natgillin/translations-raw huggingface dataset:
Approximately 6 % of patients with atopic dermatitis or asthma who received dupilumab 300 mg Q2W for 52 weeks developed ADA to dupilumab; approximately 2 % exhibited persistent ADA responses and approximately 2 % had neutralizing antibodies.
ADA so se pojavila pri približno 6 % bolnikov z atopijskim dermatitisom ali astmo, ki so 52 tednov prejemali 300 mg dupilumaba vsaka dva tedna; približno 2 % bolnikov sta imela trajen odziv ADA in približno 2 % sta imela nevtralizacijska protitelesa.
Do not heat the syringe.
Brizge ne segrevajte.
• eye dryness, redness and itching
• suhost, pordelost in srbenje oči
No clinical studies have been conducted to evaluate the effect of renal impairment on the pharmacokinetics of dupilumab.
Kliničnih študij za ovrednotenje vpliva okvare ledvic na farmakokinetiko dupilumaba niso izvedli.
Injection site erythema Injection site oedema Injection site pain Injection site pruritus
Eritem na mestu injiciranje Edem na mestu injiciranja
Very rare cases of serum sickness/serum sickness-like reactions and anaphylactic reaction have been reported following administration of dupilumab (see section 4.4).
Po uporabi dupilumaba so poročali o zelo redkih primerih serumske bolezni/serumski bolezni podobnih reakcijah in anafilaktični reakciji (glejte poglavje 4.4).
Table 9: Other secondary endpoint results of dupilumab with concomitant TCS at Week 16 and Week 52 in CHRONOS
Preglednica 9: Rezultati drugih sekundarnih opazovanih dogodkov dupilumabaskupaj s sočasnimi LKS po 16. in 52. tednih v študiji CHRONOS Sočasna uporaba LKS
Results were evaluated in the overall population (unrestricted by minimum baseline eosinophils or other type 2 inflammatory biomarkers) and subgroups based on baseline blood eosinophils count.
Rezultate so ovrednotili v celotni populaciji (ki ni bila omejena z najmanjšo izhodiščno vrednostjo eozinofilcev ali drugih bioloških označevalcev vnetja tipa 2) in v podskupinah glede na izhodiščno število eozinofilcev v krvi.
Do not put the yellow cap back on.
Rumenega pokrovčka ne nameščajte nazaj na peresnik.
If necessary, pre-filled syringes or pre-filled pens may be kept at room temperature up to 25°C for a maximum of 14 days.
Če je treba, je mogoče napolnjene injekcijske brizge ali napolnjene injekcijske peresnike shranjevati na sobni temperaturi do 25 °C največ 14 dni.
This device is a single-use pre-filled syringe.
Ta pripomoček je napolnjena injekcijska brizga za enkratno uporabo.
LS Mean Difference vs. placebo (95% CI)
LS v primerjavi s placebom (95 % IZ)
Severity Index (EASI) score ≥16, and a minimum body surface area (BSA) involvement of ≥ 10 %.
Investigator's Global Assessment) ≥ 3, oceno prizadetosti ekcemskega predela (EASI - Eczema Area and Severity Index) ≥ 16 in zajetostjo ≥ 10 % telesne površine.
The instructions for the preparation and administration of Dupixent in a pre-filled syringe are given in the package leaflet.
Navodila za pripravo in dajanje zdravila Dupixent v napolnjeni injekcijski brizgi so navedena v navodilu za uporabo zdravila.
After the last steady state dose, the median time for dupilumab concentrations to decrease below the lower limit of detection, estimated by population PK analysis, was 9 weeks for the 200 mg Q2W, 1011 weeks for the 300 mg Q2W regimen and 13 weeks for the 300 mg QW regimen.
Po zadnjem odmerku v stanju dinamičnega ravnovesja je bil s populacijsko FK analizo ocenjeni mediani čas, ko se je koncentracija dupilumaba zmanjšala pod spodnjo mejo zaznavne, je bil 9 tednov ob uporabi odmerka 200 mg vsak drugi teden, 10 -11 tednov ob uporabi odmerka 300 mg vsak drugi teden in 13 tednov po uporabi odmerka 300 mg vsak teden.
• fever
• Stegno
Clinically significant increases in pre-bronchodilator FEV1 were observed at week 12 for DRI12544 and QUEST.
Klinično pomembna povišanja FEV1 (FEV1 - Forced expiratory volume in 1 second) pred bronhodilatatorjem so bila opažena po 12. tednih v študijah DRI12544 in QUEST.
Parasitic (intestinal parasites) infection
Okužbe z zajedavci (črevesnimi zajedavci)
In the monotherapy studies, the proportion of patients who discontinued treatment due to adverse events was 1.9 % of the placebo group, 1.9 % of the dupilumab 300 mg Q2W group, 1.5 % of the dupilumab 300 mg QW group.
V študijah monoterapije je bil delež bolnikov, ki so zdravljenje prenehali zaradi neželenih učinkov, v skupini s placebom 1,9 %, skupini s 300 mg dupilumaba vsaka dva tedna 1,9 % in v skupini s 300 mg dupilumaba vsak teden 1,5 %.
Dupilumab, as a monoclonal antibody, is not expected to undergo significant renal elimination.
Ni pričakovati, da bi bil dupilumab, ki je monoklonsko protitelo, podvržen bistvenemu izločanju skozi ledvice.
For both the 200 mg and 300 mg every other week doses, significant improvements in FEV1 (LS mean change from baseline at eek 12) were observed (0.36 L and 0.27 L, respectively).
mg vsak drugi teden, so opazili pomembno izboljšanje FEV1 (razlika v povprečju LS od izhodišča do 12. tedna) (0,36 l oziroma 0,27 l).
B. Choose your injection site B1.
B. Izberite mesto injiciranja
Dupilumab 300 mg Q2W N=81
Dupilumab 300 mg vsak drugi teden N=81
VENTURE was a 24-week oral corticosteroid-reduction study in 210 patients with asthma unrestricted by baseline type 2 biomarker levels who required daily oral corticosteroids in addition to regular use of high dose inhaled corticosteroids plus an additional controller.
bolnikih z astmo (brez omejitev glede izhodiščne ravni bioloških označevalcev tipa 2), ki so morali dnevno uporabljati peroralne kortikosteroide poleg redne uporabe velikega odmerka inhalacijskih kortikosteroidov in še nekega dodatnega zdravila za obvladovanje.
The solution should be clear to slightly opalescent, colourless to pale yellow.
Raztopina mora biti bistra do rahlo opalescentna, brezbarvna ali bledo rumena.
Dupixent is available as 300 mg pre-filled syringes in a pack containing 1 or 2 pre-filled syringes or in a pack containing 3 (3 packs of 1) or 6 (3 packs of 2) pre-filled syringes.
Zdravilo Dupixent, ki je na voljo v pakiranjih, ki vsebujejo po 1 ali po 2 napolnjeni 300 mg injekcijski brizgi, ali v pakiranjih, ki vsebujejo 3 (3 pakiranja po 1) ali 6 (3 pakiranja po 2) napolnjenih injekcijskih brizg.
Mean exacerbations in previous year ± SD 2.17 (2.14) High dose ICS use (%)a
Povprečno število poslabšanj v prejšnjem letu ± std. odklon Uporaba visokoodmernih IKS (%)a
In the concomitant TCS study (CHRONOS), across all treatment groups, the mean age was 37.1, the mean weight was 74.5 kg, 39.7 % were female, 66.2 % were white, 27.2 % were Asian, and 4.6 % were black.
37,1 leta, povprečna telesna masa 74,5 kg, 39,7 % je bilo žensk, 66,2 % je bilo belcev, 27,2 % Azijcev in 4,6 % črncev.
Results were evaluated in the overall population (unrestricted by minimum baseline eosinophils or other type 2 inflammatory biomarkers) and subgroups based on baseline blood eosinophil count.
Rezultate so ovrednotili v celotni populaciji (ki ni bila omejena z najmanjšo izhodiščno vrednostjo eozinofilcev ali drugih bioloških označevalcev vnetja tipa 2) in v podskupinah glede na izhodiščno število eozinofilcev v krvi .
Very rare cases of serum sickness/serum sickness-like reactions have been reported in the atopic dermatitis development program (see section 4.4).
V programu razvoja pri atopijskem dermatitisu so v zelo redkih primerih poročali o serumski bolezni/serumski bolezni podobnih reakcijah (glejte poglavje 4.4).
• An initial dose of 400 mg (two 200 mg injections), followed by 200 mg given every other week administered as subcutaneous injection.
• Začetni odmerek 400 mg (dve 200-mg injekciji) in nato 200 mg v subkutani injekciji vsak drugi teden.
In the overall population in DRI12544 and QUEST subjects receiving either dupilumab 200 mg or 300 mg every other week had significant reductions in the rate of severe asthma exacerbations compared to placebo.
QUEST, ki so prejemali ali 200 mg ali 300 mg dupilumaba vsak drugi teden, značilno zmanjšal v primerjavi s placebom.
Relax the pinch.
Izpustite gubo.
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d Patients who received rescue treatment or with missing data were considered as non-responders.
d Bolniki, ki so prejeli rešilno zdravljenje, in bolniki z manjkajočimi podatki so bili ocenjeni kot neodzivni.
Additional secondary endpoints included mean change from baseline to week 16 in the Patient Oriented Eczema Measure (POEM), Dermatology Life Quality Index (DLQI), and Hospital Anxiety and Depression Scale (HADS) scores.
Eczema Measure), indeksa DLQI (Dermatology Life Quality Index) in ocene HADS (Hospital Anxiety and Depression Scale) od izhodišča do 16. tedna.
If needed to control intolerable symptoms, patients were permitted to receive rescue treatment at the discretion of the investigator.
Bolniki so smeli po raziskovalčevi presoji dobiti rešilno zdravljenje, če je bilo to potrebno za obvladanje neznosnih simptomov.
No dose adjustment for body weight is recommended for patients with asthma 12 years of age and older or in adults with atopic dermatitis (see section 5.2).
Bolnikom z astmo, starim 12 let ali več, in odraslim z atopijskim dermatitisom odmerka ni treba prilagoditi glede na telesno maso (glejte poglavje 5.2).
• Do not place the syringe into direct sunlight.
• Brizge ne izpostavljajte neposredni sončni svetlobi.
LS = least squares; SE = standard error a All patients were on background topical corticosteroids therapy and patients were permitted to use topical calcineurin inhibitors.
a Vsi bolniki so prejemali osnovno zdravljenje z lokalnimi kortikosteroidi in bolniki so smeli uporabljati lokalne zaviralce kalcinevrina.
In SOLO 1 and SOLO 2, from baseline to week 16, a significantly greater proportion of patients randomized to dupilumab achieved an IGA 0 or 1 response, EASI-75, and/or an improvement of > 4 points on the pruritus NRS compared to placebo (see Table 4).
V študijah SOLO 1 in SOLO 2 je od izhodišča do 16. tedna doseglo odziv IGA 0 ali 1, EASI-75 in/ali izboljšanje ocene srbenja NRS za ≥ 4 točke značilno več bolnikov, ki so prejemali dupilumab, kot tistih, ki so prejemali placebo (glejte preglednico 4).
Table 10: Efficacy results of dupilumab in the adolescent atopic dermatitis study at Week 16 (FAS)
Preglednica 10: Rezultati o učinkovitosti dupilumaba v študiji pri mladostnikih z atopijskim dermatitisom po 16 tednih (celotni nabor za analizo)
Patients received 1) an initial dose of 400 mg dupilumab (two 200 mg injections) on day 1, followed by 200 mg once every other week (Q2W) for patients with baseline weight of <60 kg or an initial dose of 600 mg dupilumab (two 300 mg injections) on day 1, followed by 300 mg Q2W for patients with baseline weight of ≥ 60 kg; 2) an initial dose of 600 mg dupilumab (two 300 mg injections) on day 1, followed by 300 mg every 4 weeks (Q4W) regardless of baseline body weight; or 3) matching placebo.
200 mg vsaka dva tedna v primeru izhodiščne telesne mase < 60 kg, ali začetni odmerek 600 mg dupilumaba (dve 300-mg injekciji) 1. dan in nato 300 mg vsaka 2 tedna v primeru izhodiščne telesne mase ≥ 60 kg, ali (2) začetni odmerek 600 mg dupilumaba (dve 300-mg injekciji) 1. dan in nato 300 mg vsake 4 tedne ne glede na izhodiščno telesno maso, ali (3) ujemajoč se placebo.
The baseline mean EASI score was 32.5, the baseline weekly pruritus NRS was 7.3, the baseline mean SCORAD score was 66.4, the baseline mean POEM score was 20.1, the baseline mean DLQI was 14.5, and the baseline mean HADS total score was 12.7.
Izhodiščna povprečna ocena EASI je bila 32,5, izhodiščna tedenska ocena srbenja NRS 7,3, izhodiščna povprečna ocena SCORAD 66,4, izhodiščna povprečna ocena POEM 20,1, izhodiščni povprečni DLQI 14,5 in izhodiščna povprečna celotna ocena HADS 12,7.
• Then lift the pen up off the skin, your injection is complete.
• Nato dvignite peresnik navzgor s kože.
Patients randomised
Randomizirani bolniki
If necessary, pre-filled syringes may be kept at room temperature up to 25°C for a maximum of 14 days.
Če je treba, je mogoče napolnjene injekcijske brizge shranjevati na sobni temperaturi do 25 °C največ 14 dni.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA
In the concomitant TCS study, the proportion of patients who discontinued treatment due to adverse events was 7.6 % of the placebo + TCS group, 1.8 % of the dupilumab 300 mg Q2W + TCS group, and 2.9 % of the dupilumab 300 mg QW + TCS group.
V študiji s sočasno uporabo LKS je bil delež bolnikov, ki so zdravljenje prenehali zaradi neželenih učinkov, v skupini s placebom + LKS 7,6 %, skupini s 300 mg dupilumaba vsaka dva tedna + LKS 1,8 % in v skupini s 300 mg dupilumaba vsak teden + LKS 2,9 %.
• Multipack containing 3 (3 packs of 1) pre-filled syringes
• Skupno pakiranje s 3 (3 pakiranja po 1) napolnjenimi injekcijskimi brizgami
An effect of dupilumab on the PK of co-administered medications is not expected.
Ni pričakovati, da bi dupilumab vplival na farmakokinetiko sočasno uporabljenih zdravil.
Dupixent is given by injection under the skin (subcutaneous injection).
Zdravilo Dupixent se daje z injekcijo pod kožo (subkutana injekcija).
NRS increased by ≥ 3 points from baseline to week 35 in the subset of patients with peak pruritus NRS ≤ 7 at baseline, n (%) †P< 0.05, *P< 0.01, **P< 0.001, ***P≤ 0.0001
7 po NRS, n (%) †p < 0,05, *p < 0,01, **p < 0,001, ***p ≤ 0,0001
Mean age (years) (SD) % Female % White
% žensk % belcev
EASI-90, % respondersd
EASI-90, % odzivnihd
If necessary, pre-filled pens may be kept at room temperature up to 25°C for a maximum of 14 days.
Če je treba, je mogoče napolnjene injekcijske peresnike shranjevati na sobni temperaturi do 25 °C največ 14 dni.
Figure 1: Mean percent change from baseline in EASI in SOLO 1a and SOLO 2a (FAS)b
Slika 1: Povprečna odstotna sprememba ocene EASI v študijah SOLO 1a in SOLO 2a (FAS)b mNK = metoda najmanjših kvadratov.
QUEST: Blood Eosinophils ≥ 300 cells/mcL
QUEST: Eozinofilci v krvi ≥ 300 celic/mcl
At baseline 46.2% of patients had a baseline IGA score of 3 (moderate AD), 53.8% of patients had a baseline IGA of 4 (severe AD), the mean BSA involvement was 56.5%, and 42.4 % of patients had received prior systemic immunosuppressants.
Izhodiščno je imelo izhodiščno oceno IGA 3 (zmeren AD) 46,2 % bolnikov in izhodiščno oceno IGA 4 (hud AD) 53,8 % bolnikov, povprečna zajetost telesne površine je bila 56,5 % in 42,4 % bolnikov je predhodno prejemalo sistemske imunosupresive.
In addition, dupilumab 300 mg Q2W + TCS and 300 mg QW + TCS reduced anxiety and depression as measured by the HADS total score at 52 weeks compared to placebo + TCS.
Poleg tega je zdravljenje s 300 mg dupilumaba vsak drugi teden + LKS in s 300 mg dupilumaba vsak teden + LKS po 52 tednih v primerjavi s placebom + LKS zmanjšalo anksioznost in depresijo, merjeni s celotno oceno HADS.
Hepatic impairment No data are available in patients with hepatic impairment (see section 5.2).
Podatkov o bolnikih z okvaro jeter ni (glejte poglavje 5.2).
Dupilumab was administered by subcutaneous (SC) injection.
Dupilumab so uporabljali v subkutanih (s.c.) injekcijah.
≥ 150 cells/mcL ≥ 300 cells/mcL
≥ 150 celic/mcl ≥ 300 celic/mcl
Dupilumab 300 mg Q2W N=57
Dupilumab 300 mg vsak drugi teden N=57
Table 4: Efficacy results of dupilumab in the adolescent atopic dermatitis study at Week 16 (FAS)
Preglednica 4: Rezultati o učinkovitosti dupilumaba v študiji pri mladostnikih z atopijskim dermatitisom po 16 tednih (celotni nabor za analizo)
N Rate (95% CI)
N Delež (95% IZ)
QUEST: Blood Eosinophils ≥ 150 cells/mcL
QUEST: Eozinofilci v krvi ≥ 150 celic/mcl
EU/1/17/1229/003 3 pre-filled syringes (3 packs of 1) EU/1/17/1229/004 6 pre-filled syringes (3 packs of 2)
EU/1/17/1229/003 3 napolnjene injekcijske brizge (3 pakiranja po 1) EU/1/17/1229/004 6 napolnjenih injekcijskih brizg (3 pakiranja po 2)
• Multipack containing 6 (3 packs of 2) pre-filled syringes
• Skupno pakiranje s 6 (3 pakiranja po 2) napolnjenimi injekcijskimi brizgami
Gender was not found to be associated with any clinically meaningful impact on the systemic exposure of dupilumab determined by population PK analysis.
Spol ni bil povezan s kakšnim klinično pomembnim vplivom na sistemsko izpostavljenost dupilumabu, ugotovljeno s populacijsko FK analizo.
Patients were randomised to receive either 200 mg (N=631) or 300 mg (N=633) Dupixent every other week (or matching placebo for either 200 mg (N = 317) or 300 mg (N= 321) every other week) following an initial dose of 400 mg, 600 mg or placebo respectively.
Po začetnem odmerku 400 mg ali 600 mg zdravila Dupixent oziroma ustreznega placeba so bili bolniki randomizirani na prejemanje zdravila Dupixent v odmerku bodisi 200 mg (N=631) bodisi 300 mg (N=633) vsak drugi teden (oziroma placeba v odmerku 200 mg (N=317) ali 300 mg (N=321) vsak drugi teden).
Dupilumab 300 mg Q2W N=48
Dupilumab 300 mg vsak drugi teden N=48
Q4W N=86
vsak 4 teden N = 86
Adults with atopic dermatitis
Odrasli z atopijskim dermatitisom
Dupixent is a clear to slightly opalescent, colourless to pale yellow solution supplied in a pre-filled syringe.
Zdravilo Dupixent je bistra do rahlo opalescentna, brezbarvna do bledo rumena raztopina v napolnjenem injekcijskem peresniku.
Approximately 9 % of patients with asthma who received dupilumab 200 mg Q2W for 52 weeks developed antibodies to dupilumab; approximately 4 % exhibited persistent ADA responses and approximately 4 % had neutralizing antibodies.
Protitelesa proti dupilumabu so se pojavila pri približno 9 % bolnikov z astmo, ki so 52 tednov prejemali 200 mg dupilumaba vsaka 2 tedna; približno 4 % bolnikov so imeli trajen odziv ADA in približno 4 % so imeli nevtralizacijska protitelesa.
Each syringe contains one dose of Dupixent (300 mg).
Ena injekcijska brizga vsebuje en odmerek zdravila Dupixent (300 mg).
Adolescents with atopic dermatitis
Mladostniki z atopijskim dermatitisom
The baseline mean EASI score was 33.0, the baseline weekly averaged pruritus NRS was 7.4, the baseline mean SCORAD score was 67.8, the baseline mean POEM score was 20.5, the baseline mean DLQI was 15.0, and the baseline mean HADS total score was 13.3.
Izhodiščna povprečna ocena EASI je bila 33,0, izhodiščna tedensko povprečena ocena srbenja NRS 7,4, izhodiščna povprečna ocena SCORAD 67,8, izhodiščna povprečna ocena POEM 20,5, izhodiščni povprečni DLQI 15,0 in izhodiščna povprečna celotna ocena
The mean ±SD steady-state trough concentrations of dupilumab were 107±51.6 mcg/mL and 46.7±26.9 mcg/mL, respectively, for 300 mg or 200 mg administered every other week.
2 tedna 107 ± 51,6 mcg/ml in med uporabo 200 mg na 2 tedna 46,7 ± 26,9 mcg/ml.
1 pre-filled pen 2 pre-filled pens 3 pre-filled pens 6 pre-filled pens
1 napolnjen injekcijski peresnik 2 napolnjena injekcijska peresnika 3 napolnjeni injekcijski peresniki 6 napolnjenih injekcijskih peresnikov
In the 52-week atopic dermatitis CHRONOS study, serious infections were reported in 0.6 % of patients treated with placebo and 0.2 % of patients treated with dupilumab.
tedenski študiji CHRONOS so o resnih okužbah poročali pri 0,6 % bolnikov, ki so prejemali placebo,
Figure 4: Mean percent change from baseline in NRS in CHRONOSa (FAS Week 52)b
Slika 4: Povprečna odstotna sprememba ocene NRS od izhodišča v študiji CHRONOSa (FAS
Sanofi Belgium
SANOFI BULGARIA EOOD
A reduction of lactate dehydrogenase (LDH), a biomarker associated with AD disease activity and severity, was observed with dupilumab treatment.
biološkega označevalca, povezanega z bolezensko aktivnostjo in izrazitostjo AD.
Table 4: Efficacy results of dupilumab monotherapy at week 16 (FAS)
Preglednica 4: Rezultati učinkovitosti monoterapije z dupilumabompo 16 tednih (FAS)
Dupixent 300 mg syringe
Dupixent 300 mg brizga
• Do not re-use the pre-filled pen.
• Napolnjenega injekcijskega peresnika ne uporabite ponovno.
Very rare cases of serum sickness/serum sickness-like reactions have been reported in the atopic dermatitis development program following the administration of dupilumab.
V kliničnih preskušanjih so po uporabi dupilumaba v programu razvoja pri atopijskem dermatitisu poročali o zelo redkih primerih serumske bolezni/serumski bolezni podobne reakcije.
• Do not freeze the pre-filled pen.
• Napolnjenega injekcijskega peresnika ne zamrznite.
Do not place the syringe in direct sunlight.
Brizge ne izpostavljajte neposredni sončni svetlobi.
These reductions in type 2 inflammatory biomarkers were comparable for the 200 mg Q2W and 300 mg Q2W regimens.
Znižanja bioloških označevalcev vnetja tipa 2 so bila s shemama 200 mg vsaka dva tedna in 300 mg vsaka dva tedna primerljiva.
1.14 ml solution in a siliconised type-1 clear glass pre-filled syringe with needle shield or pre-filled pen, with a fixed 27 gauge 12.7 mm (½ inch), thin wall stainless steel staked needle.
1,14 ml raztopine v silikonizirani napolnjeni injekcijski brizgi s ščitnikom igle ali napolnjenem injekcijskem peresnikom iz stekla tipa 1 s fiksno nameščeno iglo iz nerjavnega jekla s tanko steno, G
Also at baseline the mean Eczema Area and Severity Index (EASI) score was 35.5, the baseline weekly averaged pruritus Numerical Rating Scale (NRS) was 7.6, the baseline mean SCORing Atopic Dermatitis (SCORAD) score was 70.3, the baseline mean Patient Oriented Eczema Measure (POEM) score was 21.0, and the baseline mean Children Dermatology
Poleg tega je bila izhodiščna povprečna ocena EASI (Eczema Area and Severity Index) 35,5 %, izhodiščna tedenska povprečena ocena srbenja NRS (Numerical Rating Scale) 7,6, izhodiščna povprečna ocena SCORAD (SCORing Atopic
Dupixent 200 mg solution for injection in pre-filled syringe Dupixent 200 mg solution for injection in pre-filled pen
Dupixent 200 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Dupixent 200 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
EASI-75, % respondersd
EASI-75, % odzivnihd
Table 9: Mean Change from Baseline in Pre-Bronchodilator FEV1 at Week 12 and Week 52 in QUEST by Baseline FeNO Subgroups
Preglednica 9: Povprečna sprememba FEV1 pred bronhodilatatorjem po 12. in po 52. tednih v primerjavi z izhodiščem glede na podskupini izhodiščnega diNO v študiji QUEST
A total of 107 adolescents aged 12 to 17 years with asthma were enrolled in QUEST study.
V študijo QUEST je bilo vključenih skupno 107 mladostnikov, starih od 12 do 17 let, z zmerno do hudo astmo.
- Each pre-filled syringe contains 300 mg of dupilumab in 2 ml solution for injection (injection).
- Ena napolnjena injekcijska brizga vsebuje 300 mg dupilumaba v 2 ml raztopine za injiciranje (injekciji).
Table 15: Mean Change from Baseline in Pre-Bronchodilator FEV1 at Week 12 and Week 52 in QUEST by Baseline FeNO Subgroups
Preglednica 15: Povprečna sprememba FEV1 pred bronhodilatatorjem po 12. in po 52. tednih v primerjavi z izhodiščem glede na podskupini izhodiščnega diNO v študiji QUEST
Read the “Instructions for Use” for the syringe carefully before using Dupixent.
Pred uporabo zdravila Dupixent natančno preberite "Navodila za uporabo" injekcijske brizge.
For adolescents 12 to 17 years of age with atopic dermatitis receiving every other week dosing (Q2W) with either 200 mg (<60 kg) or 300 mg (≥60 kg), the mean ±SD steady state trough concentration of dupilumab was 54.5±27.0 mcg/ml.
60 kg) ali 300 mg (≥ 60 kg) vsak drugi teden, je bila povprečna najnižja koncentracija dupilumaba v stanju dinamičnega ravnovesja (± standardni odklon) 54,5 ± 27,0 mcg/ml.
A total of 107 adolescents aged 12 to 17 years with asthma were enrolled in the 52 week QUEST study.
V 52-tedensko študijo QUEST je bilo skupno vključenih 107 mladostnikov z astmo, starih od 12 do 17 let.
There were greater reductions in exacerbations in subjects with higher baseline levels of type 2 inflammatory biomarkers such as blood eosinophils or FeNO (Table 6 and Table 7).
Večje zmanjšanje poslabšanj je bilo pri preiskovancih, ki so imeli višje izhodiščne ravni vnetnih bioloških označevalcev kot so eozinofilci v krvi ali diNO (preglednica 6 in preglednica 7).