natgillin/translations-raw huggingface dataset:
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. 
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.
Opretholdt kortikosteroidfri remission både ved uge 24 og uge 52 hos patienter i remission ved baseline e,f 
Sustained corticosteroidfree remission at both week 24 and week 52 among patients in remission at baselinee,f
Opretholdt kortikosteroidfri remission både ved uge 24 og uge 52 hos patienter i remission ved baselined 
Sustained corticosteroid-free remission at both week 24 and week 52 among patients in remission at baselined
Opbevares i den originale pakning for at beskytte med fugt. 
Store in the original package in order to protect from moisture.
Tofacitinib 10 mg 2 gange dagligt + DMARD(s) ORAL Sync: Patienter med utilstrækkeligt respons på DMARD 
Tofacitinib 10 mg Twice Daily + DMARD(s) ORAL Sync: DMARD Inadequate Responders
N ORAL Step: Patienter med utilstrækkeligt respons på TNF Inhibitor Tofacitinib 5 mg 2 gange dagligt + MTX 
N ORAL Step: TNF Inhibitor Inadequate Responders Tofacitinib 5 mg twice daily + MTX
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). 
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).
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. 
Coadministration of tofacitinib did not have an effect on the PK of oral contraceptives, levonorgestrel and ethinyl estradiol, in healthy female volunteers.
Tegn på maveproblemer (hyppighed ”ikke almindelig”: sår eller huller i mavesækken eller tarmene) inkluderer - feber - mavesmerter - blod i afføringen - uforklarlige ændringer i afføringsvaner 
Signs of stomach problems (uncommon: ulcers or holes in your stomach or intestines) include • fever
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. 
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.
XELJANZ 10 mg filmovertrukket tablet - Det aktive stof er tofacitinib. 
XELJANZ 10 mg film-coated tablet - The active substance is tofacitinib.
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. 
Patients receiving tofacitinib 5 or 10 mg twice daily demonstrated significantly greater improvement from baseline in fatigue compared to placebo in all 5 studies.
Tabel 18: Andel af patienter, der opfylder primære og vigtige, sekundære effektmål ved uge 52 efter TNF-hæmmer-behandlingsundergruppe (OCTAVE Sustain, central endoskopivurdering) 
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)
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER KORT TIL 5 MG FILMOVERTRUKNE TABLETTER 
MINIMUM PARTICULARS TO APPEAR ON BLISTER OR STRIPS BLISTER FOR 5 MG TABLETS
b Utilstrækkelig respons på mindst 1 TNFi på grund af manglende effekt og/eller intolerans. 
b Inadequate response to a least 1 TNFi due to lack of efficacy and/or intolerability.
Remission blev defineret som klinisk remission (en samlet Mayo-score ≤ 2 uden nogen individuel subscore > 1) og en subscore for rektal blødning på 0. 
Remission was defined as clinical remission (a total Mayo score ≤ 2 with no individual subscore > 1) and rectal bleeding subscore of 0.
• 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. 
• 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
Måned 3 ORAL Sync: Patienter med utilstrækkeligt respons på DMARD Tofacitinib 5 mg 2 gange dagligt 
Month 3 ORAL Sync: DMARD Inadequate Responders Tofacitinib 5 mg twice daily
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER KORT TIL 10 MG FILMOVERTRUKNE TABLETTER 
MINIMUM PARTICULARS TO APPEAR ON BLISTER OR STRIPS BLISTER FOR 10 MG TABLETS
Forhøjet kreatinkinase i blodet 
Blood creatine phosphokinase increased
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 
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)
Lavt absolut lymfocyttal (ALC) (se pkt. 
Table 1: Low Absolute Lymphocyte Count Low Absolute Lymphocyte Count (ALC) (see section 4.4)
Normalisering af endoskopisk udseende af slimhinden blev defineret som en Mayo-endoskopisk subscore på d. 
c. Normalization of endoscopic appearance of the mucosa was defined as a Mayo endoscopic subscore of 0.
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 
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
Opnåede statistisk signifikans globalt ved p≤ 0,05 iht. 
Achieved statistical significance globally at p≤ 0.05 per the pre-specified step-down testing procedure.
Måned 6 ORAL Standard: Patienter med utilstrækkeligt respons på MTX Tofacitinib 5 mg 2 gange dagligt + MTX 
Month 6 ORAL Standard: MTX Inadequate Responders Tofacitinib 5 mg twice daily + MTX
Laboratorieværdi (x109 celler/l) 
Lab Value (cells/mm3)
Abdominals merter Opkastning Diarré Kvalme Gastritis Dyspepsi 
Abdominal pain Vomiting Diarrhoea Nausea
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). 
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).
MTX N= 168 Gennemsnit (SD)a 
MTX N=168 Mean (SD)
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. 
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Måned 3 Måned 6 Måned 12 
Month 3 Month 6 Month 12
Placebo + MTX N= 139 Gennemsnit (SD)a 
Placebo + MTX N=139 Mean (SD)a
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 
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
Sådan skal du tage XELJANZ 
How to Take XELJANZ
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). 
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).
I det randomiserede 52-ugers fase 3-vedligeholdelsesstudie var andelen af patienter med infektioner 35,9 % (71 patienter) i gruppen med tofacitinib 5 mg to gange dagligt og 39,8 % (78 patienter) i gruppen med tofacitinib 10 mg to gange dagligt, sammenlignet med 24,2 % (48 patienter) i placebogruppen. 
In the randomised 52-week Phase 3 maintenance study, the proportion of patients with infections were 35.9% (71 patients) in the 5 mg twice daily and 39.8% (78 patients) in the 10 mg twice daily tofacitinib groups, compared to 24.2% (48 patients) in the placebo group.
ORAL Step: Patienter med utilstrækkeligt respons på TNF 
NA ORAL Step: TNF Inhibitor Inadequate Responders
• Uddannelsesmateriale til læger • Informationsmateriale til patienter 
• Physician educational material
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). 
5 mg twice daily demonstrated greater improvement (p≤ 0.05) from baseline in physical functioning compared to placebo at month 3 (see Table 13).
Almene symptomer og reaktioner på administrati onsstedet 
General disorders and administration site conditions
Det anbefales ikke at initiere behandling hos patienter med et absolut neutrofiltal (ANC) under 1,0x109 celler/l. 
It is recommended not to initiate dosing in patients with an absolute neutrophil count (ANC) less than 1,000 cells/mm3.
Udseende og pakningsstørrelser XELJANZ 5 mg filmovertrukne tabletter er hvide og runde. 
What XELJANZ looks like and contents of the pack XELJANZ 5 mg film-coated tablet is white and round in appearance.
dagligt i OCTAVE Open opnåede 53 % (154/293) patienter klinisk respons, og 14 % (42/293) patienter opnåede remission. 
After an additional 8 weeks of tofacitinib 10 mg twice daily in OCTAVE Open, 53% (154/293) patients achieved clinical response and 14% (42/293) patients achieved remission.
Det anbefales ikke at initiere behandling hos patienter med et absolut lymfocyttal (ALC) under 0,75x x109 celler/l. 
It is recommended not to initiate dosing in patients with an absolute lymphocyte count (ALC) less than 750 cells/mm3.
TNFi Patienter med utilstrækkeligt responsb 
TNFi Inadequate Respondersb
N Måned 3 
N Month 3
Bakteriel pneumoni Encephalitis Atypisk mykobakteriel infektion 
Encephalitis Atypical mycobacterial infection Cytomegalovirus infection Arthritis bacterial
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. 
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
Ikke relevant ORAL Start: MTX-naive 
NA ORAL Start: MTX-naïve
ORAL Strategy: Patienter med utilstrækkeligt respons på MTX 
ORAL Strategy: MTX Inadequate Responders
monoklonale antistoffer, IL-17 antagonister, IL-12/IL-23 antagonister, anti-integriner, selektive costimuleringsmodulatorer og potente immunsuppressiva såsom azathioprin, 6-mercaptopurin, ciclosporin og tacrolimus på grund af muligheden for øget immunsuppressionen og øget risiko for infektion. 
Tofacitinib has not been studied and its use should be avoided in combination with biologics such as TNF antagonists, interleukin (IL)-1R antagonists, IL-6R antagonists, anti-CD20 monoclonal antibodies, IL-17 antagonists, IL-12/IL-23 antagonists, anti-integrins, selective co-stimulation modulators and potent immunosuppressants such as azathioprine, 6-mercaptopurine, ciclosporine and tacrolimus because of the possibility of increased immunosuppression and increased risk of infection.
Forkortelser: BSA = legemsoverfladeareal, ΔLEI = ændring fra baseline i Leeds Enthesitis Index, ΔDSS = 
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%,
Kreatininclearance Dosisjustering 
Creatinine Clearance
Patienter, som fik 5 mg eller 10 mg tofacitinib 2 gange dagligt, oplevede signifikant større forbedringer fra baseline sammenlignet med placebogruppen inden for alle 8 områder samt i scorerne for fysisk helbred og psykisk helbred ved måned 3 i ORAL Solo, ORAL Scan og ORAL Step. 
Patients receiving either 5 or 10 mg tofacitinib twice daily experienced significantly greater improvement from baseline compared to placebo in all 8 domains as well as the Physical Component Summary and Mental Component Summary scores at month 3 in ORAL Solo, ORAL Scan and ORAL Step.
Patienter, der fik 5 mg eller 10 mg tofacitinib 2 gange dagligt, opnåede betydeligt større forbedringer fra baseline i begge skemaer sammenlignet med placebogruppen i ORAL Sync, ORAL Standard og ORAL Scan. 
Patients receiving tofacitinib 5 or 10 mg twice daily demonstrated significantly greater improvement from baseline in both scales compared to placebo in ORAL Sync, ORAL Standard and ORAL Scan.
ORAL Scan: Patienter med utilstrækkeligt respons på MTX 
NA ORAL Scan: MTX Inadequate Responders
Det anbefales ikke at initiere behandling med tofacitinib hos patienter med ANC under 1,0 x109 celler/l. 
It is not recommended to initiate tofacitinib treatment in patients with an ANC less than 1,000 cells/mm3.
Tofacitinib 5 mg 2 gange dagligt + DMARD(s) 
Tofacitinib 5 mg Twice Daily + DMARD(s)
Placebo + DMARD N= 158 
Placebo + DMARD(s) N=158
Bekræftet ALC til under 0,75 x109 celler/l var forbundet med en øget incidens af alvorlige infektioner 
Confirmed ALC less than 750 cells/mm3 were associated with an increased incidence of serious infections (see section 4.4).
ACR50 Måned 3 Måned 6 
ACR50 Month 3 Month 6
Tag ikke XELJANZ: - hvis du er allergisk over for tofacitinib eller et af de øvrige indholdsstoffer i XELJANZ (angivet i afsnit 6). 
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 - if you have been informed that you have severe liver problems, including cirrhosis (scarring of the liver) - if you are pregnant or breast-feeding
Patienter, der fik 5 mg eller 10 mg tofacitinib 2 gange dagligt, udviste en signifikant større forbedring i fysisk funktion sammenlignet med placebogruppen så tidligt som uge 2 i ORAL Solo og ORAL Sync. 
Tofacitinib 5 or 10 mg twice daily-treated patients demonstrated significantly greater improvement in physical functioning compared to placebo as early as week 2 in ORAL Solo and ORAL Sync.
Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du tager XELJANZ: - hvis du tror, du har en infektion eller har symptomer på en infektion såsom feber, svedtendens, kuldegysninger, muskelsmerter, hoste, åndenød, slimdannelse eller ændring i slim, vægttab, varm eller rød eller smertefuld hud eller sår på kroppen, synkebesvær eller smerter, når du synker, diarré eller mavesmerter, brændende fornemmelse, når du lader vandet, eller lader vandet hyppigere end normalt, udtalt træthed. 
Talk to your doctor or pharmacist before taking XELJANZ: - if you think you have an infection or have symptoms of an infection such as fever, sweating, chills, muscle aches, cough, shortness of breath, new phlegm or change in phlegm, weight loss, warm or red or painful skin or sores on your body, difficulty or pain when swallowing, diarrhoea or stomach pain, burning when you urinate or urinating more often than normal, feeling very tired - if you have any condition that increases your chance of infection (e.g., diabetes, HIV/AIDS, or a weak immune system) - if you have any kind of infection, are being treated for any infection, or if you have infections that keep coming back.
ACR20 Måned 3 Måned 6 Måned 12 
ACR20 Month 3 Month 6 Month 12
I kontrollerede kliniske fase 3-studier med tofacitinib-monoterapi var infektionsraten over 03 måneder 16,2 % (100 patienter) i gruppen med 5 mg 2 gange dagligt (i alt 616 patienter), 17,9 % (115 patienter) i gruppen med 10 mg 2 gange dagligt (i alt 642 patienter) og 18,9 % (23 patienter) i placebogruppen (i alt 122 patienter). 
In controlled Phase 3 clinical studies, the rates of infections over 0-3 months in the 5 mg twice daily (total 616 patients) and 10 mg twice daily (total 642 patients) tofacitinib monotherapy groups were 16.2% (100 patients) and 17.9% (115 patients), respectively, compared to 18.9% (23 patients) in the placebo group (total 122 patients).
Pneumoni Influenza Herpes zoster Urinvejsinfek -tion 
Pneumonia Influenza Herpes zoster Urinary tract infection Sinusitis Bronchitis Nasopharyngitis Pharyngitis
d. Opretholdt kortikosteroidfri remission blev defineret som værende i remission uden at tage kortikosterioider i mindst 4 uger før besøget i både uge 24 og 52. 
d. Sustained corticosteroid-free remission was defined as being in remission and not taking corticosteroids for at least
Tofacitinib 5 mg 2 gange dagligt + MTX Gennemsnitlig forskel fra placebob (CI) 
Tofacitinib 5 mg Twice Daily + MTX Mean Difference from Placebob (CI)
Neutrofiler Behandling med tofacitinib var forbundet med en øget incidens af neutropeni (under 2,0 x109 celler/l) 
Treatment with tofacitinib was associated with an increased incidence of neutropenia (less than 2,000 cells/mm3) compared to placebo.
Ikke almindelig ≥ 1/1.000 til 
≥1/1,000 to
Tofacitinib 5 mg To gange dagligt Tofacitinib 10 mg To gange dagligt Placebo 
Tofacitinib 5 mg Twice Daily Tofacitinib 10 mg Twice Daily Placebo
Opretholdelse af klinisk respons blev defineret ud fra en reduktion i induktionsstudiets (OCTAVE Induction 1, OCTAVE Induction 2) baseline Mayo-score på ≥ 3 point og ≥ 30 %, med en ledsagende reduktion i subscoren for rektal blødning på ≥ 1 point eller en subscore for rektal blødning på 0 eller 1. 
Induction 2) baseline Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or rectal bleeding subscore of 0 or 1.
= subkutant, TNFi = tumornekrosefaktorinhibitor; PASI=Psoriasis Area and Severity indeks, PASI75 = ≥ 75 % forbedring i PASI. 
Severity index; PASI75=≥ 75% improvement in PASI.
ACR70 Måned 3 Måned 6 
ACR70 Month 3 Month 6
Cmax 
AUC Cmax
Tofacitinib 10 mg To gange dagligt Placebo 
Tofacitinib 10 mg Twice Daily Placebo
Tofacitinib 10 mg 2 gange dagligt N= 368 Gennemsnit (SD)a 
Tofacitinib 10 mg Twice Daily N=368 Mean (SD)a
N=59 for placebo, N=65 for tofacitinib 5 mg to gange dagligt, N=55 for tofacitinib 10 mg to gange dagligt. 
4 weeks prior to the visit at both week 24 and week 52. f. N=59 for placebo, N=65 for tofacitinib 5 mg twice daily, N=55 for tofacitinib 10 mg twice daily.
Hver 5 mg filmovertrukken tablet indeholder tofacitinibcitrat, svarende til 5 mg tofacitinib. 
Each 5 mg film-coated tablet contains tofacitinib citrate, equivalent to 5 mg tofacitinib.
Samtidig administration af potente CYP3A4 
Coadministration of potent inducers of CYP3A4 with tofacitinib is not recommended.
Tofacitinib 5 mg 2 gange dagligt + MTX N= 277 Gennemsnit (SD)a 
Tofacitinib 5 mg Twice Daily + MTX N=277 Mean (SD)a
Hver 10 mg filmovertrukken tablet indeholder tofacitinibcitrat, svarende til 10 mg tofacitinib. 
Each 10 mg film-coated tablet contains tofacitinib citrate, equivalent to 10 mg tofacitinib.
Forhøjet blodkreatinin Forhøjet blodkolesterol Forhøjet lavdensitetslipoprotein 
Hepatic enzyme increased Transaminases increased Liver function test abnormal Gamma glutamyltransferase increased Blood creatinine increased Blood cholesterol increased Low density lipoprotein increased Weight increased
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL 5 MG BLISTERKORT 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 5 MG BLISTER PACK
Tofacitinib 10 mg To gange dagligt N=476 
Tofacitinib 10 mg Twice Daily N=476
Tofacitinib 5 mg 2 gange dagligt N=384 
Tofacitinib 5 mg Twice Daily N=384
Placebo Tofacitinib 5 mg 2 gange dagligt 
Placebo Tofacitinib 5 mg Twice Daily
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL 10 MG BLISTERKORT 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 10 MG BLISTER PACK
Tofacitinib 10 mg 2 gange dagligt + MTX N= 290 Gennemsnit (SD)a 
Tofacitinib 10 mg Twice Daily + MTX N=290 Mean (SD)a
ACR20 Måned 3 Måned 6 
ACR20 Month 3 Month 6