FrancophonIA/ELRC3.0 huggingface dataset:
English: Normalisation 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 0.
English: Patients who did not achieve clinical response in one of the induction studies (OCTAVE Induction 1 or OCTAVE Induction 2) after 8 weeks of tofacitinib 10 mg twice daily were allowed to enter an open-label extension study (OCTAVE Open).
Danish: Patienter, der ikke opnåede klinisk respons i et af induktionsstudierne (OCTAVE Induction 1 eller OCTAVE Induction 2) efter 8 uger med XEJLANZ 10 mg to gange dagligt, fik lov til at indgå i et åbent forlængelsesstudie (OCTAVE Open).
English: • Tofacitinib monotherapy
Danish: • Tofacitinib monoterapi
English: Abdominal pain Vomiting Diarrhoea Nausea
Danish: Abdominal smerter Opkastning Diarré Kvalme Gastritis Dyspepsi
English: Treatment with tofacitinib was associated with an increased incidence of lymphopenia compared to placebo.
Danish: Behandling med tofacitinib var forbundet med en øget incidens af lymfocytopeni sammenlignet med placebo.
English: Overall infections
Danish: Infektioner generelt
English: For patients receiving tofacitinib 5 mg twice daily, dosing should be interrupted.
Danish: For patienter, der får tofacitinib 5 mg to gange dagligt, skal doseringen afbrydes.
English: Health-related and quality of life outcomes
Danish: Sundhedsrelaterede og livskvalitetsresultater
English: Benign testicular interstitial (Leydig) cell tumours were observed in rats: benign Leydig cell tumours in rats are not associated with a risk of Leydig cell tumours in humans.
Danish: Benigne Leydig-celletumorer hos rotter er ikke associeret med en risiko for Leydig celletumorer hos mennesker.
English: Tofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent (see section 5.1).
Danish: Tofacitinib er indiceret til behandling af voksne patienter med moderat til alvorlig aktiv ulcerativ colitis (UC), der har haft et utilstrækkeligt respons, ophørt respons, eller har været intolerante over for enten konventionel behandling eller et biologisk lægemiddel (se pkt.
English: Tofacitinib should not be used in patients with severe hepatic impairment (see section 4.3).
Danish: Tofacitinib bør ikke anvendes hos patienter med alvorlig nedsat leverfunktion (se pkt.
English: You can start the Xeljanz 11 mg prolonged-release tablets once daily the day following the last dose of XELJANZ 5 mg film-coated tablets.
Danish: Du kan begynde at tage XELJANZ 11 mg depottabletter én gang dagligt, dagen efter du har taget den sidste dosis XELJANZ 5 mg filmovertrukne tabletter.
English: No dose adjustment is required in patients aged 65 years and older.
Danish: Dosisjustering er ikke nødvendig hos patienter ≥ 65 år.
English: Tofacitinib 10 mg twice daily demonstrated greater improvement from baseline compared to placebo at week 8 in the total and all 4 domain scores of the Inflammatory Bowel Disease Questionnaire (IBDQ) (bowel symptoms, systemic function, emotional function, and social function) in the induction studies (OCTAVE Induction 1, OCTAVE Induction 2).
Danish: Tofacitinib 10 mg to gange dagligt udviste en større forbedring i forhold til baseline sammenlignet med placebo ved uge 8 i den samlede score og alle 4 domænescorer for spørgeskemaet Bowel Disease Questionnaire (IBDQ) (tarmsymptomer, systemisk funktion, emotionel funktion og social funktion) i induktionsstudierne (OCTAVE Induction 1, OCTAVE Induction 2).
English: Abbreviations: DMARD=disease-modifying antirheumatic drug; HAQ-DI=Health Assessment Questionnaire Disability Index; N=total number of patients in the statistical analysis; SC q2w=subcutaneously once every 2 weeks; TNFi=tumour necrosis factor inhibitor.
Danish: Forkortelser: DMARD = sygdomsmodificerende antireumatisk lægemiddel, HAQ-DI = Health Assessment Questionnaire Disability Index, IR = ikke relevant, N = samlet antal patienter i den statistiske analyse, s.c. = subkutant, TNFi = tumornekrosefaktorinhibitor.
English: XELJANZ is used to treat adult patients with moderate to severe active rheumatoid arthritis, a long-term disease that mainly causes pain and swelling of your joints.
Danish: XELJANZ bruges til at behandle voksne patienter med moderat til svær, aktiv leddegigt, en langvarig sygdom som hovedsagelig giver smerter og hævede led.
English: NMSCs have been reported in patients treated with tofacitinib.
Danish: Der er observeret NMSC hos patienter, der blev behandlet med tofacitinib.
English: Do not take XELJANZ - if you are allergic to tofacitinib or any of the other ingredients of this medicine (listed in section 6) - if you have a severe infection such as bloodstream infection or active tuberculosis
Danish: Tag ikke XELJANZ: - hvis du er allergisk over for tofacitinib eller et af de øvrige indholdsstoffer i XELJANZ (angivet i afsnit 6).
English: In general, fewer side effects were seen when XELJANZ was used alone than in combination with methotrexate in rheumatoid arthritis.
Danish: Generelt blev der set færre bivirkninger, når XELJANZ blev brugt alene til leddegigt.
English: Lipid monitoring
Danish: Lipidovervågning
English: Physical function and health-related quality of life Improvement in physical functioning was measured by the HAQ-DI.
Danish: Forbedring i fysisk funktion blev vurderet ved hjælp af HAQ-DI.
English: In OPAL BROADEN, Minimal Disease Activity (MDA) response was achieved by 26.2%, 25.5% and 6.7% of tofacitinib 5 mg BID, adalimumab and placebo treated patients, respectively (tofacitinib 5 mg BID treatment difference from placebo 19.5% [95% CI: 9.9, 29.1]) at month 3.
Danish: I OPAL BROADEN-studiet opnåede 26,2 %, 25,5 % og 6,7 % af de patienter, som fik hhv. tofacitinib 5 mg 2 gange dagligt, adalimumab og placebo, Minimal Disease Activity (MDA)-respons (behandlingsforskel mellem tofacitinib 5 mg 2 gange dagligt og placebo var 19,5 % [95 % CI: 9,9; 29,1]) ved måned 3.
English: - The prolonged-release tablets are also available in bottles with silica gel desiccant containing
Danish: - Depottabletterne findes også i tabletbeholdere med silicagel som tørremiddel indeholdende 30
English: Gastrointestinal obstruction with a non-deformable prolonged-release formulation
Danish: Obstruktion i mave-tarm-kanalen med en ikke-deformerbar depotformulering
English: croscarmellose sodium, magnesium stearate, hypromellose (E464), titanium dioxide (E171),
Danish: croscarmellosenatrium, magnesiumstearat, hypromellose (E464), titandioxid (E171),
English: MTX N=168 Mean (SD)
Danish: MTX N= 168 Gennemsnit (SD)
English: In ORAL Scan, mean SF-36 improvements were maintained to 12 months in tofacitinib-treated patients.
Danish: I ORAL Scan blev de gennemsnitlige forbedringer i SF-36 opretholdt til måned 12 hos patienter, der fik tofacitinib.
English: A significantly greater proportion of patients treated with tofacitinib 10 mg twice daily achieved remission, improvement of endoscopic appearance of the mucosa, and clinical response at week 8 compared to placebo in both studies, as shown in Table 15.
Danish: En signifikant større andel af patienter behandlet med tofacitinib 10 mg to gange dagligt opnåede remission, forbedring af endoskopisk udseende af slimhinden og klinisk respons ved uge 8 sammenlignet med placebo i begge studier som vist i Tabel 15.
English: 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 MTX (95% CI = 95% konfidensinterval)
English: As a precautionary measure, the use of tofacitinib during pregnancy is contraindicated (see section 4.3).
Danish: Af sikkerhedsmæssige årsager er tofacitinib kontraindiceret under graviditet (se pkt.
English: Achieved statistical significance globally at p≤ 0.05 per the pre-specified step-down testing procedure.
Danish: Opnået statistisk signifikans globalt ved p≤ 0,05 iht.
English: Lymphocyte counts less than 750 cells/mm3 were associated with an increased incidence of serious infections.
Danish: Lymfocyttal under 0,75 x109 celler/l var forbundet med en øget incidens af alvorlige infektioner.
English: All patients were required to have 1 concomitant csDMARD; 83.9% of patients received concomitant MTX, 9.5% of patients received concomitant sulfasalazine, and 5.7% of patients received concomitant leflunomide.
Danish: 83,9 % af patienterne fik samtidig administreret MTX, 9,5 % af patienterne fik samtidig administreret sulfasalazin, og 5,7 % af patienterne fik samtidig administreret leflunomid.
English: Furthermore, at month 12 of study OCTAVE Open, 74% (48/65) of patients who achieved remission at the end of study OCTAVE Sustain on either tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily remained in remission while receiving tofacitinib 5 mg twice daily.
Danish: Efter 12 måneder med OCTAVE Open-studiet forblev 74 % (48/65) af patienterne, der opnåede remission ved studiet OCTAVE Sustains afslutning på enten tofacitinib 5 mg to gange dagligt eller tofacitinib 10 mg to gange dagligt endvidere i remission, mens de fik tofacitinib 5 mg to gange dagligt.
English: Elevations in lipid parameters (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) were first assessed at 1 month following initiation of tofacitinib in the controlled double-blind clinical trials of RA.
Danish: I de kontrollerede, dobbeltblinde kliniske RA-studier blev stigning i lipidparametre (total-kolesterol, LDL-kolesterol, HDL-kolesterol, triglycerider) først vurderet 1 måned efter initiering af tofacitinib.
English: As with the overall ACR response in patients treated with 5 mg or 10 mg twice daily tofacitinib, each of the components of the ACR response was consistently improved from baseline including: tender and swollen joint counts; patient and physician global assessment; disability index scores; pain assessment and CRP compared to patients receiving placebo plus MTX or other DMARDs in all studies.
Danish: Som for det generelle ACR-respons hos patienter, der blev behandlet med 5 mg eller 10 mg tofacitinib 2 gange dagligt, blev alle komponenter i ACR-responset konsekvent forbedret i forhold til baseline i alle studier, inklusive antal ømme og hævede led, patientens og lægens overordnede vurdering, indeks for funktionsnedsættelse, smertevurdering og CRP sammenlignet med patienter, der fik placebo plus MTX eller andre DMARDs.
English: Driving and using machines XELJANZ has no or limited effect on your ability to drive or use machines.
Danish: Trafik- og arbejdssikkerhed XELJANZ påvirker ikke eller kun i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
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: 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: Overall, the safety profile observed in patients with active PsA treated with tofacitinib was consistent with the safety profile observed in patients with RA treated with tofacitinib.
Danish: Den observerede sikkerhedsprofil hos patienter med aktiv PsA, som blev behandlet med tofacitinib, var generelt i overensstemmelse med den observerede sikkerhedsprofil hos patienter med RA, som blev behandlet med tofacitinib.
English: Printing ink shellac (E904) ammomium hydroxide (E527) propylene glycol (E1520) black iron oxide (E172)
Danish: Trykkeblæk shellak (E904) ammomiumhydroxid (E527) propylenglycol (E1520) sort jernoxid (E172)
English: - if you have had diverticulitis (a type of inflammation of the large intestine) or ulcers in stomach or intestines (see section 4) - if you have kidney problems - if you are planning to get vaccinated, tell your doctor.
Danish: - hvis du har haft diverticulitis (en type betændelse i tyktarmen) eller mavesår eller sår i tarmene (se afsnit 4).
English: Evidence of persistence of efficacy with tofacitinib treatment for up to 7 years is also provided from data in the one ongoing and one completed open-label, long-term follow-up studies.
Danish: Data i det ene igangværende og det ene gennemførte åbne langtid-opfølgningsstudie giver også evidens for vedvarende effekt ved tofacitinib-behandling i op til 7 år.
English: Lymphoma was observed in 3 of 8 adult monkeys at 6 or 3 times the clinical tofacitinib exposure level (unbound AUC in humans at a dose of 5 mg or 10 mg twice daily), and 0 of 14 juvenile monkeys at 5 or 2.5 times the clinical exposure level of 5 mg or 10 mg twice daily.
Danish: Lymfom blev observeret hos 3 ud af 8 voksne aber ved et niveau på 6 eller 3 gange den kliniske eksponering for tofacitinib (AUC for ubundet tofacitinib hos mennesker ved en dosis på 5 mg eller 10 mg 2 gange dagligt) og hos 0 ud af 14 unge aber ved en dosis på 5 eller 2,5 gange det kliniske eksponeringsniveau på 5 mg eller 10 mg to gange dagligt.
English: Exposure in monkeys at the no observed adverse effect level (NOAEL) for the lymphomas was approximately 1 or 0.5 times the clinical exposure level of 5 mg or 10 mg twice daily.
Danish: Eksponeringsniveauet hos aber ved ingen observeret negativ virkning (NOAEL) for lymfomer var cirka 1 eller 0,5 gange det kliniske eksponeringsniveau på 5 mg eller 10 mg to gange dagligt.
English: Holes in stomach or intestines happen most often in people who also take nonsteroidal anti-inflammatory drugs or corticosteroids (e.g., prednisone).
Danish: Huller i mavesækken eller tarmene opstår oftest hos patienter, som også tager non-steroide antiinflammatoriske lægemidler (NSAID) eller kortikosteroider (f.eks. prednison).
English: XELJANZ can also be taken on its own in those cases where methotrexate treatment is not tolerated or treatment with methotrexate is not advised.
Danish: XELJANZ kan også tages alene i de tilfælde, hvor behandling med methotrexat ikke tåles eller ikke tilrådes.
English: Abbreviations: BSA=body surface area; ΔLEI=change from baseline in Leeds Enthesitis Index; ΔDSS=change from baseline in Dactylitis Severity Score; ACR20/50/70=American College of Rheumatology ≥ 20%, 50%, 70% improvement; csDMARD=conventional synthetic disease-modifying antirheumatic drug; N=number of randomised and treated patients; NA=Not applicable, as data for placebo treatment is not available beyond month 3 due to placebo advanced to tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily; SC q2w=subcutaneously once every 2 weeks; TNFi=tumour necrosis factor inhibitor; PASI=Psoriasis Area and Severity index; PASI75=≥ 75% improvement in PASI.
Danish: Forkortelser: BSA = legemsoverfladeareal, ΔLEI = ændring fra baseline i Leeds Enthesitis Index, ΔDSS = ændring fra baseline i Dactylitis Severity Score, ACR20/50/70 = American College of Rheumatology ≥20 %, 50 %, 70 % forbedring, csDMARD = konventionelt syntetisk sygdomsmodificerende antireumatisk lægemiddel, N = antal randomiserede og behandlede patienter, IR = ikke relevant, da data fra placebobehandling ikke er tilgængelige ud over måned 3 på grund af placebo overført til tofacitinib 5 mg to gange dagligt eller tofacitinib 10 mg 2 gange dagligt, s,c.
English: 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: 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: Film coat hypromellose 6cP (E464) titanium dioxide (E171) lactose monohydrate macrogol 3350 triacetin (E1518)
Danish: Filmovertræk hypromellose 6cP (E464) titandioxid (E171) lactosemonohydrat macrogol 3350 triacetin (E1518)
English: Both TNF inhibitor naïve and TNF inhibitor inadequate responder tofacitinib 5 mg BID -treated patients had significantly higher ACR20 response rates compared to placebo at month 3.
Danish: Både TNF-hæmmer-naive-patienter og patienter med utilstrækkeligt respons på TNF-hæmmer, som blev behandlet med tofacitinib 5 mg 2 gange dagligt, havde signifikant højere ACR20-responsrater sammenlignet med placebo ved måned 3.
English: In a controlled clinical trial of patients with RA initiating tofacitinib 10 mg twice daily or placebo, the number of responders to influenza vaccine was similar in both groups: tofacitinib (57%) and placebo (62%).
Danish: I kontrollerede kliniske studier med RA-patienter, der startede med tofacitinib 10 mg 2 gange dagligt eller placebo, var antallet af respondenter på influenzavaccine ens i de 2 grupper: Tofacitinib (57 %) og placebo (62 %).
English: Your doctor may do blood tests for hepatitis before you start treatment with XELJANZ and while you are taking XELJANZ - if you have ever had any type of cancer.
Danish: Lægen vil muligvis tage blodprøver og teste dig for hepatitis, før du påbegynder behandling med XELJANZ, og mens du tager XELJANZ.
English: Tofacitinib was not carcinogenic in mice at exposures up to 38 or 19 times the clinical exposure level at 5 mg or 10 mg twice daily.
Danish: Tofacitinib var ikke karcinogent hos mus ved eksponeringer på op til 38 eller 19 gange det kliniske eksponeringsniveau på 5 mg eller 10 mg to gange dagligt.
English: In the 10 mg twice daily tofacitinib monotherapy group the rate was 1.6 patients with events per 100 patient-years, 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: Improvement of endoscopic appearance of the mucosa was defined as endoscopy subscore of 0 or 1.
Danish: Forbedring af endoskopisk udseende af slimhinden blev defineret som en endoskopisk subscore på 0 eller 1.
English: Significant reductions in DAS28-4(ESR) from baseline (mean improvement) of 1.8-2.0 and 1.9-2.2 were observed in patients treated with 5 mg and 10 mg twice daily doses, respectively, compared to placebo-treated patients (0.7-1.1) at month 3.
Danish: Signifikante reduktioner i DAS28-4(ESR) i forhold til baseline (gennemsnitlig forbedring) på 1,8-2,0 og 1,9-2,2 blev observeret ved måned 3 hos patienter, der fik henholdsvis 5 mg og 10 mg tofacitinib 2 gange dagligt, sammenlignet med placebogruppen (0,7-1,1).
English: Evidence of humoral and cell-mediated responses to VZV was observed in both tofacitinib and placebo-treated patients at 6 weeks.
Danish: Der blev observeret evidens for humoralt og cellemedieret respons på VZV både i tofacitinib-gruppen og i placebogruppen efter 6 uger.
English: Viral infection
Danish: Virusinfekti on
English: Improvement of endoscopic appearance of the mucosac With prior TNF inhibitor failure
Danish: Forbedring af endoskopisk udseende af slimhinden Med tidligere svigt af TNFhæmmer
English: In studies of 6-, 12-, or 24-month duration, the rates of serious infections in the 5 mg twice daily and 10 mg twice daily tofacitinib plus DMARD groups were 3.6 and 3.4 patients with events per 100 patient-years, respectively, compared to 1.7 patients with events per 100 patient-years in the placebo plus DMARD group.
Danish: I studier af 6, 12 eller 24 måneders varighed var forekomsten af alvorlige infektioner hos grupperne med 5 mg tofacitinib 2 gange dagligt plus DMARD og 10 mg tofacitinib 2 gange dagligt plus DMARD henholdsvis 3,6 og 3,4 patienter med hændelser pr. 100 patientår sammenlignet med 1,7 patienter med hændelser pr. 100 patientår i gruppen, der fik placebo plus DMARD.
English: Sustained corticosteroid-free 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: The most common serious infections included pneumonia, herpes zoster, urinary tract infection, cellulitis, gastroenteritis and diverticulitis.
Danish: De hyppigste alvorlige infektioner inkluderede pneumoni, herpes zoster, urinvejsinfektion, cellulitis, gastroenteritis og diverticulitis.
English: BLISTER FOR 11 MG TABLETS
Danish: BLISTER TIL 11 MG TABLETTER
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. 100 patientår.
English: When ALC is greater than 750, treatment should be resumed as clinically appropriate.
Danish: Når ALC er over 0,75, genoptages behandlingen som det er klinisk relevant.
English: In both subgroups of patients with or without prior TNF inhibitor failure, a greater proportion of patients treated with tofacitinib 10 mg twice daily achieved remission and improvement of endoscopic appearance of the mucosa at week 8 as compared to placebo.
Danish: I begge undergrupper af patienter med eller uden tidligere svigt af TNF-hæmmer opnåede en større andel af patienter, der blev behandlet med tofacitinib 10 mg to gange dagligt, remission og forbedring af endoskopisk udseende af slimhinden ved uge 8 sammenlignet med placebo.
English: Steady-state AUC and Cmax of tofacitinib for tofacitinib 11 mg prolonged-release tablet administered once daily are equivalent to those of tofacitinib 5 mg film-coated tablets administered twice daily.
Danish: Steady state AUC og Cmax af tofacitinib for tofacitinib 11 mg depottablet én gang dagligt svarer til dem for tofacitinib 5 mg filmovertrukne tabletter administreret to gange dagligt.
English: Key secondary endpoint: Improvement of endoscopic appearance of the mucosa was defined as Mayo endoscop y subscore of 0 (normal or inactive disease) or 1 (erythema, decreased vascular pattern).
Danish: Vigtigt, sekundært effektmål: Forbedring af endoskopisk udseende af slimhinden blev defineret som en Mayoendoskopisk subscore på 0 (normal eller inaktiv sygdom) eller 1 (erythema, nedsat vaskulært mønster).
English: Baseline corticosteroid use
Danish: Baseline anvendelse af kortikosteroider
English: Patients receiving tofacitinib 5 mg twice daily demonstrated greater improvement (p≤ 0.05) from baseline in physical functioning compared to placebo at month 3 (see Table 13).
Danish: Patienter, som fik tofacitinib 5 mg to gange dagligt, havde en større forbedring (p< 0,05) fra baseline i fysisk funktion sammenlignet med placebo ved måned 3 (se tabel 13).
English: Patients with RA, particularly those with highly active disease may be at a higher risk (up to several-fold) than the general population for the development of lymphoma.
Danish: I forhold til den almene befolkning kan risikoen for, at patienter med RA udvikler lymfom, være højere (op til mange gange), særligt hos patienter med meget aktiv sygdom.
English: Month 3 Month 6
Danish: Måned 3 Måned 6
English: XELJANZ is used to reduce the signs and symptoms of ulcerative colitis when you did not respond well enough or were intolerant to previous ulcerative colitis treatment.
Danish: XELJANZ anvendes til at reducere tegn og symptomer på blødende tyktarmsbetændelse, hvis du ikke har reageret godt nok på eller ikke har kunnet tåle tidligere behandling af tyktarmsbetændelse.
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 baseline