natgillin/translations-raw huggingface dataset:
Modificer dosis af samtidig MTX, hvis det er hensigtsmæssigt Ved vedvarende stigning nedsæt dosis af RoActemra til 4 mg/kg eller stop behandlingen med RoActemra indtil alaninaminotransferase (ALAT) eller aspartataminotransferase (ASAT) er normaliseret Påbegynd behandlingen igen med 4 mg/kg eller 8 mg/kg efter et klinisk skøn
Modify the dose of the concomitant MTX if appropriate For persistent increases in this range, reduce RoActemra dose to 4 mg/kg or interrupt RoActemra until alanine aminotransferase (ALT) or aspartate aminotransferase (AST) have normalised
Det skal du vide for at bruge din fyldte RoActemra-injektionssprøjte sikkert.
What do I need to know to use my RoActemra pre-filled syringe safely?
Betydningsfuldt klinisk respons
Major Clinical Response
• Hvis du får allergiske reaktioner som f.eks. trykken for brystet, hvæsende vejrtrækning, svær svimmelhed eller omtågethed, hævede læber eller udslæt under eller efter infusionen, skal du omgående fortælle det til din læge.
• If you experience allergic reactions such as chest tightness, wheezing, severe dizziness or light-headedness, swelling of the lips or skin rash during or after the infusion, then tell your doctor immediately.
Brug ikke de fyldte penne, hvis udløbsdatoen er overskredet af sikkerhedsmæssige grunde.
Do not use the pre-filled pen if the expiration date has passed because it may not be safe to use.
Hvis du holder op med at få RoActemra Beslutningen om at stoppe behandlingen med RoActemra aftales med din læge.
If you stop using RoActemra You should not stop using RoActemra without discussing with your doctor first.
Ved subkutan administration er den koncentrationsafhængige tilsyneladende t1/2 ved steady-state op til 12 dage for 162 mg ugentligt og 5 dage for 162 mg hver anden uge hos patienter med RA.
For subcutaneous administration, the concentration-dependent apparent t 1/2 is up to 12 days for 162 mg every week and 5 days for 162 mg every other week in patients with RA at steady-state.
Rør ikke ved injektionssprøjtens aktiveringsknap, da det kan beskadige injektionssprøjten.
Do not touch the trigger fingers on the syringe as this may damage the syringe.
Efter 1 års behandling med RoActemra plus MTX havde 85 % af patienterne (n = 348) ingen progression af strukturel ledskade, defineret som ændring i det totale Sharp score på nul eller mindre,
Following 1 year of treatment with RoActemra plus MTX, 85% of patients(n=348) had no progression of structural joint damage, as defined by a change in the Total Sharp Score of zero or less, compared with 67% of placebo plus MTX-treated patients(n=290) (p ≤ 0.001).
For mental komponent score var den gennemsnitlige ændring fra baseline til uge 52 for både ugentlig dosis RoActemra, der fik RoActemra hver anden uge grupperne [henholdsvis 7,28; 6,12] højere end placebo plus 52 ugers aftagende prednison dosis gruppen [2,84] (selv om forskellene ikke var statistisk signifikante [p = 0,0252 for ugentligt, p = 0,1468 for hver anden uge]) og sammenlignelig med placebo plus 26 ugers aftagende prednison dosis gruppen [6,67].
For MCS, the mean change from baseline to week 52 for both RoActemra weekly and every other weekly dose groups [7.28, 6.12, respectively] were higher than the placebo plus 52 weeks prednisone taper group [2.84] (although the differences were not statistically significant [weekly p=0.0252 for weekly, p=0.1468 for every other weekly]) and similar to the placebo plus 26 weeks prednisone taper group [6.67].
Et 52-ugers, åbent, multicenter, farmakokinetisk/farmakodynamisk og sikkerhedsstudie (WA28118) blev gennemført hos pædiatriske patienter med sJIA i alderen 1-17 år.
A 52-week, open-label, multi-centre, PK/PD and safety study (WA28118) was conducted in paediatric patients with sJIA, aged 1 to 17 years, to determine the appropriate SC dose of RoActemra that achieved comparable PK/PD and safety profiles to the IV regimen.
Sammenlignet med de patienter, som fik placebo plus MTX eller andre DMARDs, blev der i alle studier hos de patienter, som blev behandlet med RoActemra 8 mg/kg, set signifikante bedringer af alle individuelle komponenter af AC-responser, herunder: Antal ømme og hævede led, patienternes og lægernes globale vurdering, disability index score, vurdering af smerter og CRP.
In patients treated with RoActemra 8 mg/kg, significant improvements were noted on all individual components of the ACR response including: tender and swollen joint counts; patients and physician global assessment; disability index scores; pain assessment and CRP compared to patients receiving placebo plus MTX or other DMARDs in all studies.
Sikkerheden observeret i tocilizumab-armen var konsistent med den kendte sikkkerhedsprofil for tocilizumab og ingen nye eller uventede bivirkninger blev observeret (se tabel 1).
The safety observed in the tocilizumab arm was consistent with the known safety profile of tocilizumab and no new or unexpected adverse drug reactions were observed (see Table 1).
I uge 24 blev der set statistisk signifikante forbedringer i hæmoglobinkoncentrationerne efter behandling med tocilizumab, sammenlignet med behandling med DMARDs (p < 0,0001).
Statistically significant improvements in haemoglobin levels were observed with tocilizumab compared with DMARDs (p< 0.0001) at week 24.
Hæmatologiske abnormiteter:
Haematological abnormalities:
Tocilizumabs virkning på reduktion af symptomerne på reumatoid artrit blev undersøgt i fem randomiserede, dobbeltblindede multicenterstudier.
The efficacy of tocilizumab in alleviating the signs and symptoms of RA was assessed in five randomised, double-blind, multi-centre studies.
Tilgængelige data for intravenøs formulering indikerer, at der observeres en klinisk forbedring inden for 12 uger efter start af behanfdling med RoActemra.
Available data with the IV formulation suggest that clinical improvement is observed within 12 weeks of initiation of treatment with RoActemra.
Der er indberetninger om alvorlige overfølsomhedssreaktioner, inklusive anafylaksi, i forbindelse med RoActemra (se pkt.
Serious hypersensitivity reactions, including anaphylaxis have been reported in association with RoActemra (see section 4.8).
Tilgængelige data tyder ikke på, at frugtbarheden påvirkes under denne behandling.
The data available so far does not suggest any effect on fertility from this treatment.
Under rutinemæssig laboratoriekontrol blandt alle tocilizumab-eksponerede patienter forekom der et fald i trombocytter til ≤50 × 103/µl uden ledsagende blødningsepisoder hos 1 % af patienterne.
During routine laboratory monitoring in the tocilizumab all exposure population, 1% of patients had a decrease in platelet count to ≤ 50 × 103/µL without associated bleeding events.
Procentdelen af patienter, der opnåede JIA-ACR30-, ACR50- og ACR70-respons ved uge 40 i forhold til baseline i udtrædningsfasen (del II) er vist i tabel 8.
During the withdrawal phase (Part II), the percentage of patients achieving JIA ACR 30, 50, and 70 responses at Week 40 relative to baseline are shown in Table 8.
I de dobbeltblindede, kontrollerede studier fik 774 patienter RoActemra 4 mg/kg i kombination med MTX, 1.870 patienter fik RoActemra 8 mg/kg i kombination med MTX eller andre DMARDs, og 288 patienter fik RoActemra 8 mg/kg som monoterapi.
In the double-blind controlled studies, 774 patients received RoActemra 4 mg/kg in combination with MTX, 1870 patients received RoActemra 8 mg/kg in combination with MTX or other DMARDs and 288 patients received RoActemra 8 mg/kg monotherapy.
Det anbefales at alle patienter, specielt ældre patienter, før påbegyndelse af RoActemra-behandling bringes ajour med alle immuniseringer i overensstemmelse med gældende retningslinjer for immunisering.
It is recommended that all patients particularly elderly patients, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating RoActemra therapy.
Dosis for voksne med leddegigt og GCA er 162 mg (indholdet i en fyldt injektionssprøjte), 1 gang om ugen.
The recommended dose The dose for RA and GCA adults is 162 mg (the content of 1 pre-filled syringe) given once a week.
Tilfælde af divertikulære perforationer, som komplikation til diverticulitis, er blevet indberettet med frekvensen ”ikke almindelige” hos patienter behandlet med RoActemra (se pkt.
Events of diverticular perforations as complications of diverticulitis have been reported uncommonly in patients treated with RoActemra (see section 4.8).
Efter 1 års behandling med tocilizumab plus MTX havde 85 % af patienterne (n = 348) ingen progression af strukturel ledskade, defineret som ændring i det totale Sharp score på nul eller mindre,
Following 1 year of treatment with tocilizumab plus MTX, 85% of patients (n=348) had no progression of structural joint damage, as defined by a change in the Total Sharp Score of zero or less, compared with 67% of placebo plus MTX-treated patients (n=290) (p ≤ 0.001).
I de dobbeltblindede, kontrollerede studier fik 774 patienter tocilizumab 4 mg/kg i kombination med MTX, 1.870 patienter fik tocilizumab 8 mg/kg i kombination med MTX eller andre DMARDs, og 288 patienter fik tocilizumab 8 mg/kg som monoterapi.
In the double-blind controlled studies, 774 patients received tocilizumab 4 mg/kg in combination with MTX, 1870 patients received tocilizumab 8 mg/kg in combination with MTX or other DMARDs and 288 patients received tocilizumab 8 mg/kg monotherapy.
Børn med sJIA (2 år og ældre)
Children with sJIA (aged 2 and over)
I studie IV blev RoActemra givet intravenøst hver 4. uge i kombination med andre DMARDs vs. placebo plus andre DMARDs.
In Study IV, RoActemra was administered intravenously every 4 weeks in combination with other DMARDs vs. placebo and other DMARDs.
Hold regnskab med dine indsprøjtninger
Record your Injection
Den grønne hætte skal blive på den fyldte RoActemra-pen under opvarmningen til stuetemperatur.
Do not remove the green cap while allowing your RoACTEMRA pre-filled pen to reach room temperature.
I de kliniske studier med tocilizumab er der set et hurtigt fald i CRP, erytrocytsedimentationsreaktionen (ESR), serumamyloid A (SAA) og fibrinogen.
In clinical studies with tocilizumab, rapid decreases in CRP, erythrocyte sedimentation rate (ESR), serum amyloid A (SAA) and fibrinogen were observed.
• reaktioner ved injektionsstedet
• injection site reactions
I de 6-måneders kontrollerede studier blev der indberettet uønskede hændelser i forbindelse med infusion (udvalgte hændelser, som indtraf under eller inden for 24 timer efter infusionen) hos 6,9 % af patienterne, der fik tocilizumab 8 mg/kg plus DMARD, og hos 5,1 % af patienterne, der fik placebo plus DMARD.
In the 6-month controlled trials adverse events associated with infusion (selected events occurring during or within 24 hours of infusion) were reported by 6.9% of patients in the tocilizumab 8 mg/kg plus DMARD group and 5.1% of patients in the placebo plus DMARD group.
Da der ved pJIA er mange samtidige sygdomme, som kan påvirke laboratorieværdierne, skal beslutningen om at seponere tocilizumab på grund af en laboratorieanormalitet baseres på en medicinsk vurdering af den enkelte patient.
As there are many co-morbid conditions that may effect laboratory values in pJIA, the decision to discontinue tocilizumab for a laboratory abnormality should be based upon the medical assessment of the individual patient.
Sammenlignet med de patienter, som fik placebo plus MTX eller andre DMARDs, blev der i alle studier hos de patienter, som blev behandlet med tocilizumab 8 mg/kg, set signifikante bedringer af alle individuelle komponenter af AC-responser, herunder: Antal ømme og hævede led, patienternes og lægernes globale vurdering, disability index score, vurdering af smerter og CRP.
In patients treated with tocilizumab 8 mg/kg, significant improvements were noted on all individual components of the ACR response including: tender and swollen joint counts; patients and physician global assessment; disability index scores; pain assessment and CRP compared to patients receiving placebo plus MTX or other DMARDs in all studies.
Blandt alle tocilizumab eksponerede patienter var den samlede hyppighed af alvorlige infektioner 4,7 hændelser pr. 100 patientår.
In the all exposure population the overall rate of serious infections was 4.7 events per 100 pt years.
Tilgængelige data indikerer, at klinisk bedring observeres inden for 12 uger efter påbegyndelse af RoActemra.
Available data suggest that clinical improvement is observed within 12 weeks of initiation of treatment with RoActemra.
De bivirkninger, som ses hos pJIA-patienterne, svarede til dem, der er set hos reumatoid artrit- og sJIA-patienter, se pkt.
The types of ADRs in pJIA patients were similar to those seen in RA and sJIA patients, see section 4.8.
Den gennemsnitlige ændring i den fysiske komponent score fra baseline til uge 52 var højere (viste større forbedring) i dem, der fik RoActemra hver eller hver anden uge [henholdsvis 4,10; 2,76] end i de to placebo-grupper [placebo plus 26 uger; -0,28, placebo plus 52 uger; -1,49], selvom det kun var sammenligningen mellem gruppen af RoActemra ugentligt dosis plus 26 ugers nedtrapningsregime af prednison gruppen og placebo plus 52 ugers nedtrapningsregime af prednison (5,59, 99% konfidensinterval: 8,6, 10,32), der viste en statistisk signifikant forskel (p = 0,0024).
The PCS mean change from baseline to week 52 was higher (showing more improvement) in the RoActemra weekly and every other weekly dose groups [4.10, 2.76, respectively] than in the two placebo groups [placebo plus 26 weeks; -0.28, placebo plus 52 weeks; -1.49], although only the comparison between RoActemra weekly plus 26 weeks prednisone taper group and placebo plus 52 weeks prednisone taper group (5.59, 99% CI: 8.6, 10.32) showed a statistically significant difference (p=0.0024).
Seponer RoActemra
How to store RoActemra
Reumatoid artrit og GCA
RA and GCA
I uge 24 blev der set statistisk signifikante forbedringer i hæmoglobinkoncentrationerne efter behandling med RoActemra, sammenlignet med behandling med DMARDs (p < 0,0001).
Statistically significant improvements in haemoglobin levels were observed with RoActemra compared with DMARDs (p< 0.0001) at week 24.
Den lineære clearance blev estimeret som en parameter i den populationsfarmakokinetiske analyse og var 6,25 ml/time.
The linear clearance was estimated as a parameter in the population pharmacokinetic analysis and was 6.25 mL/h.
Egnede patienter blev behandlet med tocilizumab 8 mg/kg (12 mg/kg for patienter, der vejede mindre end 30 kg), med eller uden supplerende høj-dosis kortikosteroid for svær eller livstruende cytokinfrigivelsessyndrom.
Evaluable patients had been treated with tocilizumab 8 mg/kg (12 mg/kg for patients < 30 kg) with or without additional high-dose corticosteroids for severe or life-threatening CRS; only the first episode of CRS was included in the analysis.
Der var en højere forekomst af patienter med pJIA, der oplevede reaktioner ved injektionsstedet efter subkutan injektion med RoActemra sammenlignet med voksne patienter med reumatoid artrit.
A higher frequency of pJIA patients experienced ISRs following SC RoActemra injections compared to adult RA.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Injektionsvæske, opløsning i en fyldt pen, ACTPen® Multipakning: 12 (3 pakker á 4) fyldte penne 162 mg/0,9 ml
PHARMACEUTICAL FORM AND CONTENTS Solution for injection in pre-filled pen, ACTPen® Multipack: 12 (3 packs of 4) pre-filled pens.
Det er ikke sandsynligt, at du får for meget RoActemra, da det leveres i en fyldt pen.
Because RoActemra is given in one pre-filled pen, it is unlikely that you will receive too much.
I studierne II, III og V blev RoActemra givet intravenøst hver 4. uge i kombination med MTX vs. placebo plus MTX.
In Studies II, III and V, RoActemra was administered intravenously every four weeks in combination with MTX vs. placebo and MTX.
Trin 6.
Step 6.
Antallet af patienter, som opnåede DAS 28-remission (DAS28 < 2,6), var også signifikant højere hos de patienter, som fik RoActemra 8 mg/kg plus DMARD, end hos de patienter, som fik RoActemra 4 mg/kg plus DMARD (31 % vs. 16 %, p < 0,0001).
Similarly the proportion of patients achieving a DAS 28 remission (DAS28 < 2.6) was significantly higher (31% vs. 16% respectively) in patients receiving RoActemra 8 mg/kg plus DMARD than in patients receiving RoActemra 4 mg/kg plus DMARD (p< 0.0001).
Adalimumab + placebo (intravenøs) N = 162
ADA + Placebo (IV) N = 162
Injektionsvæske, opløsning i en fyldt pen (ACTPen).
PHARMACEUTICAL FORM Solution for injection in pre-filled pen (ACTPen).
pJIA er en inflammations (betændelseslignende)-sygdom, som forårsager smerte og hævelse i et eller flere led.
This is an inflammatory disease that causes pain and swelling in one or more joints.
I studierne II, III og V blev tocilizumab givet intravenøst hver 4. uge i kombination med MTX vs. placebo plus MTX.
In Studies II, III and V, tocilizumab was administered intravenously every four weeks in combination with MTX vs. placebo and MTX.
Et 52-ugers, åbent, multicenter, farmakokinetisk/farmakodynamisk og sikkerhedsstudie blev gennemført hos pædiatriske patienter med pJIA i alderen 1-17 år.
A 52-week, open-label, multicenter, PK-PD and safety study was conducted in paediatric patients with pJIA, aged 1 to 17 years old, to determine the appropriate subcutaneous dose of RoActemra that achieved comparable PK/PD and safety profiles to the IV regimen.
Hvis nålen ikke er dækket, skal du forsigtigt smide den fyldte pen i kanylebeholderen for at undgå nålestikskader.
If the needle is not covered, carefully place the pre-filled pen into the sharps container to avoid any injury with the needle.
4 hætteglas á 20 ml
4 vials of 20 mL
Behandlingen vil blive ordineret og igangsat af sundhedspersonale, som har erfaring i diagnosticering og behandling af leddegigt, sJIA, pJIA og GCA.
The treatment will be prescribed and started by healthcare professionals experienced in the diagnosis and treatment of RA, sJIA, pJIA or GCA.
Der blev givet doser på 8 mg/kg tocilizumab eller placebo hver 4. uge i kombination med stabil dosis DMARDs.
Doses of 8 mg/kg tocilizumab or placebo were given every four weeks in combination with stable DMARDs.
Hos pædiatriske patienter med sJIA var det centrale fordelingsvolumen 1,87 l og det perifere fordelingsvolumen 2,14 l. Det resulterede i et fordelingsvolumen ved steady-state på 4,01 l.
In paediatric patients with sJIA, the central volume of distribution was 1.87 L, the peripheral volume of distribution was 2.14 L resulting in a volume of distribution at steady state of 4.01 L
Trin 4.
Step 4.
Forekommer hos op til 1 ud af 100 patienter
These may affect up to 1 in every 100 patients
Tocilizumabs farmakokinetiske parametre ændrede sig ikke med tiden.
Pharmacokinetic parameters of tocilizumab did not change with time.
Patienterne i adalimumab-armen fik en subkutan injektion med adalimumab (40 mg) hver 2. uge plus en intravenøs infusion med placebo hver 4. uge.
Patients in the adalimumab arm received an adalimumab SC injection (40 mg) q2w plus an IV placebo infusion q4w.
Hver fyldt pen indeholder 162 mg tocilizumab i 0,9 ml.
Each pre-filled pen contains 162 mg tocilizumab in 0.9 mL.
I kliniske studier med RoActemra er der set et hurtigt fald i CRP, erytrocyt-sedimentationsreaktionen (ESR), serumamyloid A (SAA) og fibrinogen.
In clinical studies with RoActemra, rapid decreases in CRP, erythrocyte sedimentation rate (ESR), serum amyloid A (SAA) and fibrinogen were observed.
Let nedsat nyrefunktion (creatininclearance < 80 ml/min og ≥ 50 ml/min iht.
Mild renal impairment (creatinine clearance based on Cockcroft-Gault < 80 mL/min and ≥ 50 mL/min) did not impact the pharmacokinetics of tocilizumab.
Patienterne skulle være >18 år gamle og have aktiv RA diagnosticeret i overensstemmelse med ACR-kriterier med mindst 8 ømme og 6 hævede led ved baseline.
Patients were required to be >18 years of age with active RA diagnosed according to ACR criteria who had at least 8 tender and 6 swollen joints at baseline.
Hos patienter med reumatoid artrit og GCA bør neutrofilocyt- og trombocyttallet kontrolleres 4 til 8 uger efter behandlingens start og derefter i henhold til standardpraksis.
In RA and GCA patients, neutrophils and platelets should be monitored 4 to 8 weeks after start of therapy and thereafter according to standard clinical practice.
Modificer dosis af samtidig MTX, hvis det er hensigtsmæssigt Afbryd behandlingen med RoActemra, indtil værdierne er faldet til under 3 gange øvre normalgrænse, og følg anbefalingerne for > 1 til 3 gange øvre normalgrænse ovenfor
Modify the dose of the concomitant MTX if appropriate Interrupt RoActemra dosing until < 3x ULN and follow recommendations above for >1 to 3x ULN
Der blev givet doser på 8 mg/kg RoActemra eller placebo hver 4. uge i kombination med stabil dosis DMARDs.
Doses of 8 mg/kg RoActemra or placebo were given every four weeks in combination with stable DMARDs.
Afbryd behandlingen med RoActemra, indtil værdierne er faldet < 3 gange øvre normalgrænse, og følg anbefalingerne ovenfor for > 1 til 3 gange øvre normalgrænse
Interrupt RoActemra dosing until < 3 x ULN and follow recommendations above for > 1 to 3 x ULN
RoActemra er ikke blevet undersøgt i kliniske studier hos patienter under en episode med aktiv makrofagaktiveringssyndrom
In clinical trials, RoActemra has not been studied in patients during an episode of active MAS.
I studie IV blev tocilizumab givet intravenøst hver 4. uge i kombination med andre DMARDs vs. placebo plus andre DMARDs.
In Study IV, tocilizumab was administered intravenously every 4 weeks in combination with other DMARDs vs. placebo and other DMARDs.
Efter intravenøs dosering var ca. 90 % af steady-state opnået ved uge 12 for en dosis på 10 mg/kg (legemsvægt < 30 kg) og ved uge 16 for en dosis på 8 mg/kg (legemsvægt ≥ 30 kg).
After IV dosing, approximately 90% of the steady-state was reached by week 12 for the 10 mg/kg (BW < 30 kg), and by week 16 for the 8 mg/kg (BW ≥ 30 kg) dose.
I det 52-ugers åbne subkutane studie (WA28118) oplevede henholdsvis 23,4 % og 35,4 % af patienterne en stigning i forhold til baseline af deres LDL-kolesterol værdier til ≥ 130 mg/dl og total kolesterol værdier til ≥ 200 mg/dl på et hvilket som helst tidspunkt under deres behandling.
In the 52-week open-label SC Study (WA28118), 23.4% and 35.4% of patients experienced a post baseline elevation of their LDL-cholesterol value to ≥130 mg/dL and total cholesterol value to ≥200
Afbrydelser i doseringen af tocilizumab på grund af laboratorieanormaliteter anbefales hos patienter med pJIA som angivet i tabellerne nedenfor.
Dose interruptions of tocilizumab for the following laboratory abnormalities are recommended in pJIA patients in the tables below.
• Hold pennens nåleskjold mod hudfolden i en vinkel på 90° (se figur H).
• Place the needle-shield of the pre-filled pen against your pinched skin at a 90° angle (See
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver fyldt injektionssprøjte indeholder 162 mg tocilizumab i 0,9 ml.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 162 mg of tocilizumab in 0.9 mL.
• Opbevar pennen utilgængeligt for børn.
• Keep out of the reach of children.
Hos pædiatriske patienter med pJIA var det centrale fordelingsvolumen 1,97 l og det perifere fordelingsvolumen 2,03 l. Det resulterede i et fordelingsvolumen ved steady-state på 4,0 l.
In paediatric patients with pJIA, the central volume of distribution was 1.97 L, the peripheral volume of distribution was 2.03 L, resulting in a volume of distribution at steady state of 4.0 L.
• Hold ikke injektionssprøjten i stemplet, når du fjerner hætten fra kanylen.
• Do not hold the syringe by the plunger while removing the needle-cap.
Anafylaksi (dødelig)1,2,3
(fatal)1, 2 ,3
Antallet af patienter, som opnåede DAS28-remission (DAS28 < 2,6), var også signifikant højere hos de patienter, som fik tocilizumab 8 mg/kg plus DMARD, end hos de patienter, som fik tocilizumab 4 mg/kg plus DMARD (31 % vs. 16 %, p < 0,0001).
Similarly the proportion of patients achieving a DAS28 remission (DAS28 < 2.6) was significantly higher (31% vs. 16% respectively) in patients receiving tocilizumab 8 mg/kg plus DMARD than in patients receiving tocilizumab 4 mg/kg plus DMARD (p< 0.0001).