natgillin/translations-raw huggingface dataset:
statistically significantly better than patients treated with placebo plus standard of care (p < 0.001).
V raziskavi IV je bil odziv 20 po ACR pri bolnikih, zdravljenih s Trudexo in standardno oskrbo, statistično značilno boljši kot pri bolnikih, zdravljenih s placebom in standardno oskrbo (p < 0, 001). nim
In Studies I-IV, Trudexa-treated patients achieved statistically significant ACR 20 and 50 responses na
V študijah I– IV so s Trudexo zdravljeni bolniki v primerjavi s prejemniki placeba dosegli statistično značilen odziv 20 in 50 po ACR že en do dva tedna po začetku zdravljenja.
In Study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy i
V študiji V pri bolnikih z zgodnjim revmatoidnim artritisom, ki še niso dobivali metotreksata, je kombinirana terapija s Trudexo in metotreksatom po 52 tednih prinesla hitrejše in značilno večje ilo
Me
odzive ACR kakor monoterapija z metotreksatom ali monoterapija s Trudexo, odzivi pa so se ohranili do 104. tedna (glejte tabelo 4). rav
ACR Responses in Study V (percent of patients)
Odzivi ACR v študiji V (odstotek bolnikov) Trudexa/ MT
Trudexa/ MT
Vrednost
MTX
Vrednost
Trudexa
Zd
n=268 ACR 20
Pb
14
Pc
45.9% 42.8%
45, 9%
41.2% 36.9%
41, 2%
61.6% 59.0%
61, 6%
ACR 70
14
ed
ACR
Week 52 Week 104
104. teden 42, 8% 70
27.2% 28.4%
< 0, 001 < 0, 001
a. p-value is from the pairwise comparison of methotrexate monotherapy and Trudexa/ methotrexate
Vrednost p se nanaša na parno primerjavo monoterapije z metotreksatom in kombinirane terapije s Trudexo/ metotreksatom z Mann- Whitneyevim testom U.
ris combination therapy using the Mann-Whitney U test. b. p-value is from the pairwise comparison of Trudexa monotherapy and Trudexa/ methotrexate
t b
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
me Vrednost p se nanaša na parno primerjavo monoterapije s Trudexo in kombinirane terapije s Trudexo/ metotreksatom z Mann- Whitneyevim testom U. c Vrednost p se nanaša na parno primerjavo monoterapije s Trudexo in monoterapije z metotreksatom z Mann- Whitneyevim testom U.
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.
pro Po 52. tednih je klinično remisijo (DAS28 < 2, 6) doseglo 42, 9% bolnikov, ki so dobivali kombinirano terapijo s Trudexo/ metotreksatom, 20, 6% bolnikov, ki so dobivali metotreksat v monoterapiji, in 23, 4% bolnikov, ki so dobivali Trudexo v monoterapiji.
Trudexa/ methotrexate combination therapy was clinically and statistically superior to methotrexate (p < 0.001) and Trudexa monotherapy
Za doseganje nizkega stanja bolezni pri bolnikih z nedavno diagnosticiranim zmernim do hudim revmatoidnim artritisom je bila kombinirana
r (p < 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe
za terapija s Trudexo in metotreksatom klinično in statistično boljša od monoterapije z metotreksatom (p < 0, 001) in monoterapije s Trudexo (p < 0, 001).
ge rheumatoid arthritis.
nja Rentgenografski odziv
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.
V raziskavi so strukturno prizadetost sklepov ocenjevali rentgenografsko.
Trudexa/ methotrexate patients demonstrated significantly less radiographic progression than no
Okvaro so izrazili kot spremembo modificirane celotne Sharpove ocene in njenih komponent, ocene erozij in ocene zožitve sklepne špranje.
patients receiving methotrexate alone at 6 and 12 months (see Table 5).
Pri bolnikih, ki so dobivali Trudexo in metotreksat, je bilo po 6 in 12 mesecih (glejte vo tabelo 5) statistično značilno manj rentgenografskih znakov napredovanja kot pri bolnikih, ki so dobivali samo metotreksat.
113/ 207 of patients originally treated with 40 mg Humira every t
113 od do
Among those, 66 patients showed no uc
207 bolnikov, ki so bili zdravljeni s 40 mg Trudexe vsak drugi teden, so rentgenografsko ocenili po 5- ih letih.
progression of structural damage defined by a change in the TSS of zero or less.
Med temi bolniki jih 66 ni kazalo napredovanja strukturne prizadetosi izražene s spremembo celotne Sharpove ocene 0 ali manj. eā
Radiographic Mean Changes Over 12 Months in Study III rod
Povprečne rentgenografske spremembe v 12 mesecih raziskave III
Placebo/
placebo /
TRUDEXA/ MTX
TRUDEXA/ MT
Placebo/ MTX-
placebo/ MTX -
lP
MT
MTXa
Xa
40 mg every other week
X 40 mg vsak drugi teden
TRUDEXA/ MTX (95% Confidence
TRUDEXA/ MT X (95% interval zaupanjab)
Total Sharp score Erosion score na
< 0, 001c Celotna Sharpova ocena
< 0.001c < 0.001
Ocena erozij d
JSNd score
1, 6 (0, 9, 2, 2)
1.0
<
0.1
0, 001
0.9 (0.3, 1.4)
Ocena ZSŠ a metotreksat ilo
0.002
1, 0
methotrexate b 95% confidence intervals for the differences in change scores between methotrexate and Trudexa. i
0, 1
c Based on rank analysis dic
0, 9 (0, 3, 1, 4)
d Joint Space Narrowing
0, 002
In Study V, structural joint damage was assessed radiographically and expressed as change in Me
b 95% intervali zaupanja za razlike v spremembi ocen med metotreksatom in Trudexo c na podlagi analize rangov d zožitev sklepne špranje rav
modified total Sharp score (see Table 6).
Zd
Radiographic Mean Changes at Week 52 in Study V
Povprečne rentgenografske spremembe po 52 tednih študije V
MTX
Trudexa/ MT Trudexa MTX
Trudexa
Odziv
p-valuea
vrednost
p-valueb
pa Pb
interval)
zaupanja)
n=268
(95% interval
15
15 zaupanja) Celotna Sharpova ocena
interval)
1, 3 (0, 5- 2, 1)
Total Sharp score
Ocena erozij
3.7 (2.7-4.7) 2.0 (1.2-2.8)
t Seštevek 2, 0 (1, 2- 2, 8)
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
me JSN a Vrednost p se nanaša na parno primerjavo monoterapije z metotreksatom in kombinirane terapije s Trudexo/ metotreksatom z Mann- Whitneyevim testom U b
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
pro Vrednost p se nanaša na parno primerjavo monoterapije s Trudexo in kombinirane terapije s Trudexo/ metotreksatom z Mann- Whitneyevim testom U c Vrednost p se nanaša na parno primerjavo monoterapije s Trudexo in monoterapije z metotreksatom z Mann- Whitneyevim testom U.
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
104 tednih zdravljenja je bil v skupini s kombinirano terapijo s Trudexo in metotreksatom odstotek bolnikov brez napredovanja bolezni (sprememba prilagojene Sharpove ocene od izhodišča ≤ 0, 5) značilno večji (63, 8% oz.
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).
44, 5%,
Quality of life and physical function
nja p < 0, 001).
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.
ugotovili po 52 tednih.
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.
Te izsledke podpirajo rezultati SF 36 (Short Form Health Survey) za vse odmerke/ sheme Trudexe v vseh štirih raziskavah, s statistično značilnim seštevkom PCS (Physical Component Summary) in statistično značilnima seštevkoma za področje bolečin in vitalnosti za odmerek 40 mg vsak drugi teden.
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
V vseh treh raziskavah (raziskave I, III in IV), v katerih so eā
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
ocenjevali utrujenost s funkcijsko oceno terapije kronične bolezni (functional assessment of chronic illness therapy (FACIT)), so ugotovili statistično značilno zmanjšanje utrujenosti. av
Improvement in quality of life was measured up to week 156 (36 months) and rod
Izboljšanje kvalitete življenja se je ocenjevalo do 156. tedna (36. meseca).
improvement was maintained through that time.
V tem času se je izboljšanje ohranjalo. nim
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
V študiji V sta se indeks invalidnosti HAQ in telesna komponenta SF 36 ob kombinirani terapiji s Trudexo in metotreksatom po 52 tednih izboljšala bolj (p < 0, 001) kot ob monoterapiji z metotreksatom ali ob monoterapiji s Trudexo; to se je ohranilo do 104. tedna. ilo
Psoriatic arthritis na
Psoriatični artritis rav
Study VI with 24 week duration, i dic
Študija VI je trajala 24 tednov.
treated 313 adult patients who had an inadequate response to non-steroidal anti-inflammatory drug therapy and of these, approximately 50% were taking methotrexate.
Študija VII je trajala Zd
Me
V njej so zdravili 100 bolnikov, ki se niso ustrezno odzvali na imunomodulirajočo terapijo.
ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients)
Odziv ACR v študijah psoriatičnega artritisa, kontroliranih s placebom (odstotek bolnikov)
Response
Študija VI
Placebo
Študija VIII
Trudexa
Odziv ACR 20
Placebo
Placebo N = 162
Trudexa
Trudexa N = 151
N=162
Placebo N = 49
N=151
Trudexa N = 51
Week 12
12. teden 14% 24. teden 15%
16%
16% np
39%
39% * np
Week 24 ACR 50
t me ACR 50
Week 12
12. teden 4% 24. teden 6%
***
36% *** 39% ***
2%
2% np
25%
25% *** np
***
pro
Week 12
12. teden 1%
0% ***
0% *** 0%
Week 24
24. teden 1%
tho *** p < 0.001 for all comparisons between Trudexa and placebo
*** p < 0, 001 za vse primerjave med Trudexo in placebom * p < 0, 05 za vse primerjave med Trudexo in placebom np ne pride v poštev
au ACR responses in Study VI were similar with and without concomitant methotrexate therapy.
za Odzivi ACR v študiji VI so bili podobni ob sočasni terapiji z metotreksatom in brez nje.
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.
Telesno delovanje, ocenjeno s HAQ in SF 36 (Short Form Health Survey), se je pri bolnikih, ki so
r Ankylosing spondylitis
nja dobivali Trudexo, od izhodišča do 24. tedna izboljšalo.
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.
Ankilozirajoči spondilitis lje Trudexo 40 mg vsak drugi teden so ocenili v dveh randomiziranih 24- tedenskih dvojno slepih, s placebom kontroliranih študijah pri 393 bolnikih z aktivnim ankilozirajočim spondilitisom (povprečna izhodiščna ocena aktivnosti bolezni [indeks BASDAI (Bathov indeks bolezenske aktivnosti vo ankilozirajočega spondilitisa – Bath Ankylosing Spondylitis Disease Activity Index)] je bil v vseh skupinah 6, 3), ki se niso odzvali ustrezno na konvencionalno terapijo.
Seventy-nine (20.1%) patients were treated concomitantly with disease modifying anti-rheumatic drugs, and 37 (9.4%) patients with glucocorticoids.
Devetinsedemdeset (20, 1%) bolnikov je sočasno dobivalo imunomodulacijska antirevmatična zdravila, 37 (9, 4%) bolnikov pa do
during which patients received Trudexa 40 mg every other week subcutaneously for up to an additional 28 weeks.
Slepljenemu obdobju je sledilo odprto obdobje, med katerim so bolniki dobivali 40 mg Trudexe vsak drugi teden subkutano, do največ dodatnih 28 tednov.
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
Preiskovanci (n = 215, 54, 7%), ki 12. ali 16. ali 20. teden niso dosegli ASAS 20, so začeli v predčasni odprti fazi dobivati 40 mg adalimumaba vsak drugi teden subkutano, v poznejših statističnih analizah dvojno slepe faza pa eā
In the larger study (VIII) with 315 patients, results showed statistically significant improvement of the signs and symptoms of ankylosing spondylitis in patients treated with Trudexa compared to placebo.
Rezultati obsežnejše študije (VIII) pri 315 bolnikih so pri bolnikih, ki so dobivali Trudexo, pokazali av
Significant response was first observed at Week 2 and maintained through 24 weeks (Table 8). rod
Značilen odziv so najprej opazili po 2 tednih in se je ohranil do 24. tedna (tabela 8). nim ilo rav Zd
Table 8 - Efficacy Responses in Placebo-Controlled AS Study – Study VIII Reduction of Signs and Symptoms lP
17 Tabela 8 - Odzivi učinkovitosti v študiji AS, kontrolirani s placebom - študija VIII Zmanjšanje znakov in simptomov
Response ASASa 20 na
Odziv ASASa 20
dic
t me
BASDAIb 50
nja BASDAIb 50
***, ** 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
***, ** Statistično značilno pri p < 0, 001, < 0, 01 za vse primerjave med Trudexo in placebom po 2, 12 in 24 tednih vo a Ocene pri ankilozirajočem spondilitisu (Assessments in Ankylosing Spondylitis) b Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa (Bath Ankylosing Spondylitis Disease Activity Index) do
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
Bolniki, ki so dobivali Trudexo, so imeli po 12 tednih značilno večje izboljšanje (ki se je ohranilo do 24. tedna) SF36 in ASQoL (Vprašalnik o kakovosti življenja pri ankilozirajočem spondilitisu – Ankylosing Spondylitis Quality of Life Questionnaire). eā
Similar trends (not all statistically significant) were seen in the smaller randomised, double− blind,
Podobni trendi (ki pa niso bili vsi statistično značilni) so bili opazni v manjši, randomizirani, dvojno slepi, s placebom kontrolirani študiji (IX) pri 82 odraslih bolnikih z aktivnim ankilozirajočim av
tho placebo controlled study (IX) of 82 adult patients with active ankylosing spondylitis.
spondilitisom.
Crohn’ s Disease
Crohnova bolezen nim
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.
Varnost in učinkovitost Trudexe so ocenili pri več kot 1400 bolnikih z zmerno do hudo, aktivno Crohnovo boleznijo (indeks aktivnosti Crohnove bolezni [CDAI] ≥ 220 in ≤ 450) v randomiziranih, dvojno slepih, s placebom kontroliranih študijah.
478 of the enrolled patients (32%) were defined as having a
Pri 478 zajetih bolnikih (32%) je bila bolezen opredeljena kot huda (seštevek CDAI > 300 ter sočasno zdravljenje s kortikosteroidom in/ ali ilo
r severe disease (CDAI score > 300 and concomitant corticosteroid and/ or immunosuppressants)
imunosupresivom), kar ustreza populaciji, opredeljeni pri indikacijah (glejte poglavje 4. 1).
Concomitant stable doses of aminosalicylates, corticosteroids, and/ or immunomodulatory agents were permitted and 79% of patients continued to receive at least one of these medications. lon Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies, CLASSIC I and GAIN.
Indukcijo klinične remisije (opredeljene kot CDAI < 150) so ocenili v dveh študijah, CLASSIC I in GAIN.
In GAIN, 325 patients who had lost no
V študiji CLASSIC I so 299 bolnikov, ki pred tem še niso dobivali antagonistov TNF, randomizirali v eno od štirih skupin: placebo 0. in 2. teden, 160 mg Trudexe 0. teden in 80 mg Zd
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.
V študiji GAIN so 325 bolnikov, ki so se nehali odzivati na infliksimab ali ga niso prenesli, randomizirali bodisi na 160 mg Trudexe 0. teden in 80 mg 2. teden bodisi na placebo 0. in 2. teden.
The primary non-responders were excluded from the studies and therefore these patients were not further evaluated. t uc
Študija ni vključila primarno neodzivnih bolnikov in ti tako niso bili dodatno ocenjeni.
Patients in clinical rod
Na 4. teden so bolnike randomizirali na 40 mg 18 vsak drugi teden, 40 mg vsak teden ali placebo; v celoti je študija trajala 56 tednov.
response (decrease in CDAI ≥ 70) at week 4 were stratified and analysed separately from those not in clinical response at week 4.
Bolnike s kliničnim odzivom (znižanje CDAI ≥ 70) 4. teden so stratificirali in analizirali ločeno od bolnikov brez kliničnega odziva 4. teden.
CLASSIC I and GAIN induction of remission and response rates are presented in Table 9. lP Me
Indukcijo remisije in deleže odziva v študijah CLASSIC I in GAIN prikazuje tabela 9.
18 Table 9:
t me Tabela 9:
Induction of Clinical Remission and Response (Percent of Patients)
Indukcija klinične remisije in odziva (odstotek bolnikov)
Naive Patients
Bolniki, ki še niso dobivali infliksimaba
Infliximab Experienced Patients
Bolniki, ki so že dobivali infliksimab
Trudexa 80/ 40 mg
80/ 40 mg n = 75
Trudexa 160/ 80 mg
160/ 80 mg n = 76
Placebo Trudexa N=166 160/ 80 mg
160/ 80 mg n = 159
ed Week 4
za 4. teden
N=76
21% *
ris Clinical remission
Klinična remisija
Clinical response (CR-
Klinični odziv (CR- 100)
tho 100) All p-values are pairwise comparisons of proportions for Trudexa versus placebo * p < 0.001 **
nja Vse vrednosti p so za parne primerjave deležev med Trudexo in placebom. * p < 0, 001 ** p < 0, 01 lje Z indukcijskima shemama 160/ 80 mg in 80/ 40 mg so do 8. tedna ugotovili podobne deleže remisij; neželeni učinki so bili pogostejši v skupini s shemo 160/ 80 mg. vo V študiji CHARM je imelo 4. teden klinični odziv 58% (499/ 854) bolnikov; ti so bili ocenjeni v primarni analizi.
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.
Od tistih, ki so imeli 4. teden klinični odziv, jih je 48% predhodno dobilo drugo do
Of those in clinical response at week 4, 48% had been previously exposed to other anti-TNF therapy.
terapijo proti TNF.
Clinical lon remission results remained relatively constant irrespective of previous TNF antagonist exposure.
Rezultati glede klinične remisije so ostali razmeroma stalni, ne glede na prejšnje prejemanje antagonistov TNF.
Maintenance of Clinical Remission and Response (Percent of Patients) no
(odstotek bolnikov)
40 mg Trudexa
40mg Trudexe
40 mg Trudexa
40 mg Trudexe
Week 26
26. teden Klinična remisija
t
nim
N=170
n = 170 17%
N=172
n = 172 40% *
N=157
n = 157 47% *
Clinical remission
Klinični odziv (CR- 100)
Patients in steroid-free remission rod
Bolniki v remisiji brez steroidov za ≥ 90 dnia
for > =90 daysa Week 56 Clinical remission
56. teden
N=170 12%
n = 170
N=172 36%*
n = 172
N=157 41%*
n = 157
Clinical response (CR-100)
Klinična remisija Klinični odziv (CR- 100)
41%*
36% * 41% *
48%*
41% * 48% *
Patients in steroid-free remission for > =90 daysa na
Bolniki v remisiji brez steroidov rav
* p < 0.001 for Trudexa versus placebo pairwise comparisons of proportions ** p < 0.02 for Trudexa versus placebo pairwise comparisons of proportions a i
za ≥ 90 dnia * p < 0, 001 za parne primerjave deležev med Trudexo in placebom ** p < 0, 02 za parne primerjave deležev med Trudexo in placebom Zd
Of those receiving corticosteroids at baseline dic
a Od tistih, ki so izhodiščno dobivali kortikosteroide.
These results suggest that some patients who have not responded by week 4 benefit from continued maintenance therapy through week Me
To kaže, da lahko nadaljnje zdravljenje do 12. tedna koristi nekaterim bolnikom, ki se ne odzovejo do 4. tedna.
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
19 Kvaliteta življenja Študiji CLASSIC I in GAIN sta pokazali statistično značilno izboljšanje celotnega seštevka po vprašalniku IBDQ (vprašalnik, specifičen za vnetno bolezen črevesa) do 4. tedna pri bolnikih, randomiziranih na shemi s Trudexo 80/ 40 mg in 160/ 80 mg, v primerjavi s placebom; razliko 26. in 56. teden je v skupinah, zdravljenih z adalimumabom, v primerjavi s placebom pokazala tudi študija
19 Trudexa 80/ 40 mg and 160/ 80 mg compared to placebo and was seen at weeks 26 and 56 in CHARM as well among the adalimumab treatment groups compared to the placebo group.
t CHARM.
Immunogenicity
me Imunogenost
Formation of anti-adalimumab antibodies is associated with increased clearance and reduced efficacy
pro Nastanek protiteles proti adalimumabu spremljata večji očistek in manjša učinkovitost adalimumaba.
ris Patients in Studies I, II and III were tested at multiple timepoints for antibodies to adalimumab during the 6 to 12 month period.
Pri bolnikih v študijah I, II in III so v obdobju od 6 do 12 mesecev ob različnih časih večkrat določali protitelesa proti adalimumabu.
In patients not given
V ključnih preskušanjih so protitelesa proti adalimumabu odkrili pri
tho concomitant methotrexate, the incidence was 12.4%, compared to 0.6% when adalimumab was used as add-on to methotrexate.
Pri bolnikih, ki sočasno niso dobivali metotreksata, je bila incidenca 12, 4%, pri tistih, ki so adalimumab uporabljali kot dodatek metotreksatu, pa 0, 6%.
In patients with psoriatic arthritis, adalimumab antibodies were identified in 38/ 376 subjects (10%)
nja Med bolniki s psoriatičnim artritisom so protitelesa proti adalimumabu ugotovili pri 38/ 376 (10%) tistih, ki so dobivali adalimumab.
In patients not given concomitant methotrexate, the incidence was 13.5% (24/ 178 subjects), compared to 7% (14 of 198 subjects) when adalimumab was used as add-on to methotrexate.
Pri bolnikih, ki sočasno niso dobivali metotreksata, je bila incidenca 13, 5% (24/ 178 bolnikov), pri tistih, ki so adalimumab uporabljali kot dodatek metotreksatu, pa 7% (14 lje od 198 bolnikov).
r ge In patients with ankylosing spondylitis antibodies were identified in 17/ 204 subjects (8.3%) treated with adalimumab.
Med bolniki z ankilozirajočim spondilitisom so protitelesa ugotovili pri 17/ 204 (8, 3%) tistih, ki so vo dobivali adalimumab.
In patients not given concomitant methotrexate, the incidence was 16/ 185 (8.6%), compared to 1/ 19 (5.3%) when adalimumab was used as add-on to methotrexate. lon In patients with Crohn’ s disease, adalimumab antibodies were identified in 7/ 269 subjects (2.6%) treated with adalimumab.
Pri bolnikih, ki sočasno niso dobivali metotreksata, je bila incidenca 16/ 185 (8, 6%), pri tistih, ki so adalimumab uporabljali kot dodatek metotreksatu, pa 1/ 19 (5, 3%). do
Because immunogenicity analyses are product-specific, comparison of antibody rates with those from no
Pri bolnikih s Crohnovo boleznijo so identificirali protitelesa proti adalimumabu pri 7 od 269 oseb (2, 6%), ki so bile zdravljene z adalimumabom.
other products is not appropriate.
drugih zdravilih ne pride v poštev.