FrancophonIA/ELRC3.0 huggingface dataset:
English: SOLO 2 enrolled 708 patients (236 to placebo, 233 to dupilumab 300 mg Q2W, and 239 to dupilumab 300 mg QW) and had a treatment period of 16 weeks.
Maltese: SOLO 2 irreġistra 708 pazjenti (236 għall-plaċebo, 233 għal dupilumab 300 mg Q2W, u 239 għal dupilumab 300 mg QW) u kellu perjodu ta' trattament ta' 16-il ġimgħa.
English: LS = least squares; SE = standard error a p-value < 0.0001 b p-value < 0.001
Maltese: SE = standard error a valur p < 0.0001 b valur p < 0.001
English: Step 11: Remove
Maltese: Pass 11: Neħħi
English: CDLQI, LS mean change from baseline (+/-SE)
Maltese: CDLQI, LS bidla medja mil-linja bażi (+/-SE)
English: In the 52-week atopic dermatitis dupilumab + TCS study, eczema herpeticum was reported in 0.2 % of the dupilumab + TCS group and 1.9 % of the placebo + TCS group.
Maltese: Fl-istudju ta' 52 ġimgħa ta' dermetite atopika b'dupilumab + TCS, ekżema herpeticum kienet irrappurtata f'0.2 % tal-grupp ta' dupilumab + TCS u f'1.9 % tal-grupp ta' plaċebo + TCS.
English: Patients were also permitted to use topical calcineurin inhibitors (TCI).
Maltese: Il-pazjenti kienu permessi wkoll jużaw inibituri topiċi ta' calcineurin (TCI - topical calcineurin inhibitors).
English: 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.
Maltese: Fil-linja bażi 46.2% tal-pazjenti kellhom punteġġ IGA fil-linja bażi ta' 3 (AD moderata), 53.8% tal-pazjenti kellhom IGA fil-linja bażi ta' 4 (AD severa), il-medja tal-involviment BSA kien ta' 56.5%, u 42.4 % tal-pazjenti rċevew preċedentement immunosuppressanti sistemiċi.
English: EASI-90, % respondersc
Maltese: EASI-90, % li rrispondewc c
English: Pre-specified secondary endpoint of ACQ-5 and AQLQ(S) responder rates were analysed at 24 weeks (DRI12544 and VENTURE) and at 52 weeks (QUEST).
Maltese: L-iskop finali sekondarju speċifikat minn qabel tar-rati ta' persuni li rrispondew ACQ-5 u AQLQ(S) ġie analizzat wara 24 ġimgħa (DRI12544 u VENTURE) u 52 ġimgħa (QUEST).
English: The recommended dose of dupilumab for adults and adolescents (12 years of age and older) is:
Maltese: Id-doża rakkomandata ta' dupilumab għall-pazjenti adulti u adolexxenti (12-il sena u aktar) hija:
English: Figure 2: Mean percent change from baseline in NRS in SOLO 1a and SOLO 2a (FAS)b
Maltese: Figura 2: Bidla perċentwali medja mil-linja bażi fl-NRS f'SOLO 1a u SOLO 2a (FAS)b
English: 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.
Maltese: Fl-istudji ta' monoterapija (SOLO 1 u SOLO 2), tul il-gruppi kollha ta' trattament, l-età medja kienet 38.3 snin, il-piż medju kien 76.9 kg, 42.1% kienu nisa, 68.1% kienu bojod, 21.8% kienu Asjatiċi, u
English: Dupilumab compared with placebo was evaluated in 107 adolescent and 1,795 adult patients with persistent asthma on a medium-to-high dose inhaled corticosteroid (ICS) and a second controller medication.
Maltese: Dupilumab imqabbel mal-plaċebo ġie evalwat f'107 pazjenti adolexxenti u 1,795 pazjent adult b'ażżma persistenti b'doża medja sa għolja ta' kortikosterojd li jinġibed man-nifs (ICS, inhaled corticosteroid) u t-tieni mediċina li tikkontrolla l-ażżma.
English: Placebo Dupilumab 300 mg Q2W 124 0.39 (0.27, 0.558)
Maltese: Plaċebo Dupilumab 300 mg Q2W 124 0.39 (0.27, 0.558)
English: ICS = inhaled corticosteroid; FEV1 = Forced expiratory volume in 1 second; ACQ-5 = Asthma Control Questionnaire-5; AQLQ = Asthma Quality of Life Questionnaire; AD = atopic dermatitis; NP = nasal polyposis; AR = allergic rhinitis; FeNO = fraction of exhaled nitric oxide; EOS = blood eosinophil aThe population in dupilumab asthma trials included patients on medium and high dose ICS.
Maltese: AD, atopic dermatitis = dermatite atopika; NP, nasal polyposis = polipożi fl-imnieħer; AR, allergic rhinitis = rinite allerġika; FeNO, fraction of exhaled nitric oxide = porzjon ta' nitric oxide imneħħi man-nifs;
English: 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.
Maltese: L-età medja kienet 38.4 snin, 38.8 % kienu nisa, il-punteġġ medju ta' EASI fil-linja bażi kien 33.1, BSA medja kienet 55.7, il-medja tal-NRS tal-ħakk ta' kull ġimgħa fil linja bażi kienet 6.4, il-punteġġ medju SCORAD fil-linja bażi kien 67.2, u DLQI medju fil-linja bażi kien 13.8.
English: 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.
Maltese: Dupilumab huwa antikorp monoklonali uman sħiħ kontra r-riċettur alfa ta' interleukin (ILinterleukin) 4 li jinibixxi s-sinjalar ta' IL-4/IL-13, magħmul f'ċelluli tal-Ovarju tal-Ħamster Ċiniż (CHO - Chinese Hamster Ovary) permezz ta' teknoloġija tat-tfassil tad-DNA.
English: Table 11: Demographics and Baseline Characteristics of Asthma Trials
Maltese: Tabella 11: Id-Demografiċi u l-Karatteristiċi fil-Linja Bażi tal-Provi tal-Ażżma
English: In DRI12544 and QUEST studies, the proportion of patients who discontinued treatment due to adverse events was 4.3% of the placebo group, 3.2% of the dupilumab 200 mg Q2W group, and 6.1% of the dupilumab 300 mg Q2W group.
Maltese: Fl-istudji DRI12544 u QUEST, il-proporzjon ta' pazjenti li waqqfu t-trattament minħabba reazzjonijiet avversi kien 4.3% mill-grupp tal-plaċebo, 3.2% mill grupp Q2W ta' dupilumab 200 mg, u 6.1% millgrupp Q2W ta' dupilumab 300 mg.
English: From baseline L (%)
Maltese: fil-linja bażi, n (%)
English: Key Secondary Endpoints
Maltese: Punti Finali Sekondarji Ewlenin
English: Placebo ap-value < 0.0001
Maltese: Plaċebo avalur p<0.0001
English: Placebo ap-value <0.0001
Maltese: Plaċebo avalur p < 0.0001
English: • Check the expiration date.
Maltese: • Iċċekkja d-data ta' skadenza.
English: 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.
Maltese: Riżultati oħra evalwati inkludew il-proporzjon ta' pazjenti b'titjib ta' mill-inqas 50 % u 90 % f'EASI (EASI-50 u EASI-90, rispettivament), tnaqqis fil-ħakk kif imkejjel mill-Iskala ta' Ikklassifikar Numeriku (NRSNumerical Rating Scale) ta' ħakk massimu, u bidla perċentwali fl-iskala tal-Punteġġ tad-Dermatite Atopika (SCORAD - SCORing Atopic Dermatitis) mil-linja bażi sa ġimgħa 16.
English: Dupilumab elimination is mediated by parallel linear and nonlinear pathways.
Maltese: Eliminazzjoni L-eliminazzjoni ta' Dupilumab hija medjata minn rotot paralleli lineari u mhux lineari.
English: 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).
Maltese: Persentaġġ ikbar ta' pazjenti li b'mod arbitrarju ntgħażlu għal plaċebo kellhom bżonn ta' trattament ta' salvataġġ (kortikosterojdi topiċi, kortikosterojdi sistemiċi, jew immunosuppressanti sistemiċi li mhumiex sterojdi) meta mqabbel mal-grupp ta' dupilumab (58.8% u 20.
English: Pruritus NRS, LS mean % change from baseline (+/- SE)
Maltese: Pruritus NRS, LS bidla medja % mil-linja bażi (+/- SE)
English: EASI-75, % respondersc
Maltese: EASI-75, % li rrispondewc c
English: C. Give injection C1.
Maltese: Ċ.Agħti l-injezzjoni Ċ1.
English: Concomitant Use of TCS CHRONOS at Week 16
Maltese: Użu konkomitanti ta' TCS CHRONOS f'Ġimgħa 16
English: Table 9: Other secondary endpoint results of dupilumab with concomitant TCS at Week 16 and Week 52 in CHRONOS
Maltese: Riżultati ta' punti finali sekondarji oħra ta' dupilumab b'TCS konkomitanti f'Ġimgħa 16 u Ġimgħa 52 fi CHRONOS
English: Table 4: Efficacy results of dupilumab monotherapy at week 16 (FAS)
Maltese: Tabella 4: Riżultati tal-effikaċja ta' monoterapija b'dupilumab f'ġimgħa 16 (FAS) SOLO 1 (FAS)a
English: 600 mg (two 300 mg injections)
Maltese: 600 mg (żewġ injezzjonijiet ta' 300 mg)
English: C3.
Maltese: Ċ3.
English: Table 12: Rate of Severe Exacerbations in DRI12544 and QUEST (Baseline Blood Eosinophil
Maltese: Tabella 12: Rata ta Taħrix Sever f'DRI12544 u QUEST (Livelli tal-Eosinofili fid-Demm fil-Linja
English: In the concomitant TCS study (CHRONOS), dupilumab 300 mg Q2W + TCS and dupilumab 300 mg QW + TCS improved patient-reported symptoms and the impact of AD on sleep and health-related quality of life as measured by POEM and DLQI total scores, respectively, at 52 weeks compared to placebo + TCS.
Maltese: Fl-istudju b'TCS konkomitanti (CHRONOS), dupilumab 300 mg Q2W + TCS u dupilumab 300 mg QW + TCS tejjbu s-sintomi rrappurtati mill-pazjenti u l-impatt ta' AD fuq l-irqad u l-kwalità tal-ħajja relatata mas-saħħa kif imkejla mill-punteġġi totali ta' POEM u DLQI, rispettivament, wara 52 ġimgħa meta mqabbel mal-plaċebo + TCS.
English: 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.
Maltese: Dupixent huwa indikat għat-trattament ta' dermatite atopika moderata sa severa f'adulti u f'adolexxenti ta' 12-il sena u 'l fuq li huma kandidati għal terapija sistemika.
English: The recommended dose of dupilumab for adolescent patients 12 to 17 years of age is specified in Table 1.
Maltese: Id-doża rakkomandata ta' dupilumab għall-pazjenti adolexxenti ta' età minn 12 sa 17-il sena hija speċifikata f'Tabella 1.
English: DRI12544 (n = 776)
Maltese: (n = 776)
English: • Keep unused syringes in the original carton and store in the refrigerator between 2ºC and 8ºC.
Maltese: • Żomm siringi mhux użati fil-kartuna oriġinali u aħżen fi friġġ f'temperatura bejn 2°C u 8°C.
English: • hives
Maltese: Sess
English: Dupixent 300 mg syringe
Maltese: Dupixent 300 mg siringa
English: Multipack: 3 (3 packs of 1) pre-filled syringes with needle shield Multipack: 6 (3 packs of 2) pre-filled syringes with needle shield
Maltese: Pakkett Multiplu: 3 (3 pakketti ta' 1) siringi mimlija għal-lest Pakkett Multiplu: 6 (3 pakketti ta' 2) siringi mimlija għal-lest
English: A total of 210 patients with oral corticosteroid-dependent asthma receiving high-dose inhaled corticosteroids plus up to two additional controllers were enrolled (VENTURE).
Maltese: Ġew irreġistrati total ta' 210 pazjenti b'ażżma dipendenti fuq il-kortikosterojdi mill-ħalq u sa żewġ kontrollaturi addizzjonali flimkien magħhom (VENTURE).
English: ≥ 150 cells/mcL ≥ 300 cells/mcL
Maltese: ≥ 150 ċellula/mcL ≥ 300 ċellula/mcL
English: Severity Index (EASI) score ≥16, and a minimum body surface area (BSA) involvement of ≥ 10 %.
Maltese: punteġġ tal-Indiċi tal-Erja u s-Severità tal-Ekżema (EASI - Eczema Area and Severity Index) ta' ≥16 fuq skala ta' 0 sa 72, u involviment minimu tal-erja tas-superfiċje tal-ġisem (BSA - body surface area)
English: Sanofi
Maltese: T/A SANOFI
English: Eosinophils ≥ 150 and ≥ 300 cells/mcL and FeNO ≥ 25 ppb) in QUEST
Maltese: (Eosinofili fil-Linja Bażi ≥ 150 u ≥ 300 ċelluli/mcL u FeNO ≥25 ppb) fi QUEST
English: CHRONOS at Week 52
Maltese: CHRONOS f'Ġimgħa 52
English: In all three studies, patients received 1) an initial dose of 600 mg dupilumab (two 300 mg injections) on day 1, followed by 300 mg once every two weeks (Q2W); 2) an initial dose of 600 mg dupilumab on day 1, followed by 300 mg once weekly (QW); or 3) matching placebo.
Maltese: 300 mg) f'jum 1, segwit minn 300 mg darba kull ġimagħtejn (Q2W - once every two weeks); 2) doża inizjali ta' 600 mg dupilumab f'jum 1, segwit minn 300 mg darba fil-ġimgħa (QW - once weekly); jew 3) plaċebo li jaqbel.
English: • Do not touch the plunger rod until you are ready to inject.
Maltese: • Neħħi biss it-tapp isfar eżatt meta tkun se tagħti l-injezzjoni.
English: Step 1: Remove
Maltese: Pass 1: Neħħi
English: Baseline characteristics are presented in Table 11.
Maltese: Karatterisitiċi tal-linja bażi huma ppreżentati f'Tabella 11.
English: Dupixent 200 mg pen
Maltese: Dupixent 200 mg pinna
English: Placebo 237 0.22 (14.2) ap-value <0.0001, bp-value = 0.0004, cp-value = 0.0008, dp-value = 0.0063, ep-value <0.0001
Maltese: 0001, bvalur p = 0.0004, cvalur p= 0.0008, dvalur p= 0.0063, evalur p<0.0001
English: Pre-dose FEV1 (L) at baseline ± SD Mean percent predicted FEV1 at baseline (%)(± SD) % Reversibility (± SD)
Maltese: Medja tal-perċentwal ta' FEV1 imbasssar fil-linja bażi (%)(± SD)
English: You must look out for signs of these conditions (i.e. breathing problems, swelling of the face, mouth, and tongue, fainting, dizziness, feeling lightheaded (low blood pressure), fever, general ill feeling, swollen lymph nodes, hives, itching, joint pain, skin rash) while you are taking Dupixent.
Maltese: Għandek toqgħod attent għal sinjali ta' dawn il-kondizzjonijiet (jiġifieri problemi ta' nifs, nefħa tal-wiċċ, ħalq u ilsien, ħass ħażin, sturdament, tħossok se tistordi (pressjoni baxxa tad-demm), deni, tħossok ma tiflaħx b'mod ġenerali, glandoli limfatiċi minfuħa, urtikarja, ħakk, uġigħ fil-ġogi, raxx tal-ġilda) waqt li tkun qed tieħu Dupixent.
English: Mean ACQ-5 score (± SD)
Maltese: L-ACQ-5 u l
English: Table 10: ACQ-5 and AQLQ(S) Responder Rates at Week 52 in QUEST
Maltese: Rati ta' Persuni li Rrispondew ACQ-5 u AQLQ(S) f'Ġimgħa 52 fi QUEST
English: Placebo Dupilumab 300 mg Q2W 310 0.43 (0.35, 0.54)
Maltese: Plaċebo Dupilumab 300 mg Q2W 310 0.43 (0.35, 0.54)
English: 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
Maltese: Erja u s-Severità tal-Ekżema (EASI) kien ta' 35.5, il-medja ta' ġimgħa tal-Iskala ta' Ikklassifikar Numeriku (NRS - Numerical Rating Scale) ta' pruritu fil-linja bażi kien ta' 7.6, il-medja fil-linja bażi tal-punteġġ tal- iSCORing Atopic Dermatitis (SCORAD ) kien ta' 70.3, il-medja fil-linja bażi tal-Kejl tal-Ekżema Orjentat lejn il-Pazjent (POEM - Patient Oriented Eczema Measure) kien ta' 21.0, u l medja fil-linja bażi tal-Indiċi tal-Kwalità tal-Ħajja tad-Dermatoloġija fit-Tfal (CDLQI- Children
English: The primary endpoint was change from baseline to week 12 in FEV1 (L).
Maltese: L-iskop finali primarju kien bidla mil-linja bażi sa ġimgħa 12 fl-FEV1 (L).
English: In this 24-week trial, asthma exacerbations (defined as a temporary increase in oral corticosteroid dose for at least 3 days) were reduced by 59% in subjects receiving dupilumab compared with those receiving placebo (annualized rate 0.65 and 1.60 for the dupilumab and placebo group, respectively; rate ratio 0.41 [95% CI 0.26, 0.63]) and improvement in pre-bronchodilator FEV1 from baseline to week 24 was greater in subjects receiving dupilumab compared with those receiving placebo (LS mean difference for dupilumab versus placebo of 0.22 L [95% CI: 0.09 to 0.34 L]).
Maltese: F'din il-prova ta' 24 ġimgħa, it-taħrix tal-ażżma (iddefinit bħala żieda temporanja fid-doża talkortikoserojd mill-ħalq għal mill-anqas 3 ijiem) naqas b'59% f'individwi li kienu qed jirċievu dupilumab meta mqabbel ma dawk li kieu qed jirċievu plaċebo (rata annwalizzata ta' 0.65 u 1.60 għal dupilumab u l-grupp tal-plaċebo, rispettivament; rata ta' proporzjon 0.41 [95% CI 0.26, 0.63]) u t-titjib fl-FEV1 ta' qabel il-bronkodilatatur mil-linja bażi sa ġimgħa 24 kien akbar f'individiwi li kieu qed jirċievu dupilumab meta mqabbel ma dawk li kienu qed jirċievu plaċebo (differenza medja ta' LS għal dupilumab versus plaċebo ta' 0.22 L [95% CI: 0.09 to 0.34 L]).
English: 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.
Maltese: Fis-sottogrupp ta' pazjenti li jixbhu l-popolazzjoni tal-istudju CAFE fl-istudju CHRONOS ta' 52 ġimgħa, 69.6 % tal-pazjenti ttrattati b'dupilumab 300 mg Q2W laħqu EASI-75 kontra 18.0 % talpazjenti ttrattati bi plaċebo f'ġimgħa 16, u 52.4 % tal-pazjenti ttrattati b'dupilumab 300 mg Q2W kontra 18.6 % ittrattati bi plaċebo f'ġimgħa 52.
English: Table 3: List of adverse reactions in asthma MedDRA System
Maltese: Tabella 3: Lista ta' reazzjonijiet avversi fl-ażżma Klassi tas-Sistemi u tal-Organi
English: 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.
Maltese: Punti finali addizzjonali sekondarji kienu jinkludu bidla medja mil-linja bażi sa ġimgħa 16 fil-punteġġi tal-Kejl tal-Ekżema Orjentat lejn il-Pazjent (POEM - Patient Oriented Eczema Measure), tal-Indiċi tal-Kwalità tal-Ħajja tad-Dermatoloġija (DLQI - Dermatology Life Quality Index), u tal-Iskala ta' Ansjetà u Depressjoni tal-Isptar (HADS - Hospital Anxiety and Depression Scale).
English: The efficacy and safety of dupilumab as monotherapy and with concomitant topical corticosteroids were evaluated in three pivotal randomised, double-blind, placebo-controlled studies (SOLO 1, SOLO 2, and CHRONOS) in 2,119 patients 18 years of age and older with moderate to severe atopic dermatitis (AD) defined by Investigator's Global Assessment (IGA) score ≥ 3, an Eczema Area and
Maltese: L-effikaċja u s-sigurtà ta' dupilumab bħala monoterapija u flimkien ma' kortikosterojdi topiċi kienu evalwati fi tliet studji pivitali, randomised, double-blind u kkontrollati bil-plaċebo (SOLO 1, SOLO 2, u CHRONOS) f'2119-il pazjent ta' età minn 18-il sena 'l fuq b'dermatite atopika (AD - atopic dermatitis) moderata sa severa definita minn punteġġ tal-Valutazzjoni Globali tal-Investigatur (IGAInvestigator's Global Assessment) ta' ≥3, punteġġ tal-Indiċi tal-Erja u s-Severità tal-Ekżema u (EASIEczema Area and Severity Index) ta' ≥16, u involviment minimu tal-erja tas-superfiċje tal-ġisem (BSA - body surface area) ta' ≥10 %.
English: EASI-50, % respondersc
Maltese: EASI-50, % li rrispondewc c
English: Table 2: List of adverse reactions in atopic dermatitis MedDRA System
Maltese: Tabella 2: Lista ta' reazzjonijiet avversi f'dermatite atopika Klassi tas-Sistemi u tal-Organi
English: Eczema herpeticum was reported in < 1 % of the dupilumab groups and in < 1 % of the placebo group in the 16-week atopic dermatitis monotherapy studies.
Maltese: Ekżema herpeticum kienet irrappurtata f'<1 % tal-gruppi ta' dupilumab u f'<1 % tal-grupp tal-plaċebo fl-istudji b'monoterapija ta' 16-il ġimgħa ta' dermatite atopika.
English: These reductions in type 2 inflammatory biomarkers were comparable for the 200 mg Q2W and 300 mg Q2W regimens.
Maltese: Dan it-tnaqqis fil-bijomarkaturi tal-infjammazzjoni tat-tip 2 kien kumparabbli għall-iskedi ta' 200 mg Q2W u 300 mg Q2W.
English: Excipients: arginine hydrochloride, histidine, polysorbate 80, sodium acetate, glacial acetic acid, sucrose, water for injections.
Maltese: Eċċipjenti: arginine hydrochloride, histidine, polysorbate 80, sodium acetate, glacial acetic acid, sucrose, ilma għall-injezzjonijiet.
English: Clinically significant increases in pre-bronchodilator FEV1 were observed at week 12 for DRI12544 and QUEST.
Maltese: Żidiet sinifikanti b'mod kliniku fl-FEV1 ta' qabel il-bronkodilatatur ġew osservati f'ġimgħa 12 għal DRI12544 u QUEST.
English: Baseline characteristics are presented in Table 5.
Maltese: Karatterisitiċi tal-linja bażi huma ppreżentati f'Tabella 5.
English: Figure 1: Proportion of adolescent patients with ≥4-point improvement on the pruritus NRS in AD-1526 studya (FAS)b a In the primary analyses of the efficacy endpoints, subjects who received rescue treatment or with missing data were considered non-responders.
Maltese: Proporzjon ta' pazjenti adolexxenti b'≥4-punti ta' titjib fuq l-NRS tal-pruritu flistudju AD-1526a (FAS)b a Fl-analiżi primarja tal-punti finali ta' effikaċja, suġġetti li rċevew trattament ta' salvataġġ jew b'dejta nieqsa kienu kkunsidrati bħala li ma rrispondewx.
English: Additional secondary endpoints included mean change from baseline to week 16 in the POEM and CDLQI scores.
Maltese: Punti finali sekondarji addizzjonali inkludew il-bidla medja mil-linja bażi sa ġimgħa 16 fil-punteġġ ta' POEM u CDLQI
English: Table 7: Results of the primary and secondary endpoints in SOLO CONTINUE study Placebo
Maltese: Riżultati tal-punti finali primarji u sekondarji fl-istudju SOLO CONTINUE
English: Figure 3: Mean percent change from baseline in EASI in CHRONOSa (FAS Week 52)b
Maltese: Figura 3: Bidla perċentwali medja mil-linja bażi f'EASI fi CHRONOSa (FAS ta' Ġimgħa 52)b
English: Dupixent contains the active substance dupilumab.
Maltese: Dupixent fih is-sustanza attiva dupilumab.
English: Primary and secondary endpoints for the 52 week SOLO CONTINUE study are summarized in table 7.
Maltese: Il-punti finali primarji u sekondarji għall-istudju SOLO CONTINUE ta' 52 ġimgħa huma miġbura filqosor f'tabella 7.
English: 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).
Maltese: Is-sigurtà fit-tul ta' dupilumab ġiet evalwata f'studju ta' estensjoni open-label f'pazjenti ta' età minn 12 sa 17-il sena b'dermatite atopika moderata għal severa (AD-1434).
English: Overall, 92.0% of patients had at least one co-morbid allergic condition; 65.6% had allergic rhinitis, 53.6% had asthma, and 60.8% had food allergies.
Maltese: B'mod ġenerali, 92.0% tal-pazjenti kellhom mill-inqas kondizzjoni waħda allerġika ta' mard fl-istess waqt; 65.6% kellhom rinite allerġika, 53.6% kellhom l-ażżma 60.8% kellhom allerġija għal xi ikel.
English: C2.
Maltese: Ċ2.
English: AQLQ(S) Dupilumab 200 mg Q2W Placebo
Maltese: AQLQ(S) Dupilumab 200 mg Q2W
English: All Severe Exacerbations DRI12544 study Dupilumab
Maltese: Studju DRI12544
English: Common (may affect up to 1 in 10 people) atopic dermatitis only:
Maltese: Komuni ħafna (jistgħu jaffettwaw aktar minn persuna waħda minn kull 10) dermatite atopika u ażżma:
English: Dupixent 200 mg syringe
Maltese: Dupixent 200 mg siringa
English: 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.
Maltese: Il-pazjenti irċevew 1) doża inizjali ta' 400 mg dupilumab (żewġ injezzjonijiet ta' 200 mg) f'jum 1, segwit minn 200 mg ġimgħa iva u ġimgħa le (Q2W) għal pazjenti b'piż fil-linja bażi ta' <60 kg jew doża inizjali ta' 600 mg dupilumab (żewġ injezzjonijiet ta' 300 mg) f'jum 1, segwit minn 300 mg
English: BSA LS mean % change from baseline (+/- SE)
Maltese: BSA LS bidla medja % mil-linja bażi (+/- SE)
English: Table 9: Mean Change from Baseline in Pre-Bronchodilator FEV1 at Week 12 and Week 52 in QUEST by Baseline FeNO Subgroups
Maltese: Tabella 9: Bidla Medja mil-Linja Bażi fl-FEV1 ta' qabel il-bronkodilatatur f'Ġimgħa 12 u Ġimgħa 52 fi QUEST skont is-Sottogruppi ta' FeNO fil-Linja bażi
English: 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.
Maltese: Titjib fl-ACQ-5 u fl-AQLQ(S) ġie osservat sa minn ġimgħa 2 u nżamm għal 24 ġimgħa f'l-istudju DRI12544 u 52 ġimgħa fl-istudju QUEST.
English: A5: Wait 30 minutes
Maltese: Stenna 30 minuta
English: Clinical efficacy and safety in asthma
Maltese: Effikaċja klinika u sigurtà fl-ażżma