natgillin/translations-raw huggingface dataset:
If an anaphylactic reaction or other serious allergic reaction occurs, administration of Hefiya should be discontinued immediately and appropriate therapy initiated.
Če se pojavi anafilaktična reakcija ali kakšna druga resna alergijska reakcija, je treba uporabo zdravila Hefiya nemudoma prekiniti in uvesti ustrezno zdravljenje.
In addition, no malignancies were observed in 192 paediatric patients with an exposure of 498.1 patient years during adalimumab trials in paediatric patients with Crohn's disease.
Poleg tega niso opazili nobenega malignoma tudi pri 192 pediatričnih bolnikih, ki so bili izpostavljeni 498,1 bolnikov-let med študijami z adalimumabom pri pediatričnih bolnikih s Crohnovo boleznijo.
The percent of adalimumab-treated patients achieving ACR 20, 50 and 70 responses was consistent across RA studies I, II and III.
Odstotek bolnikov, zdravljenih z adalimumabom, ki so dosegli odziv 20, 50 in 70 po ACR, se je v študijah revmatoidnega artritisa I, II in III skladal.
• benign tumours;
• benigni tumorji;
• If you have an infection, including long-term or localised infection (for example leg ulcer), consult your doctor before starting Hefiya.
• Če imate kakšno okužbo, vključno z dolgotrajno ali omejeno okužbo (npr. razjedo na nogi), se pred uporabo zdravila Hefiya posvetujte s svojim zdravnikom.
week 24 week 36 a patients with at least a partial response to adalimumab 40 mg weekly after 12 weeks of treatment.
24. teden 36. teden a bolniki z vsaj delnim odzivom na odmerek 40 mg adalimumaba po 12. tednih zdravljenja.
Worsening of symptoms of dermatomyositis1)
neznana pogostnost poslabšanje simptomov dermatomiozitisa1)
Vision related effects were not numerically in favour of adalimumab for colour vision in study UV I and for colour vision, peripheral vision and near vision in study UV II.
Učinki povezani z vidom niso bili v korist adalimumaba v primeru barvnega vida v študiji UV I in v primeru barvnega vida, perifernega vida in vida na blizu v študiji UV II.
Study UV II evaluated 226 patients with inactive uveitis requiring chronic corticosteroid treatment (oral prednisone 10 to 35 mg / day) at baseline to control their disease.
Študija UV II je ovrednotila 226 bolnikov z inaktivnim uveitisom, ki je že na začetku zahteval kronično zdravljenje s kortikosteroidi (prednizolon peroralno 10 do 35 mg/dan) za nadzor njihove bolezni.
Hefiya can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Zdravilo Hefiya je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljnje zdravljenje z metotreksatom ni primerno.
a adalimumab / MTX 40 mg every other week placebo / MTXadalimumab / MTX (95 % confidence interval b)
placebo/MTXa adalimumab/MTX 40 mg vsak drugi teden placebo/MTXadalimumab/MTX (95 % interval zaupanjab)
• Do not store the syringes in extreme heat or cold.
• Injekcijskih brizg ne hranite na ekstremni vročini ali mrazu.
Hefiya contains the active substance adalimumab, a medicine that acts on your body's immune (defence) system.
Zdravilo Hefiya vsebuje učinkovino adalimumab, ki deluje na imunski sistem (obrambni mehanizem) telesa.
Patients remained on stable doses of NSAIDs and or prednisone (≤ 0.2 mg / kg / day or 10 mg / day maximum).
Bolniki so ostali na stabilnih odmerkih nesteroidnih protivnetnih zdravil in/ali prednizona (≤ 0,2 mg/kg/dan ali največ 10 mg/dan).
For the safety and health of you and others, the pens must never be re-used.
Zaradi varnosti in zdravja vas in drugih oseb injekcijskih peresnikov nikoli ne smete ponovno uporabiti.
If new areas of damaged skin appear during or after treatment or if existing marks or areas of damage change appearance, tell your doctor.
Če se vam med zdravljenjem ali po njem pojavijo novi predeli poškodovane kože, ali če se vam spremeni videz obstoječih sprememb ali poškodovanih predelov, morate to povedati zdravniku.
Check the green indicator fills the window (see Figure J):
Po injiciranju Preverite, da je zeleni kazalnik zapolnil okence (glejte sliko J):
Flare was defined as ASDAS ≥ 2.1 at two consecutive visits four weeks apart.
Ponovni zagon bolezni je bil opredeljen kot ASDAS ≥ 2,1 pri dveh zaporednih obiskih štiri tedne narazen.
Instructions for use
NAVODILA ZA UPORABO
The inflammation leads to a decrease of vision and / or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision).
Vnetje povzroči poslabšanje vida in/ali prisotnost delcev v očesu (črnih pik ali koprenastih črt, ki se premikajo po vidnem polju).
Patients treated with adalimumab had significantly reduced risk of disease flare during the initial 12 weeks of treatment.
Bolniki, zdravljeni z adalimumabom, so imeli statistično pomembno zmanjšanje tveganja novega izbruha bolezni v začetnih 12 tednih zdravljenja.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
• Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7)
In a clinical trial with another TNF-antagonist worsening congestive heart failure and increased mortality due to congestive heart failure have been observed.
V klinični študiji z drugim antagonistom TNF so opažali poslabšanje kongestivnega srčnega popuščanja in večjo umrljivost zaradi kongestivnega srčnega popuščanja.
Both studies demonstrated an early and sustained effect of adalimumab on the treatment failure rate versus placebo (see Figure 2).
V obeh študijah je bil dokazan zgodnji in vzdrževan učinek adalimumaba na odstotek neuspeha zdravljenja proti placebu (glejte sliko 2).
• For a more comfortable injection, take the blister containing the syringe out of the refrigerator and leave it unopened on your work surface for about 15 to 30 minutes so that it reaches room temperature.
• Da bo injiciranje prijetnejše, vzemite pretisni omot, ki vsebuje injekcijsko brizgo, iz hladilnika in ga pustite zaprtega na delovni površini približno 15 do 30 minut, da se ogreje na sobno temperaturo.
Psoriasis Study II (CHAMPION) compared the efficacy and safety of adalimumab versus methotrexate and placebo in 271 patients.
Študija pri psoriazi II (CHAMPION) je primerjala učinkovitost in varnost adalimumaba z metotreksatom in placebom pri 271 bolnikih.
Greater improvements at week 12 from baseline compared to placebo were demonstrated in skin-specific health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI; Studies HS-I and HS-II), patient global satisfaction with medication treatment as measured by the Treatment Satisfaction Questionnaire - medication (TSQM; Studies HS-I and HS-II), and physical health as measured by the physical component summary score of the SF-36 (Study HS-I).
Večje izboljšanje v 12. tednu so pokazali glede na izhodiščno vrednost v primerjavi s placebom glede z zdravjem povezane kakovosti življenja, specifične za kožo, merjene z dermatološkim indeksom kakovosti življenja (“Dermatology life quality index” (DLQI), v študijah HS-I in HS-II), glede bolnikovega splošnega zadovoljstva z zdravljenjem z zdravilom, merjenem z vprašalnikom o zadovoljstvu z zdravljenjem z zdravilom (“Treatment Satisfaction Questionnaire - medication” (TSQM), v študijah HS-I in HS-II), in glede telesnega zdravja, merjenega s seštevkom telesnih komponent v vprašalniku SF-36 (“Short Form Health Survey" (SF 36) v študiji HS-I).
Some patients who have not responded by week 4 may benefit from continued maintenance therapy through week 12.
Nekaterim bolnikom, ki se ne odzovejo do 4. tedna, lahko koristi nadaljnje vzdrževalno zdravljenje do 12. tedna.
Clinical Response
Klinični odziv
If you take Hefiya the risk of getting lymphoma, leukaemia, or other cancers may increase.
Če uporabljate zdravilo Hefiya, se vam lahko poveča tveganje za pojav limfoma, levkemije ali drugih vrst raka.
• never leave the syringe unattended where others might tamper with it.
• nikoli ne pustite injekcijske brizge brez nadzora tam, kjer bi lahko kdo posegal vanjo.
• autoimmune hepatitis (inflammation of the liver caused by the body's own immune system);
• avtoimunski hepatitis (vnetje jeter, ki ga povzroči lastni imunski sistem);
Full instructions for use are given in the package leaflet, section 7, "Instructions for Use".
Celotna navodila za uporabo so navedena v navodilu za uporabo, poglavje 7, „Navodila za uporabo“.
ACR response
Odziv po ACR
No studies have been conducted that include patients with a history of malignancy or in whom treatment with adalimumab is continued following development of malignancy.
Študij, ki bi vključevale bolnike z anamnezo malignoma ali bolnike, pri katerih bi se zdravljenje z adalimumabom nadaljevalo po pojavu malignoma, ni bilo.
• throw away the used syringe right away after use.
• injekcijsko brizgo zavržete takoj po uporabi.
p-value total Sharp score c erosion score JSN
Pc celotna Sharpova ocena ocena erozij seštevek JSN
Table 17 Ps study I (REVEAL) - efficacy results at 16 weeks placebo N = 398 n (%)
Preglednica 17 študija pri psoriazi I (REVEAL) - rezultati učinkovitosti po 16 tednih placebo n = 398 n (%)
Patients who develop a new infection while undergoing treatment with Hefiya should be monitored closely and undergo a complete diagnostic evaluation.
Bolnike, pri katerih se med zdravljenjem z zdravilom Hefiya pojavi nova okužba, je treba natančno nadzirati in opraviti morajo popolno diagnostično obravnavo.
Hidradenitis suppurativa in adults and adolescents
Hidradenitis suppurativa pri odraslih in mladostnikih
• Hold your pen at 90 degrees to the cleaned injection site (see Figure G).
• Injekcijski peresnik držite pod kotom 90 stopinj na očiščeno mesto injiciranja (glejte sliko G).
It most commonly affects specific areas of the skin, such as under the breasts, the armpits, inner thighs, groin and buttocks.
Najpogosteje prizadene specifične predele kože, kot je predel pod prsmi, pod pazduhami, notranji del stegen, dimlje in zadnjico.
Hefiya is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years and enthesitis-related arthritis in children and adolescents aged 6 to 17 years.
Zdravilo Hefiya se uporablja za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa pri otrocih in mladostnikih, starih 2 do 17 let in artritisa, povezanega z entezitisom pri otrocih in mladostnikih starih od 6 do 17 let.
Spondyloarthritis Research Consortium of Canada i n=84 placebo and adalimumab j n=82 placebo and n=85 adalimumab ***,**,* statistically significant at p < 0.001, < 0.01, and < 0.05, respectively, for all comparisons between adalimumab and placebo.
i n = 84 placebo in adalimumab j n = 82 placebo in n = 85 adalimumab ***, **, * Statistično pomembno pri p < 0,001, < 0,01 in < 0,05, v tem zaporedju, za vse primerjave med adalimumabom in placebom.
Psoriasis is believed to be caused by a problem with the body's immune system that leads to an increased production of skin cells.
Domneva se, da luskavico povzroči motnja v delovanju imunskega sistema, ki ima za posledico povečano nastajanje kožnih celic.
Hefiya 40 mg solution for injection in pre-filled pen EU/1/18/1287/004
Hefiya 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku EU/1/18/1287/004
After subcutaneous administration of a single 40 mg dose, absorption and distribution of adalimumab was slow, with peak serum concentrations being reached about 5 days after administration.
Absorpcija in porazdelitev Po subkutani uporabi enega samega 40 mg odmerka sta bili absorpcija in distribucija adalimumaba počasni in največja koncentracija v serumu je bila dosežena približno 5 dni po uporabi.
Patients should be tested for HBV infection before initiating treatment with Hefiya.
Bolnike je treba pred začetkom zdravljenja z zdravilom Hefiya testirati na okužbo s HBV.
It is important that you tell your baby's doctors and other health care professionals about your Hefiya use during your pregnancy so they can decide when your baby should receive any vaccine.
Zato je pomembno, da obvestite zdravnika vašega otroka in druge zdravstvene delavce, da ste med nosečnostjo prejemali zdravilo Hefiya, da se lahko odločijo, kdaj bo vaš otrok lahko prejel katerokoli cepivo.
Taking these results into consideration, Hefiya is recommended for use in combination with MTX and for use as monotherapy in patients for whom MTX use is not appropriate (see section 4.2).
Z upoštevanjem teh ugotovitev je zdravilo Hefiya priporočljivo uporabljati v kombinaciji z metotreksatom, kot monoterapijo pa pri bolnikih, za katere uporaba metotreksata ni primerna (glejte poglavje 4.2).
PGA: clear/minimal
PGA: čisto/minimalno
These therapies include methotrexate, leflunomide, hydroxychloroquine, sulfasalazine and / or gold salts.
Terapije so vključevale metotreksat, leflunomid, hidroksiklorokin, sulfasalazin in/ali soli zlata.
No ALT elevations ≥ 3 x ULN occurred in the Phase 3 trial of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 2 to < 4 years.
Zvišanja ALT ≥ 3 x ULN se niso pojavila v preskušanju faze 3 z adalimumabom pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, ki so bili stari od 2 do < 4 leta.
Study HS-II (PIONEER II) evaluated 326 patients with 2 treatment periods.
V študiji HS-II (PIONEER II) je bilo ocenjenih 326 bolnikov v dveh obdobjih zdravljenja.
Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see table 19).
Ocena psoriaze nohtov je vključevala prilagojeni indeks izrazitosti psoriaze nohtov (mNAPSI - Modified Nail Psoriasis Severity Index), zdravnikovo globalno oceno psoriaze nohtov (PGA-F - Physician's Global Assessment of Fingernail Psoriasis) in indeks izrazitosti psoriaze nohtov (NAPSI - Nail Psoriasis Severity Index) (glejte preglednico 19).
The primary endpoint in RA study V was the percent of patients who achieved an ACR 50 response at week 52.
Primarna končna točka študije revmatoidnega artritisa V je bil odstotek bolnikov, ki so do 52. tedna dosegli odziv ACR 50.
RA study IV primarily assessed safety in 636 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old.
V študiji revmatoidnega artritisa IV je bila v prvi vrsti ocenjena varnost pri 636 bolnikih z zmerno do hudo aktivnim revmatoidnim artritisom, starih ≥ 18 let.
During 52 weeks of studies UC-I and UC-II, lower rates of all-cause hospitalisations and UC-related hospitalisations were observed for the adalimumab-treated arm compared to the placebo arm.
V 52 tednih študij UC-I in UC-II so opazili nižjo stopnjo hospitalizacije iz vseh razlogov in hospitalizacije, povezane z ulceroznim kolitisom, pri skupini, zdravljeni z adalimumabom, v primerjavi s placebo skupino.
• heart attack;
• srčni napad;
Children and adolescents with Crohn's disease
Otroci in mladostniki s Crohnovo boleznijo
• Look at the expiration date (EXP) on your syringe.
• Poglejte datum izteka roka uporabnosti (EXP) na injekcijski brizgi.
Avoid areas with scars or stretch marks.
Izogibajte se predelom z brazgotinami ali strijami.
• facial oedema (swelling) associated with allergic reactions;
• edem (otekanje) obraza, povezan z alergijskimi reakcijami;
In RA study III, most subjects who achieved improvement in physical function and continued treatment maintained improvement through week 520 (120 months) of open-label treatment.
V študiji revmatoidnega artritisa III se je pri večini bolnikov, ki so dosegli izboljšanje telesne funkcije in so nadaljevali zdravljenje, to izboljšanje ohranilo vseskozi do 520. tedna (120. meseca) odprte faze zdravljenja.
Hefiya is also used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years for whom medicines applied to the skin and treatment with UV light have either not worked very well or are not suitable.
Zdravilo Hefiya se uporablja tudi za zdravljenje hude luskavice v plakih pri otrocih in mladostnikih, starih od 4 do 17 let, pri katerih zdravila, ki se nanašajo na kožo, in zdravljenje z UV-svetlobo niso dovolj dobro delovali ali pa niso primerni.
19.3 % of patients had continued baseline oral antibiotic therapy during the study.
19,3 % bolnikov je nadaljevalo izhodiščno zdravljenje s peroralnimi antibiotiki.
Hefiya can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Zdravilo Hefiya je mogoče uporabljati tudi za zdravljenje hudega, aktivnega in napredujočega revmatoidnega artritisa brez predhodnega zdravljenja z metotreksatom.
When combining controlled portions of these trials and ongoing and completed open label extension studies with a median duration of approximately 3.3 years including 6,427 patients and over 26,439 patient years of therapy, the observed rate of malignancies, other than lymphoma and non-melanoma skin cancers is approximately 8.5 per 1,000 patient years.
Če vzamemo skupaj kontrolirane dele teh preskušanj in potekajoče in zaključene nadaljevalne študije z medianim trajanjem približno 3,3 leta s 6427 bolniki in prek 26439 bolnikov let zdravljenja, je ugotovljeni delež malignomov (razen limfoma in nemelanomskih kožnih rakov) približno 8,5 na 1000 bolnikov-let.
Hefiya is used to treat
Zdravilo Hefiya se uporablja za zdravljenje
Health-related quality of life and physical function were 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 RA study III.
Z zdravjem povezano kakovost življenja in telesno funkcijo so v štirih originalnih ustreznih in dobro kontroliranih študijah ocenjevali z indeksom invalidnosti z vprašalnikom HAQ (Health Assessment Questionnaire) in je bila v študiji revmatoidnega artritisa III vnaprej določena primarna končna točka po 52 tednih.
40 mg every other week
40 mg vsak drugi teden
If you have mild heart failure and you are being treated with Hefiya, your heart failure status must be closely monitored by your doctor.
Če imate blago srčno popuščanje in se zdravite z zdravilom Hefiya, mora zdravnik natančno nadzorovati stanje vašega srčnega popuščanja.
• symptoms of nerve root compression (including low back pain and leg pain);
• simptomi stisnjenja živčnih korenin (vključno z bolečino v spodnjem delu hrbta in nogah);
Because of the nature of the adverse events seen with the combination of etanercept and anakinra therapy, similar toxicities may also result from the combination of anakinra and other TNF-antagonists.
Glede na naravo neželenih dogodkov, opaženih pri kombiniranem zdravljenju z etanerceptom in anakinro, lahko podobne toksičnosti nastanejo tudi pri uporabi anakinre in drugih antagonistov TNF.
Tell your doctor immediately if you get symptoms like changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body.
Zdravniku takoj povejte, če se pri vas pojavijo simptomi, kot so spremembe vida, šibkost rok ali nog ali pa odrevenelost ali mravljinčenje v katerem koli delu telesa.
You may cover the injection site with a small adhesive bandage, if needed.
Na mesto injiciranja si lahko po potrebi nalepite majhen obliž.
At week 4, subjects were randomised 1:1 based on their body weight at the time to either the Low Dose or Standard Dose maintenance regimens as shown in table 25.
V 4. tednu so bili bolniki glede na njihovo telesno maso v tem času randomizirani v razmerju 1:1 bodisi v vzdrževalni režim z majhnim odmerkom ali vzdrževalni režim s standardnim odmerkom, kot kaže preglednica 25.
Adalimumab has not been studied in patients with enthesitis-related arthritis aged less than 6 years.
Adalimumaba niso preučevali pri bolnikih z artritisom, povezanim z entezitisom, starih manj kot 6 let.
Hefiya may have a minor influence on the ability to drive and use machines.
Zdravilo Hefiya ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
The infections consisted primarily of nasopharyngitis, upper respiratory tract infection, and sinusitis.
Pri okužbah je šlo predvsem za nazofaringitis, okužbo zgornjih dihal in sinusitis.
Included in your carton is:
V škatli je priloženo:
You may also use the lower abdomen, but not the area 5 cm around your navel (belly button) (see Figure E).
Uporabite lahko tudi spodnji del trebuha, vendar ne predela 5 cm okrog popka (glejte sliko E).
In Study UV I statistically significant differences in favour of adalimumab versus placebo were observed for each component of treatment failure.
V študiji UV I so opazili statistično pomembne razlike v korist adalimumaba v primerjavi s placebom za vsako od komponent neuspeha zdravljenja.
The results for the 40 mg every other week dose are summarised in table 7.
Rezultati odmerka 40 mg vsak drugi teden so strnjeni v preglednici 7.
• ankylosing spondylitis,
• ankilozirajočega spondilitisa,
• Do not throw away any medicines via wastewater or household waste.
• Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
The primary end point in RA studies I, II and III and the secondary endpoint in RA study IV was the percentage of patients who achieved an ACR 20 response at week 24 or 26.
Primarna končna točka v študijah revmatoidnega artritisa I, II in III ter sekundarna končna točka v študiji revmatoidnega artritisa IV je bil odstotek bolnikov, ki so po 24 oz. 26 tednih dosegli odziv 20 po ACR.
Note: P# = Placebo (Number of Events/Number at Risk); A# = Adalimumab (Number of Events/Number at Risk).
Opomba: P# = Placebo (število dogodkov/število rizičnih preiskovancev); A# = Adalimumab (število dogodkov/število rizičnih preiskovancev).
Table 28 response, remission and mucosal healing in study UC-II (percent of patients)
Preglednica 28 odziv, remisija in celjenje sluznice v študiji UC-II (odstotek bolnikov)
Radiographs of hands, wrists, and feet were obtained at baseline and week 24 during the double-blind period when patients were on adalimumab or placebo and at week 48 when all patients were on open-label adalimumab.
Rentgenske posnetke dlani, zapestij in stopal so naredili izhodiščno in 24. teden med dvojno slepim obdobjem, med katerim so bolniki dobivali adalimumab ali placebo, in 48. teden, ko so vsi bolniki odprto dobivali adalimumab.
Amongst those who responded (Pediatric ACR 30) at week 24 (n = 27 out of 30 patients), the Pediatric ACR 30 responses were maintained for up to 60 weeks in the OLE phase in patients who received adalimumab throughout this time period.
Med tistimi, ki so se odzvali (Pediatric ACR 30) 24. teden (n = 27 od 30 bolnikov), se je odziv Pediatric ACR 30 v odprti podaljšani fazi ohranil do 60 tednov pri bolnikih, ki so med tem celotnim obdobjem prejemali adalimumab.
A single Hefiya pre-filled syringe / pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Posamezna napolnjena injekcijska brizga ali napolnjen injekcijski peresnik zdravila Hefiya se lahko shranjuje pri temperaturi do največ 25 ºC za obdobje do 14 dni.
10, 20 and 25 mg
10, 20 in 25 mg
ACR responses in PsA study I were similar with and without concomitant methotrexate therapy.
Odzivi ACR v študiji pri psoriatičnem artritisu I so bili podobni ob sočasni terapiji z metotreksatom in brez nje.
adalimumab / M TX n = 268
adalimumab/ MTX n = 268
Infections and infestations*
Infekcijske in parazitske bolezni*
Improvement in number of active joints with arthritis was maintained during the OL period through week 156 for the 26 of 31 (84 %) patients in the adalimumab group who remained in the study.
Izboljšanje v številu aktivnih sklepov z artritisom se je ohranilo v obdobju odprtega preskušanja po 156. tednu pri 26 od 31 (84 %) bolnikov, ki so ostali v študiji in ki so prejemali adalimumab.