natgillin/translations-raw huggingface dataset:
In placebo-controlled trials, no increase in the incidence of serious infections (fatal, life threatening, or requiring hospitalisation or intravenous antibiotics) was observed.
V s placebom kontroliranih preskušanjih niso opazili zvečanja incidence resnih okužb (s smrtnim izidom, življenje ogrožajočih okužb ali takih, ki so zahtevale hospitalizacijo ali intravenske antibiotike).
Serious infections occurred in 6.3% of rheumatoid arthritis patients treated with Enbrel for up to 48 months.
Resne okužbe so se pojavile pri 6, 3% bolnikov z revmatoidnim artritisom, ki so prejemali zdravilo Enbrel do 48 mesecev dolgo.
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.
11 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.
In the 2-year active-controlled study where patients were treated with either Enbrel alone, methotrexate alone or Enbrel in combination with methotrexate, the rates of serious infections were similar among the treatment groups.
V dveletni aktivno kontrolirani raziskavi, v kateri so bili bolniki zdravljeni z zdravilom Enbrel, z metotreksatom ali s kombinacijo zdravila Enbrel in metotreksata, je bila pogostnost resnih okužb v treh skupinah podobna.
However, it cannot be excluded that the combination of Enbrel with methotrexate could be associated with an increase in the rate of infections.
Vendar pa ni mogoče izključiti možnosti, da bi se lahko pogostnost okužb pri zdravljenju s kombinacijo zdravila Enbrel in metotreksata povečala.
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.
Serious infections experienced by Enbrel-treated patients included cellulitis, gastroenteritis, pneumonia, cholecystitis, osteomyelitis, gastritis, appendicitis, Streptococcal fasciitis, myositis, septic shock, diverticulitis and abscess.
Med resnimi okužbami pri bolnikih, zdravljenih z zdravilom Enbrel, so bile flegmona, gastroenteritis, pljučnica, holecistitis, osteomielitis, gastritis, apendicitis, streptokokni fasciitis, miozitis, septični šok, divertikulitis in absces.
In the double-blind and open-label psoriatic arthritis trials, 1 patient reported a serious infection (pneumonia).
V dvojno slepih in odprtih preskušanjih psoriatičnega artritisa je en bolnik poročal o eni resni okužbi (pljučnici).
Some have occurred within a few weeks after initiating treatment with Enbrel in patients who have underlying conditions (e. g. diabetes, congestive heart failure, history of active or chronic infections) in addition to their rheumatoid arthritis (see section 4.4).
Nekatere okužbe so se pojavile nekaj tednov po začetku zdravljenja bolnikov, ki so imeli poleg revmatoidnega artritisa tudi druga obolenja (diabetes, kongestivno srčno popuščanje, aktivne ali kronične okužbe v anamnezi) (glejte poglavje 4. 4.).
Opportunistic infections have been reported in association with Enbrel including invasive fungal, protozoal, bacterial (including Listeria and Legionella), and atypical mycobacterial infections.
V povezavi z zdravilom Enbrel so poročali o oportunističnih okužbah, vključno z invazivnimi glivičnimi, protozojskimi, bakterijskimi (vključno z bakterijama Listeria in Legionella) in atipičnimi mikobakterijskimi okužbami.
In a pooled data set of clinical trials, the overall incidence of opportunistic infections was 0.09% for the 15,402 subjects who received Enbrel.
V združeni zbirki podatkov iz kliničnih preskušanj je bila celotna pojavnost oportunističnih okužb pri 15. 402 bolnikih, ki so prejeli Enbrel, 0, 09%.
In
Za izpostavljenost popravljena pogostnost je bila 0, 06 dogodka na 100 bolniških let.
12 postmarketing experience, approximately half of all of the case reports of opportunistic infections worldwide were invasive fungal infections.
Po prihodu zdravila na trg je bilo približno pol vseh primerov okužb, opisanih v poročilih o primerih oportunističnih okužb po vsem svetu, invazivnih glivičnih okužb.
The most commonly reported invasive fungal infections were Pneumocystis and Aspergillus.
Invazivne glivične okužbe, o katerih so najpogosteje poročali, sta povzročila Pneumocystis in Aspergillus.
Invasive fungal infections accounted for more than half of the fatalities amongst patient who developed opportunistic infections.
Invazivne glivične okužbe so povzročile več kot pol smrtnih primerov pri bolnikih, pri katerih so se razvile oportunistične okužbe.
The majority of the reports with a fatal outcome were in patients with Pneumocystis pneumonia, unspecified systemic fungal infections, and aspergillosis (see section 4.4).
Večina poročil o smrtnih izidih je opisovala bolnike s pljučnico, ki jo je povzročila glivica Pneumocystis, z nedoločenimi sistemskimi glivičnimi okužbami in aspergilozo (glejte poglavje 4. 4).
Of the rheumatoid arthritis patients evaluated for antinuclear antibodies (ANA), the percentage of patients who developed new positive ANA ( 1:40) was higher in patients treated with Enbrel (11%) than in placebo-treated patients (5%).
Pri bolnikih z revmatoidnim artritisom, ki so jih testirali na antinuklearna protitelesa (ANA), je bil odstotek tistih, ki so razvili nova pozitivna ANA (≥ 1: 40) višji pri bolnikih, ki so prejemali zdravilo Enbrel (11%) kot pri tistih, ki so prejemali placebo (5%).
The percentage of patients who developed new positive anti-double-stranded DNA antibodies was also higher by radioimmunoassay (15% of patients treated with Enbrel compared to 4% of placebo-treated patients) and by Crithidia luciliae assay (3% of patients treated with Enbrel compared to none of placebo-treated patients).
Tudi odstotek bolnikov, ki so razvili nova pozitivna anti- dvojno- vijačna DNK protitelesa, je bil višji, merjeno z radioimunskimi testi (15% pri zdravilu Enbrel in 4% pri placebu) in s testom na Crithidia luciliae (3% pri zdravilu Enbrel in 0% pri placebu).
The proportion of patients treated with Enbrel who developed anticardiolipin antibodies was similarly increased compared to placebo-treated patients.
Odstotek bolnikov, ki so razvili protitelesa proti kardiolipinu, je bil podobno povečan pri zdravilu Enbrel kot pri placebu.
There have been rare reports of patients, including rheumatoid factor positive patients, who have developed other autoantibodies in conjunction with a lupus-like syndrome or rashes that are compatible with subacute cutaneous lupus or discoid lupus by clinical presentation and biopsy.
Redko so poročali o bolnikih, vključno z bolniki s pozitivnim revmatoidnim faktorjem, ki so razvili druga avtoprotitelesa v povezavi z lupusu podobnim sindromom ali izpuščaji, ki bi po klinični sliki in bioptičnem izvidu lahko pomenili subakutni kožni lupus ali diskoidni lupus.
There have been postmarketing reports of pancytopenia and aplastic anaemia, some of which had fatal outcomes (see section 4.4).
Po prihodu zdravila Enbrel na tržišče so poročali o pancitopeniji in aplastični anemiji, nekateri od teh primerov so bili tudi smrtni (glejte poglavje 4. 4).
Interstitial lung disease
12 Intersticijska bolezen pljuč
There have been postmarketing reports of interstitial lung disease (including pneumonitis and pulmonary fibrosis), some of which had fatal outcomes.
Po prihodu zdravila Enbrel na trg so poročali o intersticijski bolezni pljuč (vključno s pnevmonitisom in pljučno fibrozo), nekateri primeri te bolezni so se končali z bolnikovo smrtjo.
Based on the results of clinical studies, normally no special laboratory evaluations are necessary in addition to careful medical management and supervision of patients.
Na podlagi izsledkov kliničnih raziskav lahko trdimo, da posebno laboratorijsko spremljanje običajno ni potrebno, če bolnike skrbno zdravite in nadzorujete.
In studies when adult patients received concurrent treatment with Enbrel plus anakinra, a higher rate of serious infections compared to Enbrel alone was observed and 2% of patients (3/ 139) developed neutropenia (absolute neutrophil count  1000 / mm3).
V raziskavah, v katerih so odrasli bolniki sočasno prejemali zdravilo Enbrel in anakinro, so opažali večjo pogostnost resnih okužb v primerjavi s samim etanerceptom in pri 2% bolnikov (3/ 139) se je pojavila nevtropenija (absolutno število nevtrofilcev < 1. 000/ mm3).
While neutropenic, one patient developed cellulitis that resolved after hospitalisation (see sections 4.4 and 4.5).
Med nevtropenijo se je pri enem bolniku pojavil celulitis, ki se je pozdravil po hospitalizaciji (glejte poglavji 4. 4 in 4. 5).
Undesirable effects in paediatric patients with polyarticular juvenile idiopathic arthritis
Neželeni učinki pri otrocih s poliartikularnim juvenilnim idiopatskim artritisom
Differences from adults and other special considerations are discussed in the following paragraphs.
Spodaj opisujemo razlike teh učinkov glede na odrasle bolnike in druge posebnosti.
13 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.
Severe adverse events reported included varicella with signs and symptoms of aseptic meningitis, which resolved without sequelae (see also section 4.4), appendicitis, gastroenteritis, depression/ personality disorder, cutaneous ulcer, oesophagitis/ gastritis, group A streptococcal septic shock, type I diabetes mellitus, and soft tissue and post-operative wound infection.
Resni neželeni učinki, o katerih so poročali, so bili: norice z znaki in simptomi aseptičnega meningitisa, ki se je pozdravil brez posledic (glejte tudi poglavje 4. 4), vnetje slepiča, gastroenteritis, depresija/ osebnostne motnje, kožne razjede in ezofagitis/ gastritis, streptokokni septični šok (streptokoki A), diabetes mellitus tipa I in okužbe mehkih tkiv ter postoperativnih ran.
In one study in children with juvenile idiopathic arthritis aged 4 to 17 years, 43 of 69 (62%) children experienced an infection while receiving Enbrel during 3 months of the study (part 1 open-label), and the frequency and severity of infections was similar in 58 patients completing 12 months of open-label extension therapy.
Pogostnost in resnost okužb sta bili podobni pri 58 bolnikih, ki so zaključili 12- mesečno odprto podaljšano terapijo.
The types and proportion of adverse events in juvenile idiopathic arthritis patients were similar to those seen in trials of Enbrel in adult patients with rheumatoid arthritis, and the majority were mild.
Večina teh neželenih učinkov je bila blaga.
These included headache (19% of patients, 1.7 events per patient year), nausea (9%, 1.0 event per patient year), abdominal pain (19%, 0.74 events per patient year), and vomiting (13%, 0.74 events per patient year).
Pojavljali so se glavoboli (19%, 1, 7 neželenih učinkov na bolniško leto), navzea (9%, 1, 0 neželenih učinkov na bolniško leto), bolečine v trebuhu (19%, 0, 74 neželenih učinkov na bolniško leto) in bruhanje (13%, 0, 74 neželenih učinkov na bolniško leto).
There were 4 reports of macrophage activation syndrome in juvenile idiopathic arthritis clinical trials.
V kliničnih preskušanjih pri bolnikih z juvenilnim idiopatičnim artritisom so poročali o 4 primerih sindroma aktivacije makrofagov.
In a 48-week study in 211 children aged 4 to 17 years with paediatric plaque psoriasis, the adverse events reported were similar to those seen in previous studies in adults with plaque psoriasis.
V 48- tedenski študiji pri 211 otrocih, starih 4 do 17 let, z otroško psoriazo v plakih, so bili neželeni učinki, o katerih so poročali, podobni tistim, ki so jih ugotavljali v predhodnih študijah pri odraslih s psoriazo v plakih.
No dose-limiting toxicities were observed during clinical trials of rheumatoid arthritis patients.
V kliničnih raziskavah pri bolnikih z revmatoidnim artritisom niso opazili take vrste toksičnosti, ki bi omejevala odmerjanje.
The highest dose level evaluated has been an intravenous loading dose of 32 mg/ m2 followed by subcutaneous doses of 16 mg/ m2 administered twice weekly.
Nek bolnik z revmatoidnim artritisom si je pomotoma
One rheumatoid arthritis patient mistakenly self- administered 62 mg Enbrel subcutaneously twice weekly for 3 weeks without experiencing undesirable effects.
13 subkutano injiciral 62 mg zdravila Enbrel 2- krat tedensko 3 tedne, ne da bi pri tem prišlo do kakršnega koli neželenega učinka.
Tumor Necrosis Factor alpha (TNF- α) inhibitors.
Farmakoterapevtska skupina: zaviralci tumorje nekrotizirajočega faktorja alfa (TNF- α).
In plaque psoriasis, infiltration by inflammatory cells including T-cells leads to increased TNF levels in psoriatic lesions compared with levels in uninvolved skin.
Pri psoriazi v plakih se zaradi infiltracije vnetnih celic (vključno s celicami T) v psoriatičnih spremembah v primerjavi z neprizadeto kožo poveča koncentracija TNF.
Etanercept is a competitive inhibitor of TNF-binding to its cell surface receptors and thereby inhibits the biological activity of TNF.
Etanercept je kompetitivni zaviralec vezave TNF na receptorje na površini celice in torej zavira biološko aktivnost TNF.
TNF and lymphotoxin are pro- inflammatory cytokines that bind to two distinct cell surface receptors: the 55-kilodalton (p55) and 75-kilodalton (p75) tumour necrosis factor receptors (TNFRs).
55- kilodaltonske (p55) in 75- kilodaltonske (p75) TNF receptorje.
Both TNFRs exist naturally in membrane- bound and soluble forms.
Oboji receptorji obstojajo v dveh oblikah, t. j. vezani na membrano in v topni obliki.
14 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.
Dimeric soluble receptors such as etanercept possess a higher affinity for TNF than monomeric receptors and are considerably more potent competitive inhibitors of TNF binding to its cellular receptors.
Topni dimerni receptorji, kot je etanercept, imajo večjo afiniteto za TNF kot monomerni receptorji in so veliko bolj učinkoviti kompetitivni zaviralci vezave TNF na celične receptorje.
In addition, use of an immunoglobulin Fc region as a fusion element in the construction of a dimeric receptor imparts a longer serum half-life.
Poleg tega so z uporabo Fc področja imunoglobulina kot elementa združitve pri konstrukciji dimernega receptorja dosegli daljšo razpolovno dobo zdravila v serumu.
Much of the joint pathology in rheumatoid arthritis and ankylosing spondylitis and skin pathology in plaque psoriasis is mediated by pro-inflammatory molecules that are linked in a network controlled by TNF.
Velika večina sprememb sklepov pri revmatoidnem artritisu in ankilozirajočem spondilitisu ter sprememb na koži pri psoriazi v plakih je posledica vnetnih molekul, povezanih v mrežo, ki jo nadzira TNF.
The mechanism of action of etanercept is thought to be its competitive inhibition of TNF binding to cell surface TNFR, preventing TNF-mediated cellular responses by rendering TNF biologically inactive.
Tako etanercept prepreči celični odziv, ki ga normalno sproži TNF, TNF pa postane biološko neaktiven.
Etanercept may also modulate biologic responses controlled by additional downstream molecules (e. g., cytokines, adhesion molecules, or proteinases) that are induced or regulated by TNF.
Etanercept morda tudi uravnava biološke odzive, ki jih kontrolirajo druge molekule nižje v kaskadi (kot so citokini, adhezijske molekule ali proteinaze), ki jih prav tako inducira ali regulira TNF.
This section presents data from four randomised controlled trials in adults with rheumatoid arthritis, one study in polyarticular juvenile idiopathic arthritis, one study in adults with psoriatic arthritis, one study in adults with ankylosing spondylitis, one study in paediatric patients with plaque psoriasis, and four studies in adults with plaque psoriasis.
V tem poglavju so prikazani podatki iz štirih randomiziranih kontroliranih preskušanj pri odraslih z revmatoidnim artritisom, ene študije pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, ene študije pri odraslih s psoriatičnim artritisom, ene študije pri odraslih z ankilozirajočim spondilitisom, ene študije pri otrocih s psoriazo v plakih in štirih študij pri odraslih s psoriazo v plakih.
The efficacy of Enbrel was assessed in a randomised, double-blind, placebo-controlled study.
Učinkovitost zdravila Enbrel je bila ugotovljena v randomizirani, dvojno slepi klinični raziskavi, kontrolirani s placebom.
The study evaluated 234 adult patients with active rheumatoid arthritis who had failed therapy with at least one but no more than four disease-modifying antirheumatic drugs (DMARDs).
V raziskavo je bilo vključenih 234 odraslih bolnikov z aktivnim revmatoidnim artritisom, ki so bili pred tem neuspešno zdravljeni z vsaj enim, a ne več kot 4 imunomodulirajočimi protirevmatičnimi zdravili (DMARD – » disease- modifying antirheumatic drug «).
Doses of 10 mg or 25 mg Enbrel or placebo were administered subcutaneously twice a week for 6 consecutive months.
Bolnikom so 2- krat tedensko subkutano injicirali odmerke zdravila Enbrel po 10 ali 25 mg ali placebo in to 6 mesecev zapovrstjo.
The results of this controlled trial were expressed in percentage improvement in rheumatoid arthritis using American College of Rheumatology (ACR) response criteria.
Rezultate te kontrolirane raziskave so prikazali kot odstotek izboljšanja revmatoidnega artritisa po kriterijih odziva ACR (American College of Rheumatology).
Enbrel 62% and 59%, placebo 23% and 11% at 3 and 6 months respectively:
14 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).
Approximately 15% of subjects who received Enbrel achieved an ACR 70 response at month 3 and month 6 compared to fewer than 5% of subjects in the placebo arm.
Približno 15% bolnikov, zdravljenih z zdravilom Enbrel, je do 3. meseca in 6. meseca doseglo odziv ACR 70, v primerjavi z manj kot 5% tistih, ki so prejemali placebo.
A dose response was seen; results with 10 mg were intermediate between placebo and 25 mg.
Rezultati za 10 mg odmerek so bili vmes med placebom in 25 mg.
Enbrel was significantly better than placebo in all components of the ACR criteria as well as other measures of rheumatoid arthritis disease activity not included in the ACR response criteria, such as morning stiffness.
Rezultati za zdravilo Enbrel so bili statistično značilno boljši od placeba po vseh kriterijih ACR, prav tako pa tudi po tistih merilih aktivnosti revmatoidnega artritisa, ki v kriterije odziva po ACR niso vključeni, na primer jutranja okorelost.
A Health Assessment Questionnaire (HAQ), which included disability, vitality, mental health, general health status, and arthritis-associated health status subdomains, was administered every 3 months during the trial.
Vprašalnik za ocenjevanje zdravstvenega stanja HAQ (Health Assessment Questionaire), ki je vključeval invalidnost, vitalnost, duševno zdravje, splošno zdravstveno stanje in poddomene zdravstvenega stanja, povezane z artritisom, so med raziskavo uporabili vsake 3 mesece.
All subdomains of the HAQ were improved in patients treated with Enbrel compared to controls at 3 and 6 months.
Po vseh kriterijih lestvice HAQ je bilo vidno izboljšanje pri bolnikih na zdravilu Enbrel v 3. in 6. mesecu zdravljenja v primerjavi s kontrolno skupino.
After discontinuation of Enbrel, symptoms of arthritis generally returned within a month.
Po prekinitvi zdravljenja z zdravilom Enbrel so se simptomi artritisa največkrat ponovno pojavili že v prvem mesecu.
Re-introduction of treatment with Enbrel after discontinuation of up to 24 months resulted in the same magnitudes of responses as patients who received Enbrel without interruption of therapy based on results of open-label studies.
Po podatkih iz odprtih raziskav je bila odzivnost na ponovno zdravljenje z zdravilom Enbrel po do 24 mesecev trajajoči prekinitvi enaka odzivnosti pri bolnikih, ki so zdravilo Enbrel prejemali neprekinjeno.
Continued durable responses have been seen for up to 48 months in open-label extension
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 z metotreksatom.
Doses of 10 mg or 25 mg Enbrel were administered SC twice a week for up to 24 months.
Odmerki 10 mg ali 25 mg zdravila Enbrel so bili dani subkutano 2- krat tedensko do 24 mesecev.
Methotrexate doses were escalated from 7.5 mg/ week to a maximum of 20 mg/ week over the first 8 weeks of the trial and continued for up to 24 months.
Odmerke metotreksata so stopnjevali od 7, 5 mg/ teden do največ 20 mg/ teden v prvih 8 tednih raziskave in z njimi nadaljevali do 24 mesecev.
Clinical improvement including onset of action within 2 weeks with Enbrel 25 mg was similar to that seen in the previous trials, and was maintained for up to 24 months.
Klinično izboljšanje, vključno z nastopom delovanja zdravila v 2 tednih pri 25 mg zdravila Enbrel, je bilo podobno tistemu, ki so ga ugotavljali v prejšnjih raziskavah, in se je ohranjalo 24 mesecev.
At baseline, patients had a moderate degree of disability, with mean HAQ scores of 1.4 to 1.5.
Na začetku raziskave so imeli bolniki zmerno stopnjo nezmožnosti, s srednjo oceno po HAQ od 1, 4 do 1, 5.
Treatment with Enbrel 25 mg resulted in substantial improvement at 12 months, with about 44% of patients achieving a normal HAQ score (less than 0.5).
Z zdravljenjem s 25 mg zdravila Enbrel so dosegli bistveno izboljšanje pri 12 mesecih - približno 44% bolnikov je doseglo normalen rezultat HAQ (manj kot 0, 5).
This benefit was maintained in Year 2 of this study.
To ugodno delovanje se je ohranjalo tudi v drugem letu te raziskave.