natgillin/translations-raw huggingface dataset:
- 0, 03 (0, 09) a
-0.03 (0.09)a
SE = standard error a. p = 0, 0001
SE = standard error. a. p = 0.0001.
19 Behandling med Enbrel resulterede i forbedret fysisk funktion i den dobbeltblinde undersøgelsesperiode, og denne bedring blev fastholdt i den forlængede undersøgelse på op til 2 år.
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.
Der er ikke tilstrækkeligt bevis for effekten af Enbrel hos patienter med ankyloserende spondylitis - lignende og artritis mutilans psoriasis artropatier på grund af det lille antal patienter, der er undersøgt.
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.
Der er ikke udført undersøgelser af patienter med psoriasis artrit, som blev behandlet med 50 mg en gang om ugen.
No study has been performed in patients with psoriatic arthritis using the 50mg once weekly dosing regimen.
Evidens for effekt af behandlingen med én ugentlig dosis hos denne patientgruppe er baseret på data fra undersøgelsen af patienter med ankyloserende spondylitis.
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.
Voksne patienter med ankyloserende spondylitis Effekten af Enbrel over for ankyloserende spondylitis blev bedømt i 3 randomiserede, dobbeltblinde undersøgelser, hvor indgivelse af 25 mg Enbrel to gange om ugen blev sammenlignet med placebo.
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.
Patientens almene bedømmelse, gennemsnit af VAS værdier for natlig rygsmerte og total rygsmerte, gennemsnit af 10 spørgsmål om Bath Ankylosing Spondylitis Functional Index (BASFI).
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).
Patienter med total spinal ankylose blev ikke inkluderet i undersøgelsen.
Patients with complete ankylosis of the spine were not included in the study.
Doser på 25 mg Enbrel (baseret på dosisundersøgelser hos patienter med reumatoid artrit) eller placebo blev indgivet subkutant to gange om ugen i 6 måneder hos 138 patienter.
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.
Det primære mål for effekt var en 20% forbedring i responskriterier i Assessment in Ankylosing Spondylitis (ASAS 20).
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.
RESPONS FRA PATIENTER MED ANKYLOSERENDE SPONDYLITIS I EN PLACEBO- KONTROLLERET UNDERSØGELSE Procent patienter
21 RESPONSES OF PATIENTS WITH ANKYLOSING SPONDYLITIS IN A PLACEBO-CONTROLLED TRIAL Percent of Patients
Ankyloserende spondylitis Respons ASAS 20
Ankylosing Spondylitis N Response ASAS 20
N = 139
= 139
2 uger 3 måneder 6 måneder ASAS 50
2 weeks 3 months 6 months ASAS 50
46a 60 a 58 a
46a 60a 58a
2 uger 3 måneder 6 måneder ASAS 70:
3 months 6 months
7 13 10
45a 42a
24 a 45 a 42 a
ASAS 70:
2 uger 3 måneder 6 måneder
2 weeks 3 months 6 months
12b 29 b 28 b
12b 29b 28b
A: p < 0. 001, Enbrel vs. placebo B: p=0. 002, Enbrel vs. placebo
Placebo b: p = 0.002, Enbrel vs. placebo
Hos patienter med ankyloserende spondylitis, som fik Enbrel, var den kliniske respons synlig på tidspunktet for første besøg (2 uger) og blev opretholdt gennem 6 måneders behandling.
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.
Responsen var den samme hos patienter med og uden samtidig behandling ved baseline.
Responses were similar in patients who were or were not receiving concomitant therapies at baseline.
Lignende resultater blev opnået i de 2 mindre undersøgelser af ankyloserende spondylitis.
Similar results were obtained in the 2 smaller ankylosing spondylitis trials.
20 I en fjerde undersøgelse blev sikkerhed og effekt af 50 mg Enbrel (to gange 25 mg subkutane injektioner) indgivet en gang om ugen versus 25 mg Enbrel indgivet to gange om ugen vurderet i en dobbelt- blind, placebo- kontrolleret undersøgelse med 356 patienter med aktiv ankyloserende spondylitis.
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.
Voksne patienter med plaque psoriasis Patienter, som Enbrel anbefales til er defineret i afsnit 4. 1.
Enbrel is recommended for use in patients as defined in section 4.1.
Patienter, som ” ikke responderer ” er defineret ved utilstrækkelig respons (PASI < 50 eller PGA mindre end god) eller forværring af sygdommen under behandling med mindst én af de tre systemiske behandlinger i tilstrækkelige doser og af tilstrækkelig varighed for at opnå respons.
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.
Effekten af Enbrel versus andre systemiske behandlinger til patienter med moderat til svær psorisis (responderende på andre systemiske behandlinger) er endnu ikke evalueret i direkte sammenlignende undersøgelser med Enbrel overfor andre systemiske behandlinger.
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.
Sikkerheden og effekten af Enbrel er i stedet for blevet evaluereti fire randomiserede, dobbeltblinde, placebo- kontrollerede undersøgelser.
Instead, the safety and efficacy of Enbrel were assessed in four randomised, double-blind, placebo-controlled studies.
Det primære slutmål for effekt var i alle fire studier antallet af patienter i hver gruppe, som opnåede PASI 75 (dvs mindst 75% forbedring i Psorisis Arealet og på Severity Index scoren i forhold til baseline) efter 12 ugers behandling.
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.
Patienterne var ≥ 18 år.
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.
Patienter i grupperne med aktiv behandling fortsatte til uge 24 på den dosis, de oprindeligt blev randomiseret til.
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.
Inklusionskriterierne var de samme som i studie 2.
Study 3 evaluated 583 patients and had the same inclusion criteria as study 2.
Patienterne i denne undersøgelse fik en dosis Enbrel på 25 mg eller 50 mg, eller placebo 2 gange om ugen i 12 uger, og derefter fik alle patienter i åbent studie 25 mg Enbrel to gange om ugen i yderligere 24 uger.
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.
I dette studie fik patienterne en dosis Enbrel på 50 mg eller placebo én gang om ugen i 12 uger, og derefter fik alle patienterne open- label Enbrel 50 mg én gang om ugen i yderligere 12 uger.
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.
I studie 1 var der efter 12 uger et signifikant større antal patienter med PASI 75 response i den Enbrel behandlede gruppe (30%) sammenlignet med den placebo behandlede gruppe (2%) (p < 0. 0001).
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).
Efter 24 uger havde 56% af patienterne i den Enbrel behandlede gruppe opnået PASI 75 sammenlignet med 5% i den placebo behandlede gruppe.
At 24 weeks, 56% of patients in the Enbrel-treated group had achieved the PASI 75 compared to 5% of placebo-treated patients.
RESPONS HOS PATIENTER MED PSORIASIS I STUDIE 2, 3 OG 4 ------------------------- Studie 2 ------------- ------------ Studie 3 --------- ------------ Studie 4 ---------
RESPONSES OF PATIENTS WITH PSORIASIS IN STUDIES 2, 3 AND 4 ------------------Study 2--------------- ---------------Study 3------------- ---------------Study 4-------------
--------
--
------- Enbrel ------------
--------Enbrel--------- --------Enbrel-------
------- Enbrel ----
-------Enbrel------
------- Enbrel ----
50 mg 25 mg 50 mg 50 mg
25 mg
BIW
50 mg 50 mg
BIW Placebo BIW BIW Placebo QW
50 mg
QW
Respons
n =
Placebo 25 mg 2 x uge 50 mg 2 x uge Placebo 2 x uge 2 x uge Placebo 1 x uge n = 166 n =162 n =162 n = 164 n = 164 n = 193 n = 196 n = 196 n = 46 n = 96
166 n = n = n = n = n = 193 n = 196 n = 196 n = 46
1 x uge n = 90
n = 90
(%)
Response (%)
uge 12 uge 12 uge 24a uge 12 uge 24a uge 12 uge 12 uge 12 uge 12 uge 12
wk
uge 24a
12 162 162 164 164 wk 12 wk wk wk wk 12 24a 12 24a
21 PASI 50
wk 12 wk 12 wk
58 *
wk 12
74 *
wk 24a
77
PASI 50 PASI 75 DSGA b, clear or almost
77 *
14 58* 70 74* 77 9 4 34* 44 49* 59 3
PASI 75
64* 77* 34* 49*
59
9 2
38 *
69* 38*
49 *
clear
55 4 39 * 57 *
5 34* 39 49* 55 4 39*
* p ≤ 0, 0001 sammenlignet med placebo a.
*p  0.0001 compared with placebo a.
Der blev ikke foretaget nogen statistisk sammenligning med placebo ved uge 24 i studie 2 og 4, fordi den oprindelige placebogruppe begyndte at få Enbrel 25 mg to gange om ugen eller 50 mg én gang om ugen fra uge 13 til uge 24. b.
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.
Hos patienter med plaque psoriasis, som blev behandlet med Enbrel, var der ved første besøg (2 uger) signifikant respons sammenlignet med placebo. Dette blev opretholdt gennem 24 ugers behandling.
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.
I studie 2 var der også en periode uden behandling, hvor patienter, som efter 24 uger havde opnået en forbedring på mindst 50% på PASI, fik stoppet behandlingen.
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.
Patienterne blev observeret uden behandling for at se forekomsten af rebound (PASI ≥ 150% i forhold til baseline) og se tiden tilrelapse (defineret som tab af mindst halvdelen af forbedringen opnået mellem baseline og uge 24).
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).
Der blev ikke observeret nogen rebound opblussen af sygdommen og ingen psoriasis- relaterede alvorlige bivirkninger.
No rebound flare of disease and no psoriasis-related serious adverse events were observed.
Der var tegn på at patienter, som initialt responderede på Enbrel behandlingen, havde gavn af en genoptagelse af Enbrel behandling.
There was some evidence to support a benefit of re-treatment with Enbrel in patients initially responding to treatment.
I studie 3 opretholdt hovedparten af de patienter (77%), som initialt blev randomiseret til 50 mg to gange om ugen og som fik nedsat deres Enbrel dosis til 25 mg to gange om ugen efter 12 uger, deres PASI 75 response til uge 36.
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.
For patienter som fik 25 mg to gange om ugen igennem hele studiet, fortsatte PASI 75 responsen med at forbedres mellem uge 12 og 36.
For patients who received 25 mg twice weekly throughout the study, the PASI 75 response continued to improve between weeks 12 and 36.
I studie 4 havde gruppen, som blev behandlet med Enbrel, en højere andel af patienter med PASI 75 i uge 12 (38%) sammenlignet med gruppen, som fik placebo (2%) (p < 0, 0001).
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).
For de patienter, som fik 50 mg én gang om ugen i hele undersøgelsen, fortsatte effekt- responsen med at forbedres, så 71% opnåede PASI 75 i uge 24.
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.
Pædiatriske patienter med plaque psoriasis Effekten af Enbrel blev vurderet i en randomiseret, dobbeltblind, placebo- kontrolleret undersøgelse med 211 pædiatriske patienter i alderen 4 til 17 år med moderat til svær plaque psoriasis (defineret ved en sPGA score ≥ 3, omfattende ≥ 10% af BSA og PASI ≥12).
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).
Patienterne fik 0, 8 mg/ kg Enbrel (op til 50 mg) eller placebo en gang om ugen i 12 uger.
Patients received Enbrel 0.8 mg/ kg (up to 50 mg) or placebo once weekly for 12 weeks.
Efter 12 uger havde flere patienter, der var randomiseret til Enbrel, positiv effekt- respons (f. eks.
At week 12, more patients randomised to Enbrel had positive efficacy responses (e. g.
Resultater for pædiatrisk plaque psoriasis efter 12 uger
Paediatric Plaque Psoriasis Outcomes at 12 Weeks Enbrel 0.8 mg/ kg Once
Enbrel
Weekly
0, 8 mg/ kg 1 gang om ugen (N = 106)
(N = 106)
PASI 75, n (%)
PASI 75, n (%) PASI 50, n (%)
60 (57%) a
60 (57%)a 79 (75%)a
12 (11%)
12 (11%) 24 (23%)
PASI 50, n (%)
sPGA “ clear” or “ minimal”, n (%)
79 (75%) a
56
24 (23%)
(53%)a
56 (53%) a
14 (13%)
Efter den 12 uger lange dobbeltblinde behandlingsperiode fik alle patienter 0, 8 mg/ kg Enbrel (op til 50 mg) en gang om ugen i yderligere 24 uger.
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.
Den observerede respons i den åbne undersøgelsesperiode var den samme som den, der blev observeret i den dobbeltblindede periode.
Responses observed during the open-label period were similar to those observed in the double-blind period.
I løbet af en randomiseret aftrapningsperiode fik signifikant flere patienter, som var gen- randomiseret til placebo, sygdomstilbagefald (tab af PASI 75 respons) sammenlignet med patienter, som var gen - randomiseret til Enbrel.
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.
Med fortsat behandling blev responsen fastholdt i op til 48 uger.
With continued therapy, responses were maintained up to 48 weeks.
Antistoffer mod Enbrel
24 Antibodies to Enbrel
Disse antistoffer har alle været ikke- neutraliserende og generelt forbigående.
These antibodies have all been non-neutralising and are generally transient.
6% af patienterne med reumatoid artrit, 7, 5% af patienterne med psoriasis artrit, 2% af patienterne med ankyloserende spondylitis, 7% af patienterne med psoriasis, 9, 7% af patienterne med pædiatrisk psoriasis og 3% af patienterne med juvenil, idiopatisk artrit.
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.
Andelen af patienter, som udvikler antistoffer mod etanercept i langtidsundersøgelser (af op til 3, 5 års varighed) stiger over tid som forventet.
The proportion of subjects who developed antibodies to etanercept in longer-term trials (of up to 3.5 years) increases over time, as expected.
Da antistofferne er forbigående af natur, var incidensen af antistofdannelse ved hvert bedømmelsespunkt typisk mindre end 7% af patienterne med reumatoid artrit og psoriasis.
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.
9%.
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%.
Etanercept serumværdier blev bestemt med en ELISA metode, som kan opdage ELISA- reaktive omdannelsesprodukter så vel som moderforbindelsen.
Etanercept serum values were determined by an ELISA method, which may detect ELISA-reactive degradation products as well as the parent compound.
48 timer efter en enkelt dosis.
Etanercept is slowly absorbed from the site of subcutaneous injection, reaching maximum concentration approximately 48 hours after a single dose.
Den absolutte biotilgængelighed er 76%.
The absolute bioavailability is 76%.
Med to ugentlige doser forventes det, at steady- state koncentrationerne er ca. to gange så høje som dem, der observeres efter enkelte doser.
With twice weekly doses, it is anticipated that steady-state concentrations are approximately twice as high as those observed after single doses.
Efter en enkelt subkutan dosis med 25 mg etanercept, var den gennemsnitlige maksimale serumkoncentration, som blev observeret hos sunde frivillige, 1, 65 ± 0, 66 µg/ ml, og området under kurven var 235 ± 96, 6 µg• t/ ml.
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.
Dosisproportionaliteten er ikke blevet evalueret formelt, men der er ingen klar mætning for clearance på tværs af dosisområdet.
Dose proportionality has not been formally evaluated, but there is no apparent saturation of clearance across the dosing range.
Den centrale distributionsvolumen for etanercept er 7, 6 l, mens distributionsvolumen ved steady- state er 10, 4 l.
The central volume of distribution of etanercept is 7.6 l, while the volume of distribution at steady-state is 10.4 l.
Clearance er ca.
The half-life is long, approximately 70 hours.
0, 066 l/ t hos patienter med reumatoid artrit, hvilket er noget lavere end værdien på 0, 11 l/ t, som blev observeret hos sunde frivillige.
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.
I en
Mean serum concentration profiles at steady state in treated RA patients were Cmax of 2.4 mg/ l vs 2.6 mg/ l, Cmin of 1.2 mg/ l vs 1.4 mg/ l, and partial AUC of 297 mgh/ l vs 316 mgh/ l for 50 mg Enbrel once weekly (n=21) vs 25 mg Enbrel twice weekly (n=16), respectively.
23 åben, enkeltdosis, dobbeltbehandling, cross- over undersøgelse med sunde frivillige, blev etanercept, når det blev indgivet som en enkelt 50 mg/ ml injektion, fundet at være bioekvivalent til to samtidige injektioner af 25 mg/ ml.
In an open-label, single-dose, two- treatment, crossover study in healthy volunteers, etanercept administered as a single 50 mg/ ml injection was found to be bioequivalent to two simultaneous injections of 25 mg/ ml.
I en farmakokinetisk analyse af patienter med ankyloserende spondylitis var etanercept steady- state AUC henholdsvis 466 µg* t/ ml og 474 µg* t/ ml for 50 mg Enbrel en gang om ugen (N = 154) og 25 mg to gange om ugen (N = 148).
In a population pharmacokinetics analysis in ankylosing spondylitis patients the etanercept steady state AUCs were 466  g hr/ ml and 474  g  hr/ ml for 50 mg Enbrel once weekly (N= 154) and 25 mg twice weekly (N = 148), respectively.
Selvom der er eliminering af radioaktivitet i urinen efter indgivelse af radioaktivt mærket etanercept til patienter og frivillige, blev der ikke observeret forøgede etanercept- koncentrationer hos patienter med akut nyre - eller leversvigt.
25 Although there is elimination of radioactivity in urine after administration of radiolabelled etanercept to patients and volunteers, increased etanercept concentrations were not observed in patients with acute renal or hepatic failure.
Tilstædeværelsen af nyre - og leversvækkelse bør ikke kræve en ændring i dosis.
The presence of renal and hepatic impairment should not require a change in dosage.
Methotrexat har ingen virkning på etanercepts farmakokinetik.
Methotrexate has no effect on the pharmacokinetics of etanercept.
Virkningen af Enbrel på methotrexats humane farmakokinetik er ikke undersøgt.
The effect of Enbrel on the human pharmacokinetics of methotrexate has not been investigated.
Ældre patienter Indvirkning af fremskreden alder blev undersøgt i den farmakokinetiske populationsanalyse af etanercept - serumkoncentrationer.
The impact of advanced age was studied in the population pharmacokinetic analysis of etanercept serum concentrations.
Clearance - og volumenvurderinger hos patienter mellem 65 og 87 år svarede til vurderinger hos patienter, som var under 65 år.
Clearance and volume estimates in patients aged 65 to 87 years were similar to estimates in patients less than 65 years of age.
Pædiatriske patienter med polyartikulær juvenil idiopatisk artrit I et forsøg med etanercept til patienter med polyartikulær juvenil idiopatisk artrit, fik 69 patienter (i alderen 7 til 17 år) 0, 4 mg/ kg to gange om ugen i tre måneder.
In a polyarticular juvenile idiopathic arthritis trial with Enbrel, 69 patients (aged 4 to 17 years) were administered 0.4 mg Enbrel/ kg twice weekly for three months.
Dosissimulering antyder, at mens ældre børn (10- 17 år gamle) vil have serumniveauer tæt på dem, der ses hos voksne, vil yngre børn have væsentligt lavere niveauer.
Simulation of dosing suggests that while older children (10-17 years of age) will have serum levels close to those seen in adults, younger children will have appreciably lower levels.
Pædiatriske patienter med plaque psoriasis Patienter med pædiatrisk plaque psoriasis (i alderen 4 til 17 år) fik indgivet 0, 8 mg/ kg (op til en maksimumdosis på 50 mg) etanercept en gang om ugen i op til 48 uger.
Patients with paediatric plaque psoriasis (aged 4 to 17 years) were administered 0.8 mg/ kg (up to a maximum dose of 50 mg per week) of etanercept once weekly for up to 48 weeks.
Middel serum steady- state - koncentrationer varierede fra 1, 6 til 2, 1 mcg/ ml ved uge 12, 24 og 48.
The mean serum steady state trough concentrations ranged from 1.6 to 2.1 mcg/ ml at weeks 12, 24, and 48.