FrancophonIA/ELRC3.0 huggingface dataset:
English: Upadacitinib plasma exposures are proportional to dose over the therapeutic dose range.
Croatian: Plazmatska izloženost upadacitinibu proporcionalna je dozi unutar terapijskog raspona doza.
English: Upadacitinib was not carcinogenic in a 26-week carcinogenicity study in CByB6F1-Tg(HRAS)2Jic transgenic mice.
Croatian: Upadacitinib nije bio kancerogen ni u 26-tjednom ispitivanju kancerogenosti na transgeničnim CByB6F1-Tg(HRAS)2Jic miševima.
English: The rate of serious infections remained stable with long-term exposure.
Croatian: Stopa ozbiljnih infekcija ostala je stabilna tijekom dugotrajnog izlaganja lijeku.
English: RINVOQ is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Croatian: RINVOQ je indiciran za liječenje umjerenog do teškog oblika aktivnog reumatoidnog artritisa u odraslih bolesnika koji nisu dovoljno dobro odgovorili na jedan ili više antireumatskih lijekova koji modificiraju tijek bolesti (engl. disease-modifying anti-rheumatic drug, DMARD) ili koji ne podnose takve lijekove.
English: In a pre-/postnatal development study in rats, there were no maternal effects, no effects on parturition, lactation or maternal behaviour and no effects on their offspring.
Croatian: U ispitivanju prenatalnog/postnatalnog razvoja na štakorima nisu opaženi učinci na majku, okot, laktaciju i ponašanje majke, kao ni učinci na mladunčad.
English: The pharmacologic activity of upadacitinib is attributed to the parent molecule.
Croatian: Farmakološka aktivnost upadacitiniba pripisuje se ishodišnoj molekuli.
English: The primary analysis for each of these studies included all randomised subjects who received at least 1 dose of study drug, and non-responder imputation was used for categorical endpoints.
Croatian: U svakom od tih ispitivanja primarna je analiza obuhvatila sve randomizirane ispitanike koji su primili najmanje 1 dozu ispitivanog lijeka, a za kategoričke se mjere ishoda koristila zamjena nedostajućih podataka (imputacija) za bolesnike bez odgovora.
English: Patients treated with upadacitinib should have risk factors (e.g., hypertension, hyperlipidaemia) managed as part of usual standard of care.
Croatian: bolesnika liječenih upadacitinibom potrebno je zbrinjavati faktore rizika (npr. hipertenziju, hiperlipidemiju) u sklopu uobičajenog standardnog liječenja.
English: Foil Cutting Tool - on the cap of the bottle
Croatian: Rezač za foliju - na zatvaraču bočice
English: If you are breast-feeding or are planning to breast-feed, talk to your doctor before taking this medicine.
Croatian: Ako dojite ili planirate dojiti, obratite se svom liječniku prije nego što uzmete ovaj lijek.
English: • medicines to treat Cushing's syndrome (such as ketoconazole)
Croatian: • lijekove za liječenje Cushingova sindroma (kao što je ketokonazol)
English: Do not chew, crush or break the tablet.
Croatian: Tabletu nemojte žvakati, drobiti ni lomiti.
English: Upadacitinib metabolism is mediated by CYP3A4 with a potential minor contribution from CYP2D6.
Croatian: U metabolizmu upadacitiniba posreduje CYP3A4, uz moguć manji doprinos CYP2D6.
English: The maximal inhibition was observed 1 hour after dosing which returned to near baseline by the end of dosing interval.
Croatian: Maksimalna inhibicija opažena je 1 sat nakon primjene doze lijeka, a do kraja intervala doziranja vratila se gotovo na početnu razinu.
English: Methotrexate and pH modifying medicinal products (e.g., antacids or proton pump inhibitors) have no effect on upadacitinib plasma exposures.
Croatian: Metotreksat i lijekovi koji mijenjaju pH (npr. antacidi ili inhibitori protonske pumpe) ne utječu na plazmatsku izloženost upadacitinibu.
English: Multipack: 84 (3 packs of 28) prolonged-release tablets
Croatian: Višestruko pakiranje: 84 (3 pakiranja od 28) tablete s produljenim oslobađanjem
English: Upadacitinib should not be given to patients with active TB (see section 4.3).
Croatian: Upadacitinib se ne smije davati bolesnicima s aktivnim TBC-om (vidjeti dio 4.3).
English: • with a history of a serious or an opportunistic infection
Croatian: • koji imaju ozbiljnu ili oportunističku infekciju u anamnezi
English: Detailed and updated information on this product is available by scanning the QR code included below or on the outer carton with a smart phone.
Croatian: Sve pojedinosti i najnovije informacije o ovom lijeku možete dobiti skeniranjem QR kôda u nastavku ili na vanjskom pakiranju pametnim telefonom.
English: • Primary endpoint: clinical remission
Croatian: • Primarna mjera ishoda: klinička remisija
English: • low white blood cell counts shown in blood tests
Croatian: • nizak broj bijelih krvnih stanica, vidljiv u nalazima krvnih pretraga
English: Upadacitinib was not mutagenic or genotoxic based on the results of in vitro and in vivo tests for gene mutations and chromosomal aberrations.
Croatian: Upadacitinib nije bio mutagen ni genotoksičan prema rezultatima testova na genske mutacije i kromosomske aberacije in vitro i in vivo.
English: Administration of multiple 30 mg once daily doses of upadacitinib (a dose that is twice the recommended upadacitinib dose) to healthy subjects had a limited effect on midazolam (sensitive drug substrate for CYP3A) plasma exposures (26% decrease in midazolam AUC and Cmax), indicating that upadacitinib 30 mg once daily may have a weak induction effect on CYP3A.
Croatian: Višekratna primjena upadacitiniba u dozi od 30 mg jedanput na dan (doza dvostruko veća od preporučene doze upadacitiniba) u zdravih ispitanika imala je ograničen utjecaj na plazmatsku izloženost midazolamu, osjetljivom supstratu za CYP3A (smanjenje AUC-a i Cmax midazolama za 26%), što pokazuje da upadacitinib u dozi od 30 mg jedanput na dan može imati slab indukcijski učinak na CYP3A.
English: Mean CPK values increased by 4 weeks with a mean increase of 60 U/L at 12 weeks and then remained stable at an increased value thereafter including with extended therapy.
Croatian: Srednje vrijednosti CPK-a rasle su do 4. tjedna, uz srednju vrijednost porasta od 60 jedinica/l u 12. tjednu, nakon čega se razina CPK-a stabilno zadržavala na povišenoj vrijednosti, čak i uz dugoročnu terapiju.
English: • medicines to treat tuberculosis (such as rifampicin)
Croatian: • lijekove za liječenje tuberkuloze (kao što je rifampicin)
English: RINVOQ contains the active substance upadacitinib.
Croatian: RINVOQ sadrži djelatnu tvar upadacitinib.
English: What you need to know before you take RINVOQ 3.
Croatian: Što morate znati prije nego počnete uzimati RINVOQ
English: • Film coating: poly(vinyl alcohol), macrogol, talc, titanium dioxide, iron oxide red (E172), iron oxide black (E172).
Croatian: • Film ovojnica: poli(vinilni alkohol), makrogol, talk, titanijev dioksid, crveni željezov oksid (E172), crni željezov oksid (E172).
English: Mild (Child-Pugh A) and moderate (Child-Pugh B) hepatic impairment has no clinically relevant effect on upadacitinib exposure.
Croatian: Blago (Child-Pugh stadij A) i umjereno (Child-Pugh stadij B) oštećenje jetrene funkcije nemaju klinički značajnog učinka na izloženost upadacitinibu.
English: The frequency of adverse reactions listed below is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100).
Croatian: Učestalost nuspojava navedenih u nastavku definirana je kako slijedi: vrlo često (≥ 1/10); često (≥ 1 /100 i
English: Upadacitinib is contraindicated during pregnancy (see section 4.3).
Croatian: Upadacitinib je kontraindiciran tijekom trudnoće (vidjeti dio 4.3).
English: Upadacitinib exposure is decreased when co-administered with strong CYP3A4 inducers (such as rifampin and phenytoin), which may lead to reduced therapeutic effect of upadacitinib.
Croatian: Izloženost upadacitinibu smanjuje se kod istodobne primjene snažnih induktora CYP3A4 (kao što su rifampicin i fenitoin), što može dovesti do smanjenog terapijskog učinka upadacitiniba.
English: • medicines to treat fungal infections (such as itraconazole, posaconazole or voriconazole)
Croatian: • lijekove za liječenje gljivičnih infekcija (kao što su itrakonazol, posakonazol ili vorikonazol)
English: Use of live, attenuated vaccines during or immediately prior to upadacitinib therapy is not recommended.
Croatian: Ne preporučuje se primjena živih, atenuiranih cjepiva tijekom ili neposredno prije terapije upadacitinibom.
English: There are no or limited data on the use of upadacitinib in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni upadacitiniba u trudnica ograničeni.
English: Rheumatoid arthritis patients have an increased risk for cardiovascular disorders.
Croatian: Bolesnici s reumatoidnim artritisom izloženi su povećanom riziku od kardiovaskularnih poremećaja.
English: Pack size: 1 bottle (30 prolonged-release tablets) or 3 bottles (90 prolonged-release tablets).
Croatian: Veličina pakiranja: 1 bočica (30 tableta s produljenim oslobađanjem) ili 3 bočice (90 tableta s produljenim oslobađanjem).
English: Titanium dioxide (E171) Iron oxide black (E172) Iron oxide red (E172)
Croatian: poli(vinilni alkohol) makrogol talk titanijev dioksid (E171) željezov oksid, crni (E172) željezov oksid, crveni (E172)
English: Steady-state plasma concentrations are achieved within 4 days with minimal accumulation after multiple once-daily administrations.
Croatian: Plazmatske koncentracije postižu stanje dinamičke ravnoteže unutar 4 dana, uz minimalnu akumulaciju lijeka nakon višestruke primjene doza jedanput na dan.
English: • medicines to treat bacterial infections (such as clarithromycin)
Croatian: • lijekove za liječenje bakterijskih infekcija (kao što je klaritromicin)
English: Upadacitinib exposure is increased when co-administered with strong CYP3A4 inhibitors (such as ketoconazole, itraconazole, posaconazole, voriconazole, and clarithromycin).
Croatian: Izloženost upadacitinibu povećava se kod istodobne primjene snažnih inhibitora CYP3A4 (kao što su ketokonazol, itrakonazol, posakonazol, vorikonazol i klaritromicin).
English: In the studies SELECT-MONOTHERAPY, SELECT-NEXT, and SELECT-COMPARE, treatment with upadacitinib 15 mg resulted in a significantly greater improvement in the mean duration of morning joint stiffness compared to placebo or MTX.
Croatian: U ispitivanjima SELECT-MONOTHERAPY, SELECT-NEXT i SELECT-COMPARE liječenje upadacitinibom u dozi od 15 mg dovelo je do značajno većeg poboljšanja srednjeg trajanja jutarnje ukočenosti zglobova u usporedbi s placebom ili MTX-om.
English: • SF-36 PCS
Croatian: SF-36
English: The objective of the programme is to increase awareness of HCPs and patients on the risks of serious and opportunistic infections including TB, herpes zoster, foetal malformation (pregnancy risk), MACE, and VTEs and how to manage these risks.
Croatian: Cilj je programa povećati svijest zdravstvenih radnika i bolesnika o rizicima od ozbiljnih i oportunističkih infekcija, uključujući TBC, herpesa zostera, malformacija ploda (rizik za trudnoću), MACE događaja i venskih tromboembolija (VTE) te pružiti informacije o načinu zbrinjavanja tih rizika.
English: Table 3: Clinical trials summary Study name Population (n) Treatment arms
Croatian: Naziv ispitivanja Populacija (n) Liječene skupine
English: The proportion of patients with no radiographic progression (mTSS change ≤ 0) was significantly higher with upadacitinib 15 mg in both studies.
Croatian: U oba je ispitivanja udio bolesnika bez radiografske progresije (promjena mTSS rezultata za ≤ 0) bio značajno veći uz upadacitinib u dozi od 15 mg.
English: • with chronic or recurrent infection
Croatian: • koji imaju kroničnu ili rekurentnu infekciju
English: A patient who develops a new infection during treatment with upadacitinib should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient; appropriate antimicrobial therapy should be initiated, the patient should be closely monitored, and upadacitinib therapy should be interrupted if the patient is not responding to antimicrobial therapy.
Croatian: Bolesnika u kojeg se tijekom liječenja upadacitinibom razvije nova infekcija treba odmah podvrgnuti sveobuhvatnim dijagnostičkim pretragama prikladnima za imunokompromitiranog bolesnika; potrebno je uvesti odgovarajuću antimikrobnu terapiju i pažljivo nadzirati bolesnika, a ako ne odgovori na antimikrobnu terapiju, terapiju upadacitinibom treba privremeno prekinuti.
English: bDMARD = biologic disease-modifying anti-rheumatic drug, CRP = C-Reactive Protein, DAS28 = Disease Activity Score 28 joints, mTSS = modified Total Sharp Score, csDMARD = conventional synthetic diseasemodifying anti-rheumatic drug, HAQ-DI = Health Assessment Questionnaire Disability Index, SF-36 PCS = Short Form (36) Health Survey (SF-36) Physical Component Score, CDAI = Clinical Disease Activity Index, FACIT-F = Functional Assessment of Chronic Illness Therapy-Fatigue score, IR = inadequate responder, MTX = methotrexate, n = number randomised a. Patients were naïve to MTX or received no more than 3 weekly MTX doses b Patients had inadequate response to MTX c Patients who had an inadequate response to csDMARDs; patients with prior exposure to at most one bDMARD were eligible (up to 20% of total number of patients) if they had either limited exposure (<3 months) or had to discontinue the bDMARD due to intolerability d Patients who had an inadequate response to MTX; patients with prior exposure to at most one bDMARD (except adalimumab) were eligible (up to 20% of total study number of patients) if they had either limited exposure (<3 months) or had to discontinue the bDMARD due to intolerability e Patients who had an inadequate response or intolerance to at least one bDMARD
Croatian: Bolesnici prethodno nisu primali MTX ili su primili najviše 3 tjedne doze MTX-a b Bolesnici nisu dovoljno dobro odgovorili na MTX c Bolesnici koji nisu dovoljno dobro odgovorili na ksDMARD-ove; bolesnici koji su prethodno primali najviše jedan bDMARD mogli su sudjelovati u ispitivanju (do 20% ukupnog broja bolesnika) ako je njihova izloženost tom lijeku bila ograničena (< 3 mjeseca) ili ako su morali prekinuti primjenu bDMARD-a zbog nepodnošenja d Bolesnici koji nisu dovoljno dobro odgovorili na MTX; bolesnici koji su prethodno primali najviše jedan bDMARD (osim adalimumaba) mogli su sudjelovati u ispitivanju (do 20% ukupnog broja bolesnika u ispitivanju) ako je njihova izloženost tom lijeku bila ograničena (< 3 mjeseca) ili ako su morali prekinuti primjenu bDMARD-a zbog nepodnošenja e Bolesnici koji nisu dovoljno dobro odgovorili na najmanje jedan bDMARD ili ga nisu podnosili
English: Following administration of upadacitinib to lactating rats, the concentrations of upadacitinib in milk over time generally paralleled those in plasma, with approximately 30-fold higher exposure in milk relative to maternal plasma.
Croatian: Nakon primjene upadacitiniba ženkama štakora u laktaciji, koncentracije upadacitiniba u mlijeku tijekom vremena u načelu su se kretale usporedno s onima u plazmi, uz približno 30 puta veću izloženost u mlijeku nego u plazmi majke.
English: • increase in an enzyme called creatine kinase, shown by blood tests
Croatian: • povišene vrijednosti enzima koji se zove kreatin kinaza, vidljive u nalazima krvnih pretraga
English: Treatment with upadacitinib was associated with an increased incidence of liver enzyme elevation compared to placebo.
Croatian: Liječenje upadacitinibom bilo je povezano s povećanom incidencijom porasta vrijednosti jetrenih enzima u usporedbi s placebom.
English: The most commonly reported adverse drug reactions (ADRs) are upper respiratory tract infections (13.5%), nausea (3.5%), blood creatine phosphokinase (CPK) increased (2.5%) and cough (2.2%).
Croatian: Najčešće prijavljene nuspojave lijeka su infekcije gornjih dišnih putova (13,5%), mučnina (3,5%), povišene vrijednosti kreatin fosfokinaze (engl. creatine phosphokinase, CPK) u krvi (2,5%) i kašalj (2,2%).
English: Following single dose administration of [14C]-upadacitinib immediate-release solution, upadacitinib was eliminated predominantly as the unchanged parent substance in urine (24%) and faeces (38%).
Croatian: Nakon primjene jedne doze otopine [14C]-upadacitiniba s trenutnim oslobađanjem, lijek se pretežno izlučio u obliku neizmijenjenog ishodišnog spoja kroz urin (24%) i feces (38%).
English: AbbVie (as logo)
Croatian: AbbVie (kao logotip)
English: Coadministration of upadacitinib with a high-fat meal had no clinically relevant effect on upadacitinib exposures (increased AUC by 29% and Cmax by 39%).
Croatian: Primjena upadacitiniba uz obrok s visokim udjelom masnoća nije imala klinički značajnog učinka na izloženost upadacitinibu (porast vrijednosti AUC-a za 29% i Cmax za
English: Potential for other medicinal products to affect the pharmacokinetics of upadacitinib
Croatian: Potencijal drugih lijekova da utječu na farmakokinetiku upadacitiniba
English: Patients should be monitored for the development of signs and symptoms of TB, including patients who tested negative for latent TB infection prior to initiating therapy.
Croatian: Bolesnike treba nadzirati zbog mogućeg razvoja znakova i simptoma TBC-a, uključujući i bolesnike koji su prije početka liječenja imali negativan nalaz testa na latentni TBC.
English: Patients who were positive for hepatitis B surface antigen or hepatitis B virus DNA were excluded from clinical studies.
Croatian: Bolesnici koji su bili pozitivni na površinski antigen virusa hepatitisa B ili na DNK virusa hepatitisa B nisu bili uključeni u klinička ispitivanja.
English: Abbreviations: ADA = adalimumab; IR = inadequate responder; MTX = methotrexate; PBO = placebo; UPA= upadacitinib a All placebo data at week 48 derived using linear extrapolation b SELECT-EARLY c SELECT-COMPARE
Croatian: Kratice: ADA = adalimumab; MTX = metotreksat; PBO = placebo; UPA = upadacitinib a Svi podaci za placebo u 48. tjednu dobiveni su linearnom ekstrapolacijom b SELECT-EARLY c SELECT-COMPARE
English: Upadacitinib 15 mg treatment was associated with dose-dependent increases in lipid parameters including total cholesterol, triglycerides, LDL cholesterol and HDL cholesterol.
Croatian: Povišenja vrijednosti lipida Liječenje upadacitinibom u dozi od 15 mg bilo je povezano s o dozi ovisnim povišenjima vrijednosti lipidnih parametara, uključujući ukupni kolesterol, trigliceride, LDL-kolesterol i HDL-kolesterol.
English: Upadacitinib should not be used during breast-feeding.
Croatian: Upadacitinib se ne smije primjenjivati tijekom dojenja.
English: Treatment with upadacitinib was associated with increases in lipid parameters, including total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol (see section 4.8).
Croatian: Liječenje upadacitinibom bilo je povezano s povišenim vrijednostima lipidnih parametara, uključujući ukupni kolesterol, kolesterol lipoproteina male gustoće (LDL) i kolesterol lipoproteina velike gustoće (HDL) (vidjeti dio 4.8).
English: If clinical features of DVT/PE occur, upadacitinib treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment.
Croatian: Ako se pojave klinički znakovi DVT-a/PE-a, potrebno je prekinuti liječenje upadacitinibom i odmah ocijeniti stanje bolesnika te potom uvesti odgovarajuće liječenje.
English: Laboratory measures and monitoring guidance Laboratory measure
Croatian: Tablica 1: Laboratorijski parametri i smjernice za praćenje Laboratorijski parametar
English: Push down to make a hole in the foil and move the cutting tool round the edge of the foil to continue cutting the foil.
Croatian: Pritisnite da biste probili foliju, a zatim pomičite rezač uz rub folije kako biste je izrezali.
English: If you take more RINVOQ than you should
Croatian: Ako uzmete više lijeka RINVOQ nego što ste trebali
English: Following oral administration of upadacitinib prolonged-release formulation, upadacitinib is absorbed with a median Tmax of 2 to 4 hours.
Croatian: Nakon peroralne primjene formulacije s produljenim oslobađanjem upadacitinib se apsorbira uz medijan Tmax od 2 do 4 sata.
English: It is unknown whether upadacitinib/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se upadacitinib/metaboliti u majčino mlijeko.
English: CDAI ≤10 (% of patients)
Croatian: CDAI ≤ 10 (% bolesnika)
English: Upadacitinib should be used with caution in patients receiving chronic treatment with strong CYP3A4 inhibitors.
Croatian: Upadacitinib treba primjenjivati uz oprez u bolesnika koji primaju kroničnu terapiju snažnim inhibitorima CYP3A4.
English: Upadacitinib has no relevant effects on plasma exposures of ethinylestradiol, levonorgestrel, methotrexate, or medicinal products that are substrates for metabolism by CYP1A2, CYP2B6, CYP2C9, CYP2C19, or CYP2D6.
Croatian: metotreksatu ni lijekovima koji su supstrati za metabolizam putem CYP1A2, CYP2B6, CYP2C9, CYP2C19 ili CYP2D6.
English: Among patients in the controlled studies with baseline values below the specified limits, the following frequencies of patients were observed to shift to above the specified limits on at least one occasion during 12/14 weeks (including patients who had an isolated elevated value):
Croatian: Među bolesnicima u kontroliranim ispitivanjima kojima su početne vrijednosti bile ispod specificiranih graničnih vrijednosti, udio bolesnika kod kojih je opažen porast iznad specificiranih graničnih vrijednosti pri najmanje jednom mjerenju tijekom 12/14 tjedana (uključujući izolirane slučajeve povišenih vrijednosti) bio je sljedeći:
English: RINVOQ 15 mg prolonged-release tablets are purple, oblong, biconvex tablets imprinted on one side with ‘a15'.
Croatian: RINVOQ 15 mg tablete s produljenim oslobađanjem su ljubičaste, ovalne, bikonveksne tablete koje na jednoj strani imaju utisnutu oznaku „a15”.
English: Upadacitinib should be used with caution in patients at high risk for DVT/PE.
Croatian: Upadacitinib treba primjenjivati uz oprez u bolesnika koji su izloženi visokom riziku od DVT-a/PE-a.
English: Animal studies do not indicate effects with respect to fertility (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na učinke na plodnost (vidjeti dio 5.3).
English: The pharmacokinetics of upadacitinib have not yet been evaluated in a paediatric population (see section 4.2).
Croatian: Pedijatrijska populacija Farmakokinetika upadacitiniba još nije ocijenjena u pedijatrijskoj populaciji (vidjeti dio 4.2).
English: • cold sores (herpes simplex)
Croatian: • groznica (herpes simpleks)
English: The presence of at least 6 tender and 6 swollen joints and evidence of systemic inflammation based on elevation of hsCRP was required at baseline.
Croatian: Na početku ispitivanja bolesnici su morali imati najmanje 6 bolnih i 6 otečenih zglobova te dokaze sistemske upale utvrđene na temelju povišenja vrijednosti hsCRP-a.
English: If a patient develops herpes zoster, interruption of upadacitinib therapy should be considered until the episode resolves.
Croatian: Ako se u bolesnika razvije herpes zoster, potrebno je razmotriti privremeni prekid liječenja upadacitinibom dok se epizoda ne povuče.
English: Patients who were positive for hepatitis C antibody and hepatitis C virus RNA were excluded from clinical studies.
Croatian: Bolesnici koji su bili pozitivni na protutijela na virus hepatitisa C i na RNK virusa hepatitisa C nisu bili uključeni u klinička ispitivanja.
English: In all studies, more patients treated with upadacitinib 15 mg achieved ACR20, ACR50, and ACR70 responses at 12 weeks compared to placebo, MTX, or adalimumab (Table 4).
Croatian: U svim je ispitivanjima više bolesnika tijekom 12 tjedana postiglo odgovore ACR20, ACR50 i ACR70 uz upadacitinib u dozi od 15 mg nego uz placebo, MTX ili adalimumab (Tablica 4).