FrancophonIA/ELRC3.0 huggingface dataset:
English: It is recommended that all patients, particularly sJIA and pJIA patients, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating RoActemra therapy.
Danish: Det anbefales at alle patienter, især sJIA- og pJIA-patienter, før pågyndelse af RoActemra-behandling bringes ajour med alle immuniseringer i overensstemmelse med gældende retningslinjer for immunisering.
English: Children and adolescents with sJIA (aged 1 year and over)
Danish: Børn og unge med sJIA (1 år eller ældre)
English: In the SC RoActemra study, the rate of infection in pJIA patients treated with SC RoActemra was comparable with pJIA patients treated with IV RoActemra.
Danish: I det kliniske forsøg med subkutan RoActemra var infektionshyppigheden hos patienter med pJIA behandlet med subkutan RoActemra sammenlignelig med pJIA patienterne behandlet med intravenøs RoActemra.
English: Tocilizumab PK Parameter
Danish: Tocilizumab farmakinetiske parameter
English: In GCA patients, no effect of cumulative corticosteroid dose on RoActemra exposure was observed.
Danish: Ingen effekt af kumulativ dosis kortikosteroid på RoActemra eksponering blev observeret hos GCA patienter.
English: After removing the pre-filled pen from the refrigerator the pre-filled pen should be allowed to reach room temperature (18°C to 28°C) by waiting for 45 minutes, before injecting RoActemra.
Danish: Når den fyldte pen er taget ud af køleskabet, skal den ligge i mindst 45 minutter for at blive opvarmet til stuetemperatur (18°C til 28°C) inden RoActemra injiceres.
English: The mean [SD] change scores were as follows: RoActemra weekly plus 26 weeks 5.61 [10.115], RoActemra every other weekly plus 26 weeks 1.81 [8.836], placebo plus 26 weeks 0.26 [10.702], and placebo plus 52 weeks -1.63 [6.753].
Danish: De middelværdier [SD] for ændringsscorer var følgende: Ugentlig RoActemra plus 26 uger 5,61 [10,115], RoActemra hver anden uge plus 26 uger 1,81 [8,836], placebo plus 26 uger 0,26 [10,702] og placebo plus 52 uger -1,63
English: • Monitoring of the patient for injection/infusion reactions
Danish: • Monitorering af infusionsreaktioner hos patienten
English: Seven patients (1.6%) developed positive anti-RoActemra antibodies; of these, six (1.4%) developed neutralizing anti-RoActemra antibodies.
Danish: Syv patienter (1,6%) udviklede positive anti-RoActemra-antistoffer; af disse udviklede seks (1.4%) neutraliserende anti-RoActemraantistoffer.
English: The mean change in HAQ-DI was maintained at Week 104 in the tocilizumab 8 mg/kg plus MTX group (-0.61).
Danish: Den gennemsnitlige ændring i HAQ-DI var opretholdt ved uge 104 i tocilizumab 8 mg/kg plus MTX gruppen (-0,61).
English: The rate of anaphylactic reactions (occurring in a total of 8/4,009 patients, 0.2%) was several fold higher with the 4 mg/kg dose, compared to the 8 mg/kg dose.
Danish: Hyppigheden af anafylaktiske reaktioner (som forekom hos i alt 8/4.009 patienter; 0,2 %) var flere gange højere efter en dosis på 4 mg/kg sammenlignet med en dosis på 8 mg/kg.
English: If a patient misses a subcutaneous injection of RoActemra by more than 7 days of the scheduled dose or is unsure when to inject RoActemra, call the doctor or pharmacist.
Danish: Hvis patienten glemmer en subkutan injektion med RoActemra med mere end 7 dage i forhold til den planlagte dosering eller er usikker på, hvornår RoActemra skal injiceres, skal patienten kontakte sundhedsfagligt personale på behandlingsstedet.
English: RoActemra-treated patients reported an improvement in all patient-reported outcomes (Health Assessment Questionnaire Disability Index - HAQ-DI), Short Form-36 and Functional Assessment of Chronic Illness Therapy questionnaires.
Danish: De patienter, som blev behandlet med RoActemra, berettede om forbedring i alle patientrapporterede resultater (Health Assessment Questionnaire Disability Index - HAQ-DI, den korte version af SF-36 og Functional Assessment of Chronic Illness Therapy Questionnaires).
English: (See Fig.
Danish: Se pkt.
English: Common Uncommon
Danish: Almindelig Ikke almindelig Sjælden
English: Upper respiratory tract infections
Danish: Øvre luftvejsinfektioner
English: • cough, chest discomfort/tightness, shortness of breath
Danish: • hoste, ubehag i/trykken for brystet, stakåndethed
English: Concentrate for solution for infusion 200 mg/10 mL
Danish: Koncentrat til infusionsvæske, opløsning 200 mg/10 ml
English: The assessment of the time to first GCA flare showed a significantly lower risk of flare for the RoActemra subcutaneous weekly group compared to placebo plus 26 weeks prednisone and placebo plus 52 weeks prednisone taper groups and for the RoActemra subcutaneous every other weekly group compared to placebo plus 26 weeks prednisone (when compared at a 0.01 significance level).
Danish: Vurderingen af tiden til første GCA flare viste en signifikant lavere risiko for flare i gruppen, der fik ugentlig RoActemra subkutan sammenlignet med gruppen, der fik placebo plus 26 ugers prednison dosis og grupper, der fik placebo plus 52 ugers nedtrapningsregime af prednison, og for gruppen, der fik RoActemra subkutan hver anden uge sammenlignet med placebo plus 26 ugers prednison dosis (sammenlignet med et 0,01 signifikansniveau).
English: Cholesterol increased sJIA
Danish: Forhøjet kolesterol sJIA pJIA
English: • Do not fan or blow on the clean area.
Danish: • Du må ikke vifte eller puste på den rensede hud.
English: In the SC Study (WA28118), a total of 41.2% (21/51) sJIA patients experienced ISRs to RoActemra SC.
Danish: I det subkutane studie (WA28118) oplevede et samlet antal på 41,2 % (21/51) sJIA-patienter reaktioner på injektionsstedet efter subkutan RoActemra.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled pen contains 162 mg of RoActemra (tocilizumab) in 0.9 mL.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver fyldt pen indeholder 162 mg af RoActemra ( tocilizumab ) i 0,9 ml.
English: Active hepatic disease and hepatic impairment
Danish: Aktiv leversygdom og nedsat leverfunktion
English: Your doctor will perform a blood test before you receive RoActemra, to determine if you have a low white blood cell count, low platelet count or high liver enzymes.
Danish: Før din behandling med RoActemra, vil lægen tage en blodprøve for at undersøge, om du har et lavt antal hvide blodlegemer eller blodplader, eller om du har forhøjede leverenzymer.
English: Adult patients with RA
Danish: Voksne patienter med leddegigt
English: The rate of anaphylactic reactions (occurring in a total of 6/3778patients, 0.2%) was several fold higher with the 4 mg/kg dose, compared to the 8 mg/kg dose.
Danish: Hyppigheden af anafylaktiske reaktioner (som forekom hos i alt 6/3778 patienter; 0,2 %) var flere gange højere efter en dosis på 4 mg/kg sammenlignet med en dosis på 8 mg/kg.
English: Reports of gastrointestinal perforation on tocilizumab were primarily reported as complications of diverticulitis including generalised purulent peritonitis, lower gastrointestinal perforation, fistulae and abscess.
Danish: Rapporter om gastrointestinal perforation ved tocilizumabbehandling blev primært rapporteret som komplikationer til diverticulitis, herunder generaliseret purulent peritonitis, nedre gastrointestinal perforation, fistel og absces.
English: Step 1.
Danish: Trin 1.
English: When platelet count > 100 x 103/ μ resume RoActemra at 4 mg/kg and increase to 8 mg/kg as clinically appropriate
Danish: Når trombocyttallet er > 100 x 103/µl, genoptages behandlingen med RoActemra med 4 mg/kg og øges til 8 mg/kg efter et klinisk skøn
English: In study I, superiority of tocilizumab 8 mg/kg was demonstrated against the active comparator MTX.
Danish: I studie I var tocilizumab 8 mg/kg bedre end den aktive komparator MTX.
English: Dispose of the pre-filled pen
Danish: “Bortskaffelse af den brugte pen”)
English: RoActemra is supplied as a 0.9 mL pre-filled pen containing 162 mg tocilizumab solution for injection.
Danish: RoActemra leveres som 0,9 ml fyldt pen indeholdende 162 mg tocilizumab-opløsning til injektion.
English: • Slowly inject all of the medicine by gently pushing the plunger all the way down.
Danish: • Sprøjt langsomt medicinen ind ved forsigtigt at presse stemplet helt i bund (se Fig. F).
English: • upper respiratory tract infections with typical symptoms such as cough, blocked nose, runny nose, sore throat and headache,
Danish: • luftvejsinfektioner i de øvre luftveje med typiske symptomer som f.eks. hoste, stoppet næse,
English: If an adult with RA or GCA or a child or adolescent with sJIA misses or forgets a dose
Danish: Hvis en voksen med leddegigt eller GCA, eller et barn eller en ung med sJIA glemmer en dosis Det er meget vigtigt, at du tager RoActemra præcis som lægen har foreskrevet.
English: However, doses below 1025 mg of this medicine contain less than 23 mg sodium, so they are virtually sodium free.
Danish: Dog indeholder RoActemra-doser på mindre end 1.025 mg mindre end 23 mg natrium og er derfor i princippet ”natriumfrie”.
English: In sJIA and pJIA patients, neutrophils and platelets should be monitored at the time of second infusion and thereafter according to good clinical practice, see section 4.2.
Danish: Hos patienter med sJIA og pJIA bør neutrofilocyt- og trombocyttallet kontrolleres ved 2. infusion og derefter i henhold til god klinisk praksis, se pkt.
English: Table 10.
Danish: Tabel 10.
English: Parts of your RoACTEMRA pre-filled pen (See Figure A).
Danish: En fyldt RoActemra-pen består af følgende dele (se figur A).
English: Cumulative glucocorticoid dose (mg) median at Week 52 (Tocilizumab groups vs Placebo+262) median at Week 52 (Tocilizumab groups vs Placebo +522)
Danish: Kumulativ glukokortikoid dosis (mg) Median ved uge 52 (Tocilizumab grupper vs Placebo +262)
English: RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids.
Danish: RoActemra er indiceret til behandling af aktiv systemisk juvenil idiopatisk artrit (sJIA) hos patienter, som er 2 år og ældre, og som har haft utilstrækkelig respons på tidligere behandling med NSAID'er og systemiske kortikosteroider.
English: Severe neutropenia may be associated with an increased risk of serious infections, although there has been no clear association between decreases in neutrophils and the occurrence of serious infections in clinical trials with RoActemra to date.
Danish: Der har dog ikke været en klar sammenhæng mellem fald i neutrofilocyttallet og forekomsten af alvorlige infektioner i kliniske forsøg med RoActemra til dato.
English: In Study I, tocilizumab was administered intravenously every four weeks as monotherapy.
Danish: I studie I blev tocilizumab givet intravenøst hver 4. uge som monoterapi.
English: Inject RoACTEMRA
Danish: Giv indsprøjtningen med RoActemra
English: • Throw away the green cap in a sharps container.
Danish: • Smid den grønne hætte i kanylebeholderen.
English: To mix the solution, gently invert the infusion bag to avoid foaming.
Danish: Bland opløsningen ved at vende posen forsigtigt for at undgå skumdannelse.
English: The rate of infection in sJIA patients treated with SC RoActemra was comparable to sJIA patients treated with IV RoActemra.
Danish: Infektionshyppigheden hos patienter med sJIA behandlet med subkutan RoActemra var sammenlignelig med sJIA patienterne behandlet med intravenøs RoActemra.
English: All patients, especially children, should be up-to-date with all their vaccinations before they start treatment with RoActemra.
Danish: Alle patienter, især børn, bør forud for pågyndelse af RoActemra-behandling bringes ajour med alle vaccinationer.
English: • Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard or not intact.
Danish: • Giv aldrig indsprøjtningen i skønhedspletter, ar, blå mærker eller andre steder, hvor huden er øm, rød, hård eller ikke er intakt.
English: Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents including RoActemra (see section 4.8, undesirable effects).
Danish: Alvorlige og i nogle tilfælde dødelige infektioner er blevet rapporteret hos patienter, som var i behandling med immunsuppressive lægemidler herunder RoActemra (se pkt.
English: • RoActemra can also be used to treat adults who have not had previous methotrexate treatment if they have severe, active and progressive rheumatoid arthritis.
Danish: • RoActemra kan også anvendes til at behandle svær, aktiv og fremskridende leddegigt, hvis du ikke tidligere er blevet behandlet med methotrexat.
English: ACR responses in study SC-I (% patients) at Week 24 SC-Ia
Danish: ACR-responsrater i studie SC-1 ved uge 24 (% patienter) SC-Ia
English: Results of the population PK analysis for sJIA and pJIA patients confirmed that body size is the only covariate which has an appreciable impact on the pharmacokinetics of RoActemra including elimination and absorption so that body-weight based dosing should be taken into consideration (see Tables 8 and 9).
Danish: Resultater fra de populationsfarmakokinetiske analyser af patiener med sJIA og pJIA viste, at kropsstørrelsen var den eneste kovariat, som har en betydelig indflydelse på RoActemras farmakokinetik, inklusiv elimination og absorption.
English: • Patient Information Pack
Danish: • Informationsmateriale til patienten
English: The key secondary efficacy endpoint also based on the proportion of patients achieving sustained remission at week 52, comparing tocilizumab plus 26 weeks prednisone taper with placebo plus 52 weeks prednisone taper, was also met (Table 4).
Danish: Det vigtigste sekundære effekt-endepunkt, der også var baseret på andelen af patienter, der opnåede vedvarende remission ved uge 52, sammenlignet med tocilizumab plus 26 ugers nedtrapningsregime af prednison med placebo plus 52 ugers nedtrapningsregime af prednison, blev også opfyldt (tabel 4).
English: The PK of RoActemra in GCA patients were determined using a population PK model from an analysis dataset composed of 149 GCA patients treated with 162 mg subcutaneous every week or 162 mg subcutaneous every other week.
Danish: Farmakinetiske af RoActemra hos GCA-patienter blev bestemt under anvendelse af en populations- farmakinetiske -model fra et analysedatasæt bestående af 149 GCA patienter behandlet med 162 mg subkutan hver uge eller 162 mg subkutan hver anden uge.
English: Always store the syringe in a refrigerator at a temperature of 2°C - 8°C.
Danish: Opbevar altid fyldte injektionssprøjter i køleskabet ved en temperatur på 2 ºC - 8 ºC.
English: Choose and prepare an injection site
Danish: Vælg og klargør det sted, indsprøjtningen skal gives
English: • rash, itching, hives, swelling of the lips, tongue or face If you notice any of these, tell your doctor immediately.
Danish: • udslæt, kløe, nældefeber, hævelse af læber, tunge eller ansigt Hvis du bemærker nogle af de ovenstående symptomer, kontakt omgående lægen
English: The majority of ISRs reported were Grade 1 events and all ISRs reported were non-serious and none required patient withdrawal from treatment or dose interruption.
Danish: Størstedelen af de rapporterede reaktioner på injektionsstedet var grad 1 bivirkninger og alle reaktioner på injektionsstedet blev rapporteret som ikke-alvorlige og ingen krævede seponering af behandlingen eller afbrydelse af doseringen.
English: RoActemra is supplied as a 0.9 mL pre-filled syringe containing 162 mg tocilizumab solution for injection.
Danish: RoActemra leveres som 0,9 ml fyldt injektionssprøjte indeholdende 162 mg tocilizumab-opløsning til injektion.
English: • If you weigh less than 30 kg: the dose is 12 mg for every kilogram of body weight
Danish: • Hvis barnet vejer mindre end 30 kg er dosis 12 mg pr. kg kropsvægt
English: Children with pJIA will be given RoActemra once every 4 weeks through a drip in the vein (intravenous infusion) over one hour.
Danish: Børn med pJIA vil få RoActemra én gang hver 4. uge gennem et drop (intravenøs infusion).
English: There may be local or state laws about how to throw away used syringes.
Danish: Der kan findes lokale retningslinjer om bortskaffelse af injektionsudstyr.
English: Placebo + 52 weeks prednisone taper N=51
Danish: Placebo + 52 ugers nedtrapningsregime af prednison N=51
English: The dose-response curve for tocilizumab flattens at higher exposure, resulting in smaller efficacy gains for each incremental increase in RoActemra concentration such that clinically meaningful increases in efficacy were not demonstrated in patients treated with > 800 mg of RoActemra.
Danish: Dosis-responskurven for tocilizumab flader ud ved højere eksponering, hvilket resulterer i mindre effektgevinst for hver trinvis forøgelse af tocilizumab-koncentrationen, således at klinisk relevante stigninger i effekt ikke blev vist hos patienter, som blev behandlet med > 800 mg tocilizumab.
English: Do not use the pre-filled pen if it appears to be damaged or if you have accidentally dropped the pre-filled pen.
Danish: Brug ikke den fyldte pen, hvis den ser beskadiget ud eller hvis du er kommet til at tabe den.
English: • Low absolute neutrophil count (ANC) Laboratory Value (cells x 109/ l )
Danish: • Lavt absolut neutrofilocyttal Laboratorieværdi (celler x 109/l )
English: • If you weigh less than 30 kg: the dose is 10mg for every kilogram of body weight
Danish: • Hvis barnet vejer mindre end 30 kg, er dosis 10 mg pr. kg kropsvægt
English: • Low absolute neutrophil count (ANC)
Danish: • Lavt absolut neutrofilocyttal
English: At Week 52, the mean change in HAQ-DI was -0.58 in the RoActemra 8 mg/kg plus MTX group compared with -0.39 in the placebo + MTX group.
Danish: Ved uge 52 var den gennemsnitlige ændring i HAQ-DI -0,58 i RoActemra 8 mg/kg plus MTX gruppen sammenlignet med -0,39 i placebo plus MTX gruppen.
English: • Risk of Hepatotoxicity
Danish: • Risikoen for levertoksicitet
English: Tel: +385 1 47 22 333 Ireland
Danish: Tel: +385 1 47 22 333
English: • Do not use if medicine is cloudy, hazy, discolored or contains particles
Danish: • Brug ikke medicinen, hvis den er uklar, misfarvet eller grumset
English: In the open label extension phase, decreases in neutrophil counts below 1 x 109/l, occurred in 15% of the tocilizumab group.
Danish: I den åbne forlængelsesfase forekom der fald i neutrofilocyttal til under 1 x 109/l hos 15 % af patienterne i tocilizumab-gruppen.
English: A statistically significant superior treatment effect was seen in favour of tocilizumab over adalimumab in control of disease activity from baseline to week 24 for the primary endpoint of change in DAS28 and for all secondary endpoints (Table 5).
Danish: Der blev vist en statistisk signifikant bedre behandlingseffekt af tocilizumab sammenlignet med adalimumab i kontrol af sygdomsaktivitet fra baseline til uge 24, for det primære endepunkt, der var ændring i DAS28, samt for alle sekundære endepunkter (tabel 5).
English: • Caution should be exercised when considering initiation of tocilizumab treatment in patients with elevated transaminases ALT or AST above 1.5x ULN.
Danish: • Der skal udvises forsigtighed, hvis det overvejes at påbegynde behandling med tocilizumab hos patienter med ALAT eller ASAT, der er forhøjet til > 1,5 gange øvre normalgrænse.
English: The Nurse Information Pack should contain the following key elements:
Danish: Informationsmaterialet til sygeplejerskerne skal indeholde følgende nøgleelementer:
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED PEN LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Etiket på fyldt pen
English: RoActemra has not been studied in patients with hepatic impairment.
Danish: RoActemra er ikke undersøgt hos patienter med nedsat leverfunktion.
English: A statistically significant superior treatment effect was seen in favour of RoActemra over placebo in achieving steroid-free sustained remission at week 52 on RoActemra plus 26 weeks prednisone taper compared with placebo plus 26 weeks prednisone taper and with placebo plus 52 weeks prednisone taper.
Danish: En statistisk signifikant overlegen behandlingseffekt blev set til fordel for RoActemra over placebo, hvor der blev opnået steroidfri vedvarende remission ved uge 52 med RoActemra plus 26 ugers nedtrapningsregime af prednison sammenlignet med placebo plus 26 ugers nedtrapningsregime af prednison og med placebo plus 52 ugers nedtrapningsregime af prednison.
English: How RoActemra is given
Danish: Sådan gives RoActemra
English: The safety and immunogenicity observed for RoActemra administered subcutaneous was consistent with the known safety profile of intravenous RoActemra and no new or unexpected adverse drug reactions were observed (see Table 1).
Danish: Sikkerhed og immunogenicitet der blev observeret for RoActemra administreret subkutant var i overensstemmelse med den kendte sikkerhedsprofil for intravenøst administreret RoActemra, og der blev ikke observeret nogen nye eller uventede bivirkninger (se tabel 1).
English: During routine laboratory monitoring in the tocilizumab all exposure population, elevation in ALT or AST ≥ 3xULN occurred in 3.7% and <1% of patients, respectively.
Danish: Under rutinemæssig laboratoriekontrol blandt alle tocilizumab-eksponerede patienter forekom der en stigning i ALAT eller ASAT til ≥ 3 gange øvre normalgrænse hos henholdsvis 3,7 % og <1 % af patienterne.
English: RoActemra can be used alone or in combination with MTX.
Danish: RoActemra kan bruges som monoterapi eller i kombination med MTX.
English: • If your injection is given by another person, this person must also be careful when removing the pre-filled pen and disposing of it to prevent accidental needle stick injury and passing infection.
Danish: • Hvis en anden person giver dig indsprøjtningen, skal vedkommende være forsigtig, når pennen trækkes ud og smides ud.
English: Of the patients who completed the study who were originally randomised to placebo + MTX, 86% received open-label RoActemra 8 mg/kg in year 2.
Danish: 86 % af de patienter, som fuldførte studiet, og som oprindeligt var randomiseret til placebo + MTX, fik åben behandling medRoActemra8 mg/kg i år 2.
English: • Remove the syringe from the box and visually examine the syringe, as well as the medicine in the syringe.
Danish: • Tag injektionssprøjten ud af æsken og check den og medicinen i den.
English: Elevations in lipid parameters including total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL) and triglycerides were observed in patients treated with RoActemra (see section 4.8).
Danish: Der er set stigninger i lipidparametre såsom total-kolesterol, LDL-kolesterol, HDL-kolesterol og triglycerider hos de patienter, som blev behandlet med RoActemra (se pkt.
English: RoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with methotrexate.
Danish: Når RoActemra gives i kombination med methotrexat, har det vist sig at kunne reducere hastigheden af ledskadeprogression, målt ved hjælp af røntgen, samt forbedre den fysiske funktionsevne.
English: The half life of tocilizumab in pJIA patients is up to 16 days for the two body weight categories (8 mg/kg for body weight ≥ 30 kg or 10 mg/kg for body weight < 30 kg) during a dosing interval at steady state.
Danish: Halveringstiden for tocilizumab hos pJIA-patienter er op til 16 dage for de to vægtkategorier (8 mg/kg ved en kropsvægt ≥30 kg og 10 mg/kg ved en kropsvægt <30 kg) i et dosisinterval ved steady-state.
English: In general, the safety profile observed in patients with pJIA was consistent with the known safety profile of RoActemra with the exception of ISRs (see Table 1).
Danish: Den overordnede sikkerhedsprofil observeret hos patienter med pJIA var i overensstemmelse med den allerede kendte sikkerhedsprofil for RoActemra med undtagelse af reaktioner på injektionsstedet (se tabel 1).
English: An elevation in ALT or AST ≥3 x ULN occurred in 9.6% and 3.8% patients treated with RoActemra SC,
Danish: Der blev observeret en stigning i ALAT eller ASAT til ≥ 3 x øvre normalgrænse hos henholdsvis 9,6 % og 3,8 % af patienterne behandlet med subkutan RoActemra.