natgillin/translations-raw huggingface dataset:
Similarly, on the basis of Phase III clinical trial data in patients with psoriasis, a population exposure-response relationship was established between plasma concentration of certolizumab pegol and PASI with an EC90 of 11.1 µg/ml.
Podobno je bilo na podlagi kliničnih preskušanj faze III pri bolnikih s psoriazo, razmerje med izpostavljenostjo in odzivom ugotovljeno med povprečnimi koncentracijami certolizumab pegola v plazmi in PASI z EC90 11,1 µg/ml.
You should NOT take Cimzia if you are using the following medicines used to treat rheumatoid arthritis:
Zdravila Cimzia NE smete jemati, če za zdravljenje revmatoidnega artritisa jemljete naslednja zdravila:
You will be given Cimzia as either one (200 mg dose) or two injections (400 mg dose) under the skin (subcutaneous use, abbreviation: SC).
Zdravilo Cimzia boste dobivali v eni (odmerek 200 mg) ali dveh injekcijah (odmerek 400 mg) pod kožo (subkutana uporaba, okrajšava: s.c.).
Cimzia does not contain a fragment crystallisable (Fc) region, which is normally present in a complete antibody, and therefore does not fix complement or cause antibody-dependent cell-mediated cytotoxicity in vitro.
Zdravilo Cimzia ne vsebuje dela protitelesa, ki lahko kristalizira (Fc) in je normalno prisotno v popolnem protitelesu, zato ne veže komplementa in ne povzroča od protiteles odvisne s celicami posredovane citotoksičnosti.
The pharmacokinetics of the PEG fraction of certolizumab pegol are expected to be dependent on renal function but have not been assessed in patients with renal impairment.
Pričakovati je, da je farmakokinetika frakcije PEG certolizumab pegola odvisna od delovanja ledvic, vendar pa pri motnjah v delovanju ledvic ni bila ocenjena.
Pharmacokinetics observed in patients with rheumatoid arthritis and psoriasis were consistent with those seen in healthy subjects.
Farmakokinetika, opažena pri bolnikih z revmatoidnim artritisom in psoriazo je bila skladna s farmakokinetiko pri zdravih osebah.
Cimzia was also studied in 317 patients with nonradiographic axial spondyloarthritis in a placebo-controlled study for 52 weeks (AS0006).
Zdravilo Cimzia so preučevali tudi pri 317 bolnikih z neradiografskim aksialnim spondiloartritisom v 52-tedenski s placebom nadzorovani študiji (AS0006).
• Firmly push the flat end cap into the medication/injection port at the bottom of ava - push until you hear a click.
• Močno pritisnite gladki končni pokrovček v vložek/vhod injektorja na dnu naprave avapritiskajte dokler ne slišite klika.
Cimzia is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Zdravilo Cimzia je indicirano za zdravljenje zmerne do hude psoriaze v plakih pri odraslih, ki so kandidati za sistemsko zdravljenje.
Your doctor may decide to stop treatment with Cimzia.
Zdravnik se bo morda odločil, da zdravljenje z zdravilom Cimzia prekine.
The infections consisted primarily of upper respiratory tract infections, urinary tract infections, and lower respiratory tract infections and herpes viral infections (see sections 4.3 and 4.4).
Pojavljale so se predvsem okužbe zgornjih dihal, okužbe sečil in okužbe spodnjega dela dihal ter okužbe z virusom herpesa (glejte poglavji 4.3 in 4.4).
• feeling weak and generally unwell
• občutek šibkosti in splošnega slabega počutja
In the C-EARLY trial patients were ≥ 18 years of age and had ≥ 4 swollen and tender joints each and must have been diagnosed with moderate to severe active and progressive RA within 1 year (as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria).
V preskušanju C-EARLY so imeli bolniki, stari ≥ 18 let, v ≥ 4 primerih otečene in boleče sklepe ter postavljeno diagnozo zmernega do hudega RA znotraj 1 leta (kot določajo klasifikacijskih kriteriji ACR/Evropska liga proti revmatizmu (EULAR) iz leta 2010).
• Turn on ava:
• Vklopite napravo ava:
With the current knowledge, a possible risk for the development of lymphomas, leukaemia or other malignancies in patients treated with a TNF-antagonist cannot be excluded.
Z obstoječim vedenjem možnega tveganja za razvoj limfomov, levkemije ali drugih malignih obolenj pri bolnikih, ki se zdravijo z zaviralci TNF, ne moremo izključiti.
• serious skin rashes.
• hudi kožni izpuščaji.
Approximately one-third of antibody-positive patients had antibodies with neutralising activity in vitro.
Pri približno eni tretjini bolnikov s prisotnimi protitelesi so imela le-ta nevtralizirajoči učinek in vitro.
Due to its inhibition of TNFα, Cimzia administered during pregnancy could affect normal immune response in the newborn.
Uporaba zdravila Cimzia v času nosečnosti lahko zaradi zaviranja TNFα vpliva na normalen imunski odziv pri novorojencu.
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
IZDELOVALCI BIOLOŠKE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
Patients had to fulfil ASAS criteria for nraxSpA (not including family history and good response to NSAIDs), and have had objective signs of inflammation indicated by C-reactive protein (CRP) levels above the upper limit of normal and/or sacroiliitis on magnetic resonance imaging (MRI), indicative of inflammatory disease [positive CRP (> ULN) and/or positive MRI], but without definitive radiographic evidence of structural damage on sacroiliac joints.
Bolniki so morali izpolnjevati kriterije ASAS za nr-axSpA (niso vključevali družinske anamneze in dobrega odziva na NSAID) in so imeli objektivne znake vnetja z zvišano koncentracijo C-reaktivnega proteina (CRP) nad zgornjo mejo normalne vrednosti in/ali sakroiliitis, dokazan z magnetno resonanco (MRI), kar kaže na vnetno bolezen [pozitivni CRP (> ULN) in/ali pozitivna MRI], vendar brez trdnega radiografskega dokaza za strukturne poškodbe v sakroilikalnih sklepih.
CIMPASI-1 and CIMPASI-2 evaluated 234 patients and 227 patients respectively.
V študiji CIMPASI-1 so ocenili 234 bolnikov in v študiji CIMPASI-2 227 bolnikov.
The dose-dispenser cartridge is also referred to as “medication”.
Odmerni vložek se navaja tudi kot ˝zdravilo˝.
No serious infections were reported in the placebo-treated patients.
Pri bolnikih, zdravljenih s placebom, niso poročali o resnih okužbah.
In clinical trials with Cimzia and other TNF-antagonists, more cases of lymphoma and other malignancies have been reported among patients receiving TNF-antagonists than in control patients receiving placebo (see section 4.8).
V kliničnih študijah z zdravilom Cimzia in drugimi zaviralci TNF so pri bolnikih, ki so prejemali zaviralce TNF, opazili več primerov limfomov in drugih malignih obolenj kot pri kontrolni skupini, ki je dobivala placebo (glejte poglavje 4.8).
A risk for the development of malignancies in children and adolescents treated with TNF-antagonists cannot be excluded.
Tveganje za razvoj malignih obolenj pri otrocih in mladostnikih, ki se zdravijo z zaviralci TNF ne moremo izključiti.
Statistically significant improvements at Week 16 (CIMPASI-1 and CIMPASI-2) from baseline compared to placebo were demonstrated in the DLQI (Dermatology Life Quality Index).
Statistično značilna izboljšanja od izhodišča do 16. tedna so se v primerjavi s placebom (CIMPASI-1 in CIMPASI-2) izkazala v dermatološkem indeksu kakovosti življenja (DLQI - Dermatology Life Quality Index).
If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Cimzia, treatment must be discontinued.
Če se pri bolniku pri zdravljenju z zdravilom Cimzia razvijejo simptomi, ki kažejo na lupusu podoben sindrom, je treba zdravljenje prekiniti.
Table 6 Radiographic change at Week 52 in trial C-EARLY Placebo +MTX N= 163 Mean (SD)
Preglednica 6 Radiografske spremembe v 52. tednu pri preskušanju C-EARLY Placebo + MTX n = 163 Srednja vrednost (SD)
Uncommo blood alkaline phosphatase increased, coagulation time prolonged
občasni povečane vrednosti alkalne fosfataze v krvi, podaljšanje časa koagulacije
• Use a piece of gauze, apply pressure over the injection site for a few seconds: - Do not rub the injection site.
• S kosom gaze nekaj sekund pritiskajte na mesto injiciranja: - Mesta injiciranja ne drgnite.
If you do not respond well enough to these medicines, you will be given Cimzia to:
Če se na ta zdravila ne odzovete dovolj dobro, boste prejeli zdravilo Cimzia za:
If you respond to the medicine, your doctor may prescribe an alternative maintenance dosing of 400 mg every 4 weeks.
Če se boste odzvali na zdravilo, vam bo zdravnik lahko predpisal alternativni vzdrževalni odmerek 400 mg vsake 4 tedne.
Certolizumab pegol plasma concentrations were broadly dose-proportional.
Koncentracije certolizumab pegola v plazmi so bile v veliki meri sorazmerne z velikostjo odmerka.
• Find a comfortable position and sit down for your injection.
• Za injiciranje poiščite udoben položaj in se usedite.
It can take up to 10 seconds to empty the syringe.
Da se brizga v celoti izprazni, lahko traja do 10 sekund.
Patients treated with Cimzia may receive vaccinations, except for live vaccines.
Bolniki, ki se zdravijo z zdravilom Cimzia, se lahko cepijo, vendar ne z živimi cepivi.
•Remove the cap from the needle in a straight direction, being careful not to touch the needle or let the needle touch any surface.
• Z igle odstranite pokrovček v ravni smeri, pri tem pa pazite, da se igle ne dotaknete s prsti in da se z njo česa ne dotaknete.
ACR 70 p-value*
ACR 70 p-vrednost*
• ava then shows: - Your current dose and how often you need to inject it, - This is then followed by the message, “Inspect and then insert medication”.
• Naprava ava potem pokaže: - Vaš trenutni odmerek in kako pogosto ga morati injicirati.
Because of the nature of the adverse events seen with the combination of another TNF-antagonist with either abatacept or anakinra therapy, similar toxicities may also result from the combination of anakinra or abatacept and other TNF-antagonists.
Zaradi narave neželenih učinkov pri kombiniranem zdravljenju z drugim zaviralcem TNF in abataceptom ali anakinro lahko tudi kombinacija anakinre ali abatacepta in drugih zaviralcev TNF pripelje do podobnih toksičnih učinkov.
There are insufficient data to provide a dosing recommendation in moderate and severe renal impairment.
Za priporočilo o odmerjanju pri zmernih in hudih motnjah v delovanju ledvic ni zadostnih podatkov.
- Position ava as shown so that you can comfortably reach the (Start/Pause button) without moving ava.
- Namestite napravo ava kot prikazuje slika, tako da lahko preprosto dosežete (start/pavza gumb) brez premikanja naprave ava.
PGA clear or almost clear b)
Ocena PGA brez ali skoraj čisto brezb)
Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Cimzia is indicated.
Zdravljenje z zdravilom Cimzia lahko uvede in nadzoruje le zdravnik specialist z izkušnjami v diagnosticiranju in zdravljenju bolezni, za katere je zdravilo Cimzia namenjeno.
Always take the Patient Reminder Card and the outer carton from the Cimzia package with you, even if it is empty.
S seboj vedno vzemite svojo Opozorilno kartico za bolnika in zunanjo ovojnino/škatlico, tudi če je prazna.
In an exploratory clinical trial evaluating the use of another TNF-antagonist, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients.
V raziskovalni klinični študiji za ovrednotenje uporabe infliksimaba, drugega zaviralca TNF, pri bolnikih z zmerno do hudo kronično obstruktivno pljučno boleznijo (KOPB) so ugotovili, da je bilo število malignih obolenj, zlasti na pljučih, v glavi in vratu, pri bolnikih, ki so prejemali infliksimab, večje kot pri kontrolni skupini.
If you have moderate to severe active rheumatoid arthritis, you may first be given other medicines usually methotrexate.
Če imate zmerno do hud aktivni revmatoidni artritis, vam bodo najprej morda dali druga zdravila, običajno metotreksat.
Do NOT touch the needle guard activation clips (labelled as 3 in Figure 1) during removal in order to prevent prematurely covering the needle with the needle guard.
Med odstranjevanjem se NE dotikajte aktivacijskih nastavkov varovala za iglo (označeno s 3 na Sliki 1), da predčasno ne zaprete igle z varovalom za iglo.
Clinically meaningful and statistically significant differences in Cimzia-treated patients compared with placebo-treated patients were demonstrated at each post-baseline visit.
Klinično pomembne in statistično značilne spremembe pri bolnikih, ki so se zdravili z zdravilom Cimzia, v primerjavi z bolniki, ki so prejemali placebo, so se pokazale pri vsakem nadaljnem obisku.
Do not try to repeat the injection process without speaking to your doctor or your pharmacist.
Injiciranja ne ponovite, dokler se ne posvetujete z zdravnikom ali farmacevtom.
In both placebo-controlled and open-label follow-up clinical trials for rheumatoid arthritis, cases of lupus-like syndrome were reported uncommonly.
V s placebom nadzorovanih in v odprtih sledilnih kliničnih študijah za revmatoidni artritis so občasno poročali o lupusu podobnem sindromu.
It is likely that this finding was caused by cellular uptake of the PEG moiety.
Verjetno je, da je to posledica celičnega privzema PEG dela molekule.
Thereby this TNFα is blocked by Cimzia and this decreases inflammation diseases such as in rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis and psoriasis.
Zdravilo Cimzia tako zavira TNF-α in zmanjša vnetne bolezni, kot so revmatoidni artritis, aksialni spondiloartritis, psoriatični artritis in luskavica.
Rare angioneurotic oedema, sarcoidosis, serum sickness, panniculitis (including erythema nodosum), worsening of symptoms of dermatomyositis**
Bolezni imunskega sistema redki angionevrotski edem, sarkoidoza, serumska bolezen, panikulitis (vključno z nodoznim eritemom), poslabšanje simptomov dermatomiozitisa**
During controlled clinical trials through Week 16, the proportion of patients with serious adverse events was 3.5% for Cimzia and 3.7% for placebo.
Med nadzorovanimi kliničnimi preskušanji je bil do konca 16. tedna delež bolnikov z resnimi neželenimi učinki 3,5 % za zdravilo Cimzia in 3,7 % za placebo.
- TUBERCULOSIS (TB) cases have been reported in patients treated with Cimzia, your doctor will check you for signs and symptoms of tuberculosis before starting Cimzia.
- Ker so pri bolnikih poročali o primerih TUBERKULOZE (TB), bo vaš zdravnik pred začetkom zdravljenja z zdravilom Cimzia preveril, če imate znake in simptome tuberkuloze.
**Cimzia+MTX vs placebo+MTX p<0.001.
**Cimzia+MTX v primerjavi s placebo+MTX p<0.001.
Always take the Patient Reminder Card with you.
S seboj vedno vzemite svojo Opozorilno kartico za bolnika.
• white blood cell morphology abnormal
• nenormalna morfologija belih krvničk
At week 16, patients randomized to Cimzia who achieved a PASI 50 response continued to receive Cimzia up to Week 48 at the same randomized dose.
V 16. tednu so bolniki, randomizirani za zdravilo Cimzia, ki so dosegli odziv PASI 50, nadaljevali s prejemanjem zdravila Cimzia do 48. tedna z enakim randomiziranim odmerkom.
• Choose a site on your thighs or tummy.
• Izberite mesto na stegnu ali trebuhu.
The impact of long-term treatment with Cimzia on the development of autoimmune diseases is unknown.
Vpliv dolgotrajnega zdravljenja z zdravilom Cimzia na razvoj avtoimunih bolezni ni znan.
Cimzia should only be used during pregnancy if clinically needed.
Zdravilo Cimzia se sme uporabljati med nosečnostjo samo, če je klinično potrebno.
• With one quick, short motion, push the needle all the way into the skin.
• S hitrim in kratkim gibom iglo do konca potisnite v kožo.
• allergic conditions including allergic rhinitis and allergic reactions to the medicine (including anaphylactic shock)
• alergijske reakcije, vključno z alergijskim rinitisom in alergijskimi reakcijami na zdravilo
*These events have been related to this class of medicines but the incidence with Cimzia is not known.
* Te dogodke povezujejo s to skupino zdravil, vendar pogostnost pri zdravljenju z zdravilom Cimzia ni znana.
Once clinical response is confirmed, an alternative maintenance dosing of 400 mg every 4 weeks can be considered.
Ko je klinični odziv potrjen, se lahko uporabi alternativni vzdrževalni odmerek 400 mg vsake 4 tedne.
Patients originally randomized to Cimzia who achieved a PASI75 response at Week 16 were rerandomized based on their original dosing schedule.
Bolniki, prvotno randomizirani za prejemanje zdravila Cimzia, ki so v 16. tednu dosegli odziv PASI 75, so bili ponovno randomizirani na podlagi njihovega izvornega režima odmerjanja.
Both Cimzia regimens showed sustained clinical response and were statistically significant compared to placebo at week 34.
Oba režima odmerjanja zdravila Cimzia sta v 34. tednu pokazala konstanten klinični odziv, ki je bil statistično značilen v primerjavi s placebom.
The frequency was increased both in patients treated with placebo (2.8% vs 0.4% in axSpA and RA populations, respectively) as well as in patients treated with Cimzia (4.7% vs 0.8% in axSpA and RA populations, respectively).
Pogostnost je bila povečana tako pri bolnikih, ki so prejemali placebo (2,8 % pri axSpA in 0,4 % pri RA) kot tudi pri bolnikih, ki so bili zdravljeni z zdravilom Cimzia (4,7 % pri axSpA in 0,8 % pri RA).
Patients receiving concomitant NSAIDs and conventional DMARDs were 72.6% and 70.2% respectively.
72,6 % bolnikov je sočasno prejemalo NSAID in 70,2 % konvencionalne DMARD.
In rats and monkeys, at doses higher than those given to humans, histopathology revealed cellular vacuolation, present mainly in macrophages, in a number of organs (lymph nodes, injection sites, spleen, adrenal, uterine, cervix, choroid plexus of the brain, and in the epithelial cells of the choroid plexus).
Pri podganah in opicah je ob odmerkih, ki so bili višji od odmerkov, ki so jih prejemali ljudje, histopatologija razkrila prisotnost celične vakuolizacije, predvsem v makrofagih in v številnih organih (limfni vozli, na mestu injiciranja, vranica, adrenalno, uterino, v vratu in v horoidnem pletežu v možganih ter v epitelijskih celicah horoidnega pleteža).
In patients with pre-existing or recent onset of demyelinating disorders, the benefits and risks of TNF-antagonist treatment should be carefully considered before initiation of Cimzia therapy.
Pri bolnikih z že obstoječimi demielinizirajočimi obolenji je treba pred uvedbo zdravljenja z zdravilom Cimzia skrbno pretehtati prednosti in tveganja.
Erosion Score
Ocena erozije
The additional following adverse reactions have been observed uncommonly with Cimzia in other indications: gastrointestinal stenosis and obstructions, general physical health deterioration, abortion spontaneous and azoospermia.
Občasno so pri zdravljenju z zdravilom Cimzia opazili pri drugih indikacijah naslednje neželene učinke: stenozo in obstrukcijo gastrointestinalnega trakta, splošno poslabšanje zdravja, spontani splav in azoospermijo.
• stroke, blockage in blood vessels (arteriosclerosis), poor blood circulation which makes the toes and fingers numb and pale (Raynaud's phenomenon), mottled purplish skin discoloration, small veins near the surface of the skin may become visible
• kap, zamašitev krvnih žil (arterioskleroza), slaba prekrvavitev, ki povzroči odrevenelost in bledico prstov rok in nog (Raynaudov fenomen), lisasto škrlatno obarvanje kože, majhne vene na površini kože lahko postanejo vidne
JSN Score
Ocena JSN
- If you have an infection or if you develop symptoms such as fever, wounds, tiredness or dental problems.
- Če imate okužbo ali če se pri vas pojavijo simptomi, kot so zvišana telesna temperatura, rane, občutek utrujenosti ali težave z zobmi.
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
A. IZDELOVALCI BIOLOŠKE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA
• Any unused product(s) or waste material should be disposed of in accordance with local requirements.
• Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
No effect of age was observed in a population pharmacokinetic analysis in adult patients with plaque psoriasis.
Učinka starosti v analizi populacijske farmakokinetike pri odraslih bolnikih s psoriazo v plakih niso opazili.
Tell your surgeon or dentist performing the procedure that you are having treatment with Cimzia by showing them your Patient Reminder Card.
Kirurgu ali zobozdravniku, ki bo poseg opravljal, povejte, da se zdravite z zdravilom Cimzia in mu pokažite Opozorilno kartico za bolnika.
The empty syringe and needle will automatically move back into the barrel and lock in place.
Prazna injekcijska brizga in igla se bosta samodejno premaknili nazaj v notranjost brizge in zaskočili.
In a clinical study in 17 lactating women treated with Cimzia, minimal transfer of certolizumab pegol from the plasma to breast milk was observed.
V klinični študiji pri 17 doječih ženskah, ki so prejemale zdravilo Cimzia, je bilo prehajanje certolizumab pegola iz plazme v materino mleko minimalno.
Cimzia-treated patients also had improvements compared to placebo in multiple components of axial spondyloarthritis disease activity, including CRP.
Bolniki, ki so prejemali zdravilo Cimzia, so v primerjavi z bolniki, ki so prejemali placebo, izkazali tudi izboljšanja pri več komponentah aktivnosti bolezni aksialnega spondiloartritisa, vključno s CRP.
In the placebo-controlled studies, patients receiving Cimzia had an approximately 4 times greater duration of exposure compared with the placebo group.
V študijah, nadzorovanih s placebom, je bila pri bolnikih, ki so prejemali zdravilo Cimzia, izpostavljenost v primerjavi s skupino, ki je dobivala placebo, približno štirikrat daljša.
The apparent volume of distribution (V/F) was estimated at 8.01 l in a population pharmacokinetic analysis of patients with rheumatoid arthritis and at 4.71 l in a population pharmacokinetic analysis of patients with plaque psoriasis.
V populacijski farmakokinetični analizi bolnikov z revmatoidnim artritisom je bil navidezni volumen porazdelitve (V/F) ocenjen na 8.01 l in pri 4,71 l v analizi populacijske farmakokinetike bolnikov s psoriazo v plakih.
Rheumatoid arthritis Cimzia, in combination with methotrexate (MTX), is indicated for:
Revmatoidni artritis V kombinaciji z metotreksatom (MTX) je zdravilo Cimzia namenjeno:
Cimzia-treated patients had a statistically significant higher ACR 20 response rate at Week 12 and Week 24 compared with placebo-treated patients (p<0.001).
Bolniki, ki so se zdravili z zdravilom Cimzia, so imeli statistično značilno višji odziv ACR 20 v 12. tednu in 24. tednu v primerjavi z bolniki, ki so prejemali placebo (p < 0,001).
Injection site pain was observed in 1.5% of patients treated with Cimzia with no cases leading to withdrawal.
Bolečino na mestu injiciranja so opazili pri 1,5 % bolnikov, ki so prejemali zdravilo Cimzia, vendar v nobenem primeru ni bilo potrebno prekiniti zdravljenja.
•Do not remove the cap until you are ready to inject.
• Ne snemite pokrovčka, dokler niste pripravljeni na injiciranje.
ACR 50 p-value*
ACR 50 p-vrednost*
Below is a diagram of the AutoClicks pre-filled pen.
Spodaj je shema napolnjenega injekcijskega peresnika AutoClicks.
What Cimzia looks like and contents of the pack
Izgled zdravila Cimzia in vsebina pakiranja
Improvements in ASAS5/6, Partial Remission and BASDAI-50 were statistically signficant at Week 12 and Week 24 and were sustained up to Week 48 in the overall popualtion as well as in the subpopulations.
V celotni populaciji in tudi v podpopulacijah je bilo izboljšanje ASAS 5/6, delna remisija in BASDAI50 statistično značilno v 12. tednu in 24. tednu ter je trajalo vse do 48. tedna.
- methotrexate, - corticosteroids, or - pain medicines including nonsteroidal anti-inflammatory medicines (also called NSAIDs).
- metotreksatom, - kortikosteroidi, ali - zdravili proti bolečinam, vključno z nesteroidnimi protivnetnimi zdravili (NSAID).
Table 8 Key efficacy outcomes in AS001 clinical trial (percent of patients)
Preglednica 8 Ključni rezultati glede učinkovitosti pri kliničnem preskušanju AS001 (delež bolnikov)