natgillin/translations-raw huggingface dataset:
Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis Studies I− V.
V študijah revmatoidnega artritisa I−V so pri bolnikih so ob več različnih časih testirali protitelesa v serumu.
In these trials, 11.9% of patients treated with Trudexa and 8.1% of placebo and active control− treated patients that had negative baseline anti-nuclear antibody titres reported positive titres at week 24.
V teh preskušanjih so pozitivne titre protijedrnih protiteles po 24 tednih ugotovili pri 11, 9% prejemnikov Trudexe in 8, 1% prejemnikov placeba in kontrolne učinkovine, ki so imeli izhodiščno negativne titre teh protiteles.
The patients
V vseh študijah revmatoidnega artritisa in psoriatičnega artritisa so se nim
32 improved following discontinuation of therapy.
Stanje bolnikov se je po prekinitvi zdravljenja izboljšalo.
Liver Enzyme Elevations
Zvišanje jetrnih encimov ilo
Rheumatoid arthritis clinical trials: in controlled rheumatoid arthritis clinical trials (Studies I− IV),
V kontroliranih kliničnih preskušanjih pri revmatoidnem artritisu (študije I−IV) so bila zvišanja ALT pri bolnikih, ki so dobivali adalimumab, rav
ed elevations of ALT were similar in patients receiving adalimumab or placebo.
podobna kot pri tistih, ki so dobivali placebo.
In patients with early rheumatoid arthritis (disease duration of less than 3 years) (Study V), elevations of ALT were more common in the combination arm (Trudexa / methotrexate) compared to the methotrexate monotherapy
Zd
ris arm or the Trudexa monotherapy arm.
Klinična preskušanja pri psoriatičnem artritisu:
Psoriatic arthritis clinical trials: elevations in ALT were more common in psoriatic arthritis patients
V vseh študijah (I– VII) so bili bolniki, ki so imeli zvišano ALT, asimptomatski; zvišanje je bilo večinoma prehodno in je med nadaljevanjem zdravljenja minilo.
tho (Studies VI-VII) compared with patients in rheumatoid arthritis clinical studies.
V kontroliranih kliničnih preskušanjih je bilo zvišanje ALT podobno pri bolnikih, ki so dobivali adalimumab, in pri tistih, ki so dobivali placebo.
In all studies (I-VII), patients with raised ALT were asymptomatic and in most cases elevations were transient and resolved on continued treatment.
Dodatne neželene reakcije iz obdobja postmarketinškega spremljanja ali kliničnih preizkušanj IV. faze
au Crohn’ s disease clinical trials: in controlled clinical trials, elevations of ALT were similar in patients receiving adalimumab or placebo.
t O dodatnih neželenih reakcijah (ki jih prikazuje tabela 2) so poročali v postmarketinških nadzornih ali
r Additional Adverse Reactions from Postmarketing Surveillance or Phase IV Clinical Trials
me kliničnih preskušanjih IV. faze:
ge The additional adverse reactions in Table 2 have been reported from postmarketing surveillance or Phase IV clinical trials: lon Table 2 Undesirable Effects in Postmarketing Surveillance and Phase IV Clinical Studies no
pro Neželeni učinki med postmarketinškim nadzorom in kliničnimi študijami IV. faze
System Organ Class Hepatobiliary Disorders Nervous system disorders Respiratory, thoracic and mediastinal disorders t uc
reaktiviranje hepatitisa B Bolezni jeter, žolčnika in žolčevodov
Adverse Reaction reactivation of hepatitis B demyelinating disorders (e. g. optic neuritis) interstitial lung disease, including pulmonary
za demielinizirajoče bolezni (npr. optični Bolezni živčevja nevritis)
fibrosis Skin and subcutaneous tissue disorders Immune system disorders rod
Bolezni kože in podkožja Bolezni imunskega sistema
4.9 Overdose lP
4. 9 Preveliko odmerjanje do
The highest dose level evaluated has been multiple intravenous doses of 10 mg/ kg. na
Največji ocenjeni odmerek je obsegal večkratno intravensko aplikacijo 10 mg/ kg. eā
PHARMACOLOGICAL PROPERTIES
FARMAKOLOŠKE LASTNOSTI av
L04AA17
L04AA17 nim
Adalimumab binds specifically to TNF and neutralizes the biological function of TNF by blocking its interaction with the p55 and p75 cell surface TNF receptors.
Adalimumab se specifično veže na TNF in nevtralizira njegovo biološko delovanje, ker zavre njegovo interakcijo z receptorji p55 in p75 za TNF na površini celic. ilo
Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 1-2 X 10-10 M).
Adalimumab modulira tudi biološke odzive, ki jih sproži ali uravnava TNF, vključno s spremembami koncentracije adhezijskih molekul, odgovornih za migracijo levkocitov (ELAM- 1, VCAM- 1 in rav
33 Pharmacodynamic effects
Farmakodinamični učinki Zd
After treatment with Trudexa, a rapid decrease in levels of acute phase reactants of inflammation (C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)) and serum cytokines (IL-6) was observed compared to baseline in patients with rheumatoid arthritis.
Po zdravljenju s Trudexo so pri bolnikih z revmatoidnim artritisom opažali hitro znižanje reaktantov akutne faze vnetja (C- reaktivnega proteina (CRP) in hitrosti sedimentacije eritrocitov (SR)) in serumskih citokinov (IL- 6) v primerjavi z izhodiščem.
Serum levels of matrix metalloproteinases (MMP-1 and MMP-3) that produce tissue remodelling responsible for cartilage
Po uporabi Trudexe se je zmanjšala tudi serumska raven matriksnih metaloproteinaz (MMP- 1 in MMP- 3), ki povzročajo remodeliranje tkiva, odgovorno za uničenje hrustanca.
ris A rapid decrease in CRP levels was also observed in patients with Crohn’ s disease.
33 Pri pacientih s Crohnovo boleznijo so opazili tudi naglo znižanje koncentracij CRP.
Clinical trials
Klinične raziskave
Some patients
t me V vseh kliničnih preskušanjih pri revmatoidnem artritisu so Trudexo ocenili pri več kot 3000 bolnikih.
The efficacy and safety of Trudexa for the treatment of rheumatoid arthritis were assessed in five randomised, double-blind and well-controlled studies.
Učinkovitost in varnost Trudexe za zdravljenje revmatoidnega artritisa so ocenili v petih randomiziranih, dvojno slepih in dobro kontroliranih
Study I evaluated 271 patients with moderately to severely active rheumatoid arthritis who were ≥ 18
Raziskava I je ocenila 271 bolnikov z zmerno do hudo aktivnim revmatoidnim artritisom, starih ≥ 18 let, pri katerih zdravljenje z vsaj enim imunomodulirajočim antirevmatičnim zdravilom ni bilo uspešno, pri katerih metotreksat v odmerkih od 12, 5 do 25 mg (10 mg, če so bili intolerantni za
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.
za metotreksat) vsak teden ni bil dovolj učinkovit in pri katerih je odmerek metotreksata od 10 do 25 mg ostal stalen vsak teden.
Doses of 20 or 40 mg of Trudexa were given by subcutaneous injection every other week with placebo on no
Bolniki so 24 tednov vsak drugi teden dobivali odmerke 20, 40 ali 80 mg Trudexe ali placebo.
alternative weeks or every week for 26 weeks; placebo was given every week for the same duration.
nja Raziskava II je ocenila 544 bolnikov z zmerno do hudo aktivnim revmatoidnim artritisom, starih ≥ 18 let, pri katerih zdravljenje z vsaj enim imunomodulirajočim antirevmatičnim zdravilom ni bilo uspešno.
No other disease-modifying anti-rheumatic drugs were allowed.
Bolniki so 26 tednov dobivali odmerka 20 ali 40 mg Trudexe v subkutani injekciji vsak drugi lje teden s placebom vsak vmesni teden ali vsak teden; placebo so dobivali vsak teden enako dolgo.
Study III evaluated 619 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 t uc
Uporaba drugih imunomodulirajočih zdravil ni bila dovoljena. vo 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 do
The first received placebo injections every week for 52 weeks. rod
12, 5 do 25 mg vsak teden.
The second received 20 mg of Trudexa every week for 52 weeks.
V tej raziskavi so bile tri skupine.
The third group received 40 mg of Trudexa every other week with placebo injections on alternate weeks.
Prva je 52 tednov vsak teden dobivala injekcije placeba, druga je 52 tednov vsak teden dobivala 20 mg Trudexe, tretja pa je vsak drugi teden dobivala 40 mg Trudexe in injekcije placeba vsak vmesni 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, med katero so dobivali 40 mg Trudexe vsak drugi teden v obdobju do 60 mesecev. eā
Patients were permitted to be either disease-modifying, na
Bolniki so bili lahko bodisi naivni za imunomodulirajoča antirevmatična av
anti-rheumatic drug-naïve or to remain on their pre-existing rheumatologic therapy provided that therapy was stable for a minimum of 28 days.
zdravila bodisi so ohranili svojo prejšnjo revmatološko terapijo pod pogojem, da je bila ta terapija stabilna vsaj 28 dni.
Patients were randomised to 40 mg of Trudexa i
Bolnike so randomizirali na 40 mg Trudexe ali placebo vsak drugi teden za 24 tednov. nim
This study evaluated the efficacy of Me
Ta študija je ocenila učinkovitost treh shem (kombinirana terapija s Trudexo 40 mg vsak drugi teden/ metotreksatom, monoterapija s Trudexo 40 mg vsak drugi teden in monoterapija z ilo
Trudexa 40 mg every other week/ methotrexate combination therapy, Trudexa 40 mg every other week monotherapy and methotrexate monotherapy in reducing the signs and symptoms and rate of progression of joint damage in rheumatoid arthritis for 104 weeks.
metotreksatom) za zmanjšanje znakov in simptomov ter hitrosti napredovanja sklepne okvare pri revmatoidnem artritisu v obdobju 104 tednov. rav
Study III and V had an
V študijah III in V je bila dodatna primarna končna točka po 52 tednih upočasnitev napredovanja bolezni (ugotovljena z izvidi Zd
34 additional primary endpoint at 52 weeks of retardation of disease progression (as detected by X-ray results).
rentgenskega slikanja).
The percent of Trudexa-treated patients achieving ACR 20, 50 and 70 responses was consistent across
34 Odstotek bolnikov, zdravljenih s Trudexo, ki so dosegli odziv 20, 50 in 70 po ACR, se je v raziskavah I, II in III skladal.
ACR Responses in Placebo-Controlled Trials
Odziv po ACR v raziskavah, kontroliranih s placebom (odstotek bolnikov) Odziv
ris (Percent of Patients)
Raziskava Ia **
Response
Raziskava IIa **
Study Ia**
Raziskava IIIa **
Study IIa**
t me
Study IIIa**
placebo / MTXc
tho
Trudexab / MTXc
Trudexab/ MTXc Placebo Trudexab Placebo/ n=63 n=110 n=113 MTXc n=200
Trudexab placebo / MTXc Trudexab / MTXc
Trudexab/ MTXc n=207
n = 113 n = 207 n = 200
au ACR 20
pro ACR 20
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
NP NP NP NP
**p < 0.01, Trudexa versus placebo
4, 5%
In Studies I-IV, all individual components of the ACR response criteria (number of tender and swollen t
23, 2%
joints, physician and patient assessment of disease activity and pain, disability index (HAQ) scores uc
Raziskava I po 24 tednih, raziskava II po 26 tednih in raziskava III po 24 in 52 tednih b 40 mg Trudexe vsak drugi teden c MTX = metotreksat lje ** p < 0, 01, Trudexa v prim. s placebom;
and CRP (mg/ dl) values) improved at 24 or 26 weeks compared to placebo.
26 tednih izboljšali vsi posamezni elementi vo meril odziva po ACR (število bolečih in oteklih sklepov, zdravnikova in bolnikova ocena aktivnosti bolezni in bolečin, vrednost indeksa invalidnosti (HAQ) in vrednost CRP (mg/ dl)).
There rod
Poleg tega se je delež odziva po ACR ohranil pri večini bolnikov, do
In Study IV, the ACR 20 response of patients treated with Trudexa plus standard of care was lP
Med temi je imelo 60. mesec 86 bolnikov odziv po ACR 20, 72 bolnikov odziv po ACR 50 in 41 bolnikov odziv po ACR 70. eā
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). av
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 nim
Me
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 do 104. tedna (glejte tabelo 4).
ACR Responses in Study V (percent of patients)
Odzivi ACR v študiji V ilo
Trudexa/ MT
(odstotek bolnikov) Odziv
Trudexa
Vrednost
Response
Vrednost
n=257
pa
n=274
Pb
X
Pc
n=268 ACR 20
ACR 20
62.6% 56.0%
54, 4%
54.4% 49.3%
72, 8%
72.8% 69.4%
0, 013
0.013 0.002
< 0, 001
< 0.001 < 0.001
0, 043
0.043 0.140
ACR Zd
ACR 50
104. teden 50
ACR 70
104. teden 70
a. p-value is from the pairwise comparison of methotrexate monotherapy and Trudexa/ methotrexate
35 a Vrednost p se nanaša na parno primerjavo monoterapije z metotreksatom in kombinirane terapije s Trudexo/ metotreksatom z Mann- Whitneyevim testom U. 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.
ris combination therapy using the Mann-Whitney U test. b. p-value is from the pairwise comparison of Trudexa monotherapy and Trudexa/ methotrexate
Za doseganje nizkega stanja bolezni pri
Trudexa/ methotrexate combination therapy was clinically and statistically superior to methotrexate (p < 0.001) and Trudexa monotherapy
pro bolnikih z nedavno diagnosticiranim zmernim do hudim revmatoidnim artritisom je bila kombinirana terapija s Trudexo in metotreksatom klinično in statistično boljša od monoterapije z metotreksatom (p < 0, 001) in monoterapije s Trudexo (p < 0, 001).
r (p < 0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe
V obeh krakih z monoterapijo je bil odziv podoben (p = 0, 447).
ge rheumatoid arthritis.
za 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.
Bolniki, ki so v raziskavi III dobivali Trudexo, so imeli revmatoidni artritis v povprečju približno 11 let.
Trudexa/ methotrexate patients demonstrated significantly less radiographic progression than no
Okvaro so izrazili kot
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 tabelo 5) statistično značilno manj rentgenografskih znakov napredovanja kot pri bolnikih, ki so lje dobivali samo metotreksat.
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 vo 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. do
Placebo/
placebo/ MTXa
lP
eā
MTXa
av
TRUDEXA/ MTX (95% Confidence
(95% interval zaupanjab)
Total Sharp score Erosion score na
Celotna Sharpova ocena
JSNd score
Ocena erozij Ocena ZSŠd metotreksat nim
0.002
<
c Based on rank analysis dic
0, 001 0, 002
d Joint Space Narrowing
b 95% intervali zaupanja za razlike v spremembi ocen med metotreksatom in Trudexo c na podlagi analize rangov d zožitev sklepne špranje
In Study V, structural joint damage was assessed radiographically and expressed as change in Me
V študiji V so strukturno okvaro sklepov ocenili rentgenografsko in jo izrazili kot razliko v ilo
modified total Sharp score (see Table 6).
modificirani celotni Sharpovi oceni (glejte tabelo 6). rav
MTX
Trudexa/ MTX
Trudexa
MTX
Trudexa/ MT
Trudexa
n=257
vrednost vrednost
n=274
Vrednost
X
Odziv
(95% confidence
(95% interval (95% interval zaupanja) zaupanja)
(95% confidence
(95% interval zaupanja)
interval)
5, 7 (4, 2- 7, 3)
interval)
3, 0 (1, 7- 4, 3)
n=268
1, 3 (0, 5- 2, 1)
(95%
< 0, 001
confidence
0, 0020
interval)
< 0, 001
3.7 (2.7-4.7) 2.0 (1.2-2.8)
36 Seštevek 2, 0 (1, 2- 2, 8) 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 b Vrednost p se nanaša na parno primerjavo monoterapije s Trudexo 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
t c Vrednost p se nanaša na parno primerjavo monoterapije s Trudexo in monoterapije z
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
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%, 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.
V vseh
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.
nja štirih raziskavah se je indeks invalidnosti po vprašalniku HAQ od izhodišča do 6. meseca z vsemi 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 lje 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.
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
V vseh treh raziskavah (raziskave I, III in IV), v katerih so vo ocenjevali utrujenost s funkcijsko oceno terapije kronične bolezni (functional assessment of chronic illness therapy (FACIT)), so ugotovili statistično značilno zmanjšanje utrujenosti. do
improvement was maintained through that time.
V tem času se 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 eā
methotrexate monotherapy and Trudexa monotherapy at week 52, which was maintained through week 104.
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. av
Psoriatic arthritis na
Psoriatični artritis
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.
artritisom proučili v dveh s placebom kontroliranih študijah, študiji VI in študiji VII.
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 12 tednov.
Me
Zaradi majhnega števila bolnikov ni dovolj dokazov o učinkovitosti Trudexe pri bolnikih s psoriatično 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).
artropatijo, podobno ankilozirajočemu spondilitisu (glejte tabelo 7). rav
N=162
N = 162
N=151
N = 151
Week 24 ACR 50
24. teden ACR 50
57%
57% ***
ed
37
tho *** p < 0.001 for all comparisons between Trudexa and placebo
t *** p < 0, 001 za vse primerjave med Trudexo in placebom
p < 0.05 for all comparisons between Trudexa and placebo
p < 0, 05 za vse primerjave med Trudexo in placebom
au ACR responses in Study VI were similar with and without concomitant methotrexate therapy.
Telesno
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.
pro delovanje, ocenjeno s HAQ in SF 36 (Short Form Health Survey), se je pri bolnikih, ki so dobivali Trudexo, od izhodišča do 24. tedna izboljšalo.
r Ankylosing spondylitis
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.
za 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
Seventy-nine (20.1%) patients were treated concomitantly with disease modifying anti − rheumatic drugs, and 37 (9.4%) patients with glucocorticoids.
nja ankilozirajočega spondilitisa – Bath Ankylosing Spondylitis Disease Activity Index)] je bil v vseh skupinah 6, 3), ki se niso odzvali ustrezno na konvencionalno terapijo.
The blinded period was followed by an open− label period no
Devetinsedemdeset (20, 1%) bolnikov je sočasno dobivalo imunomodulacijska antirevmatična zdravila, 37 (9, 4%) bolnikov pa glukokortikoide.
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 lje 40 mg Trudexe vsak drugi teden subkutano, do največ dodatnih 28 tednov.