natgillin/translations-raw huggingface dataset:
Patients originally randomised to ustekinumab who achieved Psoriasis Area and Severity Index 75 response (PASI improvement of at least 75% relative to baseline) at both Weeks 28 and 40 were re-randomised to receive ustekinumab every 12 weeks or to placebo (i.e., withdrawal of therapy).
Bolnike, ki so jih prvotno naključno uvrstili v skupino za prejemanje ustekinumaba in so dosegli odziv PASI 75 (tj. indeks jakosti psoriaze in telesne površine, prizadete s psoriazo - Psoriasis Area and Severity Index) (kar pomeni izboljšanje indeksa PASI za najmanj 75% glede na začetne vrednosti) tako v 28. kot v 40. tednu, so kasneje ponovno naključno razvrstili, bodisi v skupino za prejemanje ustekinumaba na 12 tednov ali pa v skupino za prejemanje placeba (tj. prenehanje zdravljenja).
Median half-life (t1/2) of ustekinumab was approximately 3 weeks in patients with ulcerative colitis, Crohn's disease, psoriasis and/or psoriatic arthritis, ranging from 15 to 32 days across all psoriasis and psoriatic arthritis studies.
Mediana vrednost razpolovnega časa (t1/2) ustekinumaba pri bolnikih z ulceroznim kolitisom, Crohnovo boleznijo, psoriazo in/ali psoriatičnim artritisom je znašala približno 3 tedne in se je gibala v razponu od 15 do 32 dni v vseh študijah psoriaze in psoriatičnega artritisa.
Crohn's disease is an inflammatory disease of the bowel.
Crohnova bolezen je vnetna bolezen prebavil.
Additionally on the basis of clinical trial data in patients with ulcerative colitis, a positive exposure-response relationship was established between trough concentrations, and clinical remission and mucosal healing.
Poleg tega so na osnovi podatkov iz kliničnih študij pri bolnikih z ulceroznim kolitisom potrdili povezanost med izpostavljenostjo in odzivom za najnižje koncentracije ustekinumaba pred naslednjim odmerjanjem in klinično remisijo ter zacelitev sluznice.
By binding the shared p40 subunit of IL-12 and IL-23, ustekinumab may exert its clinical effects in psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis through interruption of the Th1 and Th17 cytokine pathways, which are central to the pathology of these diseases.
Ustekinumab lahko z vezavo na podenoto p40 IL-12 in IL-23 in prekinitvijo poti citokinov Th1 in Th17, bistvenih pri patologiji psoriaze, psoriatičnega artritisa, Crohnove bolezni in ulceroznega kolitisa, spodbudi klinične učinke pri vseh boleznih.
If this happens, you will get training on how to inject Stelara.
V tem primeru vas bodo poučili, kako si injicirajte zdravilo Stelara.
Table 1 Recommended dose of STELARA for paediatric psoriasis Body weight at the time of dosing
Preglednica 1 Priporočeni odmerki zdravila STELARA pri pediatrični psoriazi Telesna masa ob odmerjanju
For instructions on dilution of the medicinal product before administration, see section 6.6.
Za navodila glede redčenja zdravila pred intravenskim infundiranjem glejte poglavje 6.6.
If an anaphylactic or other serious hypersensitivity reaction occurs, appropriate therapy should be instituted and administration of STELARA should be discontinued (see section 4.8).
Če se pri bolniku pojavi anafilaktična reakcija ali kakšna druga resna preobčutljivostna reakcija, je treba zdravljenje z zdravilom STELARA prekiniti in mu uvesti ustrezno zdravljenje (glejte poglavje 4.8).
Of these 51 patients, 70.6% achieved clinical response and 39.2% percent achieved clinical remission 16 weeks after receiving the first subcutaneous dose of ustekinumab.
Med temi 51 bolniki jih je 16 tednov po prejemu prvega subkutanega odmerka ustekinumaba 70,6% doseglo klinični odziv in 39,2% klinično remisijo.
Once diluted, the infusion should be completed within eight hours of the dilution in the infusion bag.
Infundiranje je treba zaključiti v osmih urah po redčenju v infuzijski vrečki.
• Back, muscle or joint pain
• bolečine v hrbtu, mišicah ali sklepih
Stelara contains the active substance ‘ustekinumab', a monoclonal antibody.
Zdravilo Stelara vsebuje učinkovino ‘ustekinumab', ki je monoklonsko protitelo.
STELARA concentrate for solution for infusion must be diluted and prepared by a healthcare professional using aseptic technique.
Zdravilo STELARA koncentrat za raztopino za infundiranje mora razredčiti in pripraviti zdravstveni delavec v aseptičnih pogojih.
Ulcerative colitis is an inflammatory disease of the bowel.
Ulcerozni kolitis je vnetna bolezen prebavil.
• Do not touch the needle or let the needle touch anything
• Pri tem se ne smete dotakniti igle in tudi igla se ne sme ničesar dotakniti.
Beyond week 12, efficacy was generally higher and better sustained in the recommended dose group compared with half of the recommended dosage group in which a modest loss of efficacy was more frequently observed toward the end of each 12 week dosing interval.
Po 12. tednu je bila učinkovitost v splošnem večja in se bolje ohranjala v skupini s priporočenim odmerkom kot v skupini, ki je prejemala polovico priporočenega odmerka.
For the posology of the intravenous dosing regimen, see section 4.2 of the STELARA 130 mg Concentrate for solution for infusion SmPC.
Za intravensko odmerjanje glejte poglavje 4.2 povzetka glavnih značilnosti zdravila STELARA 130 mg koncentrat za raztopino za infundiranje.
Make sure you tell your doctor about any illness you have before each treatment.
Pred vsakim injiciranjem zdravniku povejte o vseh vaših boleznih.
• In a single and swift motion, insert the needle through the skin as far as it will go (see Figure 4)
• Iglo vbodite v kožo z enim hitrim gibom, tako globoko, kot gre (glejte Sliko 4).
The systemic exposure of ustekinumab (Cmax and AUC) increased in an approximately dose-proportional manner after a single intravenous administration at doses ranging from 0.09 mg/kg to 4.5 mg/kg or following a single subcutaneous administration at doses ranging from approximately 24 mg to 240 mg in patients with psoriasis.
Pri bolnikih s psoriazo je sistemska izpostavljenost ustekinumabu (Cmax in AUC) po enkratni intravenski injekciji odmerkov od 0,09 mg/kg do 4,5 mg/kg ali po enkratni subkutani injekciji odmerkov od približno 24 mg do 240 mg naraščala približno sorazmerno z odmerkom.
In these induction studies, efficacy was higher and better sustained in the tiered dose group compared to the 130 mg dose group, and tiered dosing is therefore the recommended intravenous induction dose.
V obeh indukcijskih študijah je bila učinkovitost boljša in odziv dolgotrajnejši v skupini, ki je prejemala odmerek glede na telesno maso, kot v skupini, ki je prejemala odmerek 130 mg, zato je odmerek glede na telesno maso priporočeni intravenski indukcijski odmerek.
• It is important that the needle is always in the liquid.
• Pomembno je, da je igla ves čas potopljena v tekočino, da se ne bi v brizgi pojavili mehurčki
In IM-UNITI, 29 of 129 patients did not maintain response to ustekinumab when treated every 12 weeks and were allowed to dose adjust to receive ustekinumab every 8 weeks.
V študiji IM-UNITI pri odmerjanju ustekinumaba na 12 tednov 29 od 129 bolnikov ni vzdrževalo odziva in so lahko prešli na odmerjanje na 8 tednov.
Median half-life (t1/2) of ustekinumab was approximately 3 weeks in patients with psoriasis, psoriatic arthritis, Crohn's disease or ulcerative colitis, ranging from 15 to 32 days across all psoriasis and psoriatic arthritis studies.
Mediana vrednost razpolovnega časa (t1/2) ustekinumaba pri bolnikih s psoriazo, psoriatičnim artritisom, Crohnovo boleznijo ali ulceroznim kolitisom je znašala približno 3 tedne in se je gibala v razponu od 15 do 32 dni v vseh študijah psoriaze in psoriatičnega artritisa.
At 5 years (week 244), 80% of patients re-randomised to maintenance treatment were PASI 75 responders.
V petem letu (244. teden) je imelo 80% bolnikov, ki so bili ponovno naključno uvrščeni v skupino za vzdrževalno zdravljenje, odziv PASI 75.
At week 8 of UNIFI-I, patients receiving ustekinumab showed significantly greater and clinically meaningful improvements on IBDQ total score, EQ-5D and EQ-5D VAS, and SF-36 Mental Component Summary Score and SF-36 Physical Component Summary Score when compared to placebo.
Po 8 tednih v študiji UNIFI-I je pri bolnikih, zdravljenih z ustekinumabom, prišlo do statistično značilno večjega in klinično pomembnega izboljšanja pri celotni oceni po vprašalniku IBDQ, vprašalnikih EQ-5D in EQ-5D VAS ter SF-36 povzetka ocene duševnih komponent (SF-36 Mental Component Summary Score) in SF-36 povzetka ocene telesnih komponent (SF-36 Physical Component Summary Score) kot v skupini s placebom.
STELARA concentrate for solution for infusion is intended for use under the guidance and supervision of physicians experienced in the diagnosis and treatment of Crohn's disease or ulcerative colitis.
Zdravilo STELARA koncentrat za raztopino za infundiranje je namenjeno za uporabo pod vodstvom in nadzorom zdravnikov z izkušnjami z diagnostiko in zdravljenjem Crohnove bolezni oziroma ulceroznega kolitisa.
STELARA 45 mg solution for injection STELARA 90 mg solution for injection STELARA 45 mg solution for injection in pre-filled syringe STELARA 90 mg solution for injection in pre-filled syringe
STELARA 45 mg raztopina za injiciranje STELARA 90 mg raztopina za injiciranje STELARA 45 mg raztopina za injiciranje v napolnjeni injekcijski brizgi STELARA 90 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
Uncommon: Pustular psoriasis, skin exfoliation, acne Rare: Exfoliative dermatitis
Občasni: pustularna psoriaza, luščenje kože, akne Redki: eksfoliativni dermatitis Zelo redki: organizirajoča pljučnica*
At week 12, subjects treated with ustekinumab showed significantly greater improvement in their psoriasis and health related quality of life compared with placebo (Table 7).
V 12. tednu so pri preiskovancih, zdravljenih z ustekinumabom ugotovili večje izboljšanje psoriaze in z zdravjem povezane kakovosti življenja v primerjavi s preiskovanci, ki so prejemali placebo (Preglednica 7).
The recommended posology of STELARA is an initial dose of 45 mg administered subcutaneously, followed by a 45 mg dose 4 weeks later, and then every 12 weeks thereafter.
Priporočeni začetni odmerek zdravila STELARA je 45 mg (subkutana injekcija), ki mu sledi 45 mg odmerek čez 4 tedne in nato na vsakih 12 tednov.
In patients re-randomised to placebo, and who reinitiated their original ustekinumab treatment regimen after loss of ≥ 50% of PASI improvement 85% regained PASI 75 response within 12 weeks after re-initiating therapy.
85% bolnikov, ki so bili po prvotnem prejemanju ustekinumaba naključno uvrščeni v skupino za prejemanje placeba, po ≥ 50% upadu izboljšanja indeksa PASI pa so jim ponovno uvedli prvotno shemo zdravljenja z ustekinumabom, je v 12 tednih po ponovni uvedbi zdravljenja doseglo odziv PASI 75.
Serious skin conditions
Huda kožna obolenja
Consideration should be given to discontinuing treatment in patients who have shown no response up to 28 weeks of treatment.
Pri bolnikih, ki se do 28. tedna niso odzvali na zdravljenje, je treba razmisliti o prekinitvi zdravljenja.
In Psoriasis Study 1, at week 2 and week 12, significantly greater improvements from baseline were demonstrated in the DLQI in each ustekinumab treatment group compared with placebo.
V 1. študiji psoriaze so v 2. in 12. tednu dokazali bistveno izboljšanje DLQI glede na začetek študije v vseh terapevtskih skupinah z ustekinumabom v primerjavi s placebom.
The safety and efficacy of STELARA in treatment of Crohn's disease or ulcerative colitis in children less than 18 years have not yet been established.
Varnost in učinkovitost zdravila STELARA pri zdravljenju Crohnove bolezni ali ulceroznega kolitisa pri otrocih, mlajših od 18 let, nista bili dokazani.
Stelara is used in adults with moderate to severe plaque psoriasis, who cannot use ciclosporin, methotrexate or phototherapy, or where these treatments did not work.
Zdravilo Stelara uporabljamo za zdravljenje zmerne do hude psoriaze s plaki pri odraslih bolnikih, ki ne morejo uporabljati ciklosporina, metotreksata ali fototerapije, ali ta zdravljenja pri njih niso bila uspešna.
Serum concentration-time profiles of ustekinumab were generally predictable after single or multiple subcutaneous dose administrations.
Krivulje spreminjanja serumske koncentracije ustekinumaba s časom po enkratnem ali večkratnem dajanju subkutane injekcije zdravila so bile na splošno predvidljive.
Patients in UNITI-1 had failed or were intolerant to prior anti-TNFα therapy.
Pri bolnikih v študiji UNITI-1 predhodno zdravljenje z zaviralci TNFα ni bilo uspešno ali pa ga niso prenašali.
Each vial contains 130 mg ustekinumab in 26 mL (5 mg/mL).
Ena viala vsebuje 130 mg ustekinumaba v 26 ml raztopine (5 mg/ml).
Ustekinumab-treated patients showed significant improvement in physical function as assessed by the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at week 24.
Telesna zmogljivost in z zdravjem povezana kakovost življenja Telesna zmogljivost se je po oceni vprašalnika o oceni zdravstvenega stanja (HAQ-DI-Disability Index of the Health Assessment Questionnaire) pomembno izboljšala po 24 tednih zdravljena z ustekinumabom.
• If you weigh 60 kg to 100 kg, the recommended dose is 45 mg Stelara.
• Če tehtate od 60 kg do 100 kg, je priporočeni odmerek zdravila Stelara 45 mg.
In IM-UNITI, patients who completed the study through week 44 were eligible to continue treatment in a study extension.
V zdravljenje v okviru podaljšane študije so bili vključeni bolniki, ki so zaključili 44 tedensko zdravljenje v študiji IM-UNITI.
The proportion of patients achieving a modified PsA response criteria (PsARC) response was also significantly greater in the ustekinumab groups compared to placebo at week 24.
Tudi delež bolnikov, ki so dosegli odziv po modificiranih merilih odziva na zdravljenje psoriatičnega artritisa (PsARC - Psoriatic Arthritis treatment Response Criteria), je bil po 24 tednih značilno večji v skupini, ki je prejemala ustekinumab v primerjavi s placebom.
STELARA is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies (see section 5.1).
Zdravilo STELARA je indicirano za zdravljenje zmerne do hude psoriaze s plaki pri otrocih in mladostnikih, starih 6 let in več, pri katerih bolezen z drugimi sistemskimi zdravljenji ali fototerapijami ni zadostno nadzorovana, ali jih ne prenašajo (glejte poglavje 5.1).
The proportion of patients achieving a clinically meaningful ≥ 0.3 improvement in HAQ-DI score from baseline was also significantly greater in the ustekinumab groups when compared with placebo.
Delež bolnikov, ki so dosegli klinično pomembno, ≥ 0,3 izboljšanje izhodiščne ocene HAQ-DI, je bil značilno večji v skupini, ki je prejemala ustekinumab v primerjavi s placebom.
Some patients who received STELARA in clinical studies developed cutaneous and non-cutaneous malignancies (see section 4.8).
Pri nekaterih bolnikih, ki so prejemali zdravilo STELARA v kliničnih študijah, so se pojavili kožni malignomi in tudi druge vrste malignomov (glejte poglavje 4.8).
In addition, a randomised, blinded assessor, active-controlled study compared ustekinumab and etanercept in patients with moderate to severe plaque psoriasis who had had an inadequate response to, intolerance to, or contraindication to ciclosporin, MTX, or PUVA.
Dodatno so učinkovitost ustekinumaba in etanercepta primerjali v randomizirani, dvojno slepi, z učinkovino nadzorovani študiji pri bolnikih z zmerno do hudo psoriazo s plaki, ki se na zdravljenje s ciklosporinom, MTX ali PUVA niso odzvali v zadostni meri, ga niso prenašali ali je bilo le-to kontraindicirano.
Non-clinical data reveal no special hazard (e.g. organ toxicity) for humans based on studies of repeated-dose toxicity and developmental and reproductive toxicity, including safety pharmacology evaluations.
Neklinični podatki na osnovi študij toksičnosti pri ponavljajočih odmerkih in vpliva na razvoj in sposobnost razmnoževanja, vključno s študijami za ovrednotenje farmakološke varnosti zdravila, ne kažejo nobenega posebnega tveganja za človeka (npr. glede toksičnosti za organe).
Each 26 mL vial of STELARA contains 130 mg of ustekinumab.
Ena 26 ml viala zdravila STELARA vsebuje 130 mg ustekinumaba.
Do not use if visibly opaque particles, discoloration or foreign particles are observed.
Raztopine ne smete uporabiti, če vsebuje vidne neprozorne ali tuje delce ali če je spremenjene barve.
• If you are 65 years of age or over - you may be more likely to get infections.
• če ste stari 65 let ali več.
The solution is clear, colourless to light yellow.
Raztopina je bistra, brezbarvna do svetlo rumena.
Any unused product remaining in the vial and the syringe should be thrown away.
Neuporabljeno zdravilo, ki ostane v viali in brizgi je treba zavreči.
Patients receiving ustekinumab at the recommended dose showed significant improvements on the histo endoscopic mucosal healing endpoint at week 8 in the ustekinumab group (18%) as compared to theplacebo group (9%).
Pri bolnikih, ki so prejemali ustekinumab v priporočenem odmerku, se je v 8. tednu pokazalo statistično značilno večje izboljšanje glede cilja opazovanja histološko endoskopske zacelitve sluznice v skupini z ustekinumabom (18%) v primerjavi s skupino s placebom (9%).
A 45 mg vial is available for paediatric patients who need to receive less than the full 45 mg dose.
Za pediatrične bolnike, ki potrebujejo odmerek, manjši od 45 mg, je na voljo 45 mg viala.
Only use complete vials of STELARA.
Vedno uporabite celo vialo zdravila STELARA.
• Pick up the pre-filled syringe, hold the body of the syringe with one hand
• Telo brizge držite z eno roko.
** Clinical remission is defined as Mayo score ≤2 points, with no individual subscore > 1.
**Klinična remisija je definirana kot ocena Mayo ≤2, pri čemer nobena od podocen ni >1.
26 mL solution in a type I glass 30 mL vial closed with a coated butyl rubber stopper.
26 ml raztopine v 30 ml viali (steklo tipa I), zaprti z obloženo zaporko iz butilirane gume.
• the solution in the pre-filled syringe is not discoloured or cloudy and does not contain any foreign particles
• da raztopina v napolnjeni injekcijski brizgi ni spremenila barve ali je motna, da ne vsebuje tujih delcev in
No overall differences in efficacy or safety in patients age 65 and older who received STELARA were observed compared to younger patients in clinical studies in approved indications, however the number of patients aged 65 and older is not sufficient to determine whether they respond differently from younger patients.
V kliničnih študijah odobrenih indikacij pri bolnikih, starih 65 let in več, ki so prejemali zdravilo STELARA, niso opazili nobenih razlik v celokupni učinkovitosti ali varnosti v primerjavi z mlajšimi bolniki.
In the placebo-controlled period of the psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis clinical studies, the incidence of malignancies excluding non-melanoma skin cancer was 0.11 per 100 patient-years of follow-up for ustekinumab-treated patients (1 patient in 929 patient-years of follow-up) compared with 0.23 for placebo-treated patients (1 patient in 434 patient-years of follow-up).
V obdobju s placebom nadzorovanih, kliničnih študij psoriaze, psoriatičnega artritisa, Crohnove bolezni in ulceroznega kolitisa je znašala incidenca malignomov z izjemo nemelanomskega kožnega raka 0,11 na 100 bolnikov-let spremljanja pri bolnikih, zdravljenih z ustekinumabom (1 bolnik na 929 bolnikov-let spremljanja), v primerjavi z 0,23 za bolnike, ki so prejemali placebo (1 bolnik na 434 bolnikov-let spremljanja).
• the vial is not damaged and the seal is not broken
• da viala ni poškodovana in da je neprodušno zaprta,
• Press an antiseptic wipe over the injection site for a few seconds after the injection.
• Na mesto injiciranja za nekaj sekund pritisnite antiseptični zloženec.
The effect is considered demonstrated irrespective of concomitant MTX use, and was maintained through Weeks 52 (integrated analysis) and 100 (PsA Study 1).
Ta učinek se je pokazal v 1. študiji PsA. Ohranil se je do 52. tedna (sestavljena analiza) in do 100. tedna (1.
Stelara is not recommended for use in children with psoriasis under 6 years of age, or for use in children under 18 years of age with psoriatic arthritis, Crohn's disease, or ulcerative colitis because it has not been studied in this age group.
Zdravilo Stelara ni priporočljivo za otroke s psoriazo, mlajše od 6 let, ali za otroke, mlajše od 18 let s psoriatičnim artritisom, Crohnovo boleznijo ali ulceroznim kolitisom, ker ga pri teh starostnih skupinah še niso preučili.
Caution should be exercised when considering concomitant use of other immunosuppressants and STELARA or when transitioning from other immunosuppressive biologics (see section 4.5).
Če razmišljate o sočasni uporabi drugih imunosupresivov in zdravila STELARA ali če želite preiti z uporabe drugih imunosupresivnih bioloških zdravil na uporabo zdravila STELARA, je potrebna previdnost (glejte poglavje 4.5).
Stelara is used to treat the following inflammatory diseases:
Zakaj se uporablja zdravilo Stelara Zdravilo Stelara se uporablja za zdravljenje naslednjih vnetnih bolezni:
Intravenous use after dilution.
Intravenska uporaba po redčenju.
Table 6 Number of patients who achieved clinical response in Psoriatic arthritis Study 1 (PSUMMIT I) and Study 2 (PSUMMIT II) at week 24
Preglednica 6 Število bolnikov, ki so v 1. študiji psoriatičnega artritisa (PSUMMIT I) in v 2. študiji psoriatičnega artritisa (PSUMMIT II) po 24 tednih dosegli klinični odziv 1. študija psoriatičnega artritisa
Your doctor will examine you and do a test for tuberculosis, before you have Stelara.
Zdravnik vas bo pred začetkom zdravljenja z zdravilom Stelara pregledal in opravil preiskave za tuberkulozo.
In PsA Study 1, ACR 20 responses at week 100 were achieved by 57% and 64%, for 45 mg and 90 mg, respectively.
V 1. študiji PsA je v 100. tednu odziv ACR 20 doseglo 57% bolnikov, ki so prejemali 45 mg in 64% bolnikov, ki so prejemali 90 mg.
Improvements in enthesitis score and dactylitis score were maintained through weeks 52 and 100.
Izboljšanje ocene entezitisa in daktilitisa se je ohranilo do 52. in do 100. tedna.
• If you weigh more than 100 kg, the recommended dose is 90 mg Stelara.
• Če tehtate več kot 100 kg, je priporočeni odmerek zdravila Stelara 90 mg.
Cases of allergic alveolitis, eosinophilic pneumonia, and non-infectious organising pneumonia have been reported during post-approval use of ustekinumab.
V obdobju po odobritvi ustekinumaba so poročali o primerih alergijskega alveolitisa, eozinofilne pljučnice in neinfekcijske organizirajoče pljučnice.
Table 2 provides a list of adverse reactions from adult psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis clinical studies as well as adverse reactions reported from post-marketing experience.
V Preglednici 2 je podan seznam neželenih učinkov iz kliničnih študij psoriaze, psoriatičnega artritisa, Crohnove bolezni in ulceroznega kolitisa pri odraslih ter neželenih učinkov, poročanih v obdobju trženja zdravila.
VIAL LABEL TEXT (130 mg)
BESEDILO NA NALEPKI VIALE (130 mg)
Efficacy was higher in the tiered dose group (6 mg/kg) compared to the 130 mg dose group in select endpoints, and tiered dosing is therefore the recommended intravenous induction dose.
Pri določenih ciljih opazovanja je bila učinkovitost zdravljenja večja v skupini s prirejenim odmerjanjem (6 mg/kg) kot v skupini z odmerkom 130 mg, zato je za intravenski indukcijski odmerek priporočeno prirejeno odmerjanje.
In PsA Study 2, ACR 20 responses at week 52 were achieved by 47% and 48%, for 45 mg and 90 mg, respectively.
V 2. študiji PsA je v 52. tednu odziv ACR 20 doseglo 47% bolnikov, ki so prejemali 45 mg in 48% bolnikov, ki so prejemali 90 mg.