FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients should be tested for HBV infection before initiating treatment with Hefiya.
Croatian: Bolesnike je potrebno prije početka terapije lijekom Hefiya testirati na
English: Of the patients who lost adequate response after re-randomisation to placebo who then enrolled into the open-label extension trial, 38 % (25 / 66) and 55 % (36 / 66) regained PASI 75 response after 12 and 24 weeks of re-treatment, respectively.
Croatian: Među bolesnicima u kojih je nastupio gubitak primjerenog odgovora nakon ponovne randomizacije u skupinu koja je primala placebo, a koji su potom uključeni u otvoreni produžetak ispitivanja, odgovor PASI 75 ponovno je postignut u 38%
English: In patients with ulcerative colitis, a loading dose of 160 mg adalimumab on week 0 followed by 80 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 12 µg / ml during the induction period.
Croatian: Tijekom razdoblja indukcije u bolesnika s ulceroznim kolitisom, nakon udarne doze od 160 mg adalimumaba u nultom tjednu i zatim 80 mg adalimumaba u drugom tjednu postignute su najniže serumske koncentracije adalimumaba od oko 12 μg/ml.
English: Pulmonary embolism1), interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis, pleural effusion1)
Croatian: intersticijska plućna bolest, kronična opstruktivna plućna bolest,
English: No dose recommendations can be made.
Croatian: DMARD) nije postignut zadovoljavajući odgovor.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I)
English: Table 15 efficacy response in placebo-controlled period for study nr-axSpA II
Croatian: Tablica 15 Djelotvornost u placebom kontroliranom razdoblju ispitivanja nr-axSpA II dvostruko slijepo odgovor u 68. tjednu placebo N=153
English: Hidradenitis suppurativa (HS)
Croatian: Gnojni hidradenitis (Hidradenitis suppurativa)
English: Patients should be instructed to seek medical advice if signs / symptoms suggestive of a tuberculosis infection (e.g., persistent cough, wasting/weight loss, low grade fever, listlessness) occur during or after therapy with Hefiya.
Croatian: Bolesnike se mora upozoriti da se obrate liječniku ako se za vrijeme ili nakon liječenja lijekom Hefiya pojave znakovi/simptomi koji upućuju na tuberkuloznu infekciju (npr. perzistirajući kašalj,
English: In study UC-I, 390 TNF-antagonist naïve patients were randomised to receive either placebo at weeks 0 and 2, 160 mg adalimumab at week 0 followed by 80 mg at week 2, or 80 mg adalimumab at week 0 followed by 40 mg at week 2.
Croatian: U ispitivanju UC-I, 390 bolesnika koji nikad nisu primali terapiju antagonistima TNF-a randomizirani su tako da primaju ili placebo u nultom tjednu i u drugom tjednu, adalimumab u dozi od 160 mg u nultom tjednu i 80 mg u drugom tjednu ili adalimumab u dozi 80 mg u nultom tjednu i 40 mg u drugom tjednu.
English: In CD study I and CD study II, statistically significant improvement in the disease-specific inflammatory bowel disease questionnaire (IBDQ) total score was achieved at week 4 in patients randomised to adalimumab 80 / 40 mg and 160 / 80 mg compared to placebo and was seen at weeks 26 and 56 in CD study III as well among the adalimumab treatment groups compared to the placebo group.
Croatian: U 4. tjednu ispitivanja CD I i CD II, u bolesnika koji su randomizirani za primanje adalimumaba 80/40 mg i adalimumaba 160/80 mg došlo je do statistički značajnog poboljšanja ukupnog rezultata prema upitniku o upalnoj bolesti crijeva (engl.
English: Amongst those who responded at week 16 (n = 144), the paediatric ACR 30 / 50 / 70 /90 responses were maintained for up to six years in the OLE phase in patients who received adalimumab throughout the study.
Croatian: ACR 30/50/70/90 održali su se i do šest godina u otvorenom produžetku ispitivanja u bolesnika koji su uzimali adalimumab tijekom cijeloga ispitivanja.
English: • sicca syndrome (including dry eyes and dry mouth);
Croatian: • bolest vraćanja kiselog sadržaja iz želuca, • sicca (suhi) sindrom (uključujući suhoću očiju i suhoću usta),
English: Adalimumab 40 mg every other week was assessed in 393 patients in two randomised, 24 week double-blind, placebo-controlled studies in patients with active ankylosing spondylitis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in all groups) who have had an inadequate response to conventional therapy.
Croatian: U dva dvostruko slijepa, randomizirana, placebom kontrolirana ispitivanja, kroz 24 tjedna ispitivano je djelovanje adalimumaba u dozi od 40 mg svaka dva tjedna u 393 bolesnika s aktivnim ankilozantnim spondilitisom (srednja početna vrijednost aktivnosti bolesti [engl.
English: Vertigo and visual impairment may occur following administration of Hefiya (see section 4.8).
Croatian: Nakon primjene lijeka Hefiya mogu se pojaviti vrtoglavica i poremećaji vida (vidjeti dio 4.8).
English: Paediatric Crohn's disease
Croatian: Paediatric Crohn's Disease Activity Index,
English: The recommended dose of Hefiya is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg every other week starting one week later.
Croatian: Preporučeno doziranje lijeka Hefiya je početna doza od 80 mg (u obliku dvije injekcije od 40 mg u jednom danu), a zatim 40 mg svaka dva tjedna, počevši tjedan dana kasnije.
English: Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period.
Croatian: U slučaju da ni nakon 12 tjedana nema poboljšanja, potrebno je pomno razmotriti nastavak liječenja takvog bolesnika.
English: Therefore, the combination of adalimumab and anakinra is not recommended (see section 4.5).
Croatian: Stoga se istodobna primjena adalimumaba i anakinre ne preporučuje
English: Non-infectious uveitis in adults and children
Croatian: Nezarazni uveitis u odraslih i djece
English: • You might get infections more easily while you are receiving Hefiya treatment.
Croatian: • Dok primate terapiju lijeka Hefiya, možete biti podložniji infekcijama.
English: There is limited safety experience in patients undergoing arthroplasty while receiving adalimumab.
Croatian: Raspoloživi podaci o sigurnosti provedbe artroplastike u bolesnika liječenih adalimumabom su ograničeni.
English: • Only remove the cap when you are ready to use the pen.
Croatian: • Skinite zatvarač tek kad ste spremni upotrijebiti brizgalicu.
English: During the controlled portions of pivotal adalimumab trials in adults of at least 12 weeks in duration in patients with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95% confidence interval) of
Croatian: U kontroliranim dijelovima pivotalnih ispitivanja terapije adalimumabom koja su trajala barem 12 tjedana u odraslih bolesnika s umjerenim do teškim aktivnim reumatoidnim artritisom, ankilozantnim spondilitisom, aksijalnim spondiloartritisom bez radiografskog dokaza AS-a,
English: The recommended dose of Hefiya for paediatric patients with uveitis from 2 years of age is based on body weight (table 5).
Croatian: Preporučena doza lijeka Hefiya za pedijatrijske bolesnike s uveitisom u dobi od 2 i više godina određuje se na temelju tjelesne težine (tablica 5).
English: Of 207 patients who were randomised to adalimumab 40 mg every other week, 114 patients continued on adalimumab 40 mg every other week for
Croatian: Kroz 5 godina, terapiju adalimumabom 40 mg svaka dva tjedna nastavilo je 114 od 207 bolesnika koji su bili randomizirani u skupinu koja je primala adalimumab 40 mg svaki drugi tjedan.
English: Continued therapy beyond 16 weeks should be carefully considered in a patient not responding within this time period.
Croatian: Ako bolesnik ne postigne terapijski odgovor unutar 16 tjedana, nastavak liječenja nakon tog razdoblja potrebno je pomno razmotriti.
English: b among patients with baseline HS-related skin pain assessment ≥ 3, based on Numeric Rating Scale 0-10;
Croatian: b među bolesnicima s procijenjenom početnom kožnom boli uzrokovanom gnojnim hidradenitisom ≥ 3 prema brojčanoj ocjenskoj ljestvici od 0 - 10; 0 = bez kožne boli, 10 = nezamislivo jaka kožna bol.
English: There is no relevant use of adalimumab in children aged less than 4 years for this indication.
Croatian: Nema relevantne primjene adalimumaba u djece mlađe od 4 godine u ovoj indikaciji.
English: PsA study II with 12-week duration, treated 100 patients who had an inadequate response to DMARD therapy.
Croatian: Ispitivanjem PsA II u trajanju od 12 tjedana obuhvaćeno je 100 odraslih bolesnika koji nisu ostvarili odgovarajući odgovor na prethodno liječenje antireumatskim lijekovima koji modificiraju tijek bolesti.
English: The recommended dose of Hefiya for adult patients with uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose.
Croatian: Preporučena doza lijeka Hefiya u odraslih bolesnika s uveitisom je početna doza od 80 mg, nakon koje slijedi doza od 40 mg svaki drugi tjedan, počevši tjedan dana nakon početne doze.
English: Two patients out of 3,441 treated with adalimumab in all rheumatoid arthritis and psoriatic arthritis studies developed clinical signs suggestive of new-onset lupus-like syndrome.
Croatian: Klinički simptomi koji upućuju na razvoj sindroma sličnog lupusu zabilježeni su u dva od ukupno 3441 bolesnika liječenog adalimumabom iz svih ispitivanja reumatoidnog artritisa i psorijatičnog artritisa.
English: Very common
Croatian: Otežano cijeljenje
English: • polyarticular juvenile idiopathic arthritis,
Croatian: • poliartikularnog juvenilnog idiopatskog artritisa
English: Adalimumab has not been studied in these patient populations.
Croatian: Nije ispitivano djelovanje adalimumaba u toj populaciji bolesnika te se ne mogu dati preporuke za doziranje.
English: If you take Hefiya the risk of getting lymphoma, leukaemia, or other cancers may increase.
Croatian: Rizik obolijevanja od limfoma, leukemije ili drugih tumora može se povećati ako primjenjujete lijek Hefiya.
English: Pancytopaenia
Croatian: Cijepljenje
English: If a faster response is required your doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (as two 40 mg injections in one day) two weeks later, and thereafter as 40 mg every other week.
Croatian: Ako je potreban brži odgovor na liječenje, liječnik Vam može propisati početnu dozu od 160 mg (u obliku četiri injekcije od 40 mg u jednom danu ili dvije injekcije od 40 mg na dan tijekom dva uzastopna dana) i zatim 80 mg (u obliku dvije injekcije od 40 mg u jednom danu) nakon dva tjedna.
English: The usual dose for adults with psoriasis is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg given every other week starting one week after the initial dose.
Croatian: Uobičajena doza za odrasle bolesnike sa psorijazom je početna doza od 80 mg (u obliku dvije injekcije od 40 mg u jednom danu), nakon čega slijedi 40 mg svaki drugi tjedan počevši tjedan dana nakon početne doze.
English: Adalimumab-treated patients showed statistically significant improvements at week 26 compared with placebo in the DLQI.
Croatian: Bolesnici liječeni adalimumabom pokazali su statistički značajna poboljšanja DLQI rezultata u 26.
English: • fatty liver (build-up of fat in liver cells);
Croatian: • masna jetra (nakupljanje masnoće u stanicama jetre),
English: Some patients who experience decrease in their response to Hefiya 40 mg every other week may benefit from an increase in dosage to 40 mg Hefiya every week or 80 mg every other week.
Croatian: U nekih bolesnika u kojih dođe do slabljenja odgovora na terapiju Hefiyaom u dozi od 40 mg svaki drugi tjedan možda će biti korisno povećati doziranje na 40 mg lijeka Hefiya svaki tjedan ili 80 mg svaki drugi tjedan.
English: At Week 16, more patients randomised to adalimumab 0.8 mg / kg had positive efficacy responses (e.g., PASI 75) than those randomised to 0.4 mg / kg eow or MTX (table 20).
Croatian: postigao je veći broj bolesnika randomiziranih za liječenje adalimumabom u dozi od 0,8 mg/kg nego onih randomiziranih za primanje doze od 0,4 mg/kg svaki drugi tjedan ili za liječenje MTX-om (tablica 20).
English: Rash (including exfoliative rash)
Croatian: Vrlo često Osip (uključujući eksfolijativni osip)
English: The recommended Hefiya induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) and 80 mg at week 2 (given as two 40 mg injections in one day).
Croatian: Preporučena indukcijska doza lijeka Hefiya u odraslih bolesnika s umjerenim do teškim ulceroznim kolitisom je 160 mg u nultom tjednu (primijenjena u obliku četiri injekcije od 40 mg u jednom danu ili kao dvije injekcije od 40 mg na dan kroz dva uzastopna dana) i 80 mg u drugom tjednu (primijenjena u obliku dvije injekcije od 40 mg u jednom danu).
English: The syringe inside the pen is made of type I glass with a stainless steel needle and an inner rubber needle cap, containing 0.8 ml of solution.
Croatian: I s iglom od nehrđajućeg čelika, unutarnjim gumenim zatvaračem igle i gumenim čepom, a sadrži 0,8 ml otopine.
English: • headache;
Croatian: • kašalj,
English: • dyspepsia (indigestion, bloating, heart burn);
Croatian: • dispepsija (probavne smetnje, nadutost, žgaravica),
English: 6.8 (4.4, 10.5) per 1,000 patient years among 5,291 adalimumab-treated patients versus a rate of 6.3 (3.4, 11.8) per 1,000 patient years among 3,444 control patients (median duration of treatment was 4.0 months for adalimumab and 3.8 months for control-treated patients).
Croatian: psorijatičnim artritisom, psorijazom, gnojnim hidradenitisom, Crohnovom bolešću, ulceroznim kolitisom i uveitisom, primijećene su zloćudne bolesti, isključujući limfome i nemelanomske tumore kože, u stopi od 6,8 (4,4; 10,5) na 1000 bolesnik-godina (interval pouzdanosti 95%) u 5291 bolesnika liječenog adalimumabom, naspram 6,3 (3,4; 11,8) na 1000 bolesnik-godina u 3444 bolesnika iz kontrolne skupine (medijan trajanja terapije bio je 4,0 mjeseci u bolesnika liječenih adalimumabom i 3,8 mjeseci u kontrolnoj skupini bolesnika).
English: The recommended Hefiya dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at Day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at Day 15 (given as two 40 mg injections in one day).
Croatian: Preporučen režim doziranja lijeka Hefiya za odrasle bolesnike s gnojnim hidradenitisom je početna doza od 160 mg prvoga dana (primijenjena u obliku četiri injekcije od 40 mg u jednom danu ili dvije injekcije od 40 mg na dan tijekom dva uzastopna dana), nakon koje slijedi doza od 80 mg dva tjedna kasnije, 15. dana (primijenjena u obliku dvije injekcije od 40 mg u jednom danu).
English: Your injection You must read this before injecting
Croatian: Morate ovo pročitati prije primjene injekcije Tijekom injekcije čut ćete 2 glasna klika:
English: Hefiya therapy should not be continued in patients failing to respond within this time period.
Croatian: U bolesnika u kojih u ovom razdoblju ne bude odgovora, liječenje lijekom Hefiya ne treba nastaviti.
English: There is no relevant use of adalimumab in patients aged less than 2 years for this indication.
Croatian: Nema relevantne primjene adalimumaba u bolesnika mlađih od 2 godine u ovoj indikaciji.
English: There is no relevant use of adalimumab in children aged less than 6 years for this indication.
Croatian: Nema relevantne primjene adalimumaba u djece mlađe od 6 godina u ovoj indikaciji.
English: Mannitol
Croatian: tinitus
English: double-blind response at week 12
Croatian: dvostruko slijepo odgovor u 12. tjednu placebo N=94
English: Abdominal pain, nausea and vomiting
Croatian: mučnina i povraćanje
English: • facial oedema (swelling) associated with allergic reactions;
Croatian: • edem (oticanje) lica povezan s alergijskim reakcijama, • multiformni eritem (upalni kožni osip),
English: In study nr-axSpA I, adalimumab 40 mg every other week was assessed in 185 patients in a randomised, 12 week double-blind, placebo-controlled study in patients with active nr-axSpA (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.4 for patients treated with adalimumab and 6.5 for those on placebo) who have had an inadequate response to or intolerance to ≥ 1 NSAIDs, or a contraindication for NSAIDs.
Croatian: Disease Activity Index, BASDAI)] bila je 6,4 u skupini bolesnika koji su primali adalimumab i 6,5 u skupini koja je primala placebo) koji nisu imali zadovoljavajući odgovor na ≥1 NSAIL-a ili ga nisu podnosili, ili su imali kontraindikaciju za primjenu NSAIL-a.
English: Common
Croatian: skupina
English: The usual dose regimen for hidradenitis suppurativa is an initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by an 80 mg dose (as two 40 mg injections on the same day) two weeks later.
Croatian: Uobičajen režim doziranja za gnojni hidradenitis je početna doza od 160 mg (u obliku četiri injekcije od 40 mg u jednom danu ili dvije injekcije od 40 mg na dan, tijekom dva uzastopna dana), nakon koje se dva tjedna kasnije primjenjuje doza od 80 mg (u obliku dvije injekcije od 40 mg u jednom danu).
English: discontinuation of Immunomodulators2
Croatian: 26. tjedan 52. tjedan prekinuti imunomodulatori2
English: Diplopia
Croatian: Pancitopenija
English: Patients were randomised to 40 mg of adalimumab or placebo every other week for 24 weeks.
Croatian: Bolesnici su nasumce podijeljeni u dvije skupine od kojih je jedna dobivala 40 mg adalimumaba, a druga placebo svaki drugi tjedan tijekom 24 tjedna.
English: Injection site reactions
Croatian: Opći poremećaji i reakcije na mjestu primjene*
English: Non-serious allergic reactions associated with adalimumab were uncommon during clinical trials.
Croatian: Manje često su u kliničkim ispitivanjima zabilježene alergijske reakcije povezane s adalimumabom koje nisu bile ozbiljne.
English: Keep the pre-filled syringe / pre-filled pen in the outer carton in order to protect from light.
Croatian: Napunjenu štrcaljku / napunjenu brizgalicu čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: g n=73 placebo and n=70 adalimumab h
Croatian: d srednja promjena od početne vrijednosti e n=91 za placebo i n=87 za adalimumab f
English: • pulmonary fibrosis (scarring of the lung);
Croatian: • plućna fibroza (ožiljci na plućima),
English: Adalimumab showed statistically significantly greater improvement in the HAQ-S total score and the SF-36 Physical Component Score (PCS) from baseline to week 12 compared to placebo.
Croatian: Adalimumab je u 12. tjednu u odnosu na početne vrijednosti pokazala statistički značajno veće poboljšanje ukupnog rezultata HAQ-S i rezultata za fizičku komponentu (engl.
English: Thus, it is not possible to administer Hefiya to paediatric patients that require less than a full 40 mg dose.
Croatian: Zato se Hefiya ne može primijeniti u pedijatrijskih bolesnika koji zahtijevaju manje od cijele doze od
English: 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).
Croatian: Veća poboljšanja od početka ispitivanja do 12. tjedna u odnosu na placebo zabilježena su za kvalitetu života vezanu uz zdravlje specifičnu za kožne bolesti, koja se određivala indeksom kvalitete života kod dermatoloških bolesti (engl.
English: Greater improvements at week 12 from baseline compared to placebo were demonstrated in skin-specific health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI; Studies HS-I and HS-II), patient global satisfaction with medication treatment as measured by the Treatment Satisfaction Questionnaire - medication (TSQM; Studies HS-I and HS-II), and physical health as measured by the physical component summary score of the SF-36 (Study HS-I).
Croatian: [TSQM]; ispitivanja HS-I i HS-II) i fizičko zdravlje, koje se određivalo na temelju rezultata za cjelokupnu fizičku komponentu upitnika SF-36 (ispitivanje HS-I).
English: In patients with Crohn's disease, the loading dose of 80 mg adalimumab on week 0 followed by 40 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 5.5 µg / ml during the induction period.
Croatian: Tijekom razdoblja indukcije u bolesnika s Crohnovom bolešću, nakon udarne doze od 80 mg adalimumaba u nultom tjednu i zatim 40 mg adalimumaba u drugom tjednu postignute su najniže serumske koncentracije adalimumaba od oko 5,5 μg/ml, odnosno 12 μg/ml ako je udarna doza bila 160 mg adalimumaba u nultom tjednu i zatim 80 mg adalimumaba u drugom tjednu.
English: Doses of 20, 40 or 80 mg of adalimumab or placebo were given every other week for 24 weeks.
Croatian: Bolesnici su svaki drugi tjedan tijekom 24 tjedna dobivali adalimumab ili placebo u dozi od 20, 40 ili 80 mg.
English: The usual dose regimen for Crohn's disease is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg every other week starting two weeks later.
Croatian: Uobičajena početna doza lijeka za Chronovu bolest je 80 mg (u obliku dvije injekcije od 40 mg u jednom danu), nakon čega poslije dva tjedna slijedi doza od 40 mg svaki drugi tjedan.
English: 10 6250 Kundl Austria
Croatian: Sandoz GmbH Biochemiestr. 10 6250 Kundl Austrija
English: Children and adolescents from 2 years of age weighing 30 kg or more
Croatian: Djeca i adolescenti u dobi od 4 do 17 godina, tjelesne težine 30 kg ili više
English: solution for injection
Croatian: Primjena injekcije
English: The recommended dose of Hefiya for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.
Croatian: U odraslih bolesnika preporučena početna doza lijeka Hefiya je 80 mg supkutano, nakon čega slijedi 40 mg supkutano svaka dva tjedna, počevši jedan tjedan nakon početne doze.
English: Hefiya is supplied in a single-use clear type I glass syringe with a stainless steel needle with a needle guard with finger flange, rubber needle cap and plastic plunger rod, containing 0.8 ml of solution.
Croatian: I s iglom od nehrđajućeg čelika sa štitnikom za iglu sa hvatištem za prste, gumenim zatvaračem igle i plastičnim klipom, a sadrži 0,8 ml otopine.
English: Continued therapy should be reconsidered in a patient not responding within this time period.
Croatian: Ako se unutar tog razdoblja ne postigne terapijski odgovor, valja razmotriti nastavak liječenja takvog bolesnika.
English: clinical remission clinical response (CR-100) patients in steroid-free remission for > = 90 daysa * p < 0.001 for adalimumab versus placebo pairwise comparisons of proportions ** p < 0.02 for adalimumab versus placebo pairwise comparisons of proportions a of those receiving corticosteroids at baseline
Croatian: bolesnici u remisiji bez primjene steroida >= 90 danaa * p < 0,001 za adalimumab naspram placeba, sparena usporedba udjela ** p < 0,02 za adalimumab naspram placeba, sparena usporedba udjela a onih koji su na početku uzimali kortikosteroide Među bolesnicima koji u 4. tjednu nisu imali klinički odgovor, 43% bolesnika koji su primali dozu održavanja adalimumaba imalo je klinički odgovor do 12. tjedna u odnosu na 30% u skupini bolesnika koji su uzimali placebo kao terapiju održavanja.