natgillin/translations-raw huggingface dataset:
p-value is from the pairwise comparison of methotrexate monotherapy and Humira/ methotrexate combination therapy using the Mann-Whitney U test. b p-value is from the pairwise comparison of Humira monotherapy and Humira/ methotrexate combination therapy using the Mann-Whitney U test c p-value is from the pairwise comparison of Humira monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Vrednost p se nanaša na parno primerjavo monoterapije z metotreksatom in kombinirane terapije s Humiro/ metotreksatom z Mann- Whitneyevim testom U. b Vrednost p se nanaša na parno primerjavo monoterapije s Humiro in kombinirane terapije s Humiro/ metotreksatom z Mann- Whitneyevim testom U. c Vrednost p se nanaša na parno primerjavo monoterapije s Humiro in monoterapije z metotreksatom z Mann- Whitneyevim testom U.
At Week 52, 42.9% of patients who received Humira/ methotrexate combination therapy achieved clinical remission (DAS28 < 2.6) compared to 20.6% of patients receiving methotrexate monotherapy and 23.4% of patients receiving Humira monotherapy.
Po 52. tednih je klinično remisijo (DAS28 < 2, 6) doseglo 42, 9% bolnikov, ki so dobivali kombinirano terapijo s Humiro/ metotreksatom, 20, 6% bolnikov, ki so dobivali metotreksat v monoterapiji, in 23, 4% bolnikov, ki so dobivali Humiro v monoterapiji.
Humira/ methotrexate combination therapy was clinically and statistically superior to methotrexate (p < 0.001) and Humira monotherapy (p < 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe rheumatoid arthritis.
Za doseganje nizkega stanja bolezni pri bolnikih z nedavno diagnosticiranim zmernim do hudim revmatoidnim artritisom je bila kombinirana terapija s Humiro in metotreksatom klinično in statistično boljša od monoterapije z metotreksatom (p < 0, 001) in monoterapije s Humiro (p < 0, 001).
The response for the two monotherapy arms was similar (p = 0.447).
V obeh krakih z monoterapijo je bil odziv podoben (p = 0, 447).
In RA study III, where Humira 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 (TSS) and its components, the erosion score and joint space narrowing score.
Okvaro so izrazili kot spremembo modificirane celotne Sharpove ocene (“ Total Sharp Score (TSS) ”) in njenih komponent, ocene erozij in ocene zožitve sklepne špranje.
Humira/ methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see Table 5).
Pri bolnikih, ki so dobivali Humiro in metotreksat, je bilo po 6 in 12 mesecih (glejte tabelo 5) statistično značilno manj rentgenografskih znakov napredovanja kot pri bolnikih, ki so dobivali samo metotreksat.
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.
Podatki iz odprte podaljšane faze kažejo, da se upočasnitev napredovanja strukturne prizadetosti sklepov ohrani vseskozi 60 mesecev v tej podskupini bolnikov.
113/ 207 of patients originally treated with 40 mg Humira every other week were evaluated radiographically at 5 years.
113 od 207 bolnikov, ki so bili zdravljeni s 40 mg Humire vsak drugi teden, so rentgenografsko ocenili po 5- ih letih.
17 Table 5 Radiographic Mean Changes Over 12 Months in RA Study III
Povprečne rentgenografske spremembe v 12 mesecih študije pri revmatoidnem artritisu III
Placebo/ MTXa
placebo /
Placebo/ MTX- HUMIRA/ MTX
placebo/ MTX -
week
40 mg vsak drugi teden
(95% Confidence Intervalb)
HUMIRA/ MTX (95% interval zaupanjab)
a
0, 1
Total Sharp Score Erosion score JSNd score
Ocena erozij d
2.7 1.6 1.0
1, 6 (0, 9, 2, 2)
0.1 0.0 0.1
0, 001
2.6 (1.4, 3.8) 1.6 (0.9, 2.2) 0.9 (0.3, 1.4)
Ocena ZSŠ a metotreksat b
methotrexate b 95% confidence intervals for the differences in change scores between methotrexate and Humira. c Based on rank analysis d Joint Space Narrowing
95% intervali zaupanja za razlike v spremembi ocen med metotreksatom in Humiro c na podlagi analize rangov d zožitev sklepne špranje
In RA study V, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (see Table 6).
V študiji pri revmatoidnem artritisu V so strukturno okvaro sklepov ocenili rentgenografsko in jo izrazili kot razliko v modificirani celotni Sharpovi oceni (glejte tabelo 6).
Table 6 Radiographic Mean Changes at Week 52 in RA Study V
Povprečne rentgenografske spremembe po 52 tednih študije pri revmatoidnem artritisu V
Humira/ MTX
Humira/ MT Humira MTX
n=274
Odziv
(95%
Pb
(95%
Pc
(95%
(95% interval
p-valuea
zaupanja)
p-valueb
zaupanja)
p-valuec
zaupanja)
confidence confidence interval) interval)
Celotna Sharpova ocena
Total Sharp Score
Ocena erozij
3.0 (1.7-4.3)
3, 0 (1, 0- 2, 4)
Erosion score JSN score a
Seštevek 2, 0 JSN a
3.7 (2.7-4.7) 2.0 (1.2-2.8)
(1, 2- 2, 8)
< 0.001 0.151
< 0, 151
p-value is from the pairwise comparison of methotrexate monotherapy and Humira/ methotrexate combination therapy using the Mann-Whitney U test. b p-value is from the pairwise comparison of Humira monotherapy and Humira/ methotrexate combination therapy using the Mann-Whitney U test c p-value is from the pairwise comparison of Humira monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Vrednost p se nanaša na parno primerjavo monoterapije z metotreksatom in kombinirane terapije s Humiro/ metotreksatom z Mann- Whitneyevim testom U b Vrednost p se nanaša na parno primerjavo monoterapije s Humiro in kombinirane terapije s Humiro/ metotreksatom z Mann- Whitneyevim testom U c Vrednost p se nanaša na parno primerjavo monoterapije s Humiro in monoterapije z metotreksatom z Mann- Whitneyevim testom U.
Quality of life and physical function
18 Kakovost življenja in telesna funkcija
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 RA study III.
Z zdravjem povezano kakovost življenja in telesno funkcijo so v štirih originalnih ustreznih in dobro kontroliranih študijah ocenjevali z indeksom invalidnosti z vprašalnikom HAQ (Health Assessment Questionnaire) in je bila v študiji pri revmatoidnem artritisu III vnaprej določena primarna končna točka po 52 tednih.
All doses/ schedules of Humira 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 RA study III the same was seen at Week 52.
V vseh štirih študijah se je indeks invalidnosti po vprašalniku HAQ od izhodišča do 6. meseca z vsemi odmerki/ shemami Humire izboljšal statistično značilno bolj kot s placebom; v študiji pri revmatoidnem artritisu III so isto ugotovili po 52 tednih.
Results from the Short Form Health Survey (SF 36) for all doses/ schedules of Humira in all four studies support these findings, with statistically significant physical component summary (PCS) scores, as well as statistically significant pain and vitality domain scores for the 40 mg every other week dose.
Te izsledke podpirajo rezultati SF 36 (Short Form Health Survey) za vse odmerke/ sheme Humire v vseh štirih študijah, s statistično značilnim seštevkom PCS (Physical 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 (RA studies I, III, IV).
V vseh treh študijah (študije pri revmatoidnem artritisu I, III in IV), v katerih so ocenjevali utrujenost s funkcijsko oceno terapije kronične bolezni (functional assessment of chronic illness therapy (FACIT)), so ugotovili statistično značilno zmanjšanje utrujenosti.
18 In RA study III, improvement in physical function was maintained through Week 260 (60 months) of open-label treatment.
V študiji pri revmatoidnem artritisu III se je izboljšanje telesne funkcije ohranilo vseskozi do 206. tedna (60. meseca) odprte faze zdravljenja.
Improvement in quality of life was measured up to Week 156 (36 months) and improvement was maintained through that time.
V tem času se je izboljšanje tudi ohranjalo.
In RA study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p < 0.001) for Humira/ methotrexate combination therapy versus methotrexate monotherapy and Humira monotherapy at Week 52, which was maintained through Week 104.
V študiji pri revmatoidnem artritisu V sta se indeks invalidnosti HAQ in telesna komponenta SF 36 ob kombinirani terapiji s Humiro in metotreksatom po 52 tednih izboljšala bolj (p < 0, 001) kot ob monoterapiji z metotreksatom ali ob monoterapiji s Humiro; to se je ohranilo do 104. tedna.
Polyarticular juvenile idiopathic arthritis (JIA)
Poliartikularni juvenilni idiopatski artritis
The safety and efficacy of Humira were assessed in a multicentre, randomised, double-blind, parallel − group study in 171 children (4-17 years old) with polyarticular JIA.
Varnost in učinkovitost Humire so ocenili v multicentrični randomizirani dvojno slepi študiji vzporednih skupin pri 171 otrocih (starih od 4 do 17 let) s poliartikularnim juvenilnim idiopatskim artritisom.
Patients who were in the non-MTX stratum were either naïve to or had been withdrawn from MTX at least two weeks prior to study drug administration.
Bolniki v stratumu brez metotreksata le- tega sploh še niso dobivali ali so ga nehali dobivati vsaj dva tedna pred uporabo raziskovanega zdravila.
Patients remained on stable doses of NSAIDs and or prednisone (≤ 0.2 mg / kg/ day or 10 mg/ day maximum).
Bolniki so ostali na stabilnih odmerkih nesteroidnih protivnetnih zdravil in/ ali prednizona (≤ 0, 2 mg/ kg/ dan ali največ 10 mg/ dan).
In the OL LI phase all patients received 24 mg/ m2 up to a maximum of 40 mg Humira every other week for 16 weeks.
V odprti uvajalni fazi so vsi bolniki 16 tednov dobivali 24 mg/ m2 (do največ 40 mg) Humire vsak drugi teden.
The distribution of patients by age and minimum, median and maximum dose received during the OL LI phase is presented in Table 7.
Tabela 7 prikazuje porazdelitev bolnikov po starosti ter najmanjšem, srednjem in največjem odmerku, prejetem med odprto uvajalno fazo.
Table 7 Distribution of patients by age and adalimumab dose received during the OL LI phase
Tabela 7 Porazdelitev bolnikov po starosti in odmerku adalimumaba, ki so ga dobivali med odprto uvajalno fazo
4 to 7 years 8 to 12 years 13 to 17 years
4 do 7 let 8 do 12 let 13 do 17 let
10, 20 and 25 mg 20, 25 and 40 mg 25, 40 and 40 mg
10, 20 in 25 mg 20, 25 in 40 mg 25, 40 in 40 mg
Patients demonstrating a Pediatric ACR 30 response at Week 16 were eligible to be randomised into the double blind (DB) phase and received either Humira 24 mg/ m2 up to a maximum of 40 mg, or placebo every other week for an additional 32 weeks or until disease flare.
Bolniki, ki so 16. teden dosegli odziv » Pediatric ACR « 30, so bili primerni za randomizacijo v dvojno slepo fazo in so nadaljnjih 32 tednov ali do širjenja bolezni vsak drugi teden dobili Humiro 24 mg/ m2 (do največ 40 mg) ali placebo.
Disease flare criteria were defined as a worsening of ≥ 30% from baseline in ≥ 3 of 6 Pediatric ACR core criteria, ≥ 2 active joints, and improvement of > 30% in no more than 1 of the 6 criteria.
Merila širjenja bolezni so bila opredeljena kot poslabšanje ≥ 3 od 6 osnovnih meril » Pediatric ACR « za ≥ 30% v primerjavi z izhodiščem, ≥ 2 aktivna sklepa in izboljšanje ne več kot 1 od 6 meril za > 30%.
After 32 weeks or at disease flare, patients were eligible to enrol into the open label extension phase
Po 32 tednih ali v primeru širjenja bolezni so bili bolniki primerni za vključitev v odprto podaljšano fazo.
19 Table 8 Ped ACR Responses in the JIA study
19 Tabela 8 Odzivi » Pediatric ACR (Ped ACR) « v študiji pri juvenilnem idiopatskem artritisu
Stratum Phase OL-LI 16 weeks
Stratum Faza Odprta uvajalna faza 16 tednov
MTX
Metotreksat
Ped ACR 30 response (n/ N)
Odziv » Ped ACR « 30 (n/ N)
Double
Dvojno slepa
Disease flares at the end of 32 weeksa (n/ N)
64, 9% (24/ 37) b
36.8% (14/ 38)
71, 4% (20/ 28) c
64.9% (24/ 37)b
Širjenje bolezni na koncu 32- tedenskega obdobjaa (n/ N)
71.4% (20/ 28)c
43, 3% (13/ 30)
Median time to disease flare
Srednji čas do širjenja bolezni
Ped ACR 30/ 50/ 70 responses week 48 significantly greater than those of placebo treated patients b p = 0.015 c p = 0.031
Odzivi » Ped ACR « 30/ 50/ 70 so bili 48. teden značilno večji kot pri bolnikih, ki so dobivali placebo b p = 0, 015 c p = 0, 031
Amongst those who responded at Week 16 (n=144), the Pediatric ACR 30/ 50/ 70/ 90 responses were maintained for up to two years in the OLE phase in patients who received Humira throughout the study.
Med bolniki, ki so se odzvali 16. teden (n = 144), so se odzivi » Pediatric ACR « 30/ 50/ 70/ 90 v odprti podaljšani fazi ohranili do 2 leti pri tistih, ki so ves čas študije dobivali Humiro.
Overall responses were generally better and, fewer patients developed antibodies when treated with the combination of Humira and MTX compared to Humira alone.
Celotni odzivi so bili med zdravljenjem s kombinacijo Humire in metotreksata na splošno boljši in pri manj bolnikih so se pojavila protitelesa kot med zdravljenjem s Humiro samo.
Taking these results into consideration, Humira is recommended for use in combination with MTX and for use as monotherapy in patients for whom MTX use is not appropriate (see section 4.2).
Z upoštevanjem teh ugotovitev je Humiro priporočljivo uporabljati v kombinaciji z metotreksatom, kot monoterapijo pa pri bolnikih, za katere uporaba metotreksata ni primerna (glejte poglavje 4. 2).
Humira, 40 mg every other week, was studied in patients with moderately to severely active psoriatic arthritis in two placebo-controlled studies, PsA studies I and II.
Uporabo Humire 40 mg vsak drugi teden so pri bolnikih z zmernim do zelo aktivnim psoriatičnim artritisom proučili v dveh s placebom kontroliranih študijah, študijah pri psoriatičnem artritisu I in II.
PsA study I with 24 week duration, treated 313 adult patients who had an inadequate response to non-steroidal anti-inflammatory drug therapy and of these, approximately 50% were taking methotrexate.
V njej so zdravili 313 odraslih, ki se niso ustrezno odzvali na terapijo z nesteroidnimi protivnetnimi zdravili; približno 50% od teh je jemalo metotreksat.
PsA study II with 12- week duration, treated 100 patients who had an inadequate response to DMARD therapy.
V njej so zdravili 100 bolnikov, ki se niso ustrezno odzvali na imunomodulirajočo terapijo.
Upon completion of both studies, 383 patients enrolled in an open-label extension study, in which 40 mg Humira was administered eow.
Po koncu obeh študij so 383 bolnikov vključili v odprto nadaljevalno študijo, med katero so bolniki dobivali 40 mg Humire vsak drugi teden.
There is insufficient evidence of the efficacy of Humira in patients with ankylosing spondylitis-like psoriatic arthropathy due to the small number of patients studied.
Zaradi majhnega števila bolnikov ni dovolj dokazov o učinkovitosti Humire pri bolnikih s psoriatično artropatijo, podobno ankilozirajočemu spondilitisu.
20 Table 9 ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients)
20 Tabela 9:
ACR 20
Odziv ACR v študijah pri psoriatičnem artritisu, kontroliranih s placebom (odstotek bolnikov) Študija pri psoriatičnem artritisu I Študija pri psoriatičnem artritisu II Odziv ACR 20
N=162
placebo n = 162
N=151
Humira placebo n = 151 n = 49
N=49
Humira n = 51
N=51
ACR 50
Week 12 Week 24 ACR 50
12. teden 24. teden
16% N/ A
16% np
39%* N/ A
39% * np
Week 24 ACR 70
ACR 70
N/ A
np
Week 12 Week 24
12. teden
20%*** 23%***
2
0% N/ A
0% *** 0%
*** p < 0.001 for all comparisons between Humira and placebo
24. teden
p < 0.05 for all comparisons between Humira and placebo
np
N/ A not applicable
np
Radiographs of hands, wrists, and feet were obtained at baseline and Week 24 during the double-blind period when patients were on Humira or placebo and at Week 48 when all patients were on open-label Humira.
Rentgenske posnetke dlani, zapestij in stopal so naredili izhodiščno in 24. teden med dvojno slepim obdobjem, med katerim so bolniki dobivali Humiro ali placebo, in 48. teden, ko so vsi bolniki odprto dobivali Humiro.
A modified Total Sharp Score (mTSS), which included distal interphalangeal joints (i. e., not identical to the TSS used for rheumatoid arthritis), was used.
Za oceno so uporabili modificirani celotni seštevek po Sharpu (modified Total Sharp Score, mTSS), ki je vključil distalne interfalangealne sklepe (tj. ni bil enak TSS, ki se uporablja za revmatoidni artritis).
Humira treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS (mean ± SD) 0.8 ± 2.5 in the placebo group (at Week 24) compared with 0.0 ± 1.9; (p < 0.001) in the Humira group (at Week 48).
Sprememba je bila (povprečje ± standardni odklon) 0, 8 ± 2, 5 v skupini s placebom (po 24 tednih) in 0, 0 ± 1, 9; (p < 0, 001) v skupini s Humiro (po 48 tednih).
In subjects treated with Humira with no radiographic progression from baseline to Week 48 (n=102), 84% continued to show no radiographic progression through 144 weeks of treatment.
Pri 84% preiskovancev, ki so dobivali Humiro in od izhodišča do 48. tedna niso imeli rentgenografsko vidnega napredovanja (n = 102), se takšno napredovanje tudi do 144. tedna zdravljenja ni pojavilo.
Humira treated patients demonstrated statistically significant improvement in physical function as assessed by HAQ and Short Form Health Survey (SF 36) compared to placebo at Week 24.
Ob zdravljenju s Humiro so v primerjavi s placebom 24. teden ugotovili statistično značilno izboljšanje telesnega delovanja, ocenjeno s HAQ in vprašalnikom SF 36 (Short Form Health Survey).
Humira 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 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.
Humiro 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 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 glukokortikoide.
The blinded period was followed by an open − label period during which patients received Humira 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 Humire 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.
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 so bili obravnavani kot neodzivni bolniki.
In the larger AS study I with 315 patients, results showed statistically significant improvement of the signs and symptoms of ankylosing spondylitis in patients treated with Humira compared to placebo.
21 Rezultati obsežnejše študije pri ankilozirajočem spondilitisu I pri 315 bolnikih so pri bolnikih, ki so dobivali Humiro, pokazali statistično značilno izboljšanje znakov in simptomov ankilozirajočega spondilitisa v primerjavi s placebom.
Significant response was first observed at Week 2 and maintained through 24 weeks (Table 10).
Značilen odziv so najprej opazili po 2 tednih in se je ohranil do 24. tedna (tabela 10).
21 Table 10– Efficacy Responses in Placebo-Controlled AS Study – Study I Reduction of Signs and Symptoms
Tabela 10 - Odzivi učinkovitosti v študiji pri ankilozirajočem spondilitisu, kontrolirani s placebom - študija I Zmanjšanje znakov in simptomov
Response ASASa 20
20
Placebo N=107
placebo n = 107
Humira N=208
Humira n = 208
Week 2 Week 12 Week 24 ASAS 50
2. teden 12. teden 24. teden
Week 2 Week 12 Week 24 ASAS 70
2. teden 12. teden 24. teden
Week 2 Week 12 Week 24
2. teden
***, ** Statistically significant at p < 0.001, < 0.01 for all comparisons between Humira and placebo at Weeks 2, 12 and 24 a ASsessments in Ankylosing Spondylitis b Bath Ankylosing Spondylitis Disease Activity Index
***, ** Statistično značilno pri p < 0, 001, < 0, 01 za vse primerjave med Humiro 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)
Humira 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 (ASQoL).
Bolniki, ki so dobivali Humiro, 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).
The safety and efficacy of Humira 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 Humire so ocenili pri več kot 1400 bolnikih z zmerno do zelo 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 severe disease (CDAI score > 300 and concomitant corticosteroid and/ or immunosuppressants) 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.
Dovoljena je bila sočasna uporaba stabilnih odmerkov aminosalicilatov, kortikosteroidov in/ ali imunomodulacijskih zdravil; 79% bolnikov je še naprej prejemalo vsaj eno od takšnih zdravil.
In CD Study I, 299 TNF-antagonist naive patients were randomised to one of four treatment groups; placebo at Weeks 0 and 2, 160 mg Humira 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.
22 skupin: placebo 0. in 2. teden, 160 mg Humire 0. teden in 80 mg 2. teden, 80 mg 0. teden in 40 mg 2. teden oziroma 40 mg 0. teden in 20 mg 2. teden.
In CD Study II, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg Humira at Week 0 and 80 mg at Week 2 or placebo at weeks 0 and 2.
V študiji pri Crohnovi bolezni II so 325 bolnikov, ki so se nehali odzivati na infliksimab ali ga niso prenesli, randomizirali bodisi na 160 mg Humire 0. teden in 80 mg 2. teden bodisi na placebo 0. in 2. teden.