natgillin/translations-raw huggingface dataset:
Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 1-2 X 10-10 M). 
Adalimumab modulira tudi biološke odzive, ki jih sproži ali uravnava TNF, vključno s spremembami koncentracije adhezijskih molekul, odgovornih za migracijo levkocitov (ELAM-1, VCAM-1 in ICAM-1 z IK50 1-2 x 10-10 M).
If you take Trudexa your risk may increase. 
Če jemljete Trudexo, se ta verjetnost poveča.
This evaluation should include a detailed medical history with a personal history of tuberculosis or possible previous exposure to patients with active tuberculosis and previous and/or current immunosuppressive therapy. 
Pregled mora obsegati podrobno zdravstveno anamnezo z osebno anamnezo tuberkuloze ali morebitnih predhodnih stikov z bolniki z aktivno tuberkulozo ter predhodnega in/ali trenutnega imunosupresivnega zdravljenja.
Thus additional caution should be exercised in considering Trudexa treatment of these patients (see section 4.8). 
Torej je potrebna dodatna previdnost, kadar razmišljamo o zdravljenju s Trudexo pri teh bolnikih (glejte poglavje 4.8).
• Feeling weak or tired; 
• občutek šibkosti ali utrujenosti;
If you accidentally inject Trudexa more frequently than told to by your doctor, you should call your doctor and tell him/her that you have taken more. 
Če pomotoma injicirate Trudexo pogosteje, kot vam je naročil zdravnik, se morate posvetovati z njim in mu povedati, da ste uporabili večji odmerek.
Adalimumab concentrations in the synovial fluid from several rheumatoid arthritis patients ranged from 31-96% of those in serum. 
Koncentracije adalimumaba v sinovijski tekočini več bolnikov z revmatoidnim artritisom so bile od 31 do 96% tistih v serumu.
After doses of 0.5 mg/kg (~40 mg), clearances ranged from 11 to 15 ml/hour, the distribution volume (Vss) ranged from 5 to 6 litres and the mean terminal phase halflife was approximately two weeks. 
Po odmerkih 0,5 mg/kg (~40 mg) je bil očistek od 11 do 15 ml/uro, volumen distribucije (Vss) od 5 do 6 litrov in povprečni razpolovni čas terminalne faze približno dva tedna.
NA NA 9.5% 41.5% 
NP 9,5% 41,5%
Adalimumab binds specifically to TNF and neutralizes the biological function of TNF by blocking its interaction with the p55 and p75 cell surface TNF receptors. 
Adalimumab se specifično veže na TNF in nevtralizira njegovo biološko delovanje, ker zavre njegovo interakcijo z receptorji p55 in p75 za TNF na površini celic.
Of those in clinical response at week 4, 48% had been previously exposed to other anti-TNF therapy. 
Od tistih, ki so imeli 4. teden klinični odziv, jih je 48% predhodno dobilo drugo terapijo proti TNF.
• Use a new alcohol pad to clean the grey stopper on the vial. 
• Uporabite nov alkoholni zloženec in z njim očistite sivi zamašek viale.
Similar trends (not all statistically significant) were seen in the smaller randomised, double − blind, placebo controlled study (IX) of 82 adult patients with active ankylosing spondylitis. 
Podobni trendi (ki pa niso bili vsi statistično značilni) so bili opazni v manjši, randomizirani, dvojno slepi, s placebom kontrolirani študiji (IX) pri 82 odraslih bolnikih z aktivnim ankilozirajočim spondilitisom.
If your doctor determines that methotrexate is inappropriate, Trudexa can be given alone. 
Če vaš zdravnik ugotovi, da metotreksat ni primeren, lahko Trudexo dobivate samo.
• Only use each pre-filled pen for one injection. 
• Vsak napolnjeni injekcijski peresnik uporabite le za eno injiciranje.
The primary endpoint in Study V was the percent of patients who achieved an ACR 50 response at week 52. 
Primarna končna točka študije V je bil odstotek bolnikov, ki so do 52. tedna dosegli odziv ACR 50.
• Advise your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV or if you think you might be at risk of contracting HBV. Trudexa can cause reactivation of 
• Zdravniku morate povedati, če ste nosilec virusa hepatitisa B (HBV), če imate aktiven HBV ali če mislite, da bi se lahko nalezli HBV. Trudexa lahko pri nosilcih HBV povzroči reaktivacijo tega virusa.
PATIENT ALERT CARD TEXT (NOT INCLUDED IN PACK OR AS PART OF THE PACKAGE LEAFLET) 
BESEDILO BOLNIKOVE OPOZORILNE IZKAZNICE (ni priložena pakiranju ali navodiliu za uporabo)
Side effects may occur at least up to 5 months after the last treatment. 
Neželeni učinki se lahko pojavijo vsaj še 5 mesecev po zadnjem odmerku.
The efficacy and safety of Trudexa for the treatment of rheumatoid arthritis were assessed in five randomised, double-blind and well-controlled studies. 
Učinkovitost in varnost Trudexe za zdravljenje revmatoidnega artritisa so ocenili v petih randomiziranih, dvojno slepih in dobro kontroliranih študijah.
Pull the plum safety cap (labelled ‘2') straight off to expose the plum coloured activation button at the top. 
Snemite temnomodri varnostni pokrovček (označen z '2') naravnost dol, da se bo pokazal temnomodri sprožilni gumb na vrhu.
Please record the dates of the last screening for tuberculosis below: Tuberculin test: _______________ Chest X-ray: 
Spodaj zabeležite datume zadnjih presejalnih preiskav za tuberkulozo: Tuberkulinski test: Rentgenogram prsnih organov: ____________
In CHARM, at week 4, 58% (499/854) of patients were in clinical response and were assessed in the primary analysis. 
V študiji CHARM je imelo 4. teden klinični odziv 58% (499/854) bolnikov; ti so bili ocenjeni v primarni analizi.
If you have ankylosing spondylitis you will first be given other medicines. 
Če imate ankilozirajoči spondilitis, boste najprej dobili druga zdravila.
Study VII 
Študija VII
Check that the needle is below the surface of the solution. 
Preverite, da je igla pod površino raztopine.
THE MARKETING AUTHORISATION HOLDER Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2). 
Izdaja zdravila je le pod omejenimi pogoji in na recept (glejte Dodatek I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
Depending on your response, your doctor may increase the dose to 40 mg every week. 
Odvisno od vašega odziva lahko zdravnik poveča odmerek na 40 mg vsak drugi teden.
WHAT TRUDEXA IS AND WHAT IT IS USED FOR 
KAJ JE ZDRAVILO TRUDEXA IN ZA KAJ GA UPORABLJAMO
In Study III, improvement in physical function was maintained through week 260 (60 months) of open-label treatment. 
V študiji III se je izboljšanje telesne funkcije ohranilo vseskozi do 206. tedna (60. meseca) odprte faze zdravljenja.
• As cases of tuberculosis have been reported in patients treated with Trudexa, your doctor will check you for signs and symptoms of tuberculosis before starting Trudexa. 
• Ker so bili pri bolnikih, zdravljenih s Trudexo, opisani primeri tuberkuloze, vas bo zdravnik pred začetkom zdravljenja s Trudexo preiskal glede znakov in simptomov tuberkuloze.
Treatment with Trudexa should not be initiated in patients with active infections including chronic or localized infections until infections are controlled. 
Zdravljenja s Trudexo se ne sme začeti pri bolnikih z aktivnimi okužbami, vključno s kroničnimi ali lokaliziranimi, dokler te niso obvladane.
Table 8 - Efficacy Responses in Placebo-Controlled AS Study - Study VIII Reduction of Signs and Symptoms 
Tabela 8 - Odzivi učinkovitosti v študiji AS, kontrolirani s placebom - študija VIII Zmanjšanje znakov in simptomov
If latent tuberculosis is diagnosed, appropriate anti-tuberculosis prophylaxis in accordance with local recommendations must be initiated before starting treatment with Trudexa. 
Če se odkrije latentna tuberkuloza, je treba pred začetkom zdravljenja s Trudexo uvesti ustrezno protituberkulozno profilakso v skladu z lokalnimi priporočili.
• anaemia, low white blood cell counts; 
• anemija, zmanjšanje števila belih krvnih celic;
• Never put the pre-filled pens that you have used into your normal household rubbish bin. 
• Odrabljenih napolnjenih injekcijskih peresnikov nikdar ne zavrzite med običajne gospodinjske odpadke.
Maintenance of remission and response rates are presented in Table 10. 
Vzdrževanje remisije in deleže odziva prikazuje tabela 10.
However, because human immunoglobulins are excreted in milk, women must not breast-feed for at least five months after the last Trudexa treatment. 
Ker se človeški imunoglobulini izločajo v mleku, ženske ne smejo dojiti vsaj pet mesecev po zadnjem zdravljenju s Trudexo.
This will include a thorough medical history, a chest X-ray and a tuberculin test. 
To bo vključevalo natančno poizvedbo o vašem zdravju v preteklosti, rentgensko slikanje prsnih organov in tuberkulinski test.
It is not known whether adalimumab is excreted in human milk or absorbed systemically after ingestion. 
Ni znano, ali se adalimumab izloča v materinem mleku in ali se po zaužitju sistemsko absorbira.
When you do this, if you accidentally push some solution back into the vial, pull slowly back in the plunger to draw the entire contents of the vial back into the syringe. 
Če pri tem nazaj v vialo potisnete nekaj raztopine, bat počasi potegnite nazaj, da boste celotno vsebino viale dobili nazaj v brizgo.
The impact of longterm treatment with Trudexa on the development of autoimmune diseases is unknown. 
Vpliv dolgoročnega zdravljenja s Trudexo na nastanek avtoimunskih bolezni ni znan.
NA NA 24.0% 58.9% 
NP 24,0% 58,9%
Trudexa should not affect your ability to drive or use machinery. 
Trudexa naj ne bi vplivala na vašo sposobnost upravljanja vozil in strojev.
For Trudexa, no clinical data on exposed pregnancies are available 
Za Trudexo ni na voljo kliničnih podatkov od nosečnic, ki so bile izpostavljene zdravilu.
The primary end point in Studies I, II and III and the secondary endpoint in Study IV was the percent of patients who achieved an ACR 20 response at week 24 or 26. 
Primarna končna točka v raziskavah I, II in III ter sekundarna končna točka v raziskavi IV je bil odstotek bolnikov, ki so po 24 oz. 26 tednih dosegli odziv 20 po ACR.
Usually, Trudexa is used with methotrexate. 
Trudexo ponavadi uporabljamo z metotreksatom.
Study IV primarily assessed safety in 636 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old. 
Raziskava IV je v prvi vrsti ocenila varnost pri 636 bolnikih z zmerno do hudo aktivnim revmatoidnim artritisom, starih ≥ 18 let.
With the current knowledge, a possible risk for the development of lymphomas or other malignancies in patients treated with a TNF-antagonist cannot be excluded. 
S sedanjim znanjem možnega tveganja za razvoj limfomov ali drugih malignomov pri bolnikih, zdravljenih z zaviralcem TNF, ni mogoče izključiti.
If active tuberculosis is diagnosed, Trudexa therapy must not be initiated (see section 4.3). 
Če se odkrije aktivna tuberkuloza, se zdravljenja s Trudexo ne sme začeti (glejte poglavje 4.3).
Active tuberculosis or other severe infections such as sepsis, and opportunistic infections (see section 
Aktivna tuberkuloza ali druge hude okužbe, npr. sepsa, in oportunistične okužbe (glejte poglavje 4.4).
• urinary disturbances (such as blood in urine, increased urinary frequency); 
• motnje na sečilih (npr. kri v urinu, pogostejše uriniranje);
Patients in Studies I, II and III were tested at multiple timepoints for antibodies to adalimumab during the 6 to 12 month period. 
Pri bolnikih v študijah I, II in III so v obdobju od 6 do 12 mesecev ob različnih časih večkrat določali protitelesa proti adalimumabu.
Among those, 66 patients showed no progression of structural damage defined by a change in the TSS of zero or less. 
Med temi bolniki jih 66 ni kazalo napredovanja strukturne prizadetosi izražene s spremembo celotne Sharpove ocene 0 ali manj.
In Study V, structural joint damage was assessed radiographically and expressed as change in modified total Sharp score (see Table 6). 
V študiji V so strukturno okvaro sklepov ocenili rentgenografsko in jo izrazili kot razliko v modificirani celotni Sharpovi oceni (glejte tabelo 6).
• Shortness of breath with exertion or upon lying down or swelling of the feet; 
• težko dihanje ob naporu ali med ležanjem ali otekanje nog;
• increased menstrual bleeding; 
• močnejše menstruacijske krvavitve;
Administration of Trudexa without methotrexate resulted in increased formation of antibodies, increased clearance and reduced efficacy of adalimumab (see section 5.1). 
Uporaba Trudexe brez metotreksata je zvečala nastajanje protiteles, zvečala očistek in zmanjšala učinkovitost adalimumaba (glejte poglavje 5.1).
If you forget to take Trudexa: 
Če ste pozabili vzeti Trudexo
Rare hearing loss 
redki izguba sluha
In patients who develop HBV reactivation, Trudexa should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated. 
Pri bolnikih, ki se jim pojavi reaktivacija HBV, je treba uporabo Trudexe prekiniti in uvesti učinkovito protivirusno terapijo z ustreznim podpornim zdravljenjem.
There is a window on each side of the pen through which you can see the Trudexa solution inside the syringe. 
Na obeh straneh peresnika je okence; skozi okenci lahko vidite raztopino Trudexa v notranjosti brizge.
If you do not respond well enough to these medicines, you will be given Trudexa to reduce the signs and symptoms of your disease. 
Če se nanje ne boste odzvali dovolj dobro, boste za zmanjšanje znakov in simptomov bolezni dobili Trudexo.
Table 5: Radiographic Mean Changes Over 12 Months in Study III 
Tabela 5: Povprečne rentgenografske spremembe v 12 mesecih raziskave III
SPECIAL STORAGE CONDITIONS Store in a refrigerator. 
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku .
The safety and efficacy of Trudexa were assessed in over 1400 patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomised, double-blind, placebo-controlled studies. 
Varnost in učinkovitost Trudexe so ocenili pri več kot 1400 bolnikih z zmerno do hudo, aktivno Crohnovo boleznijo (indeks aktivnosti Crohnove bolezni [CDAI] ≥ 220 in ≤ 450) v randomiziranih, dvojno slepih, s placebom kontroliranih študijah.
Important information about some of the ingredients of Trudexa This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodiumfree'. 
Pomembne informacije o nekaterih sestavinah zdravila Trudexa To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) v odmerku, kar pomeni, da je količina zanemarljiva.
This alert card contains important safety information that you need to be aware of before you are given Trudexa and during treatment with Trudexa. 
Ta opozorilna izkaznica vsebuje pomembne varnostne informacije, s katerimi morate biti seznanjeni, preden prejmete Trudexo in med zdravljenjem z njo.
Trudexa is indicated for treatment of severe, active Crohn's disease, in patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies. 
Trudexa je indicirana za zdravljenje hude, aktivne Crohnove bolezni pri bolnikih, ki se ne odzovejo na popoln in ustrezen ciklus zdravljenja s kortikosteroidom in/ali imunosupresivom, ali pa takšnega zdravljenja ne prenesejo oz. imajo zanj medicinske kontraindikacije.
• After injecting Trudexa, immediately throw away the used syringe in a special container as instructed by your doctor, nurse or pharmacist. 
• Po injiciranju Trudexe porabljeno brizgo takoj zavrzite v poseben vsebnik, kot vam je naročil zdravnik, medicinska sestra ali farmacevt.
If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Trudexa and is positive for antibodies against double-stranded DNA, further treatment with Trudexa should not be given (see section 4.8). 
Če se bolniku po zdravljenju s Trudexo pojavijo simptomi, ki nakazujejo lupusu podobni sindrom, in ima pozitivna protitelesa proti dvojnoverižni DNA, zdravljenja s Trudexo ne sme nadaljevati (glejte poglavje 4.8).
With your other hand, pull the grey cap (1) straight off and discard cap. 
Z drugo roko snemite sivi pokrovček (1) naravnost dol in ga zavrzite.
In this situation, the benefit/risk balance of therapy with Trudexa should be very carefully considered. 
V takšnih primerih je treba zelo natančno pretehtati korist in tveganje zdravljenja s Trudexo.
If you do not respond well enough to these medicines, you will be given Trudexa to treat your rheumatoid arthritis. 
Če se na ta zdravila ne odzovete dovolj dobro, boste za zdravljenje revmatoidnega artritisa dobili Trudexo.
Study III and V had an additional primary endpoint at 52 weeks of retardation of disease progression (as detected by X-ray results). 
V študijah III in V je bila dodatna primarna končna točka po 52 tednih upočasnitev napredovanja bolezni (ugotovljena z izvidi rentgenskega slikanja).
Of particular importance are infections such as pneumonia, pyelonephritis, septic arthritis and septicaemia. 
Posebno pomembne okužbe so npr. pljučnica, pielonefritis, septični artritis in septikemija.
Uncommon blood creatine phosphokinase increased, activated partial thromboplastin time prolonged, autoantibodies present 
Preiskave občasni zvišanje kreatin fosfokinaze v krvi, podaljšan aktivirani parcialni tromboplastinski čas, prisotna avtoprotitelesa
If an anaphylactic reaction or other serious allergic reaction occurs, administration of Trudexa should be discontinued immediately and appropriate therapy initiated. 
Če se pojavi anafilaktična reakcija ali kakšna druga resna alergijska reakcija, je treba uporabo Trudexe nemudoma prekiniti in uvesti ustrezno zdravljenje.
Adverse events at least possibly causally-related to adalimumab for Studies I − IX, CLASSIC I, GAIN and CHARM, both clinical and laboratory, are displayed by system organ class and frequency (very common ≥ 1/10; common≥ 1/100 < 1/10; uncommon≥ 1/1000 to ≤ 1/100) and rare < 1/1000 in Table 1 below. 
Klinični in laboratorijski neželeni učinki, ki so vsaj potencialno vzročno povezani z adalimumabom v študijah I-IX, CLASSIC I, GAIN in CHARM, so navedeni po organskih sistemih in pogostnosti: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100) in redki (≥1/10.000 do <1/1.000) v tabeli 1 spodaj.
Preclinical data on postnatal toxicity and fertility effects of adalimumab are not available (see section 5.3). 
Predkliničnih podatkov o poporodni toksičnosti adalimumaba in njegovih učinkih na plodnost ni (glejte poglavje 5.3).
The Trudexa pre-filled pen is available in packs containing 1, 2, 4, and 6 pre-filled pens. 
Napolnjeni injekcijski peresnik Trudexa je na voljo v pakiranjih, ki vsebujejo 1, 2, 4 ali 6 napolnjenih injekcijskih peresnikov.
• Double vision; 
• dvojni vid;
Data from the open-label extension phase indicate that the reduction in rate of progression of structural damage is maintained for 60 months in a subset of patients. 
Podatki iz odprte podaljšane faze kažejo, da se upočasnitev napredovanja strukturne prizadetosti sklepov ohrani vseh 60 mesecev v tej podskupini bolnikov.
INFORMATION IN BRAILLE Trudexa 40 mg 
PODATKI V BRAILLOVI PISAVI Trudexa 40 mg
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 40 mg/0.8 ml 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 40 mg/0,8 ml
Health-related quality of life and physical function was assessed using the disability index of the Health Assessment Questionnaire (HAQ) in the four original adequate and well-controlled trials, which was a pre-specified primary endpoint at week 52 in Study III. 
Z zdravjem povezano kakovost življenja in telesno funkcijo so v štirih originalnih ustreznih in dobro kontroliranih raziskavah ocenjevali z indeksom invalidnosti z vprašalnikom HAQ (Health Assessment Questionnaire) in je bila v raziskavi III vnaprej določena primarna končna točka po 52 tednih.
You should not take Trudexa with medicines containing the active substance, anakinra. 
Trudexe ne smete jemati z zdravili, ki vsebujejo učinkovino anakinro.
• With the needle still in the vial, turn the vial upside down at eye level. 
• Medtem ko je igla še vedno v viali, v višini oči obrnite vialo na glavo.
• Remove the plastic cap from the Trudexa vial. 
• Z viale Trudexe odstranite plastični pokrovček.
Study IIIa** 
Raziskava IIIa**
The results for the 40 mg every other week dose are summarised in Table 3. 
Rezultati odmerka 40 mg vsak drugi teden so strnjeni v tabeli 3.
Adalimumab is a recombinant human monoclonal antibody expressed in Chinese Hamster Ovary cells. 
Adalimumab je rekombinantno humano monoklonsko protitelo, pridobljeno v celicah jajčnika kitajskega hrčka.
Your doctor will decide if you should receive Trudexa. 
Ta bo presodil, ali lahko dobivate Trudexo.
Administration of adalimumab is not recommended during pregnancy. 
Uporaba adalimumaba med nosečnostjo ni priporočljiva.
• Each new injection should be given at least 3 cm from the last injection site. 
• Vsako naslednjo injekcijo morate dati vsaj 3 cm od mesta prejšnje injekcije.
Do not press the plum activation button until properly positioned as this will result in discharge of medication. 
Ne pritisnite temnomodrega sprožilnega gumba, dokler ni pravilno nameščen, ker boste sicer iztisnili zdravilo.
• If you have an infection, including long-term or localized infection (for example, leg ulcer) consult your doctor before starting Trudexa. 
• Če imate kakšno okužbo, vključno z dolgotrajno ali omejeno okužbo (npr. razjedo na nogi), se pred uporabo Trudexe posvetujte s svojim zdravnikom.
Other side effects that have been observed in patients taking Trudexa: tuberculosis and other opportunistic infections (infections that occur when resistance to disease is lowered); lung disease. 
Drugi neželeni učinki, zabeleženi pri bolnikih, ki so jemali Trudexo: tuberkuloza in druge oportunistične okužbe (okužbe, ki se pojavijo, kadar se zmanjša odpornost proti boleznim); pljučna bolezen.
With the vial upright on a flat surface, such as a table, insert the needle straight through the centre ring of the grey stopper. 
Vialo postavite pokonci na ravno površino, npr. na mizo, in zabodite iglo naravnost skozi osrednji obroč sivega zamaška.
• Trudexa should not be used if you have moderate to severe heart failure. 
• Trudexe ne smete dobiti, če imate zmerno do hudo srčno popuščanje.
Patients treated with Trudexa should be given the special alert card. 
Bolniki, ki se zdravijo s Trudexo, morajo dobiti posebno opozorilno izkaznico.
During treatment with Trudexa, other concomitant therapies (e.g., corticosteroids and/or immunomodulatory agents) should be optimised. 
Med zdravljenjem s Trudexo je treba optimizirati druge sočasne terapije (npr. kortikosteroide in/ali imunomodulacijska zdravila).
A. MANUFACTURER(S) OF THE OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE ZDRAVILNE UČINKOVINE (UČINKOVIN) IN IMETNIK(I) DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
Trudexa treated patients had significantly greater improvement at Week 12 which was maintained through Week 24 in both the SF36 and Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL). 
Bolniki, ki so dobivali Trudexo, so imeli po 12 tednih značilno večje izboljšanje (ki se je ohranilo do 24. tedna) SF36 in ASQoL (Vprašalnik o kakovosti življenja pri ankilozirajočem spondilitisuAnkylosing Spondylitis Quality of Life Questionnaire).
Study Ia** 
Raziskava Ia**
In the pivotal trials, anti-adalimumab antibodies were identified in 58/1053 (5.5%) patients treated with adalimumab, compared to 2/370 (0.5%) on placebo. 
V ključnih preskušanjih so protitelesa proti adalimumabu odkrili pri 58/1053 (5,5%) bolnikov, zdravljenih z adalimumabom, in pri 2/370 (0,5%), ki so dobivali placebo.
Clinical remission Clinical response (CR-100) 
Klinična remisija Klinični odziv (CR-100)
Very common (≥ 1/10 patients): • injection site reactions (including pain, swelling, redness or itching). 
Zelo pogosto (≥1/10 bolnikov): • reakcije na mestu injiciranja (vključno z bolečino, oteklostjo, pordelostjo in srbenjem).