natgillin/translations-raw huggingface dataset:
Serum ustekinumab concentrations in paediatric psoriasis patients 6 to 17 years of age, treated with the recommended weight-based dose were generally comparable to those in the adult psoriasis population treated with the adult dose.
Serumske koncentracije ustekinumaba pri pediatričnih bolnikih s psoriazo, starih 6 do 17 let, zdravljenih s priporočenim odmerkom glede na telesno maso so bile v splošnem primerljive s tistimi pri odrasli populaciji bolnikov s psoriazo, ki so prejemali priporočeni odmerek za odrasle.
Crohn's Disease and Ulcerative Colitis
Crohnova bolezen in ulcerozni kolitis
At week 12, subjects treated with ustekinumab showed clinically meaningful improvements in their psoriasis and health related quality of life (Table 8).
V 12. tednu so pri preiskovancih, zdravljenih z ustekinumabom ugotovili klinično pomembnejše izboljšanje psoriaze in izboljšanje z zdravjem povezane kakovosti življenja (Preglednica 8).
• Psoriatic arthritis - in adults
• psoriatični artritis pri odraslih
In Crohn's disease and ulcerative colitis studies, concomitant use of immunosuppressants or corticosteroids did not appear to influence the safety or efficacy of STELARA.
V študijah Crohnove bolezni in ulceroznega kolitisa sočasna uporaba imunosupresivov ali kortikosteroidov ni vplivala na varnost ali učinkovitost zdravila STELARA.
No adverse effects on female fertility indices were observed using an analogous antibody to IL-12/23 in mice.
Pri miših niso opazili nobenih neželenih učinkov na pokazatelje plodnosti pri samicah pri uporabi analognega protitelesa IL-12/23.
Withdraw and then discard a volume of the sodium chloride 9 mg/mL (0.9%) solution from the 250 mL infusion bag equal to the volume of STELARA to be added (discard 26 mL sodium chloride for each vial of STELARA needed, for 2 vials- discard 52 mL, for 3 vials discard 78 mL, for 4 vials- discard 104 mL).
Iz 250 ml infuzijske vrečke odvzemite volumen 9 mg/ml (0,9%) raztopine natrijevega klorida, ki ustreza volumnu zdravila STELARA, ki ga boste dodali (za eno vialo zdravila STELARA odvzemite in zavrzite 26 ml natrijevega klorida, za dve viali 52 ml, za 3 viale 78 ml, za 4 viale 104 ml).
61% of these patients were either non-responsive, intolerant, or had a contraindication to other systemic therapy.
61% teh bolnikov se bodisi ni odzvalo na drugo sistemsko zdravljenje, ga niso prenašali ali pa so imeli kontraindikacije zanj.
The proportion of patients achieving a clinically significant improvement in fatigue (4 points in FACIT-F) was also significantly greater in the ustekinumab groups compared with placebo.
Tudi delež bolnikov, ki so dosegli klinično pomembno izboljšanje utrujenosti (4 točke po FACIT-F), je bil pomembno večji v skupini z ustekinumabom.
STELARA is available in a 1 vial pack or a pack of 1 pre-filled syringe.
Zdravilo STELARA je na voljo v pakiranjih z 1 vialo ali v pakiranjih z 1 napolnjeno injekcijsko brizgo.
Table 9: Induction of Clinical Response and Remission in UNITI-1 and UNITI 2 UNITI-1*
Preglednica 9: Indukcija kliničnega odziva in klinične remisije v študijah UNITI-1 in UNITI-2 UNITI-1*
Ustekinumab is a fully human IgG1κ monoclonal antibody to interleukin (IL)-12/23 produced in a murine myeloma cell line using recombinant DNA technology.
Ustekinumab je popolnoma človeško monoklonsko protitelo IgG1κ proti interlevkinu (IL)-12/23, izdelano v celični liniji mišjega plazmocitoma s tehnologijo rekombinantne DNA.
Table 3: Induction of Clinical Response and Remission in UNITI-1 and UNITI 2 UNITI-1*
Preglednica 3: Indukcija kliničnega odziva in klinične remisije v študijah UNITI-1 in UNITI-2 UNITI-1*
These improvements were maintained in ustekinumab-treated patients in UNIFI-M through week 44.
Ta izboljšanja so se pri bolnikih, zdravljenih z ustekinumabom v študiji UNIF-M, ohranila do 44. tedna.
The needle cover on the syringe in the STELARA pre-filled syringe is manufactured from dry natural rubber (a derivative of latex), which may cause allergic reactions in individuals sensitive to latex.
Pokrovček za iglo napolnjene injekcijske brizge vsebuje naravno gumo (lateks), ki lahko povzroči alergijske reakcije pri posameznikih s preobčutljivostjo na lateks.
Stelara contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Zdravilo STELARA vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni ‘brez natrija'.
49% of patients had failed conventional therapy, but not a biologic (of which 94% where biological-naïve).
Pri 49% bolnikov je bilo neuspešno predhodno konvencionalno zdravljenje, ne pa zdravljenje z biološkim zdravilom (med temi bolniki jih 94% predhodno ni prejemalo biološkega zdravila).
• The needle cover should not be removed until you are ready to inject the dose
• Pokrovčka ne snemajte z igle, dokler niste pripravljeni za injiciranje odmerka.
* Following response to IV ustekinumab.
* po odzivu na intravenski odmerek ustekinumaba.
Clinical response and remission were significant as early as week 3 in ustekinumab treated patients and continued to improve through week 8.
Razlika v deležu kliničnih odzivov in remisij je bila pri bolnikih, ki so prejemali ustekinumab, statistično značilna že v 3. tednu in se je povečevala do 8. tedna.
At 18 months (week 76), 84% of patients re-randomised to maintenance treatment were PASI 75 responders compared with 19% of patients re-randomised to placebo (treatment withdrawal).
Po 18. mesecih (76. teden) je imelo 84% bolnikov, ki so bili ponovno naključno uvrščeni v skupino za vzdrževalno zdravljenje, odziv PASI 75, v primerjavi z 19% bolnikov, ki so bili ponovno naključno uvrščeni v skupino za prejemanje placeba (prenehanje zdravljenja).
• If you have any new or changing lesions within psoriasis areas or on normal skin.
• če so se pojavili novi plaki ali je prišlo do sprememb obtoječih plakov na področjih kože, kjer ste imeli psoriazo, ali na zdravi koži.
No data are available on the secondary transmission of infection by live vaccines in patients receiving STELARA.
O sekundarnem prenosu okužb z živimi cepivi pri bolnikih, ki prejemajo zdravilo STELARA ni podatkov.
• Inject all of the medication by pushing in the plunger until the plunger head is completely between the needle guard wings (see Figure 5)
• Injicirajte vse zdravilo tako, da pritiskate na bat dokler glava bata ni med aktivacijskimi nastavki ščitnika igle (glejte Sliko 5).
Patients previously treated with anti-TNFα agents who received ustekinumab achieved a greater response at week 24 than patients receiving placebo (ACR 20 response at week 24 for 45 mg and 90 mg was 37% and 34%, respectively, compared with placebo 15%; p < 0.05), and responses were maintained through week 52.
Bolniki, ki so že bili zdravljeni z zaviralci TNFα in so prejemali ustekinumab so po 24 tednih zdravljenja dosegli večji odziv v primerjavi z bolniki, ki so prejemali placebo (odziv ACR 20 v 24. tednu za 45 mg in 90 mg je bil 37% in 34%, v primerjavi s 15% pri placebu; p < 0,05).
• After the starting intravenous dose, you will have the next dose of 90 mg Stelara by an injection under your skin (subcutaneous injection) 8 weeks later, and then every 12 weeks therafter.
• Po začetnemu intravenskem odmerku boste naslednji, 90 mg odmerek zdravila STELARA prejeli pod kožo (subkutana injekcija) 8 tednov kasneje, nadaljnje odmerke pa boste prejemali na vsakih 12 tednov.
The first subcutaneous dose should be given at week 8 following the intravenous dose.
Prvi subkutani odmerek je treba injicirati 8 tednov po intravenskem odmerku.
• If you weigh less than 60 kg, the recommended dose is 0.75 mg of Stelara per kg body weight.
• Če tehtate manj kot 60 kg, je priporočeni odmerek zdravila Stelara 0,75 mg na kg telesne mase.
Table 5: Summary of Key Efficacy Outcomes in UNIFI-I (Week 8) Placebo
Preglednica 5: Povzetek glavnih kazalcev učinkovitosti v študiji UNIFI-I (po 8 tednih) Placebo
Some types of vaccines (live vaccines) should not be given while using Stelara.
Med uporabo zdravila Stelara vam ne smejo dati nekaterih cepiv (živa cepiva).
If you forget or miss the appointment for receiving the dose, contact your doctor to reschedule your appointment.
Če ste pozabili ali zamudili dogovorjeni termin, da bi prejeli zdravilo, se čimprej dogovorite za naslednjega.
For patients with a body weight > 100 kg the initial dose is 90 mg administered subcutaneously, followed by a 90 mg dose 4 weeks later, and then every 12 weeks thereafter.
Pri bolnikih s telesno maso > 100 kg je začetni odmerek 90 mg (subkutana injekcija), ki mu sledi 90 mg odmerek čez 4 tedne in nato na vsakih 12 tednov.
What Stelara is and what it is used for What you need to know before you use Stelara How Stelara will be given Possible side effects
Kaj je zdravilo Stelara in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Stelara Kako uporabljati zdravilo Stelara Možni neželeni učinki
Table 2 List of adverse reactions System Organ Class
Preglednica 2: Seznam neželenih učinkov Organski sistem
Malignancies excluding non-melanoma skin cancers were reported in 62 patients in 11,561 patient-years of follow-up (incidence of 0.54 per 100 patientyears of follow-up for ustekinumab-treated patients).
O malignomu, z izjemo nemelanomskega kožnega raka, so poročali pri 62 bolnikih na 11.561 bolnikov-let spremljanja (incidenca 0,54 na 100 bolnikov-let spremljanja za bolnike, zdravljene z ustekinumabom).
Table 11: Summary of Key Efficacy Outcomes in UNIFI-I (Week 8) Placebo
Preglednica 11: Povzetek glavnih kazalcev učinkovitosti v študij UNIFI-I (po 8 tednih) Placebo
Table 3 List of adverse reactions System Organ Class
Preglednica 3: Seznam neželenih učinkov Organski sistem
• Do not remove the needle cover from the pre-filled syringe until instructed to do so
• Ne snemajte pokrovčka igle z napolnjene injekcijske brizge, dokler ni to zahtevano v navodilu.
For the posology of the subsequent subcutaneous dosing regimen, see section 4.2 of the STELARA solution for injection (vial) and solution for injection in pre-filled syringe SmPC.
Za odmerjanje vseh naslednjih subkutanih odmerkov glejte poglavje 4.2 povzetka glavnih značilnosti zdravila STELARA raztopina za injiciranje (viala) in STELARA raztopina za injiciranje v napolnjeni injekcijski brizgi.
Ustekinumab demonstrated a statistically significant decrease in the rate of progression of structural damage compared to placebo, as measured by change from baseline to week 24 in the total modified vdH-S score (mean ± SD score was 0.97 ± 3.85 in the placebo group compared with 0.40 ± 2.11 and 0.39 ± 2.40 in the ustekinumab 45 mg (p < 0.05) and 90 mg (p < 0.001) groups, respectively).
Uporaba ustekinumaba statistično značilno zmanjša hitrost napredovanja strukturnih sprememb v primerjavi s placebom v 24. tednu, merjeno s spremembo celokupne vrednosti modificiranega rezultata vdH-S (v skupini s placebom je znašala povprečna vrednost ± SD 0,97 ± 3,85, v primerjavi z 0,40 ± 2,11 in 0,39 ± 2,40 za skupini, ki sta prejemali 45 mg (p < 0,05) oziroma 90 mg (p < 0,001) ustekinumaba).
STELARA 45 mg and 90 mg vials or pre-filled syringes are for subcutaneous injection only.
Zdravilo STELARA v obliki 45 mg in 90 mg vial ali napolnjenih injekcijskih brizg je namenjeno samo subkutanemu injiciranju.
In psoriatic arthritis studies, concomitant MTX use did not appear to influence the safety or efficacy of STELARA.
V študijah psoriatričnega artritisa sočasno jemanje MTX ni vplivalo na varnost ali učinkovitost zdravila STELARA.
How to use Stelara
Kako uporabljati zdravilo Stelara
PGA of cleared (0) or minimal (1)
PGA čisto (0) ali minimalno (1) PGA čisto (0)
• Stelara is given by injection under the skin (subcutaneously)
• Zdravilo Stelara dajemo z injiciranjem pod kožo (subkutano).
STELARA should be administered at Weeks 0 and 4, then every 12 weeks thereafter.
Zdravilo STELARA je treba odmerjati ob tednu 0 in 4, nato pa na vsakih 12 tednov.
Frequency: Adverse reaction
Pogostnost: neželeni učinek
The safety and efficacy of STELARA in children with psoriasis less than 6 years of age or in children with psoriatic arthritis less than 18 years of age have not yet been established.
Učinkovitosti in varnosti zdravila STELARA pri otrocih s psoriazo, mlajših od 6 let, ali pri otrocih s psoriatičnim artritisom, mlajših od 18 let, niso ugotovili.
A TNFα antagonist and/or vedolizumab.
zaviralecTNFα in/ali vedolizumab.
Table 1 Initial intravenous dosing of STELARA Body weight of patient at the time of dosing
Preglednica 1 Začetno intravensko odmerjanje zdravila STELARA Telesna masa bolnika ob odmerjanju
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Stelara.
Če niste gotovi, ali se katera od zgornjih trditev nanaša na vaš primer, se pogovorite z zdravnikom ali farmacevtom, preden začnete uporabljati zdravilo Stelara.
In patients with Crohn's disease and ulcerative colitis, based on observed data and population PK analyses, randomized subjects who lost response to treatment had lower serum ustekinumab concentrations over time compared with subjects who did not lose response.
Pri bolnikih s Crohnovo boleznijo in ulceroznim kolitisom so bile glede na podatke na osnovi opazovanj in rezultate analize populacijske farmakokinetike sčasoma koncentracije ustekinumaba v serumu nižje pri randomiziranih preiskovancih, pri katerih je prišlo do izgube odziva na zdravljenje, kot pri tistih preiskovancih, pri katerih ni prišlo do izgube odziva.
• Push the needle into the pinched skin
• Iglo vbodite v kožno gubo.
The proportion of patients with a PGA score of cleared (0) or minimal (1) and the proportion achieving PASI 75 showed separation between the ustekinumab treated group and placebo at the first post-baseline visit at week 4, reaching a maximum by week 12.
Delež bolnikov z oceno PGA čisto (0) ali minimalno (1) in delež bolnikov, ki so dosegli PASI 75 je v prvem obisku po začetku zdravljenja (4. teden) pokazal razliko med skupino, ki je prejemala ustekinumab in skupino, ki je prejemala placebo, največjo razliko pa v 12. tednu.
• Empty vials, antiseptic wipes, and other supplies can be disposed of in your garbage.
• Prazne viale, zložence in druge pripomočke lahko zavržete med gospodinjske odpadke.
• The doctor will work out the right dose for you, including the amount (volume) of Stelara to be injected to give the right dose.
• Zdravnik bo določil za vas pravi odmerek zdravila Stelara, vključno s količino zdravila
Approximately 11% of the patients had prior exposure to biologics.
Z biološkimi zdravili pa se je že zdravilo približno 11% bolnikov.
p < 0.001 for ustekinumab 45 mg or 90 mg in comparison with etanercept.
p < 0,001 za ustekinumab v odmerku 45 mg ali 90 mg v primerjavi z etanerceptom.
In Crohn's disease and ulcerative colitis intravenous induction studies, no events of anaphylaxis or other serious infusion reactions were reported following the single intravenous dose.
V študijah indukcijskega zdravljenja Crohnove bolezni in ulceroznega kolitisa z intravenskim zdravljenjem po enkratnem intravenskem odmerku niso poročali o nobenem dogodku anafilakse ali hude infuzijske reakcije.
• Turn the vial and the syringe upside down
• Vialo in brizgo obrnite tako, da bo viala zgoraj.
Approximately 5% of the patients had prior exposure to biologics.
Z biološkimi zdravili se je že zdravilo približno 5% bolnikov.
In this case you will get training on how to inject Stelara yourself.
V tem primeru vas bodo poučili, kako si lahko zdravilo Stelara injicirate sami.
Similar proportions of adult patients developed protective levels of anti-pneumococcal and anti-tetanus antibodies and antibody titers were similar among STELARA-treated and control patients.
Deleža odraslih bolnikov, pri katerih je prišlo do nastanka proti-pneumokoknih in proti-tetanusnih protiteles, sta bila v skupini, ki je prejemala zdravilo STELARA in kontrolni skupini, podobna.
After the starting dose, you will receive the next dose of 90 mg Stelara after 8 weeks, then every 12 weeks thereafter by an injection under the skin (‘subcutaneously').
Po začetnem odmerku boste prejeli naslednji, 90 mg odmerek zdravila Stelara čez 8 tednov, nadaljnje odmerke pa boste prejemali na vsakih 12 tednov v obliki podkožne injekcije (‘subkutano').
Paediatric plaque psoriasis
Pediatrična psoriaza s plaki
• Do not use the pre-filled syringe if it is dropped without the needle cover in place.
• Brizge ne smete uporabiti, če vam je padla in je brez pokrovčka.
The efficacy of ustekinumab was studied in 44 paediatric patients aged 6 to 11 years with moderate to severe plaque psoriasis in an open label, single-arm, multicenter, phase 3, study (CADMUS Jr.).
Učinkovitost ustekinumaba so preučevali pri 44 pediatričnih bolnikih, starih 6 do 11 let z zmerno do hudo psoriazo s plaki, v odprti, multicentični študiji faze 3 z eno skupino bolnikov (CADMUS Jr).
Uncommon: Cellulitis, dental infections, herpes zoster, lower respiratory tract infection, viral upper respiratory tract infection, vulvovaginal mycotic infection
Pogosti: okužbe zgornjih dihal, nazofaringitis Občasni: celulitis, okužbe zob, herpes zoster, okužbe spodnjih dihal, virusne okužbe zgornjih dihal, vulvovaginalne glivične okužbe, sinusitis
Patients with plaque psoriasis may develop erythrodermic psoriasis, with symptoms that may be clinically indistinguishable from exfoliative dermatitis, as part of the natural course of their disease.
Pri bolnikih s psoriazo s plaki se med potekom bolezni lahko razvije eritrodermična psoriaza s simptomi, ki jih klinično ni mogoče ločiti od simptomov eksfoliativnega dermatitisa.
These improvements were generally better maintained in ustekinumab-treated patients in the IM-UNITI study through week 44 when compared to placebo.
Ta izboljšanja ocen so bila v 44 tednih v študiji IM-UNITI v splošnem bolje vzdrževana pri bolnikih, ki so prejemali ustekinumab, v primerjavi s tistimi, ki so prejemali placebo.
If this happens, please contact your doctor or pharmacist
Če se to zgodi, se posvetujte s svojim zdravnikom ali farmacevtom.
This includes a syringe, needle, antiseptic wipes, a cotton ball or gauze, and a sharps container (see Figure 1).
Pripomočke, to je brizgo, iglo in antiseptične zložence, vato ali gazo ter vsebnik za odlaganje igel (glejte Sliko 1) položite na čisto površino.
Withdraw 26 mL of STELARA from each vial needed and add it to the 250 mL infusion bag.
Iz vsake viale izvlecite 26 ml zdravila STELARA in jih dodajte v infuzijsko vrečko.
In Crohn's disease, dose adjustment from 90 mg every 12 weeks to 90 mg every 8 weeks was associated with an increase in trough serum ustekinumab concentrations and an accompanying increase in efficacy.
Pri bolnikih s Crohnovo boleznijo je bilo prilagajanje odmerjanja s sheme 90 mg vsakih 12 tednov na shemo 90 mg vsakih 8 tednov povezano z zvišanjem najnižjih koncentracij ustekinumaba pred naslednjim odmerjanjem in s spremljajočim povečanjem učinkovitosti.
• If the product has been shaken vigorously.
• če je bilo zdravilo močno stresano.
Median systemic clearance (CL) following a single intravenous administration to patients with psoriasis ranged from 1.99 to 2.34 mL/day/kg.
Mediana vrednost sistemskega očistka (CL) ustekinumaba pri bolnikih s psoriazo po enkratnem intravenskem injiciranju je bila od 1,99 do 2,34 ml/dan/kg.
Clinical Remission Clinical Response Corticosteroid-Free Clinical Remission Clinical Remission in patients: in remission at the start of maintenance therapy who entered from study CRD3002 who are Anti-TNFα naïve who entered from study CRD3001
Klinična remisija Klinični odziv Klinična remisija brez kortikosteroidov Klinična remisija pri bolnikih: v remisji ob začetku vzdrževalnega zdravljenja ki so vstopili iz študije CRD3002‡ ki se še niso zdravili z zaviralci TNFα 49% (25/51) 65% (34/52) ki so vstopili iz študije CRD3001§
At the start of treatment, your healthcare provider will assist you with your first injection.
Na začetku zdravljenja vam bo pri injiciranju prvega odmerka zdravila pomagalo medicinsko ali negovalno osebje.
Patients were treated with the recommended dose of ustekinumab (see section 4.2; n = 44) by subcutaneous injection at weeks 0 and 4 followed by every 12 week (q12w) dosing.
Bolniki so subkutano prejeli priporočeni odmerek ustekinumaba (glejte poglavje 4.2; n = 44) v tednu 0 in 4 ter nato na vsakih 12 tednov.
See ‘Serious side effects' in section 4 for a full list of these side effects.
Za celoten seznam teh neželenih učinkov glejte ‘Resni neželeni učinki' v poglavju 4.
The majority of patients who lost response and resumed ustekinumab did so within 24 weeks of the induction infusion.
Pri večini bolnikov se je to zgodilo v obdobju 24 tednov po indukcijski infuziji ustekinumaba.
At 3 years (week 148), 82% of patients re-randomised to maintenance treatment were PASI 75 responders.
V tretjem letu (148. teden), je imelo 82% bolnikov, ki so bili ponovno naključno uvrščeni v skupino za vzdrževalno zdravljenje, odziv PASI 75.
Week 16 Responders to Ustekinumab Induction Ustekinumab treated patients who were not in response at week 8 of UNIFI-I received an administration of 90 mg SC ustekinumab at week 8 (36% of patients).
Bolniki z odzivom na indukcijsko zdravljenje z ustekinumabom v 16. tednu Bolniki, ki so prejeli ustekinumab in niso dosegli odziva v 8. tednu študije UNIFI-I, so v 8. tednu prejeli subkutani odmerek 90 mg ustekinumaba (36% bolnikov).
However, before Stelara is given to you, it is mixed with a solution that contains sodium.
Preden boste prejeli zdravilo Stelara, ga je treba redčiti z raztopino, ki vsebuje natrij.
Patients who were not in clinical response to ustekinumab induction at week 8 of the UNITI-1 and UNITI-2 induction studies (476 patients) entered into the non-randomized portion of the maintenance study (IM-UNITI) and received a 90 mg subcutaneous injection of ustekinumab at that time.
Bolnike, ki po 8 tednih indukcije v študijah UNITI-1 in UNITI-2 niso dosegli kliničnega odziva (476 bolnikov), so vključili v ne-randomizirani del vzdrževalne študije (IM-UNITI) in so prejeli 90 mg ustekinumaba subkutano.
The incidence of non-melanoma skin cancer was 0.43 per 100 patient-years of follow-up for ustekinumab-treated patients (4 patients in 929 patient-years of follow-up) compared to 0.46 for placebo-treated patients (2 patients in 433 patient-years of follow-up).
Incidenca nemelanomskega kožnega raka je znašala 0,43 na 100 bolnikov-let spremljanja za bolnike, zdravljene z ustekinumabom (4 bolniki na 929 bolnikov-let spremljanja), v primerjavi z 0,46 za bolnike, ki so prejemali placebo (2 bolnika na 433 bolnikov-let spremljanja).
Calculate the dose and the number of STELARA vials needed based on patient weight (see section 4.2, Table 1).
Odmerek in potrebno število vial zdravila STELARA izračunajte na osnovi bolnikove telesne mase (glejte poglavje 4.2, Preglednica 1).
Secondary endpoints included PASI 75, PASI 90, change from baseline in Children's Dermatology Life Quality Index (CDLQI), change from baseline in the total scale score of PedsQL (Paediatric Quality of Life Inventory) at week 12.
Sekundarni cilj v 12. tednu je vključeval PASI 75, PASI 90, spremembo od izhodiščne vrednosti dermatološkega indeksa kakovosti življenja pri otrocih (CDLQI - Children's Dermatology Life Quality Index), spremembo od začetne vrednosti v celokupni pediatrični lestvici kakovosti življenja (PedsQL.
In ulcerative colitis, population PK model based simulations demonstrated that adjusting dosing from 90 mg every 12 weeks to every 8 weeks would be expected to result in a 3-fold increase in steady-state trough ustekinumab concentrations.
Pri ulceroznem kolitisu se je pri simulacijah z modelom populacijske farmakokinetike pokazalo, da je mogoče od prilagajanja odmerjanja s sheme 90 mg vsakih 12 tednov na shemo 90 mg vsakih 8 tednov pričakovati 3-kratno zvišanje najnižjih koncentracij ustekinumaba pred naslednjim odmerjanjem v stanju dinamičnega ravnovesja.