natgillin/translations-raw huggingface dataset:
In healthy subjects, ulcerative colitis patients, or Crohn's disease patients, vedolizumab does not elevate neutrophils, basophils, eosinophils, B-helper and cytotoxic T lymphocytes, total memory T helper lymphocytes, monocytes or natural killer cells, in the peripheral blood with no leukocytosis observed.
Vedolizumab pri zdravih osebah, bolnikih z ulceroznim kolitisom ali bolnikih s Crohnovo boleznijo ne zviša števila nevtrofilcev, bazofilcev, eozinofilcev, B-pomagalk in citotoksičnih limfocitov T, ter skupnega števila spominskih celic T pomagalk, monocitov ali naravnih celic ubijalk v periferni krvi brez opažene levkocitoze.
What Entyvio contains
Kaj vsebuje navodilo
The efficacy and safety of vedolizumab for the treatment of adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12 with endoscopic sub score ≥ 2) was demonstrated in a randomised, double-blind, placebo-controlled study evaluating efficacy endpoints at week 6 and week 52 (GEMINI I).
Učinkovitost in varnost vedolizumaba pri zdravljenju odraslih bolnikov z zmerno do močno aktivnim ulceroznim kolitisom (ocena Mayo od 6 do 12, endoskopska podocena ≥ 2) so dokazali v randomizirani, dvojno slepi, s placebom nadzorovani študiji, ki je vrednotila opazovane dogodke učinkovitosti v 6. in 52. tednu (GEMINI I).
• For your first 2 infusions, your doctor or nurse will monitor you closely during the infusion and for approximately 2 hours after you have completed the infusion.
• Pri prvih 2 infuzijah zdravila vas bo zdravnik ali medicinska sestra skrbno nadziral(-a) med infundiranjem in še približno 2 uri po končanem infundiranju zdravila.
Vedolizumab is a humanised IgG1 monoclonal antibody that binds to the human α4β7 integrin and is produced using recombinant DNA technology in Chinese hamster ovary (CHO) cells.
Vedolizumab je humanizirano IgG1 monoklonsko protitelo, ki se veže na humani integrin α4β7, proizvedeno z uporabo tehnologije rekombinantne DNA na ovarijskih celicah kitajskega hrčka
*The placebo group includes those subjects who received vedolizumab at week 0 and week 2, and were randomised to receive placebo from week 6 through week 52.
* Skupina s placebom vključuje tiste osebe, ki so prejele vedolizumab na 0. teden in 2. teden, in so bile nato randomizirane na placebo od 6. tedna do 52. tedna.
In contrast, vedolizumab inhibited an immune response to a gastrointestinal antigenic challenge in healthy human volunteers (see section 4.4).
V nasprotju s tem pa vedolizumab zavira imunski odziv na gastrointestinalni antigenski izziv pri zdravih prostovoljcih (glejte poglavje 4.4).
12 hours2
12 ur2
Population pharmacokinetic analyses showed no effect of age (see section 5.2).
Pri analizah populacijske farmakokinetike vpliva starosti niso ugotovili (glejte poglavje 5.2).
Observed IRRs generally resolved with no or minimal intervention following the infusion.
Opažene reakcije, povezane z infundiranjem, so običajno izzvenele brez ukrepanja ali z minimalnim ukrepanjem po infundiranju.
3 This period may include up to 12 hours at 20 °C-25 °C.
3 V ta čas se šteje največ 12 ur pri temperaturi 20 °C-25 °C.
No dose recommendations can be made.
Priporočil za odmerjanje tako ne moremo navesti.
Entyvio may affect the way you respond to a vaccination.
Zdravilo Entyvio lahko vpliva na odziv telesa na cepljenje.
Patients receiving vedolizumab treatment may continue to receive non-live vaccines.
Med zdravljenjem z vedolizumabom lahko bolniki še naprej prejemajo mrtva cepiva.
Insert the needle into the vial through the centre of the stopper and direct the stream of liquid to the wall of the vial to avoid excessive foaming.
Injekcijsko iglo zabodite skozi osrednji del zamaška viale in tok tekočine usmerite na steno viale, da preprečite prekomerno penjenje.
Exploratory analysis show clinically meaningful improvements were observed for vedolizumab groups, and the improvements were significantly greater as compared with the placebo group at week 6 and week 52 on EQ-5D and EQ-5D VAS scores, all subscales of IBDQ (bowel symptoms, systemic function, emotional function and social function), and all subscales of SF-36 including the Physical Component Summary (PCS) and Mental Component Summary (MCS).
V primerjavi s skupino, ki je prejemala placebo, so v 6. tednu in 52. tednu opazili pomembno večja izboljšanja pri ocenah EQ-5D in EQ-5D VAS, vseh podlestvicah IBDQ (črevesni simptomi, sistemsko funkcioniranje, čustveno funkcioniranje in socialno funkcioniranje) in vseh podlestvicah SF-36, vključno s skupno oceno s področja telesnega (PCS-“Physical Component Summary”) in duševnega (MCS-“Mental Component
The α4β7 integrin is expressed on a discrete subset of memory T helper lymphocytes which preferentially migrate into the gastrointestinal (GI) tract and cause inflammation that is characteristic of ulcerative colitis and Crohn's disease, both of which are chronic inflammatory immunologically mediated conditions of the GI tract.
Integrin α4β7 je izražen na posebni podskupini spominskih celic T pomagalk, ki migrirajo predvsem v gastrointestinalni (GI) trakt in povzročajo vnetje, značilno za ulcerozni kolitis in Crohnovo bolezen, imunološko pogojeni kronični vnetni bolezni gastrointestinalnega trakta.
Enrolled patients had failed at least one conventional therapy, including corticosteroids, immunomodulators, and/or the TNFα antagonist infliximab (including primary non-responders).
Vključeni bolniki se niso odzivali na vsaj eno ustaljeno zdravljenje, vključno s kortikosteroidi, imunomodulatorji in/ali zaviralcem TNFα infliksimabom (vključno s primarnim neodzivom).
Patients with Crohn's disease, who have not shown a response may benefit from a dose of Entyvio at week 10 (see section 4.4).
Bolnikom s Crohnovo boleznijo brez odziva na zdravljenje morda lahko koristi odmerek zdravila Entyvio v 10. tednu (glejte poglavje 4.4).
• There is no clinical trial experience with Entyvio in patients previously treated with natalizumab.
• Izkušnje iz kliničnega preskušanja zdravila Entyvio pri bolnikih, ki so se predhodno zdravili z natalizumabom, niso na voljo.
Each vial is for single-use only.
Ena viala je namenjena le za enkratno uporabo.
In a pharmacologically responsive species (cynomolgus monkeys), there was no evidence of cellular hyperplasia or systemic immunomodulation that could potentially be associated with oncogenesis in 13- and 26-week toxicology studies.
Pri 13- in 26-tedenskih toksikoloških študijah pri farmakološko odzivnih vrstah (opice Cynomolgus) niso opazili znakov celične hiperplazije ali sistemske imunomodulacije, ki bi potencialno lahko bila povezana z onkogenezo.
• Any patients with new onset or worsening signs and symptoms suggestive of PML should be considered for neurological referral at a center equipped to diagnose PML.
• Pri vsakem bolniku, pri katerem se pojavijo novi ali poslabšajo že prisotni znaki in simptomi, ki kažejo na možnost razvoja PML, je treba razmisliti o napotitvi na specialistični nevrološki pregled v ustanovo, ustrezno opremljeno za diagnostiko PML.
If you forget or miss an appointment to receive the infusion, make another appointment as soon as possible.
Če niste prejeli predvidene infuzije zdravila Entyvio Če ste pozabili ali zamudili predvideno infuzijo, se čim prej dogovorite za naslednji termin.
Women of childbearing potential should use adequate contraception to prevent pregnancy and to continue its use for at least 18 weeks after the last treatment.
Ženske v rodni dobi naj uporabljajo učinkovito kontracepcijo med zdravljenjem in do 18 tednov po prejemu zadnjega odmerka.
In GEMINI II,
Študija GEMINI II
M anufacture r Delpharm Novara S.r.l.
Izde lovale c Delpharm Novara S.r.l.
Healthcare professionals should monitor patients on vedolizumab for any new onset or worsening of neurological signs and symptoms as outlined in physician education materials, and consider neurological referral if they occur.
Zdravstveni delavci morajo bolnike nadzirati glede pojava kakršnih koli novih ali poslabšanja že prisotnih nevroloških znakov in simptomov, kot je opisano v izobraževalnem gradivu za zdravnike, in bolnike po potrebi napotiti na specialistični nevrološki pregled.
Inhibiting the interaction of α4β7 with MAdCAM-1 with vedolizumab prevents transmigration of gut-homing memory T helper lymphocytes across the vascular endothelium into parenchymal tissue in nonhuman primates and induced a reversible 3-fold elevation of these cells in peripheral blood.
Pri nečloveških primatih vedolizumab z zaviranjem interakcije med α4β7 in MAdCAM-1 prepreči transmigracijo v črevesu prisotnih celic T pomagalk preko žilnega endotelija v parenhimsko tkivo in povzroči reverzibilno 3-kratno zvišanje teh celic v periferni krvi.
Do not freeze the reconstituted solution in the vial or the diluted solution in the infusion bag.
Ne zamrzujte rekonstituirane raztopine v viali ali rekonstituirane raztopine v infuzijski vrečki.
This should be taken into consideration, particularly in patients with severe active disease at baseline not previously treated with TNFα antagonists.
To je treba upoštevati, še posebej pri bolnikih z močno aktivno boleznijo v izhodišču, ki se predhodno še niso zdravili z zaviralci tumorje nekrotizirajočega faktorja alfa (TNFα).
Concomitant stable doses of oral aminosalicylates, corticosteroids and/or immunomodulators were permitted.
Dovoljena je bila sočasna uporaba peroralnih aminosalicilatov, kortikosteroidov in/ali imunomodulatorjev v stabilnih odmerkih.
Vedolizumab has been studied in adult ulcerative colitis and Crohn's disease patients with concomitant administration of corticosteroids, immunomodulators (azathioprine, 6-mercaptopurine, and methotrexate), and aminosalicylates.
Uporabo vedolizumaba so raziskovali pri odraslih bolnikih z ulceroznim kolitisom in Crohnovo boleznijo, ki so sočasno uporabljali kortikosteroide, imunomodulatorje (azatioprin, 6-merkaptopurin in metotreksat) ter aminosalicilate.
Entyvio is contraindicated in patients with active tuberculosis (see section 4.3).
Pri bolnikih z aktivno tuberkulozo je uporaba zdravila Entyvio kontraindicirana (glejte poglavje 4.3).
These effects were seen whether or not immunomodulators were also concomitantly administered.
Te učinke so opazili tako pri sočasni uporabi imunomodulatorjev kot brez nje.
Immediately withdraw 5 mL (300 mg) of reconstituted Entyvio using a syringe with a 21-25 gauge needle.
Nemudoma izvlecite 5 ml (300 mg) rekonstituirane raztopine zdravila Entyvio v injekcijsko brizgo s pomočjo injekcijske igle, velikosti 21-25 G.
What Entyvio looks like and contents of the pack Entyvio is a white to off-white powder for concentrate for solution for infusion provided in a glass vial with a rubber stopper and a plastic cap.
Izgled zdravila Entyvio in vsebina pakiranja Zdravilo Entyvio je na voljo v obliki belega do sivobelega praška za koncentrat za raztopino za infundiranje v stekleni viali, zaprti z gumijastim zamaškom in plastično zaporko.
Starting at week 6, patients received 300 mg vedolizumab every eight or four weeks.
V 6. tednu so bolniki nato začeli s prejemanjem vedolizumaba v odmerku 300 mg na vsakih osem tednov ali na vsake štiri tedne.
Any time that the reconstituted solution was held in the vial should be subtracted from the time the solution may be held in the infusion bag.
Ves čas, ko je bila rekonstituirana raztopina v viali, je treba odšteti od časa, dovoljenega za shranjevanje raztopine v infuzijski vrečki.
Effects on male and female fertility have not been formally evaluated in animal studies (see section 5.3).
Pri študijah na živalih vplivov na plodnost samcev in samic niso formalno ovrednotili (glejte poglavje 5.3).
In a placebo-controlled study of healthy volunteers, a single 750 mg dose of vedolizumab did not lower rates of protective immunity to hepatitis B virus in subjects who were vaccinated intramuscularly with three doses of recombinant hepatitis B surface antigen.
V s placebom nadzorovani študiji, izvedeni pri zdravih prostovoljcih, enkratni 750-mg odmerek vedolizumaba pri osebah, ki so bile cepljene intramuskularno s tremi odmerki rekombinantnega površinskega antigena virusa hepatitisa B, ni zmanjšal deležev zaščitne imunosti proti virusu hepatitisa B. Pri vedolizumabu izpostavljenih osebah so po prejemu mrtvega peroralnega cepiva proti koleri opazili nižje deleže serokonverzije.
No clinical trial data for concomitant use of vedolizumab with biologic immunosuppressants are available.
Podatki iz kliničnega preskušanja sočasnega zdravljenja z vedolizumabom in biološkimi zdravili za zaviranje imunske odzivnosti niso na voljo.
Possible serious side effects include infusion reactions or allergic reactions (may affect up to 1 in 100 people) and infections (may affect up to 1 in 10 people).
Možni resni neželeni učinki so infuzijske reakcije ali alergijske reakcije (pojavijo se lahko pri največ 1
Ελλάδα
Celokupno^
The recommended dose regimen of Entyvio is 300 mg administered by intravenous infusion at zero, two and six weeks and then every eight weeks thereafter.
Ulcerozni kolitis Priporočeni režim odmerjanja zdravila Entyvio je 300 mg v obliki intravenske infuzije na ničti, drugi in šesti teden ter nato na vsakih osem tednov.
The plasma protein binding of vedolizumab has not been evaluated.
Vezave vedolizumaba na plazemske proteine niso vrednotili.
It is a humanised monoclonal antibody that binds specifically to the α4β7 integrin, which is preferentially expressed on gut homing T helper lymphocytes.
Je humanizirano monoklonsko protitelo, ki se specifično veže na integrin α4β7, ki je izražen predvsem na celicah T pomagalkah v črevesu.
Immunomodulatory medicinal products may increase the risk of malignancy (see section 4.8).
Zdravila, ki spreminjajo imunsko odzivnost, lahko povečajo tveganje za razvoj malignih bolezni (glejte poglavje 4.8).
Entyvio is for intravenous use only.
Zdravilo Entyvio je namenjeno le za intravensko uporabo.
Approximately one-third of patients had failed prior TNFα antagonist therapy.
Pri približno eni tretjini bolnikov je bilo predhodno zdravljenje z zaviralcem TNFα neuspešno.
In this open-label extension study, clinical remission and clinical response were observed in patients for up to 196 weeks.
V tej odprti podaljšani študiji sta se klinična remisija in klinični odziv pri bolnikih ohranila do
Patients who achieved a clinical response after receiving vedolizumab at week 0 and 2 and were then randomised to placebo (for 6 to 52 weeks) and lost response were allowed to enter the open-label extension study and receive vedolizumab every four weeks.
Bolniki s kliničnim odzivom po prejemu vedolizumaba na 0. in 2. teden, ki so nato bili randomizirani na placebo (od 6. do 52. tedna), pri čemer se je klinični odziv izgubil, so lahko vstopili v odprto podaljšano študijo in so vedolizumab prejemali na vsake štiri tedne.
The primary endpoint was the proportion of patients in clinical remission at week 6 in the TNFα antagonist failure subpopulation.
Primarni opazovani dogodek je bil delež bolnikov v klinični remisiji v 6. tednu v podpopulaciji bolnikov brez odziva na zdravljenje z zaviralcem TNFα.
Vedolizumab is a gut-selective integrin antagonist with no identified systemic immunosuppressive activity (see section 5.1).
Vedolizumab je za črevo selektiven integrinski zaviralec brez znanega sistemskega zaviranja imunske odzivnosti (glejte poglavje 5.1).
Vedolizumab 450 mg administered intravenously was not detected in the cerebrospinal fluid of healthy subjects.
Po intravenski aplikaciji vedolizumaba v odmerku 450 mg pri zdravih prostovoljcih vedolizumaba v cerebrospinalni tekočini niso odkrili.
Primary endpoint was the proportion of patients in clinical remission at week 52 (see Table 5).
Primarni opazovani dogodek je bil delež bolnikov v klinični remisiji v 52. tednu (glejte preglednico 5).
Do not add other medicinal products to the prepared infusion solution or intravenous infusion set.
V tako pripravljeno raztopino za infundiranje ali set za intravensko infundiranje ne dodajajte drugih zdravil.
• if you have an infection, or think you have an infection, if you develop chills, shivering, persistent cough or a high fever.
• če imate ali menite, da bi lahko imeli okužbo, če se pojavijo mrzlica, drgetanje, trdovraten kašelj ali zvišana telesna temperatura.
Patients previously exposed to natalizumab should normally wait a minimum of 12 weeks prior to initiating therapy with Entyvio, unless otherwise indicated by the patient's clinical condition.
Entyvio običajno treba počakati najmanj 12 tednov, razen če klinično stanje bolnika ne narekuje drugače.
Patient numbers were n = 72 for placebo, n = 70 for vedolizumab every eight weeks, and n = 73 for vedolizumab every four weeks
Število bolnikov: n = 72 za placebo, n = 70 za vedolizumab na vsakih osem tednov in n = 73 za vedolizumab na vsake štiri tedne.
Patients who failed to demonstrate response at week 6 remained in the study and received vedolizumab every four weeks.
Bolniki, pri katerih niso uspeli dokazati odziva v 6. tednu, so ostali v študiji in prejemali vedolizumab na vsake štiri tedne.
Taking into account the PRAC Assessment Report on the PSUR(s) for vedolizumab, the scientific conclusions of the CHMP are as follows:
Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni redno posodobljenih poročil o varnosti zdravila (PSUR) za vedolizumab je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
Add the 5 mL (300 mg) of reconstituted Entyvio to 250 mL of sterile sodium chloride 9 mg/mL (0.9%) solution for injection, and gently mix the infusion bag (5 mL of sodium chloride 9 mg/mL (0.9%) solution for injection does not have to be withdrawn from the infusion bag prior to adding Entyvio).
5 ml (300 mg) rekonstituirane raztopine zdravila Entyvio dodajte v 250 ml sterilne raztopine za injiciranje natrijevega klorida 9 mg/ml (0,9 %) in vsebino infuzijske vrečke nežno premešajte (pred dodajanjem zdravila Entyvio iz infuzijske vrečke ni treba odstraniti 5 ml natrijevega klorida 9 mg/ml (0,9 %) raztopine za injiciranje).
In patients who received vedolizumab at weeks 0 and 2 followed by placebo, no increase in the rate of IRR was seen upon retreatment with vedolizumab after loss of response.
Pri bolnikih, ki so prejemali vedolizumab na 0. in 2. teden nato pa placebo, pri ponovni uvedbi zdravljenja z vedolizumabom po izgubi odziva niso opazili povečanja deleža reakcij, povezanih z infundiranjem.
In patients diagnosed with TB whilst receiving vedolizumab therapy, then vedolizumab therapy should be discontinued until the TB infection has been resolved.
Pri bolnikih, pri katerih se tuberkulozo ugotovi med zdravljenjem z vedolizumabom, je treba zdravljenje z vedolizumabom prekiniti dokler se tuberkuloza ne razreši.
Therapy should be continued every eight weeks from week 14 in responding patients.
Pri bolnikih z odzivom je nato zdravljenje od 14. tedna dalje treba nadaljevati na vsakih osem tednov.
• redness and tenderness of hair follicle
• pordelost in občutljivost lasnega mešička,
There are no data on the effects of vedolizumab on human fertility.
O vplivu vedolizumaba na plodnost pri človeku ni podatkov.
The efficacy and safety of vedolizumab for the treatment of adult patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index [CDAI] score of 220 to 450) were evaluated in two studies (GEMINI II and III).
Crohnovo boleznijo (indeks aktivnosti Crohnove bolezni [CDAI-“Crohn's Disease Activity Index”] od 220 do 450) so vrednotili v dveh študijah (GEMINI II in III).
Reconstitute vedolizumab with 4.8 mL of sterile water for injections at room temperature (20 °C-25 °C), using a syringe with a 21-25 gauge needle.
Vedolizumab rekonstituirajte s 4,8 ml sterilne vode za injekcije sobne temperature (20 °C-25 °C) s pomočjo injekcijske brizge in injekcijske igle, velikosti 21-25 G.
4.1 Therapeutic indications
4.1 Terapevtske indikacije Ulcerozni kolitis
Patients showing clinical response at week 6 were required to begin corticosteroid tapering.
Bolniki, ki so dosegli klinični odziv, so v 6. tednu morali začeti z režimom zmanjševanja odmerka kortikosteroida.
The following listing of adverse reactions is based on clinical trial and post marketing experience and is displayed by system organ class.
Naslednji seznam neželenih učinkov temelji na izkušnjah iz kliničnega preskušanja in spremljanju zdravila po pridobitvi dovoljenja za promet.
Patient numbers were n = 82 for placebo, n = 82 for vedolizumab every eight weeks, and n = 80 for vedolizumab every four weeks
Število bolnikov: n = 82 za placebo, n = 82 za vedolizumab na vsakih osem tednov in n = 80 za vedolizumab na vsake štiri tedne.
No dose adjustment is required in elderly patients.
Pri starostnikih odmerka ni treba prilagajati.
Your doctor will have to decide if you can still be given Entyvio.
Zdravnik bo presodil, če se kljub temu lahko zdravite z zdravilom Entyvio.
The effect of vedolizumab on infants is unknown.
Učinek vedolizumaba na dojene novorojence ni znan.
Dose and frequency Treatment with Entyvio is the same for ulcerative colitis and Crohn's disease.
Odmerek in pogostost Zdravljenje ulceroznega kolitisa in Crohnove bolezni z zdravilom Entyvio je enako.
If a mild to moderate IRR occurs, the infusion rate can be slowed or interrupted and appropriate treatment initiated.
V primeru pojava blage do zmerne reakcije, povezane z infundiranjem, je treba hitrost infundiranja zdravila zmanjšati ali infundiranje prekiniti in uvesti ustrezno zdravljenje.
Of those patients who had infusion related reactions, those dosed with vedolizumab had more infusion related reactions with in the first 2 hours as compared to placebo patients with infusion related reactions.
Pri bolnikih, pri katerih so se pojavile reakcije, povezane z infundiranjem, se je več tovrstnih reakcij v prvih dveh urah po infundiranju pojavilo pri bolnikih, ki so prejemali vedolizumab, v primerjavi z bolniki, ki so prejemali placebo.
In GEMINI I and II controlled studies, the rate of serious infections was 0.07 per patient year in vedolizumab-treated patients and 0.06 per patient year in placebo-treated patients.
V nadzorovanih študijah GEMINI I in II je delež resnih okužb pri bolnikih, ki so se zdravili z vedolizumabom, znašal 0,07 na bolnik-leto, pri bolnikih, ki so prejemali placebo, pa 0,06 na bolnik-leto.
Entyvio is administered as an intravenous infusion over 30 minutes.
Zdravilo Entyvio je treba aplicirati v obliki 30-minutne intravenske infuzije.
Clinical response using partial Mayo scores was achieved at week 10 and week 14 by greater proportions of vedolizumab patients (32% and 39%, respectively) compared with placebo patients (15% and 21%, respectively).
Klinični odziv z uporabo delnih ocen Mayo je bil v 10. tednu in 14. tednu dosežen pri večjem deležu bolnikov, ki so prejemali vedolizumab (32 % in 39 %), kot pri bolnikih, ki so prejemali placebo (15 % in 21 %).
Vedolizumab is a gut-selective immunosuppressive biologic.
Vedolizumab je biološko zdravilo za selektivno zaviranje imunske odzivnosti v črevesu.
In clinical studies, infusion-related reactions (IRR) and hypersensitivity reactions have been reported, with the majority being mild to moderate in severity (see section 4.8).
V kliničnih študijah so poročali o pojavu reakcij, povezanih z infundiranjem, in o pojavu preobčutljivostnih reakcij, ki pa so bile večinoma blage do zmerne (glejte poglavje 4.8).
Efficacy Results for GEMINI II and III Studies at week 6 and week 10
Rezultati učinkovitosti v 6. tednu in 10. tednu v študijah GEMINI II in III Študija
In patients administered 300 mg vedolizumab as a 30 minute intravenous infusion on weeks 0 and 2, mean serum trough concentrations at week 6 were 27.9 mcg/mL (SD ± 15.51) in ulcerative colitis and 26.8 mcg/mL (SD ± 17.45) in Crohn's disease.
Pri bolnikih, ki so vedolizumab v odmerku 300 mg prejeli v obliki 30-minutne intravenske infuzije na 0. in 2. teden, je povprečna najmanjša koncentracija v serumu v 6. tednu pri bolnikih z ulceroznim kolitisom znašala 27,9 μg/ml (SD ± 15,51), pri bolnikih s Crohnovo boleznijo pa 26,8 μg/ml (SD ± 17,45).
Primary endpoint was the proportion of patients in clinical remission at week 52.
Primarni opazovani dogodek je bil delež bolnikov v klinični remisiji v 52. tednu.