FeNO, EOS)

>1 biomarker

ÖKAD FRIHET FRÅN EXACERBATIONER HOS PATIENTER MED TYP 2-ASTMA5

I en post hoc-analys uppvisade patienter med mer än en förhöjd biomarkör signifikant minskning av exacerbationer vid vecka 525

EOS + Allergic

icon

59% reduction5,a

EOS + FeNO

icon

73% reduction5,b

FeNO + Allergic

icon

64% reduction5,c

EOS + FeNO + Allergic

icon

75% reduction5,d

Biomarker_Hero Image

Förhöjd FeNO

ÖKAD FRIHET FRÅN EXACERBATIONER FÖR PATIENTER MED FÖRHÖJT FeNO18,22

Signifikant minskning av exacerbationer för patienter med typ 2-astma med FeNO ≥25 ppb vid vecka 52, bibehållen i ~3 år18,22

Elevated FeNO

up to

icon

69% reduction24,a

~3 YEARS OF SUSTAINED PROTECTION was seen in the OLE study18,b

Nitric-Oxide

ENLIGT GINA ÄR FÖRHÖJT FeNO STARKT PREDIKTIVT FÖR BEHANDLINGSSVAR MED DUPIXENT23

A severe exacerbation event was defined as a deterioration of asthma requiring the use of systemic corticosteroids for ≥3 days or hospitalization or an ED visit. The population in dupilumab asthma trials included patients on medium- to high-dose ICS. All data presented above represent the high-dose ICS population.

Förhöjd EOS

ÖKAD FRIHET FRÅN EXACERBATIONER FÖR PATIENTER MED FÖRHÖJDA EOS22

Signifikant minskning av exacerbationer för patienter med typ 2-astma med förhöjda EOS vid baslinjen vid vecka 52, bibehållen i ~3 år22

Elevated EOS

EOS ≥150 cells/μL
up to

icon

55% Reduction22,a

EOS ≥300 cells/μL
up to

icon

66% Reduction22,b

EOS ≥500 cells/μL
up to

icon

70% Reduction5,c

~3 YEARS OF SUSTAINED PROTECTION was seen in the OLE study18,d

OCS

ENLIGT GINA ÄR FÖRHÖJDA EOS STARKT PREDIKTIVA FÖR BEHANDLINGSSVAR MED DUPIXENT23

A severe exacerbation event was defined as a deterioration of asthma requiring the use of systemic corticosteroids for ≥3 days or hospitalization or an ED visit.

The population in dupilumab asthma trials included patients on medium- to high-dose ICS. All data presented above represent the high-dose ICS population.

QUEST22 was a randomized, double-blind, placebo-controlled, parallel-group trial that assessed the efficacy of DUPIXENT in 1,902 patients 12 years of age or older patients with uncontrolled, moderate-to-severe asthma. The primary endpoints were the annualized rate of severe asthma exacerbations and the absolute change from baseline to Week 12 in FEV1 before bronchodilator use in the overall trial population. Secondary endpoints included the exacerbation rate and FEV1 in patients with a blood eosinophil count of 300 or more per cubic millimeter. Asthma control and DUPIXENT safety were also assessed.

TRAVERSE5 was an open-label extension study that assessed the safety and efficacy of DUPIXENT 300 mg every 2 weeks up to 96 weeks in adults and adolescents (aged 12- 84 years) with moderate-to-severe or oral-corticosteroid–dependent severe asthma who had completed a previous DUPIXENT asthma study (including QUEST). The primary endpoint was the number and percentage of patients with any treatment-emergent adverse events. Secondary endpoints included an annualized exacerbation rate (AER) over the treatment period and change from parent study baseline in pre-bronchodilator FEV1.

OCS-eliminering (24 veckor, 49-58 veckor)

24 Veckor

DUPIXENT GÖR MER FÖR ATT eliminera24

24 Weeks

52% of patients completely eliminated OCS by Week 24 in the VENTURE study1,19,24

VENTURE Trident

49-58 weeks

DUPIXENT GÖR MER FÖR ATT SÄKERSTÄLLA ATT PATIENTER FÖRBLIR FRIA FRÅN OCS19

VENTURE

Complete elimination of OCS achieved through Week 24 and sustained through Week 9619

TRAVERSE Trident

Mukusproppar

Dupixent och mukusproppar4,6

Lung function improvement, was strongly correlated with a reduction of mucus plugging4

  • 660 mL improvement in pre-BD FEV1 vs 270 mL with placebo26,d
  • 48% improvement in ACQ-7 from baseline27,e

 

Mucus Plugs_Baseline
Mucus Plugs_Week 24

The VESTIGE trial was a phase 4, randomized, double-blind, placebo-controlled study that used functional respiratory imaging (FRI) to evaluate the effect of dupilumab on airway inflammation, as well as structural and functional changes in the lungs. The primary endpoints were proportion of patients achieving FeNO <25 ppb at Week 24, and change from baseline to Week 24 in airway volume. Secondary endpoints included change in global mucus score from baseline at Week 24 determined by high-resolution computed tomography (HRCT), and change from baseline in airway resistance.

ACQ-5 and AQLQ

DUPIXENT GÖR MER FÖR ATT FÖRBÄTTRA ASTMAKONTROLL OCH LIVSKVALITET1

Signifikant förbättrade ACQ-5- och AQLQ(S)-poäng hos patienter med typ 2-astma vid vecka 521,a

ACQ5 and AQLQ

ACQ-5
up to

icon

76% of patients improved asthma control1,b

AQLQ(S)
up to

icon

71% of patients improved QoL1,c

DUPIXENT förbättrade ACQ-5-poäng signifikant1

QUEST was a 52-week randomized, double-blind, placebo-controlled, parallel-group trial that assessed the efficacy of DUPIXENT in 1,902 patients (12 years of age or older) with uncontrolled, moderate-to-severe asthma on a medium to high dose of ICS and a second controller (+/- a third controller). Subjects were randomized to receive either 200 mg or 300 mg DUPIXENT Q2W (or matching placebo for either 200 mg or 300 mg). following an initial dose of 400 mg, 600 mg, or placebo, respectively. The primary endpoints were the annualized rate of severe asthma exacerbations during the 52-week period and the absolute change from baseline to Week 12 in pre-bronchodilator FEV1 in the overall population. Secondary endpoints included the annualized exacerbation rate and pre-BD FEV1 in patients with a blood eosinophil count of 300 or more per microliter, as well as responder rates in the ACQ-5 and AQLQ(S), and safety.1

Studieupplägg (ungdomar/vuxna, barn)

adolescents/adults

DUPIXENT HAR STUDERATS I ETT KLINISKT PROGRAM SOM INKLUDERADE ~3 000 PATIENTER1,22,24,28

Kliniska prövningar inkluderade patienter (12+) med okontrollerad, måttlig till svår astma driven av typ 21,22,24,28

Study Design

Egenskaper hos vuxna och ungdomspatienter i 3 studier1,22,24,28

Patient Characteristics

Extension trial of patients from DRI12544, QUEST, and VENTURE1,18,19

Traverse OLE Study

Primary endpoint

The number and percentage of patients with any treatment-emergent adverse events.

The LIBERTY ASTHMA TRAVERSE evaluated the long-term safety, tolerability, and efficacy of DUPIXENT in adults and adolescents who enrolled from a previous DUPIXENT study, including DRI12544, QUEST, and VENTURE.19

Select other endpoints

  • Number and annualized rate of severe exacerbation events
  • Improvement in FEV1
  • In the OCS-dependent population, percent reduction from baseline in OCS dose and proportions of patients achieving ≥50% reduction and completely tapering off OCS19

VESTIGE: the largest study using novel FRI technology with an asthma biologic.4

The VESTIGE trial was a phase 4, randomized, double-blind, placebo-controlled study that used functional respiratory imaging (FRI) to evaluate the effect of dupilumab on airway inflammation, as well as structural and functional changes in the lungs. The study population consisted of patients aged 21 to 70 years with uncontrolled moderateto- severe asthma (Asthma Control Questionnaire [ACQ]-5 score ≥1.5), pre-BD FEV1 ≤80% of predicted value, ≥1 exacerbation in prior year, blood eosinophil count ≥300 cells/μL, and FeNO ≥25 ppb.4,a

Primary endpoints:

  • Proportion of patients achieving FeNO <25 ppb at Week 24
  • Percent change from baseline to Week 24 in airway volume corrected for lung volume (siVaw) at TLC

Secondary endpoints:

  • Change in global mucus score from baseline at Week 24 determined by highresolution computed tomography (HRCT)
  • Percent change from baseline to Week 24 in airway resistance • (siRaw) at TLC

FULL INDICATION STATEMENTS

ATOPIC DERMATITIS1

DUPIXENT is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.

DUPIXENT is indicated for the treatment of severe atopic dermatitis in children 6 to 11 years old who are candidates for systemic therapy.

ASTHMA1

DUPIXENT is indicated in adults and adolescents 12 years and older as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), who are inadequately controlled with high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.

DUPIXENT is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment.

CRS WITH NASAL POLYPS (CRSwNP)1

DUPIXENT is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adults with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control.

PRURIGO NODULARIS (PN)1

DUPIXENT is indicated for the treatment of adults with moderate-to-severe prurigo nodularis (PN) who are candidates for systemic therapy.

EOSINOPHILIC ESOPHAGITIS (EoE)1

DUPIXENT is indicated for the treatment of eosinophilic esophagitis in adults and children aged 1 year and older, weighing at least 15 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy.

CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)1

DUPIXENT is indicated in adults as add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils on a combination of an inhaled corticosteroid (ICS), a long-acting beta2- agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate.

SmPC

Säkerhet

Safety

6 ÅRS ETABLERAD SÄKERHET VID ASTMA1

DUPIXENT tolererades genomgående väl hos vuxna och ungdomar med astma, och uppvisade en säkerhetsprofil liknande den som observerats hos pediatriska populationer1,a

Safety Table

API

ABBREVIATED PRESCRIBING INFORMATION

Dosering

Dosing

PATIENTER ELLER VÅRDGIVARE KAN ADMINISTRERA HEMMA ELLER DU KAN ADMINISTRERA PÅ MOTTAGNINGEN

Rekommenderade doseringsscheman per patienttyp1:

Dosing_Aged 12 up

Dosing_Aged 6-11

SmPC

Administration

DUPIXENT Pre-filled Pen1

DUPIXENT Pre-filled Syringe1

  • Single-press auto-injector
  • A clear 2-step process
  • Visual and audible feedback
  • Hidden needle
  • Manual control of injection speed
  • Finger grip
  • Visual confirmation of injection delivery
  • Needle shield

Dosing_pens

Dosing_injectors

DUPIXENT is intended for use under the guidance of a healthcare provider1

  • DUPIXENT can be injected by a patient or caregiver at home after training in a subcutaneous injection technique using the auto-injection pen (for adults and adolescents) or pre-filled syringe
  • Physicians or nurses should provide proper training to patients and/or caregivers on the preparation and administration of DUPIXENT prior to use, according to the Instructions for Use
  • DUPIXENT can be administered in the office under the guidance of a healthcare provider if the patient or caregiver is not an appropriate candidate to administer the injection

SmPC

Resources

ACQ-5, Asthma Control Questionnaire, 5-Item version
ACQ-5-IA, Asthma Control Questionnaire-5, Interviewed Administered
ACQ-7-IA, Asthma Control Questionnaire-7, Interviewer Administered
AQLQ(S), Asthma Quality of Life Questionnaire
BD, bronchodilator
COPD, chronic obstructive pulmonary disease
CRS, chronic rhinosinusitis
CRSwNP, chronic rhinosinusitis with nasal polyps
CSU, chronic spontaneous urticaria
CT, computed tomography
ED, emergency department
EoE, eosinophilic esophagitis
EOS, eosinophils
FeNO, fraction of exhaled nitric oxide
FEV1, forced expiratory volume in 1 second
FEF, Forced Expiratory Flow
FRI, functional respiratory imaging
GINA, Global Initiative for Asthma
HCPs, healthcare professionals
HD-ICS, high-dose inhaled corticosteroids
HRCT, high-resolution computed tomography
ICS, inhaled corticosteroids
ILC2, type 2 innate lymphoid cells
ISAR, International Severe Asthma Registry
ITT, intention-to-treat
LABA, long-acting beta agonist
LAMA, long-acting muscarinic antagonist
LSM, least squares mean
LTRA, leukotriene receptor antagonist
OCS, oral corticosteroids
OLE, open-label extension
OR, odds ratio
PAQLQ(S)-IA, Pediatric Asthma Quality of Life Questionnaire with Standardized Activities-Interviewer Administered
PACQLQ, Pediatric Asthma Caregiver’s Quality of Life Questionnaire
PROs, patient-reported outcomes
PSBL, parent study baseline
Q2W, once every 2 weeks
Q4W, once every 4 weeks
QoL, quality of life
SCS, systemic corticosteroid
SE, standard error
siRaw, airway resistance
siVaw, airway volume
SOC, standard of care
TLC, total lung capacity
TSLP, thymic stromal lymphopoietin

References