natgillin/translations-raw huggingface dataset:
In this study, structural joint damage was assessed radiographically and expressed as change in Total Sharp Score (TSS) and its components, the erosion score and joint space narrowing score (JSN).
V tej raziskavi je bila strukturna poškodba sklepov ocenjena na rentgenskih slikah in izražena kot sprememba skupne Sharpove ocene (Total Sharp Score, TSS) in njenih komponent, ocene erozije sklepov in ocene zožitve sklepne špranje (Joint Space Narrowing, JSN).
Radiographs of hands/ wrists and feet were read at baseline and 6, 12, and 24 months.
Rentgenske slike dlani in zapestij ter stopal so ocenili na začetku raziskave in po 6, 12 in 24 mesecih.
Enbrel 25 mg was significantly superior to methotrexate for erosion scores at both 12 and 24 months.
Učinek 25 mg odmerka zdravila Enbrel je bil bistveno boljši kot pri metotreksatu kar zadeva oceno erozije sklepov, tako po 12 kot po 24 mesecih.
RADIOGRAPHIC PROGRESSION:
15 RENTGENSKO NAPREDOVANJE:
COMPARISON OF ENBREL vs METHOTREXATE IN PATIENTS WITH RA OF < 3 YEARS DURATION
PRIMERJAVA ZDRAVILA ENBREL Z METOTRAKSATOM PRI BOLNIKIH Z REVMATOIDNIM ARTRITISOM (TRAJANJE BOLEZNI MANJ KOT 3 LETA)
Change from Baseline
2, 5
2.5
12 mesecev
12 Months 2.5
2, 5
1.5
1, 2
1.5
1, 0
1.2
0, 9
1.3
1, 0
1.0
0, 9
1.0
0, 5
0.9
0, 4 *
0.6*
0, 4 0, 4
0.4*
0, 6 *
Erosions
erozije
TSS Erosions
TSS erozije
*p < 0.05
metotreksat Enbrel 25 mg * p < 0, 05
In another active-controlled, double-blind, randomised study, clinical efficacy, safety, and radiographic progression in RA patients treated with Enbrel alone (25 mg twice weekly), methotrexate alone (7.5 to 20 mg weekly, median dose 20 mg), and of the combination of Enbrel and methotrexate initiated concurrently were compared in 682 adult patients with active rheumatoid arthritis of 6 months to 20 years duration (median 5 years) who had a less than satisfactory response to at least 1 disease-modifying antirheumatic drug (DMARD) other than methotrexate.
V drugi aktivno kontrolirani dvojno slepi randomizirani raziskavi so primerjali klinično učinkovitost, varnost in rentgensko napredovanje pri bolnikih z revmatoidnim artritisom, ki so jih zdravili samo z zdravilom Enbrel (25 mg 2- krat na teden), samo z metotreksatom (7, 5 do 20 mg na teden, mediana 20 mg) ali z zdravilom Enbrel in metotreksatom (s sočasnim začetkom), in sicer pri 682 odraslih bolnikih z aktivnim revmatoidnim artritisom, pri katerih je bolezen trajala od 6 mesecev do 20 let (mediana 5 let) in pri katerih je bil odziv na najmanj eno imunomodulirajoče protirevmatično zdravilo (DMARD) razen metotreksata manj kot zadovoljiv.
16 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:
16 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 +
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
metotreksat
Enbrel
zdravilo Enbrel
(n = 231)
Odzivi ACRa
DAS
43, 0%
Baseline scoreb
39, 8% †, φ
Week 52 scoreb
ocena na začetku raziskaveb ocena po 52 tednihb Remisijac
Baseline
na začetku raziskave
Patients who did not complete 12 months in the study were considered to be non-responders. b:
Bolniki, ki v študiji niso sodelovali 12 mesecev, so bili obravnavani kot neodzivni. b:
Values for Disease Activity Score (DAS) are means. c:
Vrednosti za oceno stopnje bolezni (DAS - Disease Activity Score) so povprečne vrednosti. c:
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 zdravilo Enbrel + metotreksat z zdravilom Enbrel.
Radiographic progression at 12 months was significantly less in the Enbrel group than in the methotrexate group, while the combination was significantly better than either monotherapy at slowing radiographic progression (see figure below).
Po 12 mesecih zdravljenja je bilo rentgensko napredovanje pri bolnikih, ki so jih zdravili z zdravilom Enbrel, statistično značilno počasnejše kot pri bolnikih, ki so jih zdravili z metotreksatom; kombinacija obeh zdravil pa je rentgensko napredovanje upočasnila statistično značilno učinkoviteje kot eno samo zdravilo (glejte spodnjo sliko).
17 RADIOGRAPHIC PROGRESSION:
17 RENTGENSKO NAPREDOVANJE:
COMPARISON OF ENBREL vs METHOTREXATE vs ENBREL IN COMBINATION WITH METHOTREXATE IN PATIENTS WITH RA OF 6 MONTHS TO 20 YEARS DURATION (12 MONTH RESULTS)
PRIMERJAVA MED ZDRAVILOM ENBREL, METOTRAKSATOM IN KOMBINACIJO ZDRAVILA ENBREL IN METOTREKSATA PRI BOLNIKIH Z REVMATOIDNIM ARTRITISOM (TRAJANJE BOLEZNI OD 6 MESECEV DO 20 LET) (12- MESEČNI REZULTATI)
2.80
3, 0 2, 5
2.5
2, 80
Enbrel + Methotrexate
metotreksat Enbrel Enbrel + metotreksat
1.5 1.12 1.0
1, 5 Sprememba v primerjavi z
0.52*
1, 12 začetkom raziskave
0.5
1, 0
0.21*
0, 52 *
0.32
0, 5
0.0
0, 21 *
-0.23 † ,
0, 32
-0.5 -1.0
0, 0
-0.54 † ,
- 0, 23 †, φ - 0, 30 † - 0, 5 - 0, 54 †, φ
-0.30 †
- 1, 0
Pairwise comparison p-values: * = p < 0.05 for comparisons of Enbrel vs methotrexate, † = 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 zdravila Enbrel z metotreksatom, † = p < 0, 05 za primerjavo kombinacije zdravilo Enbrel + metotreksat z metotreksatom in φ = p < 0, 05 za primerjavo kombinacije zdravilo Enbrel + metotreksat z zdravilom Enbrel.
In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change ≤ 0.5) at 24 months was higher in the Enbrel in combination with methotrexate group compared with the Enbrel alone and methotrexate alone groups (62%, 50%, and 36%, respectively; p < 0.05).
Odstotek bolnikov brez napredovanja (sprememba TSS ≤ 0, 5) je bil po 24 mesecih večji v skupini, ki je dobivala zdravilo Enbrel v kombinaciji z metotreksatom, kakor v skupinah, ki sta dobivali zdravilo Enbrel ali metotreksat v monoterapiji (62%, 50% in 36%, p < 0, 05).
The difference between Enbrel alone and methotrexate alone was also significant (p < 0.05).
Značilna je bila tudi razlika med monoterapijo z zdravilom Enbrel in monoterapijo z metotreksatom (p < 0, 05).
Among patients who completed a full 24 months of therapy in the study, the non-progression rates were 78%, 70%, and 61%, respectively.
Med bolniki, ki so dokončali polnih 24 mesecev terapije v študiji, je bil odstotek nenapredovanja 78%, 70% in 61%.
The safety and efficacy of 50mg Enbrel (two 25 mg SC injections) administered once weekly were evaluated in a double-blind, placebo-controlled study of 420 patients with active RA.
Varnost in učinkovitost 50 mg zdravila Enbrel (dve subkutani injekciji po 25 mg) enkrat na teden so ocenili v dvojno slepi, s placebom kontrolirani raziskavi pri 420 bolnikih z aktivnim revmatoidnim artritisom.
In this study, 53 patients received placebo, 214 patients received 50 mg Enbrel once weekly and 153 patients received 25 mg Enbrel twice weekly.
V tej raziskavi je 53 bolnikov dobivalo placebo, 214 bolnikov 50 mg zdravila Enbrel enkrat na teden in 153 bolnikov 25 mg zdravila Enbrel dvakrat na teden.
The safety and efficacy profiles of the two Enbrel treatment regimens were comparable at week 8 in their effect on signs and symptoms of RA; data at week 16 did not show comparability (non-inferiority) between the two regimens.
Profil varnosti in učinkovitosti obeh shem zdravljenja z zdravilom Enbrel je bil po 8 tednih primerljiv, kar zadeva učinek na znake in simptome revmatoidnega artritisa; podatki o učinkovitosti in varnosti 50 mg zdravila Enbrel enkrat na teden so omejeni na 16 tednov zdravljenja.
Paediatric patients with polyarticular juvenile idiopathic arthritis
Pediatrični bolniki s poliartikularnim juvenilnim idiopatskim artritisom
The safety and efficacy of Enbrel were assessed in a two-part study in 69 children with polyarticular juvenile idiopathic arthritis who had a variety of juvenile idiopathic arthritis onset types.
Učinkovitost in varnost zdravila Enbrel je bila ugotovljena v dvodelni raziskavi pri 69 otrocih z različnimi tipi zagona poliartikularnega juvenilnega idiopatskega artritisa.
Patients aged 4 to 17 years with moderately to severely active polyarticular juvenile idiopathic arthritis refractory to or intolerant of methotrexate were enrolled; patients remained on a stable dose of a single nonsteroidal anti-
Bolniki so nadaljevali zdravljenje s
18 inflammatory drug and/ or prednisone (< 0.2 mg/ kg/ day or 10 mg maximum).
18 stalnim odmerkom enega nesteroidnega protivnetnega zdravila in/ ali prednizona (< 0, 2 mg/ kg/ dan ali največ 10 mg).
In part 1, all patients received 0.4 mg/ kg (maximum 25 mg per dose) Enbrel subcutaneously twice weekly.
V prvem delu raziskave so vsi bolniki prejemali 0, 4 mg/ kg (največ 25 mg na odmerek) zdravila Enbrel subkutano, 2- krat tedensko.
In part 2, patients with a clinical response at day 90 were randomised to remain on Enbrel or receive placebo for four months and assessed for disease flare.
V drugem delu raziskave pa so bili bolniki, ki so dobro reagirali na zdravilo Enbrel na 90. dan randomizirani v dve skupini: ena je nadaljevala zdravljenje z zdravilom Enbrel, druga pa je nadaljnje 4 mesece prejemala placebo - pri njih so ocenjevali napredovanje bolezni.
Responses were measured using the JRA Definition of Improvement (DOI), defined as  30% improvement in at least three of six and  30% worsening in no more than one of six JRA core set criteria, including active joint count, limitation of motion, physician and patient/ parent global assessments, functional assessment, and erythrocyte sedimentation rate (ESR).
Učinke zdravljenja so merili po JRA kazalcih izboljšanja bolezni (Definition of Improvement, DOI); izboljšanje je pomenilo najmanj 30% izboljšanje v vsaj treh od šestih osnovnih JRA kazalcev aktivnosti bolezni in ≥ 30% poslabšanje v ne več kot enem od šestih osnovnih JRA kazalcev aktivnosti bolezni (število aktivno prizadetih sklepov, omejenost gibanja, zdravnikova splošna ocena, splošna ocena s strani bolnika ali staršev, ocena funkcionalnosti in sedimentacija eritrocitov).
Disease flare was defined as a  30% worsening in three of six JRA core set criteria and  30% improvement in not more than one of the six JRA core set criteria and a minimum of two active joints.
Ponovni zagon bolezni je bil definiran kot ≥ 30% poslabšanje treh od šestih osnovnih JRA kazalcev in ≥ 30% izboljšanje največ enega od šestih osnovnih JRA kazalcev ter najmanj 2 aktivno prizadeta sklepa.
In part 1 of the study, 51 of 69 (74%) patients demonstrated a clinical response and entered part 2.
V prvem delu raziskave je 51 od 69 (74%) bolnikov dobro reagiralo na zdravljenje z zdravilom Enbrel in so bili vključeni v drugi del raziskave.
In part 2, 6 of 25 (24%) patients remaining on Enbrel experienced a disease flare compared to 20 of 26 (77%) patients receiving placebo (p=0.007).
V drugem delu je 6 od 25 (24%) bolnikov, ki so ostali na zdravilu Enbrel, doživelo ponoven zagon bolezni, v primerjavi z 20 od 26 (77%) bolnikov, ki so v drugem delu prejemali placebo (p=0, 007).
From the start of part 2, the median time to flare was  116 days for patients who received Enbrel and 28 days for patients who received placebo.
Od začetka drugega dela raziskave je bila mediana vrednost časa do zagona bolezni ≥ 116 dni pri bolnikih na zdravilu Enbrel in 28 dni pri bolnikih na placebu.
Of patients who demonstrated a clinical response at 90 days and entered part 2 of the study, some of the patients remaining on Enbrel continued to improve from month 3 through month 7, while those who received placebo did not improve.
Od bolnikov, ki so dosegli klinični odgovor do 90. dneva in so v drugem delu ostali na zdravilu Enbrel, se je pri nekaterih klinično stanje nadalje izboljševalo od 3. do 7. meseca zdravljenja, pri tistih, ki so v drugem delu raziskave prejemali placebo, pa ni bilo izboljšanja.
Studies have not been done in patients with polyarticular juvenile idiopathic arthritis to assess the effects of continued Enbrel therapy in patients who do not respond within 3 months of initiating Enbrel therapy or to assess the combination of Enbrel with methotrexate.
Prav tako niso ovrednotili kombiniranega zdravljenja z zdravilom Enbrel in metotreksatom.
The efficacy of Enbrel was assessed in a randomised, double-blind, placebo-controlled study in 205 patients with psoriatic arthritis.
Učinkovitost zdravila Enbrel je bila ocenjena v randomizirani, dvojno slepi in s placebom kontrolirani raziskavi pri 205 bolnikih s psoriatičnim artritisom.
Patients were between 18 and 70 years of age and had active psoriatic arthritis ( 3 swollen joints and  3 tender joints) in at least one of the following forms:
Starost bolnikov je bila od 18 do 70 let in vsi so imeli aktivni psoriatični artritis (≥ 3 otekli sklepi in ≥ 3 občutljivi sklepi) v najmanj eni od naslednjih oblik:
(1) distal interphalangeal (DIP) involvement; (2) polyarticular arthritis (absence of rheumatoid nodules and presence of psoriasis); (3) arthritis mutilans; (4) asymmetric psoriatic arthritis; or (5) spondylitis-like ankylosis.
(1) distalna interfalangealna prizadetost (DIP); (2) poliartikularni artritis (odsotnost revmatoidnih nodulov in prisotnost psoriaze); (3) artritis mutilans; (4) asimetrični psoriatični artritis ali (5) spondilitisu podobna ankiloza.
Patients also had plaque psoriasis with a qualifying target lesion  2 cm in diameter.
Bolniki so imeli tudi psoriatične plake, pri čemer so za mejno oz. pražno velikost lezij šteli tiste z ≥ 2 cm premera.
Patients had previously been treated with NSAIDs (86%), DMARDs (80%), and corticosteroids (24%).
Bolniki so bili prej zdravljeni z nesteroidnimi protivnetnimi zdravili (86%), imunomodulirajočimi protirevmatičnimi zdravili (80%) in kortikosteroidi (24%).
Patients currently on methotrexate therapy (stable for  2 months) could continue at a stable dose of  25 mg/ week methotrexate.
Bolniki, ki se trenutno zdravijo z metotreksatom (stabilno odmerjanje ≥ 2 meseca), lahko nadaljujejo s stalnim odmerkom metotreksata ≤ 25 mg/ teden.
Doses of 25 mg of Enbrel (based on dose-finding studies in patients with rheumatoid arthritis) or placebo were administered SC twice a week for 6 months.
25 mg odmerki zdravila Enbrel (na podlagi raziskave za ugotovitev odmerkov pri bolnikih z revmatoidnim artritisom) ali placeba so bili dani subkutano dvakrat na teden v trajanju 6 mesecev.
At the end of the double-blind study, patients could enter a long-term open-label extension study for a total duration of up to 2 years.
Na koncu dvojno slepe raziskave so se bolniki lahko vključili v dolgoročno odprto podaljšano raziskavo, ki je v celoti trajala do 2 leti dolgo.
Results are summarised in the Table below.
Izsledki so povzeti v spodnji tabeli.
19 RESPONSES OF PATIENTS WITH PSORIATIC ARTHRITIS IN PLACEBO-CONTROLLED TRIAL Percent of Patients
19 ODZIVI BOLNIKOV S PSORIATIČNIM ARTRITISOM V S PLACEBOM KONTROLIRANI RAZISKAVI Odstotek bolnikov Zdravilo Enbrela Placebo
n = 104
Odziv psoriatičnega artritisa n = 104
Month 3 Month 6
6. mesec
Month 3 Month 6
3. mesec
11b 9c
6. mesec
25 mg Enbrel SC twice weekly b: p < 0.001, Enbrel vs. placebo c: p < 0.01, Enbrel vs. placebo
25 mg zdravila Enbrel subkutano dvakrat na teden b: p < 0, 001, zdravilo Enbrel v primerjavi s placebom c: p < 0, 01, zdravilo Enbrel v primerjavi s placebom
Among patients with psoriatic arthritis who received Enbrel, the clinical responses were apparent at the time of the first visit (4 weeks) and were maintained through 6 months of therapy.
Med bolniki s psoriatičnim artritisom, ki so prejemali zdravilo Enbrel, so bili klinični odzivi vidni že pri prvem obisku (po 4. tednih) in so se ohranjali ves čas 6 mesecev terapije.
Enbrel was significantly better than placebo in all measures of disease activity (p < 0.001), and responses were similar with and without concomitant methotrexate therapy.
Zdravilo Enbrel je bilo bistveno boljše kot placebo po vseh kriterijih aktivnosti bolezni (p < 0, 001) in odzivi so bili podobni, ne glede na sočasno zdravljenje z metotreksatom.
Quality of life in psoriatic arthritis patients was assessed at every timepoint using the disability index of the HAQ.
Kakovost življenja bolnikov s psoriatričnim artritisom je bila ocenjena v vsaki časovni točki z uporabo indeksa nezmožnosti po HAQ.
The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with Enbrel, relative to placebo (p < 0.001).
Rezultat indeksa nezmožnosti je bil bistveno boljši v vseh časovnih točkah pri bolnikih s psoriatičnim artritisom, zdravljenih z zdravilom Enbrel, v primerjavi s placebom (p < 0, 001).
Radiographic changes were assessed in the psoriatic arthritis study.
V raziskavi psoriatičnega artritisa so ocenjevali rentgenološke spremembe.
Radiographs of hands and wrists were obtained at baseline and months 6, 12, and 24.
Dlani in zapestja so rentgensko slikali v izhodišču in v 6., 12. in 24. mesecu.
The modified TSS at 12 months is presented in the Table below.
Modificirani TSS po 12 mesecih je prikazan v spodnji tabeli.
47%, respectively, p ≤ 0.001).
V analizi, v kateri je veljalo, da je pri vseh bolnikih, ki so iz kateregakoli razloga izpadli iz raziskave, bolezen napredovala, je bil odstotni delež bolnikov brez napredovanja bolezni (sprememba TSS ≤ 0, 5) po 12 mesecih večji v skupini z zdravilom Enbrel kot v skupini s placebom (73% proti 47%, p ≤ 0, 001).
The effect of Enbrel on radiographic progression was maintained in patients who continued on treatment during the second year.
Učinek zdravila Enbrel na rentgenološko napredovanje bolezni se je ohranjal pri bolnikih, ki so nadaljevali zdravljenje še drugo leto.
MEAN (SE) ANNUALIZED CHANGE FROM BASELINE IN TOTAL SHARP SCORE
POVPREČNA (SE) SPREMEMBA SKUPNE SHARPOVE OCENE OD IZHODIŠČA NA LETO
Month 12
- 0, 03 (0, 09) a
1.00 (0.29)
12. mesec
-0.03 (0.09)a
1, 00 (0, 29)
SE = standard error. a. p = 0.0001.
SE = standardna napaka. a. p = 0, 0001.
20 Enbrel treatment resulted in improvement in physical function during the double-blind period, and this benefit was maintained during the longer-term exposure of up to 2 years.
Zdravljenje z zdravilom Enbrel je povzročilo izboljšanje telesne funkcije v dvojno slepem obdobju, ta koristni učinek pa se je ohranjal med dolgotrajnejšo izpostavljenostjo, ki je trajala do 2 leti dolgo.
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.
20 Ni zadostnih dokazov za učinkovitost zdravila Enbrel pri bolnikih s psoriatičnimi artropatijami, podobnimi ankilozirajočemu spondilitisu, in artritisom mutilansom zaradi majhnega števila proučevanih bolnikov.
No study has been performed in patients with psoriatic arthritis using the 50mg once weekly dosing regimen.
Pri bolnikih s psoriatičnim artritisom klinične študije z režimom odmerjanja 50 mg enkrat na teden niso bile izvedene.
The efficacy of Enbrel in ankylosing spondylitis was assessed in 3 randomised, double-blind studies comparing twice weekly administration of 25 mg Enbrel with placebo.
Učinkovitost zdravila Enbrel pri bolnikih z ankilozirajočim spondilitisom je bila ocenjena v 3 randomiziranih dvojno slepih študijah, kjer so primerjali terapijo 25 mg zdravila Enbrel dvakrat tedensko s placebom.
The largest of these trials (n= 277) enrolled patients who were between 18 and 70 years of age and had active ankylosing spondylitis defined as visual analog scale (VAS) scores of  30 for average of duration and intensity of morning stiffness plus VAS scores of  30 for at least 2 of the following 3 parameters: patient global assessment; average of VAS values for nocturnal back pain and total back pain; average of 10 questions on the Bath Ankylosing Spondylitis Functional Index (BASFI).
Najširša od teh raziskav (n=277) je vključevala bolnike med 18. in 70. letom starosti z aktivnim ankilozirajočim spondilitisom, definiranim po vizualni analogni lestvici (VAS) z vrednostjo ≥ 30 za povprečno trajanje in intenzivnostjo jutranjega šepanja ter VAS vrednost ≥ 30 za vsaj 2 od 3 sledečih parametrov: bolnikova splošna ocena; povprečna VAS vrednost bolečine v hrbtenici ponoči in celokupna bolečina v hrbtenici; povprečno 10 vprašanj v Bath Ankylosing Spondylitis Functional Index (BASFI).
Patients receiving DMARDs, NSAIDS, or corticosteroids could continue them on stable doses.
Bolniki, ki so dobivali imunomodulirajoča protirevmatična zdravila, nesteroidna protivnetna zdravila ali kortikosteroide so lahko nadaljevali z njihovim jemanjem brez prilagajanja odmerka.
Patients with complete ankylosis of the spine were not included in the study.
Bolniki s popolno ankilozo hrbtenice niso bili vključeni v raziskavo.
Doses of 25 mg of Enbrel (based on dose-finding studies in patients with rheumatoid arthritis) or placebo were administered subcutaneously twice a week for 6 months in 138 patients.
138 bolnikov je prejemalo 25 mg odmerke zdravila Enbrel (na podlagi raziskave za ugotovitev odmerkov pri bolnikih z revmatoidnim artritisom) ali placeba subkutano dvakrat na teden v trajanju 6 mesecev.
The primary measure of efficacy (ASAS 20) was a  20% improvement in at least 3 of the 4 Assessment in Ankylosing Spondylitis (ASAS) domains (patient global assessments, back pain, BASFI, and inflammation) and absence of deterioration in the remaining domain.
Po primarnem določanju učinkovitosti (ASAS 20) je prišlo do izboljšanja v ≥ 20% pri vsaj 3 od 4 ocen domen ankilozirajočega spondilitisa (bolnikova splošna ocena, bolečina v hrbtenici, BASFI in vnetje) ter brez sprememb v ostalih domenah).
ASAS 50 and 70 responses used the same criteria with a 50% improvement or a 70% improvement, respectively.
Odziva ASAS 50 in 70 sta bila definirana po istih kriterijih, le da je šlo za 50% oziroma 70% izboljšanje.
Compared to placebo, treatment with Enbrel resulted in significant improvements in the ASAS 20, ASAS 50 and ASAS 70 as early as 2 weeks after the initiation of therapy.
V primerjavi s placebom, je po dajanju zdravila Enbrel prišlo do izboljšanja pri ASAS 20, ASAS 50 in ASAS 70 že po 2 tednih od začetka zdravljenja.
21 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
Ankylosing Spondylitis N Response ASAS 20
Odziv ankilozirajočega spondilitisa ASAS 20
= 139
Placebo N = 139
N = 138
zdravilo Enbrel N = 138 46a
2 weeks 3 months 6 months ASAS 50
2 tedna
24a
42a
3 months 6 months
6 mesecev
13 10
10
2 weeks 3 months 6 months
6 mesecev
Placebo b: p = 0.002, Enbrel vs. placebo
a: p < 0, 001, zdravilo Enbrel vs. placebo b: p = 0, 002, zdravilo Enbrel vs. placebo
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.
21 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.