FrancophonIA/ELRC3.0 huggingface dataset:
English: NA ORAL Sync: DMARD Inadequate Responders
Danish: NA ORAL Sync: Patienter med utilstrækkeligt respons på DMARD
English: As a precautionary measure, the use of tofacitinib during pregnancy is contraindicated (see section
Danish: Af sikkerhedsmæssige årsager er tofacitinib kontraindiceret under graviditet (se pkt.
English: There was a higher incidence of adverse events for the combination of tofacitinib with MTX versus tofacitinib as monotherapy in RA clinical studies.
Danish: Bivirkningsfrekvensen var højere for kombinationen tofacitinib plus MTX end for XELJANZ som monoterapi i kliniske RA-studier.
English: Corticosteroidfree remission among patients taking corticosteroids at baselinea,g
Danish: Kortikosteroidfri remission hos patienter, der tager kortikosteroider ved baseline a,g
English: 182 film-coated tablets
Danish: 182 filmovertrukne tabletter
English: Local Endoscopy Read
Danish: Lokal endoskopivurdering
English: Dyslipidaemia Hyperlipidaemia Dehydration
Danish: Dyslipidæmi Hyperlipidæmi Dehydrering
English: PHARMACEUTICAL FORM AND CONTENTS 56 film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 56 filmovertrukne tabletter
English: A controlled study was conducted in patients with RA on background MTX immunised with a live attenuated virus vaccine (Zostavax®) 2 to 3 weeks before initiating a 12-week treatment with tofacitinib 5 mg twice daily or placebo.
Danish: Der er gennemført et kontrolleret studie hos RA-patienter, som fik baggrunds-MTX, og som blev immuniseret med en levende svækket virusvaccine (Zostavax®) 2 til 3 uger før, de begyndte 12 ugers behandling med 5 mg tofacitinib 2 gange dagligt eller placebo.
English: Prior immunosuppressant failure
Danish: Tidligere immunosuppressivasvigt
English: Each film-coated tablet contains 59.44 mg of lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver filmovertrukken tablet indeholder 59,44 mg lactose.
English: Tuberculosis of central nervous system
Danish: Tuberkulose i centralnervesyst emet,
English: Table 17: Proportion of Patients Meeting Efficacy Endpoints at Week 52 (OCTAVE Sustain) Central Endoscopy Read
Danish: Tabel 17: Andel af patienter, der opfylder effektmål ved uge 52 (OCTAVE Sustain) Central endoskopivurdering
English: Table 5: Dose Adjustment for Renal Impairment Renal
Danish: Tabel 5: Dosisjustering ved nedsat nyrefunktion Nedsat nyrefunktion
English: In the 10 mg twice daily tofacitinib monotherapy group the rate was 1.6 patients with events per 100 patientyears, the rate was 0 events per 100 patient-years for the placebo group, and the rate was 1.9 patients with events per 100 patient-years for the MTX group.
Danish: I monoterapigruppen med 10 mg tofacitinib 2 gange dagligt var forekomsten 1,6 patienter med hændelser pr. 100 patientår, 0 patienter med hændelser pr. 100 patientår for placebogruppen, og 1,9 patienter med hændelser pr. 100 patientår for MTX-gruppen.
English: DAS28=Disease Activity Score 28 joints, ESR=Erythrocyte Sedimentation Rate, HAQ-DI=Health Assessment Questionnaire Disability Index, DMARD=disease-modifying antirheumatic drug, IR=inadequate responder, csDMARD=conventional synthetic DMARD, TNFi=tumour necrosis factor inhibitor, NA=not applicable, ADA=adalimumab, MTX=methotrexate.
Danish: mTSS = modificeret total Sharp-score, ACR20 (70) = American College of Rheumatology ≥ 20 % (≥ 70 %) forbedring, DAS28 = Disease Activity Score 28 led, ESR = erytrocytsedimentationshastighed, HAQ-DI = Health Assessment Questionnaire Disability Index, DMARD = sygdomsmodificerende antireumatisk lægemiddel, IR = utilstrækkeligt respons, csDMARD = konventionel syntetisk DMARD, TNFi = tumornekrosefaktorhæmmer, ADA = adalimumab, MTX = methotrexat.
English: Drug hypersensitivity* Angioedema* Urticaria*
Danish: Angioødem* Urticaria
English: A significantly greater proportion of patients in both the tofacitinib 5 mg twice daily and tofacitinib 10 mg twice daily treatment groups achieved the following endpoints at week 52 as compared to placebo: remission, improvement of endoscopic appearance of the mucosa, normalization of endoscopic appearance of the mucosa, maintenance of clinical response, remission among patients in remission at baseline, and sustained corticosteroid-free remission at both week 24 and week 52 among patients in remission at baseline, as shown in Table 17.
Danish: En signifikant større andel af patienter i begge behandlingsgrupper, tofacitinib 5 mg to gange dagligt og tofacitinib 10 mg to gange dagligt, opnåede de følgende effektmål ved uge 52 sammenlignet med placebo: remission, forbedring af endoskopisk udseende af slimhinden, normalisering af endoskopisk udseende af slimhinden, opretholdelse af klinisk respons, remission hos patienter i remission ved baseline og opretholdt kortikosteroidfri remission både ved uge 24 og uge 52 hos patienter i remission ved baseline, som vist i Tabel 17.
English: Tofacitinib total daily dose should be reduced by half in patients receiving potent inhibitors of cytochrome P450 (CYP) 3A4 (e.g., ketoconazole) and in patients receiving 1 or more concomitant medicinal products that result in both moderate inhibition of CYP3A4 as well as potent inhibition of CYP2C19 (e.g., fluconazole) (see sections 4.4 and 4.5) as follows:
Danish: Tofacitinibs samlede daglige dosis skal reduceres til halvdelen hos patienter, der får kraftige hæmmere af cytochrom P450 (CYP) 3A4 (f.eks. ketoconazol) og hos patienter, der får ét eller flere samtidige lægemidler, der både resulterer i moderat hæmning af CYP3A4 samt kraftig hæmning af CYPSC19 (f.eks. fluconazol) (se pkt.
English: Metabolism and nutrition disorders
Danish: Metabolism e og ernæring
English: *** p<0.0001, tofacitinib versus placebo + MTX, LS = least squares, N = number of patients, QOW = every other week, NA = not applicable, HAQ-DI = Health Assessment Questionnaire Disability Index
Danish: Ikke relevant Ikke relevant p<0,0001, tofacitinib versus placebo + MTX, LS = beregnet ved mindste kvadraters metode, N = antal patienter, HAQ-DI = Health Assessment Questionnaire Disability Index
English: Meningitis cryptococcal Mycobacterium avium complex infection
Danish: Mycobacterium avium-kompleks infektion
English: Table 6: Adverse Drug Reactions
Danish: Tabel 6: Bivirkninger
English: ≥1/100 to <1/10
Danish: Almindelig ≥ 1/100 til
English: (CYPRUS BRANCH) Τηλ: +357 22 817690
Danish: Τηλ: +357 22 817690
English: INFORMATION IN BRAILLE XELJANZ 5 mg
Danish: INFORMATION I BRAILLESKRIFT XELJANZ 5 mg
English: INFORMATION IN BRAILLE XELJANZ 10 mg
Danish: INFORMATION I BRAILLESKRIFT XELJANZ 10 mg
English: • The Prescriber checklist shall contain the following key messages: o Lists of tests to be conducted during the initial screening of the patient o Vaccination course to be completed before treatment o Relevant comorbidities for which caution is advised when XELJANZ is administered and conditions in which XELJANZ should not be administered o List of concomitant medications which are not compatible with treatment with XELJANZ o The need to discuss with the patients the risks associated with the use of XELJANZ, specifically in regards to infections, herpes zoster, tuberculosis (TB) and other opportunistic infections, malignancy, gastrointestinal perforations, interstitial lung disease, and laboratory abnormalities o The need to monitor for any signs and symptoms and laboratory abnormalities for early identification of the abovementioned risks.
Danish: • Tjeklisten til ordinerende læger skal indeholde følgende nøgleinformation: o Lister med tests, som skal udføres i forbindelse med den intiale screening af patienten o Hvilke vaccinationer, der skal gennemføres før behandling o Relevante samtidige sygdomme, hvor der tilrådes forsigtighed ved administration af XELJANZ, og tilstande, hvor Xeljanz ikke bør administreres o Liste over lægemidler, som ikke bør anvendes sammen med XELJANZ-behandling o Nødvendigheden af at diskutere risici ved XELJANZ-behandling med patienterne, særligt med hensyn til infektioner, herpes zoster, tuberkulose (TB) og andre opportunistiske infektioner, malignitet, gastrointestinal perforation, interstitiel lungesygdom og afvigelser i laboratorietal.
English: XELJANZ 10 mg film-coated tablet is blue and round in appearance.
Danish: XELJANZ 10 mg filmovertrukne tabletter er blå og runde.
English: Maintenance of clinical responsed
Danish: Opretholdelse af klinisk responsd
English: Physical function response and health-related outcomes
Danish: Fysisk funktion og helbredsrelateret livskvalitet
English: QOW=every other week, N=number of subjects analysed, ACR20/50/70=American College of Rheumatology ≥20, 50, 70%
Danish: N=antal forsøgspersoner analyseret, ACR20/50/70=American College of Rheumatology ≥ 20, 50, 70 % forbedring; MTX=methotrexat.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION XELJANZ 5 mg film-coated tablets
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING XELJANZ 5 mg filmovertrukne tabletter
English: ΔDSSf
Danish: ΔDSS
English: It is not recommended to initiate or continue tofacitinib treatment in patients with a confirmed lymphocyte count less than 750 cells/mm3.
Danish: Det anbefales ikke at initiere eller fortsætte behandling med tofacitinib hos patienter med et bekræftet lymfocyttal under 0,75 x109 celler/l.
English: Uncommon (may affect up to 1 in 100 people): tuberculosis, kidney infection, skin infection, herpes simplex or cold sores (oral herpes), low white blood cell counts, increased liver enzymes in the blood (sign of liver problems), blood creatinine increased (a possible sign of kidney problems), increased cholesterol, weight gain, dehydration, muscle strain, pain in the muscles and joints, tendonitis, joint swelling, abnormal sensations, poor sleep, sinus congestion, shortness of breath or difficulty breathing, skin redness, itching, fatty liver, painful inflammation of small pockets in the lining of your intestine (diverticulitis), viral infections, viral infections affecting the gut, some types of skin cancers (non-melanoma-types).
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer): tuberkulose, nyrebetændelse, betændelse i huden, herpes simplex eller forkølelsessår (oral herpes), lavt antal hvide blodlegemer, forhøjede leverenzymer i blodet (tegn på leverproblemer), forhøjet blodkreatinin (tegn på mulige nyreproblemer), forhøjet kolesterol, vægtstigning, væskemangel, forstrækning af muskler, muskel- og ledsmerter, senebetændelse, hævede led, føleforstyrrelser, dårlig søvn, tilstoppede bihuler, åndenød eller vejrtrækningsbesvær, hudrødme, kløe, fedtlever, smertefuld betændelse i de små udposninger i tarmen (diverculitis), virusinfektioner, virusinfektioner, der påvirker mave-tarm-kanalen, visse typer hudkræft (ikke-melanom typer).
English: c Achieved statistical significance globally at p≤ 0.05 per the pre-specified step-down testing procedure.
Danish: d Opnået statistisk signifikans globalt ved p≤ 0,05 iht.
English: Table 15: Proportion of Patients Meeting Efficacy Endpoints at Week 8 (OCTAVE Induction Study 1 and OCTAVE Induction Study 2) OCTAVE Induction Study 1 Central Endoscopy Read
Danish: Tabel 15: Andelen af patienter, der opfylder effektmål ved uge 8 (OCTAVE Induction 1studiet og OCTAVE Induction 2-studiet) OCTAVE Induction 1-studiet Central endoskopivurdering Lokal endoskopivurdering
English: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Danish: Benigne, maligne og uspecificere de tumorer (inkl.
English: Table 7: Phase 3 Clinical Trials of Tofacitinib 5 and 10 mg Twice Daily Doses in Patients with RA
Danish: Tabel 7: Kliniske fase 3-studier med tofacitinib i doser på 5 mg og 10 mg 2 gange dagligt hos RA-patienter
English: Noneb csDMARDs MTX MTX MTX Noneb
Danish: Baggrundsmedicin Ingen b csDMARD MTX MTX MTX Ingen b
English: Clinical responsed
Danish: Klinisk responsd
English: In the 6-month and 24-month, controlled clinical studies, the rate of serious infections in the 5 mg twice daily tofacitinib monotherapy group was 1.7 patients with events per 100 patient-years.
Danish: I de kontrollerede kliniske studier på 6 måneder og 24 måneder var forekomsten af alvorlige infektioner i monoterapigruppen med 5 mg tofacitinib 2 gange dagligt 1,7 patienter med hændelser pr.
English: Sustained corticosteroidfree remission at both week 24 and week 52 among patients in remission at baselinee,f
Danish: Opretholdt kortikosteroidfri remission både ved uge 24 og uge 52 hos patienter i remission ved baseline e,f
English: Sustained corticosteroid-free remission at both week 24 and week 52 among patients in remission at baselined
Danish: Opretholdt kortikosteroidfri remission både ved uge 24 og uge 52 hos patienter i remission ved baselined
English: Store in the original package in order to protect from moisture.
Danish: Opbevares i den originale pakning for at beskytte med fugt.
English: Tofacitinib 10 mg Twice Daily + DMARD(s) ORAL Sync: DMARD Inadequate Responders
Danish: Tofacitinib 10 mg 2 gange dagligt + DMARD(s) ORAL Sync: Patienter med utilstrækkeligt respons på DMARD
English: N ORAL Step: TNF Inhibitor Inadequate Responders Tofacitinib 5 mg twice daily + MTX
Danish: N ORAL Step: Patienter med utilstrækkeligt respons på TNF Inhibitor Tofacitinib 5 mg 2 gange dagligt + MTX
English: Patients receiving tofacitinib 5 mg twice daily demonstrated a greater improvement in arthritis pain (as measured on a 0-100 visual analogue scale) from baseline at week 2 (first post-baseline assessment) through month 3 compared to placebo in studies OPAL BROADEN and OPAL BEYOND (nominal p≤ 0.05).
Danish: Patienter, som fik tofacitinib 5 mg 2 gange dagligt, havde en større forbedring af artritsmerter (målt på en 0-100 visuel analog skala) fra baseline i uge 2 (første vurdering efter baseline) til måned 3 sammenlignet med placebo i studierne OPAL BROADEN- og OPAL BEYOND (nominel p≤ 0,05).
English: Coadministration of tofacitinib did not have an effect on the PK of oral contraceptives, levonorgestrel and ethinyl estradiol, in healthy female volunteers.
Danish: Tofacitinibs potentielle indvirkning på andre lægemidlers farmakokinetik Samtidig administration af tofacitinib havde ikke nogen indvirkning på farmakokinetikken af orale kontraceptiva indeholdende levonorgestrel og ethinylestradiol hos frivillige raske kvinder.
English: Signs of stomach problems (uncommon: ulcers or holes in your stomach or intestines) include • fever
Danish: Tegn på maveproblemer (hyppighed ”ikke almindelig”: sår eller huller i mavesækken eller tarmene) inkluderer - feber - mavesmerter - blod i afføringen - uforklarlige ændringer i afføringsvaner
English: Common (may affect up to 1 in 10 people): lung infection (pneumonia and bronchitis), shingles (herpes zoster), infections of nose, throat or the windpipe (nasopharyngitis), influenza, sinusitis, urinary bladder infection (cystitis), sore throat (pharyngitis), increased muscle enzymes in the blood (sign of muscle problems), stomach (belly) pain (which may be from inflammation of the stomach lining), vomiting, diarrhoea, feeling sick (nausea), indigestion, joint sprain, low red blood cell count (anaemia), fever, fatigue (tiredness), swelling of the feet and hands, headache, high blood pressure (hypertension), cough, rash.
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 personer): lungeinfektion (lungebetændelse og bronkitis), helvedesild (herpes zoster), infektioner i næse, hals eller luftrør (forkølelse), influenza, bihulebetændelse, urinvejsinfektion (blærebetændelse), ondt i halsen (svælgkatar), forhøjede muskelenzymer i blodet (tegn på muskelproblemer), mavesmerter (som kan skyldes betændelse i mavens slimhinde), opkastning, diarré, kvalme, fordøjelsesbesvær, forstrækning af led, lavt antal røde blodlegemer (blodmangel, anæmi), feber, udmattelse (træthedsfornemmelse), hævede fødder og hænder, hovedpine, forhøjet blodtryk (hypertension), hoste, udslæt.
English: XELJANZ 10 mg film-coated tablet - The active substance is tofacitinib.
Danish: XELJANZ 10 mg filmovertrukket tablet - Det aktive stof er tofacitinib.
English: Patients receiving tofacitinib 5 or 10 mg twice daily demonstrated significantly greater improvement from baseline in fatigue compared to placebo in all 5 studies.
Danish: Patienter, der fik 5 mg eller 10 mg tofacitinib 2 gange dagligt, opnåede signifikant større forbedringer fra baseline i træthed sammenlignet med placebo i alle 5 studier.
English: Table 18: Proportion of Patients Meeting Primary and Key Secondary Efficacy Endpoints at Week 52 by TNF Inhibitor Therapy Subgroup (OCTAVE Sustain, Central Endoscopy Read)
Danish: Tabel 18: Andel af patienter, der opfylder primære og vigtige, sekundære effektmål ved uge 52 efter TNF-hæmmer-behandlingsundergruppe (OCTAVE Sustain, central endoskopivurdering)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER OR STRIPS BLISTER FOR 5 MG TABLETS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER KORT TIL 5 MG FILMOVERTRUKNE TABLETTER
English: b Inadequate response to a least 1 TNFi due to lack of efficacy and/or intolerability.
Danish: b Utilstrækkelig respons på mindst 1 TNFi på grund af manglende effekt og/eller intolerans.
English: Remission was defined as clinical remission (a total Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 0.
Danish: Remission blev defineret som klinisk remission (en samlet Mayo-score ≤ 2 uden nogen individuel subscore > 1) og en subscore for rektal blødning på 0.
English: • The patient alert card shall contain the following key messages: o A warning message for HCPs treating the patient at any time, including in conditions of emergency, that the patient is using XELJANZ o That treatment with XELJANZ may increase the risk of infections and non melanoma skin cancer o That patients should inform health professionals if they are planning to receive any vaccine or become pregnant o Signs or symptoms of the following safety concern and when to seek attention from a HCP: infections, herpes zoster reactivation, non-melanoma skin cancer, transaminase elevation and potential for drug-induced liver injury, gastrointestinal perforation, interstitial lung disease, increased immunosuppression when used in combination with biologics and immunosuppressants including B lymphocyte depleting agents, increased risk of adverse events when XELJANZ is administered in combination with MTX, increased exposure to XELJANZ when co-administered with CYP3A4 and CYP2C19
Danish: • Patientinformationskortet skal indeholde følgende nøgleinformation: o En advarsel til sundhedsprofessionelle, som på ethvert tidspunkt behandler patienten, herunder også i nødsituationer, om, at patienten får XELJANZ o At behandling med XELJANZ kan øge risikoen for infektioner og non-melanon hudkræft o At patienten skal informere sundhedsprofessionelle, hvis de planlægger at blive vaccineret eller at blive gravid o Tegn og symptomer på følgende sikkerhedsproblemer, og hvornår der skal søges læge: Infektioner, re-aktivering af herpes zoster, non-melanom hudkræft, forhøjede aminotransferaser og risikoen for lægemiddelinduceret leverskade, gastrointestinal perforation, interstitiel lungesygdom, øget immunsuppression, når XELJANZ bruges sammen med biologiske lægemidler eller immunsuppressiva, herunder Blymfocytdepleterende lægemidler.
English: Month 3 ORAL Sync: DMARD Inadequate Responders Tofacitinib 5 mg twice daily
Danish: Måned 3 ORAL Sync: Patienter med utilstrækkeligt respons på DMARD Tofacitinib 5 mg 2 gange dagligt
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER OR STRIPS BLISTER FOR 10 MG TABLETS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER KORT TIL 10 MG FILMOVERTRUKNE TABLETTER
English: Blood creatine phosphokinase increased
Danish: Forhøjet kreatinkinase i blodet
English: a SD = Standard Deviation b Difference between least squares means tofacitinib minus placebo (95% CI = 95% confidence interval) c Month 6 and month 12 data are mean change from baseline d Difference between least squares means tofacitinib minus MTX (95% CI = 95% confidence interval)
Danish: Forskel mellem middelværdierne, fundet ved mindste kvadraters metode, for tofacitinib minus placebo (95% CI = 95% konfidensinterval) c Måned 6- og Måned 12-data er den gennemsnitlige ændring fra baseline d
English: Table 1: Low Absolute Lymphocyte Count Low Absolute Lymphocyte Count (ALC) (see section 4.4)
Danish: Lavt absolut lymfocyttal (ALC) (se pkt.
English: c. Normalization of endoscopic appearance of the mucosa was defined as a Mayo endoscopic subscore of 0.
Danish: Normalisering af endoskopisk udseende af slimhinden blev defineret som en Mayo-endoskopisk subscore på d.
English: Proportion of Patients Meeting Primary and Key Secondary Efficacy Endpoints at Week 8 by TNF Inhibitor Therapy Subgroups (OCTAVE Induction Study 1 and OCTAVE Induction Study 2, Central Endoscopy Read) OCTAVE Induction Study 1
Danish: Andel af patienter, der opfylder primære og vigtige, sekundære effektmål ved uge 8 efter TNF-hæmmer-behandlingsundergrupper (OCTAVE Induction 1-studiet og OCTAVE Induction 2-studiet, central endoskopivurdering) OCTAVE Induction 1-studiet
English: Achieved statistical significance globally at p≤ 0.05 per the pre-specified step-down testing procedure.
Danish: Opnåede statistisk signifikans globalt ved p≤ 0,05 iht.
English: Month 6 ORAL Standard: MTX Inadequate Responders Tofacitinib 5 mg twice daily + MTX
Danish: Måned 6 ORAL Standard: Patienter med utilstrækkeligt respons på MTX Tofacitinib 5 mg 2 gange dagligt + MTX
English: Lab Value (cells/mm3)
Danish: Laboratorieværdi (x109 celler/l)
English: Abdominal pain Vomiting Diarrhoea Nausea
Danish: Abdominals merter Opkastning Diarré Kvalme Gastritis Dyspepsi
English: c. Improvement of endoscopic appearance of the mucosa was defined as Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (erythema, decreased vascular pattern).
Danish: c. Forbedring af endoskopisk udseende af slimhinden blev defineret som en Mayo-endoskopisk subscore på 0 (normal eller inaktiv sygdom) eller 1 (erythema, nedsat vaskulært mønster).
English: MTX N=168 Mean (SD)
Danish: MTX N= 168 Gennemsnit (SD)a
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Dette lægemiddel indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af arvelig lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: Month 3 Month 6 Month 12
Danish: Måned 3 Måned 6 Måned 12
English: Placebo + MTX N=139 Mean (SD)a
Danish: Placebo + MTX N= 139 Gennemsnit (SD)a
English: Remissiona With prior TNF inhibitor failure Without prior TNF inhibitor failureb Improvement of endoscopic appearance of the mucosac With prior TNF inhibitor failure Without prior TNF inhibitor failureb OCTAVE Induction Study 2
Danish: Remissiona Med tidligere svigt af TNF-hæmmer Uden tidligere svigt af TNF-hæmmerb Forbedring af endoskopisk udseende af slimhindenc Med tidligere svigt af TNF-hæmmer Uden tidligere svigt af TNF-hæmmerb OCTAVE Induction 2-studiet
English: How to Take XELJANZ
Danish: Sådan skal du tage XELJANZ
English: in studies OPAL BROADEN and OPAL BEYOND was 53% and 50%, respectively in patients receiving tofacitinib 5 mg twice daily, 31% and 28%, respectively in patients receiving placebo, and 53% in patients receiving adalimumab 40 mg subcutaneously once every 2 weeks (OPAL BROADEN only).
Danish: HAQ-DI-responsraten (respons defineres som et fald fra baseline på ≥ 0,35) ved måned 3 i studierne OPAL BROADEN og OPAL BEYOND var på hhv. 53 % og 50 % hos patienter, som fik tofacitinib 5 mg 2 gange dagligt, hhv. 31 % og 28 % hos patienter, som fik placebo, og 53 % hos patienter, som fik adalimumab 40 mg subkutant en gang hver anden uge (kun OPAL BROADEN).