natgillin/translations-raw huggingface dataset:
70 It is not known whether adalimumab is excreted in human milk or absorbed systemically after ingestion.
Ni znano, ali se adalimumab izloča v materinem mleku in ali se po zaužitju sistemsko absorbira.
ed 4.7 Effects on ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
No studies on the effects on the ability to drive and use machines have been performed.
70 Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
ris 4.8 Undesirable effects
4. 8 Neželeni učinki
tho Clinical Trials
Klinična preskušanja
Trudexa was studied in 5293 patients in controlled and open label trials for up to 60 months.
t me Trudexo so raziskali pri 5293 bolnikih v kontroliranih in odprtih preskušanjih, ki so trajala do 60 mesecev.
The data in Table 1 is based on the controlled Studies (I− IX, CLASSIC I, GAIN AND CHARM) (described in section 5.1) involving 3271 patients receiving Trudexa and 1809 patients receiving placebo or active comparator during the controlled period.
Ta preskušanja so vključila bolnike z revmatoidnim artritisom (tako tiste, ki so imeli bolezen kratek čas, kot tiste, ki so jo imeli že dolgo), psoriatičnim artritisom, ankilozirajočim sponditisom in Crohnovo boleznijo.
1 below.
Podatki v tabeli 1 temeljijo na kontroliranih študijah (I−IX,
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
za kontroliranim delom raziskav I– IX, CLASSIC I, GAIN in CHARM, je bil 5, 7% v skupini, ki je prejemala Trudexo, in 5, 3% v kontrolni skupini.
Table 1 t uc
Tabela 1 vo Neželeni učinki v kliničnih študijah do
lower respiratory infections (including pneumonia, bronchitis), viral infections (including influenza, herpes infections),
Neželena reakcija okužbe spodnjih dihal (vključno s pljučnico in bronhitisom), virusne okužbe (vključno z gripo in
candidiasis, bacterial infections (including urinary tract infections), upper respiratory infection na
okužbami s herpesom), kandidoza, bakterijske okužbe (vključno z okužbami sečil), okužbe zgornjih dihal av
dic
nim
opportunistic infections (including tuberculosis, histoplasmosis), sepsis, abscess, joint infection, wound infection, skin infection
sepsa, oportunistične okužbe (vključno s tuberkulozo in histoplazmozo), absces, okužba sklepa, okužba rane, okužba kože (vključno s
(including cellulitis and impetigo), superficial fungal infections (including skin, nail and foot) Me
celulitisom in impetigom), površinske glivične okužbe (vključno s kožo, nohti in stopali)
71 cysts and polyps)
(vključno s cistami in polipi) Zd
ris
71
tho Immune system disorders
Bolezni imunskega sistema
r ge Metabolism and nutrition disorders
pro Presnovne in prehranske motnje
Psychiatric disorders
za Psihiatrične motnje
Common t uc
pogosti
lP
do
Ear and labyrinth disorders i dic
Ušesne bolezni, vključno z motnjami labirinta av
Cardiac disorders Me
Srčne bolezni
Vascular disorders
Žilne bolezni ilo
ris Gastrointestinal disorders
Bolezni prebavil
tho
72
r Hepato-biliary disorders
Bolezni jeter, žolčnika in
Rare
me
lon
redki
ge hepatic necrosis, hepatitis
nekroza jeter, hepatitis
rod
nja
lP
vo
Reproductive system and breast disorders na
Motnje reprodukcije in dojk
General disorders and administration site conditions i dic
Splošne težave in spremembe na mestu aplikacije
blood creatine phosphokinase increased, activated partial thromboplastin time prolonged, autoantibodies present
aktivirani parcialni tromboplastinski čas, prisotna avtoprotitelesa
73 Injection site reactions
Spremembe na mestu injiciranja rav
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
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.
ris Infections
Okužbe
In the twelve controlled trials, the rate of infection was 1.49 per patient year in the Trudexa treated
V dvanajstih kontroliranih preskušanjih je bil delež okužb 1, 49 na bolnik- leto med bolniki, ki so dobivali Trudexo, in 1, 42 na bolnik- leto med bolniki, ki so dobivali placebo oziroma kontrolno
tho patients and 1.42 per patient year in the placebo and active control-treated patients.
73 učinkovino.
au 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.
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
t V kontroliranih in odprtih študijah s Trudexo so poročali o resnih okužbah (vključno s smrtno
r occurred rarely) have been reported, which include reports of tuberculosis (including miliary and
me nevarnimi, ki so se pojavile redko), med katerimi so bile tuberkuloza (tudi miliarna in zunajpljučna) in invazivne oportunistične okužbe (npr. diseminirana histoplazmoza, pljučnica zaradi Pnevmocystis Carinii, aspergiloza in listerioza).
Most of the cases of tuberculosis occurred within the first eight months after initiation of therapy and may reflect recrudescence of lon latent disease.
pro po začetku zdravljenja in mogoče je, da gre za ponoven izbruh latentne bolezni.
Malignancies and lymphoproliferative disorders no
Malignomi in limfoproliferativne bolezni
During the controlled portions of ten Trudexa trials at least 12 weeks in duration (I-IX and CHARM) in patients with moderately to severely active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and Crohn’ s disease, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95% confidence interval) of 5.7 (3.3, 10.1) per 1000 patient-years among t
V kontroliranih delih desetih preskušanj Trudexe (I– IX in CHARM), ki so trajala vsaj 12 tednov, pri
2887 Trudexa treated patients versus a rate of 4.1 (1.5, 10.9) 1 per 1000 patient-years among 1570 uc
za bolnikih z zmerno do hudo aktivnim revmatoidnim artritisom, psoriatičnim artritisom, ankilozirajočim spondilitisom in Crohnovo boleznijo so malignome (razen limfoma in nemelanomskega kožnega raka) opažali z deležem (95% interval zaupanja) 5, 7 (3, 3, 10, 1) na 1000 bolnik- let med 2887 bolniki, ki so dobivali Trudexo, in 4, 1 (1, 5, 10, 9) na 1000 bolnik- let med 1570 kontrolnimi bolniki (pri prvih je
control patients (median duration of treatment was 5.7 months for Trudexa and 5.5 months for control- treated patients).
nja zdravljenje mediano trajalo 5, 7 meseca in pri drugih 5, 5 meseca).
The rate (95% confidence interval) of non-melanoma skin cancers was 7.6 (4.7, 12.4) per 1000 patient-years among Trudexa-treated patients and 2.0 (0.5, 8.2) per 1000 patient-years rod
Delež (95% interval zaupanja) nemelanomskih kožnih rakov je bil 7, 6 (4, 7, 12, 4) na 1000 bolnik- let med bolniki, ki so dobivali Trudexo, in 2, 0 (0, 5, 8, 2) na 1000 bolnik- let med kontrolnimi bolniki.
The rate (95% confidence interval) of lymphomas was 1.0 lP
Med temi kožnimi raki je bil lje delež (95% interval zaupanja) skvamocelularnega karcinoma 2, 4 (1, 0, 5, 7) na 1000 bolnik- let med bolniki, ki so dobivali Trudexo, in 0 na 1000 bolnik- let v kontrolni skupini bolnikov.
(0.2, 3.8) per 1000 patient-years among Trudexa-treated patients and 1.0 (0.1, 7.3) per 1000 patient- years among control patients.
Delež (95% interval zaupanja) limfomov je bil 1, 0 (0, 2, 3, 8) na 1000 bolnik- let med bolniki, ki so dobivali vo Trudexo, in 1, 0 (0, 1, 7, 3) na 1000 bolnik- let v kontrolni skupini bolnikov.
When combining controlled portions of ten trials (I-IX and CHARM) and ongoing open label na
Če vzamemo skupaj kontrolirane dele desetih preskušanj (I– IX in CHARM) in potekajoče do
extension studies with a median duration of approximately 2. years including 4843 patients and over 13000 patient-years of therapy, the observed rate of malignancies, other than lymphoma and non- melanoma skin cancers is approximately 13.6 per 1000 patient years.
nadaljevalne študije z medianim trajanjem približno 2 leti s 4843 bolniki in prek 13000 bolnik- leti zdravljenja, je ugotovljeni delež malignomov (razen limfoma in nemelanomskih kožnih rakov) približno 13, 6 na 1000 bolnik- let.
The observed rate of non- i dic
Ugotovljeni delež nemelanomskih kožnih rakov je približno eā
melanoma skin cancers is approximately 9.0 per 1000 patient years, and the observed rate of lymphomas is approximately 1.2 per 1000 patient years.
9, 0 na 1000 bolnik- let, ugotovljeni delež limfomov pa približno 1, 2 na 1000 bolnik- let.
In post-marketing experience from January 2003, predominately in patients with rheumatoid arthritis, Me
V obdobju pomarketinške uporabe od januarja 2003, pretežno pri bolnikih z revmatoidnim artritisom, av
The reported rates for non-melanoma skin cancers and lymphomas are approximately 0.2 and 0.4 per 1000 patient years, respectively (see section 4.4).
Ugotovljeni delež nemelanomskih rakov je približno 0, 2 na 1000 bolnik- let in limfomov približno 0, 4 na 1000 bolnik- let (glejte poglavje 4. 4). nim
74 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 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 ilo
No patients developed lupus nephritis or central
Pri nobenem rav
ed nervous system symptoms.
bolniku se niso pojavili lupusni nefritis ali simptomi s strani osrednjega živčevja.
Liver Enzyme Elevations
Zvišanje jetrnih encimov Zd
In patients with early
V kontroliranih kliničnih preskušanjih pri revmatoidnem artritisu (študije I−IV) so bila zvišanja ALT pri bolnikih, ki so dobivali adalimumab, podobna kot pri tistih, ki so dobivali placebo.
tho 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 arm or the Trudexa monotherapy arm.
Pri bolnikih z zgodnjim revmatoidnim artritisom (trajanje bolezni manj kot 3 leta) (študija V) so bila zvišanja ALT pogostejša v kraku, v katerem so uporabljali kombinacijo (Trudexa/ metotreksat), kot v kraku, v katerem so uporabljali monoterapijo z metotreksatom, ali v kraku, v katerem so uporabljali monoterapijo s Trudexo.
au Psoriatic arthritis clinical trials: elevations in ALT were more common in psoriatic arthritis patients (Studies VI-VII) compared with patients in rheumatoid arthritis clinical studies.
Zvišanja ALT so bila pri bolnikih s psoriatičnim artritisom (študiji VI– VII) pogostejša kot pri bolnikih v kliničnih študijah pri revmatoidnem artritisu.
In all studies (I-VII), patients with raised ALT were asymptomatic and in most cases elevations were
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.
r ge transient and resolved on continued treatment.
V kontroliranih kliničnih preskušanjih je bilo zvišanje ALT podobno pri bolnikih, ki so dobivali adalimumab, in pri tistih, ki so dobivali placebo.
Crohn’ s disease clinical trials: in controlled clinical trials, elevations of ALT were similar in patients receiving adalimumab or placebo. lon Additional Adverse Reactions from Postmarketing Surveillance or Phase IV Clinical Trials
pro Dodatne neželene reakcije iz obdobja postmarketinškega spremljanja ali kliničnih preizkušanj IV. faze
The additional adverse reactions in Table 2 have been reported from postmarketing surveillance or no
O dodatnih neželenih reakcijah (ki jih prikazuje tabela 2) so poročali v postmarketinških nadzorih ali kliničnih preskušanjih IV. faze:
Table 2 Undesirable Effects in Postmarketing Surveillance and Phase IV Clinical Studies t uc
za Tabela 2 Neželeni učinki med postmarketinškim nadzorom in kliničnimi študijami IV. faze
System Organ Class Hepatobiliary Disorders
Organski sistem
rod
Neželena reakcija
Adverse Reaction reactivation of hepatitis B
nja reaktiviranje hepatitisa B Bolezni jeter, žolčnika in žolčevodov
Nervous system disorders Respiratory, thoracic and mediastinal disorders
demielinizirajoče bolezni (npr. optični nevritis) Bolezni živčevja
demyelinating disorders (e. g. optic neuritis) interstitial lung disease, including pulmonary fibrosis
lje
Skin and subcutaneous tissue disorders lP
intersticijska bolezen pljuč, vključno s pljučno
cutaneous vasculitis
Bolezni dihal, prsnega koša in mediastinalnega fibrozo prostora vo kožni vaskulitis Bolezni kože in podkožja do
Immune system disorders na
Bolezni imunskega sistema eā
anaphylaxis
anafilaksija
The highest dose level evaluated has been multiple intravenous doses of 10 mg/ kg. i dic
odmerek je obsegal večkratno intravensko aplikacijo 10 mg/ kg.
PHARMACOLOGICAL PROPERTIES Me
FARMAKOLOŠKE LASTNOSTI nim
Mechanism of action
Mehanizem delovanja rav
75 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.
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).
koncentracije adhezijskih molekul, odgovornih za migracijo levkocitov (ELAM- 1, VCAM- 1 in ICAM- 1 z IK50 1– 2 x 10- 10 M).
ed Pharmacodynamic effects
Farmakodinamični učinki
Serum levels of matrix
75 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.
tho metalloproteinases (MMP-1 and MMP-3) that produce tissue remodelling responsible for cartilage destruction were also decreased after Trudexa administration.
Po uporabi Trudexe se je zmanjšala tudi serumska raven matriksnih metaloproteinaz (MMP- 1 in MMP- 3), ki povzročajo remodeliranje tkiva, odgovorno za uničenje hrustanca.
au A rapid decrease in CRP levels was also observed in patients with Crohn’ s disease.
t me Pri pacientih s Crohnovo boleznijo so opazili tudi naglo znižanje koncentracij CRP.
r Rheumatoid arthritis
pro Revmatoidni artritis
ge Trudexa was evaluated in over 3000 patients in all rheumatoid arthritis clinical trials.
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 lon rheumatoid arthritis were assessed in five randomised, double-blind and well-controlled studies.
za revmatoidnega artritisa so ocenili v petih randomiziranih, dvojno slepih in dobro kontroliranih študijah.
Study I evaluated 271 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, had failed therapy with at least one disease-modifying, anti rheumatic drug and had no
Raziskava I je ocenila 271 bolnikov z zmerno do hudo aktivnim revmatoidnim artritisom, starih ≥ 18
Doses of 20, 40 or 80 mg of Trudexa or placebo were given every other week for 24 weeks. t
nja 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 metotreksat) vsak teden ni bil dovolj učinkovit in pri katerih je odmerek od 10 do 25 mg metotreksata lje ostal stalen vsak teden.
Study II evaluated 544 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 uc
Bolniki so 24 tednov vsak drugi teden dobivali odmerke 20, 40 ali 80 mg Trudexe ali placebo. vo 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.
Doses of 20 or 40 mg of Trudexa were given by subcutaneous injection every other week with placebo on rod
Bolniki so 26 tednov dobivali odmerka 20 ali 40 mg Trudexe v subkutani injekciji vsak drugi do
alternative weeks or every week for 26 weeks; placebo was given every week for the same duration.
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 lP
Raziskava III je ocenila 619 bolnikov z zmerno do hudo aktivnim revmatoidnim artritisom, starih ≥ 18 eā
years old, had insufficient efficacy to methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexate- intolerant) every week and whose methotrexate dose remained constant at 12.5 to 25 mg every week.
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 vsak teden.
The second received 20 mg of Trudexa every week for 52 weeks.
Prva je 52 tednov vsak teden dobivala injekcije placeba, av
The third group received 40 mg of Trudexa every other week with placebo injections on alternate weeks.
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. i dic
Potem so bolnike vključili v odprto nadaljevalno fazo, med katero so dobivali 40 mg Trudexe vsak drugi teden v obdobju do 60 mesecev. nim
therapy was stable for a minimum of 28 days.
Bolniki so bili lahko bodisi naivni za imunomodulirajoča antirevmatična zdravila bodisi so ohranili svojo prejšnjo revmatološko terapijo pod pogojem, da je bila ta terapija stabilna vsaj 28 dni.
These therapies include methotrexate, leflunomide, hydroxychloroquine, sulfasalazine and/ or gold salts.
Terapije so vključevale metotreksat, leflunomid, hidroksiklorokin, sulfasalazin ilo
Study V evaluated 799 methotrexate-naïve, adult patients with moderate to severely active early rheumatoid arthritis (mean disease duration less than 9 months).
aktiven zgoden revmatoidni artritis (povprečno trajanje bolezni manj kot 9 mesecev).
This study evaluated the efficacy of Trudexa 40 mg every other week/ methotrexate combination therapy, Trudexa 40 mg every other week
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 metotreksatom) za zmanjšanje znakov in simptomov ter hitrosti napredovanja sklepne okvare pri Zd
76 monotherapy and methotrexate monotherapy in reducing the signs and symptoms and rate of progression of joint damage in rheumatoid arthritis for 104 weeks.
revmatoidnem artritisu v obdobju 104 tednov.
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
ed additional primary endpoint at 52 weeks of retardation of disease progression (as detected by X-ray results).
76 rentgenskega slikanja).
ris ACR response
Odziv po ACR
The percent of Trudexa-treated patients achieving ACR 20, 50 and 70 responses was consistent across
Odstotek bolnikov, zdravljenih s Trudexo, ki so dosegli odziv 20, 50 in 70 po ACR, se je v raziskavah
tho trials I, II and III.
t I, II in III skladal.
Table 3:
me Tabela 3:
ACR Responses in Placebo-Controlled Trials (Percent of Patients)
Odziv po ACR v raziskavah, kontroliranih s placebom (odstotek bolnikov)
au Response
pro Odziv
Study Ia**
placebo
Study IIa**
Trudexab / MTXc
Study IIIa**
n = 60 n = 63
Trudexab/ MTXc
n = 113 n = 200
Trudexab
n = 207
Trudexab/
za ACR 20
Placebo/
6 mesecev
ge ACR 20
13, 3%
MTXc n=60
65, 1%
n=63
19, 1%
n=110 lon
46, 0%
n=113
29, 5%
MTXc n=207
63, 3%
6 months 12 months
12 mesecev
65.1% NA
NP NP NP NP
19.1% NA
24, 0%
46.0% NA
58, 9%
ACR 50
nja ACR 50
6.7% NA
52, 4%
52.4% NA
22, 1%
no
9, 5%
8.2% NA
39, 1%
22.1% NA
NP NP NP NP
ACR 70 a
ACR 70 lje
23.8% NA t
23, 8%
2.5% 4.5%
12 mesecev
20.8% 23.2%
NP NP NP NP
Study I at 24 weeks, Study II at 26 weeks, and Study III at 24 and 52 weeks uc
Raziskava I po 24 tednih, raziskava II po 26 tednih in raziskava III po 24 in 52 tednih vo b 40 mg Trudexe vsak drugi teden c MTX = metotreksat ** p < 0, 01, Trudexa v prim. s placebom; NP = ni podatka do
b 40 mg Trudexa administered every other week c MTX = methotrexate **p < 0.01, Trudexa versus placebo rod
26 tednih izboljšali vsi posamezni elementi meril odziva po ACR (število bolečih in oteklih sklepov, zdravnikova in bolnikova ocena aktivnosti eā
In Study III, these lP
bolezni in bolečin, vrednost indeksa invalidnosti (HAQ) in vrednost CRP (mg/ dl)).
improvements were maintained throughout 52 weeks.
V raziskavi III so se ta izboljšanja ohranila 52 tednov.
There were 114 out of 207 patients who continued on Humira 40 mg every other week for 60 months. na
114 od 207 bolnikov je nadaljevalo z av
Among those, 86, 72, and 41 patients had ACR 20/ 50/ 70 response, respectively at month 60.
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.
In Study IV, the ACR 20 response of patients treated with Trudexa plus standard of care was i
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
statistically significantly better than patients treated with placebo plus standard of care (p < 0.001). dic
V študijah I– IV so bolniki, zdravljeni s Trudexo, v primerjavi s prejemniki placeba doživeli statistično značilen odziv 20 in 50 po ACR že en do dva tedna po začetku zdravljenja.
Me
V študiji V pri bolnikih z zgodnim revmatoidnim artritisom, ki še niso dobivali metotreksata, je ilo
In Study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with Trudexa and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and Trudexa monotherapy at week 52 and responses were sustained at week 104 (see Table 4).
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). rav
77 Table 4:
Tabela 4:
ACR Responses in Study V (percent of patients)
Odzivi ACR v študiji V (odstotek bolnikov) Zd
n=257
odziv
p-valuea
n = 257 n = 268 ACR 20
25.9% 28.1%
104. teden
au 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 combination therapy using the Mann-Whitney U test
me 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.
r c. p-value is from the pairwise comparison of Trudexa monotherapy and methotrexate monotherapy
pro c Vrednost p se nanaša na parno primerjavo monoterapije s Trudexo in monoterapije z metotreksatom z Mann- Whitneyevim testom U.