natgillin/translations-raw huggingface dataset:
For patients who remained on apremilast in the open label extension of ESTEEM 1 and ESTEEM 2 studies, improvements were generally maintained in PASI score, affected BSA, itch, nail and quality of life measures for up to 5 years.
Pri bolnikih, ki so v odprtem podaljšanju študij ESTEEM 1 in ESTEEM 2 ostali na apremilastu, so izboljšanja na splošno trajala v rezultatu PASI, prizadeti telesni površini, srbenju, nohtih in merilih kvalitete življenja do 5 let.
Otezla should be dose reduced to 30 mg once daily in patients with severe renal impairment (see sections 4.2 and 5.2).
Pri bolnikih s hudo okvaro ledvic je treba odmerek zdravila Otezla zmanjšati na 30 mg enkrat na dan (glejte poglavji 4.2 in 5.2).
The frequencies of adverse drug reactions are those reported in the apremilast arms of the four Phase III studies in PsA (n = 1,945) or the two Phase III studies in PSOR (n=1184) (highest frequency from either data pool is represented in Table 2).
Pogostnosti neželenih učinkov zdravila so tiste, o katerih so poročali v skupinah z apremilastom v štirih študijah faze III pri PsA (n = 1.945) ali v dveh študijah faze III pri psoriazi (n=1.184) (največje pogostnosti iz enih ali drugih združenih podatkov so prikazane v preglednici 2).
Otezla is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).
Zdravilo Otezla je indicirano za zdravljenje zmerne do hude kronične psoriaze v plakih pri odraslih bolnikih, ki se niso odzvali, je pri njih kontraindicirano ali ne prenašajo drugih vrst sistemskega zdravljenja, vključno s ciklosporinom, metotreksatom ali psoralenom in ultravijolično svetlobo A (PUVA).
Apremilast can be co-administered with oral contraceptives.
Apremilast lahko dajemo skupaj s peroralnimi kontracepcijskimi sredstvi.
Other medicines and Otezla
Druga zdravila in zdravilo Otezla
Apremilast pharmacokinetics are linear, with a dose-proportional increase in systemic exposure in the dose range of 10 to 100 mg daily.
Farmakokinetika apremilasta je linearna, v območju odmerkov od 10 do 100 mg na dan se sistemska izpostavljenost zvečuje sorazmerno odmerku.
These GI adverse reactions are mostly mild to moderate in severity, with 0.3% of diarrhoea and 0.3% of nausea reported as severe.
Ti GI neželeni učinki so po izraženosti večinoma blagi do zmerni, o hudi driski poročajo v 0,3 % in o hudi navzei prav tako v 0,3 %.
10 mg (pink)
10 mg (rožnata)
Co-administration of apremilast with multiple doses of rifampicin resulted in a decrease in apremilast area-under-the-concentration time curve (AUC) and maximum serum concentration (Cmax) by approximately 72% and 43%, respectively.
Sočasno dajanje apremilasta z večkratnimi odmerki rifampicina je povzročilo zmanjšanje površine pod krivuljo koncentracija-čas (AUC) za približno 72 % in največje serumske koncentracije (Cmax) apremilasta za približno 43 %.
If it is close to the time for your next dose, just skip the missed dose.
Če je že skoraj čas za naslednji odmerek, ne vzemite izpuščenega odmerka.
The mean baseline PASI score was 19.07 (median 16.80), and the proportion of patients with sPGA score of 3 (moderate) and 4 (severe) at baseline was 70.0% and 29.8%, respectively with a mean baseline BSA involvement of 25.19% (median 21.0%).
Srednji rezultat PASI v izhodišču je bil 19,07 (mediana 16,80), delež bolnikov z rezultatom sPGA 3 (zmerna) in 4 (huda) v izhodišču je bil 70,0 % oziroma 29,8 %, s povprečno BSA v izhodišču 25,19 % (mediana 21,0 %).
• The film-coating contains poly(vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc, iron oxide red (E172).
• Filmska obloga vsebuje polivinilalkohol, titanov dioksid (E171), makrogol (3350), smukec, rdeči železov oksid (E172).
Response to apremilast was rapid, with significantly greater improvements in the signs and symptoms of psoriasis, including PASI, skin discomfort/pain and pruritus, compared to placebo by week 2.
Odziv na apremilast je bil hiter, s signifikantno večjim izboljšanjem znakov in simptomov psoriaze po 2 tednih, vključno z odzivom PASI, neugodjem/bolečino v koži in pruritusom, v primerjavi s placebom.
If patients develop severe diarrhoea, nausea, or vomiting, discontinuation of treatment with apremilast may be necessary.
Če se pri bolniku pojavi huda driska, navzea ali bruhanje, bo morda potrebna prekinitev zdravljenja z apremilastom.
• difficulty sleeping (insomnia)
• motnje spanja (nespečnost),
In clinical studies, apremilast has been administered concomitantly with topical therapy (including corticosteroids, coal tar shampoo and salicylic acid scalp preparations) and UVB phototherapy.
V kliničnih študijah so dajali apremilast sočasno s topikalno terapijo (vključno s kortikosteroidi, šamponom s premogovim katranom in pripravki za lasišče s salicilno kislino) in s fototerapijo z UVB.
Instances of suicidal ideation and behaviour, including suicide, have been observed in patients with or without history of depression (see section 4.8).
Pri bolnikih z depresijo v anamnezi ali brez nje so opazili primere samomorilnih misli in vedenja, vključno s samomorom (glejte poglavje 4.8).
In clinical trials in patients with psoriasis, apremilast decreased lesional skin epidermal thickness, inflammatory cell infiltration, and expression of pro-inflammatory genes, including those for inducible nitric oxide synthase (iNOS), IL-12/IL-23p40, IL-17A, IL-22 and IL-8.
V kliničnih preskušanjih pri bolnikih s psoriazo je apremilast zmanjšal debelino povrhnjice kožnih lezij, infiltracijo vnetnih celic in ekspresijo genov, ki pospešujejo vnetje, vključno s tistimi za inducibilno sintazo dušikovega oksida (iNOS), IL-12/IL-23p40, IL-17A, IL-22 in IL-8.
There were no apremilast-related effects on duration of pregnancy, number of pregnant mice at the end of the gestation period, number of mice that delivered a litter, or any developmental effects in the pups beyond postnatal day 7.
Z apremilastom povezanih učinkov na trajanje brejosti, število brejih miši ob koncu obdobja brejosti, število miši, ki so skotile zarod, ali kakšnih učinkov na razvoj mladičev od 7. dne po skotitvi naprej ni bilo.
The results support that no dose adjustment is needed in patients with mild and moderate renal impairment.
Rezultati so v prid trditvi, da pri bolnikih z blago in zmerno okvaro ledvic prilagajanje odmerka ni potrebno.
Otezla 10 mg, 20 mg, 30 mg film-coated tablets (initiation pack) PVC/ aluminium foil blisters containing 27 film-coated tablets (4 x10 mg, 4x 20 mg, 19 x 30 mg).
Otezla 10 mg, 20 mg, 30 mg filmsko obložene tablete (pakiranje za začetek zdravljenja) Pretisni omoti iz PVC/aluminijeve folije, ki vsebujejo po 27 filmsko obloženih tablet (4 x 10 mg, 4 x 20 mg, 19 x 30 mg).
By reducing the activity of this enzyme, Otezla can help to control the inflammation associated with psoriatic arthritis and psoriasis, and thereby reduce the signs and symptoms of these conditions.
Zdravilo Otezla lahko z zmanjšanjem aktivnosti tega encima pomaga obvladovati vnetje, ki je povezano s psoriatičnim artritisom in psoriazo, in tako zmanjšuje znake in simptome teh bolezni.
Migraine* Tension headache* Headache*
Bolezni živčevja pogosti migrena* tenzijski glavobol* glavobol*
Name and address of the manufacturer responsible for batch release Celgene Distribution B.V.
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serij Celgene Distribution B.V.
• The three-month standard pack contains 168 x 30 mg film-coated tablets.
• Trimesečno standardno pakiranje vsebuje 168 x 30 mg filmsko obloženih tablet.
Increased peri- and postnatal pup deaths and reduced pup body weights during the first week of lactation were observed at ≥ 80 mg/kg/day (≥ 4.0-fold clinical exposure).
Pogostnejše peri- in postnatalne smrti mladičev in zmanjšano telesno maso mladičev v prvem tednu laktacije so opazili pri odmerku ≥ 80 mg/kg/dan (≥ 4,0-kratna klinična izpostavljenost).
If you take more Otezla than you should, talk to a doctor or go to a hospital straight away.
Če ste vzeli večji odmerek zdravila Otezla, kot bi smeli Če ste vzeli več zdravila Otezla, kot bi smeli, se posvetujte z zdravnikom ali pojdite takoj v bolnišnico.
• Do not use this medicine after the expiry date which is stated on the blister or on the wallet or on the carton after EXP.
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu ali na zgibanki ali na škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Patients who did not achieve the designated PASI response by week 32, or who were initially randomised to placebo, remained on apremilast until week 52.
Bolniki, ki do 32. tedna niso dosegli navedenega odziva PASI ali ki so bili v začetku randomizirani na placebo, so do 52. tedna ostali na apremilastu.
No such effects were observed when exposure in animals was at 1.3-fold the clinical exposure (see section 5.3).
Kadar je bila izpostavljenost živali 1,3-krat večja od klinične izpostavljenosti, takih učinkov niso opazili (glejte poglavje 5.3).
The adverse reactions observed in patients treated with apremilast are listed below by system organ class (SOC) and frequency for all adverse reactions.
Neželeni učinki, ki so jih opazili pri bolnikih, zdravljenih z apremilastom, so navedeni v nadaljevanju po organskih sistemih in pogostnosti za vse neželene učinke.
Patients with pre-existing enthesopathy (63%) or pre-existing dactylitis (42%) were enrolled.
Vključili so tudi bolnike z entezopatijo (63 %) ali daktilitisom (42 %).
The major secondary endpoint was the proportion of patients who achieved a sPGA score of clear (0) or almost clear (1) at week 16.
Najpomembnejši sekundarni končni opazovani dogodek je bil delež bolnikov, ki so v 16. tednu dosegli rezultat sPGA brez vidnih bolezenskih sprememb (0) ali skoraj brez vidnih bolezenskih sprememb (1).
Apremilast, an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4), works intracellularly to modulate a network of pro-inflammatory and anti-inflammatory mediators.
Apremilast, peroralni nizkomolekularni inhibitor fosfodiesteraze 4 (PDE4), deluje intracelularno z moduliranjem mreže mediatorjev, ki pospešujejo in zavirajo vnetje.
PDE4 inhibition elevates intracellular cAMP levels, which in turn down-regulates the inflammatory response by modulating the expression of TNF-α, IL-23, IL-17 and other inflammatory cytokines.
Inhibicija PDE4 zviša koncentracijo intracelularnega cAMP, ki nato zmanjša vnetni odziv z moduliranjem ekspresije TNF-α, IL-23, IL-17 in drugih vnetnih citokinov.
In clinical studies in patients with psoriatic arthritis, apremilast significantly modulated, but did not fully inhibit, plasma protein levels of IL-1α, IL-6, IL-8, MCP-1, MIP-1β, MMP-3, and TNF-α.
V kliničnih študijah pri bolnikih s psoriatičnim artritisom je apremilast signifikantno moduliral plazemske koncentracije beljakovin IL-1α, IL-6, IL-8, MCP-1, MIP-1β, MMP-3 in TNF-α, ni jih pa popolnoma inhibiral.
There was no clinically meaningful interaction between ketoconazole and apremilast.
Med ketokonazolom in apremilastom ni bilo klinično pomembnih interakcij.
Increased numbers of early resorptions and reduced numbers of ossified tarsals were observed at 20, 40, and 80 mg/kg/day.
Zvečano število zgodnjih resorpcij in zmanjšano število osificiranih tarzalnih kosti so opazili pri 20, 40 in 80 mg/kg/dan.
Otezla contains the active substance ‘apremilast'.
Zdravilo Otezla vsebuje učinkovino ‘apremilast'.
In animal studies in mice, no adverse effects on fertility were observed in males at exposure levels 3-fold clinical exposure and in females at exposure levels 1-fold clinical exposure.
V študijah na živalih niso ugotovili neželenih učinkov na plodnost pri mišjih samcih pri izpostavljenosti, ki je bila trikratnik klinične izpostavljenosti in pri mišjih samicah pri izpostavljenosti, ki je znašala 1-kratnik klinične izpostavljenosti.
Patients in these studies had a diagnosis of PsA for at least 6 months.
Bolniki so imeli potrjeno diagnozo PsA vsaj 6 mesecev pred vključitvijo v študije.
Otezla contains lactose (a type of sugar).
Zdravilo Otezla vsebuje laktozo (vrsta sladkorja).
NAME OF THE MARKETING AUTHORISATION HOLDER Celgene
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Celgene
In general, PASI responses were achieved by week 16 and were maintained through week 32.
Na splošno so bolniki dosegli odzive PASI po 16 tednih, trajali pa so še po 32 tednih.
Based on the study design, patients whose tender and swollen joint counts had not improved by at least 20% were considered non-responders at week 16.
Na podlagi zasnove študij so v 16. tednu bolnike, pri katerih se število občutljivih in oteklih sklepov ni zmanjšalo vsaj za 20 %, opredelili kot neodzivne na zdravljenje.
Patients with hepatic impairment No dose adjustment is necessary for patients with hepatic impairment (see section 5.2).
Bolniki z okvaro jeter Pri bolnikih z okvaro jeter prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
Apremilast exposure is decreased when administered concomitantly with strong inducers of CYP3A4 (e.g. rifampicin) and may result in reduced clinical response.
Izpostavljenost apremilastu se zmanjša, kadar ga dajemo sočasno z močnimi spodbujevalci CYP3A4 (npr. rifampicinom), kar lahko zmanjša klinični odziv.
Within each SOC and frequency grouping, adverse reactions are presented in order of decreasing seriousness.
V razvrstitvah organskih sistemov in pogostnosti so neželeni učinki navedeni po padajoči resnosti.
Hence, clinically relevant drug-drug interactions are unlikely when apremilast is co-administered with drugs that are substrates or inhibitors of these transporters.
Klinično pomembne interakcije med apremilastom in zdravili, ki so substrati ali zaviralci teh prenašalcev, niso verjetne.
Following oral administration of radiolabelled apremilast, about 58% and 39% of the radioactivity is recovered in urine and faeces, respectively, with about 3% and 7% of the radioactive dose recovered as apremilast in urine and faeces, respectively.
Po peroralnem dajanju radioaktivno označenega apremilasta iz urina oziroma blata prestrežejo okrog 58 % oziroma 39 % radioaktivnosti, pri čemer je okrog 3 % oziroma 7 % prestreženega radioaktivnega odmerka v obliki apremilasta.
If your doctor considers you to be underweight, and you observe an unintentional loss of body weight while being treated with Otezla, you should talk to your doctor.
Če zdravnik meni, da ste presuhi, in med zdravljenjem z zdravilom Otezla opazite nenamerno zmanjševanje telesne mase, se posvetujte z zdravnikom.
Driving and using machines Otezla has no effect on the ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Otezla ne vpliva na sposobnost upravljanja vozil in strojev.
The safety and efficacy of apremilast were evaluated in two multicentre, randomised, double-blind, placebocontrolled studies (Studies ESTEEM 1 and ESTEEM 2) which enrolled a total of 1,257 patients with moderate to severe plaque psoriasis who had a body surface area (BSA) involvement of ≥ 10%, Psoriasis Area and Severity Index (PASI) score ≥ 12, static Physician Global Assessment (sPGA) of ≥ 3 (moderate or severe), and who were candidates for phototherapy or systemic therapy.
Varnost in učinkovitost apremilasta so ocenili v dveh multicentričnih, randomiziranih, dvojno slepih študijah, kontroliranih s placebom (študiji ESTEEM 1 in ESTEEM 2), v katerih je bilo vključenih vsega skupaj 1.257 bolnikov z zmerno do hudo psoriazo v plakih, ki so imeli prizadete ≥ 10 % telesne površine (BSA - Body Surface Area), rezultat indeksa površine in jakosti psoriaze (PASI - Psoriasis Area and Severity Index) ≥ 12, statično zdravnikovo splošno oceno (sPGA - static Physician Global Assessment) ≥ 3 (zmerna ali huda), in ki so bili kandidati za fototerapijo ali sistemsko zdravljenje.
UNIQUE IDENTIFIER - 2D BARCODE 2 D barcode carrying the unique identifier included
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
The median time to loss of PASI-75 response among the patients re-randomised to placebo was 5.1 weeks.
Mediani čas do izgube odziva PASI 75 pri bolnikih, ponovno randomiziranih na placebo, je bil 5,1 tedna.
Consistent with apremilast being a substrate of CYP3A4, apremilast exposure is decreased when administered concomitantly with rifampicin, a strong inducer of CYP3A4.
Skladno s tem, da je apremilast substrat CYP3A4, se izpostavljenost apremilastu zmanjša, kadar ga dajemo sočasno z rifampicinom, ki je močan spodbujevalec CYP3A4.
• St John's Wort - a herbal medicine for mild anxiety and depression.
• šentjanževka - zeliščno zdravilo za zdravljenje blage anksioznosti in depresije.
Study Week
končni opazovani teden študije
Treatment with apremilast resulted in significant improvement in moderate to severe plaque psoriasis as demonstrated by the proportion of patients with PASI-75 response at week 16, compared to placebo.
Zdravljenje z apremilastom je povzročilo signifikantno izboljšanje zmerne do hude psoriaze v plakih, na kar kaže delež bolnikov z odzivom PASI 75 po 16 tednih zdravljenja v primerjavi s placebom.
Hypersensitivity reactions are uncommonly observed (see section 4.3).
Preobčutljivostne reakcije opazijo občasno (glejte poglavje 4.3).
If you forget to take Otezla
Če ste pozabili vzeti zdravilo Otezla
INFORMATION IN BRAILLE Otezla 10 mg
PODATKI V BRAILLOVI PISAVI Otezla 10 mg
There is little information about the effects of Otezla in pregnancy.
O učinkih zdravila Otezla v nosečnosti je malo podatkov.
The safety and efficacy of apremilast were evaluated in 3 multi-centre, randomised, double-blind, placebocontrolled studies (Studies PALACE 1, PALACE 2, and PALACE 3) of similar design in adult patients with active PsA (≥ 3 swollen joints and ≥ 3 tender joints) despite prior treatment with small molecule or biologic DMARDs.
Varnost in učinkovitost apremilasta so ovrednotili v treh podobno zasnovanih multicentričnih, randomiziranih, dvojno slepih, s placebom kontroliranih študijah (študije PALACE 1, PALACE 2 in PALACE 3) pri odraslih bolnikih z aktivnim PsA (≥ 3 otekli sklepi in ≥ 3 občutljivi sklepi) kljub predhodnemu zdravljenju z nizkomolekularnimi ali biološkimi DMARDs.
Following 52 weeks of treatment, patients could continue on open-label apremilast 30 mg within the long-term extension of the ESTEEM 1 and ESTEEM 2 studies for a total duration of treatment up to 5 years (260 weeks).
Po 52 tednih zdravljenja so lahko bolniki nadaljevali z odprtim apremilastom v odmerku 30 mg v dolgoročnem podaljšanju študij ESTEEM 1 in ESTEEM 2, tako da je zdravljenje v celoti trajalo do 5 let (260 tednov).
What psoriatic arthritis is
Kaj je psoriatični artritis
The proportion of patients achieving PASI-50, -75 and -90 responses, and sPGA score of clear (0) or almost clear (1), are presented in Table 4 below.
Delež bolnikov, ki so dosegli odzive PASI 50, PASI 75 in PASI 90 ter rezultat sPGA brez vidnih bolezenskih sprememb (0) ali skoraj brez vidnih bolezenskih sprememb (1), so prikazani v preglednici 4 v nadaljevanju.
Of these patients, 12% achieved a PASI-75 response at week 52 with apremilast plus topical and/or phototherapy treatment.
Od teh bolnikov jih je 12 % doseglo odziv PASI 75 po 52 tednih zdravljenja z apremilastom skupaj s topikalnimi zdravili in/ali fototerapijo.
INFORMATION IN BRAILLE Otezla 30 mg
PODATKI V BRAILLOVI PISAVI Otezla 30 mg
One qualifying psoriatic skin lesion (at least 2 cm in diameter) was also required in PALACE 3.
V študiji PALACE 3 so morali imeti bolniki tudi eno psoriatično kožno lezijo (vsaj 2 cm v premeru).
In a pre- and postnatal study, apremilast was administered orally to pregnant female mice at dosages of 10, 80 and 300 mg/kg/day from gestation day (GD) 6 to Day 20 of lactation.
V pre- in postnatalni študiji so dajali apremilast peroralno brejim mišjim samicam v odmerkih 10, 80 in 300 mg/kg/dan od 6. dneva gestacije (GD) do 20. dneva laktacije.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister (Particulars printed directly onto the wallet card with the blank blister sealed inside)
Pretisni omot (podatki, natisnjeni neposredno na zgibanko, pretisni omot brez napisa pa je zapečaten znotraj)
DMARDs N=497
N=497
After randomised withdrawal from therapy at week 32, approximately 70% of patients in Study ESTEEM 1, and 65.6% of patients in Study ESTEEM 2, regained PASI-75 (ESTEEM 1) or PASI-50 (ESTEEM 2) responses after re-initiation of apremilast treatment.
Po randomizirani odtegnitvi terapije v 32. tednu je približno 70 % bolnikov v študiji ESTEEM 1 in 65,6 % bolnikov v študiji ESTEEM 2 po ponovni uvedbi zdravljenja z apremilastom spet pridobilo odziv PASI 75 (ESTEEM 1) ali PASI 50 (ESTEEM 2).
Apremilast 30 mg twice daily
apremilast 30 mg dvakrat na dan +/DMARDs
Apremilast has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Apremilast nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
QUALITATIVE AND QUANTITATIVE COMPOSITION Otezla 10 mg film-coated tablets
KAKOVOSTNA IN KOLIČINSKA SESTAVA Otezla 10 mg filmsko obložene tablete
Apremilast can be coadministered with a potent CYP3A4 inhibitor such as ketoconazole.
Apremilast lahko dajemo sočasno z močnim zaviralcem CYP3A4, na primer ketokonazolom.
Among patients who remained on the apremilast treatment to which they were randomised at study start, these improvements were maintained through week 52.
Pri bolnikih, ki so ostali na zdravljenju z apremilastom, na katerega so bili randomizirani v začetku študije, je to izboljšanje po 52 tednih še vedno trajalo.
The NOEL in the mouse for maternal toxicity and F1 generation was 10 mg/kg/day (1.3-fold clinical AUC).
NOEL pri miših glede toksičnosti za mater in generacijo F1 je bila 10 mg/kg/dan (1,3-kratna klinična AUC).
19 film-coated tablets of 30 mg
19 filmsko obloženih tablet po 30 mg
Among patients who remained on the apremilast treatment, to which they were initially randomised at study start, improvement in physical function and FACIT- fatigue was maintained through week 52.
Pri bolnikih, ki so ostali na zdravljenju z apremilastom, na katerega so bili randomizirani v začetku študije, se je izboljšanje telesnega delovanja in FACIT-utrujenost ohranilo do vključno 52. tedna.
DMARDs N=159
N=159
In PALACE 1, PALACE 2 and PALACE 3, improvements in Disease Activity Scale (DAS) 28 C-reactive protein (CRP) and in the proportion of patients achieving a modified PsA response criteria (PsARC) were greater in the apremilast group, compared to placebo at week 16 (nominal p-value p< 0.0004, p-value ≤0.0017, respectively).
V študijah PALACE 1, PALACE 2 in PALACE 3 so bila po 16 tednih izboljšanja na lestvici aktivnosti bolezni (DAS - Disease Activity Scale) 28 C-reaktivni protein (CRP) in v deležu bolnikov, ki so dosegli merila modificiranega odziva PsA (PsARC), večja v skupini z apremilastom v primerjavi s placebom (nominalna vrednost p je bila p<0,0004 oziroma p≤0,0017).
Psoriatic Arthritis
Psoriatični artritis
In a male mouse fertility study, apremilast at oral dosages of 1, 10, 25, and 50 mg/kg/day produced no effects on male fertility; the no observed adverse effect level (NOAEL) for male fertility was greater than 50 mg/kg/day 3-fold clinical exposure).
V študiji plodnosti mišjih samcev apremilast v peroralnih odmerkih 1, 10, 25 in 50 mg/kg/dan ni vplival na plodnost samcev; raven brez opaznega neželenega učinka (no observed adverse effect level (NOAEL)) za plodnost samcev je bila večja od 50 mg/kg/dan (3-kratna klinična izpostavljenost).
The use of low potency topical corticosteroids on the face, axillae, and groin, coal tar shampoo and/or salicylic acid scalp preparations was permitted throughout the studies.
Ves čas študij je bila dovoljena uporaba šibkih lokalnih kortikosteroidov na obrazu, v pazduhah in dimljah, šampona s premogovim katranom in/ali pripravkov za lasišče s salicilno kislino.