natgillin/translations-raw huggingface dataset:
Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with Hefiya.
Bolnike je zato treba pred, med in po zdravljenju z zdravilom Hefiya natančno kontrolirati glede okužb, vključno s tuberkulozo.
In rheumatoid arthritis, methotrexate is continued while using Hefiya.
Pri revmatoidnem artritisu se uporaba metotreksata med uporabo zdravila Hefiya nadaljuje.
You may also use the lower abdomen, but not the area 5 cm around your navel (belly button) (see Figure D).
Uporabite lahko tudi spodnji del trebuha, vendar ne predela 5 cm okrog popka (glejte sliko D).
Approximately twice the proportion of patients in the placebo group in the first 12 weeks of Studies HS-I and HS-II, compared with those in the adalimumab group experienced worsening of abscesses (23.0 % vs 11.4 %, respectively) and draining fistulas (30.0 % vs 13.9 %, respectively).
Približno dvakratni delež bolnikov v skupini, ki je prejemala placebo, je v primerjevi s tistimi, ki so bili v skupini z adalimumabom, v prvih 12 tednih študije HS-I in HS-II, doživelo poslabšanje abscesov (23,0 % v primerjavi z 11,4 %, v tem zaporedju) in fistul z izcedkom (30,0 % v primerjavi s 13,9 %, v tem zaporedju).
During treatment with Hefiya, other concomitant therapies (e.g., corticosteroids and / or immunomodulatory agents) should be optimised.
Med zdravljenjem z zdravilom Hefiya je treba optimizirati druge sočasne terapije (npr. kortikosteroide in/ali imunomodulacijska zdravila).
After 5 years of adalimumab therapy, 74.0 % (37 / 50) of the 50 patients remaining in the study continued to be in clinical remission, and 92.0 % (46 / 50) of patients continued to be in clinical response per PCDAI.
Po 5 letih zdravljenja z adalimumabom se je glede na PCDAI klinična remisija nadaljevala pri 74,0 % (37/50) od 50 bolnikov, ki so ostali v študiji, klinični odziv pa se je nadaljeval pri 92,0 % (46/50) bolnikov, ki so ostali v študiji.
Axial spondyloarthritis
Aksialni spondiloartritis
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali farmacevtom.
Store in a refrigerator (2°C-8°C).
Shranjujte v hladilniku (2 °C - 8 °C).
• 80 mg at week 0 and 40 mg at week 2 ≥ 40 kg • 80 mg at week 0 and 40 mg at week 2
• 80 mg v 0. tednu in 40 mg v 2. tednu ≥ 40 kg • 80 mg v 0. tednu in 40 mg v 2. tednu
Improvement in health-related quality of life and physical function was maintained during the open- label extension through week 156.
Izboljšanje z zdravjem povezane kakovosti življenja in telesne funkcije se je pri podaljšanih študijah brez placeba ohranjalo do 156. tedna.
Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least five months after the last Hefiya treatment.
Ženske v rodni dobi morajo premisliti o uporabi ustrezne kontracepcijske zaščite za preprečitev nosečnosti in z njo nadaljevati vsaj še pet mesecev po zadnjem zdravljenju z zdravilom Hefiya.
79 (73.1) a, b a p<0.001 adalimumab vs. placebo b p<0.001 adalimumab vs. methotrexate c p<0.01 adalimumab vs. placebo d p<0.05 adalimumab vs. methotrexate
79 (73,1) a, b a p < 0,001 adalimumab v primerjavi s placebom b p < 0,001 adalimumab v primerjavi z metotreksatom c p < 0,01 adalimumab v primerjavi s placebom d p < 0,05 adalimumab v primerjavi z metotreksatom
5 How to store Hefiya Contents of the pack and other information Instructions for use
5 Shranjevanje zdravila Hefiya Vsebina pakiranja in dodatne informacije Navodila za uporabo
• raised liver enzymes.
• zvišani jetrni encimi.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
Adalimumab has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function.
Z rentgenskim slikanjem je bilo dokazano, da adalimumab upočasni hitrost napredovanja prizadetosti perifernih sklepov pri bolnikih s poliartikularno, simetrično podvrsto bolezni (glejte poglavje 5.1) in izboljša telesno funkcijo.
There is limited experience in the initiation of treatment with adalimumab alone.
O začetku zdravljenja samo z adalimumabom so izkušnje omejene.
Failure to respond to treatment for Crohn's disease may indicate the presence of fixed fibrotic stricture that may require surgical treatment.
Zapora tankega črevesa Če se bolnik ne odzove na zdravljenje Crohnove bolezni, lahko to pomeni, da ima stalno fibrotično strikturo, zaradi katere utegne biti potrebno kirurško zdravljenje.
• if you drop your syringe, do not use it if it looks damaged, or if you dropped it with the needle cap removed.
• če injekcijsko brizgo spustite, je ne uporabite, če je videti poškodovana ali če ste jo spustili z odstranjenim pokrovčkom za iglo.
There are no clinical trials with adalimumab in adolescent patients with HS.
Kliničnih študij z adalimumabom pri mladostnikih s HS ni.
Hefiya can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1).
Zdravilo Hefiya je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljnje zdravljenje z metotreksatom ni primerno (za učinkovitost monoterapije glejte poglavje 5.1).
There are no data available comparing adalimumab and MTX beyond 16 weeks of therapy.
Podatkov za primerjavo adalimumaba in metotreksata med več kot 16-tedenskim zdravljenjem ni.
• inflammation of the skin (such as eczema);
• vnetje kože (kot je ekcem);
Alternatively, if a patient has stopped Hefiya and signs and symptoms of disease recur, Hefiya may be re-administered.
Če bolnik neha uporabljati zdravilo Hefiya, pa se znaki in simptomi bolezni ponovijo, je mogoče zdravilo Hefiya znova uvesti.
TNF-antagonists including adalimumab have been associated in rare instances with new onset or exacerbation of clinical symptoms and / or radiographic evidence of central nervous system demyelinating disease including multiple sclerosis and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.
Antagonisti tumorje nekrotizirajočega faktorja (TNF), z adalimumabom vred, so bili v redkih primerih povezani s pojavom ali poslabšanjem kliničnih simptomov in/ali rentgenoloških znakov demielinizirajoče bolezni osrednjega živčnega sistema, vključno z multiplo sklerozo in optičnim nevritisom, in periferne demielinizirajoče bolezni, vključno z Guillain-Barré- jevim sindromom.
• bacterial infections;
• bakterijske okužbe;
Improved physical function continued during the open label extension up to week 136.
Izboljšanje telesnega delovanja je trajalo še med odprto nadaljevalno študijo do 136. tedna.
Non-infectious uveitis in adults and children
Neinfekcijski uveitis pri odraslih in otrocih
• neurological infections (including viral meningitis);
• nevrološke okužbe (vključno z virusnim meningitisom);
• the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
• Zdravljenje hudega, aktivnega in progresivnega revmatoidnega artritisa pri odraslih, ki prej še niso dobivali metotreksata.
Hefiya may have a minor influence on your ability to drive, cycle or use machines.
Zdravilo Hefiya ima lahko blag vpliv na sposobnost vožnje, kolesarjenja ali upravljanja strojev.
Treatment with Hefiya may result in the formation of autoimmune antibodies.
Zdravljenje z zdravilom Hefiya lahko povzroči nastanek avtoimunskih protiteles.
In a prospective cohort registry, 257 women with rheumatoid arthritis (RA) or Crohn's disease (CD) treated with adalimumab at least during the first trimester and 120 women with RA or CD not treated with adalimumab were enrolled.
V predvidenem kohortnem registru je bilo vključenih 257 žensk z revmatoidnim artritisom (RA) ali Crohnovo boleznijo (CB), zdravljenih z adalimumabom vsaj v prvem trimesečju nosečnosti, in 120
• reactivation of hepatitis B infection;
• reaktivacija okužbe s hepatitisom B;
After proper training in injection technique, patients may self-inject with Hefiya if their physician determines that it is appropriate and with medical follow-up as necessary.
Bolniki, ki se naučijo pravilnega postopka injiciranja, si zdravilo Hefiya lahko injicirajo sami, če zdravnik presodi, da je to primerno, in je zagotovljeno ustrezno medicinsko spremljanje.
No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab.
Podatkov o sekundarnem prenosu okužbe z živimi cepivi pri bolnikih, zdravljenih z adalimumabom, ni.
• do not use the pen if either the seal on the outer carton or the safety seal on the pen is broken.
• ne uporabljate injekcijskega peresnika, če je pečat zunanje škatle ali varnostni pečat na peresniku zlomljen;
Patients induced with 160 / 80 mg adalimumab achieved clinical remission versus placebo at week 8 in statistically significantly greater percentages in study UC-I (18 % vs. 9 % respectively, p = 0.031) and study UC-II (17 % vs. 9 % respectively, p = 0.019).
Bolniki, ki so za indukcijo dobili 160/80 mg adalimumaba, so 8. teden v primerjavi s placebom dosegli klinično remisijo v statistično značilno večjem odstotku tako v študiji UC-I (18 % v primerjavi z 9 %, p = 0,031) kot v študiji UC-II (17 % v primerjavi z 9 %, p = 0,019).
Study nraxSpA I evaluated patients with active nr-axSpA.
Študija nr-axSpA I je proučila bolnike z aktivnim nr-axSpA.
d score a methotrexate b 95 % confidence intervals for the differences in change scores between methotrexate and adalimumab c based on rank analysis d
< 0,001c ocena erozij ocena ZSŠd a metotreksat b 95 % intervali zaupanja za razlike v spremembi ocen med metotreksatom in adalimumabom c na podlagi analize rangov d zožitev sklepne špranje
Significant improvements at week 16 from baseline compared to placebo (Studies I and II) and MTX (Study II) were demonstrated in the DLQI (Dermatology Life Quality Index).
Značilno izboljšanje od izhodišča do 16. tedna se je v primerjavi s placebom (študiji I in II) in metotreksatom (študija II) izkazalo v dermatološkem indeksu kakovosti življenja (DLQI
An embryo-foetal developmental toxicity / perinatal developmental study has been performed in cynomolgus monkeys at 0, 30 and 100 mg / kg (9-17 monkeys / group) and has revealed no evidence of harm to the foetuses due to adalimumab.
Cynomologous z odmerki 0,30 in 100 mg/kg (od 9 do 17 opic na skupino) in ni pokazala znakov okvare plodov zaradi adalimumaba.
Leave it to dry before injecting (see Figure E).
Pustite, da se pred injiciranjem posuši (glejte sliko E).
Congestive heart failure
Kongestivno srčno popuščanje
• Twist off the cap in the direction of the arrows (see Figure F).
• Pokrovček odvijte v smeri puščic (glejte sliko F).
Table 18 Ps study II (CHAMPION) efficacy results at 16 weeks placebo N = 53 n (%)
Preglednica 18 študija pri psoriazi II (CHAMPION) - rezultati učinkovitosti po 16 tednih placebo n = 53 n (%)
No clinical exposure data are available on the use of a loading dose in children < 6 years.
Klinični podatki o izpostavljenosti pri uporabi polnilnega odmerka pri otrocih, mlajših od 6 let, niso na voljo.
Full instructions for use are provided in the package leaflet.
Celotna navodila za uporabo so navedena v navodilu za uporabo.
Hefiya is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Zdravilo Hefiya se uporablja za zdravljenje Crohnove bolezni pri odraslih in otrocih, starih od 6 do 17 let.
• Use your pen within 5 minutes of removing the cap.
• Injekcijski peresnik uporabite v 5 minutah po odstranitvi pokrovčka.
The efficacy of adalimumab in those patients was reduced compared to that in anti-TNF naïve patients.
Učinkovitost adalimumaba je bila pri teh bolnikih manjša kot pri bolnikih, ki še niso dobivali anti-TNF.
• lung diseases causing shortness of breath (including inflammation);
• pljučna bolezen, ki povzroči kratko sapo (vključno z vnetjem);
• inject Hefiya 15-30 minutes after taking it out of the refrigerator for a more comfortable injection.
• zdravilo Hefiya injicirate 15-30 minut po tem, ko ste ga vzeli iz hladilnika, da bo občutek pri injiciranju prijetnejši.
25, 40 and 40 mg
25, 40 in 40 mg
A greater proportion of patients on adalimumab had no disease flare during the double-blind period, when compared with those on placebo (70.4% vs. 47.1%, p<0.001) (Figure 1).
Pri večjem deležu bolnikov, ki so prejemali adalimumab, v dvojno slepem obdobju ni prišlo do ponovnega zagona bolezni v primerjavi s tistimi, ki so prejemali placebo (70,4 % v primerjavi s 47,1 %, p < 0,001) (slika 1).
• high blood measurements for lactate dehydrogenase;
• visoke krvne vrednosti za laktat dehidrogenazo;
This study evaluated the efficacy of adalimumab 40 mg every other week / methotrexate combination therapy, adalimumab 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 (kombinirano zdravljenje z adalimumabom 40 mg vsak drugi teden/metotreksatom, monoterapija z adalimumabom 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.
If you have moderate to severe active rheumatoid arthritis, you may first be given other disease-modifying medicines, such as methotrexate.
Če imate zmeren do hud aktiven revmatoidni artritis, boste morda najprej dobili druga imunomodulirajoča zdravila, npr.
Adults with ulcerative colitis
Odrasli z ulceroznim kolitisom
Among the 68 patients who flared in the group allocated to treatment withdrawal, 65 completed 12 weeks of rescue therapy with adalimumab, out of which 37 (56.9%) had regained remission (ASDAS < 1.3) after 12 weeks of restarting the open-label treatment.
Med 68 bolniki iz skupine namenjene prenehanju zdravljenja, pri katerih je prišlo do ponovnega zagona bolezni, jih je 65 zaključilo 12 tednov trajajoče rešilno zdravljenje z adalimumabom, od tega jih je 37 (56,9 %) po 12 tednih ponovne odprte faze zdravljenja ponovno doseglo remisijo (ASDAS
At week 4 patients were 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.
On rare occasions, a specific and severe type of lymphoma has been observed in patients taking adalimumab.
V redkih primerih so pri bolnikih, ki dobivajo adalimumab, opazili specifično in resno obliko limfoma.
Table 13 efficacy responses in placebo-controlled AS study - study I reduction of signs and symptoms response placebo N=107
kontrolirani s placebom - študija I zmanjšanje znakov in simptomov odziv placebo n = 107
Before your injection
Pred injiciranjem
The safety profile for patients with uveitis treated with adalimumab every other week was consistent with the known safety profile of adalimumab.
Varnostni profil za bolnike z uveitisom, ki so bili vsak drugi teden zdravljeni z adalimumabom, je v skladu z znanim varnostnim profilom adalimumaba.
In a study of 64 patients with rheumatoid arthritis that were treated with adalimumab, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-, B-, NK-cells, monocyte / macrophages, and neutrophils.
V študiji 64 bolnikov z revmatoidnim artritisom, zdravljenih z adalimumabom, niso odkrili znakov zavrtja odložene preobčutljivosti, znižanja koncentracije imunoglobulinov ali spremembe števila efektorskih celic T in B, naravnih celic ubijalk, monocitov/makrofagov ali nevtrofilcev.
MTX N = 110 n (%)
metotreksat n = 110 n (%)
Preclinical data on postnatal toxicity of adalimumab are not available (see section 5.3).
Predkliničnih podatkov o poporodni toksičnosti adalimumaba ni (glejte poglavje 5.3).
Adalimumab-treated patients had significantly greater improvement at week 12 which was maintained through week 24 in both the SF36 and Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL).
Bolniki, ki so dobivali adalimumab, so imeli po 12 tednih značilno večje izboljšanje (ki se je ohranilo do 24. tedna) SF36 in ASQoL (Vprašalnik o kakovosti življenja pri ankilozirajočem spondilitisu
placebo adalimumab 40 mg weekly placebo adalimumab 40 mg weekly hidradenitis suppurativa clinical response (HiSCR)a
placebo adalimumab 40 mg vsak teden placebo adalimumab 40 mg vsak teden klinični odziv pri hidradenitis suppurativa (HiSCR)a
In RA studies I-IV, adalimumab-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 revmatoidnega artritisa I- IV so bolniki, zdravljeni z adalimumabom, v primerjavi s prejemniki placeba dosegli statistično značilen odziv 20 in 50 po ACR že en do dva tedna po začetku zdravljenja.
Hefiya can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), corticosteroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).
Zdravilo Hefiya se lahko uporablja skupaj z metotreksatom ali nekaterimi imunomodulirajočimi antirevmatičnimi zdravili (sulfasalazinom, hidroksiklorokinom, leflunomidom in pripravki zlata za injiciranje), kortikosteroidi in zdravili proti bolečinam, vključno z nesteroidnimi protivnetnimi zdravili.
• the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
• Zdravljenje zmernega do hudega aktivnega revmatoidnega artritisa pri odraslih bolnikih, kadar odziv na imunomodulirajoča zdravila, vključno z metotreksatom, ni zadosten.
Serum levels of matrix metalloproteinases (MMP-1 and MMP-3) that produce tissue remodelling responsible for cartilage destruction were also decreased after adalimumab administration.
Po uporabi adalimumaba se je zmanjšala tudi serumska raven matriksnih metaloproteinaz (MMP-1 in MMP-3), ki povzročajo remodeliranje tkiva, odgovorno za uničenje hrustanca.
Hefiya is a biosimilar medicinal product.
Zdravilo Hefiya je podobno biološko zdravilo.
However, there have also been postmarketing reports of liver failure as well as less severe liver disorders that may precede liver failure, such as hepatitis including autoimmune hepatitis in patients receiving adalimumab.
Poleg tega so iz obdobja trženja zdravila poročali tako o jetrni odpovedi kot tudi o hudih boleznih jeter, ki lahko vodijo v jetrno odpoved, kot je hepatitis, vključno z avtoimunskim hepatitisom, pri bolnikih, ki so prejemali adalimumab.
• nerve disorders (such as inflammation of the optic nerve to the eye, and Guillain-Barré syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
• bolezni živčevja (kot je vnetje optičnega živca v očesu in sindrom Guillain-Barré, stanje, ki lahko povzroči šibkost mišic, nenormalna občutenja, mravljinčenje v rokah in zgornjem delu telesa);
Across all treatment groups, the mean baseline PASI score was 19.7 and the baseline PGA score ranged from “mild” (< 1 %) to “moderate” (48 %) to “severe” (46 %) to “very severe” (6 %).
PASI 19,7, izhodiščna PGA pa je segala od "blage" (< 1 %), "zmerne" (48 %) in "hude" (46 %) do "zelo hude" (6 %).
There is a known association between intermediate uveitis and central demyelinating disorders.
Znana je zveza med intermediarnim uveitisom in demielinizirajočimi boleznimi osrednjega živčevja.
• intestinal infections (including gastroenteritis);
• črevesne okužbe (vključno z gastroenteritisom);
Study nr-axSpA I
Študija nr-axSpA I
• Look at the expiration date (EXP) on your pen.
• Poglejte datum izteka roka uporabnosti (EXP) na injekcijskem peresniku.
Do not use the syringe if the expiration date has passed.
Injekcijske brizge ne uporabite, če je rok uporabnosti že potekel.
Concomitant administration of adalimumab with other biologic DMARDs (e.g, anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions (see section 4.5).
Sočasna uporaba adalimumaba z drugimi biološkimi DMARD (tj.anakinra in abacept) ali z drugimi antagonisti TNF ni priporočljiva zaradi možnega povečanega tveganja za okužbe, vključno z resnimi okužbami, in drugih potencialnih farmakoloških interakcij (glejte poglavje 4.5).
Reduction in HS-related skin pain was assessed using a Numeric Rating Scale in patients who entered the study with an initial baseline score of 3 or greater on a 11 point scale.
povezane s HS, so ocenili s pomočjo numerične ocenjevalne lestvice pri bolnikih, ki so imeli pri vključitvi v študijo izhodiščni rezultat 3 ali več na 11-stopenjski numerični ocenjevalni lestvici.
• signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding,
• znake in simptome, ki nakazujejo bolezni krvi, npr. dolgotrajno zvišana telesna temperatura,
c p = 0.083, adalimumab 0.8 mg / kg versus MTX
c p = 0,083, adalimumab 0,8 mg/kg v primerjavi z MTX
Adalimumab, 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 adalimumaba 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.
• increased uric acid in the blood;
• povečana sečna kislina v krvi;
MTX = methotrexate ** p < 0.01, adalimumab versus placebo
MTX = metotreksat ** p < 0,01, adalimumab v prim.
• if you drop your pen, do not use it if it looks damaged, or if you dropped it with the cap removed.
• če injekcijski peresnik spustite, ga ne uporabite, če je videti poškodovan ali če ste ga spustili z odstranjenim pokrovčkom;
MARKETING AUTHORISATION NUMBER(S)
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET
It is recommended that, if possible, children be given all the scheduled vaccinations for their age before they start treatment with Hefiya.
Za otroke je priporočljivo, da pred začetkom zdravljenja z zdravilom Hefiya prejmejo vsa cepljenja, predvidena za njihovo starost, če je le mogoče.
MTX = methotrexate b p = 0.027, adalimumab 0.8 mg / kg versus MTX
MTX = metotreksat b p = 0,027, adalimumab 0,8 mg/kg v primerjavi z MTX
• systemic lupus erythematosus (an immune disorder including inflammation of skin, heart, lung,
• sistemski eritematozni lupus (bolezen imunskega sistema, vključno z vnetjem kože, srca, pljuč,
Adalimumab has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
Z rentgenskim slikanjem je bilo dokazano, da adalimumab upočasni hitrost napredovanja prizadetosti sklepov in izboljša telesno funkcijo, kadar se uporablja v kombinaciji z metotreksatom.
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 40 mg adalimumaba vsak drugi teden subkutano, v poznejših statističnih analizah dvojno slepe faza pa so bili obravnavani kot neodzivni bolniki.
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)