natgillin/translations-raw huggingface dataset:
au røntgenresultater).
34 additional primary endpoint at 52 weeks of retardation of disease progression (as detected by X-ray results).
ACR respons re Den procent af Trudexa- behandlede patienter, der fik ACR 20 -, 50 - og 70- respons, var konsistent mellem forsøg I, II og III.
The percent of Trudexa-treated patients achieving ACR 20, 50 and 70 responses was consistent across
Resultaterne for 40 mg hver anden uge er opstillet i tabel 3. ge
The results for the 40 mg every other week dose are summarised in Table 3.
ACR- respons i placebokontrollerede forsøg (Procent af patienter) æn
ACR Responses in Placebo-Controlled Trials
Placebo /
tho
Trudexab / MTXc Placebo Trudexab Placebo / l
Placebo/ MTXc n=60
Trudexab /
Trudexab/ MTXc Placebo Trudexab Placebo/ n=63 n=110 n=113 MTXc n=200
n=113 MTXc
Trudexab/ MTXc n=207
13, 3% r ik
13.3% NA
te
ge
52, 4%
6 months 12 months
8, 2%
6.7% NA
22, 1%
52.4% NA
NA NA NA NA
22.1% NA
måneder ACR 70 dle
ACR 70 lon a
måneder a Forsøg I efter 24 uger, Forsøg II efter 26 uger og Forsøg III efter 24 og 52 uger mi
Study I at 24 weeks, Study II at 26 weeks, and Study III at 24 and 52 weeks b 40 mg Trudexa administered every other week c MTX = methotrexate no
b 40 mg Trudexa givet hver anden uge c MTX = methotrexat ge
**p < 0.01, Trudexa versus placebo
** p < 0, 01, Trudexa over for placebo
In Studies I-IV, all individual components of the ACR response criteria (number of tender and swollen t
I forsøg I- IV forbedredes alle individuelle komponenter af ACR- responskriterierne (antal af ømme og hævede led, læge - og patientvurderinger af sygdomsaktivitet og smerter, fysisk Læ
joints, physician and patient assessment of disease activity and pain, disability index (HAQ) scores uc
funktionsevneindeksværdier (HAQ) og CRP (mg/ dl) - værdier) efter 24 eller 26 uger sammenlignet med placebo.
and CRP (mg/ dl) values) improved at 24 or 26 weeks compared to placebo.
I tillæg hertil blev behandlingseffekt bedømt ved ACR- respons opretholdt hos størstedelen af patienterne, som blev fulgt i det åbne 36 forlængelsesforsøg til uge 104.
There rod
Blandt disse havde 86, 72 og 41 patienter ACR response på henholdvis
Among those, 86, 72, and 41 patients had ACR 20/ 50/ 70 response, respectively at month 60.
lg 20/ 50/ 70 ved 60 måneder
In Study IV, the ACR 20 response of patients treated with Trudexa plus standard of care was lP
sa I forsøg IV var ACR 20- respons for patienter behandlet med Trudexa plus standardpleje statistisk signifikant bedre end for patienter behandlet med placebo plus standardpleje (p < 0, 001).
statistically significantly better than patients treated with placebo plus standard of care (p < 0.001).
til I forsøgne I- IV opnåede Trudexa- behandlede patienter statistisk signifikant ACR 20 - og 50- respons sammenlignet med placebo allerede én til to uger efter behandlingsstart.
In Studies I-IV, Trudexa-treated patients achieved statistically significant ACR 20 and 50 responses na
ret I forsøg V med patienter med reumatoid artrit på et tidligt stadium, som var methotrexat- naive, førte kombinationsbehandlingen med Trudexa og methotrexat til hurtigere og signifikant større ACR respons end methotrexat- monoterapi og Trudexa- monoterapi i uge 52, og effekten blev opretholdt i
In Study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy i
ise 104 uger (se tabel 4).
Me
ACR Respons i studie V (Procentdel af patienter)
ACR Responses in Study V (percent of patients)
tor Trudexa/ MT
Trudexa/ MT
au ACR 20
n=268 ACR 20
0, 656
ed
Uge 104
Week 52 Week 104
a. p- værdi for den parvise sammenligning af methotrexat- monoterapi og Trudexa/ methotrexat - kombinationeterapi ved anvendelse af Mann- Whitney U test. b. p- værdi for den parvise sammenligning af Trudexa- monoterapi og Trudexa/ methotrexat - l
a. p-value is from the pairwise comparison of methotrexate monotherapy and Trudexa/ methotrexate
kombinationsterapi ved anvendelse af Mann- Whitney U test ke
ris combination therapy using the Mann-Whitney U test. b. p-value is from the pairwise comparison of Trudexa monotherapy and Trudexa/ methotrexate
c. p- værdi for den parvise sammenligning af Trudexa- monoterapi og methotrexat- monoterapi ved anvendelse af Mann- Whitney U test r ik
tho combination therapy using the Mann-Whitney U test c. p-value is from the pairwise comparison of Trudexa monotherapy and methotrexate monotherapy using the Mann-Whitney U test
I uge 52 opnåede 42, 9% af patienterne, som fik Trudexa/ methotrexat- kombinationsterapi, klinisk remission (DAS28 < 2, 6) sammenlignet med 20, 6% af patienterne, som fik methotrexat- monoterapi og 23, 4% af patienterne, som fik Trudexa- monoterapi.
au At week 52, 42.9% of patients who received Trudexa/ methotrexate combination therapy achieved clinical remission (DAS28 < 2.6) compared to 20.6% of patients receiving methotrexate monotherapy and 23.4% of patients receiving Trudexa monotherapy.
Trudexa/ methotrexat- kombinationsterapi var klinisk og statistisk bedre end methotrexat- monoterapi (p < 0, 001) og Trudexa- monoterapi (p < 0, 001) i te
Trudexa/ methotrexate combination therapy was clinically and statistically superior to methotrexate (p < 0.001) and Trudexa monotherapy
Responset i de to monoterapi- arme var ens (p=0, 447). dle
r (p < 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe
Radiografisk respons
ge rheumatoid arthritis.
I forsøg III, hvor de Trudexa- behandlede patienter havde haft reumatoid artrit gennemsnitlig i 11 år, mi
The response for the two monotherapy arms was similar (p = 0.447).
blev den strukturelle ødelæggelse af leddene vurderet radiografisk og udtrykt som ændringer i den totale modificerede Sharpscore og dennes delkomponenter, erosionsscore og ledspalteforsnævring (JSN).
Radiographic response lon In Study III, where Trudexa treated patients had a mean duration of rheumatoid arthritis of approximately 11 years, structural joint damage was assessed radiographically and expressed as change in modified total Sharp score and its components, the erosion score and joint space narrowing score.
Der blev observeret en significant mindre radiografisk progression hos Trudexa - / methotrexat - ge
Trudexa/ methotrexate patients demonstrated significantly less radiographic progression than no
patienter end hos patienter som alene fik methotrexat efter 6 måneder og 12 måneder (se Tabel 5).
patients receiving methotrexate alone at 6 and 12 months (see Table 5).
133/ 127 patienter, Læ
113/ 207 of patients originally treated with 40 mg Humira every t
der oprindeligt blev behandlet med 40 mg Trudexa hver anden uge, blev radiografisk evalueret ved 5 år.
other week were evaluated radiographically at 5 years.
Blandt disse viste 66 patienter ingen af progression af strukturel ødelæggelse defineret som ændring af TSS på nul eller mindre.
Among those, 66 patients showed no uc
37 Tabel 5:
Table 5:
Gennemsnitlige radiografiske ændringer gennem 12 måneder i Forsøg III
Radiographic Mean Changes Over 12 Months in Study III rod
Placebo /
Placebo/
sa
lP
til
Intervalb)
ret a methotrexat b 95% Konfidensintervaller for forskellen i ændring af score mellem methotrexat og Trudexa. c Baseret på ranganalyse
methotrexate b 95% confidence intervals for the differences in change scores between methotrexate and Trudexa. i
ise d Ledspalteforsnævring
d Joint Space Narrowing
I forsøg V blev strukturel ledskade vurderet radiografisk og udtrykt som ændringer i den modificrede totale Sharp score (se tabel 6).
modified total Sharp score (see Table 6).
tor Tabel 6:
Table 6:
Gennemsnitlige radiografiske ændringer i uge 52 i forsøg V
Radiographic Mean Changes at Week 52 in Study V
X
Trudexa/ MT
re
X
(95% konfidens - interval)
(95% confidence
Total Sharp score
interval)
5, 7 (4, 2- 7, 3)
interval)
3, 0 (1, 7- 4, 3)
n=268
1, 3 (0, 5- 2, 1)
36
0, 0020
confidence
Erosion score
Total Sharp score
1, 7 (1, 0- 2, 4) æn
3.0 (1.7-4.3)
JSN score
Erosion score JSN score
a. p- værdien for den parvise sammenligning af methotrexat- monoterapi og Trudexa/ methotrexat - kombinationsbehandling ved anvendelse af Mann- Whitney U test. b. p- værdien for den parvise sammenligning af Trudexa monoterapi og Trudexa/ methotrexat - l
ed a. p-value is from the pairwise comparison of methotrexate monotherapy and Trudexa/ methotrexate combination therapy using the Mann-Whitney U test. b. p-value is from the pairwise comparison of Trudexa monotherapy and Trudexa/ methotrexate
c. p- værdien for den parvise sammenligning af Trudexa monoterapi og methotrexat - monoterapi ved anvendelse af Mann- Whitney U test r ik
ris combination therapy using the Mann-Whitney U test c. p-value is from the pairwise comparison of Trudexa monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Efter henholdsvis 52 ugers og 104 ugers behandling, var procentdelen af patienter uden progression (ændring fra baseline i den modificerede totale Sharp score ≤ 0, 5) signifikant højere med Trudexa/ methotrexat- kombinationsterapi (henholdsvis 63, 8% og 61, 2%) sammenlignet med methotrexat- monoterapi (henholdsvis 37, 4% og 33, 5%, p < 0, 001) og Trudexa monoterapi (henholdsvis te
tho 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 Trudexa/ methotrexate combination therapy (63.8% and 61.2% respectively) compared to methotrexate
50, 7%, p < 0, 002 og 44, 5%, p < 0, 001).
au monotherapy (37.4% and 33.5% respectively, p < 0.001) and Trudexa monotherapy (50.7%, p < 0.002 and 44.5%, p < 0.001 respectively).
Livskvalitet og fysisk funktion dle
Quality of life and physical function
Alle doser/ skemaer for Trudexa i mi
r ge Health-related quality of life and physical function was assessed using the disability index of the Health Assessment Questionnaire (HAQ) in the four original adequate and well-controlled trials, which was a pre-specified primary endpoint at week 52 in Study III.
alle fire forsøg viste statistisk signifikant større forbedring ifølge HAQ’ s fysiske funktionsevneindeks fra baseline til 6. måned sammenlignet med placebo, og i forsøg III blev det samme set efter 52 uger.
All doses/ schedules of Trudexa lon in all four studies showed statistically significantly greater improvement in the disability index of the HAQ from baseline to Month 6 compared to placebo and in Study III the same was seen at week 52.
Resultater fra Short Form Health Survey (SF 36) for alle doser/ skemaer for Trudexa i alle fire forsøg ge
Results from the Short Form Health Survey (SF 36) for all doses/ schedules of Trudexa in all four studies support these findings, with statistically significant physical component summary (PCS) no
understøtter disse resultater med statistisk signifikant værdi for physical component summary (PCS) såvel som med statistisk signifikant værdi for smerte - og vitalitetsområde for 40 mg dosering hver anden uge.
scores, as well as statistically significant pain and vitality domain scores for the 40 mg every other week dose.
kronisk sygdomsbehandling (FACIT), blev set i alle tre forsøg (forsøg I, III, IV).
A statistically significant decrease in fatigue as measured by functional assessment of chronic illness therapy (FACIT) scores was seen in all three studies in which it was assessed (Studies I, III, IV). t uc
38 I forsøg III blev forbedringer i fysisk funktion opretholdt gennem 260 uger (60 måneder) med åben behandling.
In Study III, improvement in physical function was maintained through week 260 (60 months) of open-label treatment.
Forbedring af livskvalitet blev målt op til uge 156 (36 måneder) og forbedringen blev
Improvement in quality of life was measured up to week 156 (36 months) and rod
lg opretholdt gennem hele denne tidsperiode.
improvement was maintained through that time.
sa I forsøg V var forbedringen i HAQ funktionsevneindeks og den fysiske komponent fra SF 36 større (p < 0, 001) for Trudexa/ methotrexat- kombinationsterapi end for methotrexat- monoterapi og Trudexa - monoterapi efter 52 uger.
In Study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p < 0.001) for Trudexa/ methotrexate combination therapy versus lP
Effekten blev opretholdt i 104 uger.
methotrexate monotherapy and Trudexa monotherapy at week 52, which was maintained through week 104.
til Psoriasisartrit
Psoriatic arthritis na
ret Trudexa givet i doser af 40 mg hver anden uge blev undersøgt hos patienter med moderat til alvorlig aktiv psoriasisartrit i to placebokontrollerede forsøg, forsøgne VI og VII.
Trudexa, 40 mg every other week, was studied in patients with moderately to severely active psoriatic arthritis in two placebo-controlled studies, Studies VI and VII.
I forsøg VI blev 313 voksne patienter, som havde et utilstrækkeligt respons over for nonsteroid anti- inflammatorisk behandling,
Study VI with 24 week duration, i dic
I forsøg VII blev 100 patienter, som havde utilstrækkelig respons over for DMARD- terapi, behandlet i 12 uger.
Me
tor ankyloserende spondyltitis- lignende psoriasis arthropati, da kun få patienter er blevet undersøgt (se tabel 7).
There is insufficient evidence of the efficacy of Trudexa in patients with ankylosing spondylitis-like psoriatic arthropathy due to the small number of patients studied (see Table 7).
au Tabel 7:
Table 7:
ACR respons i placebokontrollerede psoriasisartrit forsøg (Procentdel af patienter)
ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients)
Forsøg
Study VI
VI re
Study VII
Forsøg VII
37
ge
N=151
N=151 N=49
N=49
15% æn
15%
ACR 50
ed
ACR 70 l
ris ACR 70
0%
0% ***
*** p < 0, 001 for alle sammenligninger mellem Trudexa og placebo
tho *** p < 0.001 for all comparisons between Trudexa and placebo
p < 0, 05 for alle sammenligninger mellem Trudexa og placebo r ik
p < 0.05 for all comparisons between Trudexa and placebo
ACR respons i forsøg VI var det samme med og uden methotrexat- kombinationsbehandling. te
au ACR responses in Study VI were similar with and without concomitant methotrexate therapy.
Hos patienter behandlet med Trudexa var der signifikant større bedring ifølge HAQ’ s fysiske funktionsevneindeks og Short Form Health Survey (SF 36) fra baseline til uge 24.
Trudexa treated patients demonstrated improvement in physical function as assessed by HAQ and Short Form Health Survey (SF 36), from base-line to week 24.
Ankyloserende spondylitis dle
r Ankylosing spondylitis
Trudexa 40 mg hver anden uge blev undersøgt i to randomiserede, 24 ugers dobbelt- blinde placebo - kontrollerede forsøg med 393 patienter med aktiv ankyloserende spondylitis (gennemsnits score ved mi
ge Trudexa 40 mg every other week was assessed in 393 patients in two randomised, 24 week double− blind, placebo− controlled studies in patients with active ankylosing spondylitis (mean lon baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in all groups) who have had an inadequate response to conventional therapy.
baseline for sygdomsaktivitet [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] var 6, 3 i alle grupper), som ikke havde responderet tilstrækkeligt på konventionel behandling.
Seventy-nine (20.1%) patients were treated concomitantly with disease modifying anti − rheumatic drugs, and 37 (9.4%) patients with glucocorticoids.
Nioghalvfjerds (20, 1%) af patienterne blev samtidigt behandlet med sygdomsmodificerende ge
The blinded period was followed by an open− label period no
Den blindede periode blev efterfulgt af en åben periode, hvor patienterne modtog Trudexa 40 mg hver anden uge subkutant i op til yderligere 28 uger.
during which patients received Trudexa 40 mg every other week subcutaneously for up to an additional 28 weeks.
Forsøgspersoner (n=215, 54, 7%), som ikke opnåede ASAS 20 ved uge 12, Læ
Subjects (n=215, 54.7%) who failed to achieve ASAS 20 at Weeks 12, or 16 or 20 received early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently treated as non-responders in the double-blind statistical analyses. t uc
Første signifikante respons blev observeret ved uge 2 og blev opretholdt frem til uge 24
Significant response was first observed at Week 2 and maintained through 24 weeks (Table 8). rod
sa Tabel 8 - Effekt respons i placebo- kontrolleret AS forsøg – forsøg VIII Reduktion af tegn og symptomer
Table 8 - Efficacy Responses in Placebo-Controlled AS Study – Study VIII Reduction of Signs and Symptoms lP
Respons ASASa 20
Response ASASa 20 na
ret
dic
ise ASAS 50
ASAS 50 Me
Uge 12
Week 2 Week 12 Week 24
38% ***
3% 10% 11%
BASDAIb 50 re
BASDAIb 50
***, ** Statistisk signifikant på < 0, 001, < 0, 01 for alle sammenligning mellem Trudexa og placebo ved uge 2, 12 og 24 a Assessment in Ankylosing Spondylitis æn
***, ** Statistically significant at p < 0.001, < 0.01 for all comparisons between Trudexa and placebo at Weeks 2, 12 and 24 a ASsessments in Ankylosing Spondylitis
Patienter i behandling med Trudexa havde signifikant større forbedringer ved uge 12, som blev l
Trudexa treated patients had significantly greater improvement at Week 12 which was maintained through Week 24 in both the SF36 and Ankylosing Spondylitis Quality of Life Questionnaire
opretholdt frem til uge 24, i både SF36 og ankyloserende spondylitis livskvalitetsspørgeskema (ASQoL). ke
ris (ASQoL).
Lignende tendenser (ikke alle statistisk signifikante) blev set i det mindre, randomiserede, dobbelt - blindede, placebokontrollerede forsøg (IX) på 82 voksne patienter med aktiv ankyloserende r ik
Similar trends (not all statistically significant) were seen in the smaller randomised, double− blind,
spondylitis.
tho placebo controlled study (IX) of 82 adult patients with active ankylosing spondylitis.
Crohns sygdom te
Crohn’ s Disease
Sikkerhed og effekt af Trudexa er undersøgt i randomiserede, dobbelt- blinde, placebo- kontrollerede forsøg i over 1400 patienter med moderat til svær aktiv Crohns sygdom (Crohns sygdoms - dle
au The safety and efficacy of Trudexa were assessed in over 1400 patients with moderately to severely active Crohn’ s disease (Crohn’ s Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomised, double-blind, placebo-controlled studies.
aktivitetsindeks (CDAI) ≥ 220 og ≤ 450).
478 of the enrolled patients (32%) were defined as having a
Samtidige faste doser af mi
r severe disease (CDAI score > 300 and concomitant corticosteroid and/ or immunosuppressants)
aminosalicylater, kortikosteroider, og/ eller immunmodulerende- midler var tilladt, og 79% af patienterne fortsatte med at modtage mindst et af disse lægemidler. ge
ge corresponding to the population defined in the indication (see section 4.1).
In CLASSIC I, blev 299 TNF- antagonist- naive patienter randomiseret til en af fire behandlingsgrupper; placebo i uge 0 og 2, 160 mg Trudexa i uge 0 og 80 mg i uge 2, 80 mg i uge 0 og Læ
In CLASSIC I, 299 TNF-antagonist naive patients were randomised to one of four treatment groups; placebo at weeks 0 and 2, 160 mg Trudexa at week 0 and 80 mg at week 2, 80 mg at week 0 and 40 mg at week 2, and 40 mg at week 0 and 20 mg at week 2.
I GAIN, blev 325 patienter, der ikke længere responderede eller var intolerante over for infliximab, randomiseret til at modtage enten 160 mg
In GAIN, 325 patients who had lost no
40 Trudexa i uge 0 og 80 mg i uge 2 eller placebo i uge 0 og 2.
response or were intolerant to infliximab were randomised to receive either 160 mg Trudexa at week 0 and 80 mg at week 2 or placebo at weeks 0 and 2.
De oprindelige non- responders blev ekskluderet fra forsøgene, og derfor blev disse patienter ikke yderligere undersøgt.
The primary non-responders were excluded from the studies and therefore these patients were not further evaluated. t uc
lg Vedligeholdelse af klinisk remission blev undersøgt i CHARM.
Maintenance of clinical remission was evaluated in CHARM.
I CHARM modtog 854 patienter
In CHARM, 854 patients received open-label 80 mg at week 0 and 40 mg at week 2.
Patienter i klinisk respons (nedgang i CDAI ≥ 70) i uge 4 blev stratificeret og analyseret adskilt fra dem, som ikke havde
Patients in clinical rod
til klinisk respons ved uge 4.
response (decrease in CDAI ≥ 70) at week 4 were stratified and analysed separately from those not in clinical response at week 4.
Tabel 9 viser rater for induktion af remission og respons i CLASSIC I og GAIN.
CLASSIC I and GAIN induction of remission and response rates are presented in Table 9. lP Me
ret Table 9:
39 Table 9:
Induktion af Klinisk Remission og Respons (Procent af Patienterne)
Induction of Clinical Remission and Response (Percent of Patients)
Infliximab Naive Patienter Placebo Trudexa Trudexa
Infliximab Naive Patients
Infliximab Erfarne Patienter Placebo Trudexa
Infliximab Experienced Patients
tor Uge 4
ed Week 4
au Klinisk remission
ris Clinical remission
Alle p- værdier er parvise sammenligninger af forholdet for Trudexa vs. placebo re * p < 0, 001 ** p < 0, 01 ge
tho 100) All p-values are pairwise comparisons of proportions for Trudexa versus placebo * p < 0.001 **
Lignende remissions- rater sås for 160/ 80 mg og 80/ 40 mg induktionsregimerne ved uge 8, mens æn
au p < 0.01
bivirkninger oftere sås i gruppen med 160/ 80 mg.
Similar remission rates were observed for the 160/ 80 mg and 80/ 40 mg induction regimens by week 8 and adverse events were more frequently noted in the 160/ 80 mg group.
I CHARM var 58% (499/ 854) af patienterne i klinisk respons i uge 4 og blev vurderet i den primære analyse.
r ge In CHARM, at week 4, 58% (499/ 854) of patients were in clinical response and were assessed in the primary analysis.
Blandt patienter med klinisk respons i uge 4 havde 48% tidligere været eksponeret for anden l
Of those in clinical response at week 4, 48% had been previously exposed to other anti-TNF therapy.
Raterne for ke
Maintenance of remission and response rates are presented in Table 10.
klinisk remission forblev forholdvis konstante uanset tidligere TNF- antagonist- eksposition. r ik te dle mi ge Læ
Clinical lon remission results remained relatively constant irrespective of previous TNF antagonist exposure.
41 Tabel 10:
Table 10:
Vedligeholdelse af Klinisk Remission og Respons
Maintenance of Clinical Remission and Response (Percent of Patients) no
sa
every other week
hver anden uge
every week
hver uge
Week 26
Uge 26 Klinisk remission
t
til Klinisk respons (CR- 100)
Clinical response (CR-100)
Patienter i steroid- fri remission i
Patients in steroid-free remission rod
ret > =90 dagea Uge 56 Klinisk remission
for > =90 daysa Week 56 Clinical remission
N=172 36% *
N=172 36%*
N=157 41% *
N=157 41%*
ise Klinisk respons (CR- 100)
Clinical response (CR-100)
tor * p < 0, 001 for Trudexa vs. placebo parvise sammenligninger af forholdet ** p < 0, 02 for Trudexa vs. placebo parvise sammenligninger af forholdet
* p < 0.001 for Trudexa versus placebo pairwise comparisons of proportions ** p < 0.02 for Trudexa versus placebo pairwise comparisons of proportions a i
au a Af dem som modtog kortikosteroider ved baseline
Of those receiving corticosteroids at baseline dic
Disse re resultater tyder på, at nogle patienter, som ikke har responderet ved uge 4, har fordel af fortsat vedligeholdelsesbehandling til og med uge 12.
These results suggest that some patients who have not responded by week 4 benefit from continued maintenance therapy through week Me
Livskvalitet æn
Quality of Life
I CLASSIC I og GAIN, blev der opnået statistisk signifikante forbedringer i total score i det sygdoms - specifikke tarm- sygdoms- spørgeskema (IBDQ) ved uge 4 for patienter randomiseret til Trudexa 80/ 40 mg og 160/ 80 mg sammenlignet med placebo, og i CHARM blev det set ved uge 26 og 56, såvel som blandt den adalimumab- behandlede- grupper sammenlignet med placebo- gruppen. l ke
In CLASSIC I and GAIN, statistically significant improvement in the disease-specific inflammatory bowel disease questionnaire (IBDQ) total score was achieved at week 4 in patients randomised to
Dannelse af adalimumab- antistoffer er forbundet med øget clearence og reduceret effekt af r ik
Formation of anti-adalimumab antibodies is associated with increased clearance and reduced efficacy
adalimumab.
ed of adalimumab.