FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of dupilumab in paediatric patients (< 12 years of age) with atopic dermatitis has not been studied.
Maltese: Il-farmakokinetika ta' dupilumab f'pazjenti pedjatriċi (età < 12 il-sena) b'dermatite atopika ma ġietx studjata.
English: EASI, LS mean % change from baseline (+/-SE)
Maltese: EASI, LS bidla medja % mil-linja bażi (+/-SE)
English: SCORAD, LS mean % change from baseline (+/SE)
Maltese: SCORAD, LS bidla medja % mil-linja bażi (+/SE)
English: 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.
Maltese: Fit-tliet studji pivitali kollha, il-punti finali ko-primarji kienu l-proporzjon ta' pazjenti b'IGA ta' 0 jew 1 (“imfejqa” jew “kważi imfejqa”) bi tnaqqis ta' ≥ 2 punti fuq skala ta' IGA ta' 0-4 u l-proporzjon ta' pazjenti b'titjib ta' mill-inqas 75 % f'EASI (EASI-75) mil-linja bażi sa ġimgħa 16.
English: EU/1/17/1229/011 3 pre-filled syringes with needle shield (3 packs of 1) EU/1/17/1229/012 6 pre-filled syringes with needle shield (3 packs of 2)
Maltese: EU/1/17/1229/011 3 siringi mimlija għal-lest bi protezzjoni tal-labra (3 pakketti ta' 1) EU/1/17/1229/012 6 siringi mimlija għal-lest bi protezzjoni tal-labra (3 pakketti ta' 2)
English: EASI-75, % respondersd
Maltese: EASI-75, % ta' persuni li rrispondewd
English: Similar results were observed in VENTURE.
Maltese: Riżultati jixxiebhu ġew osservati f'VENTURE.
English: The safety profile observed in adolescents aged 12 to 17 years in atopic dermatitis clinical trials was similar to that seen in adults.
Maltese: Il-profil ta' sigurtà osservat fl-adolexxenti ta' età minn 12 sa 17-il sena b'dermatite atopika kien simili għal dak li deher fl-adulti.
English: The primary endpoint was the proportion of patients with EASI-75 at week 16.
Maltese: Il-punt finali primarju kien il-proporzjon ta' pazjenti b'EASI-75 f'ġimgħa 16.
English: Levels ≥ 150 and ≥ 300 cells/mcL)
Maltese: Bażi ≥ 150 u ≥ 300 ċellula/mcL)
English: Rate Ratio (95%CI)
Maltese: Proporzjon tar-Rata (95%CI)
English: Adolescents with atopic dermatitis
Maltese: Tfal u adolexxenti
English: • An initial dose of 400 mg (two 200 mg injections), followed by 200 mg given every other week administered as subcutaneous injection.
Maltese: • Doża fil-bidu ta' 400 mg (żewġ injezzjonijiet ta' 200 mg), segwita minn 200 mg ġimgħa iva u ġimgħa le li tingħata bħala injezzjoni subkutaneja.
English: • Do not keep Dupixent at room temperature (< 25ºC) for more than 14 days.
Maltese: • Iżżomx Dupixent f'temperatura tal-kamra (<25ºC) għal aktar minn 14-il ġurnata.
English: Patients randomized IGA 0 or 1c, % respondersd
Maltese: Pazjenti randomised IGA ta' 0 jew 1c, % ta' persuni li rrispondewd
English: A total of 107 adolescents aged 12 to 17 years with moderate to severe asthma were enrolled in QUEST study and received either 200 mg (N=21) or 300 mg (N=18) dupilumab (or matching placebo either 200 mg [N=34] or 300 mg [N=34]) every other week.
Maltese: Total ta' 107 adolexxenti li kellhom minn 12 sa 17-il sena b'ażżma minn moderata sa severa ġew irreġistrati fl-istudju QUEST u rċivew 200 mg (N=21) jew 300 mg (N=18) dupilumab (jew plaċebo jaqbel mat-200 mg [N=34] jew mat-300 mg [N=34]) darba kull ġimagħtejn.
English: After a single subcutaneous (SC) dose of 75-600 mg dupilumab, median times to maximum concentration in serum (tmax) were 3-7 days.
Maltese: Wara doża waħda taħt il-ġilda (SC - subcutaneous) ta' 75-600 mg dupilumab, iż-żmien medjani għall konċentrazzjoni massima fis-serum (tmax) kien ta' 3-7 ijiem.
English: EASI-50, % respondersd
Maltese: EASI-50, % ta' persuni li rrispondewd
English: In CHRONOS, a significantly greater proportion of patients randomized to dupilumab 300 mg Q2W + TCS achieved an IGA 0 or 1 response, EASI-75, and/or an improvement of > 4 points on the pruritis NRS from baseline to week 16 and week 52 compared to placebo + TCS (see Table 5).
Maltese: 300 mg Q2W + TCS kisbu rispons ta' IGA ta' 0 jew 1, EASI-75, u/jew titjib ta' >4 punti fuq l-NRS
English: Placebo Dupilumab 300 mg Q2W
Maltese: Plaċebo Dupilumab 300 mg Q2W
English: SOLO 1
Maltese: Neħħi
English: Adults with atopic dermatitis
Maltese: Adulti b'dermatite atopika
English: 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.
Maltese: (Q2W) dożaġġ jew ta' 200 mg (<60 kg) jew 300 mg (≥60 kg), il-medja ±SD tal-inqas konċentrazzjoni ta' dupilumab fl-istat fiss kien 54.5±27.0 mcg/ml.
English: An evaluation of the available evidence related to IL-4Rα inhibition and animal toxicology data with surrogate antibodies does not suggest an increased carcinogenic potential for dupilumab.
Maltese: Valutazzjoni tal-evidenza disponibbli relatata ma' inibizzjoni ta' IL-4Rα u data tossikoloġika mill-annimali b'antikorpi sostituti ma jissuġġerux żieda fil-potenzjal karċinoġeniku għal dupilumab.
English: Immune responses to TdaP vaccine and meningococcal polysaccharide vaccine were assessed, see section 4.5.
Maltese: Ġew stmati r-risponsi immuni għat-tilqima TdaP u għat tilqima tal-polisakkarid meningokokkali, ara sezzjoni 4.5.
English: Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Maltese: Tnaqqis fid-doża tal-kortikosterojd tista' tkun assoċjata ma' sintomi sistemiċi ta' waqfien ta' mediċina li tivvizzja u/jew tikxef kundizzjonijiet li qabel ikunu soppressi bit-terapija tal-kortikosterojdi sistemiċi.
English: EASI-90, % respondersd
Maltese: EASI-90, % ta' persuni li rrispondewd
English: Dupixent can cause serious side effects, including very rare allergic (hypersensitivity) reactions, including anaphylactic reaction; the signs of allergic reaction or anaphylactic reaction may include:
Maltese: Dupixent jista' jikkawża effetti sekondarji serji, inklużi b'mod rari ħafna reazzjonijiet allerġiċi (sensittività eċċessiva), inkluż reazzjoni anafilattika; is-sinjali ta' reazzjoni allerġika jew reazzjoni anafilattika jistgħu jinkludu:
English: Step 5: Choose
Maltese: Pass 5: Agħżel
English: EU/1/17/1229/007 3 pre-filled syringes with needle shield (3 packs of 1) EU/1/17/1229/008 6 pre-filled syringes with needle shield (3 packs of 2)
Maltese: EU/1/17/1229/007 3 siringi mimlija għal-lest bi protezzjoni tal-labra (3 pakketti ta' 1) EU/1/17/1229/008 6 siringi mimlija għal-lest bi protezzjoni tal-labra (3 pakketti ta' 2)
English: In this subset, the percent change of pruritus NRS from baseline was -51.4 % vs -30.2 % at week 16 and -54.8 % vs -30.9 % at week 52, for the dupilumab 300 mg Q2W and placebo groups respectively.
Maltese: F'dan is-sottosett, il-bidla perċentwali fl-NRS tal-ħakk mil-linja bażi kienet -51.4 % kontra -30.2 % f'ġimgħa 16 u -54.8 % kontra -30.
English: Dupilumab is a recombinant human IgG4 monoclonal antibody that inhibits interleukin-4 and interleukin-13 signaling.
Maltese: IgG4 rikombinanti uman li jinibixxi s-sinjalar ta' interleukin-4 u interleukin-13.
English: % patients with EOS
Maltese: % ta' pazjenti b'EOS
English: A total of 325 patients were enrolled, with 210 patients who were previously exposed to ciclosporin and 115 patients who have never been exposed to ciclosporin because ciclosporin treatment was medically inadvisable.
Maltese: Kienu rreġistrati total ta' 325 pazjent, b'210 pazjenti li qabel kienu esposti għal ciclosporin u 115-il pazjent li qatt ma kienu esposti għal ciclosporin peress li trattament b'ciclosporin ma kienx rakkomandat b'mod mediku.
English: C4.
Maltese: Ċ4.
English: • the Dupixent pre-filled syringe
Maltese: • Tpoġġix is-siringa fil-friża.
English: 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.
Maltese: Il-pazjenti li jkunu qed jiġu ttrattati għall-ażżma jista' jkollhom eosinofilja sistemika serja li xi drabi tidher b'fatturi kliniċi ta' pulmonite eosinofilika jew vaskulite konsistenti ma' granulomatożi eosinofilika b'polianġite, kundizzjonijiet li ħafna drabi jiġu ttrattati b'terapija ta' kortikosterojdi sistemiċi.
English: Figure 2: Mean Change from Baseline in Pre-Bronchodilator FEV1 (L) Over Time (Baseline
Maltese: Figura 2: Bidla Medja mil-Linja Bażi fl-FEV1 (L) Qabel il-Bronkodilatatur Maż-Żmien
English: The mutagenic potential of dupilumab has not been evaluated; however monoclonal antibodies are not expected to alter DNA or chromosomes.
Maltese: Il-potenzjal mutaġeniku ta' dupilumab ma ġiex evalwat; madankollu antikorpi monoklonali mhux mistennija li jbiddlu d-DNA jew il-kromosomi.
English: - Keep this leaflet.
Maltese: F'każ ta' doża eċċessiva,
English: Figure 6: Mean Change from Baseline in Pre-Bronchodilator FEV1 (L) Over Time (Baseline
Maltese: Figura 6: Bidla Medja mil-Linja Bażi fl-FEV1 (L) Qabel il-Bronkodilatatur Maż-Żmien
English: These effects were sustained throughout treatment.
Maltese: Dupilumab huwa intenzjonat għal trattament fit-tul.
English: Of the 1,977 patients with asthma exposed to dupilumab, a total of 240 patients were 65 years or older and 39 patients were 75 years or older.
Maltese: Mill-1,977 pazjent bl-ażżma esposti għal dupilumab, total ta' 240 pazjent kellhom 65 sena jew aktar u 39 pazjent kellhom 75 sena jew aktar.
English: Table 17: Effect of dupilumab on OCS dose reduction, VENTURE (Baseline Blood Eosinophil Levels
Maltese: Tabella 17: Effett ta' dupilumab fuq it-tnaqqis fid-doża ta' OCS, VENTURE (Livelli tal-Eosinofili fidDemm fil-Linja bażi ≥ 150 u ≥ 300 ċellula/mcL u FeNO ≥ 25 ppb)
English: Of the 1,472 patients with atopic dermatitis exposed to dupilumab in a phase 2 dose-ranging study or phase 3 placebo-controlled studies, a total of 67 were 65 years or older.
Maltese: Minn 1,472 pazjent b'dermatite atopika esposti għal dupilumab fi studju ta' fażi 2 b'firxa ta' dożi jew studji ta'fażi 3 ikkontrollati bil-plaċebo, total ta' 67 kellhom 65 sena jew aktar.
English: Odds ratio (95% CI)
Maltese: Proporzjo n tarRata (95%CI)
English: b FAS week 52 includes all patients randomized at least one year before the cutoff date of the primary analysis.
Maltese: b FAS ta' ġimgħa 52 jinkludi l-pazjenti kollha randomised mill-inqas sena qabel id-data li fiha waqfet l-analiżi primarja.
English: Eye problems (if you have atopic dermatitis)
Maltese: Problemi fl-għajnejn (jekk għandek dermatite atopika)
English: 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.
Maltese: Il-punteġġ medju ta' EASI fil-linja bażi kien 32.5, il-medja tal-NRS tal-ħakk ta' kull ġimgħa fil-linja bażi kienet 7.3, il-punteġġ medju SCORAD fil-linja bażi kien 66.4, il-punteġġ medju ta' POEM fil-linja bażi kien 20.1, DLQI medju fil-linja bażi kien 14.5, u l-punteġġ totali medju ta' HADS fil-linja bażi kien 12.7.
English: A total of 107 adolescents aged 12 to 17 years with asthma were enrolled in QUEST study.
Maltese: Total ta' 107 adolexxenti bl-ażżma li kellhom minn 12 sa 17-il sena ġew irreġistrati fl-istudju QUEST.
English: Dupilumab should not be used to treat acute bronchospasm or status asthmaticus.
Maltese: Dupilumab m'għandux jintuża biex jitratta bonkospażmu akut jew status asthmaticus.
English: Fertility studies conducted in male and female mice using a surrogate antibody against IL-4Rα showed no impairment of fertility (see section 4.6).
Maltese: Fertilità Studji fl-annimali ma wrew l-ebda indeboliment fuq il-fertilità (ara sezzjoni 5.3).
English: • swollen lymph nodes
Maltese: • problem biex tieħu n-nifs
English: Monotherapy
Maltese: Monterapija
English: (> 4-point improvement)
Maltese: (+/- SE)
English: respondersc, d
Maltese: MANIFATTUR(I)
English: Dupilumab may influence the immune response against helminth infections by inhibiting IL-4/IL-13 signaling.
Maltese: Dupilumab jista' jinfluwenza r-rispons immuni kontra infezzjonijiet mill-elminti billi jinibixxi ssinjalar ta' IL-4/IL-13.
English: Headache
Maltese: Tnaqqis
English: In the pooled analysis of DRI12544 and QUEST, hospitalizations and/or emergency room visits due to severe exacerbations were reduced by 25.5% and 46.9% with dupilumab 200 mg or 300 mg every other week, respectively.
Maltese: Fl-analiżi miġbura ta' DRI12544 u QUEST, rikoverar l-isptar u/jew visti l-emerġenza minħabba taħrix sever naqsu b'25.5% u 46.9% b'dupilumab 200 mg jew 300 mg mogħti darba kull ġimagħtejn, rispettivament.
English: Listed in Table 2 are adverse reactions observed in atopic dermatitis clinical trials presented by system organ class and frequency, using the following categories: very common (≥ 1/10); common (≥ 1/100 to
Maltese: Elenkati fit-Tabella 2 hemm reazzjonijiet avversi osservati fi provi kliniċi ta' dermatite atopika ppreżentati skont il-klassi tas-sistemi u tal-organi u l-frekwenza, bl-użu tal-kategoriji li ġejjin: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000).
English: How to Store Dupixent
Maltese: Tużax Dupixent
English: EU/1/17/1229/003 EU/1/17/1229/004 EU/1/17/1229/005 EU/1/17/1229/006 EU/1/17/1229/007 EU/1/17/1229/008
Maltese: EU/1/17/1229/001 EU/1/17/1229/002 EU/1/17/1229/003 EU/1/17/1229/004
English: Very common Common
Maltese: Komuni Komuni Komuni
English: Population PK analysis did not identify mild or moderate renal impairment as having a clinically meaningful influence on the systemic exposure of dupilumab.
Maltese: Analiżi tal-PK tal-popolazzjoni ma wrietx li indeboliment ħafif jew moderat tal-kliewi għandu influwenza klinikament sinifikanti fuq l-esponiment sistemiku għal dupilumab.
English: For patients 12 to 17 years of age with atopic dermatitis, the recommended every other week dose is 200 mg (<60 kg) or 300 mg (≥60 kg).
Maltese: Għal pazjenti ta' 12 sa 17-il sena ta' età b'dermatite atopika, id-doża rrakkomandata ġimgħa iva u ġimgħa le hija ta' 200 mg (< 60 kg) jew 300 mg (≥ 60 kg).
English: In a subset of patients with HADS-anxiety or HADS-depression subscale scores ≥ 8 at baseline (the cut-off value for anxiety or depression), a larger proportion of patients in the dupilumab groups achieved HADS-anxiety and HADS-depression scores < 8 at week 16 compared to placebo (See Table 8).
Maltese: F'sottosett ta' pazjenti b'punteġġi fis-sottoskala tal-ansjetà ta' HADS jew tad-depressjoni ta' HADS ta' ≥ 8 fil-linja bażi (l-għola valur għall-ansjetà jew depressjoni), proporzjon akbar ta' pazjenti fil gruppi ta' dupilumab kisbu punteġġi ta' ansjetà ta' HADS u ta' depressjoni ta' HADS ta' < 8 f'ġimgħa 16 meta mqabbel mal-plaċebo (Ara Tabella 8).
English: Figure 1 and Figure 2 show the mean percent change from baseline in EASI and the mean percent change from baseline in NRS, respectively up to week 16.
Maltese: Figura 1 u Figura 2 juru il-bidla perċentwali medja mil-linja bażi f'EASI u l-bidla perċentwali medja mil-linja bażi f'NRS, rispettivament sa ġimgħa 16.
English: Anaphylactic reaction has been reported very rarely in the asthma development program (see section 4.4).
Maltese: Reazzjoni anafilattika ġiet irrappurtata b'mod rari ħafna fl-iżvilupp ta' programm għall-ażżma (ara sezzjoni 4.4).
English: Rate of Severe Exacerbations in QUEST Defined by Baseline FeNO Subgroups
Maltese: Rata ta' Taħrix Sever fi QUEST Definita mis-Sottogruppi ta' FeNO fil-linja bażi
English: Placebo Dupilumab 300 mg Q2W + TCS
Maltese: Plaċebo Dupilumab 300 mg Q2W + TCS
English: SOLO 1 at Week 16
Maltese: SOLO 1 f'Ġimgħa 16
English: The long-term safety profile of dupilumab observed in adolescents was consistent with that seen in adults with atopic dermatitis.
Maltese: Il-profil ta' sigurtà fit-tul ta' dupilumab osservat fl-adolexxenti kien konsistenti ma' dak li deher fl-adulti b'dermatite atopika.
English: Table 11: Effect of dupilumab on OCS dose reduction, VENTURE (Baseline Blood Eosinophil Levels
Maltese: Tabella 11: Effett ta' dupilumab fuq it-tnaqqis fid-doża ta' OCS, VENTURE (Livelli tal-Eosinofili fidDemm fil-Linja bażi ≥ 150 u ≥ 300 ċellula/mcL u FeNO ≥ 25 ppb)
English: A. Check expiration date
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: ≥ 300 cells/mcL
Maltese: ≥300 ċellula/mcL
English: 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.
Maltese: Il-pazjenti ntagħżlu b'mod arbitrarju biex jirievu 200 mg (N=631) jew 300 mg (N=633) Dupixent darba kull ġimagħtejn (jew plaċebo li jaqbel mat-200 mg (N = 317) jew mat-300 mg (N= 321) darba kull ġimagħtejn) wara doża tal-bidu ta' 400 mg, 600 mg jew plaċebo,
English: Number of patients with POEM ≥4 at baseline POEM (≥ 4-point improvement), % responders
Maltese: POEM (titjib ta' ≥ 4 punti), % ta' persuni li rrispondew
English: 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:
Maltese: Id-doża rrakkomandata ta' Dupixent għall-adolexxenti (12 sa 17-il sena) b'dermatite atopika hija bbażata fuq il-piż tal-ġisem:
English: 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.
Maltese: IGA fil-linja bażi ta' 4 u 33.6 % tal-pazjenti irċevew immunosoppressanti sistemiċi preċedenti.
English: Pruritus NRS
Maltese: Rispons Kliniku
English: Age was not found to be associated with any clinically meaningful impact on the systemic exposure of dupilumab determined by population PK analysis.
Maltese: L-età ma nstabitx li hija assoċjata ma' xi impatt kliniku sinifikanti fuq l-esponiment sistemiku għal dupilumab determinat mill-analiżi tal-PK tal-popolazzjoni.
English: Patients randomised IGA 0 or 1b, % respondersc
Maltese: Pazjenti randomised IGA ta' 0 jew 1b, % ta' persuni li rrispondewc
English: The asthma development program included three randomised, double-blind, placebo-controlled, parallel-group, multi-centre studies (DRI12544, QUEST, and VENTURE) of 24 to 52 weeks in treatment duration which enrolled a total of 2,888 patients (12 years of age and older).
Maltese: arbitrarji, b'ħafna ċentri, ikkontrollati bi plaċebo, bi grupp paralell, fejn la l-investigaturi u lanqas lindividwi ma kienu jafu liema sustanza qed tintuża b'tul ta' żmien tat-trattament ta' 24 sa 52 ġimgħa li rreġistraw fihom total ta' 2,888 pazjent (12-il sena jew aktar).
English: There were greater improvements in FEV1 in the subjects with higher baseline levels of type 2 inflammatory biomarkers such as blood eosinophils or FeNO (Table 8 and Table 9).
Maltese: infjammazzjoni tat-tip 2 fil-linja bażi bħal eosinofili fid-demm jew FeNO (Tabella 8 u Tabella 9).
English: • Do not use the syringe if it has been damaged.
Maltese: • Iċċekkja li t-tieqa kollha saret safra.
English: Baseline Characteristics
Maltese: Karatteristiċi fil-Linja Bażi
English: Step 9: Insert
Maltese: Pass 6: Naddaf
English: Pre-filled syringe 300 mg - Multipack (contains Blue Box)
Maltese: Siringa mimlija għal-lest 300 mg - Pakkett Multiplu (mingħajr Kaxxa Blu)
English: CHRONOS
Maltese: TIKKETTAR
English: Each pre-filled syringe contains 300 mg of dupilumab in 2 ml solution (150 mg/ml).
Maltese: Kull siringa mimlija għal-lest fiha 300 mg ta' dupilumab f'2 ml ta' soluzzjoni (150 mg/ml).
English: Asthma treatment guidelines define type 2 inflammation as eosinophilia ≥ 150 cells/mcL and/or FeNO ≥ 20 ppb.
Maltese: Il-linji gwida tat-trattament tal-ażżma jiddefinixxu infjammazzjoni tat-tip 2 bħala eosinofilja b'≥ 150 ċellula/mcL u/jew FeNO ≥ 20 ppb.
English: EU/1/17/1229/009 1 pre-filled syringe with needle shield EU/1/17/1229/010 2 pre-filled syringes with needle shield
Maltese: EU/1/17/1229/009 siringa mimlija għal-lest waħda bi protezzjoni tal-labra EU/1/17/1229/010 2 siringi mimlija għal-lest bi protezzjoni tal-labra
English: EXP
Maltese: TCS
English: In this study, the mean age was 14.5 years, the median weight was 59.4 kg, 41.0 % were female, 62.5% were White, 15.1% were Asian, and 12.0% were Black.
Maltese: F'dan l-istudju, l-età medja kienet ta' 14.5 snin, il-piż medjan kien ta' 59.4 kg, 41.0 % kienu nisa, 62.5% kienu Bojod, 15.
English: EU/1/17/1229/005 1 pre-filled syringe with needle shield EU/1/17/1229/006 2 pre-filled syringes with needle shield
Maltese: EU/1/17/1229/005 siringa mimlija għal-lest waħda bi protezzjoni tal-labra EU/1/17/1229/006 2 siringi mimlija għal-lest bi protezzjoni tal-labra
English: 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).
Maltese: F'SOLO 1 u SOLO 2, mil-linja bażi sa ġimgħa 16, proporzjon akbar b'mod sinifikanti ta' pazjenti randomised għal dupilumab kisbu rispons ta' IGA ta' 0 jew 1, EASI-75, u/jew titjib ta' >4 punti fuq l
English: 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.
Maltese: Madwar 9 % tal-pazjenti bl-ażżma li rċivew dupilumab 200 mg Q2W għal 52 ġimgħa żviluppaw antikorpi għal dupilumab; madwar 4 % urew risponsi persistenti ta' ADA u madwar 4 % kellhom antikorpi li jinnewtralizzaw.
English: c Patients who received rescue treatment or with missing data were considered as non-responders (58.8% and 20.7% in the placebo and dupilumab arms, respectively).
Maltese: (58.8% u 20.7% fil-fergħat ta' plaċebo u dupilumab, rispettivament).
English: Mean total IgE IU/mL (± SD) Mean baseline Eosinophil count (± SD) cells/mcL
Maltese: Medja tat-total ta' IgE IU/mL (± SD) Medja tal-għadd tal-eosinofili fil-linja bażi
English: Very limited data are available in patients with severe renal impairment (see section 5.2).
Maltese: Hija disponibbli data limitata ħafna f'pazjenti b'indeboliment sever tal-kliewi (ara sezzjoni 5.2).
English: 400 mg (two 200 mg injections)
Maltese: Inqas minn 60 kg 400 mg (żewġ injezzjonijiet ta' 200 mg)
English: DRI12544 study Dupilumab 200 mg
Maltese: Studju QUEST Dupilumab 200 mg
English: The safety profile of dupilumab in patients followed through week 52 was similar to the safety profile observed at week 16 in AD-1526 study.
Maltese: sigurtà osservat f'ġimgħa 16 fl-istudju AD-1526.
English: Biomarkers of type 2 inflammation may be suppressed by systemic corticosteroid use.
Maltese: Bijomarkaturi tal-infjammazzjoni tat-tip 2 jistgħu jiġu soppressi permezz tal-użu ta' kortikosterojdi sistemiċi.
English: b Responder was defined as a patient with IGA 0 or 1 (“clear” or “almost clear”) with a reduction of > 2 points on a 0-4 IGA scale.
Maltese: b Persuna li rrispondiet kienet definita bħala pazjent b'IGA ta' 0 jew 1 (“imfejqa” jew “kawżi imfejqa”) bi tnaqqis ta' >2 punti fuq l-iskala ta' IGA ta' 0-4.
English: If needed to control intolerable symptoms of atopic dermatitis, patients were permitted to receive rescue treatment (which included higher potency topical steroids or systemic immunosuppressants) at the discretion of the investigator.
Maltese: Jekk meħtieġ biex jiġu ikkontrollati sintomi intollerabbli ta' dermatite atopika,il pazjenti kienu permessi jirċievu trattament ta' salvataġġ (li kien jinkludi sterojdi topiċi ta' qawwa ogħla jew immunosoppressanti sistemiċi) fid-diskrezzjoni tal-investigatur.