natgillin/translations-raw huggingface dataset:
In Studies ESTEEM 1 and ESTEEM 2, significant improvements in quality of life as measured by the Dermatology Life Quality Index (DLQI) and the SF-36v2MCS were demonstrated in patients receiving apremilast compared with placebo-treated patients (Table 4). 
U ispitivanjima ESTEEM 1 i ESTEEM 2, značajna poboljšanja u kvaliteti života mjerenoj prema dermatološkom indeksu kvalitete života (DLQI) i rezultatima SF-36v2MCS, pokazala su se u bolesnika koji su primali apremilast u usporedbi s onima koji su primali placebo (tablica 4).
Reductions in maternal body weight and weight gain, and one death associated with difficulty in delivering pups were observed at 300 mg/kg/day. 
Smanjenja u težini majke i dobivanje na težini te jedna smrt povezana s teškim okotom mladunčadi bile su opažene pri dozi od 300 mg/kg na dan.
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). 
Nakon 52 tjedna liječenja bolesnici su mogli nastaviti primati apremilast od 30 mg u dugoročnim otvorenim nastavcima ispitivanja ESTEEM 1 i ESTEEM 2 s ukupnim trajanjem liječenja do 5 godina (260 tjedana).
Placebo patients who were considered non-responders were rerandomised 1:1 in a blinded fashion to either apremilast 20 mg twice daily or 30 mg twice daily. 
Bolesnici koji su primali placebo i za koje se smatralo da nisu odgovorili na liječenje, bili su ponovno randomizirani u omjeru 1:1 na slijepi način kako bi primali apremilast od 20 mg dvaput na dan ili 30 mg dvaput na dan.
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. 
U prenatalnom i postnatalnom ispitivanju, apremilast je peroralno primijenjen skotnim ženkama miša u dozama od 10, 80 i 300 mg/kg na dan od 6. dana gestacije do 20. dana laktacije.
Otezla contains the active substance ‘apremilast'. 
Otezla sadrži djelatnu tvar apremilast.
Among patients who remained on the apremilast treatment to which they were randomised at study start, these improvements were maintained through week 52. 
Među bolesnicima koji su ostali na terapiji apremilastom na koju su randomizirani na početku ispitivanja, ova poboljšanja održala su se do 52. tjedna.
The maternal and developmental NOEL in the mouse was 10 mg/kg/day (1.3-fold clinical exposure). 
Maternalni i razvojni NOEL u miševa bio je 10 mg/kg na dan (1,3 puta veće od kliničke izloženosti).
The no observed effect level (NOEL) for female fertility was 10 mg/kg/day (1.0-fold clinical exposure). 
Razina pri kojoj nije opažen učinak (NOEL) na plodnost ženki bila je 10 mg/kg na dan (1,0 puta veća od kliničke izloženosti).
Apremilast undergoes extensive metabolism with only 3% and 7% of the administered parent compound recovered in urine and faeces, respectively. 
Apremilast se opsežno metabolizira, s tim da se od primijenjenog osnovnog spoja samo 3% nađe u mokraći, a 7% u stolici.
The NOEL in the mouse for maternal toxicity and F1 generation was 10 mg/kg/day (1.3-fold clinical AUC). 
NOEL u miševa za maternalnu toksičnost i F1 naraštaj bio je 10 mg/kg na dan (1,3 puta veći od kliničkog AUC-a).
Following 52 weeks of treatment, patients could continue on open label apremilast 20 mg or 30 mg within the long-term extension of the PALACE 1, PALACE 2, and PALACE 3 studies for a total duration of treatment up to 5 years (260 weeks). 
Nakon 52 tjedna liječenja bolesnici su mogli nastaviti s primjenom apremilasta od 20 mg ili 30 mg u dugoročnim otvorenim nastavcima ispitivanja PALACE 1, PALACE 2 i PALACE 3, s ukupnim trajanjem liječenja do 5 godina (260 tjedana).
INFORMATION IN BRAILLE Otezla 30 mg 
16. PODACI NA BRAILLEOVOM PISMU Otezla 30 mg
Clinical improvement measured by sPGA, PASI-50 and PASI-90 responses were also demonstrated at week 16. 
U 16. tjednu pokazalo se također kliničko poboljšanje mjereno kao rezultat sPGA, PASI-50 i PASI-90.
Proportion of patients with ACR responses in studies PALACE 1, PALACE 2 and PALACE 3 and pooled studies at week 16 
Udio bolesnika s odgovorima ACR u ispitivanjima PALACE 1, PALACE 2 i PALACE 3 te objedinjenim ispitivanjima u 16. tjednu
In Study ESTEEM 1, patients randomised to apremilast at the start of the study who did not achieve a PASI75 response at week 32 were permitted to use concomitant topical therapies and/or UVB phototherapy between weeks 32 to 52. 
U ispitivanju ESTEEM 1, bolesnicima randomiziranim na apremilast na početku ispitivanja koji nisu postigli odgovor PASI-75 u 32. tjednu bile su dopuštene primjena istodobne topikalne terapije i/ili UVB fototerapija između 32. i 52. tjedna.
The results support that no dose adjustment is needed in patients with mild and moderate renal impairment. 
Rezultati potvrđuju da nije potrebna prilagodba doze u bolesnika s blagim i umjerenim oštećenjem funkcije bubrega.
Among 832 patients initially randomised to apremilast 30 mg twice daily, 443 patients (53%) entered the open-label extension studies of ESTEEM 1 and ESTEEM 2, and of these 115 patients (26%) were still on treatment at week 260. 
Od 832 bolesnika prvotno randomizirana na apremilast od 30 mg dvaput na dan, 443 (53%) bolesnika uključena su u otvorene nastavke ispitivanja ESTEEM 1 i ESTEEM 2, a od njih je 115 (26%) primalo terapiju još i u 260. tjednu.
In addition, at week 32, subjects who did not achieve a PASI-75 response in ESTEEM 1, or a PASI-50 response in ESTEEM 2, were permitted to use topical psoriasis therapies and/or phototherapy in addition to apremilast 30 mg twice daily treatment. 
Nadalje, u 32. tjednu, ispitanicima koji nisu postigli odgovor PASI-75 u ispitivanju ESTEEM 1 ili odgovor PASI-50 u ESTEEM 2, bila je dopuštena primjena topikalnih terapija za psorijazu i/ili fototerapija uz terapiju apremilastom od 30 mg dvaput na dan.
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 10 mg, 20 mg or 30 mg of apremilast. 
NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadrži 10 mg, 20 mg ili 30 mg apremilasta.
Among 497 patients initially randomised to apremilast 30 mg twice daily, 375 (75%) patients were still on this treatment on week 52. 
Od 497 bolesnika koji su na početku ispitivanja randomizirani na apremilast od 30 mg dvaput na dan, 375 (75%) bolesnika bilo je još uvijek na toj terapiji u 52. tjednu.
Patients with hepatic impairment No dose adjustment is necessary for patients with hepatic impairment (see section 5.2). 
U bolesnika s oštećenjem funkcije jetre nije potrebna prilagodba doze (vidjeti dio 5.2).
Among patients who were initially randomised to apremilast 30 mg twice daily treatment, the change from baseline in the HAQ-DI score at week 52 was -0.333 in the apremilast 30 mg twice daily group in a pooled analysis of the open label phase of studies PALACE 1, PALACE 2 and PALACE 3. 
Među bolesnicima koji su na početku ispitivanja randomizirani na terapiju apremilastom od 30 mg dvaput na dan, promjena rezultata HAQ-DI u 52. tjednu u odnosu na početni rezultat iznosila je -0,333 u skupini koja je primala apremilast od 30 mg dvaput na dan u analizi objedinjenih podataka otvorene faze ispitivanja PALACE 1, PALACE 2 i PALACE 3.
Figure 1 Proportion of ACR 20/50/70 responders through week 52 in the pooled analysis of studies PALACE 1, PALACE 2 and PALACE 3 (NRI*) 
Slika 1 Udio bolesnika koji su postigli odgovore ACR 20/50/70 do 52. tjedna u analizi objedinjenih ispitivanja PALACE 1, PALACE 2 i PALACE 3 (NRI*)
19 film-coated tablets of 30 mg 
19 filmom obloženih tableta od 30 mg
bN is based on subjects with moderate or greater scalp psoriasis at baseline who were re-randomised to APR 30 twice daily at week 32. 
N se odnosi na ispitanike s umjerenom ili većom psorijazom vlasišta na početku koji su u 32. tjednu ponovno randomizirani na APR 30 dvaput na dan.
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). 
Učestalosti nuspojava na lijek odnose se na nuspojave koje su prijavljene u skupini koja je primala apremilast u četiri ispitivanja faze III psorijatičnog artritisa (n = 1945) ili dva ispitivanja faze III psorijaze (n = 1184) (najveća učestalost iz jednog ili drugog skupa objedinjenih podataka prikazana je u tablici 2).
Common side effects (may affect up to 1 in 10 people) 
Česte nuspojave (mogu se pojaviti u do 1 na 10 osoba)
During the Randomised Treatment Withdrawal Phase (weeks 32-52), patients originally randomised to apremilast who achieved at least a 75% reduction in their PASI score (PASI-75) (ESTEEM 1) or a 50% reduction in their PASI score (PASI-50) (ESTEEM 2) were re-randomised at week 32 to either placebo or apremilast 30 mg twice daily. 
Za vrijeme faze obustave randomiziranog liječenja (od 32. do 52. tjedna), bolesnici koji su najprije bili randomizirani na apremilast i koji su u rezultatu PASI imali smanjenje od najmanje 75% (PASI-75) (ESTEEM 1) ili smanjenje od 50% u rezultatu PASI (PASI-50) (ESTEEM 2) bili su ponovno randomizirani u 32. tjednu na placebo ili apremilast od 30 mg dvaput na dan.
Improvements in DLQI were maintained through week 52 in subjects who were re-randomised to apremilast at week 32 (Table 5). 
Poboljšanja u DLQI održala su se do 52. tjedna u ispitanika koji su ponovno randomizirani na apremilast u 32. tjednu (tablica 5).
Increased numbers of early resorptions and reduced numbers of ossified tarsals were observed at 20, 40, and 80 mg/kg/day. 
Veći broj ranih resorpcija i smanjeni broj osifikacija tarzalnih kostiju opaženi su pri dozama od 20, 40 i 80 mg/kg na dan.
Uncommon side effects (may affect up to 1 in 100 people) 
Manje česte nuspojave (mogu se pojaviti u do 1 na 100 osoba)
Otezla 30 mg tablets apremilast 
Otezla 30 mg tablete apremilast
MARKETING AUTHORISATION NUMBER(S) EU/1/14/981/001 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/981/001
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). 
U ispitivanju plodnosti mužjaka miševa, apremilast u peroralnim dozama od 1, 10, 20 i 50 mg/kg na dan nije prouzročio učinke na plodnost mužjaka; razina doze bez opaženog štetnog učinka (NOAEL) na plodnost mužjaka bila je veća od 50 mg/kg na dan (3 puta veća od kliničke izloženosti).
In both studies, the mean percent improvement in PASI from baseline remained stable during the Randomised Treatment Withdrawal Phase for patients re-randomised to apremilast at week 32 (Table 5). 
U oba ispitivanja, srednja vrijednost postotka poboljšanja u rezultatu PASI u odnosu na početnu vrijednost ostala je stabilna tijekom faze obustave randomiziranog liječenja u bolesnika koji su ponovno randomizirani na apremilast u 32. tjednu (tablica 5).
Apremilast is the major circulating component following oral administration. 
Nakon peroralne primjene apremilast je glavna cirkulirajuća komponenta.
Driving and using machines Otezla has no effect on the ability to drive and use machines. 
Otezla ne utječe na sposobnost upravljanja vozilima i strojevima.
Reduced foetal weights and retarded ossification of the supraoccipital bone of the skull were observed at 40 and 80 mg/kg/day. 
Smanjene fetalne težine i zakašnjela osifikacija supraokcipitalne kosti lubanje opaženi su pri dozama od 40 i 80 mg/kg na dan.
Otezla should be dose reduced to 30 mg once daily in patients with severe renal impairment (see sections 4.2 and 5.2). 
U bolesnika s teškim oštećenjem funkcije bubrega, dozu lijeka Otezla potrebno je smanjiti na 30 mg jedanput na dan (vidjeti dijelove 4.2 i 5.2).
In a monkey embryo-foetal developmental toxicity study, oral dosages of 20, 50, 200, and 1000 mg/kg/day resulted in a dose-related increase in prenatal loss (abortions) at dosages of 50 mg/kg/day and above; no test article-related effect in prenatal loss was observed at 20 mg/kg/day (1.4-fold clinical exposure). 
U ispitivanju embriofetalne razvojne toksičnosti u majmuna, peroralne doze od 20, 50, 200 i 1000 mg/kg na dan rezultirale su povećanjem prenatalnog gubitka (pobačaji) povezanim s dozom i to pri dozama od 50 mg/kg na dan i višim; učinak povezan s ispitivanim lijekom nije opažen u prenatalnom gubitku pri dozama od 20 mg/kg na dan (1,4 puta veća od kliničke izloženosti).
Suicidal ideation and behaviour 
Manje često suicidalne ideje i ponašanje
MARKETING AUTHORISATION NUMBER(S) EU/1/14/981/002 56 film-coated tablets EU/1/14/981/003 168 film-coated tablets 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/981/002 56 filmom obloženih tableta EU/1/14/981/003 168 filmom obloženih tableta
Patient weight was measured routinely in clinical studies. 
U kliničkim ispitivanjima redovito je mjerena težina bolesnika.
Upper respiratory tract infection Nasopharyngitis* 
Često bronhitis infekcije gornjih dišnih puteva nazofaringitis*
• The other ingredients in the tablet core are cellulose microcrystalline, lactose monohydrate, 
• Drugi sastojci jezgre tablete su mikrokristalična celuloza, laktoza hidrat, umrežena karmelozanatrij i magnezijev stearat.
Among 497 patients initially randomised to apremilast 30 mg twice daily, 375 (75%) patients entered the long term extension studies, and of these, 221 patients (59%) were still on this treatment at week 260. 
Od 497 bolesnika koji su na početku ispitivanja randomizirani na apremilast od 30 mg dvaput na dan, 375 (75%) bolesnika uključeno je u dugoročne produžetke ispitivanja, a od njih je 221 bolesnik (59%) bio na toj terapiji još i u 260. tjednu.
Otezla 10 mg film-coated tablets Otezla 20 mg film-coated tablets Otezla 30 mg film-coated tablets apremilast 
Otezla 10 mg filmom obložene tablete Otezla 20 mg filmom obložene tablete Otezla 30 mg filmom obložene tablete apremilast
Underweight patients 
Pothranjeni bolesnici
Pregnancy should be excluded before treatment can be initiated. 
Da bi se moglo započeti s liječenjem mora se isključiti trudnoća.
a FAS = Full Analysis Set b LOCF= Last Observation Carried forward c PASI = Psoriasis Area and Severity Index d sPGA = Static Physician Global Assessment e BSA = Body Surface Area f VAS = Visual Analog Scale; 0 = best, 100 = worst g DLQI = Dermatology Life Quality Index; 0 = best, 30 = worst h SF-36 MCS = Medical Outcome Study Short Form 36-Item Health Survey, Mental Component Summary 
* p < 0,0001 za apremilast naspram placeba, osim za ESTEEM 2 PASI 90 i promjenu u SF-36 MCS gdje je p = 0,0042 odnosno p = 0,0078. a FAS = svi ispitanici za analizu b LOCF = prijenos zadnjeg opažanja c PASI = pokazatelj površine i stupnja težine psorijaze d sPGA = statička opća liječnička procjena e BSA = površina tijela f VAS = vizualna analogna ljestvica; 0 = nema svrbeža, 100 = najjači svrbež g DLQI = dermatološki indeks kvalitete života; 0 = bez utjecaja, 30 = osobito jak utjecaj h SF-36 MCS = kratki upitnik o zdravstvenom stanju od 36 čestica kao dio ispitivanja medicinskih ishoda liječenja, mentalno zdravlje
NAME OF THE MARKETING AUTHORISATION HOLDER Celgene 
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Celgene
People with severe kidney problems 
Osobe s teškim bubrežnim tegobama
If you forget to take Otezla 
Ako ste zaboravili uzeti lijek Otezla
MARKETING AUTHORISATION NUMBER(S) Otezla 10 mg, 20 mg, 30 mg film-coated tablets (initiation pack) EU/1/14/981/001 
Otezla 10 mg, 20 mg, 30 mg filmom obložene tablete (pakiranje za započinjanje liječenja) EU/1/14/981/001
In Study ESTEEM 1, approximately 61% of patients re-randomised to apremilast at week 32 had a PASI-75 response at week 52. 
U ispitivanju ESTEEM 1, približno 61% bolesnika ponovno randomiziranih na apremilast u 32. tjednu imalo je odgovor PASI-75 u 52. tjednu.
The proportion of patients with ACR 20/50/70 (responses in studies PALACE 1, PALACE 2 and PALACE 3, and the pooled data for studies PALACE 1, PALACE 2 and PALACE 3) for apremilast 30 mg twice daily at week 16 are shown in Table 3. 
Udio bolesnika s odgovorima ACR 20/50/70 (u ispitivanjima PALACE 1, PALACE 2 i PALACE 3 te objedinjenim podacima ispitivanja PALACE 1, PALACE 2 i PALACE 3) za apremilast od 30 mg dvaput na dan u 16. tjednu prikazani su u tablici 3. Odgovori ACR 20/50/70 održali su se do 24. tjedna.
DMARDs N=497 
DMARD terapija N=497
• The one-month standard pack contains 56 x 30 mg film-coated tablets. 
• Standardno pakiranje za mjesec dana liječenja sadrži 56 filmom obloženih tableta x 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. 
Među bolesnicima koji su ostali na terapiji apremilastom, na koju su bili randomizirani na početku ispitivanja, poboljšanje fizičkog funkcioniranja i rezultata za FACITumor održalo se do 52. tjedna.
No dosage adjustment is necessary for elderly patients. 
U bolesnika starije dobi nije potrebna prilagodba doze.
Day 5 
5. dan
Of the patients with at least a PASI-50 response who were re-randomised to placebo at week 32, 24.2% were PASI-50 responders at week 52. 
Od bolesnika s odgovorom najmanje PASI-50, koji su u 32. tjednu ponovno randomizirani na placebo, 24,2% imalo je odgovor PASI-50 u 52. tjednu.
DMARDs N=159 
DMARD terapija N=159
In a combined female mouse fertility and embryo-foetal developmental toxicity study with oral dosages of 10, 20, 40, and 80 mg/kg/day, a prolongation of oestrous cycles and increased time to mating were observed at 20 mg/kg/day and above; despite this, all mice mated and pregnancy rates were unaffected. 
U kombiniranom ispitivanju plodnosti ženke miša i embriofetalne razvojne toksičnosti pri peroralnim dozama od 10, 20, 40 i 80 mg/kg na dan, produljenje ciklusa estrusa i dulje vrijeme do parenja opaženo je pri dozi od 20 mg/kg na dan i višoj; unatoč tome, svi su se miševi parili i stope skotnosti nisu se promijenile.
30 mg (beige) 
30 mg (bež)
• hives (urticaria) 
• koprivnjača (urtikarija)
In Study ESTEEM 2, approximately 80.3% of patients re-randomised to apremilast at week 32 had a PASI50 response at week 52. 
U ispitivanju ESTEEM 2, približno 80,3% bolesnika ponovno randomiziranih na apremilast u 32. tjednu imalo je odgovor PASI-50 u 52. tjednu.
4 film-coated tablets of 20 mg 
4 filmom obložene tablete od 20 mg
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). 
Disease Activity Scale, DAS) u 28 zglobova na temelju razine C-reaktivnog proteina (CRP) te poboljšanja u udjelu bolesnika koji su postigli odgovor prema modificiranim kriterijima za procjenu odgovora u psorijatičnom artritisu (PsARC) bila su veća u skupini koja je primala apremilast u usporedbi s placebom u 16. tjednu (nominalna p-vrijednost p ≤ 0,0004 odnosno p ≤ 0,0017).
Change in Pruritus VASf (mm), mean± SD Change in DLQIg, mean± SD 
Postotak promjene u BSAe (%) srednja vrijednost ± SD Promjena u pruritusu VASf (mm), srednja vrijednost ± SD
The adverse reactions observed in patients treated with apremilast are listed below by system organ class (SOC) and frequency for all adverse reactions. 
Nuspojave opažene u bolesnika liječenih apremilastom navedene su u nastavku prema klasifikaciji organskih sustava i učestalosti svih nuspojava.
Each film-coated tablet contains 171 mg of lactose (as lactose monohydrate). 
Jedna filmom obložena tableta sadrži 171 mg laktoze (u obliku laktoze hidrata).
Each film-coated tablet contains 57 mg of lactose (as lactose monohydrate). 
Jedna filmom obložena tableta sadrži 57 mg laktoze (u obliku laktoze hidrata).
The improvements were generally maintained in subjects who were re-randomised to apremilast at week 32 through week 52 (Table 5). 
Poboljšanja su se obično održala u ispitanika koji su od 32. do 52. tjedna ponovno randomizirani na apremilast (tablica 5).
Summary of adverse reactions in psoriatic arthritis (PsA) and/or psoriasis (PSOR) 
Tablica 2. Sažeti prikaz nuspojava kod psorijatičnog artritisa (PsA) i/ili psorijaze (PSOR) Klasifikacija organskih sustava
Each film-coated tablet contains 114 mg of lactose (as lactose monohydrate). 
Jedna filmom obložena tableta sadrži 114 mg laktoze (u obliku laktoze hidrata).
Otezla is for oral use. 
Otezla je za peroralnu primjenu.
4.4 Special warnings and precautions for use 
4.4 Posebna upozorenja i mjere opreza pri uporabi Proljev, mučnina i povraćanje
The 30 mg tablets also contain iron oxide yellow (E172) and iron oxide black (E172). 
Tablete od 30 mg sadrže također žuti željezov oksid (E172) i crni željezov oksid (E172).
No dose adjustment is needed in patients with mild and moderate renal impairment. 
Nije potrebna prilagodba doze u bolesnika s blagim i umjerenim oštećenjem funkcije bubrega.
DMARDs N=496 
DMARD terapija N=496
Of the patients with at least a PASI-75 response who were re-randomised to placebo at week 32 during a Randomised Treatment Withdrawal Phase, 11.7% were PASI-75 responders at week 52. 
Od bolesnika s odgovorom najmanje PASI-75, koji su u fazi obustave randomiziranog liječenja u 32. tjednu ponovno randomizirani na placebo, 11,7% imalo je odgovor PASI-75 u 52. tjednu.
Time Point 
Vremenska točka procjene
• Otezla 20 mg film-coated tablets: each film-coated tablet contains 20 mg of apremilast. 
• Otezla 20 mg filmom obložena tableta: jedna filmom obložena tableta sadrži 20 mg apremilasta.
One qualifying psoriatic skin lesion (at least 2 cm in diameter) was also required in PALACE 3. 
Za uključivanje u ispitivanje PALACE 3, kriterij je bilo i postojanje jedne psorijatične lezije na koži (promjera najmanje 2 cm).
Patients who were re-randomised to placebo and who lost PASI-75 response (ESTEEM 1) or lost 50% of the PASI improvement at week 32 compared to baseline (ESTEEM 2) were retreated with apremilast 30 mg twice daily. 
Bolesnici koji su prema toj ponovnoj randomizaciji primali placebo, a koji su u usporedbi s početnim vrijednostima u 32. tjednu izgubili odgovor PASI-75 (ESTEEM 1) ili su izgubili 50%-tno poboljšanje u rezultatu PASI (ESTEEM 2), vraćeni su na terapiju apremilastom od 30 mg dvaput na dan.
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. 
Sigurnost i djelotvornost apremilasta bile su procijenjene u dva multicentrična, randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja (ispitivanja ESTEEM 1 i ESTEEM 2), u koja je bilo uključeno ukupno 1257 bolesnika s umjerenom do teškom plak psorijazom koja je zahvaćala ≥ 10% tjelesne površine (engl.
Otezla contains lactose 
Otezla sadrži laktozu
Improved physical function as assessed by the HAQ-DI and the SF36v2PF domain, and the FACIT-fatigue scores were maintained in the open-label extension studies for up to 5 years of treatment. 
U otvorenim nastavcima ispitivanja, poboljšanje fizičkog funkcioniranja procijenjeno na temelju upitnika HAQ-DI i domene PF upitnika SF-36v2 te rezultata za FACIT-umor održalo se do 5 godina liječenja.
• Otezla 30 mg film-coated tablets: each film-coated tablet contains 30 mg of apremilast. 
• Otezla 30 mg filmom obložena tableta: jedna filmom obložena tableta sadrži 30 mg apremilasta.
• Otezla 10 mg film-coated tablets: each film-coated tablet contains 10 mg of apremilast. 
• Otezla 10 mg filmom obložena tableta: jedna filmom obložena tableta sadrži 10 mg apremilasta.