natgillin/translations-raw huggingface dataset:
r Trudexa and 5.3% for control treated patients.
Klinični in laboratorijski neželeni učinki, ki so vsaj potencialno vzročno povezani z adalimumabom v
ge Adverse events at least possibly causally-related to adalimumab for Studies I− IX, CLASSIC I, GAIN and CHARM, both clinical and laboratory, are displayed by system organ class and frequency (very lon common ≥ 1/ 10; common≥ 1/ 100 < 1/ 10; uncommon≥ 1/ 1000 to ≤ 1/ 100) and rare < 1/ 1000 in Table 1 below.
nja študijah I– IX, CLASSIC I, GAIN in CHARM, so navedeni po organskih sistemih in pogostnosti: zelo pogosti (≥1/ 10), pogosti (≥1/ 100 do < 1/ 10), občasni (≥1/ 1. 000 do < 1/ 100) in redki (≥1/ 10. 000 do < 1/ 1. 000) v tabeli 1 spodaj.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. no
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči lje resnosti.
Table 1 Undesirable Effects in Clinical Studies t
Tabela 1 vo Neželeni učinki v kliničnih študijah do
System Organ Class
Organski sistem Infekcijske in parazitske bolezni eā
lower respiratory infections (including pneumonia, bronchitis), viral infections
Neželena reakcija okužbe spodnjih dihal (vključno s pljučnico in bronhitisom), virusne okužbe (vključno z gripo in okužbami s herpesom), kandidoza, bakterijske
(including influenza, herpes infections), candidiasis, bacterial infections (including urinary tract infections), upper respiratory infection lP
okužbe (vključno z okužbami sečil), okužbe zgornjih dihal av
na
nim
opportunistic infections (including tuberculosis, histoplasmosis), sepsis, abscess,
sepsa, oportunistične okužbe (vključno s tuberkulozo in histoplazmozo), absces, okužba sklepa, okužba rane, okužba kože (vključno s
joint infection, wound infection, skin infection (including cellulitis and impetigo), superficial fungal infections (including skin, nail and foot) i dic
celulitisom in impetigom), površinske glivične okužbe (vključno s kožo, nohti in stopali)
Me
ilo
Neoplasms benign and malignant (including
Benigne, maligne in neopredeljene novotvorbe rav
cysts and polyps)
(vključno s cistami in polipi) Zd
8 Blood and the lymphatic system disorders
Bolezni krvi in limfatičnega sistema
neutropaenia (including agranulocytosis), leucopaenia, thrombocytopaenia, anaemia,, lymphadenopathy, leucocytosis
nevtropenija (vključno z agranulocitozo), levkopenija, trombocitopenija, anemija, limfadenopatija, levkocitoza
ed
8
ris Immune system disorders
Bolezni imunskega sistema
systemic lupus erythematosus, angioedema, drug hypersensitivity, seasonal allergy
sistemski eritematozni lupus, angioedem, preobčutljivost na zdravila, sezonska alergija
tho
t
serum sickness
serumska bolezen
Endocrine disorders
me Bolezni endokrinega sistema
au Metabolism and nutrition disorders
pro Presnovne in prehranske motnje
ge Psychiatric disorders
za Psihiatrične motnje
dizziness (including vertigo), headache, neurologic sensation disorders (including paraesthesias)
omotica (vključno z vrtoglavico), glavobol,
no
nja motnje nevrološkega občutenja (vključno s parestezijami) lje
Rare t uc
redki
multiple sclerosis
multipla skleroza vo
infection, irritation or inflammation of the eye
okužba, draženje ali vnetje očesa
rod
do
vision disorder, ocular sensation disorders
bolezni vida, motnje vidnega zaznavanja
Panophthalmitis, iritis, glaucoma
panoftalmitis, iritis, glavkom
Ear and labyrinth
Ušesne bolezni, vključno z motnjami labirinta av
tinnitus, ear discomfort (including pain and
tinitus, neprijetno občutenje v ušesu (vključno z bolečino in otekanjem)
Cardiac dic
Srčne bolezni
disorders i
nim
Vascular disorders Me
Žilne bolezni ilo
9
Zd
ed Gastrointestinal disorders
Bolezni prebavil
ris
9
au Hepato-biliary disorders
Bolezni jeter, žolčnika in
hepatic necrosis, hepatitis
nekroza jeter, hepatitis
r ge Skin and subcutaneous tissue disorders
Bolezni kože in podkožja
Musculoskeletal,
Bolezni mišično- skeletnega sistema in vezivnega tkiva
connective tissue and bone disorders
nja
Rare t
redki
Uncommon uc
občasni
disorders
lje
urethral symptoms
hematurija, okvara ledvične funkcije, simptomi sečnega mehurja in sečnice
Reproductive system and breast disorders lP
vo Motnje reprodukcije in dojk
General disorders and administration site conditions na
Splošne težave in spremembe na mestu aplikacije
i
av
Investigations Me
Preiskave
blood creatine phosphokinase increased, activated partial thromboplastin time
zvišanje kreatin fosfokinaze v krvi, podaljšan aktivirani parcialni tromboplastinski čas, prisotna
prolonged, autoantibodies present
avtoprotitelesa
Injury and poisoning
Poškodbe in zapleti pri
10 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.
krvavitve, bolečine ali oteklost) imelo 16% bolnikov, ki so dobivali Trudexo, in 10% bolnikov, ki so dobivali placebo ali kontrolno učinkovino.
Injection site reactions generally did not necessitate discontinuation of the medicinal product.
Zd
The infections
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 učinkovino.
ris consisted primarily of upper respiratory tract infections, bronchitis and urinary tract infections.
Pri okužbah je šlo predvsem za okužbe zgornjih dihal, bronhitis in okužbe sečil.
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.
10 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 okužbami, ki so se pojavile redko), med katerimi so bile tuberkuloza (tudi miliarna 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 zunajpljučna) in invazivne oportunistične okužbe (npr. diseminirana histoplazmoza, pljučnica zaradi
Most of the cases of tuberculosis occurred within the first eight months after initiation of therapy and may reflect recrudescence of
Večina primerov tuberkuloze se je pojavila v prvih osmih mesecih po začetku zdravljenja in mogoče je, da gre za ponoven izbruh latentne bolezni.
r ge latent disease.
pro Malignomi in limfoproliferativne bolezni
Malignancies and lymphoproliferative disorders lon 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 no
V kontroliranih delih desetih preskušanj Trudexe (I– IX in CHARM), ki so trajala vsaj 12 tednov, pri bolnikih z zmerno do hudo aktivnim revmatoidnim artritisom, psoriatičnim artritisom, ankilozirajočim spondilitisom in Crohnovo boleznijo so malignome (razen limfoma in nemelanomskega kožnega raka)
2887 Trudexa treated patients versus a rate of 4.1 (1.5, 10.9) 1 per 1000 patient-years among 1570 control patients (median duration of treatment was 5.7 months for Trudexa and 5.5 months for control- treated patients).
za 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 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 t
Delež (95% interval zaupanja) nemelanomskih kožnih rakov je bil 7, 6 (4, 7, 12, 4) na 1000 bolnik- let med bolniki, ki so dobivali
among control patients.
nja Trudexo, in 2, 0 (0, 5, 8, 2) na 1000 bolnik- let med kontrolnimi bolniki.
Of these skin cancers, squamous cell carcinomas occurred at rates (95% uc
Med temi kožnimi raki je bil 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.
The rate (95% confidence interval) of lymphomas was 1.0 rod
Delež (95% lje interval zaupanja) limfomov je bil 1, 0 (0, 2, 3, 8) na 1000 bolnik- let med bolniki, ki so dobivali Trudexo, in 1, 0 (0, 1, 7, 3) na 1000 bolnik- let v kontrolni skupini bolnikov. vo Če vzamemo skupaj kontrolirane dele desetih preskušanj (I– IX in CHARM) in potekajoče 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) do
(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.
približno 13, 6 na 1000 bolnik- let.
When combining controlled portions of ten trials (I-IX and CHARM) and ongoing open label lP
Ugotovljeni delež nemelanomskih kožnih rakov je približno 9, 0 na 1000 bolnik- let, ugotovljeni delež limfomov pa približno 1, 2 na 1000 bolnik- let. eā
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.
V obdobju pomarketinške uporabe od januarja 2003, pretežno pri bolnikih z revmatoidnim artritisom, je bil zabeleženi delež malignomov (razen limfomov in nemelanomskih kožnih rakov) približno 1, 7 na 1000 bolnik- let.
The observed rate of non- melanoma skin cancers is approximately 9.0 per 1000 patient years, and the observed rate of na
Ugotovljeni delež nemelanomskih rakov je približno 0, 2 na 1000 bolnik- let in av
lymphomas is approximately 1.2 per 1000 patient years.
limfomov približno 0, 4 na 1000 bolnik- let (glejte poglavje 4. 4).
In post-marketing experience from January 2003, predominately in patients with rheumatoid arthritis, i dic
V vseh študijah revmatoidnega artritisa in psoriatičnega artritisa so se klinični znaki, ki so nakazovali novonastali lupusni sindrom, pojavili pri 2 od 3441 bolnikov, ilo
the reported rate of malignancies other than lymphomas and non-melanoma skin cancers is approximately 1.7 per 1000 patient years.
Stanje bolnikov se je po prekinitvi zdravljenja izboljšalo.
Me
Pri nobenem bolniku se niso pojavili lupusni nefritis ali simptomi s strani osrednjega živčevja. rav
Autoantibodies
Zvišanje jetrnih encimov
Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis Studies I− V.
Klinična preskušanja pri revmatoidnem artritisu:
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 kontroliranih kliničnih preskušanjih pri revmatoidnem artritisu (študije I−IV) so bila zvišanja ALT pri bolnikih, ki so dobivali adalimumab, Zd
The patients
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.
11 improved following discontinuation of therapy.
11 Klinična preskušanja pri psoriatičnem artritisu:
No patients developed lupus nephritis or central nervous system symptoms.
Zvišanja ALT so bila pri bolnikih s psoriatičnim artritisom (študiji VI– VII) pogostejša kot pri bolnikih v kliničnih študijah pri revmatoidnem artritisu.
Rheumatoid arthritis clinical trials: in controlled rheumatoid arthritis clinical trials (Studies I− IV),
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.
ed elevations of ALT were similar in patients receiving adalimumab or placebo.
t Klinična preskušanja pri Crohnovi bolezni:
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
V kontroliranih kliničnih preskušanjih je bilo zvišanje
ris arm or the Trudexa monotherapy arm.
me ALT podobno pri bolnikih, ki so dobivali adalimumab, in pri tistih, ki so dobivali placebo.
Psoriatic arthritis clinical trials: elevations in ALT were more common in psoriatic arthritis patients
Dodatne neželene reakcije iz obdobja postmarketinškega spremljanja ali kliničnih preizkušanj IV. faze
tho (Studies VI-VII) compared with patients in rheumatoid arthritis clinical studies.
pro O dodatnih neželenih reakcijah (ki jih prikazuje tabela 2) so poročali v postmarketinških nadzornih ali kliničnih preskušanjih IV. faze:
In all studies (I-VII), patients with raised ALT were asymptomatic and in most cases elevations were transient and resolved on continued treatment.
za Neželeni učinki med postmarketinškim nadzorom in kliničnimi študijami IV. faze
au Crohn’ s disease clinical trials: in controlled clinical trials, elevations of ALT were similar in patients receiving adalimumab or placebo.
nja reaktiviranje hepatitisa B Bolezni jeter, žolčnika in žolčevodov
r Additional Adverse Reactions from Postmarketing Surveillance or Phase IV Clinical Trials
demielinizirajoče bolezni (npr. optični nevritis) Bolezni živčevja
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
lje
System Organ Class Hepatobiliary Disorders Nervous system disorders Respiratory, thoracic and mediastinal disorders t uc
intersticijska bolezen pljuč, vključno s pljučno
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 do
fibrosis Skin and subcutaneous tissue disorders Immune system disorders rod
Bolezni imunskega sistema
cutaneous vasculitis anaphylaxis
anafilaksija
4.9 Overdose lP
4. 9 Preveliko odmerjanje eā
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. av
PHARMACOLOGICAL PROPERTIES
FARMAKOLOŠKE LASTNOSTI nim
5.1 Pharmacodynamic properties i dic
5. 1 Farmakodinamične lastnosti
ATC code:
Farmakoterapevtska skupina: zdravila za selektivno zaviranje imunske odzivnosti, oznaka ATC:
L04AA17
L04AA17 ilo
Mechanism of action Me
Mehanizem delovanja
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 rav
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 Zd
12 Pharmacodynamic effects
Farmakodinamični učinki
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
ed 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.
ris A rapid decrease in CRP levels was also observed in patients with Crohn’ s disease.
Pri pacientih s Crohnovo boleznijo so opazili tudi naglo znižanje koncentracij CRP.
Clinical trials
t me Klinične raziskave
tho Rheumatoid arthritis
Revmatoidni artritis
Some patients
pro V vseh kliničnih preskušanjih pri revmatoidnem artritisu so Trudexo ocenili pri več kot 3000 bolnikih.
au were treated for up to 60 months duration.
Nekatere bolnike so zdravili do 60 mesecev.
Study I evaluated 271 patients with moderately to severely active rheumatoid arthritis who were ≥ 18
za 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.
nja 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. lje 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 vo uspešno.
alternative weeks or every week for 26 weeks; placebo was given every week for the same duration.
Bolniki so 26 tednov dobivali odmerka 20 ali 40 mg Trudexe v subkutani injekciji vsak drugi teden s placebom vsak vmesni teden ali vsak teden; placebo so dobivali vsak teden enako dolgo.
No other disease-modifying anti-rheumatic drugs were allowed.
Uporaba drugih imunomodulirajočih zdravil ni bila dovoljena. do
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 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.
12, 5 do 25 mg vsak teden.
The first received placebo injections every week for 52 weeks. rod
Potem so bolnike vključili v odprto av
The second received 20 mg of Trudexa every week for 52 weeks.
nadaljevalno fazo, med katero so dobivali 40 mg Trudexe vsak drugi teden v obdobju do 60 mesecev.
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
Raziskava IV je v prvi vrsti ocenila varnost pri 636 bolnikih z zmerno do hudo aktivnim revmatoidnim nim
Study IV primarily assessed safety in 636 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old.
artritisom, starih ≥ 18 let.
anti-rheumatic drug-naïve or to remain on their pre-existing rheumatologic therapy provided that 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.
Patients were randomised to 40 mg of Trudexa i
Bolnike so randomizirali na 40 mg Trudexe ali placebo vsak drugi teden za 24 tednov. ilo
This study evaluated the efficacy of Me
Ta študija je ocenila učinkovitost treh shem (kombinirana terapija s Trudexo 40 mg vsak drugi rav
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.
Zd
The primary end point in Studies I, II and III and the secondary endpoint in Study IV was the percent of patients who achieved an ACR 20 response at week 24 or 26.
26 tednih dosegli odziv 20 po ACR.
Study III and V had an
Primarna končna točka študije V je bil odstotek bolnikov, ki so do 52. tedna dosegli odziv ACR 50.
13 additional primary endpoint at 52 weeks of retardation of disease progression (as detected by X-ray results).
V študijah III in IV je bila dodatna primarna končna točka po 52 tednih upočasnitev napredovanja bolezni (ugotovljena z izvidi rentgenskega slikanja).
ACR response
13 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 I, II in III skladal.
Table 3:
t Tabela 3:
ACR Responses in Placebo-Controlled Trials
Odziv po ACR v raziskavah, kontroliranih s placebom
ris (Percent of Patients)
me (odstotek bolnikov) Odziv
Study Ia**
Raziskava Ia **
Study IIa**
Raziskava IIa **
Study IIIa**
Raziskava IIIa **
tho
pro
Placebo/ MTXc n=60
placebo
Trudexab/ MTXc Placebo Trudexab Placebo/ n=63 n=110 n=113 MTXc n=200
Trudexab placebo / MTXc
Trudexab/ MTXc n=207
Trudexab / MTXc
au ACR 20
n = 60 n = 63
6 months 12 months
6 mesecev
13.3% NA
19, 1%
65.1% NA
46, 0%
19.1% NA
29, 5%
46.0% NA
63, 3%
29.5% 24.0%
12 mesecev
63.3% 58.9%
NP NP NP NP
6.7% NA
6, 7%
39.1% 41.5%
12 mesecev
3.3% NA
3, 3%
1.8% NA
1, 8%
12.4% NA
12, 4%
2.5% 4.5%
20, 8%
20.8% 23.2%
12 mesecev
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
**p < 0.01, Trudexa versus placebo
NP NP lje
In Studies I-IV, all individual components of the ACR response criteria (number of tender and swollen t
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 vo ** p < 0, 01, Trudexa v prim. s placebom;
joints, physician and patient assessment of disease activity and pain, disability index (HAQ) scores uc
26 tednih izboljšali vsi posamezni elementi do
and CRP (mg/ dl) values) improved at 24 or 26 weeks compared to placebo.
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, eā
were 114 out of 207 patients who continued on Humira 40 mg every other week for 60 months.
ki so jih med odprto nadaljevalno fazo spremljali do 104. tedna.
Among those, 86, 72, and 41 patients had ACR 20/ 50/ 70 response, respectively at month 60.
114 od 207 bolnikov je nadaljevalo z jemanjem 40 mg Trudexe vsak drugi teden 60 mesecev.
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. av