natgillin/translations-raw huggingface dataset:
In the pivotal controlled trials, 15% of patients treated with Humira developed injection site reactions (erythema and/ or itching, haemorrhage, pain or swelling), compared to 9% of patients receiving placebo or active control.
V ključnih kontroliranih preskušanjih je reakcije na mestu injiciranja (eritem in/ ali srbenje, krvavitve, bolečine ali oteklost) imelo 15% bolnikov, ki so dobivali Humiro, in 9% bolnikov, ki so dobivali placebo ali kontrolno učinkovino.
In the pivotal controlled trials, the rate of infection was 1.58 per patient year in the Humira treated patients and 1.42 per patient year in the placebo and active control-treated patients.
V ključnih kontroliranih preskušanjih je bil delež okužb 1, 58 na bolnik- leto med bolniki, ki so dobivali Humiro, in 1, 42 na bolnik- leto med bolniki, ki so dobivali placebo oziroma kontrolno učinkovino.
The infections consisted primarily of nasopharyngitis, upper respiratory tract infection, and sinusitis.
Pri okužbah je šlo predvsem za nazofaringitis, okužbo zgornjih dihal in sinuzitis.
Most patients continued on Humira after the infection resolved.
Večina bolnikov je po ozdravitvi okužbe nadaljevala zdravljenje s Humiro.
The incidence of serious infections was 0.04 per patient year in Humira treated patients and 0.03 per patient year in placebo and active control − treated patients.
Incidenca resnih okužb je bila 0, 04 na bolnik- leto med bolniki, ki so dobivali Humiro, in 0, 03 na bolnik- leto med bolniki, ki so dobivali placebo oziroma kontrolno učinkovino.
In controlled and open label studies with Humira, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e. g. disseminated or extrapulmonary histoplasmosis, blastomycosis, coccidioidomycosis, pneumocystis, candidiasis, aspergillosis and listeriosis).
V kontroliranih in odprtih študijah s Humiro so poročali o resnih okužbah (vključno s smrtno nevarnimi okužbami, ki so se pojavile redko), med katerimi so bile tuberkuloza (tudi miliarna in zunajpljučna) in invazivne oportunistične okužbe (npr. diseminirana ali zunajpljučna histoplazmoza, blastomikoza, kokcidioidomikoza, pnevmocistoza, kandidaza, aspergiloza in listerioza).
No malignancies were observed in 171 patients with an exposure of 192.5 patient years during a Humira trial in juvenile idiopathic arthritis patients.
V kontroliranih delih ključnih preskušanj Humire, ki so trajala vsaj 12 tednov, pri bolnikih z zmerno do hudo aktivnim revmatoidnim artritisom, psoriatičnim artritisom, ankilozirajočim spondilitisom,
During the controlled portions of pivotal Humira trials at least 12 weeks in duration in patients with moderately to severely active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’ s disease and psoriasis, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95% confidence interval) of 5.9 (3.5, 9.9) per 1,000 patient-years among 3853 Humira treated patients versus a rate of 4.3 (1.8, 10.4) per 1,000 patient-years among 2,183 control patients (median duration of treatment was 5.5 months for Humira and 3.9 months for control-treated patients).
12 Crohnovo boleznijo in psoriazo so malignome (razen limfoma in nemelanomskega kožnega raka) opažali z deležem (95% interval zaupanja) 5, 9 (3, 5, 9, 9) na 1000 bolnik- let med 3853 bolniki, ki so dobivali Humiro, in 4, 3 (1, 8, 10, 4) na 1000 bolnik- let med 2183 kontrolnimi bolniki (pri prvih je zdravljenje mediano trajalo 5, 5 meseca in pri drugih 3, 9 meseca).
The rate (95% confidence interval) of non-melanoma skin cancers was 8.8 (5,7, 13.5) per 1,000 patient-years among Humira-treated patients and 2.6 (0.8, 8.0) per 1,000 patient-years among control patients.
Delež (95% interval zaupanja) nemelanomskih kožnih rakov je bil 8, 8 (5, 7, 13, 5) na 1000 bolnik- let med bolniki, ki so dobivali Humiro, in 2, 6 (0, 8, 8, 0) na 1000 bolnik- let med kontrolnimi bolniki.
Of these skin cancers, squamous cell carcinomas occurred at rates (95% confidence interval) of 2.5 (1.1, 5.6) per 1,000 patient-years among Humira-treated patients and 0 per 1,000 patient-years among control patients.
Med temi kožnimi raki je bil delež (95% interval zaupanja) skvamocelularnega karcinoma 2, 5 (1, 1, 5, 6) na 1000 bolnik- let med bolniki, ki so dobivali Humiro, in 0 na 1000 bolnik- let v kontrolni skupini bolnikov.
The rate (95% confidence interval) of lymphomas was 0.8 (0.2, 3.3) per 1,000 patient-years among Humira-treated patients and 0.9 (0.1, 6.1) per 1,000 patient-years among control patients.
Delež (95% interval zaupanja) limfomov je bil 0, 8 (0, 2, 3, 3) na 1000 bolnik- let med bolniki, ki so dobivali Humiro, in 0, 9 (0, 1, 6, 1) na 1000 bolnik- let v kontrolni skupini bolnikov.
When combining controlled portions of these trials and ongoing open label extension studies with a median duration of approximately 1.7 years including 6,539 patients and over 16,000 patient-years of therapy, the observed rate of malignancies, other than lymphoma and non-melanoma skin cancers is approximately 10.1 per 1,000 patient years.
Če vzamemo skupaj kontrolirane dele teh preskušanj in potekajoče nadaljevalne študije z medianim trajanjem približno 1, 7 leta s 6539 bolniki in prek 16000 bolnik- leti zdravljenja, je ugotovljeni delež malignomov (razen limfoma in nemelanomskih kožnih rakov) približno 10, 1 na 1000 bolnik- let.
The observed rate of non-melanoma skin cancers is approximately 9.0 per 1,000 patient years, and the observed rate of lymphomas is approximately 1.1 per 1000 patient years.
Ugotovljeni delež nemelanomskih kožnih rakov je približno 9, 0 na 1000 bolnik- let, ugotovljeni delež limfomov pa približno 1, 1 na 1000 bolnik- let.
In post-marketing experience from January 2003, predominately in patients with rheumatoid arthritis, the reported rate of malignancies other than lymphomas and non-melanoma skin cancers is approximately 1.7 per 1,000 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 reported rates for non-melanoma skin cancers and lymphomas are approximately 0.2 and 0.4 per 1,000 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).
Rare post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with adalimumab (see section 4.4).
V redkih postmarketinških primerih so pri bolnikih, zdravljenih z adalimumabom, poročali o hepatospleničnem limfomu celic T (glejte poglavje 4. 4).
13 Autoantibodies
Avtoprotitelesa
Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis Studies I − V.
V študijah pri revmatoidnem artritisu I−V so pri bolnikih ob več različnih časih testirali protitelesa v serumu.
In these trials, 11.9% of patients treated with Humira 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 Humire in 8, 1% prejemnikov placeba in kontrolne učinkovine, ki so imeli izhodiščno negativne titre teh protiteles.
Two patients out of 3,441 treated with Humira in all rheumatoid arthritis and psoriatic arthritis studies developed clinical signs suggestive of new-onset lupus-like syndrome.
V vseh študijah revmatoidnega artritisa in psoriatičnega artritisa so se klinični znaki, ki so nakazovali novonastali lupusni sindrom, pojavili pri 2 od 3441 bolnikov, zdravljenih s Humiro.
Rheumatoid arthritis clinical trials: in controlled rheumatoid arthritis clinical trials (RAstudies I − IV), elevations of ALT were similar in patients receiving adalimumab or placebo.
V kontroliranih kliničnih preskušanjih pri revmatoidnem artritisu (študije pri revmatoidnem artritisu I−IV) so bila zvišanja ALT pri bolnikih, ki so dobivali adalimumab, podobna kot pri tistih, ki so dobivali placebo.
In patients with early rheumatoid arthritis (disease duration of less than 3 years) (RA study V), elevations of ALT were more common in the combination arm (Humira / methotrexate) compared to the methotrexate monotherapy arm or the Humira monotherapy arm.
Pri bolnikih z zgodnjim revmatoidnim artritisom (trajanje bolezni manj kot 3 leta) (študija pri revmatoidnem artritisu V) so bila zvišanja ALT pogostejša v kraku, v katerem so uporabljali kombinacijo (Humira/ metotreksat), kot v kraku, v katerem so uporabljali monoterapijo z metotreksatom, ali v kraku, v katerem so uporabljali monoterapijo s Humiro.
In the JIA trial the few transaminase elevations were small and similar in the placebo and adalimumab exposed patients, and mostly occurred in combination with methotrexate.
V preskušanju pri juvenilnem idiopatskem artritisu je bilo zvišanj transaminaz malo in so bila podobna pri bolnikih, izpostavljenih placebu in adalimumabu; večinoma so se pojavila med kombinirano uporabo z metotreksatom.
Psoriatic arthritis clinical trials: elevations in ALT were more common in psoriatic arthritis patients (PsA studies I - II) compared with patients in rheumatoid arthritis clinical studies.
Zvišanja ALT so bila pri bolnikih s psoriatičnim artritisom (študiji pri psoriatičnem artritisu I - II) pogostejša kot pri bolnikih v kliničnih študijah pri revmatoidnem artritisu.
In all rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis studies, patients with raised ALT were asymptomatic and in most cases elevations were transient and resolved on continued treatment.
V vseh študijah pri revmatoidnem artritisu, poliartikularnem juvenilnem idiopatskem artritisu in psoriatičnem artritisu so bili bolniki, ki so imeli zvišano ALT, asimptomatski; zvišanje je bilo večinoma prehodno in je med nadaljevanjem zdravljenja minilo.
Crohn’ s disease clinical trials: in controlled clinical trials, elevations of ALT were similar in patients receiving adalimumab or placebo.
V kontroliranih kliničnih preskušanjih je bilo zvišanje ALT podobno pri bolnikih, ki so dobivali adalimumab, in pri tistih, ki so dobivali placebo.
Psoriasis clinical trials: in controlled psoriasis clinical trials, elevations of ALT were similar in patients receiving adalimumab or placebo.
Klinične študije pri psoriazi: zvišanje ALT je bilo v kontroliranih kliničnih preskušanjih pri psoriazi podobno pri bolnikih, ki so dobivali adalimumab, in tistih, ki so dobivali placebo.
System Organ Class Gastrointestinal disorders Hepatobiliary disorders Nervous system disorders
reaktiviranje hepatitisa B Bolezni jeter, žolčnika in žolčevodov
Adverse Reaction intestinal perforation reactivation of hepatitis B demyelinating disorders (e. g. optic neuritis, Guillian-Barré syndrome)
demielinizirajoče bolezni (npr. optični nevritis, Bolezni živčevja Guillain- Barréjev sindrom)
Respiratory, thoracic and mediastinal disorders
intersticijska bolezen pljuč, vključno s pljučno Bolezni dihal, prsnega koša in mediastinalnega fibrozo prostora
interstitial lung disease, including pulmonary fibrosis
kožni vaskulitis Bolezni kože in podkožja
Skin and subcutaneous tissue disorders Immune system disorders Neoplasma benign, malignant and unspecified (including cysts and polyps)
Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)
cutaneous vasculitis anaphylaxis hepatosplenic T-cell lymphoma
hepatosplenični limfom celic T
14 4.9 Overdose
4. 9 Preveliko odmerjanje
The highest dose level evaluated has been multiple intravenous doses of 10 mg/ kg, which is approximately 15 times the recommended dose.
Največji ocenjeni odmerek je obsegal večkratno intravensko aplikacijo 10 mg/ kg, kar je približno 15- kraten priporočen odmerek.
ATC code:
Zdravila za selektivno zaviranje imunske odzivnosti, oznaka ATC:
L04AB04
L04AB04.
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 of0.1-0.2 nM).
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 ICAM- 1 z IK50 0, 1- 0, 2 nM).
Pharmacodynamic effects
14 Farmakodinamični učinki
After treatment with Humira, 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 Humiro 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 destruction were also decreased after Humira administration.
Po uporabi Humire se je zmanjšala tudi serumska raven matriksnih metaloproteinaz (MMP- 1 in MMP- 3), ki povzročajo remodeliranje tkiva, odgovorno za uničenje hrustanca.
Patients treated with Humira usually experienced improvement in haematological signs of chronic inflammation.
S Humiro zdravljenim bolnikom so se ponavadi izboljšali hematološki znaki kroničnega vnetja.
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.
A rapid decrease in CRP levels was also observed in patients with polyarticular juvenile idiopathic arthritis.
Pri pacientih s poliartikularnim juvenilnim idiopatskim artritisom so opazili tudi naglo znižanje koncentracij CRP.
Humira was evaluated in over 3,000 patients in all rheumatoid arthritis clinical trials.
V vseh kliničnih preskušanjih pri revmatoidnem artritisu so Humiro ocenili pri več kot 3000 bolnikih.
The efficacy and safety of Humira for the treatment of rheumatoid arthritis were assessed in five randomised, double-blind and well-controlled studies.
Učinkovitost in varnost Humire za zdravljenje revmatoidnega artritisa so ocenili v petih randomiziranih, dvojno slepih in dobro kontroliranih študijah.
RAstudy 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 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.
Študija pri revmatoidnem artritisu 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 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, 40 or 80 mg of Humira or placebo were given every other week for 24 weeks.
Bolniki so 24 tednov vsak drugi teden dobivali odmerke 20, 40 ali 80 mg Humire ali placebo.
RA study II evaluated 544 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old and had failed therapy with at least one disease-modifying, anti-rheumatic drugs.
Študija pri revmatoidnem artritisu 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 Humira were given by subcutaneous injection every other week with placebo on 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 Humire v subkutani injekciji vsak drugi teden s placebom vsak vmesni teden ali vsak teden; placebo so dobivali vsak teden enako dolgo.
RA study III evaluated 619 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, and who had an ineffective response to methotrexate at doses of 12.5 to 25 mg, or
Študija pri revmatoidnem artritisu III je ocenila 619 bolnikov z zmerno do zelo aktivnim revmatoidnim artritisom, starih ≥ 18 let, ki se niso učinkovito odzvali na odmerke metotreksata od 12, 5 do 25 mg ali niso prenašali 10 mg metotreksata vsak teden.
The third group received 40 mg of Humira 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 Humire, tretja pa je vsak drugi teden dobivala 40 mg Humire in injekcije placeba vsak vmesni teden.
Thereafter, patients enrolled in an open-label extension phase in which 40 mg of Humira was administered every other week up to 60 months.
Potem so bolnike vključili v odprto nadaljevalno fazo, med katero so dobivali 40 mg Humire vsak drugi teden v obdobju do 60 mesecev.
RA study IV primarily assessed safety in 636 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old.
Študija pri revmatoidnem artritisu IV je v prvi vrsti ocenila varnost pri 636 bolnikih z zmerno do hudo aktivnim revmatoidnim artritisom, starih ≥ 18 let.
These therapies include methotrexate, leflunomide, hydroxychloroquine, sulfasalazine and/ or gold salts.
Terapije so vključevale metotreksat, leflunomid, hidroksiklorokin, sulfasalazin in/ ali soli zlata.
Patients were randomised to 40 mg of Humira or placebo every other week for 24 weeks.
Bolnike so randomizirali na 40 mg Humire ali placebo vsak drugi teden za 24 tednov.
RA study V evaluated 799 methotrexate-naïve, adult patients with moderate to severely active early rheumatoid arthritis (mean disease duration less than 9 months).
Študija pri revmatoidnem artritisu V je ocenila 799 odraslih bolnikov, ki še niso dobivali metotreksata in so imeli zmerno do zelo aktiven zgoden revmatoidni artritis (povprečno trajanje bolezni manj kot 9 mesecev).
This study evaluated the efficacy of Humira 40 mg every other week/ methotrexate combination therapy, Humira 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.
Ta študija je ocenila učinkovitost treh shem (kombinirana terapija s Humiro 40 mg vsak drugi teden/ metotreksatom, monoterapija s Humiro 40 mg vsak drugi teden in monoterapija z metotreksatom) za zmanjšanje znakov in simptomov ter hitrosti napredovanja sklepne okvare pri revmatoidnem artritisu v obdobju 104 tednov.
The primary end point in RA studies I, II and III and the secondary endpoint in RA 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.
The primary endpoint in RA study V was the percent of patients who achieved an ACR 50 response at Week 52.
Primarna končna točka študije pri revmatoidnem artritisu V je bil odstotek bolnikov, ki so do 52. tedna dosegli odziv ACR 50.
RA study III also had a primary endpoint of changes in quality of life.
Študija pri revmatoidnem artritisu III je imela kot primarno končno točko tudi spremembe v kakovosti življenja.
The percent of Humira-treated patients achieving ACR 20, 50 and 70 responses was consistent across RA studies I, II and III.
Odstotek bolnikov, zdravljenih s Humiro, ki so dosegli odziv 20, 50 in 70 po ACR, se je v študijah pri revmatoidnem artritisu I, II in III skladal.
Table 3 ACR Responses in Placebo-Controlled Trials (Percent of Patients)
Odziv po ACR v študijah, kontroliranih s placebom (odstotek bolnikov) Odziv
Response
Študija pri revmatoidnem a
RA Study Ia**
Študija pri
RA Study IIa**
Študija pri revmatoidnem artritisu IIIa **
RA Study IIIa**
artritisu I **
ACR 20
placebo / MTXc Humirab / MTXc placebo Humirab placebo / MTXc Humirab / MTXc ACR 20
Placebo/ MTXc n=60
n = 113 n = 200
Humirab/ MTXc n=63
6 mesecev
Placebo n=110
29, 5%
Humirab n=113
63, 3%
Placebo/ MTXc n=200
12 mesecev
Humirab/ MTXc n=207
NP NP NP NP
6 months 12 months ACR 50
58, 9%
13.3% NA
ACR 50
65.1% NA
6 mesecev
19.1% NA
52, 4%
46.0% NA
22, 1%
29.5% 24.0%
39, 1%
63.3% 58.9%
12 mesecev
6 months 12 months ACR 70
NP NP NP NP
6.7% NA
9, 5%
8.2% NA
ACR 70
22.1% NA
6 mesecev
9.5% 9.5%
3, 3%
39.1% 41.5%
23, 8%
6 months 12 months a
12, 4%
3.3% NA
2, 5%
23.8% NA
20, 8%
1.8% NA
12 mesecev
12.4% NA
NP NP NP NP
RA study I at 24 weeks, RA study II at 26 weeks, and RA study III at 24 and 52 weeks b 40 mg Humira administered every other week c MTX = methotrexate **p < 0.01, Humira versus placebo
Študija pri revmatoidnem artritisu I po 24 tednih, študija pri revmatoidnem artritisu II po 26 tednih in študija pri revmatoidnem artritisu III po 24 in 52 tednih b 40 mg Humire vsak drugi teden c MTX = metotreksat ** p < 0, 01, Humira v prim. s placebom;
In RA studies I-IV, all individual components of the ACR response criteria (number of tender and swollen joints, physician and patient assessment of disease activity and pain, disability index (HAQ) scores and CRP (mg/ dl) values) improved at 24 or 26 weeks compared to placebo.
26 tednih izboljšali vsi posamezni elementi 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)).
In RA study III, these improvements were maintained throughout 52 weeks.
V študiji pri revmatoidnem artritisu III so se ta izboljšanja ohranila 52 tednov.
In addition, ACR response rates were maintained in the majority of patients followed in the open-label extension phase to Week 104.
Poleg tega se je delež odziva po ACR ohranil pri večini bolnikov, ki so jih med odprto nadaljevalno fazo spremljali do 104. tedna.
There 16 were 114 out of 207 patients who continued on Humira 40 mg every other week for 60 months.
114 od 207 bolnikov je nadaljevalo z jemanjem 40 mg Humire vsak drugi teden 60 mesecev.
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 RA study IV, the ACR 20 response of patients treated with Humira plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p < 0.001).
V študiji pri revmatoidnem artritisu IV je bil odziv 20 po ACR pri bolnikih, zdravljenih s Humiro in standardno oskrbo, statistično značilno boljši kot pri bolnikih, zdravljenih s placebom in standardno oskrbo (p < 0, 001).
In RA studies I-IV, Humira-treated patients achieved statistically significant ACR 20 and 50 responses compared to placebo as early as one to two weeks after initiation of treatment.
V študijah pri revmatoidnem artritisu I– IV so s Humiro 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 RA study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with Humira and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and Humira monotherapy at Week 52 and responses were sustained at Week 104 (see Table 4).
V študiji pri revmatoidnem artritisu V pri bolnikih z zgodnjim revmatoidnim artritisom, ki še niso dobivali metotreksata, je kombinirana terapija s Humiro in metotreksatom po 52 tednih prinesla hitrejše in značilno večje odzive ACR kakor monoterapija z metotreksatom ali monoterapija s Humiro, odzivi pa so se ohranili do 104. tedna (glejte tabelo 4).
Table 4 ACR Responses in RA Study V (percent of patients)
Odzivi ACR v študiji pri revmatoidnem artritisu V (odstotek bolnikov)
Humira/ MTX
Vrednost Pc
ACR 50
ACR
Week 52 Week 104
52. teden 104. teden 50
ACR 70
ACR
Week 52 Week 104
52. teden 104. teden 70
Week 52 Week 104
52. teden 104. teden