natgillin/translations-raw huggingface dataset:
Concomitant immunosuppressive therapy The safety and efficacy of STELARA in combination with other immunosuppressants, including biologics, or phototherapy have not been evaluated.
Sočasno imunosupresivno zdravljenje Varnost in učinkovitost zdravila STELARA v kombinaciji z drugimi imunosupresivi, vključno z biološkimi zdravili ali fototerapijo, še nista bili ovrednoteni.
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).
Special populations Children and adolescents (< 18 years) STELARA is not recommended for use in children below age 18 due to a lack of data on safety and efficacy.
Posebne skupine bolnikov Otroci in mladostniki (< 18 let) Uporaba zdravila STELARA ni priporočena pri otrocih mlajših od 18 let, ker ni dovolj podatkov o varnosti in učinkovitosti.
Elderly patients (≥ 65 years) No overall differences in efficacy or safety in patients age 65 and older who received STELARA were observed compared to younger patients.
Starostniki (≥ 65 let) 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.
Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly.
Ker je na splošno, pojavnost okužb v tej populaciji večja, je pri zdravljenju starostnikov potrebna previdnost.
Hepatic and renal impairment Specific studies have not been conducted in patients with hepatic and renal impairment (see section 4.2).
Jetrna in ledvična okvara Pri bolnikih z jetrno in ledvično okvaro niso opravili specifičnih študij (glejte poglavje 4. 2).
In the population pharmacokinetic analysis of the phase III studies, the effect of the most frequently used concomitant medicinal products in patients with psoriasis (including paracetamol, ibuprofen, acetylsalicylic acid, metformin, atorvastatin, levothyroxine) on pharmacokinetics of ustekinumab was explored.
V analizi populacijske farmakokinetike na podlagi študij III. faze so raziskovali vpliv zdravil, ki jih najpogosteje sočasno uporabljamo pri bolnikih s psoriazo (vključno s paracetamolom, ibuprofenom, acetilsalicilno kislino, metforminom, atorvastatinom in levotiroksinom), na farmakokinetiko ustekinumaba.
Live vaccines should not be given concurrently with STELARA (see section 4.4).
Živih cepiv se ne sme dajati sočasno z zdravilom STELARA (glejte poglavje 4. 4).
The safety and efficacy of STELARA in combination with other immunosuppressants, including biologics, or phototherapy have not been evaluated (see section 4.4).
Varnosti in učinkovitosti zdravila STELARA v kombinaciji z drugimi imunosupresivi, vkjučno z biološkimi zdravili ali fototerapijo, še niso ovrednotili (glejte poglavje 4. 4).
Pregnancy There are no adequate data from the use of ustekinumab in pregnant women.
Nosečnost Ni zadostnih podatkov o uporabi ustekinumaba pri nosečnicah.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/ foetal development, parturition or postnatal development (see section 5.3).
Študije na živalih niso pokazale neposrednih ali posrednih škodljivih vplivov na nosečnost, razvoj zarodka/ plodu, porod ali postnatalni razvoj (glejte poglavje 5. 3).
Women of childbearing potential should use effective methods of contraception during treatment and up to 15 weeks after treatment.
Ženske v rodni dobi morajo med zdravljenjem in do 15 tednov po njem uporabljati učinkovito in varno kontracepcijsko metodo.
4 Lactation It is unknown whether ustekinumab is excreted in human breast milk.
Dojenje Ni znano, ali se ustekinumab izloča v materino mleko pri človeku.
Because of the potential for adverse reactions in nursing infants from ustekinumab, a decision on whether to discontinue breast-feeding during treatment and up to 15 weeks after treatment or to discontinue therapy with STELARA must be made taking into account the benefit of breast-feeding to the child and the benefit of STELARA therapy to the woman.
4 med zdravljenjem in do 15 tednov po njem preneha dojiti ali naj se raje preneha zdraviti z zdravilom STELARA, ob upoštevanju koristi dojenja za otroka in koristi zdravljenja z zdravilom STELARA za mater.
No studies on the effects on the ability to drive and use of machines have been performed.
Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli.
The safety data described below reflect exposure to ustekinumab in 3 studies of 2,266 patients, including 1,970 exposed for at least 6 months and 1,285 exposed for at least 1 year, and 373 for at least 18 months.
Spodaj navedeni podatki o varnosti zdravila temeljijo na stopnjah izpostavljenosti ustekinumabu v 3 študijah pri 2. 266 bolnikih, vključno z 1. 970 bolniki, ki so bili zdravilu izpostavljeni najmanj 6 mesecev, 1. 285 bolniki, ki so mu bili izpostavljeni najmanj 1 leto, ter 373 bolniki, ki so mu bili izpostavljeni najmanj 18 mesecev.
The following serious adverse reactions were reported: • Serious infections • Malignancies
Poročali so o naslednjih resnih neželenih učinkih: • resne okužbe • malignomi
The most common adverse reactions (> 10%) in controlled and uncontrolled portions of the psoriasis clinical studies with ustekinumab were nasopharyngitis and upper respiratory tract infection.
Najpogostejša neželena učinka (> 10%) v nadzorovanih in nenadzorovanih delih kliničnih študij psoriaze z ustekinumabom sta bila rinofaringitis in okužbe zgornjih dihal.
Most were considered to be mild and did not necessitate discontinuation of study treatment.
Večinoma pa sta bila blaga in zaradi njiju ni bila potrebna prekinitev zdravljenja v študiji.
Table 1 provides a summary of adverse reactions from psoriasis clinical studies.
V preglednici 1 je podan povzetek neželenih učinkov iz kliničnih študij psoriaze.
Very common (≥ 1/ 10), Common (≥ 1/ 100 to < 1/ 10), Uncommon (≥ 1/ 1,000 to < 1/ 100), Rare (≥ 1/ 10,000 to < 1/ 1,000), Very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Neželeni učinki so razvrščeni po organskih sistemih in po pogostnosti z upoštevanjem naslednjega dogovora: zelo pogosti (≥ 1/ 10), pogosti (≥ 1/ 100 do < 1/ 10), občasni (≥ 1/ 1. 000 do < 1/ 100), redki (≥ 1/ 10. 000 do < 1/ 1. 000), zelo redki (< 1/ 10. 000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Table 1 Summary of adverse reactions in psoriasis clinical studies System Organ Class
Povzetek neželenih učinkov v kliničnih študijah psoriaze Organski sistem
Adverse reaction
Pogostnost: neželeni učinek
Cellulitis, viral upper respiratory tract infection
Zelo pogosti: okužbe zgornjih dihal, rinofaringitis Pogosti: celulitis, virusne okužbe zgornjih dihal
Depression
Pogosti: depresija
Dizziness, headache
Pogosti: omotica, glavobol
Pharyngolaryngeal pain, nasal congestion
Pogosti: bolečine v grlu in žrelu, oteklost nosne sluznice
Diarrhoea
Pogosti: driska
Pruritus
Pogosti: pruritus
Back pain, myalgia
Pogosti: bolečine v hrbtu, mialgija
Injection site reactions (including pain, swelling, pruritus, induration, haemorrhage, bruising and irritation)
Pogosti: utrujenost, eritem na mestu injiciranja Občasni: reakcije na mestu injiciranja (vključno z bolečinami, otekanjem, srbečico, zatrdlino, krvavitvijo, podplutbami in draženjem)
5 Infections In controlled studies of psoriasis patients, the rates of infection or serious infection were similar between ustekinumab-treated patients and those treated with placebo.
Okužbe V nadzorovanih študijah pri bolnikih s psoriazo so bile pogostnosti okužb in resnih okužb pri bolnikih, zdravljenih z ustekinumabom, podobne kot pri tistih, ki so prejemali placebo.
In the placebo-controlled period of clinical studies of psoriasis patients, the rate of infection was 1.39 per patient-year of follow-up in ustekinumab-treated patients, and 1.21 in placebo-treated patients.
5 pri bolnikih, zdravljenih z ustekinumabom, oziroma 1, 21 pri bolnikih, zdravljenih s placebom.
Serious infections occurred in 0.01 per patient-year of follow-up in ustekinumab-treated patients (5 serious infections in 407 patient-years of follow-up) and 0.02 in placebo-treated patients (3 serious infections in 177 patient-years of follow-up) (see section 4.4).
Resne okužbe so se pojavljale s pogostnostjo 0, 01 na bolnikov- let spremljanja pri bolnikih, zdravljenih z ustekinumabom (5 resnih okužb na 407 bolnikov- let spremljanja), in s pogostnostjo 0, 02 pri bolnikih, ki so prejemali placebo (3 resne okužbe na 177 bolnikov- let spremljanja) (glejte poglavje 4. 4).
In the controlled and non-controlled portions of psoriasis clinical studies, the rate of infection was 1.24 per patient-year of follow-up in ustekinumab-treated patients, and the incidence of serious infections was 0.01 per patient-year of follow-up in ustekinumab-treated patients (24 serious infections in 2,251 patient-years of follow-up) and serious infections reported included cellulitis, diverticulitis, osteomyelitis, viral infections, gastroenteritis, pneumonia, and urinary tract infections.
V nadzorovanih in nenadzorovanih delih kliničnih študij psoriaze je znašala pogostnost okužb 1, 24 na bolnikov- let spremljanja za bolnike, zdravljene z ustekinumabom, incidenca resnih okužb pa je znašala 0, 01 na bolnikov- let spremljanja tudi za bolnike, zdravljene z ustekinumabom (24 resnih okužb na 2251 bolnikov - let spremljanja) in med poročane resne okužbe so sodili celulitis, divertikulitis, osteomielitis, virusne okužbe, gastroenteritis, pljučnica in okužbe sečil.
Malignancies In the placebo-controlled period of the psoriasis clinical studies, the incidence of malignancies excluding non-melanoma skin cancer was 0.25 per 100 patient-years of follow-up for ustekinumab-treated patients (1 patient in 406 patient-years of follow-up) compared with 0.57 for placebo-treated patients (1 patient in 177 patient-years of follow-up).
Malignomi V s placebom nadzorovanem obdobju kliničnih študij psoriaze je znašala incidenca malignomov z izjemo nemelanomskega kožnega raka 0, 25 na 100 bolnikov- let spremljanja pri bolnikih, zdravljenih z ustekinumabom (1 bolnik na 406 bolnikov- let spremljanja), v primerjavi z 0, 57 za bolnike, ki so prejemali placebo (1 bolnik na 177 bolnikov- let spremljanja).
The incidence of non-melanoma skin cancer was 0.74 per 100 patient-years of follow-up for ustekinumab-treated patients (3 patients in 406 patient-years of follow-up) compared to 1.13 for placebo-treated patients (2 patients in 176 patient-years of follow-up).
Incidenca nemelanomskega kožnega raka je znašala 0, 74 na 100 bolnikov- let spremljanja za bolnike, zdravljene z ustekinumabom (3 bolniki na 406 bolnikov- let spremljanja), v primerjavi z 1, 13 za bolnike, ki so prejemali placebo (2 bolnika na 176 bolnikov- let spremljanja).
In the controlled and non-controlled portions of psoriasis clinical studies, the incidence of malignancies excluding non-melanoma skin cancers was 0.36 per 100 patient-years of follow-up for ustekinumab-treated patients (8 patients in 2,249 patient-years of follow-up) and malignancies reported included breast, colon, head and neck, kidney, prostate, and thyroid cancers.
V nadzorovanih in nenadzorovanih delih kliničnih študij psoriaze je znašala incidenca malignomov brez nemelanomskega kožnega raka 0, 36 na 100 bolnikov- let spremljanja za bolnike, zdravljene z ustekinumabom (8 bolnikov na 2249 bolnikov- let spremljanja) in med poročane malignome so sodili rak dojk, rak debelega črevesa, rak glave in vratu, rak ledvic, rak prostate in rak žleze ščitnice.
The rate of malignancies reported in ustekinumab-treated patients was comparable to the rate expected in the general population (standardised incidence ratio = 0.68 [95% confidence interval:
Pogostnost malignomov, prijavljenih pri bolnikih, zdravljenih z ustekinumabom, je bila podobna pričakovani pogostnosti v splošni populaciji (standardiziran količnik incidence = 0, 68 [95% interval zaupanja:
The incidence of non-melanoma skin cancer was 0.80 per 100 patient-years of follow-up for ustekinumab-treated patients (18 patients in 2,245 patient-years of follow-up) (see section 4.4).
Incidenca nemelanomskega kožnega raka je znašala 0, 80 na 100 bolnikov- let spremljanja pri bolnikih, zdravljenih z ustekinumabom (18 bolnikov na 2245 bolnikov- let spremljanja) (glejte poglavje 4. 4).
Hypersensitivity reactions In clinical studies of ustekinumab, rash and urticaria have each been observed in < 2% of patients.
Preobčutljivostne reakcije V kliničnih študijah ustekinumaba so izpuščaje in urtikarijo opažali pri < 2% bolnikov.
Immunogenicity Approximately 5% of ustekinumab-treated patients developed antibodies to ustekinumab, which were generally low-titer.
Imunogenost Pri približno 5% bolnikov, zdravljenih z ustekinumabom, so se pojavila protitelesa proti ustekinumabu, ki pa so bila običajno v majhnih titrih.
No apparent correlation of antibody development to injection site reactions was seen.
Niso opazili nobene očitne korelacije med nastankom protiteles in pojavom reakcije na mestu injiciranja.
Efficacy tended to be lower in patients positive for antibodies to ustekinumab; however, antibody positivity does not preclude a clinical response.
Pri bolnikih s pozitivnim izvidom na protitelesa proti ustekinumabu je bila učinkovitost zdravljenja manjša, vendar pozitiven izvid na protitelesa ne pomeni, da se bolnik ne bo odzval na zdravljenje.
Single doses up to 4.5 mg/ kg have been administered intravenously in clinical studies without dose-limiting toxicity.
V kliničnih študijah so bolnikom dajali enkratne intravenske odmerke do 4, 5 mg/ kg, brez toksičnih učinkov, ki bi omejevali odmerek zdravila.
Pharmacotherapeutic group:
Farmakoterapevtska skupina: zaviralci interlevkina.
Interleukin inhibitors, ATC code:
Oznaka ATC:
Mechanism of action Ustekinumab is a fully human IgG1κ monoclonal antibody that binds with high affinity and specificity to the p40 protein subunit of the human cytokines IL-12 and IL-23.
Ustekinumab je popolnoma človeško monoklonsko protitelo IgG1κ, ki se z veliko afiniteto in specifičnostjo veže na proteinsko podenoto p40 človeških citokinov IL- 12 in IL- 23.
Ustekinumab inhibits the activity of human IL-12 and IL-23 by preventing these cytokines from binding to their IL-12Rβ 1 receptor protein expressed on the surface of immune cells.
Ustekinumab zavira aktivnost človeških interlevkinov IL- 12 in IL- 23, ker preprečuje vezavo teh citokinov na njihov receptorski protein IL- 12Rβ1, ki se nahaja na površini imunskih celic.
Ustekinumab cannot bind to IL-12 or IL-23 that is pre-bound to IL-12Rβ 1 cell surface receptors.
Ustekinumab se ne more vezati na interlevkina IL- 12 in IL- 23, ki sta se pred tem vezala na receptorje IL- 12Rβ1 na celični površini.
Thus, ustekinumab is not likely to contribute to complement- or antibody-mediated cytotoxicity of the receptor-bearing cell.
Malo je torej verjetno, da bi ustekinumab prispeval k citotoksičnemu učinku na receptorske celice, posredovanemu prek komplementa ali protiteles.
IL-12 and IL-23 are heterodimeric cytokines secreted by activated antigen presenting cells, such as macrophages and dendritic cells.
Interlevkina IL- 12 in IL- 23 sta heterodimerna citokina, ki ju izločajo aktivirane celice za predstavitev antigena, na primer makrofagi in dendritične celice.
IL-12 and IL-23 participate in immune function by contributing to natural killer (NK) cell activation and CD4+ T-cell differentiation and activation.
Interlevkina IL- 12 in IL- 23 sodelujeta v delovanju imunskega sistema, saj prispevata k aktivaciji naravnih celic ubijalk (celic NK) ter diferenciaciji in aktivaciji celic CD4+T, nenormalno regulacijo IL- 12 in IL- 23 pa so povezovali z imunskimi boleznimi, na primer s psoriazo.
However, abnormal regulation of IL-12 and IL-23 has been associated with immune-mediated diseases, such as psoriasis.
Ustekinumab preprečuje prispevek interlevkinov IL- 12 in IL- 23 k aktivaciji celic imunskega sistema, na primer medcelično signaliziranje in izločanje citokinov.
Ustekinumab prevents IL-12 and IL-23 contributions to immune cell activation, such as intracellular signaling and cytokine secretion.
Menijo tudi, da ustekinumab prekine prenos signalov ter sproščanje kaskade citokinov, ki so bistveni pri patologiji psoriaze.
Thus, ustekinumab is believed to interrupt signaling and cytokine cascades that are relevant to psoriasis pathology.
Klinična učinkovitost in varnost
Clinical efficacy and safety The safety and efficacy of ustekinumabwas assessed in 1,996 patients in two randomised, double-blind, placebo-controlled studies in patients with moderate to severe plaque psoriasis and who were candidates for phototherapy or systemic therapy.
Varnost in učinkovitost ustekinumaba so ocenili pri 1. 996 bolnikih v dveh randomiziranih, dvojno slepih in s placebom nadzorovanih študijah pri bolnikih z zmerno do hudo psoriazo s plaki, ki so bili kandidati za fototerapijo ali sistemsko terapijo.
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).
Patients who were re-randomised to placebo at Week 40 reinitiated ustekinumab at their original dosing regimen when they experienced at least a 50% loss of their PASI improvement obtained at Week 40.
Bolnikom, ki so jih kasneje naključno uvrstili v skupino za prejemanje placeba v 40. tednu, so potem ponovno uvedli ustekinumab v prvotni shemi odmerjanja, če so pri njih opazili najmanj 50% upad izboljšanja indeksa PASI, doseženega v 40. tednu.
Psoriasis Study 2 (PHOENIX 2) evaluated 1230 patients.
V 2. študiji psoriaze (PHOENIX 2) so ovrednotili 1230 bolnikov.
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.
In both studies, baseline disease characteristics were generally consistent across all treatment groups with a median baseline PASI score from 17 to 18 and median baseline Body Surface Area (BSA) ≥ 20, median Dermatology Life Quality Index (DLQI) range from 10 to 12.
Mediana vrednost indeksa PASI na začetku študije je bila od 17 do 18, mediana vrednost ocene prizadete telesne površine (Body Surface Area- BSA) na začetku študije je bila ≥ 20, mediana vrednost dermatološkega indeksa kakovosti življenja (Dermatology Life Quality Index - DLQI) pa se je gibala v razponu od 10 do 12.
Approximately one third (PHOENIX 1) and one quarter (PHOENIX 2) of subjects had Psoriatic Arthritis (PsA).
Približno ena tretjina preizkušancev v študiji PHOENIX 1 in ena četrtina preizkušancev v študiji PHOENIX 2 je imela psoriatični artritis (Psoriatic Arthritis- PsA).
The primary endpoint in both studies was the proportion of patients who achieved PASI 75 response from baseline at Week 12 (see Table 2).
7 Preglednica 2:
7 Table 2 Summary of clinical response in Psoriasis Study 1 (PHOENIX 1) and Psoriasis Study 2 (PHOENIX 2)
Povzetek rezultatov za klinični odziv v 1. študiji psoriaze (PHOENIX 1) in v 2. študiji psoriaze (PHOENIX 2)
Week 12 (2 injections)
12. teden (2 injekciji)
Week 28 (3 injections)
28. teden (3 injekcije)
Number of patients randomised
Število naključno razvrščenih bolnikov
PASI 50 response N (%)
Odziv PASI 50 N (%)
213 (84%) a 220
a
(86%) a
170 (66%) a
PASI 75 response N (%)
Odziv PASI 75 N (%)
171 (67%) a
171 (67%)
170 (66%) a
a
PASI 90 response N (%)
Odziv PASI 90 N (%)
106 (42%) a
106 (42%)
94 (37%) a
94 (37%)
273 (67%) a
173 (42%) a
311 (76%) a
209 (51%) a
p < 0.001 for 45 mg or 90 mg in comparison b PGA = Physician Global Assessment
p < 0, 001 za 45 mg ali 90 mg odmerek v primerjavi s placebom (PBO). b PGA = zdravnikova splošna ocena (Physician Global Assessment)
In Psoriasis Study 1 maintenance of PASI 75 was significantly superior with continuous treatment compared with treatment withdrawal (p < 0.001).
V 1. študiji psoriaze je bilo ohranjanje PASI 75 bistveno boljše pri neprekinjenem zdravljenju kot pri prenehanju zdravljenja (p < 0, 001).
At Week 52, 89% of patients re-randomised to maintenance treatment were PASI 75 responders compared with 63% of patients re-randomised to placebo (treatment withdrawal) (p < 0.001).
V 52. tednu je 89% bolnikov, ki so bili ponovno naključno uvrščeni v skupino za vzdrževalno zdravljenje, pokazalo odziv PASI 75, v primerjavi s 63% bolnikov, ki so bili ponovno naključno uvrščeni v skupino za prejemanje placeba (prenehanje zdravljenja) (p < 0, 001).
At 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).
V 76. tednu pa 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).
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.
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 improvement was sustained through Week 28.
Izboljšanje je bilo dokazano tudi v 28. tednu.
Similarly, significant improvements were seen in Psoriasis Study 2 at Week 4 and 12, which were sustained through Week 24.
Podobna statistično značilna izboljšanja so dokazali v 2. študiji psoriaze v 4. in 12. tednu, trajala pa so tudi v 24. tednu.
In Psoriasis Study 1, improvements in nail psoriasis (Nail Psoriasis Severity Index), in the physical and mental component summary scores of the SF-36 and in the Itch Visual Analogue Scale (VAS) were also significant in each ustekinumab treatment group compared with placebo.
V 1. študiji psoriaze so bila tudi izboljšanja v psoriazi na nohtih (indeks jakosti psoriaze na nohtih - Nail Psoriasis Severity Index), skupni oceni telesnega in duševnega stanja z vprašalnikom SF- 36 in vizualni analogni lestvici (Visual Analogue Scale - VAS) statistično značilna v obeh terapevtskih skupinah z ustekinumabom v primerjavi s placebom.
8 5.2 Pharmacokinetic properties
8 5. 2 Farmakokinetične lastnosti
Absorption The median time to reach the maximum serum concentration (tmax) was 8.5 days after a single 90 mg subcutaneous administration in healthy subjects.
Absorpcija Pri zdravih preizkušancih je bila mediana vrednost časa do doseganja največje serumske koncentracije (tmax) po enkratni 90 mg subkutani injekciji zdravila 8, 5 dni.