qanastek/EMEA-V3 huggingface dataset:
Doses of 10 mg or 25 mg Enbrel were administered SC twice a week for up to 24 months.
Dożi ta ’ 10 mg u 25 mg kienu mogħtija SC darbtejn f’ ġimgħa sa 24 xahar.
Methotrexate doses were escalated from 7.5 mg/ week to a maximum of 20 mg/ week over the first 8 weeks of the trial and continued for up to 24 months.
Id- dożi ta ’ methotrexate kienu miżjuda minn 7. 5 mg/ ġimgħa għall- massimu ta ’ 20 mg/ ġimgħa fl- ewwel 8 ġimgħat ta ’ l- istudju u tkomplew sa 24 xahar.
Clinical improvement including onset of action within 2 weeks with Enbrel 25 mg was similar to that seen in the previous trials, and was maintained for up to 24 months.
Titjib kliniku li jinkludi l- bidu ta ’ l- azzjoni fl- ewwel ġimagħtejn b’ Enbrel 25 mg kien simili għal dak li kien miksub fl- istudji ta ’ qabel, u kienu miżmuma sa 24 xahar.
At baseline, patients had a moderate degree of disability, with mean HAQ scores of 1.4 to 1.5.
Fil- linja bażi l- pazjenti kellhom diżabilità moderata, bi skor medju ta ’ HAQ minn 1. 4 għal 1. 5.
Treatment with Enbrel 25 mg resulted in substantial improvement at 12 months, with about 44% of patients achieving a normal HAQ score (less than 0.5).
Kura b’ Enbrel 25mg ta riżultati ta ’ titjib sostanzjali fi 12- il xahar, b’ bejn wieħed u ieħor 44% tal- pazjenti jiksbu skor normali tal- HAQ (inqas minn 0. 5).
This benefit was maintained in Year 2 of this study.
Dan il- benefiċċju inżamm fit- tieni sena ta ’ dan l- istudju.
In this study, structural joint damage was assessed radiographically and expressed as change in Total Sharp Score (TSS) and its components, the erosion score and joint space narrowing score (JSN).
F’ dan l- istudju, ħsarat strutturali fil- ġogi kienu assessjati radjografikament u espressi bħala bidla fl - iSkor Totali tat- Tingiż (TSS) u l- komponenti tiegħu, l- iskor ta ’ tħassir u l- iskor tad- tidjiq fl- ispazju tal - ġogi (JSN).
Radiographs of hands/ wrists and feet were read at baseline and 6, 12, and 24 months.
Qari mill- radjografi ta ’ l- idejn/ tal- poloz u tas- sieq kienu meħuda fil- linja bażi u fis- 6, 12 u 24 xahar.
The 10 mg Enbrel dose had consistently less effect on structural damage than the 25 mg dose.
Id- doża ta ’ Enbrel tal- 10 mg dejjem kellha anqas effett fuq il- ħsara strutturali mid- doża ta ’ 25 mg.
Enbrel 25 mg was significantly superior to methotrexate for erosion scores at both 12 and 24 months.
Id- doża ta ’ Enbrel ta ’ 25 mg kienet sinjifikament superjuri għal methotrexate għall- iskor fit - tħassir kemm fit- 12 kif ukoll fl- 24 xahar.
The differences in TSS and JSN were not statistically significant between methotrexate and Enbrel 25 mg.
Id- differenzi fit- TSS u JSN ma kinux statistikament sinjifikanti bejn methotrexate u Enbrel 25 mg.
The results are shown in the figure below.
Ir- riżultati jidhru fil- figuri t’ hawn taħt.
RADIOGRAPHIC PROGRESSION:
15 PROGRESSJONI RADJOGRAFIKA:
COMPARISON OF ENBREL vs METHOTREXATE IN PATIENTS WITH RA OF < 3 YEARS DURATION
ENBREL MQABBEL MA ’ METHOTREXATE F’ PAZJENTI B ’ RATA TA ’ < 3 SNIN
Change from Baseline
Bidla mil- linja bażi ta ’ riferiment
12 Months 2.5
12- il xahar
2.2
24- il xahar
24 Months
2. 5 2. 2
1.3
1. 2
1.5
1. 3
1.2
0. 9
1.3
0. 9
1.0
1. 0 0. 5
0.9
0. 4 *
0.6*
0. 4 0. 4
0.5
1. 0 0. 5
0.4*
0. 6 *
Erosions
Tghawwir
TSS Erosions
Tghawwir
In another active-controlled, double-blind, randomised study, clinical efficacy, safety, and radiographic progression in RA patients treated with Enbrel alone (25 mg twice weekly), methotrexate alone (7.5 to 20 mg weekly, median dose 20 mg), and of the combination of Enbrel and methotrexate initiated concurrently were compared in 682 adult patients with active rheumatoid arthritis of 6 months to 20 years duration (median 5 years) who had a less than satisfactory response to at least 1 disease-modifying antirheumatic drug (DMARD) other than methotrexate.
Fi studju ieħor ikkontrollat attivament, double- blind u b’ għażla każwali, l- effikaċja klinika, is- sigurtà, u l- progressjoni radjografika f’ pazjenti b’ RA kkurati b’ Enbrel waħdu (25 mg darbtejn f’ ġimgħa) b’ methotrexate waħdu (7. 5 sa 20 mg fil- ġimgħa, b’ doża medja ta ’ 20 mg), u Enbrel mibdi flimkien ma ’ methotrexate ġew imqabbla f’ 682 pazjent adult b’ artrite rewmatojde attiva ta ’ bejn 6 xhur u 20 sena (medjan 5 snin) li kellhom rispons anqas minn sodisfaċenti għal ta ’ l- anqas waħda mill- mediċina anti- rewmatojde li timmodifika l- marda barra methotrexate.
16 Patients in the Enbrel in combination with methotrexate therapy group had significantly higher ACR 20, ACR 50, ACR 70 responses and improvement for DAS and HAQ scores at both 24 and 52 weeks than patients in either of the single therapy groups (results shown in table below).
Il- pazjenti fil- grupp ta ’ Enbrel flimkien mat- terapija ta ’ methotrexate kellhom risponsi sinjifikament aktar għolja ta ’ ACR 20, ACR 50, ACR 70 u titjib fl- iskor tad- DAS u HAQ kemm f’ 24 kif ukoll f’ 52 ġimgħa minn pazjenti li kienu fil- gruppi ta ’ terapija b’ mediċina waħda (ir- riżultati jidhru fit- tabella t’ hawn taħt).
Significant advantages for Enbrel in combination with methotrexate compared with Enbrel monotherapy and methotrexate monotherapy were also observed after 24 months.
Vantaġġi sinifikattivi għal Enbrel flimkien ma ’ methotrexate imqabblin ma ’ monoterapija b’ Enbrel u monoterapija b’ methotrexate kienu osservati wkoll wara 24 xahar.
CLINICAL EFFICACY RESULTS AT 12 MONTHS:
16 RIŻULTATI TA ’ L- EFFIKAĊJA KLINIKA WARA 12- IL XAHAR:
COMPARISON OF ENBREL vs METHOTREXATE vs ENBREL IN COMBINATION WITH METHOTREXATE IN PATIENTS WITH RA OF 6 MONTHS TO 20 YEARS DURATION Enbrel +
Enbrel +
Endpoint
Punt ta 'tmiem
ACR Responsesa
Risponsi ACRa
ACR 20 ACR 50 ACR 70
74. 5% †, φ
DAS
43. 0%
Baseline scoreb
39. 8% †, φ
5.5
16. 7%
5.7
22. 0%
Week 52 scoreb
Skor tal- linja bażib Ġimgħa 52 skorb Remissjonic
3.0 3.0
5. 5 3. 0 14%
2.3 † ,
5. 7 3. 0 18%
Remissionc
5. 5 2. 3 †, φ 37% †, φ
14%
HAQ
18%
Linja bażi
37% † ,
1. 7
HAQ
1. 7
Baseline
1. 8 0. 8 †, φ
Week 52
52 Ġimgħa
Patients who did not complete 12 months in the study were considered to be non-responders. b:
Pazjenti fl- istudju li ma komplewx sat- 12- il xahar kienu kkunsidrati li huma non- responders. b:
Values for Disease Activity Score (DAS) are means. c:
Valuri għal Disease Activity Score (DAS) huma medji. ċ:
Remission is defined as DAS < 1.6 Pairwise comparison p-values: † = p < 0.05 for comparisons of Enbrel + methotrexate vs methotrexate and  = p < 0.05 for comparisons of Enbrel + methotrexate vs Enbrel
Remissjoni hi definita bħala DAS < 1. 6 p- valuri mqabbla f’ pari: † = p < 0. 05 għal Enbrel + methotrexate mqabbla ma ’ methotrexate u φ = p < 0. 05 għal Enbrel u methotrexate mqabbla ma ’ Enbrel.
Radiographic progression at 12 months was significantly less in the Enbrel group than in the methotrexate group, while the combination was significantly better than either monotherapy at slowing radiographic progression (see figure below).
Il- progressjoni radjografika wara 12- il xahar kienet sinjifikament anqas fil- grupp ta ’ Enbrel milli l - grupp ta ’ methotrexate, waqt li meta ttieħdu flimkien id- dawmien fil- progressjoni radjografika kienet sinjifikament aħjar milli meta l- mediċini ttieħdu weħidhom (ara t- tabella t’ hawn taħt).
17 RADIOGRAPHIC PROGRESSION:
17 PROGRESSJONI RADJOGRAFIKA:
COMPARISON OF ENBREL vs METHOTREXATE vs ENBREL IN COMBINATION WITH METHOTREXATE IN PATIENTS WITH RA OF 6 MONTHS TO 20 YEARS DURATION (12 MONTH RESULTS)
TQABBIL BEJN ENBREL U METHOTREXATE U ENBREL FLIMKIEN MA ’ METHOTREXATE F’ PAZJENTI B’ RATA TA ’ BEJN 6 XHUR U 20 SENA (RIŻULTATI FIT- 12- IL XAHAR)
-0.54 † ,
- 0. 23 †, φ - 0. 30 † - 0. 5 - 0. 54 †, φ - 1. 0 -- Tgħawwir --
Pairwise comparison p-values: * = p < 0.05 for comparisons of Enbrel vs methotrexate, † = p < 0.05 for comparisons of Enbrel + methotrexate vs methotrexate and  = p < 0.05 for comparisons of Enbrel + methotrexate vs Enbrel
p- valuri mqabbla f’ pari: * = p < 0. 05 għal Enbrel imqabbel ma ’ methotrexate, † = p < 0. 05 għal Enbrel + methotrexate mqabbel ma ’ methotrexate u φ = p < 0. 05 għal Enbrel + methotrexate mqabbel ma ’ Enbrel
Significant advantages for Enbrel in combination with methotrexate compared with Enbrel monotherapy and methotrexate monotherapy were also observed after 24 months.
Vantaġġi sinifikattivi għal Enbrel flimkien ma ’ methotrexate meta mqabblin ma ’ monoterapija b’ Enbrel u monoterapija b’ methotrexate kienu osservati wkoll wara 24 xahar.
Similarly, the significant advantages for Enbrel monotherapy compared with methotrexate monotherapy were also observed after 24 months.
Bl- istess mod, il - vantaġġi sinifikattivi għal monoterapija b’ Enbrel imqabbla ma ’ monoterapija b’ methotrexate kienu osservati wkoll wara 24 xahar.
In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 24 months was higher in the Enbrel in combination with methotrexate group compared with the Enbrel alone and methotrexate alone groups (62%, 50%, and 36%, respectively; p < 0.05).
F’ analiżi f’ liema l- pazjenti kollha li ħarġu mill- istudju għal kwalunkwe raġuni kienu kkunsidrati li pprogressaw, il- perċentwal ta ’ pazjenti mingħajr progressjoni (bidla TSS ≤ 0. 5) fl- 24 xahar kienet ogħla fil- grupp li ngħata Enbrel ma ’ methotrexate meta mqabbel mal- gruppi li ħadu Enbrel waħdu u methotrexate waħdu (62%, 50%, and 36%, rispettivament; p < 0. 05).
The difference between Enbrel alone and methotrexate alone was also significant (p < 0.05).
Id- differenza bejn Enbrel waħdu u methotrexate waħdu kienet ukoll sinifikattiva (p < 0. 05).
Among patients who completed a full 24 months of therapy in the study, the non-progression rates were 78%, 70%, and 61%, respectively.
Fost pazjenti li komplew l- 24 xahar kollha ta ’ terapija fl- istudju, ir- rati fejn ma sar l- ebda progress kienu ta ’ 78%, 70%, u 61%, rispettivament.
The safety and efficacy of 50mg Enbrel (two 25 mg SC injections) administered once weekly were evaluated in a double-blind, placebo-controlled study of 420 patients with active RA.
Is- sigurtà u l- effikaċja ta ’ 50 mg Enbrel (żewġ injezzjonijiet 25 mg SC) mogħtija darba fil- ġimgħa kienu evalwati fi stħarriġ double- blind, ikkontrollat bi plaċebo ta ’ 420 pazjent b’ RA attiva.
In this study, 53 patients received placebo, 214 patients received 50 mg Enbrel once weekly and 153 patients received 25 mg Enbrel twice weekly.
F’ dan l - istudju, 53 pazjent ingħataw plaċebo, 214 pazjent ingħataw 50 mg Enbrel darba fil- ġimgħa u 153 pazjent ingħataw 25 mg Enbrel darbtejn fil- ġimgħa.
The safety and efficacy profiles of the two Enbrel treatment regimens were comparable at week 8 in their effect on signs and symptoms of RA; data at week 16 did not show comparability (non-inferiority) between the two regimens.
Il- profili tas- sigurtà u l- effikaċja taż- żewġ reġimens ta ’ trattament b’ Enbrel kienu komparabbli f’ ġimgħa 8 fl- effett tagħhom fuq sinjali u sintomi ta ’ RA; dejta f’ ġimgħa 16 ma wrietx tqabbil (non- inferiority) bejn iż- żewġ reġimens.
Paediatric patients with polyarticular juvenile idiopathic arthritis
Pazjenti pedjatriċi b’ artrite idjopatika ġuvenili poliartikulari
The safety and efficacy of Enbrel were assessed in a two-part study in 69 children with polyarticular juvenile idiopathic arthritis who had a variety of juvenile idiopathic arthritis onset types.
Is- sigurtà u l- effikaċja ta ’ Enbrel ġew assessjati fi studju maqsum f’ żewġ partijiet fejn 69 tfal b’ artrite idjopatika tal- minorenni b’ kors poliartikulari, u li fil- bidu kellhom varjetà ta ’ artrite idjopatika tal - minorennni.
Patients aged 4 to 17 years with moderately to severely active polyarticular juvenile idiopathic arthritis refractory to or intolerant of methotrexate were enrolled; patients remained on a stable dose of a single nonsteroidal anti-
Kienu studjati pazjenti ta ’ bejn 4 u 17- il sena b’ artrite idjopatika tal- minorenni b’ kors poliartikulari bejn moderata u severament li ma fiqitx b’ methotrexate jew kienet intolleranti għal methotrexate; il- pazjenti tħallew fuq doża stabbli ta ’ mediċini kontra l- infjammazzjoni li mhumiex sterojdi u/ jew fuq prednisone (< 0. 2 mg/ kg/ kuljum jew massimu ta’ 10 mg).
In part 1, all patients received 0.4 mg/ kg (maximum 25 mg per dose) Enbrel subcutaneously twice weekly.
Fl- ewwel parti, il- pazjenti kollha rċevew Enbrel ta ’ 0. 4 mg/ kg (massimu ta ’ 25 mg kull doża) taħt il- ġilda darbtejn f’ ġimgħa.
In part 2, patients with a clinical response at day 90 were randomised to remain on Enbrel or receive placebo for four months and assessed for disease flare.
Fit - 18 tieni parti, pazjenti b’ rispons kliniku fid- 90 ġurnata, kienu b’ għażla każwali f’ dawk li kellhom jibqgħu fuq Enbrel u f’ oħrajn biex jirċievu l- plaċebo għal erba ’ xhur u jiġu assessjati għal xi żjieda qawwija fl - intensità tal- marda.
Responses were measured using the JRA Definition of Improvement (DOI), defined as  30% improvement in at least three of six and  30% worsening in no more than one of six JRA core set criteria, including active joint count, limitation of motion, physician and patient/ parent global assessments, functional assessment, and erythrocyte sedimentation rate (ESR).
Ir- rispons kien imkejjel bil- JRA Definizzjoni għat- Titjib (DOI), definita bħala ≥ 30% titjib f’ mill- inqas tlieta minn sitta, u ≥ 30% eħżen f’ mhux aktar minn wieħed minn sitta tal - kriterji bażiċi magħżula tal- JRA, li jinkludu total ta ’ ġogi attivi, limitazzjoni ta ’ ċaqliq, assessjar globali tat- tabib u tal- pazjent/ ġenitur, assessjar funzjonali u rata ta ’ sedimentazzjoni taċ- ċelloli l - ħomor tad- demm (ESR).
Disease flare was defined as a  30% worsening in three of six JRA core set criteria and  30% improvement in not more than one of the six JRA core set criteria and a minimum of two active joints.
Żjieda qawwija fl- intensità tal- marda kien definit bħala ≥ 30% eħżen fi tlieta minn sitta kriterji bażiċi magħżula tal- JRA, u pazjenti b’ ≥ 30% titjib f’ mhux aktar minn waħda minn sitta kriterji bażiċi magħżula tal- JRA u b’ ta ’ l- anqas żewġ ġogi attivi.
In part 1 of the study, 51 of 69 (74%) patients demonstrated a clinical response and entered part 2.
Fl- ewwel parti ta ’ l- istudju, 51 minn 69 (74%) tal- pazjenti wrew rispons kliniku u daħlu għat- tieni parti ta ’ l- istudju.
In part 2, 6 of 25 (24%) patients remaining on Enbrel experienced a disease flare compared to 20 of 26 (77%) patients receiving placebo (p=0.007).
Fit- tieni parti, 6 minn 25 (24%) tal- pazjenti li baqgħu fuq Enbrel esperjenzaw żjieda qawwija fl- intensità tal- marda mqabbla ma ’ 20 minn 26 (77%) pazjenti li rċevew il- plaċebo (p=0. 007).
From the start of part 2, the median time to flare was  116 days for patients who received Enbrel and 28 days for patients who received placebo.
Mill- bidu tat- tieni parti, iż- żmien medjan għall- żjieda qawwija fl- intensità tal- marda kien ta ’ ≥ 116 ġurnata għall- pazjenti li ħadu Enbrel u 28 ġurnata għall- pazjenti li ħadu l- plaċebo.
Of patients who demonstrated a clinical response at 90 days and entered part 2 of the study, some of the patients remaining on Enbrel continued to improve from month 3 through month 7, while those who received placebo did not improve.
Mill- pazjenti li wrew rispons kliniku fid- 90 jum u li daħlu għat- tieni parti ta ’ l- istudju, x’ uħud minnhom li baqgħu fuq Enbrel komplew juru titjib mit- tielet xahar sas- seba ’ xahar, waqt li dawk li ħadu l- palċebo ma wrew l - ebda titjib.
Studies have not been done in patients with polyarticular juvenile idiopathic arthritis to assess the effects of continued Enbrel therapy in patients who do not respond within 3 months of initiating Enbrel therapy or to assess the combination of Enbrel with methotrexate.
Ma sarux studji f’ pazjenti b’ artrite idjopatika tal- minorenni b’ kors poliartikulari sabiex jiġu assessjati l- effetti tat- terapija b’ Enbrel li kompliet f’ pazjenti li ma tawx rispons fl- ewwel 3 xhur li nbdiet it - terapija ta ’ Enbrel, jew biex jiġi assessjat Enbrel flimkien ma ’ methotrexate.
Adult patients with psoriatic arthritis
Pazjenti adulti b’ artrite psorjatika
The efficacy of Enbrel was assessed in a randomised, double-blind, placebo-controlled study in 205 patients with psoriatic arthritis.
L- effikaċja ta ’ Enbrel kienet assessjata f’ 205 pazjenti li kellhom artrite psorjatika fi studju b’ għażla każwali, double- blind u kkontrollat bi plaċebo.
Patients were between 18 and 70 years of age and had active psoriatic arthritis ( 3 swollen joints and  3 tender joints) in at least one of the following forms:
Il- pazjenti kienu bejn it- 18- il u s- 70 sena u kellhom artrite psorjatika attiva (≥ 3 ġogi minfuħin u ≥ 3 ġogi sensittivi) f’ mill- anqas waħda minn dawn il - forom:
(1) distal interphalangeal (DIP) involvement; (2) polyarticular arthritis (absence of rheumatoid nodules and presence of psoriasis); (3) arthritis mutilans; (4) asymmetric psoriatic arthritis; or (5) spondylitis-like ankylosis.
(1) involviment distali interfalanġjali (DIP); (2) artrite poliartkulari (nuqqas ta ’ noduli rewmatojdi u presenza ta ’ psorijażi); (3) artrite mutilans; (4) artrite psorjatika asimmetrika; jew (5) immobilità tal- vertebre li tixbaħ infjammazzjoni.
Patients also had plaque psoriasis with a qualifying target lesion  2 cm in diameter.
Il- pazjenti kellhom ukoll psorijażi bil- qxur b’ ġerħa li tikwalifika għat- targit ta ’ dijametru ta ’ ≥ 2cm.
Patients had previously been treated with NSAIDs (86%), DMARDs (80%), and corticosteroids (24%).
Il- pazjenti ġew ikkurati qabel b’ NSAIDs (86%), DMARDs (80%), u kortikosterojdi (24%).
Patients currently on methotrexate therapy (stable for  2 months) could continue at a stable dose of  25 mg/ week methotrexate.
Pazjenti li kienu fuq it- terapija b’ methotrexate (stabbli għal ≥ xahrejn) setgħu jkomplu fuq doża stabbli ta ’ ≤ 25 mg/ fil- ġimgħa methotrexate.
Doses of 25 mg of Enbrel (based on dose-finding studies in patients with rheumatoid arthritis) or placebo were administered SC twice a week for 6 months.
Dożi ta ’ Enbrel tal- 25 mg (ibażżati fuq tagħrif minn studju fuq id- dożi mill- pazjenti b’ artrite rewmatojde) jew plaċebo kienu mogħtija SC darbtejn f’ ġimgħa għal sitt xhur.
At the end of the double-blind study, patients could enter a long-term open-label extension study for a total duration of up to 2 years.
Fi tmiem ta ’ l- istudju double- blind, il - pazjenti setgħu jidħlu fi studju fit- tul tat- tip open- label extension, għal żmien totali sa sentejn.
Clinical responses were expressed as percentages of patients achieving the ACR 20, 50, and 70 response and percentages with improvement in Psoriatic Arthritis Response Criteria (PsARC).
Ir- riżultati kienu espressi f’ perċentwali tal- pazjenti li kisbu rispons ta ’ ACR 20, 50 u 70, u f’ perċentwali ta ’ titjib fil- Kriterji tar- Rispons ta ’ l- Artrite Psorjatika (PsARC).
Results are summarised in the Table below.
Ir- riżultati jidhru fil - qosor fit- tabella t’ hawn taħt:
19 RESPONSES OF PATIENTS WITH PSORIATIC ARTHRITIS IN PLACEBO-CONTROLLED TRIAL Percent of Patients
19 RISPONSI TA ’ PAZJENTI B’ ARTRITE PSORJATIKA FI STUDJU KKONTROLLAT BI PLAĊEBO% ta ’ Pazjenti Enbrela Plaċebo
Psoriatic Arthritis Response
Rispons ta ’ Artrite Psorjatika ACR 20
n = 101
= 101 59b
Month 3 Month 6
Is- sitt xahar ACR 50
ACR 50
38b
Month 3 Month 6
It- tielet xahar
ACR 70
Is- sitt xahar ACR 70
Month 3 Month 6
4
0 1
11b
11b 9c
9c
PsARC
Is- sitt xahar PsARC
Month 3 Month 6
Is- sitt xahar
25 mg Enbrel SC twice weekly b: p < 0.001, Enbrel vs. placebo c: p < 0.01, Enbrel vs. placebo
25 mg Enbrel SC dabtejn f’ ġimgħa b: p < 0. 001, Enbrel vs. plaċebo c: p < 0. 01, Enbrel vs. plaċebo
Among patients with psoriatic arthritis who received Enbrel, the clinical responses were apparent at the time of the first visit (4 weeks) and were maintained through 6 months of therapy.
Fost il- pazjenti bl- artrite psorjatika li rċevew Enbrel, ir- risponsi kliniċi kienu dehru fl- ewwel viżta (4 ġimgħat) u komplew matul is- sitt xhur tat- terapija.
Enbrel was significantly better than placebo in all measures of disease activity (p < 0.001), and responses were similar with and without concomitant methotrexate therapy.
Enbrel kien sinjifikament aħjar mill- plaċebo meta tkejlet l- attività tal- marda (p < 0. 001), u r- riponsi kienu simili f’ terapija b’ Enbrel waħdu u f’ terapija flimkien ma ’ methotrexate.
Quality of life in psoriatic arthritis patients was assessed at every timepoint using the disability index of the HAQ.
Il- kwalità tal- ħajja f’ pazjenti bl- artrite psorjatika kienet assessjata f’ kull punt ta ’ żmien bl- użu ta ’ l- indiċi tad- diżabilità tal- HAQ.
The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with Enbrel, relative to placebo (p < 0.001).
L- iskor ta ’ l- indiċi tad- diżabilità kien sinjifikament aħjar f’ kull punt ta ’ żmien f’ pazjenti bl- artrite psorjatika ikkurati b’ Enbrel, relatat mal - plaċebo (p < 0. 001).
Radiographic changes were assessed in the psoriatic arthritis study.
Il- bidliet radjografiċi kienu evalwati fl- istudju dwar l- artrite psorjatika.
Radiographs of hands and wrists were obtained at baseline and months 6, 12, and 24.
Radjografiji ta ’ l- idejn u l- polz inkisbu fil- linja bażi u wara 6, 12, u 24 xahar.
The modified TSS at 12 months is presented in the Table below.
It- TSS modifikat wara 12- il xahar hu ppreżentat fit - Tabella ta ’ hawn taħt.
In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 12 months was higher in the Enbrel group compared with the placebo group (73% vs.
F’ analiżi li fiha l- pazjenti kollha li ħarġu mill- istudju għal xi raġuni kienu kkunsidrati li kienu pprogressaw, il- perċentwali ta ’ pazjenti mingħajr progressjoni (bidla fit- TSS ta ’ ≤ 0. 5) wara 12- il xahar kien ogħla fil- grupp ta ’ Enbrel meta mqabbel mal- grupp tal- plaċebo (73% vs.
47%, respectively, p ≤ 0.001).
47%, rispettivament, p ≤ 0. 001).
The effect of Enbrel on radiographic progression was maintained in patients who continued on treatment during the second year.
L- effett ta ’ Enbrel fuq il- progressjoni radjografika nżamm f’ pazjenti li komplew fuq il- kura matul it- tieni sena.
The slowing of peripheral joint damage was observed in patients with polyarticular symmetrical joint involvement.
It- tnaqqis tal- ħsara periferali tal- ġogi kien osservat f’ pazjenti b’ involviment simmetriku poliartikulari tal- ġogi.
MEAN (SE) ANNUALIZED CHANGE FROM BASELINE IN TOTAL SHARP SCORE
IL- MEDJA (SE) TAL- BIDLA ANNWALIZZATA MILL- LINJA BAŻI B’ PUNTEĠĠ TOTALI SHARP
Time
Ħin
1.00 (0.29)
Xahar 12
20 Enbrel treatment resulted in improvement in physical function during the double-blind period, and this benefit was maintained during the longer-term exposure of up to 2 years.
Il- kura b’ Enbrel irriżultat fit- titjib tal- funzjoni fiżika matul il- perjodu double- blind, u dan il- benefiċċju inżamm matul l- espożizzjoni għal tul ta ’ żmien sa sentejn.
There is insufficient evidence of the efficacy of Enbrel in patients with ankylosing spondylitis-like and arthritis mutilans psoriatic arthropathies due to the small number of patients studied.
Ma hemmx biżżejjed evidenza ta ’ l- effikaċja ta ’ Enbrel f’ pazjenti li kellhom artropatiji psorjatiċi tat - tip ankylosing spondylitis- like u artrite mutilans minħabba n- numru żgħir ta ’ pazjenti li kienu studjati.
No study has been performed in patients with psoriatic arthritis using the 50mg once weekly dosing regimen.
20 Ma sar l- ebda studju fejn intuża r- reġimen ta ’ dożi ta ’ 50 mg darba fil- ġimgħa f’ pazjenti b’ artrite psorjatika.
Evidence of efficacy for the once weekly dosing regimen in this patient population has been based on data from the study in patients with ankylosing spondylitis.
Evidenza ta ’ effikaċja għar- reġimen ta ’ dożaġġ ta ’ darba fil- ġimgħa f’ din il- popolazzjoni ta ’ pazjenti hija bbażata fuq dejta mill- istħarriġ ta ’ pazjenti b’ ankylosing spondylitis.
Adult patients with ankylosing spondylitis
Pazjenti adulti li għandhom ankylosing spondylitis
The efficacy of Enbrel in ankylosing spondylitis was assessed in 3 randomised, double-blind studies comparing twice weekly administration of 25 mg Enbrel with placebo.
L- effikaċja ta ’ Enbrel f’ ankylosing spondylitis kienet assessjata fi 3 studji b’ għażla każwali, double - blind li qabblu l- għoti ta ’ 25 mg Enbrel darbtejn fil- ġimgħa ma ’ plaċebo.
A total of 401 patients were enrolled from which 203 were treated with Enbrel.
Total ta ’ 401 pazjent kienu reġistrati li fosthom 203 kienu ttrattati b ’ Enbrel.
The largest of these trials (n= 277) enrolled patients who were between 18 and 70 years of age and had active ankylosing spondylitis defined as visual analog scale (VAS) scores of  30 for average of duration and intensity of morning stiffness plus VAS scores of  30 for at least 2 of the following 3 parameters: patient global assessment; average of VAS values for nocturnal back pain and total back pain; average of 10 questions on the Bath Ankylosing Spondylitis Functional Index (BASFI).
L- akbar numru f ’ dawn l- istudji (n= 277) kienu pazjenti ta ’ bejn it- 18- il u s- 70 sena u li kellhom immobilità tal- vertebre kawża ta ’ infjammazzjoni attiva definita bħala skala analoga viżwali (VAS) bi skor ta’ ≥ 30 għal użu ta ’ żmien medju u intensità ta ’ ebbusija ta ’ fil- għodu; flimkien ma ’ skor VAS ta ’ ≥ 30 għal mill- inqas 2 minn dawn it- 3 parametri: assessjar globali tal- pazjent; valur medju tal- VAS għal uġigħ fid- dahar matul il- lejl u uġigħ totali fid - dahar; medja ta ’ 10 domandi fuq l- Indiċi Funzjonali ta ’ l- immobilità tal- vertebre kawża ta ’ infjammazzjoni fil- Banju (BASFI).
Patients receiving DMARDs, NSAIDS, or corticosteroids could continue them on stable doses.
Pazjenti li jirċievu DMARDs, NSAIDS jew kortikosterjodi setgħu jkomplu joħduhom fuq dożi stabbli.
Doses of 25 mg of Enbrel (based on dose-finding studies in patients with rheumatoid arthritis) or placebo were administered subcutaneously twice a week for 6 months in 138 patients.
Dożi ta ’ 25 mg ta ’ Enbrel (minn bażi ta ’ studji fuq dożi użati minn pazjenti bl- artrite rewmatojde) jew plaċebo kienu mogħtija taħt il- ġilda darbtejn f’ ġimgħa għal sitt xhur f’ 138 pazjent.
The primary measure of efficacy (ASAS 20) was a  20% improvement in at least 3 of the 4 Assessment in Ankylosing Spondylitis (ASAS) domains (patient global assessments, back pain, BASFI, and inflammation) and absence of deterioration in the remaining domain.
Il- kejl ewlieni ta ’ l- effikaċja (ASAS 20) kienet titjib ta ’ ≥ 20% f’ ta ’ mill- anqas 3 mill- 4 dominji ta ’ l - Assessjar fl- immobilità tal- vertebre kawża ta ’ infjammazzjoni (ASAS) (assessjar globali tal- pazjent, uġigħ fid- dahar, BASFI, u infjammazzjoni) u nuqqas ta ’ deterjojazzjoni fid- dominju li jifdal.
ASAS 50 and 70 responses used the same criteria with a 50% improvement or a 70% improvement, respectively.
Risponsi ASAS 50 u 70 użaw l- istess kriterji b’ titjib ta ’ 50% u 70% rispettivament.
Compared to placebo, treatment with Enbrel resulted in significant improvements in the ASAS 20, ASAS 50 and ASAS 70 as early as 2 weeks after the initiation of therapy.
Meta mqabbla ma ’ plaċebo, il- kura b’ Enbrel uriet titjib sinjifikattiv f’ ASAS 20, ASAS 50 u ASAS 70 minn kmieni, jiġifieri minn ġimagħtejn wara li nbiet it- terapija.
21 RESPONSES OF PATIENTS WITH ANKYLOSING SPONDYLITIS IN A PLACEBO-CONTROLLED TRIAL Percent of Patients
RISPONSI TA ’ PAZJENTI B’ ANKYLOSING SPONDYLITIS FI STUDJU KKONTROLLAT BIL- PLAĊEBO Perċentwali ta ’ Pazjenti
Ankylosing Spondylitis N Response ASAS 20
kawża ta ’ infjammazzjoni ASAS 20
2 weeks 3 months 6 months ASAS 50
2 ġimgħat
2 weeks
3 xhur
3 months 6 months
6 xhur
45a 42a
ġimgħat
ASAS 70:
3 xhur
2 weeks 3 months 6 months
6 xhur
a: p < 0.001, Enbrel vs.
a: p < 0. 001, Enbrel vs.
Placebo b: p = 0.002, Enbrel vs. placebo
Plaċebo
Among patients with ankylosing spondylitis who received Enbrel, the clinical responses were apparent at the time of the first visit (2 weeks) and were maintained through 6 months of therapy.
Fost il- pazjenti b’ immobilità tal- vertebre kawża ta ’ infjammazzjoni li rċevew Enbrel, ir- risponsi kliniċi kienu jidhru fl- ewwel viżta ġimagħtejn u komplew matul is- sitt xhur tat- terapija.
Responses were similar in patients who were or were not receiving concomitant therapies at baseline.
Ir- risponsi kienu simili f’ pazjenti li kienu qed jieħdu jew ma kienux qed jieħdu terapija oħra fil- linja bażi.
Similar results were obtained in the 2 smaller ankylosing spondylitis trials.
Riżultati simili kienu miksuba f’ żewġ studji iżgħar ta ’ pazjenti b’ immobilità tal- vertebre kawża ta ’ infjammazzjoni.
In a fourth study, the safety and efficacy of 50 mg Enbrel (two 25 mg SC injections) administered once weekly vs 25 mg Enbrel administered twice weekly were evaluated in a double-blind, placebo-controlled study of 356 patients with active ankylosing spondylitis.
21 Fir- raba ’ studju, is- sigurtà u l- effikaċja ta ’ 50 mg Enbrel (żewġ injezzjonijiet SC ta ’ 25 mg) mogħtija darba fil- ġimgħa vs 25 mg Enbrel mogħtija darbtejn fil- ġimgħa kienu evalwati fi studju double- blind, ikkontrollat bi plaċebo ta ’ 356 pazjent b’ ankylosing spondylitis attiva.
The safety and efficacy profiles of the 50 mg once weekly and 25 mg twice weekly regimens were similar.
Il- profili ta ’ sigurta u effikaċja tar- reġimens ta ’ 50 mg darba fil- ġimgħa jew 25 mg darbtejn fil- ġimgħa kienu simili.
Adult patients with plaque psoriasis
Pazjenti adulti bi psorjasi tal- plakka
Enbrel is recommended for use in patients as defined in section 4.1.
Enbrel huwa rrakkomandat għal użu f’ pazjenti kif definit f’ sezzjoni 4. 1.
Patients who “ failed to respond to ” in the target population is defined by insufficient response (PASI < 50 or PGA less than good), or worsening of the disease while on treatment, and who were adequately dosed for a sufficiently long duration to assess response with at least each of the three major systemic therapies as available.
Pazjenti li “ fallew milli jirrispondu ” mill- popolazzjoni mmirata huma mfissra b’ rispons insuffiċjenti (PASI < 50 jew PGA anqas minn tajba) jew deterjorament tal- marda waqt l- għoti tal- kura, u li kienu dożati adegwatament għal tul ta ’ żmien suffiċjenti biex jiġi assessjat ir- rispons b ’ tal- anqas kull waħda mit- tliet terapiji sistemiċi kif jeżistu.
The efficacy of Enbrel versus other systemic therapies in patients with moderate to severe psoriasis (responsive to other systemic therapies) has not been evaluated in studies directly comparing Enbrel with other systemic therapies.
L- effikaċja ta ’ Enbrel kontra terapiji sistemiċi oħra f’ pazjenti bi psorjasi moderata għal severa (li rrispondiet għal terapiji sistemiċi oħra) ma ġietx evalwata fi studju b’ Enbrel ikkomparat direttament ma ’ terapiji sistemiċi oħrajn.
Instead, the safety and efficacy of Enbrel were assessed in four randomised, double-blind, placebo-controlled studies.
Minflok, is- sigurtà u l- effikaċja ta ’ Enbrel kienu assessjati f’ erba ’ studji b’ għażla każwali, double- blind u kkontrollati bi plaċebo.
The primary efficacy endpoint in all four studies was the proportion of patients in each treatment group who achieved the PASI 75 (i. e. at least a 75% improvement in the Psoriasis Area and Severity Index score from baseline) at 12 weeks.
L- endpoint ta ’ l- effikaċja primarja fl- erba ’ studji kollha kien il- proporzjon ta ’ pazjenti f’ kull grupp ta ’ trattament li kisbu PASI 75 (i. e., mill - anqas 75% titjib fil- punteġġ tal- Psoriasis Area and Severity Index mil- linja bażi) fit- 12- il ġimgħa.
22 Study 1 was a Phase 2 study in patients with active but clinically stable plaque psoriasis involving  10% of the body surface area that were  18 years old.
Studju 1 kien prova ta ’ Fażi 2 f’ pazjenti bi psorjasi tal- plakka klinikament stabbli imma attiva li tinvolvi ≥ 10% tal- erja tal- wiċċ tal- ġisem li kellhom ≥ 18- il sena.
One hundred and twelve (112) patients were randomised to receive a dose of 25 mg of Enbrel (n=57) or placebo (n=55) twice a week for 24 weeks.
Mija u tnax- il pazjent (112) kienu magħżula b’ mod każwali biex jingħataw doża ta ’ 25 mg ta ’ Enbrel (n=57) jew plaċebo (n=55) darbtejn fil- ġimgħa għal 24 ġimgħa.
Study 2 evaluated 652 patients with chronic plaque psoriasis using the same inclusion criteria as study 1 with the addition of a minimum psoriasis area and severity index (PASI) of 10 at screening.
Studju 2 evalwa 652 pazjent bi psorjasi tal- plakka kronika billi ntużaw l- istess kriterji ta ’ inklużjoni bħal fi studju 1 biż- żieda ta ’ minimum psoriasis area and severity index (PASI) ta ’ 10 waqt screening.
Enbrel was administered at doses of 25 mg once a week, 25 mg twice a week or 50 mg twice a week for 6 consecutive months.
Enbrel kien mogħti f’ dożi ta ’ 25 mg darba fil- ġimgħa, 25 mg darbtejn fil- ġimgħa jew 50 mg darbtejn fil- ġimgħa għal 6 xhur konsekuttivi.
During the first 12 weeks of the double-blind treatment period, patients received placebo or one of the above three Enbrel doses.
Waqt l- ewwel 12- il ġimgħa tal- perijodu tat- trattament double - blind, pazjenti ngħataw plaċebo jew waħda mit- tliet dożi ta ’ Enbrel ta ’ hawn fuq.
After 12 weeks of treatment, patients in the placebo group began treatment with blinded Enbrel (25 mg twice a week); patients in the active treatment groups continued to week 24 on the dose to which they were originally randomised.
Wara tnax- il ġimgħa ta ’ trattament, pazjenti fil- grupp plaċebo bdew trattament blinded b’ Enbrel (25 mg darbtejn fil - ġimgħa); pazjenti fil- grupp tat- trattament attiv komplew sa ġimgħa 24 fuq id- doża li fiha kienu magħżula b’ mod każwalifil- bidu nett.
Study 3 evaluated 583 patients and had the same inclusion criteria as study 2.
Studju 3 evalwa 583 pazjent u kellu l- istess kriterji ta ’ inkluzjoni bħal studju 2.
Patients in this study received a dose of 25 mg or 50 mg Enbrel, or placebo twice a week for 12 weeks and then all patients received open-label 25 mg Enbrel twice weekly for an additional 24 weeks.
Pazjenti f’ dan l- istudju ngħataw doża ta ’ 25 mg jew 50 mg Enbrel, jew plaċebo darbtejn fil- ġimgħa għal 12- il ġimgħa u wara l- pazjenti kollha ngħataw 25 mg Enbrel open- label darbtejn fil- ġimgħa għal 24 ġimgħa addizzjonali.
Study 4 evaluated 142 patients and had similar inclusion criteria to studies 2 and 3.
Studju 4 evalwa 142 pazjent u kellu kriterji simili ta ’ l- inkluzjoni bħal studji 2 u 3.
Patients in this study received a dose of 50 mg Enbrel or placebo once weekly for 12 weeks and then all patients received open- label 50 mg Enbrel once weekly for an additional 12 weeks.
Pazjenti f’ dan l - istudju ngħataw doża ta ’ 50 mg Enbrel jew plaċebo darba fil- ġimgħa għal 12- il ġimgħa, u wara l- pazjenti kollha ngħataw 50 mg Enbrel open- label darba fil- ġimgħa għal 12- il ġimgħa addizzjonali.
In study 1, the Enbrel-treated group had a significantly higher proportion of patients with a PASI 75 response at week 12 (30%) compared to the placebo-treated group (2%) (p < 0.0001).
Fi studju 1, il- grupp ta ’ trattament b’ Enbrel kellhom proporzjon ogħla ta ’ pazjenti b’ rispons PASI 75 f’ ġimgħa 12 (30%) meta mqabbel mal- grupp ittrattat bi plaċebo (2%) (p < 0. 0001).
At 24 weeks, 56% of patients in the Enbrel-treated group had achieved the PASI 75 compared to 5% of placebo-treated patients.
F’ ġimgħa 24, 56% ta ’ pazjenti fil- grupp ittrattat b’ Enbrel kienu kisbu l- PASI 75 meta mqabbla ma ’ 5% ta ’ pazjenti kontrollati bi plaċebo.
Key results of studies 2, 3 and 4 are shown below.
Ir- riżultati ewlenin tat- 2, it- 3 u r- 4 studju jidhru hawn taħt.
RESPONSES OF PATIENTS WITH PSORIASIS IN STUDIES 2, 3 AND 4 ------------------Study 2--------------- ---------------Study 3------------- ---------------Study 4-------------
22 REAZZJONIJIET TA ’ PAZJENTI BI PSORJASI FI STUDJI 2, 3 U 4 -------------------- Studju 2 ------------------ ---------------- Studju 3 ------------- ------------- Studju 4 ------------
--
--------
--------Enbrel--------- --------Enbrel-------
-------- Enbrel --------------- -------- Enbrel -------
50 mg
------- Enbrel ------ 50 mg 50 mg
Placebo
darba darba
BIW
darbtejn
BIW Placebo BIW BIW Placebo QW
fil - darbtejn fil - darbtejn darbtejn fil -
QW
fil -
n =
Plaċebo
166 n = n = n = n = n = 193 n = 196 n = 196 n = 46
Plaċebo
n = 96
ġimgħa Plaċebo n = 96
n = 90
ġimgħa n = 90
Response (%)
n = 196
wk
n = 46
wk 12 wk 12 wk
ġimgħa
12
ġimgħa
wk 12
ġimgħa
wk 24a
12 12
PASI 50 PASI 75 DSGA b, clear or almost
PASI 50 PASI 75 b DSGA, ċar jew
*p  0.0001 compared with placebo a.
* p ≤0. 0001 ikkomparata ma ’ plaċebo a.
No statistical comparisons to placebo were made at week 24 in studies 2 and 4 because the original placebo group began receiving Enbrel 25 mg BIW or 50 mg once weekly from week 13 to week 24. b.
L- ebda paraguni statistiċi ma ’ plaċebo ma ’ ġew magħmula f’ ġimgħa 24 fi Studju 2 u 4 għaliex il - grupp plaċebo oriġinali beda jingħata Enbrel 25 mg darbtejn fil- ġimgħa jew 50 mg darba fil- ġimgħa minn ġimgħa 13 sa ġimgħa 24. b.
Clear or almost clear defined as 0 or 1 on a 0 to 5 scale.
Ikkurati jew kważi ikkurati iddefiniti bħala 0 jew 1 fuq skala 0 to 5.
Among patients with plaque psoriasis who received Enbrel, significant responses relative to placebo were apparent at the time of the first visit (2 weeks) and were maintained through 24 weeks of therapy.
Fost pazjenti b’ psorjasi tal- plakek li ngħataw Enbrel, risponsi sinifikattivi relattivi ma ’ plaċebo kienu jidhru waqt iż- żmien ta ’ l- ewwel viżta (2 ġimgħat) u kienu miżmumin waqt l- 24 ġimgħa tat- terapija.
23 Study 2 also had a drug withdrawal period during which patients who achieved a PASI improvement of at least 50% at week 24 had treatment stopped.
Studju 2 kellu wkoll perijodu fejn il- mediċina ma ngħatatx waqt liem żmien pazjenti li kienu kisbu titjib PASI ta ’ mill- anqas 50% f’ ġimgħa 24 kellhom it- trattament imwaqqaf.
Patients were observed off treatment for the occurrence of rebound (PASI  150% of baseline) and for the time to relapse (defined as a loss of at least half of the improvement achieved between baseline and week 24).
Pazjenti kienu osservati mingħajr trattament għall- okkorrenza ta ’ rebound (PASI ≥150% tal- linja bażi) u għaż- żmien li kellu jgħaddi biex jkollhom rikaduta (mfissra bħala telf ta ’ mill- anqas nofs it- titjib miksub bejn il- linja bażi u ġimgħa 24).
During the withdrawal period, symptoms of psoriasis gradually returned with a median time to disease relapse of 3 months.
Waqt il- perijodu ta ’ żmien fejn ma ħadux il- mediċina, sintomi ta ’ psorjasi gradwalment ġew lura bi żmien medjan tar- rikaduta tal- marda ta ’ 3 xhur.
No rebound flare of disease and no psoriasis-related serious adverse events were observed.
Ma kienx osservat tqanqil rebound tal - marda u l- ebda reazzjonijiet avversi serji relatati ma ’ psorjasi.
There was some evidence to support a benefit of re-treatment with Enbrel in patients initially responding to treatment.
Kien hemm xi evidenza li ssostni is- siwi ta ’ trattament mill- ġdid b’ Enbrel f’ pazjenti li fil- bidu nett irrispondew għat- trattament.
In study 3, the majority of patients (77%) who were initially randomised to 50 mg twice weekly and had their Enbrel dose decreased at week 12 to 25 mg twice weekly maintained their PASI 75 response through week 36.
Fi studju 3, il- maġġoranza tal- pazjenti (77%) li fil- bidu nett kienu magħżula b’ mod każwali għal 50 mg darbtejn fil- ġimgħa u li kellhom id- doża tagħhom ta ’ Enbrel imnaqqsa f’ ġimgħa 12 għal 25 mg darbtejn fil- ġimgħa żammew ir- rispons PASI 75 tagħhom sa ġimgħa 36.
For patients who received 25 mg twice weekly throughout the study, the PASI 75 response continued to improve between weeks 12 and 36.
Għal pazjenti li ngħataw 25 mg darbtejn fil- ġimgħa matul l- istudju, ir- rispons PASI 75 kompla jitjieb bejn il- ġimgħat 12 u 36.
In study 4, the Enbrel-treated group had a higher proportion of patients with PASI 75 at week 12 (38%) compared to the placebo-treated group (2%) (p < 0.0001).
Fi studju 4, il- grupp ikkurat b’ Enbrel kellu proporzjon ogħla ta ’ pazjenti b’ PASI 75 f’ ġimgħa 12 (38%) meta mqabbel mal- grupp ikkurat bil- plaċebo (2%) (p < 0. 0001).
For patients who received 50 mg once weekly throughout the study, the efficacy responses continued to improve with 71% achieving PASI 75 at week 24.
Għal pazjenti li rċivew 50 mg darba fil- ġimgħa matul l- istudju kollu, ir- risponsi ta ’ l- effikaċja komplew jitjiebu, b’ 71% li laħqu PASI 75 f’ ġimgħa 24.
Paediatric patients with plaque psoriasis
Pazjenti pedjatriċi bi psorjasi tal- plakka
The efficacy of Enbrel was assessed in a randomised, double-blind, placebo-controlled study in 211 paediatric patients aged 4 to 17 years with moderate to severe plaque psoriasis (as defined by a sPGA score ≥ 3, involving ≥ 10% of the BSA, and PASI ≥ 12).
L- effikaċja ta ’ Enbrel kienet evalwata fi studju randomised, double- blind, u kkontrollat bil- plaċebo li sar fuq 211- il pazjent pedjatriku bejn l- 4 u 17- il sena, li kellhom psorjasi tal- plakka minn moderata sa severa (kif definita minn punteġġ sPGA ta ’ ≥ 3, li tinvolvi ≥ 10% tal- BSA, u PASI ta ’ ≥ 12).
Eligible patients had a history of receiving phototherapy or systemic therapy, or were inadequately controlled on topical therapy.
Il - pazjenti eliġibbli kellhom storja medika li kienu jirċievu fototerapija jew terapija sistemika jew li ma kinux ikkontrollati b’ mod adegwat fuq terapija topika.
Patients received Enbrel 0.8 mg/ kg (up to 50 mg) or placebo once weekly for 12 weeks.
Il- pazjenti rċivew Enbrel 0. 8 mg/ kg (sa 50 mg) jew il- plaċebo darba f’ ġimgħa għal 12- il ġimgħa.
At week 12, more patients randomised to Enbrel had positive efficacy responses (e. g.
F’ ġimgħa 12, iktar pazjenti li kienu randomised għal Enbrel kellhom risponsi pożittivi tal- effikaċja (eż.
PASI 75) than those randomised to placebo.
PASI 75) milli minn dawk li kienu randomised għal plaċebo.
Paediatric Plaque Psoriasis Outcomes at 12 Weeks Enbrel 0.8 mg/ kg Once
23 Riżultati tal- Psorjasi Pedjatrika tal- Plakka f’ Ġimgħa 12 Enbrel 0. 8 mg/ kg Darba fil -
Weekly
Ġimgħa
After the 12-week double-blind treatment period, all patients received Enbrel 0.8 mg/ kg (up to 50 mg) once weekly for additional 24 weeks.
Wara l- kura double- blind ta ’ 12- il ġimgħa, il- pazjenti kollha rċivew Enbrel 0. 8 mg/ kg (sa 50 mg) darba f’ ġimgħa għal 24 ġimgħa addizzjonali.
Responses observed during the open-label period were similar to those observed in the double-blind period.
Ir- risponsi osservati matul il- perjodu open- label kienu simili għal dawk osservati fil- perjodu double- blind.
During a randomised withdrawal period, significantly more patients re-randomised to placebo experienced disease relapse (loss of PASI 75 response) compared with patients re-randomised to Enbrel.
Matul perjodu randomised meta l- pazjenti ma baqgħux jieħdu l- mediċina, iktar pazjenti b’ mod sinifikanti li kienu re- randomised għall- plaċebo kellhom rikaduta tal- marda (telf tar- rispons PASI 75) meta mqabbel ma ’ pazjenti li kienu re- randomised għal Enbrel.
With continued therapy, responses were maintained up to 48 weeks.
Mat- tkomplija tat- terapija, ir- risponsi nżammu sa 48 ġimgħa.
24 Antibodies to Enbrel
Antikorpi għal Enbrel
Antibodies to etanercept have been detected in the sera of some subjects treated with etanercept.
Antikorpi għal etanercept kienu osservati fis- sera ta ’ xi pazjenti li kienu kkurati b’ etanercept.
These antibodies have all been non-neutralising and are generally transient.
Dawn l- antikorpi kienu kollha non- newtralizzanti u huma ġeneralment temporanji.
There appears to be no correlation between antibody development and clinical response or adverse events.
Jidher li m’ hemm l- ebda korrelazzjoni bejn l- iżvilupp ta ’ l- antikorpi u r- rispons kliniku jew avvenimenti avversi.
In subjects treated with approved doses of etanercept in clinical trials for up to 12 months, cumulative rates of anti-etanercept antibodies were approximately 6% of subjects with rheumatoid arthritis, 7.5% of subjects with psoriatic arthritis, 2% of subjects with ankylosing spondylitis, 7% of subjects with psoriasis, 9.7% of subjects with paediatric psoriasis, and 3% of subjects with juvenile idiopathic arthritis.
F’ pazjenti kkurati b’ dożi approvati ta ’ etanercept fi provi kliniċi sa 12- il xahar, ir- rati kumulattivi ta ’ antikorpi għal etanercept kienu ta ’ madwar 6% tal- pazjenti b’ artrite rewmatojde, 7. 5% tal- pazjenti b’ artrite psorjatika 2% tal- pazjenti bi spondilite ankylosing, 7% tal- pazjenti bi psorjasi, 9. 7% tal - pazjenti bi psorjasi pedjatrika, u 3% tal- pazjenti b’ artrite idjopatika ġuvenili.
The proportion of subjects who developed antibodies to etanercept in longer-term trials (of up to 3.5 years) increases over time, as expected.
Il- proporzjon ta ’ pazjenti li żviluppaw antikorpi għal etanercept fi provi li damu aktar fit- tul (sa 3. 5 snin) jiżdied maż- żmien, kif mistenni.
However, due to their transient nature, the incidence of antibodies detected at each assessment point was typically less than 7% in rheumatoid arthritis subjects and psoriasis subjects.
Madankollu, minħabba n- natura temporanja tagħhom, l - inċidenza ta ’ antikorpi osservati f’ kull punt ta ’ evalwazzjoni kienet tipikament ta ’ inqas minn 7% fil - pazjenti b’ artrite rewmatojde u f’ pazjenti bi psorjasi.
In a long-term psoriasis study in which patients received 50 mg twice weekly for 96 weeks, the incidence of antibodies observed at each assessment point was up to approximately 9%.
Fi studju fit- tul dwar il- psorjasi li fih pazjenti rċivew 50 mg darbtejn f’ ġimgħa għal 96 ġimgħa, l- inċidenza ta ’ antikorpi osservati f’ kull punt ta ’ evalwazzjoni kienet ta ’ madwar 9%.
Etanercept serum values were determined by an ELISA method, which may detect ELISA-reactive degradation products as well as the parent compound.
Il- valur ta ’ Etanercept fis- serum kien determinat bil- metodu ELISA, li bih jistgħu jiġu osservati l - prodotti ta ’ degradazzjoni li jagħmlu reazzjoni għal ELISA, kif ukoll is- sustanza originali.
Etanercept is slowly absorbed from the site of subcutaneous injection, reaching maximum concentration approximately 48 hours after a single dose.
Etanercept hu assorbit bil- mod mis- sit ta ’ l- injezzjoni taħt il- ġilda, u jilħaq il- konċentrazzjoni massima f’ 48 siegħa wara doża waħda.
The absolute bioavailability is 76%.
Il- biodisponibiltà assoluta hija 76%.
With twice weekly doses, it is anticipated that steady-state concentrations are approximately twice as high as those observed after single doses.
B’ dozi ta ’ darbtejn f’ ġimgħa, hu antiċipat li l- konċentrazzjonijet fissi huma bejn wieħed u ieħor darbtejn ogħla minn dawk osservati b’ dożi waħda.
After a single subcutaneous dose of 25 mg Enbrel, the average maximum serum concentration observed in healthy volunteers was 1.65  0.66  g/ ml, and the area under the curve was 235  96.6  g hr/ ml.
Wara doża waħda taħt il- ġilda ta ’ Enbrel ta ’ 25 mg, il- medja tal- konċentrazzjoni massima fis- serum osservata f’ voluntiera b’ saħħithom kien 1. 65 ± 0. 66 μg/ ml, u l- erja ta ’ taħt il- kurva kienet 235 ± 96. 6 μg• hr/ ml.
Dose proportionality has not been formally evaluated, but there is no apparent saturation of clearance across the dosing range.
Il- proporzjonalità tad- doża għadha ma ġietx evalwata formalment, iżda ma jidhirx li hemm saturazzjoni tal- clearance fid- dożi kollha.
A biexponential curve is required to describe the concentration time curve of etanercept.
24 Irid ikun hemm kurva biesponenzjali biex tiddeskrivi il- kurva ta ’ konċentrazzjoni vs ħin ta ’ etanercept.
The central volume of distribution of etanercept is 7.6 l, while the volume of distribution at steady-state is 10.4 l.
Il- volum ċentrali tad- distribuzzjoni ta ’ etanercept hu 7. 6 l, waqt li l- volum ta ’ distribuzzjoni fiss hu ta’ 10. 4 l.
Etanercept is cleared slowly from the body.
Etancercept hu mneħħi bil- mod mill- ġisem.
The half-life is long, approximately 70 hours.
Il- half- life huwa twil, madwar 70 siegħa.
Clearance is approximately 0.066 l/ hr in patients with rheumatoid arthritis, somewhat lower than the value of 0.11 l/ hr observed in healthy volunteers.
Il- clearance hu ta ’ madwar 0. 066 l/ hr f’ pazjenti bl- artrite rewmatojde, xi ftit aktar baxx minn dak ta ’ 0. 11 l/ hr osservat f’ voluntiera b’ saħħithom.
Additionally, the pharmacokinetics of Enbrel in rheumatoid arthritis patients, ankylosing spondylitis and plaque psoriasis patients are similar.
Il- farmakokinetiċi ta ’ Enbrel f’ pazjenti bl- artrite rewmatojde, f’ pazjenti b’ immobilità tal- vertebra kawża ta ’ infjammazzjoni u psorjasi tal- plakek huma simili.