natgillin/translations-raw huggingface dataset:
In the Phase I/II study, treatment with canakinumab had a rapid onset of action, with disappearance or clinically significant improvement of symptoms within one day after dosing.
V študiji faze I/II je zdravljenje s kanakinumabom začelo hitro delovati, tako da so simptomi izzveneli ali se klinično pomembno izboljšali v enem dnevu po odmerjanju.
It is not known whether Ilaris passes into human milk.
Ni znano, ali zdravilo Ilaris pri človeku prehaja v materino mleko.
CAPS in adults and children  4 years of age  15 kg
CAPS pri odraslih in otrocih, starih  4 leta in z  15 kg
However, the risk of severe hypersensitivity reactions, which is not uncommon for injectable proteins, cannot be excluded (see section 4.3).
Kljub temu pa tveganja za hude preobčutljivostne reakcije ni mogoče izključiti, saj pri proteinih, ki so primerni za injiciranje, te niso redek pojav (glejte poglavje 4.3).
The majority of paediatric patients achieved improvement in clinical symptoms and objective markers of inflammation (e.g. SAA and CRP).
Pri večini pediatričnih bolnikov je prišlo do izboljšanja kliničnih simptomov in vrednosti objektivnih označevalcev vnetja (na primer SAA in CRP).
Of the total 128 patients who entered Part I taking corticosteroids, 92 attempted corticosteroid tapering.
Izmed skupno 128 bolnikov, ki so ob vstopu v 1. obdobje jemali kortikosteroide, jih je 92 poskušalo postopno ukiniti zdravljenje z njimi.
Ilaris is intended for subcutaneous use.
Zdravilo Ilaris je namenjeno podkožni uporabi.
If you need another treatment with Ilaris, and got relief from the last dose, you must wait at least 12 weeks before the next dose.
Če ponovno potrebujete zdravljenje z zdravilom Ilaris in vam je predhodni odmerek ustrezno pomagal, morate do naslednjega odmerka počakati najmanj 12 tednov.
An increased dose was administered more frequently to patients aged 2 to < 4 years and to patients with NOMID/CINCA symptoms compared with FCAS or MWS.
Odmerke so pogosteje zvišali bolnikom, ki so bili stari od 2 do < 4 leta, in bolnikom s sindromom NOMID/CINCA v primerjavi z bolniki, ki so imeli sindrom FCAS ali MWS.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Navodila za rekonstrukcijo zdravila pred uporabo so v poglavju 6.6.
Now, gently turn the vial upside down and back again ten times, again taking care not to touch the rubber stopper.
Zatem vialo desetkrat nežno obrnite na glavo in spet nazaj in pazite, da se pri tem ne dotaknete gumijastega zamaška.
These crystals cause excessive production of IL-1 beta, which in turn can lead to sudden, severe pain, redness, warmth and swelling in a joint (known as a gouty arthritis attack).
Ti kristali povzročajo prekomerno nastajanje snovi IL-1 beta, ta pa lahko povzroči nenadne hude bolečine, rdečino, toploto in otekanje sklepov (kar poznamo kot napad uričnega artritisa).
Exposure parameters (such as AUC and Cmax) increased in proportion to dose over the dose range of 0.30 to 10.0 mg/kg given as intravenous infusion or from 150 to 600 mg as subcutaneous injection.
Parametri izpostavljenosti zdravilu (kot sta AUC in Cmax) se zvišujejo sorazmerno z odmerkom v obsegu odmerkov od 0,30 do 10,0 mg/kg pri intravenskem infundiranju oziroma v obsegu odmerkov od 150 do 600 mg pri subkutanem injiciranju zdravila.
Your doctor will discuss with you the potential risks of taking Ilaris during pregnancy.
Zdravnik vam bo razložil možna tveganja pri zdravljenju z zdravilom Ilaris med nosečnostjo.
The apparent clearance (CL/F) of canakinumab increases with body weight.
Navidezni očistek (CL/F) kanakinumaba se povečuje s telesno maso.
Uric acid increases were not observed in clinical trials in non-gouty arthritis populations (see section 5.1).
Zvišanja koncentracije sečne kisline niso opažali v kliničnih preskušanjih pri populacijah brez uričnega artritisa (glejte poglavje 5.1).
What you need to know before you use Ilaris
Kaj morate vedeti, preden boste uporabili zdravilo Ilaris
The causal relationship of canakinumab to these events cannot be excluded.
Vzročne povezave med temi dogodki in kanakinumabom ne moremo izključiti.
Find a clean place in which to prepare and administer the injection.
Poiščite čist prostor, v katerem boste pripravljali in uporabili injekcijo.
Serum amyloid A ≤ 10 mg/l
serumski amiloid A ≤ 10 mg/l
The doctor or nurse will demonstrate how to administer Ilaris injections.
Zdravnik ali medicinska sestra vam bosta pokazala, kako je treba injicirati zdravilo Ilaris.
Physicians should exercise caution when administering canakinumab to patients with infections, a history of recurring infections, or underlying conditions which may predispose them to infections.
Zdravniki morajo biti previdni, kadar dajejo kanakinumab bolnikom z okužbo, z anamnezo ponavljajočih se okužb ali z boleznijo, zaradi katere so bolniki nagnjeni k okužbam.
Clinical experience with dosing at intervals of less than 4 weeks or at doses above 600 mg or 8 mg/kg is limited.
Kliničnih izkušenj z odmerjanjem v intervalih, ki so krajši od 4 tednov, in z uporabo odmerkov nad 600 mg oziroma 8 mg/kg je malo.
Canakinumab N=43
kanakinumab N=43
Secondary endpoints (disease and inflammatory markers)
Sekundarni cilji študije (označevalci bolezni in vnetja)
Only patients with confirmed NLRP3 mutation were included in the pivotal study.
V ključno študijo so bili vključeni samo bolniki s potrjeno mutacijo NLRP3.
Make sure 1.0 ml of water is in the syringe, then take the needle out of the vial.
Preverite, če je v brizgi res 1,0 ml vode, nato pa izvlecite iglo iz viale.
(There may be solution remaining in the vial.)
(V viali lahko ostane določena količina raztopine.)
The aim of the study was to assess efficacy, safety, and tolerability of canakinumab (150 mg or 2 mg/kg every 8 weeks) in patients with CAPS.
Namen študije je bil oceniti učinkovitost, varnost in prenašanje kanakinumaba (150 mg oziroma 2 mg/kg vsakih 8 tednov) pri bolnikih s CAPS.
The estimated steady state AUCtau was 636.7 ± 260.2 μg*d/ml.
Ocenjena vrednost AUCtau v stanju dinamičnega ravnovesja je 636,7 ± 260,2 μg*d/ml.
Laboratory parameters such as high CRP and SAA, high neutrophils and platelet counts normalised rapidly within days of canakinumab injection.
Laboratorijski parametri, kot so visoke koncentracije CRP, SAA, nevtrofilcev in trombocitov, so se hitro normalizirale v nekaj dneh po injekciji kanakinumaba.
Your doctor may check whether you have tuberculosis using a specific test. if you have signs of a liver disorder such as yellow skin and eyes, nausea, loss of appetite, darkcoloured urine and light-coloured stools.
Zdravnik lahko s posebnim testom preveri, ali imate tuberkulozo; če imate znake jetrne bolezni, kot so rumena koža in oči, občutek slabosti, izguba apetita, temno obarvan urin in svetlo blato; če morate biti cepljeni.
• Familial Mediterranean fever (FMF).
• družinska mediteranska vročica (angl. familial Mediterranean fever, s kratico FMF).
Then gently turn the vial upside down and back again ten times.
Zatem vialo desetkrat nežno obrnite na glavo in spet nazaj.
Each vial is for single use in a single patient, for a single dose.
Posamezna viala je namenjena za enkratno uporabo pri posameznem bolniku za odmerjanje enega odmerka.
No apparent correlation of antibody development to clinical response or adverse events was observed.
Prav tako niso opažali nobene jasne povezave med razvojem protiteles in kliničnim odzivom oziroma neželenimi dogodki.
Ilaris is indicated for the treatment of the following autoinflammatory periodic fever syndromes in adults, adolescents and children aged 2 years and older:
Zdravilo Ilaris je indicirano za zdravljenje naslednjih avtoinflamatornih periodičnih vročinskih sindromov pri odraslih, mladostnikih in otrocih, starih 2 leti ali več:
Should vaccination with live vaccines be indicated after initiation of canakinumab treatment, the recommendation is to wait for at least 3 months after the last canakinumab injection and before the next one (see section 4.4).
Če je cepljenje z živim cepivom indicirano po začetku zdravljenja s kanakinumabom, je priporočeno s cepljenjem počakati vsaj 3 mesece po zadnji injekciji kanakinumaba in zdravljenje s kanakinumabom nadaljevati šele 3 mesece po cepljenju (glejte poglavje 4.4).
Do not inject into scar-tissue as this may mean you do not get all of your medicine.
Zdravila ne injicirajte v brazgotino, ker bi to lahko pomenilo, da ne boste prejeli celotnega odmerka.
3 Based on estimated creatinine clearance, most were transient 4 Most represented transient trace to 1+ positive urinary protein by dipstick 5 See further information below
3 glede na ocenjen očistek kreatinina, večinoma so bile vrednosti zvišane le prehodno 4 večina izvidov je pomenila prehodno prisotnost beljakovin v urinu v sledeh oziroma do vrednosti 1+ na testnem lističu 5 za več podatkov glejte spodaj
Macrophage activation syndrome (MAS) is a known, life-threatening disorder that may develop in patients with rheumatic conditions, in particular Still's disease.
Sindrom aktivacije makrofagov (macrophage activation syndrome - MAS) je znana, življenjsko nevarna motnja, do katere lahko pride pri bolnikih z revmatičnimi boleznimi, zlasti s Stillovo boleznijo.
Your doctor will monitor you for potential triggering factors of MAS that include infections and re-activation of the underlying Still's disease (flare).
Zdravnik vas bo spremljal in opazoval morebiten pojav sprožilnih dejavnikov sindroma aktivacije makrofagov, med katerimi so okužbe in ponovna aktivacija osnovne Stillove bolezni (zagon).
Fifty-seven (62%) of the 92 patients who attempted to taper were able to successfully taper their corticosteroid dose and 42 (46%) discontinued corticosteroids.
Sedeminpetdeset (62 %) od 92 bolnikov, ki so začeli postopno opuščanje, je uspelo znižati odmerjanje kortikosteroidov, 42 bolnikov (46 %) pa je povsem prekinilo jemanje kortikosteroidov.
In the long-term, open-label studies with dose escalation, events of infections (gastroenteritis, respiratory tract infection, upper respiratory tract infection), vomiting and dizziness were more frequently reported in the 600 mg or 8 mg/kg dose group than in other dose groups.
V dolgoročnih odprtih študijah s stopnjevanjem odmerkov so o dogodkih, ki so obsegali okužbe (gastroenteritis, okužbe dihal, okužbe zgornjih dihal), bruhanje in omotičnost, poročali pogosteje v skupinah bolnikov, ki so prejemali odmerke 600 mg oziroma 8 mg/kg, kot v skupinah z drugimi odmerki.
Neutropenia (absolute neutrophil count [ANC] < 1.5 x 10
Nevtropenijo (absolutno število nevtrofilcev < 1,5 x 10
Ilaris is used in adults to treat the symptoms of frequent gouty arthritis attacks if other treatments have not worked well enough.
Zdravilo Ilaris uporabljamo pri odraslih za zdravljenje simptomov pri pogostih napadih uričnega artritisa, če druga zdravila pri tem niso bila uspešna.
Table 1 Tabulated list of adverse reactions
Preglednica 1 Tabelarični pregled neželenih učinkov
For chronic or repeated therapies, it is also recommended to assess WBC counts periodically during treatment.
V primeru kroničnega ali večkratnega zdravljenja je priporočeno določati število levkocitov v rednih presledkih med zdravljenjem.
MedDRA System Organ Class
Organski sistem po klasifikaciji MedDRA
Use of canakinumab with TNF inhibitors is not recommended because this may increase the risk of serious infections.
Uporaba kanakinumaba z zaviralci TNF ni priporočena, saj bi lahko povečala tveganje za resne okužbe.
Part II: In the withdrawal period of the pivotal study, the primary endpoint was defined as the proportion of patients with a disease relapse/flare: none (0%) of the patients randomised to canakinumab flared, compared with 81% of the patients randomised to placebo.
2. obdobje: V obdobju opuščanja zdravila te ključne študije je bil primarni cilj opazovanja opredeljen kot delež bolnikov s ponovitvijo/zagonom bolezni: do ponovnega zagona ni prišlo pri nobenem (0 %) od bolnikov, ki so bili randomizirani na uporabo kanakinumaba, v primerjavi z 81 % bolnikov, ki so bili randomizirani na uporabo placeba.
Release the pinched skin and pull the needle straight out.
Sprostite kožno gubo in naravnost izvlecite iglo.
In patients with periodic fever syndromes (CAPS, TRAPS, HIDS/MKD and FMF), the body produces too much IL-1 beta.
Pri bolnikih s periodičnimi vročinskimi sindromi (CAPS, TRAPS, HIDS/MKD in FMF) v telesu nastaja preveč IL-1 beta.
If you accidentally inject more Ilaris than the recommended dose, it is unlikely to be serious, but you should inform your doctor, pharmacist or nurse as soon as possible.
Če ste uporabili večji odmerek zdravila Ilaris, kot bi smeli Če si nehote injicirate več zdravila Ilaris, kot je priporočeni odmerek, se vam verjetno ne bo zgodilo nič resnega, vendar morate kljub temu čimprej obvestiti zdravnika, farmacevta ali medicinsko sestro.
If drops remain on the stopper, tap the side of the vial to remove them.
Če so na zamašku ostale kapljice tekočine, potrkajte po steni viale, da jih odstranite.
A total of 185 patients aged 28 days and above were enrolled and a total of 181 patients aged 2 years and above were randomised in part II of the study.
Skupno so v študijo vključili 185 bolnikov, ki so bili stari 28 dni ali več, v 2. obdobje študije pa so randomizirali skupno 181 bolnikov, ki so bili stari 2 leti ali več.
Based on the population pharmacokinetic modelling analysis, the expected exposures after a dose of 2 mg/kg were comparable across the CAPS paediatric age groups, but were approximately 40% lower in paediatric patients of very low body weight (e.g. 10 kg) than in adult patients (150 mg dose).
Na podlagi analize populacijskega farmakokinetičnega modeliranja so bile pričakovane izpostavljenosti po odmerjanju 2 mg/kg primerljive med vsemi starostnimi skupinami pediatričnih bolnikov s CAPS, pri tem pa so bile pri pediatričnih bolnikih z zelo majhno telesno maso (na primer 10 kg) približno za 40 % manjše kot pri odraslih bolnikih (z odmerkom 150 mg).
Ilaris is available in packs containing one vial.
Zdravilo Ilaris je na voljo v pakiranjih, ki vsebujejo po eno vialo.
It is recommended to select a different injection site each time the product is injected to avoid soreness.
Priporočeno je, da vsakokrat, ko injicirate zdravilo, izberete drugo mesto injiciranja, s čimer lahko preprečite bolečino.
During clinical development of Ilaris in over 2,600 patients, no anaphylactoid or anaphylactic reactions were reported.
V času kliničnega razvoja zdravila Ilaris pri več kot 2.600 bolnikih o primerih anafilaktoidnih ali anafilaktičnih reakcij niso poročali.
You are advised to avoid being vaccinated with a type of vaccine called a live vaccine while being treated with Ilaris (see also “Other medicines and Ilaris”).
Priporočeno je, da se v času zdravljenja z zdravilom Ilaris izogibate cepljenju z določenimi vrstami cepiv, ki jih imenujemo živa cepiva (glejte tudi "Druga zdravila in zdravilo Ilaris").
For children given a starting dose of 4 mg/kg who have not responded well enough after 7 days, the doctor may give a second dose of 4 mg/kg.
Otrokom, ki so prejeli začetni odmerek 4 mg/kg, vendar pri njih po 7 dneh ni prišlo do dovolj dobrega odziva, lahko zdravnik da drugi odmerek 4 mg/kg.
- The solution should be used immediately after first piercing the vial stopper to prepare the injection.
- Raztopino je treba uporabiti takoj po tem, ko predrete zamašek na viali, da bi pripravili zdravilo za injiciranje.
Treatment with canakinumab induced a reduction of pain and reduced the risk of subsequent attacks in patients using ULT and unable to use both NSAIDs and colchicine, although the observed treatment difference compared to triamcinolone acetonide was less pronounced than with the overall study population.
Zdravljenje s kanakinumabom je olajšalo bolečine in zmanjšalo tveganje za nadaljnje napade pri bolnikih, ki so uporabljali zdravila za zmanjševanje količine urata, niso pa mogli uporabljati niti nesteroidnih protivnetnih zdravil niti kolhicina, vendar je bila pri njih razlika v primerjavi z uporabo triamcinolon acetonida manj izrazita kot pri celotni študijski populaciji.
On initiation of canakinumab in patients being treated with this type of medicinal product, therapeutic monitoring of the effect or of the active substance concentration should be performed and the individual dose of the medicinal product adjusted as necessary.
Pri bolnikih, ki se zdravijo s to vrsto zdravil, je treba ob začetku zdravljenja s kanakinumabom spremljati terapevtski učinek ali koncentracijo zdravilne učinkovine in, če je treba, posameznemu bolniku ustrezno prilagoditi odmerek zdravila.
Treatment with Ilaris may result in dizziness/vertigo or asthenia (see section 4.8).
Zdravljenje ze zdravilom Ilaris lahko povzroča omotičnost/vrtoglavico ali splošno oslabelost (glejte poglavje 4.8).
9/l were reported in 2% of patients in the comparative trials.
9/l pri 2 % bolnikov.
The results of a 56-week, open label study in CAPS patients aged 4 years and younger demonstrated that all patients who received non-live, standard of care childhood vaccinations developed protective antibody levels.
Rezultati 56-tedenske odprte študije pri bolnikih s CAPS, ki so bili stari 4 leta ali manj, so pokazali, da se je pri vseh bolnikih, ki so bili cepljeni z neživimi cepivi po standardnem programu cepljenja v otroški dobi, razvila zaščitna raven protiteles.
No neutralising antibodies were detected.
Pri nobenem bolniku niso odkrili nevtralizirajočih protiteles.
In the event of conversion from a negative to a positive PPD test, especially in high-risk patients, alternative means of screening for a tuberculosis infection should be considered.
Če pri bolniku pride do konverzije iz negativnega v pozitivni rezultat testa s PDD, je treba zlasti pri bolnikih s povečanim tveganjem razmisliti o presejalnem pregledu glede okužbe z bacilom tuberkuloze.
Transient and asymptomatic cases of elevations of serum transaminases or bilirubin have been reported in clinical trials (see section 4.8).
V kliničnih preskušanjih so poročali o prehodnih in asimptomatskih zvišanjih koncentracij aminotransferaz ali bilirubina v serumu (glejte poglavje 4.8).
Study G2301 was a randomised, double-blind, placebo-controlled withdrawal study of flare prevention by canakinumab.
Študija G2301 je bila randomizirana, dvojno slepa, s placebom kontrolirana študija opuščanja zdravljenja ob uporabi kanakinumaba za preprečevanje zagona bolezni.
- Part IV: All Part III patients treated with canakinumab were eligible to enter into a 72-week open-label treatment extension period.
- 4. obdobje: vsi bolniki, ki so v 3. obdobju prejemali kanakinumab, so bili primerni za vstop v 72-tedensko obdobje podaljšanja z odprtim zdravljenjem.
Sixty-three of the 100 patients entering Part II, whether assigned to placebo or canakinumab, did not experience a flare over the observation period (up to a maximum of 80 weeks).
Pri triinšestdesetih od 100 bolnikov, ki so vstopili v 2. obdobje in so prejemali placebo ali kanakinumab, ni prišlo do zagona v opazovanem obdobju (največ 80 tednov).
For gouty arthritis, the physician should be experienced in the use of biologics and Ilaris should be administered by a healthcare professional.
Pri uričnem artritisu mora imeti zdravnik izkušnje z uporabo bioloških zdravil, zdravilo Ilaris pa naj bolniku aplicira usposobljen zdravstveni delavec.
They should not be used with Ilaris because this may increase the risk of infections.
Navedenih zdravil ne smete uporabljati sočasno z zdravilom Ilaris, saj to lahko poveča tveganje za okužbe.
The patient or caregiver and the doctor should decide together who will administer the Ilaris injections.
Bolnik oziroma skrbnik naj se skupaj z zdravnikom odloči, kdo bo bolniku injiciral zdravilo Ilaris.
Immediately proceed to administering the injection.
Takoj nadaljujte z injiciranjem zdravila.
Elderly No dose adjustment is required.
Prilagajanje odmerkov ni potrebno.
Canakinumab had no effect on male fertility parameters in marmosets (C. jacchus).
Kanakinumab pri marmozetkah (C. jacchus) ni vplival na parametre moške plodnosti.
Patients who experience such symptoms during Ilaris treatment should wait for this to resolve completely before driving or operating machines.
Bolniki, pri katerih med zdravljenjem z zdravilom Ilaris prihaja do tovrstnih simptomov, ne smejo voziti ali upravljati s stroji, dokler ta simptom popolnoma ne izzveni.
Make sure the tip of the transfer needle is covered by the water and slowly pull the syringe plunger down to slightly past the 1.0 ml mark.
Ko se prepričate, da je konica igle pod vodno gladino, počasi potegnite bat navzdol, da nekoliko preseže oznako 1,0 ml.
Still's disease (AOSD and SJIA)
Stillova bolezen (AOSD in SJIA)
The most frequent adverse drug reactions were infections predominantly of the upper respiratory tract.
Najbolj pogosti neželeni učinki zdravila so bile okužbe zlasti zgornjih dihal.
Based on clinical trial experience, canakinumab does not appear to increase the incidence of MAS in SJIA patients, but no definitive conclusion can be made.
Po izkušnjah iz kliničnih študij ne kaže, da bi kanakinumab povečal pogostnost sindroma aktivacije makrofagov pri bolnikih s SJIA, vendar dokončnega zaključka ni mogoče podati.
Slowly inject the water into the vial containing the Ilaris powder.
Počasi vbrizgajte vodo v vialo s praškom Ilaris.
Activation of macrophages and concomitant over-production of IL-1 beta results in an acute painful inflammatory response.
Aktivacija makrofagov in spremljajoče prekomerno nastajanje IL-1 beta povzročita boleč akutni vnetni odziv.
Clean the injection site with a new alcohol swab.
Mesto za injiciranje očistite z novo alkoholno blazinico.
Concomitant use of canakinumab with tumour necrosis factor (TNF) inhibitors is not recommended because this may increase the risk of serious infections (see section 4.5).
Sočasna uporaba kanakinumaba in zaviralcev tumor nekrotizirajočega faktorja (TNF - tumor necrosis factor) ni priporočljiva ker lahko poveča tveganje za resne okužbe (glejte poglavje 4.5).
- Do not use this medicine if you notice that the solution is not clear to opalescent or contains particles.
- Ne uporabljajte tega zdravila, če opazite, da raztopina ni bistra ali opalescentna ali če vsebuje delce.
Periodic fever syndromes Ilaris is used in adults and children aged 2 years and older to treat the following: - Cryopyrin-associated periodic syndromes (CAPS) - this is a group of auto-inflammatory diseases, which include:
Periodični vročinski sindromi Zdravilo Ilaris uporabljamo pri odraslih in otrocih, ki so stari 2 leti ali več za zdravljenje naslednjih bolezni: - s kriopirinom povezani periodični sindromi s kratico CAPS - gre za skupino avtoinflamatornih (avtovnetnih) bolezni, med katerimi so:
Ilaris should be injected by a healthcare professional only.
Zdravilo Ilaris vam sme injicirati samo usposobljen zdravstveni delavec.
The median improvement from baseline to end of Part I of study G2301 was 0.88 (79%).
V študiji G2301 je znašala mediana vrednost izboljšanja od izhodišča do konca 1. obdobja 0,88 (79 %).
In patients who respond and require re-treatment, there should be an interval of at least 12 weeks before a new dose of canakinumab may be administered (see section 5.2).
Bolniki, ki se odzovejo in potrebujejo ponovno zdravljenje, lahko prejmejo naslednji odmerek kanakinumaba šele po preteku najmanj 12 tednov (glejte poglavje 5.2).
In an exploratory analysis of the primary endpoint, it was observed that in patients with an inadequate response after the first dose, an up-titration within the first month to a dose of 300 mg (or 4 mg/kg) every 4 weeks further improved flare control, reduced disease activity and normalised CRP and SAA levels.
V raziskovalni analizi primarnega cilja študije so opazili, da je pri bolnikih z nezadostnim odzivom po prvem odmerku, zvišanje odmerjanja v prvem mesecu na 300 mg (oziroma na 4 mg/kg) vsake 4 tedne dodatno izboljšalo obvladovanje zagonov, zmanjšalo aktivnost bolezni in omogočilo normalizacijo vrednosti CRP in SAA.