FrancophonIA/ELRC3.0 huggingface dataset:
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 Humira/methotrexate combination therapy (63.8% and 61.2% respectively) compared to methotrexate monotherapy (37.4% and 33.5% respectively, p < 0.001) and Humira monotherapy (50.7%, p < 0.002 and 44.5%, p < 0.001 respectively).
Maltese: Wara kura ta' 52 ġimgħa u ta' 104 ġimgħat, il-persentaġġ ta' pazjenti li ma avvanzatilhomx il-marda (bidla mil-linja bażi fit-tibdil tal-Puteġġ Totali Sharp  0.5) kien sinifikament ogħla bit-terapija kombinata ta' Humira/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'Humira waħdu (50.7%, p < 0.002 u 44.5%, p < 0.001 rispettivament).
English: In controlled and open label adult and paediatric studies with Humira, 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'Humira fl-adulti u fit-tfal, ġew irrappurtati infezzjonijiet serji (inklużi infezzjonijiet fatali, li ġraw rarament), li jinkludu rapporti ta' tuberkulosi (inklużi tuberkulosi b'ħafna għoqod tuberkulari mal-ġisem kollu u tuberkulosi f'postijiet barra mill-pulmun) u infezzjonijiet opportunistiċi li jinvadu (eż. histoplasmosis mifruxa jew barra l-pulmun, blastomycosis, coccidioidomycosis, pneumocystis, candidiasis aspergillosis u listeriosis).
English: Humira is contraindicated in moderate to severe heart failure (see section 4.3).
Maltese: Humira huwa kontro-indikat f'pazjenti li jbatu minn insuffiċjenza tal-qalb minn moderata sa severa (ara sezzjoni 4.3).
English: Time to Treatment Failure At or After Week 6 in Study UV I Primary analysis (ITT) Placebo Adalimumab 110 60 (54.5) 5.6 Time to Treatment Failure At or After Week 2 in Study UV II Primary analysis (ITT) Placebo Adalimumab 115 45 (39.1) NE Note: Treatment failure at or after Week 6 (Study UV I), or at or after Week 2 (Study UV II), was counted as event.
Maltese: Żmien għall-Falliment tat-Trattament fi jew wara Ġimgħa 6 fi Studju UV I Analiżi Primarja (ITT) Plaċebo Adalimumab 110 60 (54.5) 5.6 Żmien għall-Falliment tat-Trattament fi jew wara Ġimgħa 2 fi Studju UV II Analiżi Primarja (ITT) Plaċebo Adalimumab 115 45 (39.1) NE
English: Week 26 Week 52, p value for Standard Dose versus Low Dose comparison.
Maltese: Ġimgħa 26 Ġimgħa 52, valur p li huwa paragun tad-Doża Standard kontra Doża Baxxa.
English: • moderate to severe hidradenitis suppurativa in adults and
Maltese: • hidradenitis suppurativa moderata sa severa fl-adulti u
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 Humira 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 Humira li kellhom aggravament ta' axxessi (23.0% vs 11.4%, rispettivament) u fistuli li jnixxu (30.0 % vs 13.9%, rispettivament).
English: Treatment with Humira 40 mg every week significantly reduced the risk of worsening of abscesses and draining fistulas.
Maltese: Trattament b'Humira 40 mg kull ġimgħa naqqas b'mod sinifikanti r-riskju ta' aggravar ta' axxessi u fistuli li jnixxu.
English: Response
Maltese: RESPONSABBLI
English: Table 17 Maintenance regimen Patient Weight
Maltese: Tabella 17 Reġim ta' Manteniment
English: In patients not given concomitant methotrexate, the incidence was 25.6% (22/86) compared to 5.9% (5/85) when adalimumab was used as add-on to methotrexate.
Maltese: 6% (22/86), meta mqabbla ma 5.9% (5/85) meta adalimumab kien użat flimkien ma methotrexate.
English: Of 207 patients, 81 patients continued on Humira 40 mg every other week for 10 years.
Maltese: Minn 207 pazjenti, 81 pazjent komplew bi Humira 40 mg ġimgħa iva u ġimgħa le għal 10 snin.
English: Hepatitis reactivation of hepatitis B autoimmune hepatitis
Maltese: Epatite riattivazzjoni tal-epatite B epatite awtoimmuni
English: Contents of the pack and other information Injecting Humira
Maltese: Kontenut tal-pakkett u informazzjoni oħra Injettar tal-Humira
English: Following 3 years of adalimumab therapy, 75% (301/402) continued to be in clinical remission per partial Mayo score.
Maltese: Wara 3 snin ta' terapija b'adalimumab, 75% (301/402) baqgħu fi stat ta' titjib kliniku skont il-punteġġ Mayo parzjali
English: The safety and efficacy of Humira in children aged 4-17 years have been established for plaque psoriasis.
Maltese: Is-sigurtà u l-effikaċja ta' Humira fi tfal b'età ta' 4-17 snin ġew stabbiliti għal psorjasi tal-plakka.
English: Adults with psoriasis
Maltese: Adulti bil-psorijasi
English: STEP 2
Maltese: STADJU 2
English: In patients with paediatric psoriasis, anti-adalimumab antibodies were identified in 5/38 subjects (13%) treated with 0.8 mg/kg adalimumab monotherapy.
Maltese: F'pazjenti bi psorjasi pedjatrika, antikorpi ta' anti-adalimumab ġew identifikati fil-5/38 suġġetti (13%) ttrattati bi 0.8 mg/kg b'adalimumab waħdu.
English: Study HS-I (PIONEER I) evaluated 307 patients with 2 treatment periods.
Maltese: Studju HS-I (PIONEER I) evalwa 307 pazjent bi perijodi ta' trattament 2.
English: Assessment of SpondyloArthritis international Society Bath Ankylosing Spondylitis Disease Activity Index Ankylosing Spondylitis Disease Activity Score mean change from baseline n=91 placebo and n=87 Humira high sensitivity C-Reactive Protein (mg/L) n=73 placebo and n=70 Humira Spondyloarthritis Research Consortium of Canada n=84 placebo and Humira n=82 placebo and n=85 Humira ***, **, * Statistically significant at p < 0.001, < 0.01, and < 0.05, respectively, for all comparisons between Humira and placebo.
Maltese: Konsorzju tal-Kanada għar-riċerka ta' Spondyloarthritis i n= 84 plaċebo u Humira j n= 82 plaċebo u n=85 Humira ***, **, * Statistikament sinifikanti meta p < 0.001, < 0.01, u < 0.05, rispettivament, għal paraguni kollha bejn Humira u l-plaċebo.
English: The recommended Humira dose is up to a maximum of 40 mg per dose.
Maltese: Iddoża ta' Humira rrakkomandata hija sa massimu ta' 40 mg kull doża.
English: Table 15 Maintenance regimen Patient Weight
Maltese: Tabella 15 Reġim ta' Manteniment
English: Patients received Humira 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: Pazjenti rċevew Humira 0.8 mg/kg eow (sa 40mg), 0.4 mg/kg eow (sa 20 mg), jew methotrexate 0.10.4 mg/kg kull ġimgħa (sa 25 mg).
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 antirewmatika li taffetwa l-proċess tal-mard.
English: Placebo/ MTX n=200
Maltese: Plaċebo/ MTXc n=200
English: • angioedema (localized swelling of the skin)
Maltese: • anġjoedima (nefħa lokalizzata tal-ġilda)
English: RA study I evaluated 271 patients with moderately to severely active rheumatoid arthritis who were  18 years old, had failed therapy with at least one disease-modifying, anti rheumatic drug and had insufficient efficacy with methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexate-intolerant) every week and whose methotrexate dose remained constant at 10 to 25 mg every week.
Maltese: Studju RA I evalwa 271 pazjent li jbatu minn artrite rewmatika attiva minn moderata sa severa li kellhom  18 -il sena, ma kinux irrispondew għal kura b'mill-inqas mediċina waħda anti-rewmatika li taffetwa l-proċess tal-mard u li kellhom effikaċja insuffiċjenti b'methotrexate f'dożi minn 12.5 sa 25 mg (10 mg jekk kienu intolleranti għal methotrexate) fil-ġimgħa, u li d-doża ta' methotrexate tagħhom baqgħet kostanti minn 10 sa 25 mg fil-ġimgħa.
English: Of the 364 remaining patients, 269 evaluable patients (74%) reached 78 weeks of open-label adalimumab treatment.
Maltese: Mit-364 pazjent li fadal, 269 pazjent evalwabbli (74%) laħqu 78 ġimgħa ta' trattament b'adalimumab open-label.
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: Il-kriterji 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: Tuberculosis, including reactivation and new onset of tuberculosis, has been reported in patients receiving Humira.
Maltese: Tuberkulosi, inkluż riattivazzjoni u bidu ġdid ta' tuberkulosi, kienet irrapurtata f'pazenti li jierċievu Humira.
English: In Study UV I statistically significant differences in favour of adalimumab versus placebo were observed for each component of treatment failure.
Maltese: Fi Studju UV I kienu osservati differenzi statistikament sinifikanti favur adalimumab kontra plaċebo għal kull komponent tal-falliment tat-trattament.
English: • benign tumours
Maltese: • tumuri beninni
English: • reproductive tract infections
Maltese: • infezzjonijiet fis-sistema riproduttiva
English: • musculoskeletal pain.
Maltese: • uġigħ muskolu-skeltrali.
English: In patients with enthesitis-related arthritis, anti-adalimumab antibodies were identified in 10.9% (5/46) of patients treated with adalimumab.
Maltese: F'pazjenti b'artrite relatata mal-entesite, anti-korpi anti-andalimumbkienu identifikati f'10.9% (5/46) f'pazjenti trattati b'adalimumab.
English: Injecting Humira
Maltese: Uveite mhux infettiva
English: Of the patients who lost adequate response after re-randomisation to placebo who then enrolled into the open-label extension trial, 38% (25/66) and 55% (36/66) regained PASI 75 response after 12 and 24 weeks of re-treatment, respectively.
Maltese: Minn dawk il-pazjenti li tilfu r-rispons adegwat wara li intgħażlu b'ordni addoċċ biex jirċievu l-plaċebo, li mbagħad ġew miktuba fil-prova ta' estensjoni open-label, 38% (25/66) u 55% (36/66) reġgħu laħqu rispons ta' l-PASI ta' 75 wara 12 u 24 ġimgħa ta' kura għal darba oħra, rispettivament.
English: • reactivation of hepatitis B
Maltese: • riattivazzjoni ta' epatite B
English: Based on the observed data approach, 216 (80.3%) 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 178 (66.2%) were in steroid-free quiescence.
Maltese: Ibbażat fuq l-approwċ tad-dejta osservat, 216 (80.3%) 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 178 (66.2% ) kienu bla kwiesċenza ta' sterojdi.
English: Humira showed statistically significantly greater improvement in the HAQ-S total score and the SF-36 Physical Component Score (PCS) from baseline to Week 12 compared to placebo.
Maltese: Humira wera aktar titjib statistikament sinifikanti fil-punteġġ totali ta' HAQ-S u filPunteġġ Kompetenti Fisiku (PCS) tal-SF-36 mill-linja bażi sa ġimgħa 12 meta mqabbel mal-plaċebo.
English: Usually, Humira is used with methotrexate.
Maltese: Ġeneralment, Humira jintuża ma' methotrexate.
English: • dehydration
Maltese: • deidratazzjoni
English: Table 17 Ps Study I (REVEAL) - Efficacy Results at 16 Weeks Placebo N=398 n (%)
Maltese: Tabella 17 Studju Ps I (REVEAL)Riżultati ta' l-Effikaċja f' 16 -il Ġimgħa Plaċebo N=398 n (%)
English: • Do NOT shake the syringe.
Maltese: • perforazzjoni ta' l-intestini;
English: In adult patients with psoriasis, anti-adalimumab antibodies were identified in 77/920 subjects (8.4%) treated with adalimumab monotherapy.
Maltese: F'pazjenti adulti li jbatu mill-psorijasi, ġew identifikati anti-korpi ta' kontra adalimumab f'77/920 suġġett (8.4%) ikkurati b'adalimumab biss.
English: • Paediatric uveitis
Maltese: • Uveite pedjatrika
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 Humira group who remained inthe study.
Maltese: Titjib fin-numru ta' ġogi attivi bl-artrite kien mantenut waqt ilperijodu OL fil-Ġimgħa 156 għall-26 minn 31 (84%) pazjent fil-grupp ta' Humira li baqa' fl-istudju.
English: • inflammations
Maltese: • infjammazzjonijiet
English: Psoriasis Study II (CHAMPION) compared the efficacy and safety of Humira versus methotrexate and placebo in 271 patients.
Maltese: Studju Psorajisi II (CHAMPION) qabbel l-effikaċja u s-sigurtà ta' Humira kontra methotrexate u plaċebo f'271 pazjent.
English: Table 8 Ps Study I (REVEAL) - Efficacy Results at 16 Weeks Placebo N=398 n (%)
Maltese: Tabella 8 Studju Ps I (REVEAL)Riżultati ta' l-Effikaċja f' 16 -il Ġimgħa Plaċebo N=398 n (%)
English: Humira is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Maltese: Humira huwa ndikat għall-trattament ta' kolite ulċerattiva attiva minn moderata sa severa f'pazjenti adulti li ma kellhomx rispons adegwat meta ngħataw kura konvenzjonali li tinkludi kortikosteroidi u 6mercaptopurine (6-MP) jew azathioprine (AZA), jew f'pazjenti li għandhom intolleranza jew kontraindikazzjonijiet mediċi għal dawn it-terapiji.
English: In an open-label extension study, for patients who dose escalated from 40 mg every other week to 40 mg weekly due to a PASI response below 50%, 26.4% (92/349) and 37.8% (132/349) of patients achieved PASI 75 response at Week 12 and 24, respectively.
Maltese: Fi studju ta' estensjoni open-label, għal pazjenti li d-doża eskalat minn 40 mg ġimgħa iva u ġimgħa le għal 40 mg kull ġimgħa minħabba rispons PASI taħt 50%, 26.4% (92/349) u 37.8% (132/349) talpazjenti kisbu rispons ta' PASI 75 f' Ġimgħa 12 u 24, rispettivament.
English: Injection site pain of Humira 40 mg/0.4 ml was assessed in two randomised, active control, single-blind, two-period crossover studies.
Maltese: Hmira 40 mg/0.4 ml ġie vvalutat f'żewġ studji crossover ta żewġ perjodi randomizzati, ta' kontroll attiv, single-blind.
English: Humira 40 mg eow N=80
Maltese: Humira 40 mg kull eow N=80
English: Table 8 ACR Responses in RA Study V (percent of patients)
Maltese: Tabella 8 Risponsi għall-ACR fi Studju RA V (persentaġġ ta' pazjenti)
English: Table 10 ACR Responses in RA Study V (percent of patients)
Maltese: Tabella 10 Risponsi għall-ACR fi Studju RA V (persentaġġ ta' pazjenti)
English: d score methotrexate
Maltese: d methotrexate
English: The rate (95% confidence interval) of lymphomas was 0.7 (0.2, 2.7) per 1,000 patient-years among Humira-treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among control patients.
Maltese: Ir-rata (95% intervall ta' konfidenza) ta' limfomi kienet ta' 0.7 (0.2, 2.7) kull 1,000 sena ta' pazjent fost pazjenti kkurati b'Humira u 0.6 (0.1, 4.5) kull 1,000 sena ta' pazjent fost pazjenti mogħtija kura kontrollata.
English: Table 9 Ps Study II (CHAMPION) Efficacy Results at 16 Weeks
Maltese: Tabella 9 Studju Ps II (CHAMPION)
English: Patients remained on stable doses of non-steroidal anti-inflammatory drugs (NSAIDs) and or prednisone ( 0.2 mg /kg/day or 10 mg/day maximum).
Maltese: Ilpazjenti nżammu fuq dożi stabbli ta' mediċini anti-infjammatorji mhux sterojdi (NSAIDs - nonsteroidal anti-inflammatory drugs) u jew prednisolone ( 0.2 mg /kg/ġurnata jew massimu ta' 10 mg/ġurnata).
English: • systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other organ systems);
Maltese: • lupus erythematosus sistemiku (li tinkludi infjammazzjoni tal ġilda, tal qalb, tal pulmun, tal ġogi u ta' sistemi ta' organi oħra);
English: • double vision
Maltese: Double Blind
English: Improved physical function continued during the open label extension up to Week 136.
Maltese: It-titjib fil-funzjoni fiżika tkompla matul l-estensjoni open-label sa Ġimgħa 136.
English: * P < 0.05, ***P < 0.001, Humira versus placebo Among all randomised patients.
Maltese: * P < 0.05, ***P < 0.001, Humira kontra plaċebo h
English: Opportunistic infections, including invasive fungal infections have been observed in patients receiving Humira.
Maltese: Infezzjonijiet opportunistiċi, li jinkludu infezzjonijiet fungali invażivi, ġew osservati f'pazjenti li kienu qed jirċievu Humira.
English: • Non-infectious uveitis
Maltese: • Uveite mhux infettiva
English: In patients not given concomitant methotrexate, the incidence was 13.6% (3/22), compared to 8.3% (2/24) when adalimumab was used as add-on to methotrexate.
Maltese: F'pazjenti li ma ngħatawx methotraxate fl-istess ħin, l-inċidenza kienet ta' 13.6% (3/22), imqabbla ma' 8.3% (2/24) meta adalimumab kien użat flimkien ma methotrexate.
English: Stratum
Maltese: Tieqa
English: A risk for the development of hepatosplenic T-cell lymphoma in patients treated with Humira cannot be excluded (see section 4.8).
Maltese: Ma jistax jiġi eskluż ir-riskju li tiżviluppa hepatosplenic T-cell lymphoma f'pazjenti ttratati b' Humira (ara sezzjoni 4.8).
English: • pulmonary fibrosis (scarring of the lung)
Maltese: • fibrożi fil-pulmun (marki fil-pulmun)
English: Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1.
Maltese: Fir-rigward tal-kombinazzjoni ma' mediċini antirewmatiċi li jimmodifikaw l-marda minbarra methotrexate ara sezzjonijiet 4.4 u 5
English: Placebo/ MTX n=60
Maltese: Plaċebo/ MTXc n=60
English: b 50 Week 2 Week 12 Week 24 ***,** Statistically significant at p < 0.001, < 0.01 for all comparisons between Humira and placebo at Weeks 2, 12 and 24 Assessments in Ankylosing Spondylitis Bath Ankylosing Spondylitis Disease Activity Index
Maltese: Ġimgħa 24 ***,** Statistikament sinifikanti f'p < 0.001, <0.01 għall-paraguni kollha bejn Humira u lplaċebo f'Ġimgħa 2, 12 u 24
English: Humira 40 mg/0.8 ml injection adalimumab
Maltese: Humira 40 mg/0.8 ml soluzzjoni għall-injezzjoni adalimumab
English: In adult Crohn's disease studies, higher incidences of malignant and serious infection-related adverse events were seen with the combination of Humira and azathioprine/6-mercaptopurine compared with Humira alone.
Maltese: Fi studji tal-marda Crohn (Crohn's disease) fl-adulti, kien hemm inċidenzi aktar għoljin ta' avvenimenti avversi malinni u serji relatati mall-infezjoni meta Humira kienet kkombinata ma' azathioprine/6-mercaptopurine meta mqabbla ma' Humira waħeda.
English: Greater improvements at Week 12 from baseline compared to placebo were demonstrated in skin-specific health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI; Studies HS-I and HS-II), patient global satisfaction with medication treatment as measured by the Treatment Satisfaction Questionnaire - medication (TSQM; Studies HS-I and HS-II), and physical health as measured by the physical component summary score of the SF-36 (Study HS-I).
Maltese: HS-I u HS-II), is-sodisfazzjon globali tal-pazjent bi trattament tal medikazzjoni kif imkejjel mill-Kwestjonarju dwar is-Sodisfazzjoni tat-Trattament - medikazzjoni(TSQM; Studji HS-I u HS-II), u s-saħħa fiżika kif imkejla mis-sommarju tal-punteġġ b'komponent fiżiku ta' SF-36 (Studju HS-I).
English: In subjects treated with Humira with no radiographic progression from baseline to Week 48 (n=102), 84% continued to show no radiographic progression through 144 weeks of treatment.
Maltese: Fil-każ ta' suġġetti kkurati b'Humira li ma urew l-ebda progress radjografiku mil-linja bażi sa Ġimgħa 48 (n=102), 84% baqgħu ma urew l-ebda progress radjografiku matul 144 ġimgħa ta' kura.
English: In a study of 64 patients with rheumatoid arthritis that were treated with Humira, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-, B-, NK-cells, monocyte/macrophages, and neutrophils.
Maltese: Fi studju ta' 64 pazjent li jbatu minn artrite rewmatika li kienu kkurati b'Humira, ma kien hemm lebda evidenza ta' tnaqqis ta' sensitivita eċċessiva imdewma, tnaqqis tal-livelli ta' immunoglobuli, jew tibdil fin-numri ta' ċelloli effettivi T-, B-, NK-, monoċistiċi /makrofaġi, u newtrofili.
English: Table 18 Response, Remission and Mucosal Healing in Study UC-II (Percent of Patients)
Maltese: Tabella 18 Rispons, Titjib kliniku u Fejqan tal-Mukoża fi Studju UC-II (Persentaġġ ta' Pazjenti)
English: • Psoriatic arthritis
Maltese: • Artrite psorjatika
English: • Rheumatoid arthritis
Maltese: • Artrite rewmatika
English: In adult patients with non-infectious uveitis, anti-adalimumab antibodies were identified in 4.8% (12/249) of patients treated with adalimumab.
Maltese: F'pazjenti adulti b'uveite mhux infettiva, antikorpi kontra adalimumab ġew identifikati fl-4.8% (12/249) tal-pazjenti ttrattati b'adalimumab.
English: Following subcutaneous administration of 40 mg of adalimumab every other week in adult nonradiographic axial spondyloarthritis patients, the mean (±SD) trough steady-state concentration at Week 68 was 8.0 ± 4.6 g/ml.
Maltese: Wara amministrazzjoni ta' 40 mg ta' adalimumab kull ġimgħa supplenti ta' adolimumab f'pazjenti adulti mhux radjografiċi spondyloarthritis axjali, il-medja (± SD) ħawt (trough) ta' konċentrazzjoni ta' stat stabbli f'Ġimgħa 68 kienet ta' 8.0 ± 4.6 μg/ml.
English: • vision disturbances
Maltese: • disturbi fil-vista
English: Clinical Response Clinical Remission Mucosal Healing
Maltese: Effikaċja klinika u sigurtà Artrite Rewmatika
English: MTX = methotrexate P=0.027, Humira 0.8 mg/kg versus MTX P=0.083, Humira 0.8 mg/kg versus MTX
Maltese: 027, Humira 0.8 mg/kg kontra MTX
English: • abdominal pain;
Maltese: • uġigħ addominali;
English: pleural effusion
Maltese: SPARCC SpinaMRI
English: In CD Study I, 299 TNF-antagonist naive patients were randomised to one of four treatment groups; placebo at Weeks 0 and 2, 160 mg Humira at Week 0 and 80 mg at Week 2, 80 mg at Week 0 and 40 mg at Week 2, and 40 mg at Week 0 and 20 mg at Week 2.
Maltese: Fi studju CD I, 299 pazjent li qatt ma ħadu antagonist ta' TNF ġew imqassma bl-addoċċ f'wieħed minn erbgħa gruppi ta' nies li kienu qegħdin jieħdu l-kura; plaċebo f'Ġimgħat 0 u 2, 160 mg Humira f'Ġimgħa 0 u 80 mg f'Ġimgħa 2, 80 mg f'Ġimgħa 0 u 40 mg f'Ġimgħa 2, u 40 mg f'Ġimgħa 0 u 20 mg f'Ġimgħa 2.
English: There are no data available comparing Humira and MTX beyond 16 weeks of therapy.
Maltese: M'hemmx informazzjoni disponibbli li tipparaguna Humira u MTX wara 16 -il ġimgħa ta' terapija.
English: Table 11: Efficacy Results at 12 Weeks, HS Studies I and II
Maltese: Tabella 11: Riżultati ta' effikaċja fi 12-il Ġimgħat, HS Studji I u II
English: For more information on vaccines see the “Warnings and precautions” section).
Maltese: Għal aktar informazzjoni dwar it-tilqim ara s-sezzjoni “Twissijiet u prekawzjonijiet”.