natgillin/translations-raw huggingface dataset:
Children and adolescents (aged 13 to 17 years) Polyarticular Juvenile Idiopathic Arthritis The recommended dose of Humira for patients with polyarticular juvenile idiopathic arthritis, aged 13 years and above is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Priporočeni odmerek Humire za bolnike s poliartikularnim juvenilnim idiopatskim artritisom, stare nad 13 let, je 40 mg adalimumaba vsak drugi teden v enkratnem odmerku v subkutani injekciji.
Impaired renal and/ or hepatic function
Okvarjeno delovanje ledvic in/ ali jeter
Humira has not been studied in these patient populations.
Humira pri teh populacijah bolnikov še ni bila preskušena.
31 4.3 Contraindications
31 4. 3 Kontraindikacije
Administration of Humira should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infectionis controlled.
Če se bolniku pojavi nova resna okužba ali sepsa, je treba uporabo Humire prekiniti in uvesti ustrezno protimikrobno ali protimikotično zdravljenje, dokler okužba ni obvladana.
Appropriate screening tests, i. e. tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may apply).
Pri vseh bolnikih je treba narediti ustrezne presejalne preiskave, tj. tuberkulinski kožni test in rentgensko slikanje prsnih organov (veljajo lahko lokalna priporočila).
32 If active tuberculosis is diagnosed, Humira therapy must not be initiated (see section 4.3).
Če se odkrije aktivna tuberkuloza, se zdravljenja s Humiro ne sme začeti (glejte poglavje 4. 3).
If latent tuberculosis issuspected, a physician with expertise in the treatment of tuberculosis should be consulted.
32 Če sumite na latentno tuberkulozo, se posvetujte z zdravnikom, ki ima izkušnje z zdravljenjem tuberkuloze.
If inactive (‘ latent’) tuberculosis is diagnosed, appropriate treatment for latent tuberculosis must be started with anti-tuberculosis prophylaxis therapy before the initiation of Humira, and in accordance with local recommendations.
Če ugotovite neaktivno (“ latentno ”) tuberkulozo, morate pred uvedbo Humire začeti zdraviti latentno tuberkulozo s protituberkulozno profilaktično terapijo v skladu z lokalnimi priporočili.
Non-serious allergic reactions associated with Humira were uncommon during
S Humiro povezane alergijske reakcije, ki niso bile resne, so se v kliničnih študijah pojavljale
33 clinical trials.
33 občasno.
All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (e. g. persistent fever, bruising, bleeding, pallor) while on Humira.
Vsem bolnikom je treba naročiti, naj nemudoma poiščejo zdravniško pomoč, če se jim med uporabo Humire pojavijo znaki ali simptomi krvnih diskrazij (npr. trajno zvišana telesna temperatura, podplutbe, krvavitve, bledica).
Discontinuation of Humira therapy should be considered in patients with confirmed significant haematologic abnormalities.
Pri bolnikih s potrjenimi pomembnimi hematološkimi nepravilnostmi je treba razmisliti o prekinitvi terapije s Humiro.
34 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 treated with adalimumab or placebo.
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
It is recommended that polyarticular juvenile idiopathic arthritis patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating Humira therapy.
Za bolnike s poliartikularnim juvenilnim idiopatskim artritisom je priporočljivo, da pred začetkom zdravljenja s Humiro opravijo vsa cepljenja v skladu z veljavnimi smernicami za cepljenje, če je le mogoče.
Cases of worsening congestive heart failure have also been reported in patients receiving Humira.
O primerih poslabšanja kongestivnega srčnega popuščanja so poročali pri bolnikih, ki so prejemali Humiro.
Humira is contraindicated in moderate to severe heart failure (see section 4.3).
Pri bolnikih z zmernim ali hudim srčnim popuščanjem je Humira kontraindicirana (glejte poglavje 4. 3).
(See section 4.5).
Kombinacija Humire in abatacepta ni priporočljiva (glejte poglavje 4. 5).
35 4.5 Interaction with other medicinal products and other forms of interaction
35 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Antibody formation was lower when Humira was given together with methotrexate in comparison with use as monotherapy.
Če je bila Humira uporabljena skupaj z metotreksatom, je bilo nastajanje protiteles v primerjavi z monoterapijo manjše.
Dizziness (including vertigo, vision disorder and fatigue) may occur following administration of Humira (see Section 4.8).
Po dajanju Humire se lahko pojavi omotica (vključno z vrtoglavico, motnjami vida in utrujenostjo) (glejte poglavje 4. 8).
Humira was studied in 6,593 patients in controlled and open label trials for up to 60 months.
Humiro so raziskali pri 6593 bolnikih v kontroliranih in odprtih preskušanjih, ki so trajala do 60 mesecev.
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 vključile 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 spondilitisom, Crohnovo boleznijo in psoriazo.
The data in Table 1 is based on the pivotal controlled Studies involving 4,355 patients receiving Humira and 2,487 patients receiving placebo or active comparator during the controlled period.
Podatki v tabeli 1 temeljijo na kontroliranih ključnih študijah, ki zajemajo 4355 bolnikov, ki so med kontroliranim obdobjem dobivali Humiro, in 2487 bolnikov, ki so med tem obdobjem dobivali placebo ali primerjalno učinkovino.
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, kontroliranim delom ključnih študij, je bil 4, 5% v skupini, ki je prejemala Humiro, in 4, 5% v kontrolni skupini.
36 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.
36 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.
ear discomfort (including pain and swelling)
neprijetno občutenje v ušesu (vključno z bolečino in otekanjem)
37 System Organ Class Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora
Adverse Reaction cough, nasopharyngeal pain
kašelj, bolečine v nazofarinksu
rectal haemorrhage, vomiting, dyspepsia, abdominal bloating, constipation
Neželeni učinki rektalna krvavitev, bruhanje, dispepsija, napenjanje v trebuhu, zaprtje
haematuria, renal impairment, bladder and urethral symptoms
hematurija, ledvična okvara, simptomi sečnega mehurja in sečnice
38 System Organ Class Infections and infestations
Infekcijske in parazitske bolezni
Vascular disorders
38 Organski sistem Žilne bolezni
hypertension, flushing, haematoma
Neželeni učinki hipertenzija, zardevanje, hematom
injection site reaction (including pain, swelling, redness or pruritus)
reakcija na mestu injiciranja (vključno z bolečino, oteklostjo, pordelostjo ali srbenjem)
39 Injection site reactions
Spremembe na mestu injiciranja
The infections consisted primarily nasopharyngitis, upper respiratory tract infection, and sinusitis.
Pri okužbah je šlo predvsem za nazofaringitis, okužbo zgornjih dihal in sinuzitis.
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).
Malignancies and lymphoproliferative disorders
39 Malignomi in limfoproliferativne bolezni
No malignancies were observed in 171 patients with an exposure of 192.5 patient years during a Humira trial in juvenile idiopathic arthritis patients.
Med 171 bolniki z juvenilnim idiopatskim artritisom, ki so bili med preskušanjem Humire zdravilu izpostavljeni 192, 5 bolnik- leta, niso ugotovili nobenega malignoma.
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 or 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 2,183 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 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.
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 1,000 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.
40 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 so ob več različnih časih testirali protitelesa v serumu.
In patients with early rheumatoid arthritis (disease duration of less than 3 years) (RAstudy 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 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.
40 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.
Adverse Reaction intestinal perforation reactivation of hepatitis B demyelinating disorders (e. g. optic neuritis, Guillain-Barré syndrome)
demielinizirajoče bolezni (npr. optični nevritis, Guillain- Barréjev sindrom)
Skin and subcutaneous tissue disorders Immune system disorders Neoplasm benign, malignant and unspecified (including cysts and polyps)
Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)
41 No dose-limiting toxicity was observed during clinical trials.
V kliničnih študijah niso opazili toksičnih učinkov, ki bi omejevali odmerek.
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).
41 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).
Humira was evaluated in over 3000 patients in all rheumatoid arthritis clinical trials.
V vseh kliničnih preskušanjih pri revmatoidnem artritisu so Humiro ocenili pri več kot 3000 bolnikih.
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 metotreksata od 10 do 25 mg 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 been intolerant to 10 mg of methotrexate every week.
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.
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 42 mesecev).
Response
Študija pri revmatoidnem artritisu Ia **
RA Study IIIa**
ACR
Placebo/ MTXc n=60
= 110 n = 113
Placebo n=110
19, 1% 46, 0%
There
Poleg tega se je delež odziva po ACR ohranil pri večini bolnikov, ki so jih med odprto nadaljevalno fazo spremljali do 104. tedna.
43 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 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).
43 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) Odziv
Humira
Vrednost
Humira/ MTX
Pc
p-valuec
52. teden
Week
62, 6%
62.6%
54, 4%
54.4%
72, 8%
72.8%
0, 013
0.013
< 0, 001
< 0.001
0, 043
0.043
ACR
104
104. teden 50
Week
52. teden
104
104. teden 70
< 0.001 < 0.001
0, 162
0.656
a
104
52. teden 104. teden
a. p-value is from the pairwise comparison of methotrexate monotherapy and Humira/ methotrexate combination therapy using the Mann-Whitney U test. b. p-value is from the pairwise comparison of Humira monotherapy and Humira/ methotrexate combination therapy using the Mann-Whitney U test c. p-value is from the pairwise comparison of Humira monotherapy and methotrexate monotherapy using the Mann-Whitney U test
Vrednost p se nanaša na parno primerjavo monoterapije z metotreksatom in kombinirane terapije s Humiro/ metotreksatom z Mann- Whitneyevim testom U. b Vrednost p se nanaša na parno primerjavo monoterapije s Humiro in kombinirane terapije s Humiro/ metotreksatom z Mann- Whitneyevim testom U. c Vrednost p se nanaša na parno primerjavo monoterapije s Humiro in monoterapije z metotreksatom z Mann- Whitneyevim testom U.
Data from
Pri bolnikih, ki so dobivali Humiro in metotreksat, je bilo po 6 in 12 mesecih (glejte tabelo 5) statistično značilno manj rentgenografskih znakov napredovanja kot pri bolnikih, ki so dobivali samo metotreksat.
44 the open-label extension phase indicate that the reduction in rate of progression of structural damage is maintained for 60 months in a subset of patients.
Podatki iz odprte podaljšane faze kažejo, da se upočasnitev napredovanja strukturne prizadetosti sklepov ohrani vseskozi 60 mesecev v tej podskupini bolnikov.
Table 5 Radiographic Mean Changes Over 12 Months in RA Study III
Povprečne rentgenografske spremembe v 12 mesecih študije pri revmatoidnem artritisu III
Placebo/ MTXa
placebo/ MTXa
HUMIRA/ MTX 40 mg every
HUMIRA/ MTX 40 mg vsak drugi teden
Placebo/ MTX- HUMIRA/ MTX
placebo/ MTX - HUMIRA/ MTX (95% interval zaupanjab)
p-value
vrednost p < 0, 001c
(95% Confidence Intervalb)
2, 6 (1, 4, 3, 8)
Total Sharp Score Erosion score JSNd score
Ocena erozij Ocena ZSŠd metotreksat
2.6 (1.4, 3.8) 1.6 (0.9, 2.2) 0.9 (0.3, 1.4)
1, 6 (0, 9, 2, 2) 0, 9 (0, 3, 1, 4)
0.001c 0.001 0.002
0, 001 0, 002
(95%
pa
p-valuea
1, 3 (0, 5- 2, 1)
p-valuec
0, 0020
confidence confidence interval) interval)
< 0, 001
confidence interval)
Ocena erozij
Total Sharp Score
3, 7 (2, 7- 4, 7)
5.7 (4.2-7.3)
3, 0 (1, 0- 2, 4)
3.0 (1.7-4.3)
0, 8 (0, 4- 1, 2)
Erosion score JSN score a
Seštevek JSN a
45 Health-related quality of life and physical function was assessed using the disability index of the Health Assessment Questionnaire (HAQ) in the four original adequate and well-controlled trials, which was a pre-specified primary endpoint at Week 52 in RA study III.
Z zdravjem povezano kakovost življenja in telesno funkcijo so v štirih originalnih ustreznih in dobro kontroliranih študijah ocenjevali z indeksom invalidnosti z vprašalnikom HAQ (Health Assessment Questionnaire) in je bila v študiji pri revmatoidnem artritisu III vnaprej določena primarna končna točka po 52 tednih.
Results from the Short Form Health Survey (SF 36) for all doses/ schedules of Humira in all four studies support these findings, with statistically significant physical component summary (PCS) scores, as well as statistically significant pain and vitality domain scores for the 40 mg every other week dose.
V vseh treh študijah (študije pri
A statistically significant decrease in fatigue as measured by functional assessment of chronic illness therapy (FACIT) scores was seen in all three studies in which it was assessed (RA studies I, III, IV).
45 revmatoidnem artritisu I, III in IV), v katerih so ocenjevali utrujenost s funkcijsko oceno terapije kronične bolezni (functional assessment of chronic illness therapy (FACIT)), so ugotovili statistično značilno zmanjšanje utrujenosti.
In RA study III, improvement in physical function was maintained through Week 260 (60 months) of open-label treatment.
V študiji pri revmatoidnem artritisu III se je izboljšanje telesne funkcije in kakovosti življenja ohranilo vseskozi do 206. tedna (60. meseca) odprte faze zdravljenja.
Disease flare criteria were defined as a worsening of ≥ 30% from baseline in ≥ 3 of 6 Pediatric ACR core criteria, ≥ 2 active joints, and improvement of > 30% in no more than 1 of the 6 criteria.
Merila širjenja bolezni so bila opredeljena kot poslabšanje ≥ 3 od 6 osnovnih meril Pediatric ACR za ≥ 30% v primerjavi z izhodiščem, ≥ 2 aktivna sklepa in izboljšanje ne več kot 1 od 6 meril za > 30%.
After 32 weeks or at disease flare, patients were eligible to enroll into the open label extension phase
Po 32 tednih ali v primeru širjenja bolezni so bili bolniki primerni za vključitev v odprto podaljšano fazo.
46 Table 8 Ped ACR Responses in the JIA study
46 Tabela 8 Odzivi » Pediatric ACR (Ped ACR) « v študiji pri juvenilnem idiopatskem artritisu
Disease flares at the end of 32 weeksa (n/ N)
Širjenje bolezni na koncu 32- tedenskega obdobjaa (n/ N)
Humira, 40 mg every other week, was studied in patients with moderately to severely active psoriatic arthritis in two placebo-controlled studies, PsA studies I and II.
Uporabo Humire 40 mg vsak drugi teden so pri bolnikih z zmernim do hudim aktivnim psoriatičnim artritisom proučili v dveh s placebom kontroliranih študijah, študijah pri psoriatičnem artritisu I in II.
47 Table 9 ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients)
Odziv ACR v študijah pri psoriatičnem artritisu, kontroliranih s placebom (odstotek bolnikov)
Placebo
Študija pri psoriatičnem artritisu I placebo Humira
Placebo
Študija pri psoriatičnem artritisu II placebo Humira
N=162
n = 162 n = 151
N=151
n = 49 n = 51
Week 12 Week 24 ACR 50
12. teden
16% N/ A
np
39%* N/ A
np
Week 12 Week 24 ACR 70
12. teden
Week 12 Week 24
24. teden
0% N/ A
np
*** p < 0.001 for all comparisons between Humira and placebo
*** p < 0, 001 za vse primerjave med Humiro in placebom
p < 0.05 for all comparisons between Humira and placebo
p < 0, 05 za vse primerjave med Humiro in placebom
N/ A not applicable
np ne pride v poštev
Seventy-nine (20.1%) patients were treated concomitantly with disease modifying anti − rheumatic drugs, and 37 (9.4%) patients with glucocorticoids.
Devetinsedemdeset (20, 1%) bolnikov je sočasno dobivalo imunomodulacijska antirevmatična zdravila, 37 (9, 4%) bolnikov pa glukokortikoide.
Subjects (n=215, 54.7%) who failed to achieve ASAS 20 at Weeks 12, or 16 or 20 received early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently treated as non-responders in the double-blind statistical analyses.
Preiskovanci (n = 215, 54, 7%), ki 12. ali 16. ali 20. teden niso dosegli ASAS 20, so začeli v predčasni odprti fazi dobivati