FrancophonIA/ELRC3.0 huggingface dataset:
English: In RA study IV, the ACR 20 response of patients treated with adalimumab plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p < 0.001).
Croatian: U ispitivanju RA IV, ACR 20 odgovor u bolesnika liječenih adalimumabom uz standardnu skrb bio je statistički značajno bolji nego u bolesnika koji su primali placebo uz standardnu skrb (p < 0,001).
English: The apparent adalimumab plasma concentration that produces half the maximum probability of PedACR 50 response (EC50) was 3 µg/mL
Croatian: Prividna plazmatska koncentracija adalimumaba uz koju se postiže polovica maksimalne vjerojatnosti za odgovor PedACR 50 (EC50) bila je 3 μg/ml (95% CI: 1-6 μg/ml).
English: • Gently remove cap by pulling it straight off. Do not touch needle or let needle touch anything.
Croatian: Nemojte dotaknuti iglu ili dozvoliti da igla išta dotakne.
English: * p value for Standard Dose versus Low Dose comparison.
Croatian: * p vrijednost za standardnu dozu u usporedbi s niskom dozom.
English: During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Croatian: Tijekom liječenja održavanja, doza kortikosteroida može se postupno smanjivati u skladu s kliničkim
English: Of those patients who had a response at week 8, 47 % were in response, 29 % were in remission, 41 % had mucosal healing, and 20 % were in steroid-free remission for ≥ 90 days at week 52.
Croatian: Od bolesnika koji su imali odgovor u 8. tjednu, 47% ih je postiglo klinički odgovor, 29% ih je bilo u remisiji, a 41% je imalo zacjeljivanje sluznice, dok ih je u 52. tjednu 20% bilo u remisiji bez primjene
English: Usually, Cyltezo is used with methotrexate.
Croatian: Cyltezo se obično primjenjuje u kombinaciji s metotreksatom.
English: When needed (for example when you are travelling), a single Cyltezo pre-filled syringe may be stored at room temperature (up to 25°C) for a maximum period of 14 days - be sure to protect it from light.
Croatian: Ako je potrebno (primjerice, ako putujete), pojedinačna napunjena brizgalica lijeka Cyltezo može se čuvati na sobnoj temperaturi (do 25°C) najviše do 14 dana - pazite da je zaštitite od svjetlosti.
English: How to use Cyltezo
Croatian: Kako primjenjivati lijek Cyltezo
English: In the open-label extension, improvement in the signs and symptoms was maintained with adalimumab
Croatian: U otvorenom nastavku ispitivanja poboljšanje znakova i simptoma se održalo uz liječenje
English: Cyltezo can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Croatian: Cyltezo se može davati i u obliku monoterapije ako bolesnik ne podnosi metotreksat ili kada kontinuirana primjena metotreksata nije prikladna.
English: The tip's needle guard will automatically move down to cover the needle.
Croatian: Poklopac vrha igle automatski će se spustiti
English: Cyltezo is contraindicated in moderate to severe heart failure (see section 4.3).
Croatian: Primjena lijeka Cyltezo je kontraindicirana u bolesnika s umjerenim do teškim zatajenjem srca (vidjeti dio 4.3).
English: Should treatment be interrupted, Cyltezo may be re-introduced as appropriate.
Croatian: Ako liječenje treba privremeno prekinuti, lijek Cyltezo se kasnije, po potrebi, može ponovno uvesti.
English: Adalimumab demonstrated a treatment benefit in nail psoriasis patients with different extents of skin involvement (BSA ≥ 10% (60 % of patients) and BSA < 10 % and ≥ 5 % (40 % of patients)).
Croatian: Adalimumab je ostvario povoljan terapijski učinak u bolesnika s psorijazom noktiju i različitim stupnjevima zahvaćenosti kože (≥ 10% tjelesne površine [60% bolesnika] te < 10% i ≥ 5% tjelesne površine [40% bolesnika]).
English: Vision related effects were not numerically in favour of adalimumab for colour vision in Study UVI and for colour vision, peripheral vision
Croatian: Učinci povezani s vidom koji nisu brojčano išli u prilog adalimumabu bili su učinci na vid u boji u ispitivanju UV I, odnosno učinci na vid u boji, periferni vid i vid na blizinu u
English: The number of all cause hospitalisations in the adalimumab treatment group was 0.18 per patient year vs. 0.26 per patient year in the placebo group and the corresponding figures for UC-related hospitalisations were 0.12 per patient
Croatian: Broj hospitalizacija zbog bilo kojeg uzroka u skupini liječenoj adalimumabom bio je 0,18 po bolesnik-godini u odnosu na 0,26 po bolesnik-godini u skupini koja je primala placebo, a odgovarajuće vrijednosti za hospitalizaciju povezanu s UC-om bile su 0,12 po bolesnik-godini u odnosu na 0,22 po bolesnik-godini.
English: Amongst those who responded (Pediatric ACR 30) at week 24 (n = 27 out of 30 patients), the Pediatric ACR 30 responses were maintained for up to 60 weeks in the OLE phase in patients who received adalimumab throughout this time period.
Croatian: Među onima koji su odgovorili na liječenje (pedijatrijski odgovor ACR 30) u 24. tjednu (n = 27 od 30 bolesnika), pedijatrijski odgovori ACR 30 održali su se do 60 tjedana u otvorenom nastavku ispitivanja u bolesnika koji su primali adalimumab tijekom ovog razdoblja.
English: It is recommended that children, if possible, be given all the scheduled vaccinations for their age before they start treatment with Cyltezo.
Croatian: Ako je moguće, preporučuje se da djeca prime sva cjepiva za svoju dob prema rasporedu cijepljenja prije početka liječenja lijekom Cyltezo.
English: Бьорингер Ингелхайм РЦВ ГмбХ и Ко.
Croatian: България Бьорингер Ингелхайм РЦВ ГмбХ и Ко.
English: You will inject into this raised area of • Before injecting, read steps 8 A-C to learn correct way to administer dose.
Croatian: • Prije ubrizgavanja, pročitajte korake 8 A-C kako biste naučili ispravan način za primjenu doze.
English: Placebo Adalimumab 40 mg Weekly
Croatian: Placebo Adalimumab 40 mg svaki tjedan
English: Some patients who have not responded by week 4 may benefit from continued maintenance therapy through week 12.
Croatian: Nekim bolesnicima koji ne odgovore na liječenja do 4. tjedna mogao bi koristiti nastavak liječenja održavanja do 12. tjedna.
English: week 12 results showed statistically significant improvement of the signs and symptoms of active nr-axSpA in patients treated with adalimumab compared to placebo (Table 14).
Croatian: Rezultati u 12. tjednu pokazali su značajno poboljšanje znakova i simptoma aktivnog nr-axSpA u bolesnika koji su liječeni adalimumabom u odnosu na placebo (Tablica 14).
English: 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.
Croatian: Istodobna primjena adalimumaba i drugih bioloških antireumatika koji modificiraju tijek bolesti (npr. anakinra i abatacept) ili drugih antagonista TNF-a se ne preporučuje zbog mogućeg povećanog rizika od razvoja infekcija, uključujući ozbiljne infekcije, i drugih potencijalnih farmakoloških
English: The Cyltezo pre-filled syringe is made of glass.
Croatian: Napunjena štrcaljka lijeka Cyltezo izrađena je od stakla.
English: Excipients: sodium acetate trihydrate, glacial acetic acid, trehalose dihydrate, polysorbate 80 and water for injections.
Croatian: Pomoćne tvari: natrijev acetat trihidrat, ledena octena kiselina, trehaloza dihidrat, polisorbat 80 i voda za injekcije.
English: In patients who develop HBV reactivation, Cyltezo should be stopped and effective anti-viral therapy with appropriate supportive treatment should be
Croatian: U bolesnika u kojih se javi reaktivacija HBV infekcije mora se prekinuti liječenje lijekom Cyltezo i početi učinkovito antivirusno liječenje uz odgovarajuće potporne mjere.
English: Thus, it is not possible to administer Cyltezo to paediatric patients that require less than a full 40 mg dose.
Croatian: Stoga nije moguće primijeniti lijek Cyltezo u pedijatrijskih bolesnika koji zahtijevaju dozu koja je manja od pune doze od 40 mg.
English: • signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness.
Croatian: • znakove i simptome koji upućuju na poremećaje u krvi poput uporne vrućice, stvaranja modrica,
English: 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).
Croatian: Bolesnici koji su primili indukciju adalimumabom u dozi od 160/80 mg u osmom su tjednu postigli kliničku remisiju u značajno većem postotku u odnosu na placebo i u ispitivanju UC-I (18%, odnosno 9%, p = 0,031) i u ispitivanju UC-II (17%, odnosno 9%, p = 0,019).
English: A total of 76.5 % (218/285) of patients who entered the retreatment period had a response of PGA “clear” or “minimal” after 16 weeks of retreatment, irrespective of whether they relapsed during withdrawal (69.1 % [123/178] and 88.8 % [95/107] for patients who relapsed and who did not relapse during the withdrawal period, respectively).
Croatian: Ukupno je 76,5% (218/285) bolesnika kojima je liječenje ponovno uvedeno imalo PGA odgovor “bez bolesti” ili “minimalno” nakon 16 tjedana liječenja, bez obzira jesu li doživjeli relaps u razdoblju kada je liječenje bilo ukinuto (69,1%[123/178] za bolesnike s relapsom, odnosno 88,8% [95/107] za bolesnike bez relapsa).
English: Patients participating in Studies HS-I and HS-II were eligible to enrol into an open-label extension study in which adalimumab 40 mg was administered every week.
Croatian: Bolesnici koji su sudjelovali u ispitivanjima HS-I i HS-II mogli su sudjelovati u otvorenom nastavku ispitivanja u kojem se adalimumab primjenjivao svaki tjedan u dozi od 40 mg.
English: The observed rate of non-melanoma skin cancers is approximately 9.6 per 1,000 patient-years, and the observed rate of lymphomas is approximately 1.3 per
Croatian: Primijećena stopa nemelanomskih tumora kože je približno 9,6 na 1000 bolesnik-godina, a limfoma 1,3 na
English: If adequate response is achieved with 40 mg every week or 80 mg every other week, the dosage may subsequently be reduced to 40 mg every other
Croatian: Ako se s dozom od 40 mg svaki tjedan ili 80 mg svaki drugi tjedan postigne zadovoljavajući odgovor, doziranje se potom može smanjiti na 40 mg svaka dva tjedna.
English: Kaplan-Meier Curves Summarizing Time to Flare in Study nr-axSpA II
Croatian: Kaplan-Meierove krivulje koje sažeto prikazuju vrijeme do egzacerbacije u ispitivanju nr-axSpA II
English: The combination of Cyltezo and abatacept is not recommended (see section 4.4 “Concurrent administration of biologic DMARDS or TNF-antagonists”).
Croatian: Kombinirano liječenje lijekom Cyltezo i abataceptom se ne preporučuje (vidjeti dio 4.4 “ Istodobna primjena bioloških antireumatika koji modificiraju tijek bolesti ili antagonista TNF-a“).
English: Elevated liver enzymes
Croatian: • povišena razina jetrenih enzima.
English: In Psoriasis Study I, 28 % of patients who were PASI 75 responders and were re-randomised to placebo at week 33 compared to 5 % continuing on adalimumab, p < 0.001, experienced “loss of adequate response” (PASI score after week 33 and on or before week 52 that resulted in a < PASI 50 response relative to baseline with a minimum of a 6-point increase in PASI score relative to week 33).
Croatian: U ispitivanju Psoriasis Study I, u 28% bolesnika s odgovorom PASI 75 kojima je nakon 33. tjedna pri ponovnoj randomizaciji dodijeljen placebo, u usporedbi s 5% bolesnika koji su nastavili primati adalimumab (p< 0,001), uočen je „gubitak primjerenog odgovora“ (PASI rezultat nakon 33. i u ili prije 52. tjedna koji je rezultirao odgovorom < PASI 50 u odnosu na početak liječenja, uz porast PASI rezultata za najmanje 6 bodova u odnosu na 33. tjedan).
English: Hypersensitivity, allergies (including seasonal allergy)
Croatian: često manje često preosjetljivost, alergije (uključujući sezonske alergije) sarkoidoza
English: • Do not select tender, bruised, or scarred areas.
Croatian: • Ne birajte predio koji je nježan, ima modricu ili ožiljak.
English: Patients who achieved sustained remission for at least 12 weeks (N = 305) (ASDAS < 1.3 at weeks 16, 20, 24, and 28) during the open-label period were then randomised to receive either continued treatment with adalimumab 40 mg eow (N = 152) or placebo (N = 153) for an additional 40 weeks in a double-blind, placebo-controlled period (total study duration 68 weeks).
Croatian: Bolesnici koji su tijekom razdoblja otvorene primjene postigli remisiju koja se održala tijekom najmanje 12 tjedana (N=305) (ASDAS rezultat < 1,3 u 16., 20., 24. i 28. tjednu) zatim su bili randomizirani za nastavak liječenja adalimumabom u dozi od 40 mg svaka dva tjedna (N=152) ili za primanje placeba (N=153) tijekom dodatnih 40 tjedana u dvostruko slijepom, placebom kontroliranom razdoblju (ukupno trajanje ispitivanja: 68 tjedana).
English: Treatment failure was defined by a multi-component outcome based on inflammatory chorioretinal and/or inflammatory retinal vascular lesions, anterior chamber (AC) cell grade, vitreous haze (VH) grade and best corrected visual acuity (BCVA).
Croatian: Neuspjeh liječenja definirao se višekomponentnim ishodom koji se temeljio na upalnim korioretinalnim i/ili upalnim retinalnim vaskularnim lezijama, stupnju prema broju stanica u prednjoj očnoj komori (engl. anterior chamber [AC] cell grade), stupnju prema zamućenju staklovine (engl. vitreous haze [VH] grade) te najboljoj korigiranoj oštrini vida (engl. best corrected visual
English: 5) Clean injection site
Croatian: 5) Očistite mjesto za primjenu injekcije
English: In the open-label extension for RA study V, ACR response rates were maintained when followed for up to 10 years.
Croatian: U otvorenom nastavku ispitivanja RA V, stope ACR odgovora održale su se tijekom praćenja u trajanju do 10 godina.
English: Time to Treatment Failure At or After Week 2 in Study UV II
Croatian: Vrijeme do neuspjeha liječenja u 2. tjednu ili nakon njega u ispitivanju UV II
English: Maintenance of remission and response rates are presented in Table 24.
Croatian: Održavanje remisije i stope kliničkog odgovora se nalaze u Tablici 24.
English: The safety and efficacy of adalimumab were assessed in a multicentre, randomised, double-blind, parallel-group study in 171 children (4-17 years old) with polyarticular JIA.
Croatian: Sigurnost i djelotvornost primjene adalimumaba ocijenjene su u multicentričnom, randomiziranom, dvostruko-slijepom ispitivanju na paralelnim skupinama koje je uključivalo 171 dijete (u dobi od 4-17 godina) s poliartikularnim JIA.
English: 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.
Croatian: Ispitanici (n = 215, 54,7%) koji nisu uspjeli postići ASAS 20 u 12., 16. ili 20. tjednu ranije su prebačeni u otvoreni dio ispitivanja i dobivali su 40 mg adalimumaba supkutano svaki drugi tjedan.
English: • You will be instructed by your doctor, nurse or pharmacist on the technique of self-injection.
Croatian: • U tehniku samostalnog ubrizgavanja uputit će Vas liječnik, medicinska sestra ili ljekarnik.
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Cyltezo and is positive for antibodies against double-stranded DNA, further treatment with Cyltezo should not be given (see section
Croatian: Ako bolesnik nakon primjene lijeka Cyltezo razvije simptome koji upućuju na sindrom nalik lupusu i pozitivan je na protutijela usmjerena protiv dvolančane DNK, terapija lijekom Cyltezo se ne smije nastaviti (vidjeti dio 4.8).
English: Injection site reaction (including injection site erythema)
Croatian: vrlo često reakcije na mjestu primjene injekcije (uključujući eritem na mjestu primjene injekcije)
English: • Remove cap by pulling it straight off pen.
Croatian: • Skinite poklopac ravno ga povlačeći s brizgalice.
English: Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified Total Sharp Score ≤ 0.5) was significantly higher with adalimumab/methotrexate combination therapy (63.8 % and 61.2 % respectively) compared to methotrexate monotherapy (37.4 % and 33.5 % respectively, p < 0.001) and adalimumab monotherapy (50.7 %, p < 0.002 and 44.5 %, p < 0.001
Croatian: Nakon 52 i 104 tjedna liječenja, postotak bolesnika bez progresije bolesti (promjena ukupnog zbroja bodova prema Sharpu ≤ 0,5) bio je značajno veći u skupini liječenoj kombinacijom adalimumaba i metotreksata (63,8% odnosno 61,2%) u usporedbi sa skupinom koja je dobivala monoterapiju metotreksatom (37% odnosno 33,5%, p < 0,001) i monoterapiju adalimumabom (50,7%, p < 0,002 odnosno 44,5%, p < 0,001).
English: In the pivotal controlled trials in adults and children, 12.9 % of patients treated with adalimumab developed injection site reactions (erythema and/or itching, haemorrhage, pain or swelling), compared to 7.2 % of patients receiving placebo or active control.
Croatian: U pivotalnim kontroliranim ispitivanjima u odraslih i djece, reakcije na mjestu primjene (eritem i/ili svrbež, krvarenje, bol ili oticanje) pojavile su se u 12,9% bolesnika liječenih adalimumabom u usporedbi sa 7,2% bolesnika koji su dobivali placebo ili aktivni kontrolni lijek.
English: Of those in clinical response at week 4, 48 % had been previously exposed to other TNFantagonists.
Croatian: 48% bolesnika koji su imali klinički odgovor u 4. tjednu već je prije koristilo neki drugi antagonist TNF-a.
English: In the open-label lead in phase (OL LI) patients were stratified into two groups, MTX (methotrexate)-treated or non-MTX-treated.
Croatian: U otvorenoj uvodnoj fazi ispitivanja bolesnici su podijeljeni u dvije skupine, jedna koja je uzimala metotreksat (označena s MTX) i ona koja nije (označena s neMTX).
English: The needle cover of the syringe contains latex
Croatian: Poklopac igle na štrcaljki sadrži lateks.
English: Kaplan-Meier Curves Summarizing Time to Treatment Failure on or after Week 6 (Study UV I) or Week 2 (Study UV II)
Croatian: Kaplan-Meierove krivulje koje sažeto prikazuju vrijeme do neuspjeha liječenja u 6. tjednu ili nakon njega (ispitivanje UV I) odnosno u 2. tjednu ili nakon njega
English: Induction of Clinical Remission and Response (Percent of Patients)
Croatian: Tablica 23: Indukcija kliničke remisije i kliničkog odgovora (postotak bolesnika)
English: Amongst those who responded at week 16 (n = 144), the Pediatric 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: Među bolesnicima koji su imali klinički odgovor u 16. tjednu (n = 144), pedijatrijski odgovori ACR 30/50/70/90 održali su se i do šest godina u otvorenom nastavku ispitivanja u bolesnika koji su primali adalimumab tijekom cijeloga ispitivanja.
English: The safety and efficacy of adalimumab was assessed in a randomised, double-masked, controlled study of 90 paediatric patients from 2 to < 18 years of age with active JIA-associated noninfectious anterior uveitis who were refractory to at least 12 weeks of methotrexate treatment.
Croatian: Sigurnost i djelotvornost adalimumaba ocjenjivale su se u randomiziranom, dvostruko maskiranom, kontroliranom ispitivanju provedenom u 90 pedijatrijskih bolesnika u dobi od 2 do < 18 godina koji su imali aktivan neinfektivni anteriorni uveitis povezan s JIA i koji su bili refraktorni na najmanje 12 tjedana liječenja metotreksatom.
English: By week 68, patients receiving continuous adalimumab treatment showed statistically significant greater improvement of the signs and symptoms of active nr-axSpA as compared to patients allocated to treatment withdrawal during the double-blind period of the study (Table 15).
Croatian: Bolesnici koji su neprekidno primali adalimumab su do 68. tjedna pokazali statistički značajno veće poboljšanje znakova i simptoma aktivnog nr-axSpA u usporedbi s bolesnicima kojima je terapija ukinuta tijekom dvostruko slijepog razdoblja ispitivanja (Tablica 15).
English: Cyltezo is administered every other week via subcutaneous injection.
Croatian: Cyltezo se primjenjuje svaki drugi tjedan supkutanom injekcijom.
English: Overall responses were generally better and, fewer patients developed antibodies when treated with the combination of adalimumab and MTX compared to adalimumab alone.
Croatian: Ukupni odgovor na liječenje bio je uglavnom bolji i manje je bolesnika razvilo protutijela kada su bolesnici primali kombinirano liječenje adalimumabom i metotreksatom u odnosu na monoterapiju adalimumabom.
English: Clinical remission results remained relatively constant irrespective of previous TNF-antagonist exposure.
Croatian: Rezultati kliničke remisije održali su se relativno stalnim bez obzira na prethodno liječenje
English: In study UC-II, treatment with adalimumab resulted in improvements in the Inflammatory Bowel Disease
Croatian: U ispitivanju UC-II liječenje adalimumabom rezultiralo je poboljšanjem rezultata upitnika o upalnoj bolesti crijeva (IBDQ).
English: Neurologic evaluation should be performed in patients with non-infectious intermediate uveitis prior to the initiation of Cyltezo therapy and regularly during treatment to assess for pre-existing or developing central demyelinating disorders.
Croatian: U bolesnika s neinfektivnim intermedijarnim uveitisom treba provoditi neurološku procjenu prije početka liječenja lijekom Cyltezo i redovito tijekom liječenja kako bi se utvrdili otprije postojeći ili novorazvijeni demijelinizirajući poremećaji središnjeg živčanog sustava.
English: The adjusted OR (accounting for baseline differences) was 1.10 (95 % CI 0.45-2.73) with RA and CD combined.
Croatian: Prilagođen OR (kod kojega su uzete u obzir početne razlike) iznosio je 1,10 (95% CI: 0,45-2,73) za reumatoidni artritis i Crohnovu bolest zajedno.
English: • A warning message for HCPs treating the patient at any time, including in conditions of emergency,
Croatian: • Poruku s upozorenjem za zdravstvenog radnika koji u bilo kojoj situaciji liječi bolesnika, uključujući hitne slučajeve, da taj bolesnik primjenjuje Cyltezo.
English: It is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly
Croatian: Preporučuje se svake godine ocijeniti omjer koristi i rizika kontinuiranog dugotrajnog liječenja
English: If you have ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis, you will first be given other medicines.
Croatian: Ako bolujete od ankilozantnog spondilitisa ili aksijalnog spondiloartritisa bez radiološkog dokaza ankilozantnog spondilitisa, prvo će Vam biti dani drugi lijekovi.
English: Cyltezo 40 mg solution for injection in pre-filled syringe Cyltezo 40 mg solution for injection in single-use pre-filled syringe (type I glass) with a plunger stopper (butyl rubber) and a needle with a cap (outer part made of plastic material and inner part made of elastomer containing latex).
Croatian: Cyltezo 40 mg otopina za injekciju u napunjenoj štrcaljki Cyltezo 40 mg otopina za injekciju u napunjenoj štrcaljki za jednokratnu primjenu (staklo tipa I), s čepom klipa (butilna guma) i iglom sa zatvaračem (vanjski dio proizveden od plastičnog materijala, a unutarnji dio od elastomera koji sadrži lateks).
English: Note: P = Placebo (Number at Risk); H = ADALIMUMAB (Number at Risk).
Croatian: P = Placebo (broj bolesnika pod rizikom); H = ADALIMUMAB (broj bolesnika pod rizikom).