natgillin/translations-raw huggingface dataset:
Enbrel 62% and 59%, placebo 23% and 11% at 3 and 6 months respectively:
Odstotek bolnikov, ki so po 3 oziroma 6 mesecih dosegli odziv ACR 20 ali ACR 50, je bil v skupini bolnikov, ki so bili zdravljeni z zdravilom Enbrel, večji kot pri bolnikih, ki so prejemali placebo (ACR 20, po 3 oziroma 6 mesecih: zdravilo Enbrel 62% oziroma 59%, placebo 23% oziroma 11%; ACR 50, po 3 oziroma 6 mesecih: zdravilo Enbrel 41% oziroma 40%, placebo 8% oziroma 5%; p < 0, 01 za zdravilo Enbrel proti placebu v vseh časovnih točkah, tako za odziv ACR 20 kot za odziv ACR 50).
Continued durable responses have been seen for up to 48 months in open-label extension treatment trials when patients received Enbrel without interruption; longer-term experience in not available.
Dolgotrajna odzivnost na neprekinjeno zdravljenje z zdravilom Enbrel je bila v odprtih podaljšanih kliničnih raziskavah potrjena za obdobja do 48 mesecev; izkušenj z daljšim zdravljenjem še ni.
The efficacy of Enbrel was compared to methotrexate in a randomised, active-controlled study with blinded radiographic evaluations as a primary endpoint in 632 adult patients with active rheumatoid arthritis (< 3 years duration) who had never received treatment with methotrexate.
V randomizirani aktivno kontrolirani raziskavi s slepo radiografsko oceno kot primarnim opazovanim dogodkom so primerjali učinkovitost zdravila Enbrel z učinkovitostjo metotreksata pri 632 odraslih bolnikih z aktivnim revmatoidnim artritisom (trajanje bolezni manj kot 3 leta), ki se prej niso zdravili
Enbrel 25
metotreksat Enbrel 25 mg
147 CLINICAL EFFICACY RESULTS AT 12 MONTHS:
140 KLINIČNA UČINKOVITOST PO 12 MESECIH:
COMPARISON OF ENBREL vs METHOTREXATE vs ENBREL IN COMBINATION WITH METHOTREXATE IN PATIENTS WITH RA OF 6 MONTHS TO 20 YEARS DURATION Enbrel + Endpoint
PRIMERJAVA MED ZDRAVILOM ENBREL, METOTRAKSATOM IN KOMBINACIJO ZDRAVILA ENBREL IN METOTREKSATA PRI BOLNIKIH Z REVMATOIDNIM ARTRITISOM (TRAJANJE BOLEZNI OD 6 MESECEV DO 20 LET) zdravilo Enbrel + metotreksat
Methotrexate
Opazovani dogodek
Enbrel
metotreksat
Methotrexate
zdravilo Enbrel
148 RADIOGRAPHIC PROGRESSION:
141 RENTGENSKO NAPREDOVANJE:
149 Adult patients with plaque psoriasis
142 Odrasli bolniki s psoriazo v plakih
Enbrel is recommended for use in patients as defined in section 4.1.
Zdravilo Enbrel priporočajo za uporabo pri bolnikih, kot je opredeljeno v poglavju 4. 1.
Patients who “ failed to respond to” in the target population is defined by insufficient response (PASI < 50 or PGA less than good), or worsening of the disease while on treatment, and who were adequately dosed for a sufficiently long duration to assess response with at least each of the three major systemic therapies as available.
Bolnike v ciljni populaciji, ki “ se niso odzvali ”, opredeljuje nezadosten odziv (PASI < 50 ali PGA – Physician Global Assesment - manj kot dober) ali poslabšanje bolezni med zdravljenjem, ko je bolnik prejemal najmanj vsako od treh glavnih razpoložljivih sistemskih zdravljenj v zadostnem odmerku in dovolj časa, da je bilo možno oceniti odziv.
Instead, the safety and efficacy of Enbrel were assessed in four randomised, double-blind, placebo-controlled studies.
Učinkovitosti zdravila Enbrel v primerjavi z drugimi sistemskimi zdravljenji pri bolnikih z zmerno do hudo psoriazo (ki se odziva na druga sistemska zdravljenja) niso ovrednotili s študijami, v katerih bi neposredno orimerjali zdravilo Enbrel z drugimi sistemskimi terapijami. tega so varnost in učinkovitost zdravila Enbrel ocenili v štirih randomiziranih, dvojno slepih, s placebom kontroliranih študijah.
The primary efficacy endpoint in all four studies was the proportion of patients in each treatment group who achieved the PASI 75 (i. e., at least a 75% improvement in the Psoriasis Area and Severity Index score from baseline) at 12 weeks.
Primarni opazovani dogodek učinkovitosti v vseh štirih študijah je bil tisti delež bolnikov v vsaki terapevtski skupini, ki je po 12 tednih dosegel PASI 75 (tj. vsaj 75- odstotno izboljšanje indeksa PASI – Psoriasis Area and Severity Index; indeks površine in izrazitosti psoriaze - v primerjavi z izhodiščem).
Study 1 was a Phase 2 study in patients with active but clinically stable plaque psoriasis involving  10% of the body surface area that were  18 years old.
Študija 1 je bila študija 2. faze pri bolnikih, starih ≥ 18 let, z aktivno, a klinično stabilno psoriazo v plakih, ki je zajemala ≥ 10% površine telesa.
Study 2 evaluated 652 patients with chronic plaque psoriasis using the same inclusion criteria as study 1 with the addition of a minimum psoriasis area and severity index (PASI) of 10 at screening.
Študija 2 je ocenila 652 bolnikov s kronično psoriazo v plakih in je imela enaka vključitvena merila kot študija 1, le da so imeli bolniki ob presejanju dodatno še minimalen predel s psoriazo in indeks PASI vsaj 10.
In study 1, the Enbrel-treated group had a significantly higher proportion of patients with a PASI 75 response at week 12 (30%) compared to the placebo-treated group (2%) (p < 0.0001).
V študiji 1 je bil v 12. tednu delež bolnikov z odzivom PASI 75 signifikantno večji v skupini, zdravljeni z zdravilom Enbrel (30%), kot v skupini, ki je dobivala placebo (2%) (p < 0, 0001).
At 24 weeks, 56% of patients in the Enbrel-treated group had achieved the PASI 75 compared to 5% of placebo-treated patients.
V 24. tednu je 56% bolnikov doseglo PASI 75 v skupini, zdravljeni z zdravilom Enbrel, v skupini s placebom pa 5% bolnikov.
150 RESPONSES OF PATIENTS WITH PSORIASIS IN STUDIES 2, 3 AND 4 ------------------Study 2--------------- ---------------Study 3------------- ---------------Study 4-------------
143 ODZIVI BOLNIKOV S PSORIAZO V ŠTUDIJAH 2, 3 IN 4 ------------------- Študija 2 ---------------- -------------- Študija 3 ---------- -------------- Študija 4 ------------ --
--
-----
--------Enbrel--------- --------Enbrel-------
--- Zdravilo Enbrel -------- --- Zdravilo Enbrel --- - 25 mg 50 mg
-------Enbrel------
---- Zdravilo Enbrel ----
25 mg
25
50 mg
mg 50 mg 2x/ tede 2x/ tede
Placebo
50 mg 50 mg
BIW
2x/ teden
BIW Placebo BIW BIW Placebo QW
2x/ teden n=
166 n = n = n = n = n = 193 n = 196 n = 196 n = 46
n = 196
wk 12 wk 12 wk
162 24. tedena
wk 12
teden
PASI 50 PASI 75 DSGA b, clear or almost
PASI 50
14 58* 70 74* 77 9 4 34* 44 49* 59 3
14
64* 77* 34* 49*
77 *
9 2
9
69* 38*
69 *
83 71
71
clear
čisto
*p  0.0001 compared with placebo a.
* p ≤ 0, 0001 v primerjavi s placebom a.
No statistical comparisons to placebo were made at week 24 in studies 2 and 4 because the original placebo group began receiving Enbrel 25 mg BIW or 50 mg once weekly from week 13 to week 24. b.
V študijah 2 in 4 po 24 tednih niso opravili statističnih primerjav s placebom, ker je skupina, ki je prvotno dobivala placebo, začela dobivati 25 mg zdravila Enbrel dvakrat na teden ali 50 mg enkrat na teden od 13. do 24. tedna. b.
Study 2 also had a drug withdrawal period during which patients who achieved a PASI improvement of at least 50% at week 24 had treatment stopped.
Študija 2 je vključevala tudi obdobje odtegnitve zdravila, med katerim so zdravljenje prekinili bolniki, ki so 24. teden dosegli izboljšanje PASI za vsaj 50%.
In study 3, the majority of patients (77%) who were initially randomised to 50 mg twice weekly and had their Enbrel dose decreased at week 12 to 25 mg twice weekly maintained their PASI 75 response through week 36.
V šudiji 3 je večina bolnikov (77%), ki so bili uvodoma randomizirani na 50 mg dvakrat na teden in so jim odmerek zdravila Enbrel po 12 tednih znižali na 25 mg dvakrat na teden, odziv PASI 75 ohranila do 36. tedna.
For patients who received 25 mg twice weekly throughout the study, the PASI 75 response continued to improve between weeks 12 and 36.
Pri štirih bolnikih, ki so dobivali 25 mg dvakrat na teden ves čas študije, se je PASI 75 med 12. in 36. tednom še naprej izboljševal.
In study 4, the Enbrel-treated group had a higher proportion of patients with PASI 75 at week 12 (38%) compared to the placebo-treated group (2%) (p < 0.0001).
V študiji 4 je bil v 12. tednu delež bolnikov z odzivom PASI 75 večji v skupini, zdravljeni z zdravilom Enbrel (38%), kot v skupini, ki je dobivala placebo (2%) (p < 0, 0001).
For patients who received 50 mg once weekly throughout the study, the efficacy responses continued to improve with 71% achieving PASI 75 at week 24.
Pri bolnikih, ki so dobivali 50 mg enkrat na teden ves čas študije, so se učinkovitostni odzivi še naprej izboljševali, tako da jih je v 24. tednu 71% doseglo PASI 75.
Eligible patients had a history of receiving phototherapy or systemic therapy, or were inadequately controlled on topical therapy.
144 Bolniki, primerni za vključitev v študijo, so imeli v anamnezi bodisi fototerapijo bodisi sistemsko terapijo ali pa z lokalno terapijo njihove bolezni ni bilo mogoče zadostno obvladati.
151 Patients received Enbrel 0.8 mg/ kg (up to 50 mg) or placebo once weekly for 12 weeks.
Bolniki so 12 tednov enkrat na teden prejemali zdravilo Enbrel v odmerku 0, 8 mg/ kg (do 50 mg) ali placebo.
152 Paediatric patients with polyarticular juvenile idiopathic arthritis
145 Otroci s poliartikularnim juvenilnim idiopatskim artritisom
Although there is elimination of radioactivity in urine after administration of radiolabelled etanercept to patients and volunteers, increased etanercept concentrations were not observed in patients with acute renal or hepatic failure.
Čeprav se pri prostovoljcih in pri bolnikih po prejemu radioaktivno označenega etanercepta le- ta izloča v urinu, ni zaznati povečanih koncentracij etanercepta pri bolnikih z akutno odpovedjo ledvic ali jeter.
153 Methotrexate has no effect on the pharmacokinetics of etanercept.
146 Metotreksat ne vpliva na farmakokinetiko etanercepta.
Water for injections Benzyl alcohol.
Vehikel: voda za injekcije, benzilalkohol.
After reconstitution, chemical and physical stability has been demonstrated for 14 days at 2 C – 8 C.
Po pripravi sta kemična in fizikalna stabilnost med uporabo dokazani za 14 dni pri temperaturi od 2 °C do 8 °C.
From a microbiological point of view, once reconstituted, the product may be stored for a maximum of 14 days at 2 C – 8 C.
Z mikrobiološkega stališča je lahko pripravljeno zdravilo shranjeno največ 14 dni po pripravi pri temperaturi od 2 °C do 8 °C.
Other storage times and conditions are the responsibility of the user.
Drugi časi shranjevanja in pogoji med uporabo so odgovornost uporabnika.
154 6.5 Nature and contents of container
6. 5 Vrsta ovojnine in vsebina
Enbrel is supplied with pre-filled syringes containing bacteriostatic water for injections.
Zdravilu Enbrel je priložena napolnjena injekcijska brizga, ki vsebuje bakteriostatsko vodo za injekcije.
Cartons contain 4 vials of Enbrel with 4 pre-filled solvent syringes, 8 empty plastic syringes, 20 stainless steel needles and 24 alcohol swabs.
Vsaka škatla vsebuje po 4 viale zdravila Enbrel, 4 z vehiklom napolnjene injekcijske brizge, 8 praznih plastičnih brizg, 20 igel iz nerjavečega jekla in 24 alkoholnih tamponov.
6.6 Special precautions for disposal and other handling
147 6. 6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
Enbrel is reconstituted with 1 ml bacteriostatic water for injections before use, and administered by subcutaneous injection.
Pred uporabo in subkutanim injiciranjem zdravilo Enbrel raztopite v 1 ml bakteriostatske vode za injekcije.
Comprehensive instructions for the preparation, administration and re-use of the reconstituted Enbrel vial are given in the package leaflet, section 7, "Instructions for preparation and giving an injection of Enbrel.
Izčrpna navodila za pripravo, aplikacijo in ponovno uporabo pripravljene viale zdravila Enbrel so navedena v navodilu za uporabo, poglavje 7, "Navodila za pripravo in dajanje injekcij zdravila Enbrel".
155 1.
148 1.
The solution is clear, and colourless or pale yellow (see section 6.5).
Raztopina je bistra in brezbarvna ali bledorumena (glejte poglavje 6. 5).
156 Polyarticular juvenile idiopathic arthritis
Poliartikularni juvenilni idiopatski artritis
Psoriatic arthritis
149 Psoriatični artritis
Enbrel has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.
Izkazalo se je, da Enbrel izboljša telesno funkcijo pri bolnikih s psoriatičnim artritisom in da upočasni hitrost napredovanja okvar perifernih sklepov, izmerjeno z rentgenskim slikanjem, pri bolnikih s poliartikularnimi simetričnimi podvrstami bolezni.
Comprehensive instructions for administration are given in the package leaflet, section 7, "Instructions for preparation and giving an injection of Enbrel."
Izčrpna navodila za aplikacijo so navedena v navodilu za uporabo, poglavje 7, "Navodila za pripravo in dajanje injekcij zdravila Enbrel".
157 Plaque psoriasis
Psoriaza v plakih
If re-treatment with Enbrel is indicated, the above guidance on treatment duration should be followed.
150 V primeru ponovnega zdravljenja z zdravilom Enbrel je potrebno upoštevati zgornja navodila glede trajanja zdravljenja.
Enbrel is available as a single use syringe for patients weighing 62.5 kg or more.
Enbrel je na voljo v obliki injekcijske brizge za enkratno uporabo za bolnike, ki tehtajo vsaj 62, 5 kg.
Lyophilized vials containing a reconstituted dose of 25 mg/ ml are available from which doses less than 25 mg can be administered.
Na voljo so liofilizirane viale, ki vsebujejo rekonstituirani odmerek 25 mg/ ml, ki omogočajo dajanje odmerkov, manjših od 25 mg.
Juvenile idiopathic arthritis (age 4 years and above)
Juvenilni idiopatski artritis (starost 4 leta ali več)
0.4 mg/ kg (up to a maximum of 25 mg per dose) given twice weekly as a subcutaneous injection with an interval of 3-4 days between doses.
0, 4 mg/ kg telesne mase (do največ 25 mg na odmerek), dano 2- krat tedensko v obliki subkutane injekcije z razmikom med odmerki od 3 do 4 dni.
Paediatric plaque psoriasis (age 8 years and above)
Otroška psoriaza v plakih (starost 8 let ali več)
158 4.4 Special warnings and precautions for use
4. 4 Posebna opozorila in previdnostni ukrepi
Physicians should exercise caution when considering the use of Enbrel in patients with a history of recurring or chronic infections or with underlying conditions that may predispose patients to infections such as advanced or poorly controlled diabetes.
151 Zdravniki morajo biti zelo previdni, ko se odločajo za zdravljenje s tem zdravilom pri bolnikih s ponavljajočimi se ali kroničnimi okužbami v anamnezi ali z drugimi osnovnimi stanji, kot je na primer napredovala ali neurejena sladkorna bolezen, ki bi lahko povečala dovzetnost bolnika za okužbe.
159 Worsening of hepatitis C
Poslabšanje hepatitisa C
There have been reports of worsening of hepatitis C in patients receiving Enbrel.
Poročali so o poslabšanju hepatitisa C pri bolnikih, ki so prejemali Enbrel.
Allergic reactions have included angioedema and urticaria; serious reactions have occurred.
Če se pojavi
If any serious allergic or anaphylactic reaction occurs, Enbrel therapy should be discontinued immediately and appropriate therapy initiated.
152 kakršna koli resna alergijska ali anafilaktična reakcija, je potrebno terapijo s tem zdravilom takoj prekiniti in uvesti ustrezno zdravljenje.
160 In the controlled portions of clinical trials of TNF-antagonists, more cases of lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients.
V nadzorovanih delih kliničnih preskušanj z zaviralci TNF so pri bolnikih, ki so prejemali zaviralec TNF, opazili več primerov limfomov kot pri kontrolni skupini bolnikov.
Rare cases of pancytopenia and very rare cases of aplastic anaemia, some with fatal outcome, have been reported in patients treated with Enbrel.
Posebna previdnost je potrebna pri
Caution should be exercised in patients being treated with Enbrel who have a previous history of blood dyscrasias.
153 bolnikih, zdravljenih z zdravilom Enbrel, ki imajo krvno diskrazijo v anamnezi.
161 The use of Enbrel in combination with other systemic therapies or phototherapy for the treatment of psoriasis has not been studied.
Uporaba zdravila Enbrel v kombinaciji z drugimi sistemskimi zdravljenji ali fototerapijo za zdravljenje psoriaze ni raziskana.
4.5 Interaction with other medicinal products and other forms of interaction
154 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
162 Non-interactions
Medsebojno nedelovanje
4.8 Undesirable effects
155 4. 8 Neželeni učinki
163 placebo-controlled trials, serious adverse events occurred at a frequency of 4% in 349 patients treated with Enbrel compared with 5% of 152 placebo-treated patients.
Pri bolnikih z revmatoidnem artritisom, zdravljenih v s placebom kontroliranih raziskavah, so se pojavili resni neželeni učinki s pogostnostjo 4% pri 349 bolnikih, zdravljenih z zdravilom Enbrel, v primerjavi s 5% od 152 bolnikov, zdravljenih s placebom.
164 Skin and subcutaneous tissue disorders:
Bolezni kože in podkožja:
Additional information
157 Dodatne informacije
165 There were a total of 15 lymphomas reported in 5,966 patients treated with Enbrel in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis clinical trials.
V raziskavah revmatoidnega artritisa, psoriatičnega artritisa, ankilozirajočega spondilitisa in psoriaze, ki so vključevale 5. 966 bolnikov, zdravljenih z zdravilom Enbrel, so zabeležili skupno 15 limfomov.
These included abscess (at various sites), bacteraemia, bronchitis, bursitis, cellulitis, cholecystitis, diarrhoea, diverticulitis, endocarditis (suspected), gastroenteritis, hepatitis B, herpes zoster, leg ulcer, mouth infection, osteomyelitis, otitis, peritonitis, pneumonia, pyelonephritis, sepsis, septic arthritis, sinusitis, skin infection, skin ulcer, urinary tract infection, vasculitis, and wound infection.
158 različnih mestih), bakteriemija, bronhitis, burzitis, celulitis, holecistitis, diareja, divertikulitis, endokarditis (sum nanj), gastroenteritis, hepatitis B, herpes zoster, razjeda na nogi, okužba ustne votline, osteomielitis, otitis, peritonitis, pljučnica, pielonefritis, sepsa, septični artritis, sinuzitis, okužbe kože, kožne razjede, okužbe sečil, vaskulitis in okužbe ran.
There were no differences in rates of infection among patients treated with Enbrel and those treated with placebo for plaque psoriasis in placebo controlled trials of up to 24 weeks duration.
Ni bilo razlik v pogostnosti okužb med bolniki, zdravljenimi z zdravilom Enbrel. in tistimi, ki so prejemali placebo za zdravljenje psoriaze v plakih v preskušanjih, kontroliranih s placebom, ki so trajali do 24 tednov.
Interstitial lung disease
159 Intersticijska bolezen pljuč
167 The types of infections seen in clinical trials in juvenile idiopathic arthritis patients aged 2 to 18 years were generally mild to moderate and consistent with those commonly seen in outpatient paediatric populations.
Vrste okužb, ki so jih opazili v kliničnih preskušanjih pri bolnikih z juvenilnim idiopatskim artritisom, starih od 2 do 18 let, so bile na splošno blage do zmerne in skladne s tistimi, ki jih pogosto vidimo pri skupinah ambulantnih pediatričnih bolnikov.
Several adverse events were reported more commonly in 69 juvenile idiopathic arthritis patients receiving 3 months of Enbrel compared to the 349 adult rheumatoid arthritis patients.
Nekateri neželeni učinki so bili pogosteje opaženi pri 69 bolnikih z juvenilnim idiopatskim artritisom, ki so Enbrel prejemali 3 mesece, kot pri 349 odraslih bolnikih z revmatoidnim artritisom.
One rheumatoid arthritis patient mistakenly self-administered 62 mg Enbrel subcutaneously twice weekly for 3 weeks without experiencing undesirable effects.
160 subkutano injiciral 62 mg zdravila Enbrel 2- krat tedensko 3 tedne, ne da bi pri tem prišlo do kakršnega koli neželenega učinka.
168 TNF and lymphotoxin exist predominantly as homotrimers, with their biological activity dependent on cross-linking of cell surface TNFRs.
TNF in limfotoksin obstajata pretežno v obliki homotrimerov in njihova biološka aktivnost je odvisna od navzkrižne vezave na TNF receptorje na površini celice.
Enbrel 41% and 40%, placebo 8% and 5% at months 3 and 6 respectively; p < 0.01 Enbrel vs Placebo at all time points for both ACR 20 and ACR 50 responses).
161 Odstotek bolnikov, ki so po 3 oziroma 6 mesecih dosegli odziv ACR 20 ali ACR 50, je bil v skupini bolnikov, ki so bili zdravljeni z zdravilom Enbrel, večji kot pri bolnikih, ki so prejemali placebo (ACR 20, po 3 oziroma 6 mesecih: zdravilo Enbrel 62% oziroma 59%, placebo 23% oziroma 11%; ACR 50, po 3 oziroma 6 mesecih: zdravilo Enbrel 41% oziroma 40%, placebo 8% oziroma 5%; p < 0, 01 za zdravilo Enbrel proti placebu v vseh časovnih točkah, tako za odziv ACR 20 kot za odziv ACR 50).
The efficacy of Enbrel was compared to methotrexate in a third randomised, active-controlled study with blinded radiographic evaluations as a primary endpoint in 632 adult patients with active rheumatoid arthritis (< 3 years duration) who had never received treatment with methotrexate.
V randomizirani aktivno kontrolirani raziskavi s slepo radiografsko oceno kot primarnim opazovanim dogodkom so primerjali učinkovitost zdravila Enbrel z učinkovitostjo metotreksata pri 632 odraslih bolnikih z aktivnim revmatoidnim artritisom (trajanje bolezni manj kot 3 leta), ki se prej niso zdravili z metotreksatom.
RADIOGRAPHIC PROGRESSION:
162 RENTGENSKO NAPREDOVANJE:
170 Patients in the Enbrel in combination with methotrexate therapy group had significantly higher ACR 20, ACR 50, ACR 70 responses and improvement for DAS and HAQ scores at both 24 and 52 weeks than patients in either of the single therapy groups (results shown in table below).
Pri bolnikih, ki so prejemali zdravilo Enbrel v kombinaciji z metotreksatom, so bili odzivi ACR 20, ACR 50 in ACR 70 ter izboljšanja na lestvicah ocene stopnje bolezni (DAS – » Disease Activity Score «) in HAQ tako po 24 kot po 52 tednih statistično značilno večja kot pri bolnikih, ki so jih zdravili z enim samim zdravilom (izsledki so povzeti v spodnji tabeli).
CLINICAL EFFICACY RESULTS AT 12 MONTHS:
163 KLINIČNA UČINKOVITOST PO 12 MESECIH:
Remission is defined as DAS < 1.6 Pairwise comparison p-values: † = p < 0.05 for comparisons of Enbrel + methotrexate vs methotrexate and  = p < 0.05 for comparisons of Enbrel + methotrexate vs Enbrel
Vrednosti p za primerjavo po parih: † = p < 0, 05 za primerjavo kombinacije zdravilo Enbrel + metotreksat z metotreksatom in φ = p < 0, 05 za primerjavo kombinacije zdraviloEnbrel + metotreksat z zdravilom Enbrel.
171 RADIOGRAPHIC PROGRESSION:
164 RENTGENSKO NAPREDOVANJE:
172 intolerant of methotrexate were enrolled; patients remained on a stable dose of a single nonsteroidal anti- inflammatory drug and/ or prednisone (< 0.2 mg/ kg/ day or 10 mg maximum).
165 stalnim odmerkom enega nesteroidnega protivnetnega zdravila in/ ali prednizona (< 0, 2 mg/ kg/ dan ali največ 10 mg).
173 RESPONSES OF PATIENTS WITH PSORIATIC ARTHRITIS IN PLACEBO-CONTROLLED TRIAL Percent of Patients
166 ODZIVI BOLNIKOV S PSORIATIČNIM ARTRITISOM V S PLACEBOM KONTROLIRANI RAZISKAVI Odstotek bolnikov zdravilo Enbrela Placebo
174 MEAN (SE) ANNUALIZED CHANGE FROM BASELINE IN TOTAL SHARP SCORE
POVPREČNA (SE) SPREMEMBA SKUPNE SHARPOVE OCENE OD IZHODIŠČA NA LETO
There is insufficient evidence of the efficacy of Enbrel in patients with ankylosing spondylitis-like and arthritis mutilans psoriatic arthropathies due to the small number of patients studied.
167 Ni zadostnih dokazov za učinkovitost zdravila Enbrel pri bolnikih s psoriatičnimi artropatijami, podobnimi ankilozirajočemu spondilitisu, in artritisom mutilansom zaradi majhnega števila proučevanih bolnikov.
175 RESPONSES OF PATIENTS WITH ANKYLOSING SPONDYLITIS IN A PLACEBO-CONTROLLED TRIAL Percent of Patients
ODZIVI BOLNIKOV Z ANKILOZIRAJOČIM SPONDILITISOM V S PLACEBOM KONTROLIRANI RAZISKAVI Odstotek bolnikov
Among patients with ankylosing spondylitis who received Enbrel, the clinical responses were apparent at the time of the first visit (2 weeks) and were maintained through 6 months of therapy.
168 Med bolniki z ankilozirajočim spondilitisom, ki so prejemali zdravilo Enbrel, so bili klinični odzivi vidni že pri prvem obisku (po 2 tednih) in so se ohranjali ves čas 6 mesecev terapije.