natgillin/translations-raw huggingface dataset:
52 In the twelve controlled trials, 16% of patients treated with Trudexa developed injection site reactions (erythema and/ or itching, haemorrhage, pain or swelling), compared to 10% of patients receiving placebo or active control.
V dvanajstih kontroliranih preskušanjih je reakcije na mestu injiciranja (eritem in/ ali srbenje, krvavitve, bolečine ali oteklost) imelo 16% bolnikov, ki so dobivali Trudexo, in 10% bolnikov, ki so dobivali placebo ali kontrolno učinkovino.
tho The incidence of serious infections was 0.03 per patient year in Trudexa treated patients and 0.03 per patient year in placebo and active control− treated patients.
52 Incidenca resnih okužb je bila 0, 03 na bolnik- leto med bolniki, ki so dobivali Trudexo, in 0, 03 na bolnik- leto med bolniki, ki so dobivali placebo oziroma kontrolno učinkovino.
In controlled and open label studies with Trudexa, serious infections (including fatal infections, which
V kontroliranih in odprtih študijah s Trudexo so poročali o resnih okužbah (vključno s smrtno nevarnimi, ki so se pojavile redko), med katerimi so bile tuberkuloza (tudi miliarna in zunajpljučna) in
au occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e. g. disseminated histoplasmosis, pneumocystis carinii pneumonia, aspergillosis and listeriosis).
t invazivne oportunistične okužbe (npr. diseminirana histoplazmoza, pljučnica zaradi Pnevmocystis
the reported rate of malignancies other than lymphomas and non-melanoma skin cancers is approximately 1.7 per 1000 patient years.
Stanje bolnikovo se je po prekinitvi zdravljenja izboljšalo.
53 improved following discontinuation of therapy.
53 Klinična preskušanja pri psoriatičnem artritisu:
Adverse Reaction reactivation of hepatitis B demyelinating disorders (e. g. optic neuritis) interstitial lung disease, including pulmonary
Bolezni dihal, prsnega koša in mediastinalnega fibrozo prostora vo kožni vaskulitis Bolezni kože in podkožja
54 Pharmacodynamic effects
Farmakodinamični učinki
r ge years old, had failed therapy with at least one disease-modifying, anti rheumatic drug and had insufficient efficacy with methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexate-intolerant) every week and whose methotrexate dose remained constant at 10 to 25 mg every week.
nja metotreksat) vsak teden ni bil dovolj učinkovit in pri katerih je odmerek od 10 do 25 mg metotreksata ostal stalen vsak teden.
Study III evaluated 619 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 t uc
Raziskava III je ocenila 619 bolnikov z zmerno do hudo aktivnim revmatoidnim artritisom, starih ≥ 18 let, pri katerih metotreksat v odmerkih od 12, 5 do 25 mg (10 mg, če so bili intolerantni za metotreksat) vsak teden ni bil dovolj učinkovit in pri katerih je odmerek metotreksata ostal stalen od 12, 5 do 25 mg eā
The first received placebo injections every week for 52 weeks. rod
vsak teden.
Thereafter, patients enrolled in an open-label extension phase in which 40 mg of Trudexa was administered every other week up to 60 months. lP
Potem so bolnike vključili v odprto nadaljevalno fazo, av
Study IV primarily assessed safety in 636 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old.
med katero so dobivali 40 mg Trudexe vsak drugi teden v obdobju do 60 mesecev.
Patients were permitted to be either disease-modifying, na
Raziskava IV je v prvi vrsti ocenila varnost pri 636 bolnikih z zmerno do hudo aktivnim revmatoidnim nim
55 additional primary endpoint at 52 weeks of retardation of disease progression (as detected by X-ray results).
V študijah III in V je bila dodatna primarna končna točka po 52 tednih upočasnitev napredovanja bolezni (ugotovljena z izvidi rentgenskega slikanja).
ACR response
55 Odziv po ACR
13.3% NA
13, 3% 65, 1%
65.1% NA
19, 1%
19.1% NA
46, 0% 29, 5%
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).
In Studies I-IV, Trudexa-treated patients achieved statistically significant ACR 20 and 50 responses na
V študijah I– IV so bolniki, zdravljeni s Trudexo, v primerjavi s prejemniki placeba doživeli statistično nim
compared to placebo as early as one to two weeks after initiation of treatment.
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 zgodnim revmatoidnim artritisom, ki še niso dobivali metotreksata, je kombinirana terapija s Trudexo in metotreksatom po 52 tednih prinesla hitrejše in značilno večje odzive ACR kakor monoterapija z metotreksatom ali monoterapija s Trudexo, odzivi pa so se ohranili ilo
Me
do 104. tedna (glejte tabelo 4).
ACR Responses in Study V (percent of patients)
(odstotek bolnikov)
Trudexa
vrednost
Response
vrednost
n=257
odziv Zd
n=268 ACR 20
pb
56
pc
54.4% 49.3%
104. teden
72.8% 69.4%
49, 3%
0.013 0.002
69, 4%
41.2% 36.9%
104. teden
ris combination therapy using the Mann-Whitney U test. b. p-value is from the pairwise comparison of Trudexa monotherapy and Trudexa/ methotrexate
t me b 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 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 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.
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.
za terapija s Trudexo in metotreksatom klinično in statistično boljša od monoterapije z metotreksatom (p < 0, 001) in monoterapije s Trudexo (p < 0, 001).
Trudexa/ methotrexate combination therapy was clinically and statistically superior to methotrexate (p < 0.001) and Trudexa monotherapy
V obeh krakih z monoterapijo je bil odziv podoben (p = 0, 447).
r (p < 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe
nja Rentgenografski odziv
ge rheumatoid arthritis.
Bolniki, ki so v raziskavi III dobivali Trudexo, so imeli revmatoidni artritis v povprečju približno 11 lje let.
The response for the two monotherapy arms was similar (p = 0.447).
V raziskavi so strukturno prizadetost sklepov ocenjevali rentgenografsko.
Data from the open-label extension phase indicate that the reduction in rate of progression of structural damage is maintained for 60 months in a subset of patients.
strukturne prizadetosti sklepov ohrani vseh vseh 60 mesecev v tej podskupini bolnikov.
113/ 207 of patients originally treated with 40 mg Humira every t
113 od 207 bolnikov, ki so bili zdravljeni s 40 mg Trudexe vsak drugi teden, so rentgenografsko ocenili po 5- ih letih.
Among those, 66 patients showed no uc
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 av
lP
X
MTXa
nim
Intervalb)
(95% interval zaupanjab)
< 0.001c < 0.001
Ocena erozij Ocena ZSŠd a metotreksat b
JSNd score
1, 6 1, 0
methotrexate b 95% confidence intervals for the differences in change scores between methotrexate and Trudexa. i
0, 001 0, 002
c Based on rank analysis dic
95% intervali zaupanja za razlike v spremembi ocen med metotreksatom in Trudexo ilo
d Joint Space Narrowing
c na podlagi analize rangov d zožitev sklepne špranje rav
MTX
Trudexa/ MT
n=257
X
X
vrednost
p-valueb
vrednost
(95% confidence
pc
(95% confidence
(95% interval (95% interval zaupanja)
(95%
celotna
confidence
5, 7 (4, 2- 7, 3) 3, 0 (1, 7- 4, 3)
Total Sharp score
Sharpova ocena
5.7 (4.2-7.3)
ocena erozij
Erosion score JSN score
seštevek JSN a
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
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 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.
Quality of life and physical function
za Kakovost življenja in telesna funkcija
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.
nja kontroliranih raziskavah ocenjevali z indeksom invalidnosti z vprašalnikom HAQ (Health Assessment Questionnaire) in je bila v raziskavi III vnaprej določena primarna končna točka 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.
V vseh štirih raziskavah se je indeks invalidnosti po vprašalniku HAQ od izhodišča do 6. meseca z vsemi lje odmerki/ shemami Trudexe izboljšal statistično značilno bolj kot s placebom; v raziskavi III so isto ugotovili po 52 tednih.
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
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 vo Component Summary) in statistično značilnima seštevkoma za področje bolečin in vitalnosti za odmerek 40 mg vsak drugi teden.
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
illness therapy (FACIT)), so ugotovili statistično značilno zmanjšanje utrujenosti.
Improvement in quality of life was measured up to week 156 (36 months) and rod
V tem času se eā
improvement was maintained through that time.
je izboljšanje ohranjalo.
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 av
methotrexate monotherapy and Trudexa monotherapy at week 52, which was maintained through week 104.
metotreksatom ali ob monoterapiji s Trudexo; to se je ohranilo do 104. tedna.
Psoriatic arthritis na
Psoriatični artritis nim
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 ilo
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).
Zaradi majhnega števila bolnikov ni dovolj dokazov o učinkovitosti Trudexe pri bolnikih s psoriatično rav
Table 7:
artropatijo, podobno ankilozirajočemu spondilitisu (glejte tabelo 7).
ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients)
Odziv ACR v študijah psoriatičnega artritisa, kontroliranih s placebom (odstotek bolnikov) Zd
Response
Odziv ACR 20
Week 24 ACR 50
24. teden
***
ACR 50
Week 12
12. teden 24. teden
4%
4% 6%
p < 0.05 for all comparisons between Trudexa and placebo
pro Odzivi ACR v študiji VI so bili podobni ob sočasni terapiji z metotreksatom in brez nje.
r Ankylosing spondylitis
za Ankilozirajoči spondilitis
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.
nja placebom kontroliranih študijah pri 393 bolnikih z aktivnim ankilozirajočim spondilitisom (povprečna izhodiščna ocena aktivnosti bolezni [indeks BASDAI (Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa – Bath Ankylosing Spondylitis Disease Activity Index)] je bil v vseh lje skupinah 6, 3), ki se niso odzvali ustrezno na konvencionalno terapijo.
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 vo 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 do
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 statistično značilno izboljšanje znakov in simptomov ankilozirajočega spondilitisa v primerjavi s eā
Table 8 - Efficacy Responses in Placebo-Controlled AS Study – Study VIII Reduction of Signs and Symptoms lP
Tabela 8 - Odzivi učinkovitosti v študiji AS, kontrolirani s placebom - študija VIII av
Response ASASa 20 na
Zmanjšanje znakov in simptomov
Placebo N=107
placebo
dic
20
i
n =
ASAS 70
ASAS 70 Zd
***, ** 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 a Ocene pri ankilozirajočem spondilitisu (Assessments in Ankylosing Spondylitis) b Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa (Bath Ankylosing Spondylitis Disease Activity Index)
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
t me 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).
tho placebo controlled study (IX) of 82 adult patients with active ankylosing spondylitis.
pro 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 spondilitisom.
Crohn’ s Disease
za Crohnova bolezen
478 of the enrolled patients (32%) were defined as having a
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,
r severe disease (CDAI score > 300 and concomitant corticosteroid and/ or immunosuppressants)
nja dvojno slepih, s placebom kontroliranih študijah.
ge corresponding to the population defined in the indication (see section 4.1).
Pri 478 zajetih bolnikih (32%) je bila bolezen opredeljena kot huda (seštevek CDAI > 300 ter sočasno zdravljenje s kortikosteroidom in // ali 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.
Dovoljena lje je bila sočasna uporaba stabilnih odmerkov aminosalicilatov, kortikosteroidov in/ ali imunomodulacijskih zdravil; 79% bolnikov je še naprej prejemalo vsaj eno od takšnih zdravil. vo 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 do
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. eā
Patients in clinical rod
Na 4. teden so bolnike randomizirali na 40 mg av
Corticosteroid taper was permitted after week 8.
Po 8. tednu je bilo dovoljeno postopno zmanjševanje kortikosteroida. nim
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. ilo rav Zd
60 Table 9:
60 Tabela 9:
Placebo Trudexa N=74 80/ 40 mg
Bolniki, ki še niso dobivali infliksimaba placebo Trudexa Trudexa
Trudexa 160/ 80 m
Bolniki, ki so že dobivali placebo
Placebo Trudexa N=166 160/ 80 mg
infliksimab Trudexa
ed Week 4
t me 4. teden
N = 75
80/ 40 mg n = 75
g N=76
n = 166
tho 100) All p-values are pairwise comparisons of proportions for Trudexa versus placebo * p < 0.001 **
Vse vrednosti p so za parne primerjave deležev med Trudexo in placebom. * p < 0, 001
au p < 0.01
za ** p < 0, 01
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.
Z indukcijskima shemama 160/ 80 mg in 80/ 40 mg so do 8. tedna ugotovili podobne deleže remisij;
Of those in clinical response at week 4, 48% had been previously exposed to other anti-TNF therapy.
Od tistih, ki so imeli 4. teden klinični odziv, jih je 48% predhodno dobilo drugo lje terapijo proti TNF.
Table 10:
Rezultati glede klinične remisije so ostali razmeroma stalni, ne glede na prejšnje prejemanje antagonistov TNF. vo Tabela 10:
Maintenance of Clinical Remission and Response (Percent of Patients) no
Vzdrževanje klinične remisije in odziva (odstotek bolnikov) do
Clinical remission
Klinična remisija Klinični odziv (CR- 100)
Patients in steroid-free remission rod
Bolniki v remisiji brez steroidov av
for > =90 daysa Week 56 Clinical remission
za ≥ 90 dnia 56. teden Klinična remisija
lP
nim
N=170 12%
n = 170 12%
N=172 36%*
n = 172 36% *
N=157 41%*
n = 157 41% *
Clinical response (CR-100)
Klinični odziv (CR- 100)
20%
*
* p < 0.001 for Trudexa versus placebo pairwise comparisons of proportions ** p < 0.02 for Trudexa versus placebo pairwise comparisons of proportions a i
p < 0, 001 za parne primerjave deležev med Trudexo ilo
Of those receiving corticosteroids at baseline dic
** p < 0, 02 za parne primerjave deležev med Trudexo in placebom a Od tistih, ki so izhodiščno dobivali kortikosteroide. rav
These results suggest that some patients who have not responded by week 4 benefit from continued maintenance therapy through week Me
Zdravljenje prek Zd
Therapy continued beyond 12 weeks did not result in significantly more responses (see section 4.2).
12. tedna ni prineslo značilno več odzivov (glejte poglavje 4. 2).
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
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 61 56. teden je v skupinah, zdravljenih z adalimumabom, v primerjavi s placebom pokazala tudi študija CHARM.
There is no apparent correlation between the presence of anti-adalimumab antibodies and adverse events.
t Med prisotnostjo protiteles proti adalimumabu in neželenimi učinki ni očitne korelacije.
ris Patients in Studies I, II and III were tested at multiple timepoints for antibodies to adalimumab during the 6 to 12 month period.
me 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 58/ 1053 (5, 5%) bolnikov, zdravljenih z adalimumabom, in pri 2/ 370 (0, 5%), ki so dobivali placebo.
tho concomitant methotrexate, the incidence was 12.4%, compared to 0.6% when adalimumab was used as add-on to methotrexate.
pro 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%)
Med bolniki s psoriatičnim artritisom so protitelesa proti adalimumabu ugotovili pri 38/ 376 (10%)
au treated with adalimumab.
za tistih, ki so dobivali adalimumab.
r ge In patients with ankylosing spondylitis antibodies were identified in 17/ 204 subjects (8.3%) treated with adalimumab.
nja Med bolniki z ankilozirajočim spondilitisom so protitelesa ugotovili pri 17/ 204 (8, 3%) tistih, ki so 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%). lje Pri bolnikih s Crohnovo boleznijo so identificirali protitelesa proti adalimumabu pri 7 od 269 oseb (2, 6%), ki so bile zdravljene z adalimumabom. vo Ker so analize imunogenosti specifične za posamezno zdravilo, primerjava z deleži protiteles pri drugih zdravilih ne pride v poštev. do
After subcutaneous administration of a single 40 mg dose, absorption and distribution of adalimumab uc
Po subkutani uporabi enega samega 40 mg odmerka sta bili absorpcija in distribucija adalimumaba eā
was slow, with peak serum concentrations being reached about 5 days after administration.
počasni in največja koncentracija v serumu je bila dosežena približno 5 dni po uporabi.
The average absolute bioavailability of adalimumab estimated from three studies following a single 40 mg rod
Povprečna absolutna biološka uporabnost adalimumaba, ocenjena iz treh raziskav po enem 40 mg odmerku subkutano, je 64%.
subcutaneous dose was 64%.
sorazmerne odmerku.