natgillin/translations-raw huggingface dataset:
på ≥ 4 point på NRS for kløe fra baseline til uge 16 og uge 52 sammenlignet med placebo + TKS (se tabel 5).
In CHRONOS, a significantly greater proportion of patients randomized to dupilumab 300 mg Q2W + TCS achieved an IGA 0 or 1 response, EASI-75, and/or an improvement of &gt; 4 points on the pruritis NRS from baseline to week 16 and week 52 compared to placebo + TCS (see Table 5).
[9] &lt; Der forventes ingen virkning på graviditeten, da sytemisk eksponering af {Aktivt stof} er neglegiabel. &gt;
[9] &lt; No effects during pregnancy are anticipated, since systemic exposure to {Active substance} is negligible. &gt;
[4] &lt; Der er ingen eller utilstækkelige data fra anvendelse af {Aktivt stof} til gravide kvinder.
[4] &lt; There are no or limited amount of data from the use of {Active substance} in pregnant women.
&lt; Det skal besluttes, om amning skal ophøre eller behandling med {(Sær)navn} seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen. &gt;
&lt; A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from {Invented name} therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. &gt;
[1] &lt; Baseret på humane data [specificer] medfører {Aktivt stof} &lt; medfødte misdannelser [specificer], når det anvendes under graviditeten. &gt; [eller] &lt; skadelige farmakologiske virkninger på graviditeten og/eller fostret/det nyfødte barn. &gt;
[1] &lt; Based on human experience [specify] {Active substance} causes &lt; congenital malformations [specify] when administered during pregnancy. &gt; [or] &lt; harmful pharmacological effects during pregnancy and/or on the fetus/newborn child. &gt;
&lt; Amning skal ophøre under behandling med {(Sær)navn}. &gt;
&lt; Breast-feeding should be discontinued during treatment with {Invented name}. &gt;
[5] &lt; Der er ingen eller utilstrækkelige data (mindre end 300 gravide forsøgspersoner) fra anvendelse af {Aktivt stof} til gravide kvinder.
[5] &lt; There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of {Active substance} in pregnant women.
[2] &lt; Det er ukendt, om {Aktivt stof}/metabolitter udskilles i human mælk. &gt;
[2] &lt; It is unknown whether {Active substance}/metabolites are excreted in human milk. &gt;
&lt; {Aktivt stof}/metabolitter udskilles ikke i human mælk. &gt;
&lt; {Active substance}/metabolites are not excreted in human milk. &gt;
&lt; {Aktivt stof}/metabolitter udskilles i human mælk i så stor en mængde, at en påvirkning af ammede nyfødte/spædbørn er sandsynlig. &gt;
&lt; {Active substance}/metabolites are excreted in human milk to such an extent that effects on the breastfed newborns/infants are likely. &gt;
&lt; De tilgængelige farmakodynamiske/toksikologiske data fra dyreforsøg viser, at {Aktivt stof}/metabolitter udskilles i mælk (se pkt.
&lt; Available pharmacodynamic/toxicological data in animals have shown excretion of {Active substance}/metabolites in milk (for details see 5.3). &gt;
[2] &lt; Baseret på humane data [specificer] er {Aktivt stof} under mistanke for at medføre medfødte misdannelser [specificer], når det anvendes under graviditeten.
[2] &lt; Based on human experience [specify] {Active substance} is suggested / suspected to cause congenital malformations [specify] when administered during pregnancy.
[3] &lt; Baseret på humane data [specificer] er {Aktivt stof} under mistanke for at medføre medfødte misdannelser [specificer], når det anvendes under graviditeten.
[3] &lt; Based on human experience [specify] {Active substance} is suggested / suspected to cause congenital malformations [specify] when administered during pregnancy.
&lt; {Aktivt stof}/metabolitter er ikke påvist i plasma hos nyfødte/spædbørn, ammet af mødre, som er i behandling. &gt;
&lt; {Active substance}/metabolites have not been identified in plasma of breastfed newborns/infants of treated mothers. &gt;
&lt; Fysisk-kemiske data indikerer, at {Aktivt stof}/metabolitter udskilles i human mælk. &gt;
&lt; Physico-chemical data suggest excretion of {Active substance}/metabolites in human milk. &gt;
[1] &lt; {Aktivt stof}/metabolitter udskilles i human mælk, og påvirkning er set hos nyfødte/spædbørn, ammet af kvinder, der er i behandling med {Aktivt stof}. &gt;
[1] &lt; {Active substance}/metabolites are excreted in human milk and effects have been shown in breastfed newborns/infants of treated women. &gt;
&lt; {Aktivt stof}/metabolitter er påvist hos nyfødte/spædbørn, ammet af kvinder, som er i behandling med {Aktivt stof}. &gt; &lt; Virkningen af {Aktivt stof} på det ammede barn er ukendt. &gt; [eller] &lt; Der foreligger utilstrækkelige data for virkningen af {Aktivt stof} på det ammede barn. &gt; &gt;
&lt; The effect of {Active substance} on newborns/infants is unknown. &gt; [or] &lt; There is insufficient information on the effects of {Active substance} in newborns/infants. &gt; &gt;
trimester &gt; , medmindre kvindens kliniske tilstand kræver behandling med {Aktivt stof}.
{Invented name} should not be used &lt; during pregnancy &gt; &lt; during {trimester} of pregnancy &gt; unless the clinical condition of the woman requires treatment with {Active substance}.
&lt; Der forventes ingen påvirkning af nyfødte/spædbørn, ammet af mødre i behandling med {Aktivt stof}, da den systemiske eksponering er neglegiabel. &gt;
&lt; No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to {Active substance} is negligible. &gt;
[8] &lt; Data fra anvendelse af {Aktivt stof} hos et stort antal gravide kvinder (mere end 1000) indikerer ingen misdannelser eller føtal/neonatal toksicitet af {Aktivt stof}. &gt;
[8] &lt; A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicate no malformative nor feto/ neonatal toxicity of {Active substance}. &gt;
&lt; {Aktivt stof}/metabolitter udskilles i human mælk, men der forventes ingen påvirkning af det ammede barn ved terapeutiske doser af {(Sær)navn}. &gt;
&lt; {Active substance}/metabolites are excreted in human milk, but at therapeutic doses of {Invented name} no effects on the breastfed newborns/infants are anticipated. &gt;
[3] &lt; Der er ikke set nogen påvirkning af nyfødte/spædbørn, ammet af mødre i behandling med {Aktivt stof}. &gt;
[3] &lt; No effects of {Active substance} have been shown in breastfed newborns/infants of treated mothers. &gt;
[7] &lt; Data fra anvendelse af {Aktivt stof} hos et begrænset antal gravide kvinder (mellem 300 og 1000) indikerer ingen misdannelser eller føtal/neonatal toksicitet af {Aktivt stof}. &gt;
[7] &lt; A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/ neonatal toxicity of {Active substance}. &gt;
[6] &lt; Data fra anvendelse af {Aktivt stof} hos et begrænset antal gravide kvinder (mellem 300 og 1000) indikerer ingen misdannelser eller føtal/neonatal toksicitet af {Aktivt stof}.
[6] &lt; A moderate amount of data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/ neonatal toxicity of {Active substance}.
&lt; Data for udskillelse af {Aktiv stof}/metabolitter i human mælk er utilstrækkelige. &gt;
&lt; There is insufficient information on the excretion of {Active substance}/metabolites in human milk. &gt;
&lt; Data for udskillelse af {Aktivt stof}/metabolitter i mælk hos dyr er utilstrækkelige. &gt;
&lt; There is insufficient information on the excretion of {Active substance}/metabolites in animal milk. &gt;
{(Sær)navn} kan anvendes &lt; under graviditeten &gt; &lt; i graviditetens {antal.}
{Invented name} can be used &lt; during pregnancy &gt; &lt; during {trimester} of pregnancy &gt; if clinically needed.
&lt; {(Sær)navn} &lt; er kontraindiceret under amning (se pkt.
{Invented name} is contraindicated &lt; during pregnancy &gt; &lt; during {trimester} of pregnancy &gt; [this case is a strict contraindication] (see section 4.3).
For en sikkerheds skyld bør {(Sær)navn} undgås &lt; under graviditeten &gt; &lt; i graviditetens {antal.}
As a precautionary measure, it is preferable to avoid the use of {Invented name} &lt; during pregnancy &gt; &lt; during {trimester} of pregnancy &gt; .
Hvis det er indiceret, kan anvendelse af {(Sær)navn} overvejes &lt; under graviditeten &gt; &lt; i graviditetens {antal.}
The use of {invented name} may be considered &lt; during pregnancy &gt; &lt; during {trimester} of pregnancy &gt; , if necessary.
trimester &gt; og til kvinder i den fertile alder, som ikke anvender sikker kontraception. &gt;
{Invented name} is not recommended &lt; during pregnancy &gt; &lt; during {trimester} of pregnancy &gt; and in women of childbearing potential not using contraception. &gt;
4.3) &gt; [eller] &lt; må ikke anvendes under amning &gt; . &gt;
&lt; {Invented name} &lt; is contraindicated during breast-feeding (see section 4.3) &gt; [or] &lt; should not be used during breast-feeding &gt; . &gt;
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Adrovance til Merck Sharp &amp; Dohme Ltd. den 4. januar 2007.
The European Commission granted a marketing authorisation valid throughout the European Union for Adrovance to Merck Sharp &amp; Dohme Ltd. on 4 January 2007.
Informationen til lÃ¦ger bÃ¸r indeholde essentielle oplysninger om fÃ¸lgende:
The physician information should contain the following key messages:
*p &lt; 0,0001, sammenligning af rilonacept versus placebo **p &lt; 0,001, sammenligning af rilonacept versus placebo, NS = ikke signifikant
*p &lt; 0.0001, comparison of rilonacept vs. placebo **p &lt; 0.001, comparison of rilonacept vs. placebo, NS = not significant
I en undersøgelse af osteoartritis udviklede en patient forbigående neutropeni (absolut neutrofilttal &lt; 1 x 109/l), efter at have fået en meget stor dosis (2000 mg).
One patient in a study of osteoarthritis developed transient neutropenia (absolute neutrophil count &lt; 1 x 109/l) after receiving a very large dose (2000 mg).
Infektion i de Ã¸vre luftveje, sinuitis meget almindelig
Upper respiratory tract infection; sinusitis very common
Patienter, som blev behandlet med rilonacept, oplevede en 84 % reduktion i den gennemsnitlige symptomscoring i Del A, sammenlignet med 13 % for de patienter, der blev behandlet med placebo (p &lt; 0,0001).
Patients treated with rilonacept experienced an 84% reduction in the mean symptom score in Part A compared to 13% for placebo-treated patients (p &lt; 0.0001).
En signifikant større andel patienter i rilonacept-gruppen, sammenlignet med placebogruppen, oplevede forbedringer i forhold til udgangspunktet i den sammensatte scoring på mindst 30 % (96 % versus 29 % af patienterne), på mindst 50 % (87 % versus 8 %) og på mindst 75 % (70 % versus 0 %) (p &lt; 0,0001).
A significantly higher proportion of patients in the rilonacept group compared to the placebo group experienced improvement from baseline in the composite score by at least 30% (96% vs. 29% of patients), by at least 50% (87% vs. 8%) and by at least 75% (70% vs. 0%) (p &lt; 0.0001).
p-værdi for sammenligning af ændring fra baseline inden for gruppen p &lt; 0,0001 NS
p-value for within group comparison of change from Baseline p &lt; 0.0001 NS
Det gennemsnitlige antal af symptomatiske “opblussende” dage (defineret som en dag, hvor den indberettede gennemsnitlige symptomscoring i patientens dagbog var større end 3) i løbet af den 21dages periode, der udgjorde udgangspunktet før behandling, og slutperioden under behandling i Del A, var reduceret fra 8,6 ved udgangspunktet til 0,1 ved behandlingsophør for gruppen på rilonacept, sammenlignet med en ændring fra 6,2 til 5,0 for placebogruppen (p &lt; 0,0001 versus placebo).
The mean number of symptomatic “flare” days (defined as a day in which the mean symptom score reported on the patient diary was greater than 3) during the 21-day pre-treatment baseline period and the on-treatment endpoint period, in Part A, decreased from 8.6 at baseline to 0.1 at endpoint for the group on rilonacept, compared to a change from 6.2 to 5.0 for the placebo group (p &lt; 0.0001 vs. placebo).
Følgende hyppighedsfrekvenser anvendes: meget almindelig (≥1/10), almindelig (≥1/100 til &lt; 1/10) ikke almindelig (≥1/1.000 til &lt; 1/100).
ADRs to Rilonacept Regeneron reported during the Phase 2/3 program in a total of 109 patients, some treated for longer than 2 years, are listed below using the following categories of frequency: very common (≥1/10); common (≥ 1/100 to &lt; 1/10), uncommon (≥1/1000 to &lt; 1/100).
9/l) er hyppigt observeret ved anvendelse af et andet lægemiddel, der hæmmer IL-1, i en anden patientpopulation (reumatoid artritis) end CAPS.
Neutropenia (absolute neutrophil count [ANC] &lt; 1.5 x 109/l) has been observed commonly with another medicinal product that inhibits IL-1 used in a patient population (rheumatoid arthritis) other than CAPS.
&lt; særnavn &gt; frarådes anvendt hos pædiatriske patienter, da sikkerheden og virkningen ikke er klarlagt hos denne patientgruppe.
&lt; Invented name &gt; is not recommended in paediatric patients since its safety and efficacy have not been established in this patient group.
Desuden var der tale om følgende: EKG viste hypertrofi af venstre ventrikel, venstre ventrikel havde en uddrivningsfraktion ≤45 % eller et slutdiastolisk mål &gt; 55 mm, alder ≥65 år, diabetes, hypertension, perifer karsygdom eller cerebrovaskulær sygdom.
In addition one of the following was also in force: left ventricular hypertrophy on the ECG, left ventricular ejection fraction ≤45%, or an end diastolic dimension of &gt; 55mm, age ≥65, diabetes, hypertension, peripheral vascular disease, or cerebrovascular disease.
der ikke er tilfredsstillende kontrolleret, eller når førstevalgsbehandlingerne af angina (såsom betablokkere og/eller calciumantagonister) er kontraindicerede eller ikke tolereres.
The proposed indication should be revised as follows: &lt; Invented name &gt; is indicated in adults for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or have a contraindication or intolerance to first-line anti-anginal therapies (such as beta-blockers and/or calcium antagonists).
&lt; særnavn &gt; er indiceret hos voksne til symptomatisk behandling af stabil angina pectoris,
Comparison of nicorandil and atenolol in stable angina pectoris.
Hyppighed er angivet 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); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequency categories are defined using the following convention: 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).
C-Rivastigmin var renal udskillelse hurtig og nærmest fuldstændig ( &gt; 90%) inden for 24 timer.
C-rivastigmine, renal elimination was rapid and essentially complete ( &gt; 90 %) within 24 hours.
Mindst 4-pointsforbedring af ADAS-Cog med ingen forværring af CIBIC-Plus og PDS *p &lt; 0,05, **p &lt; 0,01, ***p &lt; 0,001
At least 4 points improvement on ADASCog with no worsening on CIBIC-Plus and PDS *p &lt; 0.05, **p &lt; 0.01, ***p &lt; 0.001
Denne metabolit viser in vitro minimal hæmning af acetylkolinesterase ( &lt; 10%).
In vitro, this metabolite shows minimal inhibition of acetylcholinesterase ( &lt; 10 %).
Infektioner og parasitÃ¦re sygdomme
Infections and infestations Very rare
Den 5. november 2007 meddelte INFAL, Institut für biomedizinische Analytik &amp; NMR-Imaging GmbH, officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at man ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Gastromotal til in vivo-diagnose af fast-fase gastrisk halv tømningstid ved gastriske motilitetsforstyrrelser.
On 5 November 2007, INFAI, Institut für biomedizinische Analytik &amp; NMR-Imaging GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Gastromotal, for in vivo diagnosis of solidphase gastric half emptying time in gastric motility disorders.
Merck Sharp &amp; Dohme B.V.
Merck Sharp &amp; Dohme Limited
Den 1. marts 2007 indbragte GlaxoSmithKline Research &amp; Development Limited en sag for EMEA i henhold til artikel 30 i direktiv 2001/83/EF med senere ændringer for at harmonisere produktresumé, etikettering og indlægsseddel, herunder kvalitetsaspekter, der er godkendt i medlemsstaterne, for lægemidlet Lamictal og tilknyttede navne.
On 1 March 2007, GlaxoSmithKline Research &amp; Development Limited presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet including quality aspects of the medicinal product Lamictal and associated names.
Taltz var forbundet med en hurtigt indsættende virkning med en reduktion i gennemsnitlig PASI på &gt; 50 % i uge 2 (figur 1).
Taltz was associated with a fast onset of efficacy with &gt; 50 % reduction in mean PASI by Week 2 (Figure 1).
Patienter behandlet med Taltz rapporterede forbedringer i helbredsrelateret livskvalitet, målt ved Physical Component Summary of the Short Form-36 Health Survey (SF-36 PCS)-score (p &lt; 0,001).
Taltz-treated patients reported improvements in health-related quality of life as measured by the Physical Component Summary of the Short Form-36 Health Survey (SF-36 PCS) score (p &lt; 0.001).
&lt; 1/10), ikke almindelig (≥ 1/1.000 til &lt; 1/100), sjælden (≥ 1/10.000 til &lt; 1/1.000) og meget sjælden
to &lt; 1/100); rare (≥ 1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000).
Figur 3 Primær endepunkt (samtidig ACR 50 &amp; PASI 100) og største sekundære endepunkter (ACR 50; PASI 100) responsrater uge 0 - 24 [ITT population, NRI]**
Figure 3: Primary Endpoint (Simultaneous ACR 50 &amp; PASI 100) and Major Secondary Endpoints (ACR 50; PASI 100) Response Rates Week 0 - 24 [ITT population, NRI]**
Ca. 25 % af de patienter, der blev behandlet med Taltz, havde opnået en PASI-score &lt; 5 i uge 2, mere end 55 % havde opnået PASIscore &lt; 5 i uge 4, og procentdelen var steget til 85 % i uge 12 (sammenlignet med 3 %, 14 % og 50 % for etanercept).
Approximately 25 % of patients treated with Taltz achieved a PASI score &lt; 5 by Week 2, more than 55 % achieved the PASI score &lt; 5 by Week 4, and increased to 85 % by Week 12 (compared to 3 %, 14 % and 50 % for etanercept).
Der var ligeledes forbedringer i træthedsscoren, målt ved Fatigue severity NRS- score (p &lt; 0,001).
There were also improvements demonstrated in fatigue as assessed by Fatigue severity NRS scores (p &lt; 0.001).
Ixekizumab er et monoklonalt antistof af typen IgG4, der med høj affinitet ( &lt; 3 pM) og specificitet binder sig til interleukin 17A (både IL-17A og IL-17A/F).
Ixekizumab is an IgG4 monoclonal antibody that binds with high affinity ( &lt; 3 pM) and specificity to interleukin 17A (both IL-17A and IL-17A/F).
Hyppighedskategorien for de enkelte bivirkninger er baseret på følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til
In addition, the corresponding frequency category for each ADR is based on the following convention: very common (≥ 1/10); common (≥ 1/100 to &lt; 1/10); uncommon (≥ 1/1,000
0,1 % af patienterne behandlet med Taltz udviklede et neutrofiltal &lt; 1.000 celler/mm3.
0.1% of patients receiving Taltz developed a neutrophil count &lt; 1000 cells/mm3.
Responsstart var superior på PASI 75 allerede ved uge 2 (p &lt; 0,001), og på PASI 90 og PASI 100 ved uge 4 (p &lt; 0,001).
Onset of response was superior on PASI 75 as early as week 2 (p &lt; 0.001) and on PASI 90 and PASI 100 by week 4 (p &lt; 0.001).
Patienter (n) PASI 75, n (%) 120 (88,2 %) 114 (68,7 %) PASI 90, n (%) 99 (72,8 %)§ PASI 100, n (%) 49 (36,0 %) * Ixekizumab 160 mg blev givet som en loading dosis efterfulgt af 80 mg ved uge 2,4,6,8,10 og 12, samt 80 mg Q4W derefter ** Vægtbaseret dosering: Patienter behandlet med ustekinumab fik 45 mg eller 90 mg ved uge 0 og 4, og derefter hver 12. uge indtil uge 52 (doseret efter vægt pr. godkendt dosering) §p &lt; 0,001 versus ustekinumab (p-værdi kun angivet for det primære endepunkt)
Patients (n) PASI 75, n (%) 120 (88.2 %) 114 (68.7 %) PASI 90, n (%) PASI 100, n (%) 49 (36.0 %) * Ixekizumab 160 mg was given as a loading dose followed by 80 mg at week 2,4,6,8,10 and 12, and 80 mg Q4W thereafter ** Weight based dosing: Patients treated with ustekinumab received 45 mg or 90 mg at Weeks 0 and 4, then every 12 weeks until Week 52 (dosed by weight as per approved posology) §p &lt; 0.001 versus ustekinumab (p value only provided for primary endpoint)
Hos patienter med dactylitis eller enthesitis i anamnesen, resulterede behandling med Taltz Q4W i en forbedring i dactylitis og enthesitis ved uge 24 sammenlignet med placebo (henholdsvis en resolution på 78% vs. 24%; p &lt; 0,001, og 39% vs 21%; p &lt; 0,01).
In patients with pre-existing dactylitis or enthesitis, treatment with Taltz Q4W resulted in improvement in dactylitis and enthesitis at Week 24 compared to placebo (resolution: 78% vs. 24%; p &lt; 0.001, and 39% vs. 21%; p &lt; 0.01, respectively).
Ved uge 12 opnåede signifikant flere patienter i Taltz-gruppen sammenlignet med placebogruppen en sPGA of Genitalia 0/1 og en sPGA 0/1 uafhængigt af baseline BSA (baseline BSA 1 % - &lt; 10 % hhv. ≥ 10 %: sPGA of Genitalia ‘'0” eller “1”: Taltz 71 %, hhv. 75 %; placebo: 0 %, hhv. 13 %).
At Week 12, significantly more subjects in the TALTZ group than placebo group achieved a sPGA of Genitalia 0/1 and a sPGA 0/1 independent of baseline BSA (baseline BSA 1% - &lt; 10% resp. ≥10%: sPGA of Genitalia ‘'0” or “1”: Taltz 71%, resp. 75%; placebo: 0%, resp. 13%).
Hos patienter med samtidig moderat til svær psoriasis og psoriasisartrit, viste Taltz Q2W doseringsregimet en signifikant højere responsrate for PASI 75, PASI 90 og PASI 100 sammenlignet med placebo (p &lt; 0,001), og demonstrerede en klinisk meningsfuld fordel over Q4W doseringsregimet.
In patients with concomitant moderate to severe psoriasis and psoriatic arthritis, Taltz Q2W dose regimen showed significantly higher response rate for PASI75, PASI 90 and PASI 100 compared to placebo (p &lt; 0.001) and demonstrated clinically meaningful benefit over the Q4W dose regimen.
Hos 3% af patienterne behandlet med Taltz ændrede trombocyttallet sig fra normalt ved baseline til 75.000-150.000 celler/mm3.
3% of patients exposed to Taltz had a shift from a normal baseline platelet value to &lt; 150,000 platelet cells/mm3 to ≥75,000 cells/mm3.
Andelen af patienter, der opnåede PASI 75, PASI 90, og PASI 100-respons ved uge 24, var større med Taltz Q4W sammenlignet med placebo (p &lt; 0,001).
The proportion of patients achieving a PASI 75, PASI 90, and PASI 100 response at Week 24 was greater with Taltz Q4W compared to placebo (p &lt; 0.001).
Hos patienter med ≥3% BSA, var forbedringen i heling af huden ved uge 12 (målt ved 75% forbedring i Psoriasis Area Severity Index (PASI 75)) 67% (94/141) for patienterne behandlet med Q4W doseringsregimet og 9% (12/134) for patienterne behandlet med placebo (p &lt; 0,001).
In patients with ≥3% BSA, the improvement in skin clearance at Week 12 as measured by 75% improvement in Psoriasis Area Severity Index (PASI 75), was 67% (94/141) for those treated with the Q4W dosing regimen, and 9% (12/134) for those treated with placebo (p &lt; 0.001).