natgillin/translations-raw huggingface dataset:
In the larger AS study I with 315 patients, results showed statistically significant improvement of the signs and symptoms of ankylosing spondylitis in patients treated with Humira compared to placebo.
Rezultati obsežnejše študije pri ankilozirajočem spondilitisu I pri 315 bolnikih so pri bolnikih, ki so dobivali Humiro, pokazali statistično značilno izboljšanje znakov in simptomov ankilozirajočega spondilitisa v primerjavi s placebom.
48 Table 10 – Efficacy Responses in Placebo-Controlled AS Study – Study I Reduction of Signs and Symptoms
Tabela 10 - Odzivi učinkovitosti v študiji pri ankilozirajočem spondilitisu, kontrolirani s placebom - študija I Zmanjšanje znakov in simptomov
478 of the enrolled patients (32%) were defined as having a severe disease (CDAI score > 300 and concomitant corticosteroid and/ or immunosuppressants) corresponding to the population defined in the indication (see section 4.1).
Pri 478 zajetih bolnikih (32%) je bila bolezen opredeljena kot huda (seštevek CDAI > 300 ter sočasno zdravljenje s kortikosteroidom in // ali imunosupresivom), kar ustreza populaciji, opredeljeni pri indikacijah (glejte poglavje 4. 1).
Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies, CD Study I (CLASSIC I) and CD Study II (GAIN).
49 Indukcijo klinične remisije (opredeljene kot CDAI < 150) so ocenili v dveh študijah, študiji pri Crohnovi bolezni I (CLASSIC I) in študiji pri Crohnovi bolezni II (GAIN).
In CD Study I, 299 TNF-antagonist naive patients were randomised to one of four treatment groups; placebo at Weeks 0 and 2, 160 mg Humira at Week 0 and 80 mg at Week 2, 80 mg at Week 0 and 40 mg at Week 2, and 40 mg at Week 0 and 20 mg at Week 2.
V študiji pri Crohnovi bolezni I so 299 bolnikov, ki pred tem še niso dobivali antagonistov TNF, randomizirali v eno od štirih skupin: placebo 0. in 2. teden, 160 mg Humire 0. teden in 80 mg 2. teden, 80 mg 0. teden in 40 mg 2. teden oziroma 40 mg 0. teden in 20 mg 2. teden.
In CD Study II, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg Humira at Week 0 and 80 mg at Week 2 or placebo at Weeks 0 and 2.
V študiji pri Crohnovi bolezni II so 325 bolnikov, ki so se nehali odzivati na infliksimab ali ga niso prenesli, randomizirali bodisi na 160 mg Humire 0. teden in 80 mg 2. teden bodisi na placebo 0. in 2. teden.
49 randomised to 40 mg every other Week, 40 mg every Week, or placebo with a total study duration of 56 Weeks.
Na 4. teden so bolnike randomizirali na 40 mg vsak drugi teden, 40 mg vsak teden ali placebo; v celoti je študija trajala 56 tednov.
CD study I and CD study II induction of remission and response rates are presented in Table 11.
Indukcijo remisije in deleže odziva v študiji pri Crohnovi bolezni I in študiji pri Crohnovi bolezni II prikazuje tabela 11.
CDStudy I:
Študija pri Crohnovi bolezni I:
12% 24% 36%* **
12% 24% **
InCD Study III, at Week 4, 58% (499/ 854) of patients were in clinical response and were assessed in the primary analysis.
V študiji pri Crohnovi bolezni III je imelo 4. teden klinični odziv 58% (499/ 854) bolnikov; ti so bili ocenjeni v primarni analizi.
50 Table 12 Maintenance of Clinical Remission and Response (Percent of Patients)
Vzdrževanje klinične remisije in odziva (odstotek bolnikov)
Therapy continued beyond 12 Weeks did not result in significantly more responses (see section 4.2).
Zdravljenje prek 12. tedna ni prineslo značilno več odzivov (glejte poglavje 4. 2).
51 by 40 mg every other week (starting one week after the initial dose) for 16 weeks.
51 nadaljnjim povečanjem odmerka skozi 12 tednov do največjega odmerka 25 mg, ali začetni odmerek 80 mg Humire in potem 40 mg vsak drugi teden (začenši en teden po začetnem odmerku) 16 tednov.
Table 13 Ps Study I (REVEAL) - Efficacy Results at 16 Weeks
Študija pri psoriazi I (REVEAL) Rezultati učinkovitosti po 16 tednih Humira 40 mg placebo vsak 2. teden n = 398 n = 814 n (%) n (%) 578 (70, 9) b a
Clear/ minimal
PASI ≥ 75 PASI 100 PGA: čisto/ minimalno a
Percent of patients achieving PASI75 response was calculated as center- adjusted rate b p < 0.001, Humira vs. placebo
Odstotek bolnikov, ki so dosegli odziv PASI 75, je bil izračunan kot delež, korigiran za center. b p < 0, 001, Humira v primerjavi s placebom
Placebo N=53 n (%)
placebo
MTX N=110 n (%)
vsak 2. teden
Humira 40 mg eow N=108 n (%)
n (%) 86 (79, 6) a, b
≥ PASI 75 PASI 100 PGA:
PASI ≥ 75
86 (79.6) a, b 18 (16.7) c, d 79 (73.1) a, b
PGA: čisto/ minimalno a
Clear/ minimal a p < 0.001 Humira vs. placebo b p < 0.001 Humira vs. methotrexate c p < 0.01 Humira vs. placebo d p < 0.05 Humira vs. methotrexate
p < 0, 001 Humira v primerjavi s placebom b p < 0, 001 Humira v primerjavi z metotreksatom c p < 0, 01 Humira v primerjavi s placebom d p < 0, 05 Humira v primerjavi z metotreksatom
In an open-label extension study, for patients who dose escalated from 40 mg every other week to 40 mg weekly due to a PASI response below 50 and were evaluated at 12 weeks after dose escalation, 59/ 243 (24.3%) of patients regained PASI 75 response.
52 V odprti podaljšani študiji je odziv PASI 75 znova doseglo 59 od 243 (24, 3%) bolnikov, ki so jim zaradi odziva PASI pod 50 odmerek povečali s 40 mg vsak drugi teden na 40 mg vsak teden ter so jih ocenili 12 tednov po povečanju odmerka.
52 Immunogenicity
Imunogenost
Following the administration of 24 mg/ m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with polyarticular juvenile idiopathic arthritis (JIA) the mean trough steady-state (values measured from Week 20 to 48) serum adalimumab concentration was 5.6 ± 5.6 µg/ mL (102 %CV) Humira monotherapy and 10.9 ± 5.2 µg/ mL (47.7% CV) with concomitant methotrexate.
53 Po uporabi 24 mg/ m2 (do največ 40 mg) subkutano vsak drugi teden pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom je bila povprečna najnižja koncentracija adalimumaba v serumu v stanju dinamičnega ravnovesja (vrednosti merjene od 20. do 48. tedna) med monoterapijo s Humiro 5, 6 ± 5, 6 µg/ ml (koeficient variacije 102%) in med uporabo z metotreksatom 10, 9 ± 5, 2 µg/ ml (koeficient variacije 47, 7%).
53 In patients with Crohn’ s disease, the loading dose of 80 mg Humira on Week 0 followed by 40 mg Humira on Week 2 achieves serum adalimumab trough concentrations of approximately 5.5 µg/ ml during the induction period.
Pri bolnikih s Crohnovo boleznijo doseže polnilni odmerek 80 mg Humire na 0. teden, ki mu sledi 40 mg Humire 2. teden, med obdobjem indukcije najnižjo koncentracijo v serumu približno 5, 5 μg/ ml.
Population pharmacokinetic analyses with data from over 1,300 RA patients revealed a trend toward higher apparent clearance of adalimumab with increasing body weight.
Analize populacijske farmakokinetike s podatki za več kot 1. 300 bolnikov z revmatoidnim artritisom so pokazale trend k večjemu navideznemu očistku adalimumaba z večanjem telesne teže.
Humira has not been studied in patients with hepatic or renal impairment.
Humira ni raziskana pri bolnikih z okvaro jeter ali ledvic.
Mannitol Citric acid monohydrate Sodium citrate Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Sodium chloride Polysorbate 80 Sodium hydroxide Water for injections
manitol citronska kislina monohidrat natrijev citrat natrijev dihidrogenfosfat dihidrat natrijev hidrogenfosfat dihidrat natrijev klorid polisorbat 80 natrijev hidroksid voda za injekcije
6.3 Shelf life
54 6. 3 Rok uporabnosti
54 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina
Humira 40 mg solution for injection in single-use pre-filled syringe (type I glass) for patient use:
Humira 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi (steklo tipa I) za enkratno bolnikovo uporabo.
Packs of: • 1 pre-filled syringe (0.8 ml sterile solution) with 1 alcohol pad in a blister. • 2 pre-filled syringes (0.8 ml sterile solution), each with 1 alcohol pad, in a blister. • 4 pre-filled syringes (0.8 ml sterile solution), each with 1 alcohol pad, in a blister. • 6 pre-filled syringes (0.8 ml sterile solution), each with 1 alcohol pad, in a blister.
Pakiranja: • 1 napolnjena injekcijska brizga (0, 8 ml sterilne raztopine) z 1 alkoholnim zložencem v pretisnem omotu. • 2 napolnjeni injekcijski brizgi (0, 8 ml sterilne raztopine), vsaka z 1 alkoholnim zložencem, v pretisnem omotu. • 4 napolnjene injekcijske brizge (0, 8 ml sterilne raztopine), vsaka z 1 alkoholnim zložencem, v pretisnem omotu. • 6 napolnjenih injekcijskih brizg (0, 8 ml sterilne raztopine), vsaka z 1 alkoholnim zložencem, v pretisnem omotu.
DATE OF FIRST AU`THORISATION/ RENEWAL OF THE AUTHORISATION
DATUM PRIDOBITVE/ PODALJŠANJA DOVOLJENJA ZA PROMET
Clear solution for injection in pre-filled syringe with needleguard.
Bistra raztopina za injiciranje v napolnjeni injekcijski brizgi s ščitnikom za iglo
Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Humiro je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljnje zdravljenje z metotreksatom ni primerno.
56 Ankylosing spondylitis
56 Ankilozirajoči spondilitis
57 The recommended dose of Humira for patients with psoriatic arthritis or ankylosing spondylitis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
57 Psoriatični artritis in ankilozirajoči spondilitis
58 4.3 Contraindications
58 4. 3 Kontraindikacije
In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidiomycosis, or blastomycosis, the risk and benefits of treatment with Humira should be considered prior to initiating therapy (see Opportunistic infections).
Pred začetkom zdravljenja je treba tveganja in koristi zdravljenja s Humiro pretehtati pri bolnikih, ki so bili izpostavljeni tuberkulozi, in bolnikih, ki so potovali na območja, kjer obstaja veliko tveganje tuberkuloze ali endemičnih mikoz, npr. histoplazmoze, kokcidioidomikoze ali blastomikoze (glejte Oportunistične okužbe).
Serious infections including sepsis, due to bacterial, mycobacterial, invasive fungal viral, or other opportunistic infections such as listeriosis, and pneumocystis have been reported in patients receiving Humira.
Pri bolnikih, ki so dobivali Humiro, so bile opisane resne okužbe, vključno s sepso, zaradi bakterijskih, mikobakterijskih, invazivnih glivičnih, virusnih in drugih oportunističnih okužb, npr. listerioza in pnevmocistična okužba.
59 If latent tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted.
59 Če sumite na latentno tuberkulozo, se posvetujte z zdravnikom, ki ima izkušnje z zdravljenjem tuberkuloze.
In all situations described below, the benefit/ risk balance of therapy should be very carefully considered.
V vseh spodaj navedenih okoliščinah je treba korist in tveganje zdravljenja s Humiro zelo natančno pretehtati.
These infections have not consistently been recognised in patients taking TNF-blockers and this has resulted in delays in appropriate treatment, sometimes resulting in fatal outcomes.
Takšne okužbe se pri uporabnikih zaviralcev TNF niso pojavljale vedno, zato je v primerih njihovega nastanka prihajalo do zamud pri ustreznem zdravljenju, kar je včasih povzročilo smrt.
Non-serious allergic reactions associated with Humira were uncommon during clinical trials.
S Humiro povezane alergijske reakcije, ki niso bile resne, so se v kliničnih študijah pojavljale
60 very rarely following Humira administration.
V pomarketinškem obdobju so po uporabi Humire v zelo redkih primerih poročali o resnih alergijskih reakcijah, vključno z anafilaksijo.
In the controlled portions of clinical trials of TNF-antagonists, more cases of malignancies including lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients.
V kontroliranih delih kliničnih preizkušanj z antagonisti TNF je bilo opaženih več primerov malignomov, vključno z limfomi tako pri bolnikih, ki so prejemali antagonist TNF, kot pri kontrolnih bolnikih.
Rare reports of pancytopenia including aplastic anaemia have been reported with TNF atagonists.
Pri uporabi antagonistov TNF je bila v redkih primerih opisana pancitopenija, vključno z aplastično anemijo.
Vaccinations Similar antibody responses to the standard 23-valent pneumococcal vaccine and the influenza trivalent virus vaccination were observed in a study in 226 adult subjects with rheumatoid arthritis who were
V študiji 226 odraslih preiskovancev z revmatoidnim artritisom, ki so dobivali adalimumab ali placebo, so ugotovili podobne odzive protiteles na standardno 23- valentno pnevmokokno cepivo in
61 treated with adalimumab or placebo.
61 trivalentno virusno cepivo proti influenci.
62 4.5 Interaction with other medicinal products and other forms of interaction
62 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Humira has been studied in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis patients taking Humira as monotherapy and those taking concomitant methotrexate.
Humiro so raziskali pri bolnikih z revmatoidnim artritisom, poliartikularnim juvenilnim idiopatskim artritisom in revmatoidnim artritisom, ki so Humiro jemali v monoterapiji, kot pri tistih, ki so jo jemali hkrati z metotreksatom.
These trials included rheumatoid arthritis patients with short term and long standing disease, polyarticular juvenile idiopathic arthritis as well as psoriatic arthritis, ankylosing spondylitis, Crohn’ s disease and psoriasis patients.
Ta preskušanja so vključila bolnike z revmatoidnim artritisom (tako tiste, ki so imeli bolezen kratek čas, kot tiste, ki so jo imeli že dolgo), poliartikularnim juvenilnim idiopatskim artritisom, psoriatičnim artritisom, ankilozirajočim sponditisom, Crohnovo boleznijo in psoriazo.
The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of pivotal studies was 4.5% for patients taking Humira and 4.5% for control treated patients.
Delež bolnikov, ki so zaradi neželenih učinkov prekinili zdravljenje med dvojno slepim, s placebom kontroliranim delom ključnih študij, je bil 4, 5% v skupini, ki je prejemala Humiro, in 4, 5% v kontrolni skupini.
63 Adverse events at least possibly causally-related to adalimumab for pivotal studies, both clinical and laboratory, are displayed by system organ class and frequency (very common ≥ 1/ 10; common ≥ 1/ 100 to < 1/ 10; uncommon ≥ 1/ 1,000 to < 1/ 100 and rare ≥ 1/ 10,000 to < 1/ 1,000) in Table 1 below.
63 Klinični in laboratorijski neželeni učinki, ki so vsaj potencialno vzročno povezani z adalimumabom v ključnih študijah, 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.
vision disorder, ocular sensation disorders, infection, irriaation or inflammation of the eye
bolezni vida, motnje vidnega zaznavanja, okužba, draženje ali vnetje očesa
64 System Organ Class Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora
Gastrointestinal disorders
64 Organski sistem Bolezni prebavil
Common
Pogostnost pogosti
diarrhoea, abdominal pain, stomatitis and mouth ulceration, nausea
Neželeni učinki diareja, bolečine v trebuhu, stomatitis in razjede v ustih, navzeja
65 System Organ Class Infections and infestations
Infekcijske in parazitske bolezni
Neoplasms benign, malignant and
Benigne, maligne in neopredeljene novotvorbe
unspecified (including cysts and polyps)
65 Organski sistem (vključno s cistami in polipi)
Rare
Pogostnost redki
lymphoma, solid organ tumours (including breast, ovarian, testicular), malignant melanoma, squamous cell carcinoma of the skin
Neželeni učinki limfom, tumorji parenhimskih organov (vključno z dojkami, jajčniki in testisi), maligni melanom, ploščatocelični karcinom kože
66 Injection site reactions
Spremembe na mestu injiciranja
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).
Večina primerov tuberkuloze
Most of the cases of tuberculosis occurred within the first eight months after initiation of therapy and may reflect recrudescence of latent disease.
66 se je pojavila v prvih osmih mesecih po začetku zdravljenja in mogoče je, da gre za ponoven izbruh latentne bolezni.
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 3,853 Humira treated patients versus a rate of 4.3 (1.8, 10.4) per 1,000 patient-years among 2183 control patients (median duration of treatment was 5.5 months for Humira and 3.9 months for control-treated 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, 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 1000 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.
67 Autoantibodies
Avtoprotitelesa
Rheumatoid arthritis clinical trials: in controlled rheumatoid arthritis clinical trials (RA studies 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.
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.
Skin and subcutaneous tissue disorders Immune system disorders Neoplasmsbenign, malignant and unspecified (including cysts and polyps)
Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)
68 4.9 Overdose
4. 9 Preveliko odmerjanje
Mechanism of action
68 Mehanizem delovanja
RA 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 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 od 10 do 25 mg metotreksata ostal stalen vsak teden.
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 have
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.
Patients were permitted to be either disease-modifying, anti-rheumatic drug-naïve or to remain on their pre-existing rheumatologic therapy provided that therapy was stable for a minimum of 28 days.
Terapije so vključevale metotreksat,
These therapies include methotrexate, leflunomide, hydroxychloroquine, sulfasalazine and/ or gold salts.
69 leflunomid, hidroksiklorokin, sulfasalazin in/ ali soli zlata.
The primary end point in RA studies I, II and III and the secondary endpoint in RA study IV was the percentage of patients who achieved an ACR 20 response at Week 24 or 26.
26 tednih dosegli odziv 20 po ACR.
Placebo/ MTXc n=60
n = 110 n = 113
70 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)).
There 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.
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).
70 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 bolniki, zdravljeni s Humiro, v primerjavi s prejemniki placeba doživeli 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 zgodnim 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).
Response ACR 20
vrednost
n=257
vrednost
p-valuea
n = 257 ACR 20
p-valueb
52. teden
ACR 50
0, 043
Week 52 Week 104
104. teden
0.043 0.140
104. teden
Week 52 Week 104
52. teden
Week 52 Week 104
104. teden a