natgillin/translations-raw huggingface dataset:
Patienter, som opnåede vedvarende remission i mindst 12 uger (N=305) (ASDAS &lt; 1,3 ved uge 16, 20, 24, og 28) i den åbne periode, blev herefter randomiseret til at modtage enten fortsat behandling med adalimumab 40 mg hver anden uge (N=152) eller placebo (N=153) i yderligere 40 uger i den dobbeltblindede, placebokontrollerede periode (total studie varighed 68 uger).
Patients who achieved sustained remission for at least 12 weeks (N=305) (ASDAS &lt; 1.3 at Weeks 16, 20, 24, and 28) during the open-label period were then randomized to receive either continued treatment with adalimumab 40 mg eow (N=152) or placebo (N=153) for an additional 40 weeks in a double-blind, placebo-controlled period (total study duration 68 weeks).
506 (62,2)b a Procentdel af patienterne, som opnåede PASI 75-respons beregnet med justering for center variation b p &lt; 0,001; Adalimumab versus placebo
506 (62.2)b a Percent of patients achieving PASI 75 response was calculated as centre-adjusted rate b p &lt; 0.001, adalimumab vs. placebo
SPARCC MRI rygsøjlend,j a Assessments of Spondyloarthritis International Society b Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d gennemsnitlig ændring fra baseline e N=91 placebo og N=87 adalimumab f høj følsomhed C-reaktivt protein (mg/l) g N=73 placebo og N=70 adalimumab h Spondyloarthritis Research Consortium of Canada i N=84 placebo og adalimumab j N=82 placebo og N=85 adalimumab ***, **, * Statistisk signifikant ved henholdvis p &lt; 0,001; &lt; 0,01 og &lt; 0,05 for alle sammenligninger mellem adalimumab og placebo.
SPARCC MRI Spined,j a Assessments in SpondyloArthritis International Society b Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d mean change from baseline e n=91 placebo and n=87 adalimumab f high sensitivity C-Reactive Protein (mg/L) g n=73 placebo and n=70 adalimumab h Spondyloarthritis Research Consortium of Canada i n=84 placebo and adalimumab j n=82 placebo and n=85 adalimumab
I Psoriasis-studie I oplevede 28 % af de patienter, som opnåede PASI 75-respons, og som blev genrandomiseret til placebo i uge 33, “tab af tilstrækkeligt respons” (PASI-score efter uge 33 og ved eller før uge 52, som resulterede i et &lt; PASI 50-respons i forhold til baseline med en stigning på minimum 6 point i PASI-score i forhold til uge 33), sammenlignet med 5 %, som fortsatte på adalimumab (p &lt; 0,001).
In Psoriasis study I, 28 % of patients who were PASI 75 responders and were re-randomised to placebo at week 33 compared to 5 % continuing on adalimumab, p &lt; 0.001, experienced “loss of adequate response” (PASI score after week 33 and on or before week 52 that resulted in a &lt; PASI 50 response relative to baseline with a minimum of a 6-point increase in PASI score relative to week 33).
Efter henholdsvis 52 ugers og 104 ugers behandling, var procentdelen af patienter uden progression (ændring fra baseline i modificeret Total Sharp Score ≤ 0,5) signifikant højere med adalimumab/methotrexat-kombinationsterapi (henholdsvis 63,8 % og 61,2 %) sammenlignet med methotrexat-monoterapi (henholdsvis 37,4 % og 33,5 %, p &lt; 0,001) og adalimumab-monoterapi (henholdsvis 50,7 %, p &lt; 0,002 og 44,5 %, p &lt; 0,001).
Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified Total Sharp Score ≤0.5) was significantly higher with adalimumab/methotrexate combination therapy (63.8 % and 61.2 % respectively) compared to methotrexate monotherapy (37.4 % and 33.5 % respectively, p &lt; 0.001) and adalimumab monotherapy (50.7 %, p &lt; 0.002 and 44.5 %, p &lt; 0.001 respectively).
-56,2a a p &lt; 0,001; adalimumab versus placebo
-56.2a a p &lt; 0.001, adalimumab vs. placebo
Adalimumabs sikkerhed og virkning blev undersøgt i et randomiseret, dobbeltblindet, kontrolleret studie hos 90 pædiatriske patienter fra 2 til &lt; 18 år med aktiv JIA-associeret non-infektiøs anterior uveitis, som var refraktære overfor mindst 12 ugers behandling med methotrexat.
The safety and efficacy of adalimumab was assessed in a randomized, double-masked, controlled study of 90 paediatric patients from 2 to &lt; 18 years of age with active JIA-associated noninfectious anterior uveitis who were refractory to at least 12 weeks of methotrexate treatment.
Kriterier for opblussen af sygdommen var defineret som en forværring på ≥ 30 % i forhold til baseline af ≥ 3 ud af 6 pædiatrisk ACR-hovedkriterier, ≥ 2 aktive led og en forbedring på &gt; 30 % i ikke mere end 1 af de 6 kriterier.
Disease flare criteria were defined as a worsening of ≥30% from baseline in ≥3 of 6 Paediatric ACR core criteria, ≥2 active joints,
Sammenlignet med placebo reducerede adalimumab progressionshastigheden, hvormed de perifere led destrueres, målt ved ændring i mTSS fra baseline (gennemsnit + SD) 0,8 ± 2,5 i placebogruppen (ved uge 24) sammenlignet med 0,0 ± 1,9 i adalimumab-gruppen (ved uge 48) (p &lt; 0,001).
Adalimumab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS (mean ± SD) 0.8 ± 2.5 in the placebo group (at week 24) compared with 0.0 ± 1.9; (p &lt; 0.001) in the adalimumab group (at week 48).
• ≥ 40 kg: 40 mg hver uge eller 80 mg hver anden uge Fortsat behandling skal overvejes nøje hos patienter, som ikke responderer inden for 12 uger.
 &lt; 40 kg: 20 mg every week  ≥ 40 kg: 40 mg every week or 80 mg every other week Continued therapy should be carefully considered in a subject not responding by week 12.
Klinisk remission Klinisk respons (CR-100) Patienter i steroid-fri remission i ≥ 90 dagea
Clinical remission Clinical response (CR-100) Patients in steroid-free remission for &gt; =90 daysa
De gennemsnitlige dal-serumkoncentrationer (±SD) af adalimumab, som blev opnået ved uge 4, var 15,7 ± 6,6 µg/ml for patienter ≥ 40 kg (160/80 mg) og 10,6 ± 6,1 µg/ml for patienter &lt; 40 kg (80/40 mg).
The mean (±SD) serum adalimumab trough concentrations achieved at week 4 were 15.7±6.6 µg/ml for patients ≥40 kg (160/80 mg) and 10.6±6.1 µg/ml for patients &lt; 40 kg (80/40 mg).
**p &lt; 0,01, adalimumab over for placebo - Ikke relevant
**p &lt; 0.01, adalimumab versus placebo - Not applicable
Adalimumab forsinkede tiden til behandlingssvigt signifikant sammenlignet med placebo (se figur 3, P &lt; 0,0001 fra log rank test).
Adalimumab significantly delayed the time to treatment failure, as compared to placebo (See Figure 3, P &lt; 0.0001 from log rank test).
Adalimumab forsinkede tiden til behandlingssvigt signifikant sammenlignet med placebo (se figur 1, P &lt; 0,0001 fra log rank test).
Adalimumab significantly delayed the time to treatment failure, as compared to placebo (See Figure 1, P &lt; 0.0001 from log rank test).
På tværs af alle behandlingsgrupper var den gennemsnitlige baseline-PASI-score 19,7, og baseline-PGA-score varierede sig fra “let” ( &lt; 1 %) til “moderat” (48 %), “alvorlig” (46 %) og “meget alvorlig” (6 %).
Across all treatment groups, the mean baseline PASI score was 19.7 and the baseline PGA score ranged from “mild” ( &lt; 1%) to “moderate” (48%) to “severe” (46%) to “very severe” (6%).
79 (73,1) a, b a p &lt; 0,001; adalimumab versus placebo b p &lt; 0,001; adalimumab versus methotrexat c p &lt; 0,01; adalimumab versus placebo d p &lt; 0,05; adalimumab versus methotrexat
79 (73.1)a, b a p &lt; 0.001 adalimumab vs. placebo b p &lt; 0.001 adalimumab vs. methotrexate c p &lt; 0.01 adalimumab vs. placebo d p &lt; 0.05 adalimumab vs. methotrexate
Uge 24 *** p &lt; 0,001 for alle sammenligninger mellem adalimumab og placebo * p &lt; 0,05 for alle sammenligninger mellem adalimumab og placebo - Ikke relevant
Week 12 Week 24 *** p &lt; 0.001 for all comparisons between adalimumab and placebo * p &lt; 0.05 for all comparisons between adalimumab and placebo
***,** Statistisk signifikant ved p &lt; 0,001, &lt; 0,01 for alle sammenligninger mellem adalimumab og placebo ved uge 2, 12 og 24 a Assessment in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
Week 2 Week 12 Week 24 ***,** Statistically significant at p &lt; 0.001, &lt; 0.01 for all comparisons between adalimumab and placebo at weeks 2, 12 and 24 a Assessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
Klinisk respons er fald fra baseline i Mayo score på &gt; 3 point og &gt; 30 % samt et fald i rektal blødning-subscore [RBS] på &gt; 1 eller en absolut RBS på 0 eller 1; * p &lt; 0,05 for adalimumab versus placebo ved parvis sammeligning af andelene ** p &lt; 0,001 for adalimumab versus placebo ved parvis sammeligning af andelene a
Sustained Response Sustained Remission Sustained Mucosal Healing Clinical remission is Mayo score ≤2 with no subscore &gt; 1; Clinical response is decrease from baseline in Mayo score ≥3 points and ≥30% plus a decrease in the rectal bleeding subscore [RBS] ≥1 or an absolute RBS of 0 or 1; * p &lt; 0.05 for adalimumab vs. placebo pairwise comparison of proportions
* p &lt; 0,05, ***p &lt; 0,001; adalimumab versus placebo a Blandt alle randomiserede patienter b Blandt patienter med HS-relateret evaluering af hudsmerte ≥ 3 ved baseline, baseret på en numerisk vurderingsskala 0-10; 0 = ingen hudsmerte, 10 = hudsmerte så slem, som du kan forestille dig
* p &lt; 0.05, ***p &lt; 0.001, adalimumab versus placebo a Among all randomised patients b Among patients with baseline HS-related skin pain assessment ≥ 3, based on Numeric Rating Scale 0
Adalimumabs sikkerhed og virkning blev vurderet i et åben-label, multicenter studie med 32 børn (2 &lt; 4 år gamle eller 4 år og derover med en vægt &lt; 15 kg) med moderat til alvorlig aktiv polyartikulær JIA.
The safety and efficacy of adalimumab was assessed in an open-label, multicentre study in 32 children (2 &lt; 4 years old or aged 4 and above weighing &lt; 15 kg) with moderately to severely active polyarticular JIA.
Der forekom ingen ALAT-stigninger ≥ 3 × ULN i fase 3-studiet med adalimumab hos patienter med polyartikulær juvenil idiopatisk artrit, som var fra 2 til &lt; 4 år.
No ALT elevations ≥3 × ULN occurred in the Phase 3 trial of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 2 to &lt; 4 years.
Adalimumabs sikkerhed og virkning ved induktions- og vedligeholdelsesbehandling med doser afhængige af legemsvægt ( &lt; 40 kg eller ≥ 40 kg) er undersøgt i et multicenter, randomiseret, dobbeltblindet klinisk studie med 192 pædiatriske patienter i alderen 6 til 17 (inklusive) år med moderat til svær Crohns sygdom (CD), defineret som Paediatric Crohn's Disease Activity Index (PCDAI) score &gt; 30.
Adalimumab was assessed in a multicentre, randomised, double-blind clinical trial designed to evaluate the efficacy and safety of induction and maintenance treatment with doses dependent on body weight ( &lt; 40 kg or ≥40 kg) in 192 paediatric subjects between the ages of 6 and 17 (inclusive) years, with moderate to severe Crohn´s disease (CD) defined as Paediatric Crohn's Disease Activity Index (PCDAI) score &gt; 30.
Steroid-fri remission i &gt; 90 dagea
Patients in steroid-free remission for &gt; =90 daysa
6 pædiatriske ACR-hovedkriterier, ≥ 2 aktive led og en forbedring på &gt; 30 % i ikke mere end 1 af de 6 kriterier.
and improvement of &gt; 30% in no more than 1 of the 6 criteria.
36,8 % (14/38) 64,9 % (24/37)b
36.8 % (14/38) 64.9 % (24/37)b 43.3 % (13/30) 71.4 % (20/28)c Median time to disease flare &gt; 32 weeks
Uge 52 27,2 % 25,9 % Uge 104 28,4 % 28,1 % ap-værdi for den parvise sammenligning af methotrexat-monoterapi og adalimumab/methotrexatkombinationeterapi ved anvendelse af Mann-Whitney U test. bp-værdi for den parvise sammenligning af adalimumab-monoterapi og adalimumab/methotrexatkombinationsterapi ved anvendelse af Mann-Whitney U test cp-værdi for den parvise sammenligning af adalimumab-monoterapi og methotrexat-monoterapi ved anvendelse af Mann-Whitney U test
104 Week 28.4% 28.1% 46.6% &lt; 0.001 &lt; 0.001 0.864 a p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test. b p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test c p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Adalimumabs virkning er undersøgt i et randomiseret, dobbelt-blindet kontrolleret studie med 114 pædiatriske patienter fra 4 år med svær kronisk plaque-psoriasis (defineret ved PGA (physician global assessment) ≥ 4 eller &gt; 20 % BSA (body surface area)-involvering eller &gt; 10 % BSAinvolvering med meget tykke læsioner eller PASI (psoriasis area and severity index) ≥ 20 eller ≥ 10 med klinisk relevante manifestioner i ansigt, på kønsorganer eller hånd/fod), som ikke havde opnået tilstrækkelig kontrol med topikal behandling og helioterapi eller lysbehandling.
The efficacy of adalimumab was assessed in a randomised, double-blind, controlled study of 114 paediatric patients from 4 years of age with severe chronic plaque psoriasis (as defined by a Physician's Global Assessment (PGA) ≥4 or &gt; 20% BSA involvement or &gt; 10 % BSA involvement with very thick lesions or Psoriasis Area and Severity Index (PASI) ≥20 or ≥10 with clinically relevant facial, genital, or hand/ foot involvement) who were inadequately controlled with topical therapy and heliotherapy or phototherapy.
Alle patienter fik åben induktionsbehandling med doser baseret på deres baseline-legemsvægt: henholdsvis 160 mg i uge 0 og 80 mg i uge 2 til patienter ≥ 40 kg og 80 mg henholdsvis 40 mg til patienter &lt; 40 kg.
All subjects received open-label induction therapy at a dose based on their Baseline body weight: 160 mg at week 0 and 80 mg at week 2 for subjects ≥40 kg, and 80 mg and 40 mg, respectively, for subjects &lt; 40 kg.
Hos patienter med polyartikulær JIA, som var 2til &lt; 4 år eller 4 år og derover med en vægt &lt; 15 kg, som blev doseret med adalimumab 24 mg/m2, var den gennemsnitlige dal-serumkoncentration af adalimumab ved steady state 6,0 ± 6,1 µg/ml (101 % CV) for adalimumab uden samtidig methotrexat og 7,9 ± 5,6 µg/ml (71,2 % CV) med samtidig methotrexat.
In patients with polyarticular JIA who were 2 to &lt; 4 years old or aged 4 and above weighing &lt; 15 kg dosed with adalimumab 24 mg/m2 , the mean trough steady-state serum adalimumab concentrations was 6.0 ± 6.1 µg/ml (101% CV) for adalimumab without concomitant methotrexate and 7.9 ± 5.6 µg/ml (71.2% CV) with concomitant methotrexate.
Uge 52 62,6 % 54,4 % Uge 104 56,0 % 49,3 %
104 Week 56.0% 49.3% 69.4% 0.002 &lt; 0.001 0.140
Uge 52 45,9 % 41,2 % Uge 104 42,8 % 36,9 %
104 Week 42.8% 36.9% 59.0% &lt; 0.001 &lt; 0.001 0.162
Patienter i steroid-fri remission i ≥ 90 dagea * p &lt; 0,001 for adalimumab vs. placebo parvise sammenligninger af andelene ** p &lt; 0,02 for adalimumab vs. placebo parvise sammenligninger af andelene a
* p &lt; 0.001 for adalimumab versus placebo pairwise comparisons of proportions ** p &lt; 0.02 for adalimumab versus placebo pairwise comparisons of proportions a Of those receiving corticosteroids at baseline
a a a p &lt; 0,001; adalimumab versus placebo
* p &lt; 0.05, ***p &lt; 0.001, adalimumab versus placebo a
Fjern sprøjten &amp; bortskaf den
Remove syringe &amp; dispose
Grækenland Viofar EPE Ethnikis Antistaseos &amp; Trifyllias,
Ethnikis Antistaseos &amp; Trifyllias,
InfusionslÃ¶sung
Solution for infusion
Meget sjælden( &lt; 1/10.000)
Very rare ( &lt; 1/10,000)
Almindelig (≥1/100 til &lt; 1/10)
Common (≥1/100 to, &lt; 1/10)
Waarderweg 39, 2031 BN Haarlem Holland
Merck Sharp &amp; Dohme B.V. Waaderweg 39, 2031 BN Haarlem The Netherlands
BCVA blev enten forbedret eller vedligeholdt ( &lt; 5 forringelse i forhold til bogstaver) i 88,6% af øjnene i uge 78.
BCVA was either improved or maintained ( &lt; 5 letters deterioration) in 88.6% of the eyes at week 78.
Klinisk remission er Mayo-score &lt; 2 uden subscore &gt; 1;
Clinical remission is Mayo score ≤ 2 with no subscore &gt; 1;
Klinisk remission (defineret som Mayo-score &lt; 2 med ingen subscore &gt; 1) blev vurderet i uge 8.
Clinical remission (defined as Mayo score ≤ 2 with no subscore &gt; 1) was assessed at Week 8.
Humira viste en behandlingsfordel hos patienter med neglepsoriasis med forskellig omfang af hudinvolvering (BSA≥10% (60 % af patienterne) og BSA &lt; 10% og ≥5% (40 % af patienterne)).
Humira demonstrated a treatment benefit in nail psoriasis patients with different extents of skin involvement (BSA≥10% (60% of patients) and BSA &lt; 10% and ≥5% (40% of patients)).
Blandt de 68 patienter, som havde opblussen af sygdom i gruppen, som var allokeret til seponering af behandling, fuldførte 65 patienter 12 ugers rescue-behandling med Humira, ud af hvilke 37 (56,9%) genvandt remission (ASDAS &lt; 1,3) 12 uger efter genstart af behandling i den åbne periode.
Among the 68 patients who flared in the group allocated to treatment withdrawal, 65 completed 12 weeks of rescue therapy with Humira, out of which 37 (56.9%) had regained remission (ASDAS &lt; 1.3) after 12 weeks of restarting the open-label treatment.
En større del af patienterne på Humira havde ingen opblussen af sygdommen i den dobbeltblinde periode ved sammenligning med dem på placebo (70,4% versus 47,1%, p &lt; 0,001) (Figur
A greater proportion of patients on Humira had no disease flare during the double-blind period, when compared with those on placebo (70.4% vs. 47.1%, p &lt; 0.001) (Figure 1).
Blandt de patienter, som havde et respons ved uge 8, var 47 % i respons, 29 % var i remission, 41 % havde slimhindeheling, og 20 % var i steroid-fri remission i &gt; 90 dage ved uge 52.
Of those patients who had a response at Week 8, 47% were in response, 29% were in remission, 41% had mucosal healing, and 20% were in steroid-free remission for ≥ 90 days at Week 52.
c Ankylosing Spondylitis Disease Activity Score d Delvis opblussen af sygdom er defineret som ASDAS ≥ 1,3 men &lt; 2,1 ved 2 på hinanden følgende besøg.
Ankylosing Spondylitis Disease Activity Score Partial flare is defined as ASDAS ≥ 1.3 but &lt; 2.1 at 2 consecutive visits.
I RA-studie IV var ACR 20-respons for patienter behandlet med Humira plus standardpleje statistisk signifikant bedre end for patienter behandlet med placebo plus standardpleje (p &lt; 0,001).
In RA study IV, the ACR 20 response of patients treated with Humira plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p &lt; 0.001).
N/A N/A *** p &lt; 0,001 for alle sammenligninger mellem Humira og placebo * p &lt; 0,05 for alle sammenligninger mellem Humira og placebo N/A ikke relevant
N/A N/A *** p &lt; 0.001 for all comparisons between Humira and placebo * p &lt; 0.05 for all comparisons between Humira and placebo N/A not applicable
I uge 52 opnåede 42,9% af patienterne, som fik Humira/methotrexat-kombinationsterapi, klinisk remission (DAS28 &lt; 2,6) sammenlignet med 20,6 % af patienterne, som fik methotrexat-monoterapi og 23,4% af patienterne, som fik Humira-monoterapi.
At Week 52, 42.9% of patients who received Humira/methotrexate combination therapy achieved clinical remission (DAS28 (CRP) &lt; 2.6) compared to 20.6% of patients receiving methotrexate monotherapy and 23.4% of patients receiving Humira monotherapy.
Humira/methotrexat-kombinationsterapi var klinisk og statistisk bedre end methotrexat-monoterapi (p &lt; 0,001) og Humira-monoterapi (p &lt; 0,001) i opnåelsen af lav sygdomstilstand hos patienter med nylig diagnosticeret moderat til alvorlig reumatoid artrit.
Humira/methotrexate combination therapy was clinically and statistically superior to methotrexate (p &lt; 0.001) and Humira monotherapy (p &lt; 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe rheumatoid arthritis.
NA NA 4,5% 23,2% a RA-studie I efter 24 uger, RA-studie II efter 26 uger og RA-studie III efter 24 og 52 uger b 40 mg Humira givet hver anden uge c MTX = methotrexat **p &lt; 0,01, Humira over for placebo
NA NA 4.5% 23.2% RA study I at 24 weeks, RA study II at 26 weeks , and RA study III at 24 and 52 weeks 40 mg Humira administered every other week MTX = methotrexate **p &lt; 0.01, Humira versus placebo
Patienter, som opnåede vedvarende remission i mindst 12 uger (N=305) (ASDAS &lt; 1,3 ved uge 16, 20, 24, og 28) i den åbne periode, blev herefter randomiseret til at modtage enten fortsat behandling med Humira 40 mg hver anden uge (N=152) eller placebo (N=153) i yderligere 40 uger i den dobbeltblindede, placebokontrollerede periode (total studie varighed 68 uger).
Patients who achieved sustained remission for at least 12 weeks (N=305) (ASDAS &lt; 1.3 at Weeks 16, 20, 24, and 28) during the open-label period were then randomized to receive either continued treatment with Humira 40 mg eow (N=152) or placebo (N=153) for an additional 40 weeks in a double-blind, placebo-controlled period (total study duration 68 weeks).
***, ** Statistisk signifikant ved p &lt; 0,001 og &lt; 0,01, henholdvis, ved alle sammenligninger af Humira og placebo.
***, ** Statistically significant at p &lt; 0.001 and &lt; 0.01, respectively, for all comparisons between Humira and placebo.
SPARCC MRI rygsøjlend,j a Assessments of SpondyloArthritis international Society b Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d gennemsnitlig ændring fra baseline e n=91 placebo og n=87 Humira f høj følsomhed C-reaktivt protein (mg/l) g n=73 placebo and n=70 Humira h Spondyloarthritis Research Consortium of Canada i n=84 placebo og Humira j n=82 placebo og n=85 Humira ***, **, * Statistisk signifikant ved henholdvis p &lt; 0,001, &lt; 0,01 og &lt; 0,05 for alle sammenligninger mellem Humira og placebo.
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 &lt; 0.001, &lt; 0.01, and &lt; 0.05, respectively, for all comparisons between Humira and placebo.
Kriterier for opblussen af sygdommen var defineret som en forværring på ≥ 30 % i forhold til baseline af ≥ 3 ud af 6 pædiatrisk ACRhovedkriterier, ≥ 2 aktive led og en forbedring på &gt; 30 % i ikke mere end 1 af de 6 kriterier.
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.
* p &lt; 0,05, ***p &lt; 0,001, Humira versus placebo c Blandt alle randomiserede patienter.
* P &lt; 0.05, ***P &lt; 0.001, Humira versus placebo Among all randomised patients.
Inflammationen kan fÃ¸re til nedsat syn og/eller fluer i Ã¸jet (svÃ¦rm af uklarheder i Ã¸jet, som bevÃ¦ger sig i synsfeltet).
This inflammation may lead to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision).
I de puljede data fra RA-overkrydsnings-studier VI og VII sås umiddelbart efter dosering en statistisk signifikant forskel i smerter ved injektionsstedet mellem Humira 40 mg/0,8 ml og Humira 40 mg/0,4 ml (gennemsnitlig 3,7 cm versus 1,2 cm på en visuel analog skala (VAS) fra 0 til10 cm, p &lt; 0,001).
For the pooled crossover RA studies VI and VII, a statistically significant difference for injection site pain immediately after dosing was observed between Humira 40 mg/0.8 ml and Humira 40 mg/0.4 ml (mean VAS of 3.7 cm versus 1.2 cm, scale of 0-10 cm, P &lt; 0.001).