FrancophonIA/ELRC3.0 huggingface dataset:
English: Although not statistically significant, the majority of patients demonstrated clinical improvement in secondary endpoints such as number of sites of enthesitis, tender joint count (TJC), swollen joint count (SJC), Pediatric ACR 50 response, and Pediatric ACR 70 response.
Maltese: Għalkemm mhux statistikament sinifikanti, il-maġġoranza tal-pazjenti wrew titjib kliniku fil-punti tat-tmiem sekondarji bħal numru ta' siti ta' entesite, għadd ta' ġogi sensittivi (TJC, tender joint count), għadd ta' ġogi minfuħa (SJC, swollen joint count), rispons Pedjatriku ACR 50, u rispons Pedjatriku ACR 70.
English: b 2-sided P value from log rank test. c NE = not estimable.
Maltese: b valur P ta' 2 naħat minn test log rank.
English: Note: P = Placebo (Number at Risk (flared)); A = Adalimumab (Number at Risk (flared)).
Maltese: Nota: P = Plaċebo (Numru f'Riskju (marru għall-agħar)); A = Adalimumab (Numru f'Riskju (marru għall-agħar)).
English: Table 8: ACR Responses in RA Study V (percent of patients)
Maltese: Tabella 8: Risponsi għall-ACR fi Studju RA V (perċentwali ta' pazjenti)
English: Hulio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Maltese: Hulio huwa indikat għat-trattament ta' psorjasi tal-plakka kronika li hi minn moderata sa severa f'pazjenti adulti li huma kandidati għal terapija sistemika.
English: Respiratory, thoracic and mediastinal disorders*
Maltese: Disturbi respiratorji, toraċiċi u medjastinali*
English: Placebo / MTXc n=60
Maltese: Plaċebo/MTXc n=60
English: Injecting Hulio
Maltese: Tużax Hulio
English: Hulio is used to treat ulcerative colitis in adults.
Maltese: Hulio huwa intenzjonat għall-kura ta' kolite ulċerattiva fl-adulti.
English: Table 17: Efficacy Results at 12 weeks, HS Studies I and II
Maltese: Tabella 17: Riżultati tal-Effikaċja f'Ġimgħa 12, Studji tal-HS I u II Studju HS I
English: Standard Dose 40/20 mg eow N = 93
Maltese: Doża Standard 40/20 mg ġimgħa iva u ġimgħa le N=93
English: ACR 20 week 12 week 24
Maltese: ACR 20 Ġimgħa 12 Ġimgħa 24
English: - polyarticular juvenile idiopathic arthritis in children aged 2-17 years; - enthesitis-related arthritis in children aged 6-17 years; - Crohn's disease in children aged 6-17 years - plaque psoriasis in children aged 4-17 years; - hidradenitis suppurativa in adolescents aged 12-17 years; - chronic non-infectious uveitis in children aged 2-17 years affecting the front of the eye.
Maltese: - artrite idjopatika poliartikulari taż-żgħażagħ fi tfal ta' bejn 2 - 17-il sena; - artrite relatata mal-entesite fi tfal ta' bejn 6 - 17-il sena; - Marda ta' Crohn fi tfal ta' bejn 6 - 17-il sena - psorjasi tal-plakka fi tfal ta' bejn 4 - 17-il sena; - hidradenitis suppurativa f'adolexxenti ta' bejn 12 - 17-il sena; - uveite mhux infettiva kronika fi tfal ta' bejn 2 - 17-il sena li taffettwa n-naħa ta' quddiem tal għajn.
English: ≥30% Reduction in Skin Painb
Maltese: ≥30% Tnaqqis fl-Uġigħ talĠildab
English: Of those patients who had a response at week 8, 47% were in response, 29% were in remission, 41% had mucosal healing, and 20% were in steroid-free remission for ≥ 90 days at week 52.
Maltese: Mill-pazjenti li kellhom rispons f'ġimgħa 8, 47% kienu fi stat ta' rispons, 29% kienu fi stat ta' titjib kliniku, 41% kellhom fejqan mukosali, u 20% kienu fi stat ta' titjib mingħajr sterojdi għal ≥90 jum f'ġimgħa 52.
English: Hulio 40 mg solution for injection in pre-filled syringe EU/1/18/1319/001
Maltese: Hulio 40 mg soluzzjoni għall-injezzjoni f'siringa mimlija għal-lest EU/1/18/1319/001
English: JSNd score a methotrexate b 95% confidence intervals for the differences in change scores between methotrexate and adalimumab.
Maltese: Punteġġ tal-erożjoni Punteġġ JSNd a methotrexate b 95% intervall ta' kunfidenza għad-differenzi bejn il-punteġġi ta' methotrexate u adalimumab.
English: Placebo
Maltese: - Plaċebo
English: Statistically and clinically significant improvements from Baseline were also observed in both treatment groups for quality of life parameters (including IMPACT III).
Maltese: Titjib statistikament u klinikament sinifikanti mil-Linja Bażi kien ukoll osservat fiż-żewġ gruppi tattrattament għal parametri tal-kwalità tal-ħajja (inkluż IMPACT III).
English: Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified Total Sharp Score ≤ 0.5) was significantly higher with adalimumab /methotrexate combination therapy (63.8% and 61.2% respectively) compared to methotrexate monotherapy (37.4% and 33.5% respectively, p < 0.001) and adalimumab monotherapy (50.7%, p < 0.002 and 44.5%, p < 0.001 respectively).
Maltese: Wara kura ta' 52 ġimgħa u ta' 104 ġimgħat, il-perċentwali ta' pazjenti li ma avvanzatilhomx il-marda (bidla mil-linja bażi fil-Punteġġ Totali Sharp modifikat ≤0.5) kien sinifikament ogħla bit-terapija kkombinata ta' adalimumab/methotrexate (63.8% u 61.2% rispettivament) meta pparagunat ma' kura b'methotrexate waħdu (37.4% u 33.5% rispettivament, p<0.001) u kura b'adalimumab waħdu (50.7%, p<0.002 u 44.5%, p<0.001 rispettivament).
English: Neurological infections (including viral meningitis), opportunistic infections and tuberculosis (including coccidioidomycosis, histoplasmosis and mycobacterium avium complex infection), bacterial infections, eye infections, diverticulitis1)
Maltese: Infezzjonijiet newroloġiċi (li jinkludu meninġite virali), infezzjonijiet opportunistiċi u tuberkulożi (li jinkludu kokkidijojdomikożi, istoplasmożi u infezzjoni tal-mycobacterium avium complex), infezzjonijiet batterjali, infezzjonijiet fl-għajnejn, divertikulite1)
English: At week 12 and week 24, PedACR30 response was 93.5% and 90.0%, respectively, using the observed data approach.
Maltese: F'ġimgħa 12 u ġimgħa 24, ir-rispons Ped ACR 30 kien ta' 93.5% u 90.0% rispettivament meta ntuża l-approċċ tad-dejta osservata.
English: Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies, CD Study I (CLASSIC I) and CD Study II (GAIN).
Maltese: Il-bidu tal-qlib għall-aħjar fl-istat kliniku (definit bhala CDAI <150) ġie evalwat f'żewġ studji, Studju CD I (CLASSIC I) u Studju CD II (GAIN).
English: 14 weeks a Ped ACR 30/50/70 responses week 48 significantly greater than those of placebo treated patients b p = 0.015 c p = 0.031
Maltese: 14 ġimgħa a Risponsi Ped ACR 30/50/70 f'ġimgħa 48 kienu sinifikament akbar minn dawk ta' pazjenti kkurati bil-plaċebo b p=0.015 c p=0.031
English: Among those, 154 patients (90.6%) had ACR 20 responses; 127 patients (74.7%) had ACR 50 responses; and 102 patients (60.0%) had ACR 70 responses.
Maltese: 6%) kellhom rispons għall-ACR 20; 127 pazjent (74.7%) kellhom rispons għallACR 50; u 102 pazjent (60.0%) kellhom rispons għall-ACR 70.
English: Table 14: Efficacy Response in Placebo-Controlled Study nr-axSpA I
Maltese: Risponsi ta' l-Effikaċja fi Studju kontrollat bil-Plaċebo nr-axSpA I
English: Other medicines and Hulio
Maltese: Mediċini oħra u Hulio
English: • 1 needle (5)
Maltese: • labra 1 (5)
English: Study UV I evaluated 217 patients with active uveitis despite treatment with corticosteroids (oral prednisone at a dose of 10 to 60 mg/day).
Maltese: Studju UV I evalwa 217-il pazjent b'uveite attiva minkejja t-trattament b'kortikosterojdi (prednisone orali f'doża ta' 10 sa 60 mg/jum).
English: Myocardial infarction1), arrhythmia, congestive heart failure
Maltese: Infart mijokardijaku1), arritmija, insuffiċjenza konġestiva tal-qalb
English: Maintenance of clinical remission was evaluated in CD Study III (CHARM).
Maltese: Il-fatt jekk ġiex mantenut it-titjib kliniku ġie evalwat fi studju CD III (CHARM).
English: • respiratory tract infections (including cold, runny nose, sinus infection, throat infection,
Maltese: • infezzjonijiet fis-sistema respiratorja (li jinkludu riħ, flisjoni, infezzjoni tas-sinus, pulmonite);
English: In controlled and open label adult and paediatric studies with adalimumab, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e.g. disseminated or extrapulmonary histoplasmosis, blastomycosis, coccidioidomycosis, pneumocystis candidiasis, aspergillosis and listeriosis).
Maltese: Fi studji kontrollati u open-label b'adalimumab fl-adulti u fit-tfal, ġew irrappurtati infezzjonijiet serji (inklużi infezzjonijiet fatali, li ġraw rarament), li jinkludu rapporti ta' tuberkulożi (inklużi tuberkulożi b'ħafna għoqod tuberkulari mal-ġisem kollu u tuberkulożi f'postijiet barra mill-pulmun) u infezzjonijiet opportunistiċi invażivi (eż. istoplasmożi mifruxa jew barra 'l pulmun, blastomikożi, kokkidijojdomikożi, pnewmoċistite, kandidjażi, asperġillożi u listerjożi).
English: 1 sterile needle
Maltese: 1 labra sterili
English: In the open-label extension, improvement in the signs and symptoms was maintained with adalimumab therapy through week 156.
Maltese: Fl-estensjoni open-label, titjib fis-sinjali u s-sintomi inżamm b'terapija b'adalimumab sa ġimgħa 156.
English: Placebo Adalimumab 40 mg weekly
Maltese: Plaċebo Adalimumab 40 mg Kull Ġimgħa
English: Adverse events of the haematologic system, including medically significant cytopenia (e.g. thrombocytopenia, leukopenia) have been reported with adalimumab.
Maltese: Avvenimenti avversi tas-sistema ematoloġika, li jinkludu ċitopenija li hi medikament sinifikanti (eż. tromboċitopenija, lewkopenija) ġew irrappurtati b'adalimumab.
English: • systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other organ systems);
Maltese: • lupus erythematosus sistemiku (li jinkludi infjammazzjoni tal-ġilda, tal-qalb, tal-pulmun, tal ġogi u ta' sistemi ta' organi oħra);
English: Orange Activator (Needle Inside)
Maltese: Attivatur Oranġjo (Labra Ġewwa)
English: Room spinning sensation (vertigo) and vision disturbances may occur after taking Hulio.
Maltese: Jista' jkun hemm sensazzjoni li l-kamra qed iddur bik (vertigo) u disturbi fil-vista wara li tingħata Hulio.
English: Hulio 40 mg injection adalimumab Subcutaneous use SC
Maltese: Hulio 40 mg injezzjoni adalimumab Użu taħt il-ġilda SC
English: • 160 mg at week 0 and 80 mg at week 2
Maltese: • 160 mg f'Ġimgħa 0 u 80 mg f'Ġimgħa 2
English: Rare reports of pancytopenia including aplastic anaemia have been reported with TNF-antagonists.
Maltese: Rapporti rari ta' panċitopenija, inkluża anemija aplastika, ġew irrappurtati b'antagonisti tat-TNF.
English: Hulio is contraindicated in moderate to severe heart failure (see section 4.3).
Maltese: Hulio huwa kontraindikat f'pazjenti li jbatu minn insuffiċjenza tal-qalb minn moderata sa severa (ara sezzjoni 4.3).
English: Table 8: Ped ACR 30 Responses in the JIA study
Maltese: Tabella 8: Risponsi Ped ACR 30 fl-istudju tal-JIA
English: Number of patients at Baseline n (%)
Maltese: Grupp ta' Età Numru ta' pazjenti filLinja Bażi n (%)
English: Paediatric plaque psoriasis
Maltese: Psorijasi tal-plakka pedjatrika
English: Adalimumab 0.8 mg/kg eow N=38
Maltese: Adalimumab 0.8 mg/kg ġimgħa iva u ġimgħa le N=38
English: Hulio 40 mg solution for injection in pre-filled pen EU/1/18/1319/004
Maltese: Hulio 40 mg soluzzjoni għall-injezzjoni f'pinna mimlija għal-lest EU/1/18/1319/004
English: What Hulio contains - The active substance is adalimumab.
Maltese: X'fih Hulio - Is-sustanza attiva hi adalimumab.
English: Vertigo and visual impairment may occur following administration of Hulio (see section 4.8).
Maltese: Jista' jkun hemm vertigo u indeboliment fil-vista wara li jingħata Hulio (ara sezzjoni 4.8).
English: The percent of adalimumab-treated patients achieving ACR 20, 50 and 70 responses was consistent across RA studies I, II and III.
Maltese: Il-perċentwali ta' pazjenti kkurati b'adalimumab li laħqu risponsi għall-ACR 20, 50 u 70 kien konsistenti fl-istudji tal-I, II u III.
English: 1 sterile vial adapter
Maltese: 1 adattur sterili tal-kunjett
English: Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis
Maltese: Artrite idjopatika poliartikulari taż-żgħażagħ u artrite relatata mal-entesite
English: Reduction of inflammatory lesions and prevention of worsening of abscesses and draining fistulas was assessed using Hidradenitis Suppurativa Clinical Response (HiSCR; at least a 50% reduction in total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count relative to Baseline).
Maltese: Tnaqqis ta' leżjonijiet infjammatorji u prevenzjoni ta' aggravar ta' axxessi u tal-fistuli li jnixxu ġew evalwati bl-użu ta' Hidradenitis Suppurativa Rispons Kliniku (HiSCR; mill-inqas tnaqqis ta' 50% flaxxess total u l-għadd tal-noduli infjammatorji bl-ebda żieda fl-għadd tal-axxess u l-ebda żieda filgħadd relattiv tal-fistula li tkun qed tnixxi mal-Linja Bażi).
English: Patients received adalimumab 0.8 mg/kg eow (up to 40 mg), 0.4 mg/kg eow (up to 20 mg), or methotrexate 0.1 - 0.4 mg/kg weekly (up to 25 mg).
Maltese: Il-pazjenti rċivew adalimumab 0.8 mg/kg ġimgħa iva u ġimgħa le (sa 40 mg), 0.4 mg/kg ġimgħa iva u ġimgħa le (sa 20 mg), jew methotrexate 0.1 - 0.4 mg/kg kull ġimgħa (sa 25 mg).
English: ACR 70 week 12 week 24
Maltese: ACR 70 Ġimgħa 12 Ġimgħa 24
English: Hulio 40 mg/0.8 ml solution for injection adalimumab
Maltese: Hulio 40 mg/0.8 mL injezzjoni adalimumab
English: RA study II evaluated 544 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old and had failed therapy with at least one disease-modifying, anti-rheumatic drugs.
Maltese: Studju RA II evalwa 544 pazjent li jbatu minn artrite rewmatika attiva minn moderata sa severa li kellhom ≥18-il sena u li ma kinux irrispondew għal kura b'mill-inqas mediċina waħda anti-rewmatika li taffetwa l-proċess tal-mard.
English: Based on the observed data approach, 222 (80.4%) were in quiescence (no active inflammatory lesions, AC cell grade ≤ 0.5+, VH grade ≤ 0.5+) with a concomitant steroid dose ≤ 7.5 mg per day, and 184 (66.7 %) were in steroid-free quiescence.
Maltese: 4%) kienu f'sekwenza (l-ebda leżjoni infjammatorja attiva, grad ta' ċellula AC ≤0.5+, VH grad ≤0.5+) b'doża ta' sterojdi konkomitanti ≤7.5 mg kuljum, u 184 (66.7%) kienu bla kwiesċenza ta' sterojdi.
English: Step 11 - Check and set prescribed dose
Maltese: Pass 11 - Iċċekkja u ssettja d-doża preskritta
English: Each single pack containing 1 vial (0.8 ml sterile solution), 1 empty sterile injection syringe, 1 sterile needle, 1 sterile vial adapter and 2 alcohol pads.
Maltese: Kull pakkett waħdu fih kunjett 1 (0.8 mL soluzzjoni sterili), siringa vojta sterili għall-injezzjoni 1, labra sterili 1, adattur tal-kunjett 1 u 2 tajjariet bl-alkoħol.
English: Hulio is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Maltese: Hulio huwa indikat fi trattament ta' hidradenitis suppurativa (acne inversa) li hi minn attiva modera sa severa f'adolexxenti minn 12-il sena 'l fuq b'rispons inadegwat għat-terapija konvenzjonali ta' HS sistemika (ara sezzjonijiet 5.1 u 5.2).
English: Improvement in number of active joints with arthritis was maintained during the OL period through week 156 for the 26 of 31 (84%) patients in the adalimumab group who remained in the study.
Maltese: Titjib fin-numru ta' ġogi attivi bl-artrite kien mantenut waqt il-perjodu OL sa ġimgħa 156 għal 26 minn 31 (84%) pazjent fil-grupp ta' adalimumab li baqa' fl-istudju.
English: Table 1: Hulio Dose for Patients with Polyarticular Juvenile Idiopathic Arthritis
Maltese: Tabella 1: Doża ta' Hulio għal Pazjenti b'Artrite Idjopatika Poliartikulari taż-Żgħażagħ
English: Approximately twice the proportion of patients in the placebo group in the first 12 weeks of Studies HS-I and HS-II, compared with those in the adalimumab group experienced worsening of abscesses (23.0% vs 11.4%, respectively) and draining fistulas (30.0% vs 13.9%, respectively).
Maltese: HS-I u HS-II, meta mqabbla ma' dawk fil-grupp adalimumab li kellhom aggravament ta' axxessi (23.0% vs 11.4%, rispettivament) u fistuli li jnixxu (30.
English: Adalimumab/methotrexate combination therapy was clinically and statistically superior to methotrexate (p < 0.001) and adalimumab monotherapy (p < 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe rheumatoid arthritis.
Maltese: It-terapija kkombinata b'adalimumab/methotrexate kienet klinikament u statistikament superjuri għal methotrexate (p<0.001) u adalimumab mogħtija waħedhom (p<0.001) fit-tilħiq ta' stat baxx ta' mard f'pazjenti li kienu ġew riċentament iddijanjostikati b'artrite rewmatika minn moderata sa severa.
English: Side effects may occur up to 4 months or more after the last Hulio injection.
Maltese: Effetti sekondarji jistgħu jitfaċċaw sa 4 xhur jew aktar wara l-aħħar injezzjoni ta' Hulio.
English: Ulcerative Colitis
Maltese: Kolite Ulċerattiva
English: Adalimumab 40 mg eow N=108 n (%)
Maltese: Adalimumab 40 mg ġimgħa iva u ġimgħa le N=108 n (%)
English: The posology of adalimumab in these patients has been determined from pharmacokinetic modelling and simulation (see section 5.2).
Maltese: Il-pożoloġija ta' adalimumab f'dawn il-pazjenti ġiet iddeterminata minn mudellar u simulazzjoni farmakokinetiċi (ara sezzjoni 5.2).
English: The safety and efficacy of adalimumab were assessed in adult patients with non-infectious intermediate, posterior, and panuveitis, excluding patients with isolated anterior uveitis, in two randomised, double-masked, placebo-controlled studies (UV I and II).
Maltese: Is-sigurtà u l-effikaċja ta' adalimumab ġew ivvalutati f'pazjenti adulti b'intermedja, posterjuri u panuveite mhux infettiva, esklużi pazjenti b'uveite anterjuri iżolata, f'żewġ studji każwali, doublemasked, ikkontrollati bi plaċebo (UV I u II).
English: • hepatosplenic T-cell lymphoma (a rare blood cancer);
Maltese: • limfoma epatosplenika taċ-Ċelluli T (tip ta' kanċer fid-demm rari);
English: CD Study II: Infliximab Experienced Patients
Maltese: Studju CD II Pazjenti li Kienu Diġà Ħadu Infliximab Qabel
English: The rate (95% confidence interval) of nonmelanoma skin cancers was 8.8 (6.0, 13.0) per 1,000 patient-years among adalimumab-treated patients and 3.2 (1.3, 7.6) per 1,000 patient-years among control patients.
Maltese: Ir-rata (95% intervall ta' kunfidenza) ta' kanċer tal-ġilda li mhux melonoma kienet ta' 8.8 (6.0, 13.0) kull 1,000 sena ta' pazjent fost pazjenti kkurati b'adalimumab u 3.2 (1.3, 7.6) kull 1,000 sena ta' pazjent fost pazjenti mogħtija kura bis-sustanza ta' kontroll.
English: Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see Table 16).
Maltese: Valutazzjonijiet tal-psorjasi tad-dwiefer inkludew l-Indiċi Modifikata tasSeverità tal-Psorijasi tad-Dwiefer (mNAPSI, Modified Nail Psoriasis Severity Index), il-Valutazzjoni Globali tat-Tabib tal-Psorijasi tad-Dwiefer (PGA-F, Physician's Global Assessment of Fingernail Psoriasis) u l-Indiċi tas-Severità tal-Psorijasi tad-Dwiefer (NAPSI, Nail Psoriasis Severity Index) (ara Tabella 16).
English: Hulio is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Maltese: Hulio huwa indikat għattrattament ta' hidradenitis suppurativa (acne inversa) attiva li hi minn moderata sa severa f'pazjenti adulti u adolexxenti minn 12-il sena b'rispons inadegwat għat-terapija konvenzjonali ta' HS sistemika (ara sezzjonijiet 5.1 u 5.2).
English: During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Maltese: Waqt trattament ta' manteniment, kortikosterojdi jistgħu jigu mnaqqsa bil-mod skont il-linji gwida talprattika klinika.
English: 1 sterile injection syringe
Maltese: 1 siringa sterili għall-injezzjoni
English: < 40 kg • 40 mg at week 0 and 20 mg at week 2
Maltese: <40 kg • 40 mg f'Ġimgħa 0 u 20 mg f'Ġimgħa 2
English: CD Study I: Infliximab Naive Patients
Maltese: Studju CD I: Pazjenti li Qatt Ma Ħadu Infliximab
English: Hulio is used to treat Crohn's disease in adults, and children aged 6 to 17 years.
Maltese: Hulio huwa intenzjonat għall-kura tal-marda ta' Crohn (Crohn's disease) fl-adulti, u fi tfal li għandhom bejn 6 u 17-il sena.
English: SPARCC MRI Spined,j a Assessment of Spondyloarthritis International Society b Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d mean change from baseline e n=91 placebo and n=87 adalimumab f high sensitivity C-Reactive Protein (mg/L) g n=73 placebo and n=70 adalimumab h Spondyloarthritis Research Consortium of Canada i n=84 placebo and adalimumab j n=82 placebo and n=85 adalimumab
Maltese: Ċ-reattiva b'sensittività għolja (mg/L) g n=73 plaċebo u n=70 adalimumab h Konsorzju tal-Kanada għar-Riċerka ta' Spondyloarthritis i n=84 plaċebo u adalimumab j n=82 plaċebo u n=85 adalimumab ***, **, * Statistikament sinifikanti f'p<0.001, <0.01, u <0.05, rispettivament, għall-paraguni kollha bejn adalimumab u l-plaċebo.
English: Disease flare criteria were defined as a worsening of ≥ 30% from baseline in ≥ 3 of 6 Pediatric ACR core criteria, ≥ 2 active joints, and improvement of > 30% in no more than 1 of the 6 criteria.
Maltese: Ilkriterji li jiddefinixxu li l-marda tmur għal-agħar huma li tmur lura b'≥30% mill linja bażi f' ≥3 minn 6 kriterji prinċipali ta' ACR pedjatriċi ≥2 ġogi attivi, u titjib ta' > 30% f'mhux aktar minn 1 minn 6 kriterji.
English: Adolescent hidradenitis suppurativa (from 12 years of age, weighing at least 30 kg) There are no clinical trials with adalimumab in adolescent patients with HS.
Maltese: Hidradenitis suppurativa fl-adolexxenti (minn 12-il sena, li jiżnu mill-anqas 30 kg) M'hemm l-ebda provi kliniċi b'adalimumab f'pazjenti adolexxenti bi HS.
English: ***,** Statistically significant at p < 0.001, < 0.01 for all comparisons between adalimumab and placebo at weeks 2, 12 and 24 a Assessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
Maltese: Ġimgħa 24 ***,** Statistikament sinifikanti f'p<0.001, <0.01 għall-paraguni kollha bejn adalimumab u l-plaċebo f'ġimgħat 2, 12 u 24 a Valutazzjonijiet f'Ankylosing Spondylitis b Indiċi tal-Attività tal-Marda Ankylosing Spondylitis ta' Bath
English: Adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Maltese: Adulti b'artrite rewmatika, artrite psorjatika, ankylosing spondylitis jew spondiloartrite assjali mingħajr evidenza radjografika ta' ankylosing spondylitis
English: Low Dose 20/10 mg eow N = 95
Maltese: Doża Baxxa 20/10 mg ġimgħa iva u ġimgħa le N=95
English: N Failure N
Maltese: Komuni ħafna
English: A total of 233 PASI 75 responders at week 16 and week 33 received continuous adalimumab therapy for 52 weeks in Psoriasis Study I, and continued adalimumab in the open-label extension trial.
Maltese: Fl-Istudju tal-Psorijasi I, total ta' 233 pazjent li wrew rispons tal-PASI 75 f'ġimgħa 16 u ġimgħa 33 ingħataw terapija kontinwa b'adalimumab għal 52 ġimgħa, u komplew jingħataw adalimumab filprova ta' estensjoni open-label.
English: The rate (95% confidence interval) of lymphomas was 0.7 (0.2, 2.7) per 1,000 patient-years among adalimumab-treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among control patients.
Maltese: Ir-rata (95% intervall ta' kunfidenza) ta' limfomi kienet ta' 0.7 (0.2, 2.7) kull 1,000 sena ta' pazjent fost pazjenti kkurati b'adalimumab u 0.6 (0.1, 4.5) kull 1,000 sena ta' pazjent fost pazjenti mogħtija kura bis-sustanza ta' kontroll.