natgillin/translations-raw huggingface dataset:
Percent of patients whose IGA response at week 36 was maintained within 1 point of baseline in the subset of patients with IGA (0,1) at baseline, n (%) Percent of patients with IGA (0,1) at week 36 in the subset of patients with IGA (0,1) at baseline, n (%) Percent of patients whose peak pruritus
točke v primerjavi z izhodiščem, v podskupini bolnikov, ki so izhodiščno imeli IGA (0,1), n (%) Odstotek bolnikov z IGA (0,1) po 36 tednih v podskupini bolnikov, ki so izhodiščno imeli IGA (0,1), n (%)
The long-term safety of dupilumab was assessed in an open-label extension study in patients 12 to 17 years of age with moderate-to-severe atopic dermatitis (AD-1434).
Dolgoročno varnost dupilumaba so ocenili v odprtem podaljšanju študije pri bolnikih z zmernim do hudim atopijskim dermatitisom, starih od 12 do 17 let (študija AD-1434).
The results for VENTURE by baseline biomarkers are presented in the Table 17.
Rezultati v študiji VENTURE po izhodiščnih bioloških označevalcih so prikazani v preglednici 17.
In the subgroup of patients resembling the CAFE study population within the 52 week CHRONOS study, 69.6 % of dupilumab 300 mg Q2W-treated patients reached EASI-75 vs 18.0 % placebo-treated patients at week 16, and 52.4 % of dupilumab 300 mg Q2W-treated vs 18.6 % placebo-treated at week 52.
V podskupini bolnikov, ki so bili podobni populaciji študije CAFE, je v 52-tedenski študiji CHRONOS po 16 tednih doseglo EASI-75 69,6 % bolnikov, ki so prejemali 300 mg dupilumaba vsak drugi teden, in 18,0 % bolnikov, ki so prejemali placebo, po 52 tednih pa 52,4 % bolnikov, ki so prejemali 300 mg dupilumaba vsak drugi teden, in 18,6 % bolnikov, ki so prejemali placebo.
After use, place the pre-filled syringe into a puncture-resistant container and discard as required by local regulations.
Po uporabi je treba dati napolnjeno injekcijsko brizgo v vsebnik, odporen proti prebadanju, in zavreči, kot zahtevajo lokalnimi predpisi.
Do not use the pre-filled pen if the window is yellow.
Napolnjenega injekcijskega peresnika ne uporabite, če je okence rumeno.
During a reproductive toxicology study conducted in monkeys, using a surrogate antibody specific to the monkey IL-4Rα, no fetal abnormalities were observed at dosages that saturate the IL-4Rα.
Med študijo reproduktivne toksičnosti pri opicah z uporabo nadomestnih protiteles, specifičnih za opičji IL-4Rα, med uporabo odmerkov, ki zasitijo IL-4Rα, niso opažali nenormalnosti pri plodovih.
Patients were also permitted to use topical calcineurin inhibitors (TCI).
Bolniki so smeli uporabljati tudi lokalne zaviralce kalcinevrina.
Dupilumab compared with placebo was evaluated in adult patients with moderate to severe asthma on a medium-to-high dose inhaled corticosteroid and a long acting beta agonist.
Dupilumab so v primerjavi s placebom ocenili pri odraslih bolnikih z zmerno do hudo astmo, ki so prejemali srednje velik ali velik odmerek inhalacijskega kortikosteroida in dolgodelujoč agonist beta.
Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment for atopic dermatitis.
Pri bolnikih, ki se v 16 tednih zdravljenja atopijskega dermatitisa ne odzovejo, je treba razmisliti o prenehanju zdravljenja.
How to use Dupixent
Kako uporabljati zdravilo Dupixent
Pruritus NRS
Ocena srbenja NRS,
In this study, 53.1 % of patients had a baseline IGA score of 3 and 46.9 % of patients had a baseline IGA of 4 and 33.6 % of patients received prior systemic immunosuppressants.
V tej študiji je imelo 53,1 % bolnikov izhodiščno oceno IGA 3 in 46,9 % bolnikov izhodiščno oceno IGA 4, 33,6 % bolnikov pa je predhodno prejemalo sistemske imunosupresive.
Pruritus NRS (>4-point improvement), % respondersc
Ocena srbenja NRS (izboljšanje za > 4 točke),
The safety and efficacy of dupilumab in children with atopic dermatitis below the age of 12 years have not been established (see section 5.2).
Varnost in učinkovitost dupilumaba pri otrocih z atopijskim dermatitisom do 12. leta starosti nista ugotovljeni (glejte poglavje 5.2).
After use, place the pre-filled syringe or the pre-filled pen into a puncture-resistant container and discard as required by local regulations.
Po uporabi je treba dati napolnjeno injekcijsko brizgo ali napolnjen injekcijski peresnik v vsebnik, odporen proti prebadanju, in zavreči, kot zahtevajo lokalnimi predpisi.
• Let your skin dry before injecting.
• Pustite, da se koža pred injiciranjem posuši.
The long-term safety profile of dupilumab observed in adolescents was consistent with that seen in adults with atopic dermatitis.
Dolgoročne varnostne značilnosti dupilumaba pri mladostnikih so se skladale s tistimi pri odraslih z atopijskim dermatitisom.
• Store pre-filled pens in the original carton to protect it from light.
• Napolnjene injekcijske peresnike shranjujte v originalni škatli za zagotovitev zaščite pred svetlobo.
• Do not try to put the yellow cap back on the pre-filled pen.
• Ne poskušajte rumenega pokrovčka namestiti nazaj na napolnjeni injekcijski peresnik.
Number of patients with HADS-anxiety
Število bolnikov z izhodiščno oceno HADS
Very limited data are available in patients with severe renal impairment (see section 5.2).
Podatkov o bolnikih s hudo okvaro ledvic je zelo malo (glejte poglavje 5.2).
• Do not use the syringe if it has been dropped on a hard surface or damaged.
• Ne uporabite brizge, če vam je padla na trdo površino ali je poškodovana.
• Do not touch the plunger rod until you are ready to inject.
• Ne dotikajte se bata, dokler niste pripravljeni za injiciranje.
Dupilumab-treated patients had a greater mean initial increase from baseline in eosinophil count compared to patients treated with placebo.
Pri bolnikih, ki so prejemali dupilumab, je bil povprečni začetni porast števila eozinofilcev v primerjavi z izhodiščem večji kot pri bolnikih, ki so prejemali placebo.
Step 11: Release and Remove
11. korak: Sprostite in izvlecite iglo
respondersd, e
% odzivnihd, e
Number of patients with baseline pruritus NRS score > 4
Število bolnikov z izhodiščno oceno srbenja NRS > 4
A larger percentage of patients randomised to placebo needed rescue treatment (topical corticosteroids, systemic corticosteroids, or systemic non-steroidal immunosuppressants) as compared to the dupilumab group (58.8% and 20.7%, respectively).
Rešilno zdravljenje (lokalne kortikosteroide, sistemske kortikosteroide ali sistemske nesteroidne imunosupresive) je potreboval večji odstotek bolnikov v skupini s placebom (58,8 %) kot v skupini z dupilumabom (20,7 %).
Let your skin dry before injecting.
Pustite, da se koža pred injiciranjem posuši.
Recommended dose in adult and adolescent patients with asthma For asthma, the recommended dose of Dupixent for adult and adolescents patients (12 years of age and older) is:
Priporočeni odmerek za odrasle in mladostnike z astmo Za astmo je priporočeni odmerek zdravila Dupixent za odrasle in mladostnike (stare 12 let ali več):
Hold the syringe in the middle of the syringe body with the needle pointing away from you and pull off the needle cap.
Brizgo primite na sredi telesa brizge in tako, da je igla usmerjena proč od vas, in snemite pokrovček igle.
The safety and efficacy of dupilumab in children with severe asthma below the age of 12 years have not been established (see section 5.2).
Varnost in učinkovitost dupilumaba nista ugotovljeni pri otrocih s hudo astmo, mlajših od 12 let (glejte poglavje 5.2).
Dupilumab can be used with or without topical corticosteroids.
Dupilumab je mogoče uporabljati z lokalnimi kortikosteroidi ali brez njih.
Anaphylactic reaction has been reported very rarely in the asthma development program (see section 4.4).
V programu razvoja pri astmi so zelo redko poročali o anafilaktični reakciji (glejte poglavje 4.4).
Antibody responses to both tetanus vaccine and meningococcal polysaccharide vaccine were similar in dupilumab-treated and placebo-treated patients.
Odzivi protiteles na cepivo proti tetanusu in na meningokokno polisaharidno cepivo so bili pri bolnikih, ki so prejemali dupilumab, podobni kot pri tistih, ki so prejemali placebo.
• Do not remove the yellow cap until just before you give the injection.
• Rumeni pokrovček odstranite šele tik pred injiciranjem.
If somebody else administers the injection, the upper arm can also be used.
Če bolniku zdravilo injicira kdo drug, lahko uporabi tudi nadlaket.
Patients with comorbid asthma should be monitored carefully following discontinuation of dupilumab.
Bolnike s pridruženo astmo je treba po prenehanju zdravljenja z dupilumabom skrbno nadzirati.
Do not remove the yellow cap until you are ready to inject.
Ne odstranite rumenega pokrovčka, dokler niste pripravljeni za injiciranje.
The data gathered from this study did not indicate clinically relevant effects of dupilumab on CYP1A2, CYP3A, CYP2C19, CYP2D6, or CYP2C9 activity.
CYP1A2, CYP3A4, CYP2C19, CYP2D6 ali CYP2C9.
Select the injection site.
Izberite mesto injiciranja
Approximately 5 % of patients in the placebo groups in the 52 week studies were also positive for antibodies to dupilumab; approximately 2 % exhibited persistent ADA response and approximately 1% had neutralizing antibodies.
V 52-tedenskih študijah je bilo za protitelesa proti dupilumabu pozitivnih tudi približno 5 % bolnikov v skupinah s placebom; približno 2 % bolnikov sta imela trajen odziv ADA in približno 1 % je imel nevtralizacijska protitelesa.
Do not inject into skin that is tender, damaged, bruised or scarred.
Ne injicirajte v kožo, ki je občutljiva, poškodovana, podpluta ali zabrazgotinjena.
In these studies, 51.6 % of patients had a baseline IGA score of 3 (moderate AD), 48.3 % of patients had a baseline IGA of 4 (severe AD) and 32.4 % of patients had received prior systemic immunosuppressants.
V teh študijah je imelo 51,6 % bolnikov izhodiščno oceno IGA 3 (zmeren AD), 48,3 % bolnikov je imelo izhodiščno oceno IGA 4 (hud AD) in 32,4 % bolnikov je predhodno prejemalo sistemske imunosupresive.
Step 10: Push
10. korak: Potisnite bat
The primary endpoints were the annualized rate of severe exacerbation events during the 52-week placebo controlled period and change from baseline in pre-bronchodilator FEV1 at week 12 in the overall population (unrestricted by minimum baseline eosinophils or other type 2 inflammatory biomarkers) and subgroups based on baseline blood eosinophils and FeNO.
Primarna opazovana dogodka sta bila letni delež hudih poslabšanj med 52-tedenskim s placebom kontroliranim obdobjem in sprememba FEV1 pred bronhodilatatorjem po 12 tednih v primerjavi z izhodiščem v celotni populaciji (ki ni bila omejena z najmanjšo izhodiščno ravnjo eozinofilcev ali drugih bioloških označevalcev tipa 2) in v podskupinah glede na izhodiščno število eozinofilcev v krvi in diNO.
In the monotherapy studies (SOLO 1 and SOLO 2), across all treatment groups, the mean age was 38.3, the mean weight was 76.9 kg, 42.1% were female, 68.1% were white, 21.8% were Asian, and 6.8% were black.
Izhodiščne značilnosti V študijah monoterapije (SOLO 1 in SOLO 2) je bila v vseh terapevtskih skupinah skupaj povprečna starost 38,3 leta, povprečna telesna masa 76,9 kg, 42,1 % je bilo žensk, 68,1 % je bilo belcev, 21,8 %
Placebo ap-value = 0.0003, bp-value = 0.0001, cp-value = 0.0116, dp-value = 0.0024, ep-value <0.0001
Placebo ap-vrednost = 0,0003, bp-vrednost = 0,0001, cp-vrednost = 0,0116, dp-vrednost = 0,0024, ep-vrednost <0,0001
Table 2: List of adverse reactions in atopic dermatitis MedDRA System
Preglednica 2: Seznam neželenih učinkov pri atopijskem dermatitisu
Recommended dose in adolescents with atopic dermatitis The recommended dose of Dupixent for adolescents (12 to 17 years of age) with atopic dermatitis is based on body weight:
Priporočeni odmerek za mladostnike z atopijskim dermatitisom Priporočeni odmerek zdravila Dupixent za mladostnike (stare od 12 do 17 let) z atopijskim dermatitisom je odvisen od telesne mase:
Dupilumab is a fully human monoclonal antibody against interleukin (IL)-4 receptor alpha that inhibits IL-4/IL-13 signalling, produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Dupilumab je popolnoma humanomonoklonsko protitelo proti receptorju alfa interlevkina (IL)-4, ki zavre signalizacijo IL-4/IL-13; dupilumab je pridobljen v celicah jajčnika kitajskega hrčka s tehnologijo rekombinantne DNA.
• Do not use the pre-filled pen if the yellow cap is missing or not securely attached.
• Ne uporabite napolnjenega injekcijskega peresnika, če rumeni pokrovček manjka ali ni trdno nameščen.
Number of patients with baseline pruritus NRS score ≥ 4
Število bolnikov z izhodiščno oceno srbenja NRS ≥ 4
Improvements in ACQ-5 and AQLQ(S) were observed as early as week 2 and maintained for 24 weeks in DRI12544 study and 52 weeks in QUEST study.
Izboljšanja ACQ-5 in AQLQ(S) so opazili že po 2 tednih in so se ohranila 24 tednov v študiji DRI12544 in 52 tednov v študiji QUEST.
A total of 210 patients with oral corticosteroid-dependent asthma receiving high-dose inhaled corticosteroids plus up to two additional controllers were enrolled (VENTURE).
bolnikov z astmo, odvisno od peroralnih kortikosteroidov, ki so prejemali velike odmerke inhalacijskih kortikosteroidov in do dve dodatni zdravili za obvladovanje (VENTURE).
• Keep the pre-filled pen(s) and all medicines out of the reach of children.
• Napolnjene injekcijske peresnike in vsa zdravila shranjujte nedosegljivo otrokom!
Dupixent is also used with other asthma medicines for the maintenance treatment of severe asthma in adults and adolescents (12 years of age and older) whose asthma is not controlled with their current asthma medicines.
Zdravilo Dupixent se uporablja tudi z drugimi zdravili za astmo za vzdrževalno zdravljenje hude astme pri odraslih in mladostnikih (starih 12 let ali več), ki bolezni nimajo urejene s svojimi trenutnimi zdravili za astmo.
For clinical data in adults with atopic dermatitis please refer to the dupilumab 300 mg Summary of Product Characteristics.
Za klinične podatke o odraslih z atopijskim dermatitisom glejte povzetek glavnih značilnosti zdravila za
Additional secondary endpoints included mean change from baseline to week 16 in the POEM and CDLQI scores.
Med dodatnimi sekundarnimi opazovanimi dogodki sta bili povprečni spremembi ocen POEM in CDLQI od izhodišča do 16. tedna.
Duration of Asthma (years), mean ± SD Never smoked, (%)
odklon Nikoli kadili (%)
Table 1: Dose of dupilumab for subcutaneous administration in adolescent patients 12 years to 17 years of age with atopic dermatitis Body Weight of Patient
Preglednica 1: Odmerek dupilumaba za subkutano uporabo pri mladostnikih z atopijskim dermatitisom od 12. do 17. leta starosti Bolnikova telesna masa
CHRONOS at Week 52
CHRONOS po 52 tednih
At Week 52
52. teden
Dupixent is a clear to slightly opalescent, colourless to pale yellow solution supplied in a glass prefilled syringe with or without needle shield.
Zdravilo Dupixent je bistra do rahlo opalescentna, brezbarvna do bledo rumena raztopina v stekleni napolnjeni injekcijski brizgi s ali brez ščitnika igle.
Table 5: Efficacy results of dupilumab with concomitant TCSa at Week 16 and Week 52 in CHRONOS
Preglednica 5: Rezultati učinkovitosti dupilumaba skupaj s sočasnimi LKSa po 16. in 52. tednih v študiji CHRONOS
The absolute bioavailability of dupilumab following a SC dose is similar between AD and asthma patients, ranging between 61% and 64 %, as determined by a population pharmacokinetics (PK) analysis.
S populacijsko farmakokinetično (FK) analizo ocenjena absolutna biološka uporabnost dupilumaba je podobna pri pri bolnikih z atopijskim dermatitisom kot pri bolnikih z astmo in znaša po subkutanem odmerku med 61% in 64 %.
Do not put the yellow cap back on the pre-filled pen after you have removed it.
Ne nameščajte rumenega pokrovčka nazaj na napolnjeni injekcijski peresnik, ko ste ga že sneli.
CHRONOS enrolled 740 patients (315 to placebo + topical corticosteroid (TCS), 106 to dupilumab 300 mg Q2W + TCS, and 319 to dupilumab 300 mg QW + TCS) and had a treatment period of 52 weeks.
Študija CHRONOS je zajela 740 bolnikov (315 na placebu + lokalni kortikosteroid (LKS), 106 na dupilumabu 300 mg vsak drugi teden + LKS in 319 na dupilumabu 300 mg vsak teden + LKS); obdobje zdravljenja je trajalo 52 tednov.
• If you see any blood at the site, lightly dab a cotton ball or gauze pad.
• Če na mestu injiciranja opazite nekaj krvi, s kosmom vate ali zložencem gaze rahlo pritisnite nanj.
Lay the syringe on a flat surface for at least 45 minutes and let it get to room temperature naturally.
Brizgo za vsaj 45 minut položite na ravno površino in pustite, da se naravno segreje na sobno temperaturo.
Patients on dupilumab for moderate-to-severe atopic dermatitis who also have comorbid asthma should not adjust or stop their asthma treatments without consultation with their physicians.
Bolniki z atopijskim dermatitisom in pridruženo astmo Bolniki, ki prejemajo dopilumab za zmeren do hud atopijski dermatitis in s pridruženo astmo ne smejo prilagajati ali prenehati svojega zdravljenja za astmo, ne da bi se posvetovali z zdravnikom.
Lay the syringe on a flat surface for at least 30 minutes and let it get to room temperature naturally.
Brizgo za vsaj 30 minut položite na ravno površino in pustite, da se naravno segreje na sobno temperaturo.
• For patients with severe asthma and who are on oral corticosteroids or for patients with severe asthma and co-morbid moderate-to-severe atopic dermatitis, an initial dose of 600 mg (two 300 mg injections), followed by 300 mg every other week administered as subcutaneous injection.
• Za bolnike s hudo astmo in ki prejemajo peroralne kortikosteroide ali za bolnike s hudo astmo in s pridruženim zmernim do hudim atopijskim dermatitisom je začetni odmerek 600 mg (dve 300 mg injekciji) in nato 300 mg v subkutani injekciji vsak drugi teden.
Dupilumab is administered by subcutaneous injection into the thigh or abdomen, except for the 5 cm around the navel.
Dupilumab se injicira subkutano v stegno ali trebuh (razen v predelu 5 cm okrog popka).
You must not try to give yourself or someone else the injection unless you have received training from your healthcare professional.
Ne poskušajte si sami dati injekcije ali zdravila injicirati komu drugemu, dokler vas tega ne nauči zdravnik.
• Do not keep Dupixent at room temperature (< 25°C) for more than 14 days.
• Zdravila Dupixent ne shranjujte na sobni temperaturi (< 25 °C) več kot 14 dni.
Number of patients with POEM ≥4 at baseline POEM (≥ 4-point improvement), % responders
Število bolnikov z izhodiščno oceno POEM POEM (izboljšanje za
Do not stop or reduce your asthma medicines, unless instructed by your doctor.
Ne prenehajte uporabljati svojih zdravil za astmo in ne zmanjšujte njihovega odmerka, ne da bi vam eno ali drugo naročil zdravnik.
• Choose a different injection site for each injection
• Za vsako injiciranje izberite drugo injekcijsko mesto.
In all three pivotal studies, the co-primary endpoints were the proportion of patients with IGA 0 or 1 (“clear” or “almost clear”) with a reduction of ≥ 2 points on a 0-4 IGA scale and the proportion of patients with improvement of at least 75 % in EASI (EASI-75) from baseline to week 16.
V vseh treh ključnih študijah sta bila soprimarna opazovana dogodka delež bolnikov z IGA 0 ali 1 ("čisto" ali "skoraj čisto") z zmanjšanjem na lestvici IGA 0-4 za ≥ 2 točki ter delež bolnikov z izboljšanjem EASI za vsaj 75 % (EASI-75) od izhodišča do 16. tedna.
Talk to your doctor if you have any new or worsening eye problems, including eye pain or changes in vision.
Težave z očmi (če imate atopijski dermatitis) V primeru novonastalih težav z očmi ali poslabšanja takšnih težav, vključno z bolečinami v očeh in spremembami vida, se posvetujte z zdravnikom.
Table 8: Additional secondary endpoint results of dupilumab monotherapy at Week 16
Preglednica 8: Dodatni rezultati sekundarnih opazovanih dogodkov monoterapije z dupilumabom po 16. tednih
Dupixent is used to treat adults and adolescents 12 years and older with moderate-to-severe atopic dermatitis, also known as atopic eczema.
Zdravilo Dupixent se uporablja za zdravljenje odraslih in mladostnikov, starih 12 let ali več, z zmernim do hudim atopijskim dermatitisom, znanim tudi kot atopijski ekcem.
Do not touch the injection site again or blow on it before the injection.
Pred injiciranjem se mesta injiciranja ne smete več dotakniti in vanj tudi ne smete pihati.
Do not use the syringe if it has been dropped on a hard surface or damaged.
Ne uporabite brizge, če je padla na trdo podlago ali je poškodovana.
Description of selected adverse reactions in atopic dermatitis and asthma indications
Srbenje na mestu injiciranja Opis izbranih neželenih učinkov pri atopijskem dermatitisu in pri astmi
It is recommended that patients should be brought up to date with live and live attenuated immunisations in agreement with current immunisation guidelines prior to treatment with dupilumab.
Priporočljivo je, da bolniki pred zdravljenjem z dupilumabom opravijo vsa cepljenja z živimi in živimi oslabljenimi cepivi v skladu z veljavnimi smernicami za cepljenje.
If you have forgotten to inject a dose of Dupixent, talk to your doctor, pharmacist or nurse.
Če ste pozabili uporabiti zdravilo Dupixent Če ste pozabili injicirati odmerek zdravila Dupixent, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
• Do not use the syringe if it has been damaged.
• Ne uporabite brizge, če je poškodovana.
Solution for injection (injection) Clear to slightly opalescent, colourless to pale yellow solution, which is free from visible particulates.
Raztopina za injiciranje (injekcija) Bistra do rahlo opalescentna, brezbarvna do bledo rumena raztopina brez vidnih delcev.
• a puncture-resistant container* (See Step 12)
• 1 kosem vate ali zloženec gaze* • proti prebadanju odporen vsebnik* (glejte 12. korak)
The mean age was 38.4 years, 38.8 % were female, the baseline mean EASI score was 33.1, the mean BSA was 55.7, the baseline weekly average pruritis NRS was 6.4, the baseline mean SCORAD score was 67.2, and the baseline mean DLQI was 13.8.
Povprečna starost je bila 38,4 leta, 38,8 % je bilo žensk, izhodiščna povprečna ocena EASI je bila 33,1, povprečna telesna površina 55,7, izhodiščno tedensko povprečje ocene srbenja NRS 6,4, izhodiščna povprečna ocena SCORAD 67,2 in izhodiščni povprečni DLQI 13,8.
The dupilumab group significantly improved patient-reported symptoms, the impact of AD on sleep and health-related quality of life as measured by POEM, SCORAD, and CDLQI scores at 16 weeks compared to placebo.
V skupini z dupilumabom so se po 16 tednih v primerjavi s placebom značilno izboljšali simptomi po navedbi bolnikov, vpliv AD na spanje in zdravstvena kakovost življenja, merjeni z ocenami POEM, SCORAD in CDLQI.
• a puncture-resistant container* (See Step D)
• 1 kosem vate ali zloženec gaze* • proti prebadanju odporen vsebnik* (glejte korak D)
Other evaluated outcomes included the proportion of patients with improvement of at least 50 % and 90 % in EASI (EASI-50 and EASI-90, respectively), reduction in itch as measured by the peak pruritus Numerical Rating Scale (NRS), and percent change in the SCORing Atopic Dermatitis (SCORAD) scale from baseline to week 16.
Drugi ocenjeni izidi so vključevali delež bolnikov z izboljšanjem EASI za vsaj 50 % in vsaj 90 % (EASI-50 in EASI-90), zmanjšanje srbenja, merjeno z lestvico največjega srbenja NRS (Numerical Rating Scale), in odstotno spremembo na lestvici SCORAD (SCORing Atopic Dermatitis) od izhodišča do 16. tedna.
Patients who received rescue treatment were considered non-responders.
Bolniki, ki so prejeli rešilno zdravljenje, so bili ocenjeni kot neodzivni.
Patients being treated for asthma may present with serious systemic eosinophilia sometimes presenting with clinical features of eosinophilic pneumonia or vasculitis consistent with eosinophilic granulomatosis with polyangiitis, conditions which are often treated with systemic corticosteroid therapy.
Ta se včasih pokaže s klinično sliko eozinofilne pljučnice ali vaskulitisa, ki ustreza eozinofilni granulomatozi s poliangiitisom, bolezni, ki jih pogosto zdravijo s sistemskimi kortikosteroidi.