natgillin/translations-raw huggingface dataset:
Patients received 5 mg/kg infliximab- or placebo-infusions at weeks 0, 2, and 6 followed by maintenance therapy every 8 weeks through week 22 in the placebo group and through week 46 in the infliximab group.
Bolesnici su primili infuziju infliksimaba u dozi od 5 mg/kg ili placeba u 0., 2. i 6. tjednu, nakon čega je slijedila terapija održavanja svakih 8 tjedana koja je trajala do 22. tjedna u placebo skupini, odnosno do 46. tjedna u skupini koja je primala infliksimab.
Zessly and Kineret should not be used together.
Zessly i Kineret ne smiju se istodobno uzimati.
HAQ change from baseline over timee (patients evaluated)
Promjena HAQ-a od početne vrijednostie (evaluirani bolesnici)
Tachycardia, palpitation.
Često: tahikardija, palpitacije
Zessly should be administered intravenously.
Zessly se primjenjuje intravenski.
When reconstitution and dilution are performed under aseptic conditions, Zessly infusion solution can be used within 24 hours if stored at 2°C - 8°C.
Kada se rekonstitucija otopine i razrjeđivanje izvode u aseptičnim uvjetima, otopina za infuziju lijeka Zessly može se uporabiti u roku od 24 sata ako se čuva na temperaturi od 2°C do 8°C.
Patients received 3 or 6 mg/kg infliximab as a 3dose induction regimen (weeks 0, 2, 6 or weeks 14, 16, 20 respectively) followed by maintenance therapy every 8 weeks, in combination with methotrexate.
Bolesnici su kao uvodnu terapiju primili 3 doze infliksimaba u dozi od 3 mg/kg (u 0., 2. i 6. tjednu) ili 6 mg/kg (u 14., 16. i 20. tjednu), a nakon toga se provodila terapija održavanja svakih 8 tjedana, u kombinaciji s metotreksatom.
A patient who requires surgery while on Zessly should be closely monitored for infections, and appropriate actions should be taken.
Bolesnika kojemu je za vrijeme liječenja lijekom Zessly potrebna operacija nužno je pomno nadzirati kako bi se utvrdile eventualne infekcije i poduzele odgovarajuće mjere.
After infliximab treatment, patients exhibited decreased levels of serum interleukin 6 (IL-6) and C-reactive protein (CRP), and increased haemoglobin levels in rheumatoid arthritis patients with reduced haemoglobin levels, compared with baseline.
bolesnici su imali snižene koncentracije interleukina 6 (IL-6) i C-reaktivnog proteina (CRP) u serumu u odnosu na vrijednosti na početku liječenja, dok je u bolesnika s reumatoidnim artritisom i sniženom koncentracijom hemoglobina na početku liječenja došlo do povišenja koncentracije hemoglobina.
In long-term safety follow-up of clinical studies with infliximab of up to 5 years, representing 6,234 patients-years (3,210 patients), 5 cases of lymphoma and 38 cases of non-lymphoma malignancies were reported.
što predstavlja ukupno 6234 bolesnik-godina (3210 bolesnika), prijavljeno je 5 slučajeva limfoma i 38 slučajeva zloćudne bolesti koja nije bila limfom.
Tell your doctor straight away if you develop symptoms of lupus during treatment with Zessly.
Odmah obavijestite Vašeg liječnika ako razvijete simptome lupusa za vrijeme liječenja lijekom Zessly.
The efficacy of infliximab was assessed in two multicentre, randomised, double-blind, pivotal clinical studies.
Djelotvornost infliksimaba ispitivana je u dva multicentrična, randomizirana, dvostruko slijepa, klinička ispitivanja.
Anaphylactic shock, vasculitis, sarcoid-like reaction.
Rijetko: anafilaktički šok, vaskulitis, reakcija nalik na sarkoidozu Psihijatrijski poremećaji
Table 3 Effects on ACR20, Structural Joint Damage and Physical Function at week 54, study 1
Učinci na ACR20, strukturna oštećenja zglobova i funkcionalnu sposobnost u 54. tjednu,
If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Zessly and is positive for antibodies against double-stranded DNA, further treatment with Zessly must not be given (see section 4.8).
Ako bolesnik nakon liječenja lijekom Zessly razvije simptome koji ukazuju na sindrom sličan lupusu i ako ima pozitivan nalaz protutijela na dvolančanu DNK, ne smije nastaviti liječenje lijekom Zessly
The efficacy of repeated infusions with infliximab in patients with fistulising Crohn's disease was studied in a 1-year clinical study (clinical Study 5).
Terapija održavanja u fistulirajućoj, aktivnoj Crohnovoj bolesti Djelotvornost ponovljenih infuzija infliksimaba u bolesnika s fistulirajućim oblikom Crohnove bolesti ispitivala se u jednogodišnjem kliničkom ispitivanju (ispitivanje 5).
The safety and efficacy of infliximab have not been studied in children with Crohn's disease below the age of 6 years.
Sigurnost i djelotvornost infliksimaba u djece mlađe od 6 godina koja boluju od Crohnove bolesti nisu ispitivani.
Patients treated with Zessly should be given the package leaflet and the patient reminder card.
Bolesnici koji se liječe lijekom Zessly moraju dobiti uputu o lijeku i karticu s podsjetnikom za bolesnika.
Maintenance (n = 99)
Terapija održavanja placebom (n = 99)
Malignancies, some fatal, have been reported among children, adolescents and young adults (up to
Zloćudne bolesti, neke sa smrtnim ishodom, prijavljene su u djece, adolescenata i mladih odraslih osoba (do 22 godine starosti) koji su liječeni TNF-blokatorima (liječenje započeto u dobi
The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indication of juvenile rheumatoid arthritis have not been established.
Sigurnost i djelotvornost infliksimaba u djece i adolescenata mlađih od 18 godina koji boluju od juvenilnog reumatoidnog artritisa nisu još ustanovljene.
• The other ingredients are disodium succinate hexahydrate, succinic acid, sucrose, polysorbate 80.
• Druge pomoćne tvari su dinatrijev sukcinat heksahidrat, sukcinatna kiselina, saharoza i polisorbat 80.
PREGNANCY AND VACCINATIONS
TRUDNOĆA I CIJEPLJENJE
A population-based retrospective cohort study found an increased incidence of cervical cancer in women with rheumatoid arthritis treated with infliximab compared to biologics-naïve patients or the general population, including those over 60 years of age (see section 4.4).
Populacijsko retrospektivno kohortno ispitivanje pokazalo je povećanu incidenciju raka cerviksa u žena s reumatoidnim artritisom liječenih infliksimabom u usporedbi s bolesnicama koje nisu bile liječene biološkim lijekovima ili općom populacijom, uključujući i one starije od 60 godina
Zessly 100 mg powder for concentrate for solution for infusion.
Zessly 100 mg prašak za koncentrat za otopinu za infuziju.
Zessly is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Zessly je indiciran za liječenje umjerenog do teškog, aktivnog ulceroznog kolitisa u odraslih bolesnika koji nisu na odgovarajući način odgovorili na konvencionalnu terapiju uključujući kortikosteroide i 6-merkaptopurin (6-MP) ili azatioprin (AZA), odnosno koji ne podnose ili imaju medicinske kontraindikacije za takve terapije.
Elevations of aminotransferases were observed (ALT more common than AST) in a greater proportion of patients receiving infliximab than in controls, both when infliximab was given as monotherapy and when it was used in combination with other immunosuppressive agents.
(češće ALT nego AST) primijećene su u većem postotku u bolesnika koji su primali infliksimab nego u kontrolnim skupinama, kako pri primjeni infliksimaba u monoterapiji, tako i pri primjeni u kombinaciji s drugim imunosupresivima.
Table 2 Proportion of patients with increased ALT activity in clinical studies
Udio bolesnika s povišenom aktivnošću ALT-a u kliničkim ispitivanjima
3rd dose
3. doza
Mean ± SDd a p < 0.001, for each infliximab treatment group vs. control.
Prosječna vrijednost ± SDd a p < 0,001 za svaku skupinu liječenu infliksimabom u odnosu na kontrolnu skupinu.
The number of ulcerative colitis-related hospitalisations was significantly lower in the 5 and 10 mg/kg infliximab treatment groups than in the placebo group (mean number of hospitalisations per 100 subject-years: 21 and 19 vs. 40 in the placebo group; p = 0.019 and p = 0.007, respectively).
Broj hospitalizacija vezanih uz ulcerozni kolitis bio je značajno manji u skupinama koje su primale dozu infliksimaba od 5 mg/kg odnosno 10 mg/kg u odnosu na skupinu koja je primala placebo (prosječan broj hospitalizacija na 100 bolesnik godina: 21 odnosno 19 naspram 40 u placebo skupini, p = 0,019, odnosno p = 0,007).
Mean ± SDc b all infliximab doses given in combination with methotrexate and folate with some on corticosteroids and/or NSAIDs c p < 0.001, for each infliximab treatment group vs. control d greater values indicate more joint damage.
Dopuštala se istodobna primjena ustaljenih doza peroralnih kortikosteroida (≤ 10 mg/dan) i/ili nesteroidnih protuupalnih lijekova, a davala se i nadomjesna terapija folatima. b sve doze infliksimaba davale su se u kombinaciji s metotreksatom i folatima, a u nekim slučajevima i s kortikosteroidima i/ili nesteroidnim protuupalnim lijekovima c p < 0,001 za svaku skupinu liječenu infliksimabom u usporedbi s kontrolnom skupinom d veće vrijednosti znače jače oštećenje zgloba e
The safety and efficacy of re-administration, other than every 6 to 8 weeks, has not been established (see sections 4.4 and 4.8).
Ponovna primjena u ankilozantnom spondilitisu Sigurnost i djelotvornost lijeka pri ponovnoj primjeni nisu ustanovljene, osim kada se daje svakih 6 do 8 tjedana (vidjeti dijelove 4.4 i 4.8).
Signs and symptoms included myalgia and/or arthralgia with fever and/or rash, with some patients experiencing pruritus, facial, hand or lip oedema, dysphagia, urticaria, sore throat and headache.
Znakovi i simptomi obuhvaćali su mialgiju i/ili artralgiju s vrućicom i/ili osipom, dok su neki bolesnici razvili pruritus, edem lica, šaka ili usana,
In both studies, patients were randomised to receive either placebo, 5 mg/kg infliximab, or 10 mg/kg infliximab at weeks 0, 2, 6, 14, and 22, and in study 6 at weeks 30, 38, and 46.
U oba klinička ispitivanja bolesnici su bili randomizirani u skupine koje su primale placebo, infliksimab u dozi od 5 mg/kg ili infliksimab u dozi od 10 mg/kg i to u 0., 2., 6., 14. i 22. tjednu, a u ispitivanju 6 još i u 30., 38. i 46. tjednu.
infliximab (week 98)
Infliksima b (98. tjedan
Study 2 evaluated responses at 54 weeks in 1,004 methotrexate naive patients with early (≤ 3 years disease duration, median 0.6 years) active rheumatoid arthritis (median swollen and tender joint count of 19 and 31, respectively).
U ispitivanju 2 ocjenjivali su se odgovori na terapiju nakon 54 tjedna u 1004 bolesnika s aktivnim reumatoidnim artritisom (medijan broja otečenih zglobova 19, a osjetljivih zglobova 31) u ranoj fazi
In Phase III clinical studies, 18% of infliximabtreated patients compared with 5% of placebo-treated patients experienced an infusion-related reaction.
U kliničkim ispitivanjima faze III reakciju vezanu uz infuziju razvilo je 18% bolesnika liječenih infliksimabom u odnosu na 5%
Zessly is indicated for treatment of severely active ulcerative colitis, in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.
Zessly je indiciran za liječenje teškog oblika aktivnog ulceroznog kolitisa u djece i adolescenata u dobi između 6 i 17 godina koji nisu na odgovarajući način odgovorili na konvencionalnu terapiju uključujući kortikosteroide i 6-MP ili AZA, odnosno u onih koji ne podnose ili imaju medicinske kontraindikacije za takve terapije.
Amnesia, agitation, confusion, somnolence, nervousness.
Često: depresija, nesanica Manje često: amnezija, agitacija, konfuzija, somnolencija, nervoza Rijetko: apatija
Zessly is however, diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion.
Zessly se razrijeđuje u 0,9%-tnoj (9 mg/ml) otopini natrijeva klorida za infuziju.
INFECTIONS Before treatment with Zessly
Prije liječenja lijekom Zessly
If active tuberculosis is diagnosed, Zessly therapy must not be initiated (see section 4.3).
Ako se dijagnosticira aktivna tuberkuloza, ne smije se započeti liječenje lijekom Zessly
(4) visual analogue pain scale and (5) erythrocyte sedimentation rate or C-reactive protein.
brzini sedimentacije eritrocita ili C-reaktivnog proteina.
Tuberculosis, bacterial infections, including sepsis and pneumonia, invasive fungal, viral, and other opportunistic infections have been observed in patients receiving infliximab.
U bolesnika liječenih infliksimabom opažene su tuberkuloza, bakterijske infekcije uključujući sepsu i pneumoniju, invazivne gljivične, virusne i druge oportunističke infekcije.
b Based on patients with PASI ≥ 2.5 at baseline for study 10, and patients with ≥ 3% BSA
Na temelju broja bolesnika s početnim PASI ≥ 2,5 u ispitivanju 10 i bolesnika s početnom zahvaćenošću kože psorijazom ≥ 3% BSA u ispitivanju 11.
Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 ≤ 400) in a randomised, double blinded, placebo-controlled, dose-response study.
CDAI, ≥ 220 i ≤ 400) u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju odgovora na dozu.
Table 8 Effects on clinical response in adult patients with moderately to severely active ulcerative colitis, clinical remission and mucosal healing at weeks 8 and 30.
Učinci na klinički odgovor, kliničku remisiju i cijeljenje sluznice u 8. i 30. tjednu u odraslih bolesnika s umjerenim do teškim aktivnim ulceroznim kolitisom.
Maintenance treatment in moderately to severely active Crohn's disease in adults
Terapija održavanja u umjerenoj do teškoj, aktivnoj Crohnovoj bolesti u odraslih bolesnika
The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indication of psoriasis have not been established.
Sigurnost i djelotvornost infliksimaba u djece i adolescenata mlađih od 18 godina koji boluju od psorijaze nisu još ustanovljene.
The primary endpoints were the reduction of signs and symptoms as assessed by the American College of Rheumatology criteria (ACR20 for study 1 (described below), landmark ACR-N for study 2 (described below)), the prevention of structural joint damage, and the improvement in physical function.
American College of Rheumatology, ACR) (ACR20 za ispitivanje 1 (opisano u nastavku), granična vrijednost ACR-N za ispitivanje 2 (opisano u nastavku)),
Uncommon (may affect up to 1 in 100 people)
Manje česte: mogu se javiti u do 1 na 100 osoba
Arthralgia, myalgia, back pain.
Često: artralgija, mialgija, bol u leđima
Infusion-related reaction, pain.
Vrlo često: reakcije vezane uz infuziju, bol
The most serious ADRs associated with the use of TNF blockers that have been reported for infliximab include HBV reactivation, CHF (congestive heart failure), serious infections (including sepsis, opportunistic infections and TB), serum sickness (delayed hypersensitivity reactions), haematologic reactions, systemic lupus erythematosus/lupus-like syndrome, demyelinating disorders, hepatobiliary events, lymphoma, HSTCL, leukaemia, Merkel cell carcinoma, melanoma, paediatric malignancy, sarcoidosis/sarcoid-like reaction, intestinal or perianal abscess (in Crohn's disease), and serious infusion reactions (see section 4.4).
(uključujući sepsu, oportunističke infekcije i tuberkulozu), serumsku bolest (reakcija kasne preosjetljivosti), hematološke reakcije, sistemski eritematozni lupus/sindrom sličan lupusu, demijelinizacijske poremećaje, poremećaje jetre i žuči, limfom, hepatosplenički limfom T-stanica, leukemiju, karcinom Merkelovih stanica, melanom, zloćudne bolesti u pedijatrijskih bolesnika,
In addition, post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with infliximab with the vast majority of cases occurring in Crohn's disease and ulcerative colitis, and most of whom were adolescent or young adult males (see section 4.4).
Nadalje, nakon stavljanja lijeka u promet prijavljeni su slučajevi hepatospleničkog limfoma T-stanica u bolesnika liječenih infliksimabom, s time da se većina slučajeva javila u bolesnika s Crohnovom bolešću i ulceroznim kolitisom i to većinom u adolescenata i mlađih odraslih muškaraca
If you were using Zessly during pregnancy, tell your baby's doctor and other health care professionals caring for your baby about your Zessly use before the baby receives any vaccines.
obavijestite pedijatra Vašeg djeteta ili druge zdravstvene radnike koji skrbe za Vaše dijete da ste uzimali Zessly prije nego što dijete primi bilo koje cjepivo.
Tell your doctor straight away if you get new or worsening signs of heart failure during treatment with Zessly.
Odmah obavijestite svog liječnika ako dobijete nove simptome zatajenja srca ili se postojeći simptomi pogoršaju tijekom liječenja lijekom Zessly.
Post-marketing spontaneous serious adverse reactions with infliximab in the paediatric population have included malignancies including hepatosplenic T-cell lymphomas, transient hepatic enzyme abnormalities, lupus-like syndromes, and positive auto-antibodies (see sections 4.4 and 4.8).
Ozbiljne nuspojave infliksimaba u pedijatrijskih bolesnika spontano prijavljene nakon stavljanja lijeka u promet uključivale su zloćudne bolesti među kojima i hepatosplenički limfom T-stanica, prolazne poremećaje vrijednosti jetrenih enzima, sindrome slične lupusu i pozitivan nalaz autoprotutijela
• Feeling tired or weak
• umor ili slabost
In the paediatric Crohn's disease study, infections were reported in 56.3% of randomised subjects treated with infliximab.
U kliničkom ispitivanju Crohnove bolesti u pedijatrijskih bolesnika infekcije su prijavljene u 56,3%
Paediatric patients on infliximab may receive concurrent vaccinations, except for live vaccines (see sections 4.5 and
Pedijatrijski bolesnici koji se liječe infliksimabom mogu istodobno primati cjepiva, osim živih cjepiva (vidjeti dijelove 4.5 i 4.6).
Zessly 100 mg powder for concentrate for solution for infusion infliximab
Zessly 100 mg prašak za koncentrat za otopinu za infuziju infliksimab
Excipients: Disodium succinate hexahydrate, succinic acid, sucrose, polysorbate 80.
POPIS POMOĆNIH TVARI Pomoćne tvari: dinatrijev sukcinat heksahidrat, sukcinatna kiselina, saharoza, polisorbat 80.
The dilution can be accomplished by withdrawing a volume of the sodium chloride 9 mg/ml (0.9%) solution for infusion from the 250-ml glass bottle or infusion bag equal to the volume of reconstituted Zessly.
Razrjeđivanje se može provesti tako da se iz 250-mililitarske staklene boce ili vrećice za infuziju s 0,9%-tnom (9 mg/ml) otopinom natrijeva klorida za infuziju izvuče volumen jednak volumenu rekonstituirane otopine lijeka Zessly.
In rheumatoid arthritis clinical studies, the incidence of serious infections including pneumonia was higher in infliximab plus methotrexate-treated patients compared with methotrexate alone especially at doses of 6 mg/kg or greater (see section 4.4).
bila je veća u skupini bolesnika liječenih infliksimabom i metotreksatom nego u skupini koja je primala samo metotreksat, osobito pri dozama od 6 mg/kg ili višim (vidjeti dio 4.4).
22 years of age) treated with TNF-blocking agents (initiation of therapy ≤ 18 years of age),
U djece, adolescenata i mladih odraslih osoba (do 22 godine starosti) koji su liječeni TNF-blokatorima (terapija započeta u dobi
The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indications of juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis have not been established.
Juvenilni idiopatski artritis, psorijatični artritis i ankilozantni spondilitis Sigurnost i djelotvornost infliksimaba u djece i adolescenata mlađih od 18 godina koji boluju od juvenilnog idiopatskog artritisa, psorijatičnog artritisa i ankilozantnog spondilitisa nisu još ustanovljene.
Interstitial lung disease (including rapidly progressive disease, lung fibrosis and pneumonitis).
Manje često: edem pluća, bronhospazam, pleuritis, pleuralni izljev Rijetko: intersticijska bolest pluća (uključujući brzu progresivnu bolest, fibrozu pluća i pneumonitis)
Dilute the total volume of the reconstituted Zessly solution dose to 250 ml with sodium chloride 9 mg/ml (0.9%) solution for infusion.
Razrijedite ukupan volumen rekonstituirane otopine lijeka Zessly s 0,9%-tnom (9 mg/ml) otopinom natrijeva klorida za infuziju do ukupnog volumena od 250 ml.
Paediatric Crohn's disease (6 to 17 years)
Crohnova bolest u pedijatrijskih bolesnika (6 do 17 godina)
Number of patients evaluated for ALT.
3 Broj bolesnika uključenih u analizu ALT-a.
• Slow down the damage in your joints
• usporilo oštećenje zglobova • poboljšala
Other uses of therapeutic infectious agents such as live attenuated bacteria (e.g., BCG bladder instillation for the treatment of cancer) could result in clinical infections, including disseminated infections.
intravezikalna instilacija BCG-a za liječenje raka) mogla bi dovesti do kliničkih infekcija, uključujući diseminirane infekcije.
Dizziness may occur following administration of infliximab (see section 4.8).
Nakon primjene infliksimaba može nastupiti omaglica (vidjeti dio 4.8).
a p < 0.001, for each infliximab treatment group vs. control.
50. tjedan a p < 0,001 za svaku skupinu liječenu infliksimabom u odnosu na kontrolnu skupinu.
• Children should receive recommended vaccinations before starting Zessly treatment.
• Prije započinjanja liječenja lijekom Zessly djeca trebaju primiti preporučena cjepiva.
• Signs of infection (including TB) such as fever, feeling tired, cough which may be persistent, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, collection of pus in the gut or around the anus (abscess), dental problems or burning sensation when urinating.
• Znakove infekcije (uključujući TBC) kao što su vrućica, umor, kašalj koji može biti ustrajan, nedostatak zraka, simptomi nalik gripi, gubitak tjelesne težine, noćno znojenje, proljev, rane,
The primary endpoint was the proportion of patients who experienced a clinical response, defined as ≥ 50% reduction from baseline in the number of fistulae draining upon gentle compression on at least two consecutive visits (4 weeks apart), without an increase in the use of medicinal products or surgery for Crohn's disease.
Primarna mjera ishoda bila je udio bolesnika koji su pokazali klinički odgovor, definiran kao ≥ 50%-tno smanjenje početnog broja fistula koje su se cijedile na lagani pritisak u najmanje dva uzastopna posjeta (u razmaku od 4 tjedna),
It is recommended that live vaccines not be given concurrently with Zessly.
Ne preporučuje se istodobna primjena živih cjepiva s lijekom Zessly.
Infliximab with or without AZA was assessed in a randomised, double-blind, active comparator study of 508 adult patients with moderate to severe Crohn's disease (CDAI ≥ 220 ≤ 450) who were naive to biologics and immunosuppressants and had a median disease duration of 2.3 years.
Infliksimab s ili bez AZA ispitivao se u randomiziranom, dvostruko slijepom ispitivanju s aktivnom kontrolom u 508 odraslih bolesnika sa srednje teškom do teškom Crohnovom bolešću
The safety and efficacy of infliximab have not been studied in children with ulcerative colitis below the age of 6 years.
Sigurnost i djelotvornost infliksimaba u djece mlađe od 6 godina koja boluju od ulceroznog kolitisa nisu ispitivani.
At week 4, following administration of a single dose, 22/27 (81%) of infliximab-treated patients receiving a 5 mg/kg dose achieved a clinical response vs. 4/25 (16%) of the placebo-treated patients (p < 0.001).
Četvrtog tjedna nakon primjene jednokratne doze ispitivanog lijeka klinički su odgovor postigla 22 od 27 (81%) bolesnika liječenih infliksimabom u dozi od 5 mg/kg naspram 4 od 25 (16%)