natgillin/translations-raw huggingface dataset:
Hyppighederne defineres som: meget almindelige (≥1/10), almindelige (≥1/100 til &lt; 1/10), ikke almindelig (≥1/1.000 til &lt; 1/100), sjælden (≥1/10.000 til &lt; 1/1.000), meget sjælden ( &lt; 1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to &lt; 1/10), uncommon (≥ 1/1,000 to &lt; 1/100), rare (≥ 1/10,000 to &lt; 1/1,000), very rare ( &lt; 1/10,000), not known (cannot be estimated from the available data).
Formålet med denne behandling er at opnå plasma frit kobber (også kendt som non-ceruloplasmin plasma kobber) mindre end 250 mikrogram/l (normalt 100-150 mikrogram/l) og urin kobber ekskreationen under 125 mikrogram/24 timer (normalt: &lt; 50 mikrogram/24 timer).
The aim of the treatment is to maintain the plasma free copper (also known as non-ceruloplasmin plasma copper) below 250 microgram/l (normal: 100-150 microgram/l) and the urinary copper excretion below 125 microgram/24 h (normal: &lt; 50 microgram/24 h).
Hvis plasma zink niveauerne er markant forhøjede ( &gt; 10 mg/l), så bør en tungmetal chelatbehandling overvejes.
Heavy metal chelation therapy should be considered if plasma zinc levels are markedly elevated ( &gt; 10 mg/l).
Infektioner og parasitÃ¦re sygdomme
Infections and infestations
Bivirkningernes hyppighed er defineret efter følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til &lt; 1/10), ikke almindelig (≥ 1/1.000 til &lt; 1/100), sjælden (≥ 1/10.000 til &lt; 1/1.000), meget sjælden ( &lt; 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
common (≥1/100 to &lt; 1/10); uncommon (≥1/1,000 to &lt; 1/100); rare (≥1/10,000 to &lt; 1/1,000); very rare
Den gennemsnitlige årlige hyppighed af eksacerbationer var 0,91 og 1,07 for henholdsvis FF/UMEC/VI og FF/VI (rate ratio: 0,85; 95 % CI: 0,80, 0,90; p &lt; 0,001).
The mean annual rate of exacerbations was 0.91 and 1.07 for FF/UMEC/VI and FF/VI respectively (Rate Ratio: 0.85; 95% CI: 0.80, 0.90; p &lt; 0.001).
I et fase III-studie af 6 måneders varighed (DB2113373) viste Rolufta Ellipta klinisk relevant forbedring af lungefunktionen i forhold til placebo (målt ved forceret eksspiratorisk volumen i første sekund [FEV1]) over 24 timer efter administration én gang daglig, som var tydelig 30 minutter efter administration af den første dosis, med en forbedring på 102 ml (p &lt; 0,001∗) sammenlignet med placebo.
In a Phase III, 6-month study (DB2113373) Rolufta Ellipta provided a clinically meaningful improvement over placebo in lung function (as measured by forced expiratory volume in 1 second [FEV1]) over 24 hours following once daily administration, which was evident at 30 minutes following administration of the first dose (improvement over placebo by 102 mL, p &lt; 0.001*).
De gennemsnitlige forbedringer i FEV1 inden for de første 6 timer efter dosering, i forhold til placebo, var 130 ml (p &lt; 0,001∗) ved uge 24.
The mean peak improvements in FEV1 within the first 6 hours following dosing relative to placebo were 130 ml (p &lt; 0.001*) at Week 24.
I to 12-ugers placebokontrollerede studier (200109 og 200110) viste tillæg af Rolufta Ellipta til fluticasonfuroat/vilanterol (FF/VI) (92/22 mikrogram) én gang daglig til voksne patienter med en klinisk diagnose af KOL en statistisk signifikant og klinisk relevant forbedring af det primære endepunkt troughFEV1 ved dag 85, sammenlignet med placebo plus FF/VI (124 ml 95 % CI: 93, 154; p &lt; 0,001 og 122 ml 95 % CI: 91, 152; p &lt; 0,001).
In two 12-week, placebo controlled studies (200109 and 200110), the addition of Rolufta Ellipta to fluticasone furoate/vilanterol (FF/VI) (92/22 micrograms) once daily in adult patients with a clinical diagnosis of COPD, resulted in statistically significant and clinically meaningful improvements in the primary endpoint of trough FEV1 at Day 85 compared to placebo plus FF/VI (124 mL 95% CI: 93, 154; p &lt; 0.001 and 122 mL 95% CI: 91, 152; p &lt; 0.001).
Rolufta Ellipta viste desuden en forbedring af den helbredsrelaterede livskvalitet målt ved St. George's Respiratory Questionnaire (SGRQ), indikeret ved en reduktion i den samlede SGRQ-score ved uge 12 sammenlignet med placebo (-7,90 enheder, p &lt; 0,001) i studiet af 12 ugers varighed.
Rolufta Ellipta also demonstrated a statistically significant improvement in health-related quality of life measured using the St. George's Respiratory Questionnaire (SGRQ) as indicated by a reduction in SGRQ total score at Week 12 compared with placebo (-7.90 units, p &lt; 0.001) in the 12-week study.
Rolufta Ellipta viste en statistisk signifikant større forbedring i forhold til baseline i vægtet middelværdi for FEV1 over 0-6 timer efter dosering ved uge 12 sammenlignet med placebo (166 ml, p &lt; 0,001) i det pivotale studie af 12 ugers varighed.
Rolufta Ellipta demonstrated a statistically significant greater improvement from baseline in weighted mean FEV1 over 0-6 hours post-dose at Week 12 compared with placebo (166 ml, p &lt; 0.001) in the 12-week pivotal study.
Der blev påvist en statistisk signifikant forbedring sammenlignet med placebo i TDI fokal score ved uge 24 for Rolufta Ellipta (1,0 enheder, p &lt; 0,001) i studiet af 24 ugers varighed.
A statistically significant improvement compared with placebo in the TDI focal score at Week 24 was demonstrated for Rolufta Ellipta (1.0 units, p &lt; 0.001) in the 24-week study.
Forbedring af lungefunktionen blev understøttet af et reduceret forbrug af salbutamol i ugerne 1-12 (-0,4 pust pr. dag (95 % CI: -0,7, -0,2; p &lt; 0,001) og -0,3 pust pr. dag (95 % CI: -0,5, -0,1; p = 0,003)), sammenlignet med placebo plus FF/VI.
Improvements in lung function were supported with reductions in use of salbutamol over Weeks 1-12 (-0.4 puffs per day (95% CI: -0.7, -0.2; p &lt; 0.001) and -0.3 puffs per day (95% CI: -0.5, -0.1; p=0.003)) compared to placebo plus FF/VI but improvements in SGRQ at week 12 were not statistically significant (200109) or clinically relevant (200109 and 200110).
Rolufta Ellipta viste en større forbedring i forhold til baseline i vægtet middelværdi for FEV1 over 0-6 timer efter dosering ved uge 24 sammenlignet med placebo (150 ml, p &lt; 0,001∗) i det pivotale studie af 24 ugers varighed.
Rolufta Ellipta demonstrated a greater improvement from baseline in weighted mean FEV1 over 0-6 hours post-dose at Week 24 compared with placebo (150 ml, p &lt; 0.001*) in the 24-week pivotal study.
viste ingen tegn på øget systemisk eksponering over for umeclidiniumbromid (Cmax og AUC), og der var ingen tegn på ændret proteinbinding mellem patienter med svært nedsat nyrefunktion og raske personer.
Subjects with severe renal impairment (creatinine clearance &lt; 30mL/min) showed no evidence of an increase in systemic exposure to umeclidinium bromide (Cmax and AUC), and no evidence of altered protein binding between subjects with severe renal impairment and healthy volunteers.
for FF/UMEC/VI sammenlignet med FF/VI (gennemsnitlig forskel: +94 ml vs. -3 ml; behandlingsforske: 97 ml; 95 % CI: 85, 109; p &lt; 0,001).
At Week 52, a statistically significant improvement in the least-squares (LS) mean change from baseline in trough FEV1 was observed for FF/UMEC/VI compared with FF/VI (mean change: +94 mL vs. -3 mL; treatment difference: 97 mL; 95% CI: 85, 109; p &lt; 0.001).
I studiet af 24 ugers varighed viste Rolufta Ellipta en større forbedring sammenlignet med placebo i ændring i forhold til baseline af den samlede SRGQ-score ved uge 24 (-4,69 enheder, p &lt; 0,001∗).
A greater improvement compared with placebo in the change from baseline in SGRQ total score at Week 24 was demonstrated for Rolufta Ellipta (-4.69 units, p &lt; 0.001∗) in the 24-week study.
Infusionen indgives over 90 minutter dag 1, 3 og 5 i en fÃ¸rste behandlingsserie.
The dose is calculated based on the patient's height and weight; the infusion is given over 90 minutes on days 1, 3 and 5 of an initial treatment course; if the disease responds and the doctor considers further courses would be of benefit, Vyxeos is given on days 1 and 3 of each further course.
De Tchaves &amp; Cie E.E
Chemipharm S.G. De Tchaves &amp; Cie E.E
Epidural anvendelse _ Intrabursal anvendelse _ Intrakoronar anvendelse _ Intradiskal anvendelse _ Intramuskulær anvendelse _ Intravenøs anvendelse _ Perineural anvendelse _ Retrobulbær anvendelse
Epidural Use _ Intrabursal Use _ Intracoronary Use _ Intradiscal Use _ Intramuscular Use _ Intravenous Use _ Perineural Use_ Retrobulbar Use
Intravenøs brug _ Subkutan brug
Intravenous Use _ Subcutaneous Use
Intramuskulær anvendelse _ Intratekal anvendelse _ Intravenøs injektion
Solution For Injection Intramuscular Use _ Intrathecal Use _ Intravenous Injection
Metotrexato Pfizer Methotrexat 1g flaske Injektionsvæske, opløsning
Metotrexato Pfizer Methotrexate 1g Bottle Solution For Injection Intraarterial Use _ Intramuscular Use _ Intrathecal Use _
Intramuskulær anvendelse _ Intravenøs anvendelse
Solution For Injection Intravenous Use
Intraarteriel brug _ Intramuskulær brug _ Intratekal brug _ Intravenøs brug _ Intraventikulær brug
Intraarterial Use _ Intramuscular Use _ Intrathecal Use _ Intravenous Use _ Intraventricular Use
Intramuskulær anvendelse _ Subkutan anvendelse
Solution For Injection Subcutaneous Use
Intramuskulær anvendelse _ Intravenøs injektion_ Subkutan anvendelse
Solution For Injection Intramuscular Use _ Intravenous Injection _ Subcutaneous Use
Intraarterial anvendelse _ Intramuskulær anvendelse _ Intratekal anvendelse _ Intratumoral anvendelse _ Intravenøs anvendelse
Intraarterial Use _ Intramuscular Use _ Intrathecal Use _ Intratumoral Use _ Intravenous Use
Intraarterial anvendelse _ Intramuskulær anvendelse _ Intravenøs anvendelse
Solution For Injection Intraarterial Use _ Intramuscular Use _ Intravenous Use
Intramuskulær anvendelse _ Intratekal anvendelse _ Intravenøs anvendelse _ Subkutan anvendelse
Solution For Injection Intramuscular Use _ Intravenous Use _ Oral Use _ Subcutaneous Use
Intramuskulær anvendelse _ Intratekal anvendelse _ Intravenøs anvendelse
Solution For Injection Intramuscular Use _ Intravenous Use
Intraartikulær anvendelse _ Intramuskulær anvendelse _ Intratekal anvendelse _ Intravenøs anvendelse
Solution For Injection Intraarticular Use _ Intramuscular Use _ Intrathecal Use _ Intravenous Use
Hyppighedskategorierne defineres som følger: meget almindelig (≥1/10), almindelig (≥1/100 til &lt; 1/10), ikke almindelig (≥1/1.000 til &lt; 1/100), sjælden (≥1/10.000) til &lt; 1/1.000), meget sjælden ( &lt; 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequency categories are defined as follows: very common (≥ 1/10); common (≥ 1/100 to &lt; 1/10); uncommon (≥ 1/1,000 to &lt; 1/100); rare (≥ 1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000) and not known (frequency cannot be estimated from the available data).
Disse andele var signifikant større (p &lt; 0,0001) end ved metaanalyse med tilfældige effekter af lokaliseringsprocenten med kolloidale midler til lymfeknudekortlægning i klinisk praksis i Europa, som fremgår af den publicerede litteratur.
These rates were significantly greater (p &lt; 0.0001) against a random effects meta-analysis of localisation rates from published literature for colloidal lymphatic mapping agents as used in European clinical practice.
Tærsklen var baggrundsaktiviteten plus tre gange standardafvigelsen på middel-baggrundsaktiviteten (dvs. tre sigmareglen, der repræsenterer en sandsynlighed på &gt; 99.7 % for afvigelse fra baggrundsniveauet) (se tabel 4).
In clinical studies using Lymphoseek, study investigators employed a threshold rule for positive localisation of technetium Tc 99m that was estimated using the background radioactivity counts plus three standard deviations from the mean background count level (i.e., the three-sigma rule, representing &gt; 99.7% probable difference from background) [see Table 4].
BCVA blev enten forbedret eller vedligeholdt ( &lt; 5 forringelse i forhold til bogstaver) i 88,4 % af øjnene i uge 78.
BCVA was either improved or maintained ( &lt; 5 letters deterioration) in 88.4 % of the eyes at week 78.
Klinisk remission (defineret som Mayo-score ≤ 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.
&gt; 32 uger
&gt; 32 weeks
Induktion af klinisk remission (defineret som CDAI &lt; 150) blev undersøgt i to studier, CD-studie I (CLASSIC I) og CD-studie II (GAIN).
Induction of clinical remission (defined as CDAI &lt; 150) was evaluated in two studies, CD Study I (CLASSIC I) and CD Study II (GAIN).
Nedenstående liste over bivirkninger er baseret på erfaring fra kliniske studier og erfaring efter markedsføring og er inddelt efter organklassesystem og hyppighed i tabel 6 nedenfor: meget almindelig (≥ 1/10); almindelig(≥1/100 til &lt; 1/10); ikke almindelig (≥1/1.000 til &lt; 1/100), sjælden (≥1/10.000 til &lt; 1/1.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class (SOC) and frequency in table 6 below: very common (≥ 1/10); common (≥ 1/100 to &lt; 1/10); uncommon (≥ 1/1,000 to &lt; 1/100); rare (≥ 1/10,000 to &lt; 1/1,000); and not known (cannot be estimated from the available data).
Der foreligger ingen kliniske eksponeringsdata for brugen af en induktionsdosis hos børn &lt; 6 år.
No clinical exposure data are available on the use of a loading dose in children &lt; 6 years.
Adalimumab 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)).
Adalimumab 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)).
Inflammationen kan fÃ¸re til nedsat syn og/eller fluer i Ã¸jet (sorte pletter eller svÃ¦rm af uklarheder i Ã¸jet, som bevÃ¦ger sig i synsfeltet).
The inflammation leads 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).
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 d partial flare is defined as ASDAS ≥ 1.3 but &lt; 2.1 at 2 consecutive visits.
Adalimumab/methotrexat-kombinationsterapi var klinisk og statistisk bedre end methotrexat-monoterapi (p &lt; 0,001) og adalimumab-monoterapi (p &lt; 0,001) i opnåelsen af lav sygdomstilstand hos patienter med nylig diagnosticeret moderat til alvorlig reumatoid artrit.
Adalimumab / methotrexate combination therapy was clinically and statistically superior to methotrexate (p &lt; 0.001) and adalimumab monotherapy (p &lt; 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe rheumatoid arthritis.
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 adalimumab, 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 adalimumab, out of which 37 (56.9%) had regained remission (ASDAS &lt; 1.3) after 12 weeks of restarting the open-label treatment.
* p &lt; 0,05, ***p &lt; 0,001, adalimumab versus placebo a blandt alle randomiserede patienter.
* p &lt; 0.05, *** p &lt; 0.001, adalimumab versus placebo a among all randomised patients.
En større del af patienterne på adalimumab 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 1).
A greater proportion of patients on adalimumab 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).
Infektionerne var primÃ¦rt nasofaryngitis, Ã¸vre luftvejsinfektioner og sinuitis.
The infections consisted primarily of nasopharyngitis, upper respiratory tract infection, and sinusitis.
Infektioner og parasitÃ¦re sygdomme*
Infections and infestations*
I RA-studie IV var ACR 20-respons for patienter behandlet med adalimumab 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 adalimumab plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p &lt; 0.001).
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
Alle p-værdier er parvise sammenligninger af andelene for adalimumab vs. placebo * p &lt; 0,001 ** p &lt; 0,01
All p-values are pairwise comparisons of proportions for adalimumab versus placebo * p &lt; 0.001 ** p &lt; 0.01
I uge 52 opnåede 42,9 % af patienterne, som fik adalimumab /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 adalimumab-monoterapi.
At week 52, 42.9 % of patients who received adalimumab / methotrexate combination therapy achieved clinical remission (DAS28 &lt; 2.6) compared to 20.6 % of patients receiving methotrexate monotherapy and 23.4% of patients receiving adalimumab monotherapy.
Patienterne fik enten placebo eller 20 mg adalimumab (hvis &lt; 30 kg) eller 40 mg adalimumab (hvis ≥ 30 kg) hver anden uge i kombination med deres baseline dosis af methotrexat.
Patients received either placebo or 20 mg adalimumab (if &lt; 30 kg) or 40 mg adalimumab (if ≥ 30 kg) every other week in combination with their baseline dose of methotrexate.
Der forekom ingen ALAT-stigninger ≥ 3 x 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 x ULN occurred in the Phase 3 trial of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 2 to &lt; 4 years.
Når Hefiya behandlingen påbegyndes kan en induktionsdosis på 40 mg til patienter &lt; 30 kg eller 80 mg til patienter ≥ 30 kg administreres en uge før start af vedligeholdelsesbehandling.
When Hefiya therapy is initiated, a loading dose of 40 mg for patients &lt; 30 kg or 80 mg for patients ≥ 30 kg may be administered one week prior to the start of maintenance therapy.
MTX = methotrexat ** p &lt; 0,01, adalimumab over for placebo
MTX = methotrexate ** p &lt; 0.01, adalimumab 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 adalimumab 40 mg hver anden uge (N=152) eller placebo (N=153) i yderligere 40 uger i den dobbeltblindede, placebokontrollerede periode (total studievarighed 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 procent af patienterne, som opnåede PASI 75-respons beregnet med justering for centervariation b p &lt; 0,001, adalimumab versus placebo
506 (62.2)b a percent of patients achieving PASI75 response was calculated as centreadjusted rate b p &lt; 0.001, adalimumab vs. placebo
Der foreligger ingen kliniske data om brugen af en adalimumab-induktionsdosis til børn &lt; 6 år (se pkt.
No clinical data are available on the use of an adalimumab loading dose in children &lt; 6 years of age (see section 5.2).
På tværs af alle behandlingsgrupper var den gennemsnitlige baseline-PASI-score 19,7, og baseline-PGA-score varierede fra “let” ( &lt; 1 %) til “moderat” (48 %), “svær” (46 %) og “meget svær” (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 %).
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).
***, ** Statistisk signifikant ved henholdsvis p &lt; 0,001 og &lt; 0,01 ved alle sammenligninger af adalimumab og placebo.
***, ** statistically significant at p &lt; 0.001 and &lt; 0.01, respectively, for all comparisons between adalimumab and placebo.
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).
Adalimumabs sikkerhed og virkning blev vurderet i et åben-label, multicenterstudie 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.
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, and improvement of &gt; 30 % in no more than 1 of the 6 criteria.
Adalimumabs sikkerhed og virkning 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 non-infectious anterior uveitis who were refractory to at least 12 weeks of methotrexate treatment.