natgillin/translations-raw huggingface dataset:
71,6 % af patienterne fik samtidig administreret MTX, 15,7 % af patienterne fik samtidig administreret sulfasalazin og 8,6 % af patienterne fik samtidig administreret leflunomid.
All patients were required to have 1 concomitant csDMARD; 71.6% of patients received concomitant MTX, 15.7% of patients received concomitant sulfasalazine, and 8.6% of patients received concomitant leflunomide.
XELJANZ bruges til at behandle en sygdom, som kaldes psoriasisgigt.
XELJANZ is used to treat a condition called psoriatic arthritis.
Der er observeret lymfomer hos patienter, som blev behandlet med tofacitinib.
Lymphomas have been observed in patients treated with tofacitinib.
En patient, der udvikler en ny infektion under behandling med tofacitinib, skal med det samme gennemgå en komplet diagnostisk udredning, der er passende for en immunkompromitteret patient.
A patient who develops a new infection during treatment with tofacitinib should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient, appropriate antimicrobial therapy should be initiated, and the patient should be closely monitored.
Den generelle incidens af infektioner med tofacitinib i langtidssikkerhedspopulationen ved alle niveauer af eksponering (i alt 4.867 patienter) var 46,1 patienter med hændelser pr. 100 patientår (henholdsvis 43,8 og 47,2 patienter med hændelser for 5 mg og 10 mg 2 gange dagligt).
The overall incidence rate of infections with tofacitinib in the long-term safety all exposure population (total 4,867 patients) was 46.1 patients with events per 100 patient-years (43.8 and 47.2 patients with events for 5 mg and 10 mg twice daily, respectively).
28 depottabletter 91 depottabletter
28 prolonged-release tablets 91 prolonged-release tablets
I ORAL Scan blev der givet 10 mg tofacitinib 2 gange dagligt plus baggrunds-MTX, hvilket resulterede i betydelig større hæmning af progression af strukturel skade sammenlignet med placebo plus MTX ved måned 6 og 12.
In ORAL Scan, tofacitinib 10 mg twice daily plus background MTX resulted in significantly greater inhibition of the progression of structural damage compared to placebo plus MTX at months 6 and 12.
TNFi-IR MTXnaive
(TNFi-naïve)
Det er blevet vist, at XELJANZ 11 mg depottabletter nedsætter smerte og hævelse i leddene og forbedrer evnen til at udføre daglige aktiviteter, når det tages alene eller sammen med methotrexat.
XELJANZ 11 mg prolonged-release tablets have been shown to reduce pain and swelling of the joints and improve the ability to perform daily activities, when given on its own or together with methotrexate.
Hæmoglobin skal monitoreres ved baseline, efter 4 til 8 ugers behandling og derefter hver 3. måned.
Haemoglobin should be monitored at baseline and after 4 to 8 weeks of treatment and every 3 months thereafter.
Forhøjet total- og LDLkolesterol i forbindelse tofacitinib-behandling kan reduceres til baseline-niveau med statinbehandling.
Increases in total and LDL cholesterol associated with tofacitinib may be decreased to pretreatment levels with statin therapy.
Behandling med tofacitinib har været associeret med et fald i hæmoglobinniveau.
Treatment with tofacitinib has been associated with decreases in haemoglobin levels.
• Den anbefalede dosis er 10 mg to gange dagligt i 8 uger, efterfulgt af 5 mg to gange dagligt.
• The recommended dose is 10 mg twice a day for 8 weeks, followed by 5 mg twice a day.
Blå, rund tablet med en diameter på 9,5 mm, med “Pfizer” indgraveret på den ene side og “JKI 10” på den anden.
Blue, round tablet of 9.5 mm diameter, debossed “Pfizer” on one side and “JKI 10” on the other.
Tofacitinib er ikke en hæmmer af MDR1, OATP1B1/1B3, OCT2, OAT1/3 eller MRP ved klinisk relevante koncentrationer.
Tofacitinib is not an inhibitor of MDR1, OATP1B1/1B3, OCT2, OAT1/3, or MRP at clinically meaningful concentrations.
Hvis skoldkopper i anamnesen ikke med sikkerhed kan bekræftes, anbefales det at teste for antistoffer mod VZV.
If the history of chickenpox is considered doubtful or unreliable it is recommended to test for antibodies against VZV.
Almindelig ≥ 1/100 til
Common ≥1/100 to <1/10
Tabletkerne mikrokrystallinsk cellulose lactosemonohydrat croscarmellosenatrium magnesiumstearat
Tablet core microcrystalline cellulose lactose monohydrate croscarmellose sodium magnesium stearate
Forskel mellem middelværdierne, fundet ved mindste kvadraters metode, for tofacitinib minus placebo (95% CI = 95% konfidensinterval)
Difference between least squares means tofacitinib minus placebo (95% CI = 95% confidence interval)
Tabel 5: Dosisjustering ved nedsat nyrefunktion Nedsat nyrefunktionkategori
Table 5: Dose adjustment for renal impairment Renal impairment category
Det skal du vide, før du begynder at tage XELJANZ
What you need to know before you take XELJANZ
Reumatoid artrit og psoriasisartrit
Rheumatoid arthritis and psoriatic arthritis
Samtidig administration af ketoconazol (potent CYP3A4-hæmmer), fluconazol (moderat CYP3A4- og potent CYP2C19-hæmmer), tacrolimus (svag CYP3A4-hæmmer) og ciclosporin (moderat CYP3A4hæmmer) øgede tofacitinibs AUC, mens rifampicin (potent CYP-induktor) nedsatte tofacitinibs AUC.
Coadministration with ketoconazole (strong CYP3A4 inhibitor), fluconazole (moderate CYP3A4 and potent CYP2C19 inhibitor), tacrolimus (mild CYP3A4 inhibitor) and ciclosporine (moderate CYP3A4 inhibitor) increased tofacitinib AUC, while rifampicin (potent CYP inducer) decreased tofacitinib AUC.
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.
Maintenance of clinical response was defined by a decrease from the induction study (OCTAVE Induction 1, OCTAVE 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.
Incidensraterne og typerne af alvorlige infektioner ved de kliniske UC-studier lignede generelt dem, der blev indberettet i kliniske RA-studier i behandlingsgrupperne med tofacitinib som monoterapi.
The incidence rates and types of serious infections in the UC clinical studies were generally similar to those reported in RA clinical studies with tofacitinib monotherapy treatment groups.
- hvis du har fået at vide, at du har alvorlige leverproblemer inklusive skrumpelever (cirrose,
- if you have been informed that you have severe liver problems, including cirrhosis (scarring of the liver) - if you are pregnant or breast-feeding
Blisterkort af aluminiumsfolie/aluminiumsfolie med PVC-bagside med 14 filmovertrukne tabletter.
Aluminium foil/PVC backed aluminium foil blisters containing 14 film-coated tablets.
Normalisering af endoskopisk udseende af slimhinden blev defineret som en Mayo-endoskopisk subscore på 0.
Normalisation of endoscopic appearance of the mucosa was defined as a Mayo endoscopic subscore of 0.
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).
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).
• Tofacitinib monoterapi
• Tofacitinib monotherapy
Abdominal smerter Opkastning Diarré Kvalme Gastritis Dyspepsi
Abdominal pain Vomiting Diarrhoea Nausea
Behandling med tofacitinib var forbundet med en øget incidens af lymfocytopeni sammenlignet med placebo.
Treatment with tofacitinib was associated with an increased incidence of lymphopenia compared to placebo.
Infektioner generelt
Overall infections
For patienter, der får tofacitinib 5 mg to gange dagligt, skal doseringen afbrydes.
For patients receiving tofacitinib 5 mg twice daily, dosing should be interrupted.
Sundhedsrelaterede og livskvalitetsresultater
Health-related and quality of life outcomes
Benigne Leydig-celletumorer hos rotter er ikke associeret med en risiko for Leydig celletumorer hos mennesker.
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.
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.
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).
Tofacitinib bør ikke anvendes hos patienter med alvorlig nedsat leverfunktion (se pkt.
Tofacitinib should not be used in patients with severe hepatic impairment (see section 4.3).
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.
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.
Dosisjustering er ikke nødvendig hos patienter ≥ 65 år.
No dose adjustment is required in patients aged 65 years and older.
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).
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).
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.
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.
XELJANZ bruges til at behandle voksne patienter med moderat til svær, aktiv leddegigt, en langvarig sygdom som hovedsagelig giver smerter og hævede led.
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.
Der er observeret NMSC hos patienter, der blev behandlet med tofacitinib.
NMSCs have been reported in patients treated with tofacitinib.
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
Generelt blev der set færre bivirkninger, når XELJANZ blev brugt alene til leddegigt.
In general, fewer side effects were seen when XELJANZ was used alone than in combination with methotrexate in rheumatoid arthritis.
Lipidovervågning
Lipid monitoring
Forbedring i fysisk funktion blev vurderet ved hjælp af HAQ-DI.
Physical function and health-related quality of life Improvement in physical functioning was measured by the HAQ-DI.
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.
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.
- Depottabletterne findes også i tabletbeholdere med silicagel som tørremiddel indeholdende 30
- The prolonged-release tablets are also available in bottles with silica gel desiccant containing
Obstruktion i mave-tarm-kanalen med en ikke-deformerbar depotformulering
Gastrointestinal obstruction with a non-deformable prolonged-release formulation
croscarmellosenatrium, magnesiumstearat, hypromellose (E464), titandioxid (E171),
croscarmellose sodium, magnesium stearate, hypromellose (E464), titanium dioxide (E171),
MTX N= 168 Gennemsnit (SD)
MTX N=168 Mean (SD)
I ORAL Scan blev de gennemsnitlige forbedringer i SF-36 opretholdt til måned 12 hos patienter, der fik tofacitinib.
In ORAL Scan, mean SF-36 improvements were maintained to 12 months in tofacitinib-treated patients.
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.
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.
Forskel mellem middelværdierne, fundet ved mindste kvadraters metode, for tofacitinib minus MTX (95% CI = 95% konfidensinterval)
Difference between least squares means tofacitinib minus MTX (95% CI = 95% confidence interval)
Af sikkerhedsmæssige årsager er tofacitinib kontraindiceret under graviditet (se pkt.
As a precautionary measure, the use of tofacitinib during pregnancy is contraindicated (see section 4.3).
Opnået statistisk signifikans globalt ved p≤ 0,05 iht.
Achieved statistical significance globally at p≤ 0.05 per the pre-specified step-down testing procedure.
Lymfocyttal under 0,75 x109 celler/l var forbundet med en øget incidens af alvorlige infektioner.
Lymphocyte counts less than 750 cells/mm3 were associated with an increased incidence of serious infections.
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.
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.
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.
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.
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.
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.
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.
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.
Trafik- og arbejdssikkerhed XELJANZ påvirker ikke eller kun i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
Driving and using machines XELJANZ has no or limited effect on your ability to drive or use machines.
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
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
Tabel 17: Andel af patienter, der opfylder effektmål ved uge 52 (OCTAVE Sustain) Central endoskopivurdering
Table 17: Proportion of patients meeting efficacy endpoints at week 52 (OCTAVE sustain) Central endoscopy read
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.
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.
Trykkeblæk shellak (E904) ammomiumhydroxid (E527) propylenglycol (E1520) sort jernoxid (E172)
Printing ink shellac (E904) ammomium hydroxide (E527) propylene glycol (E1520) black iron oxide (E172)
- hvis du har haft diverticulitis (en type betændelse i tyktarmen) eller mavesår eller sår i tarmene (se afsnit 4).
- 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.
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.
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.
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.
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.
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.
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.
Huller i mavesækken eller tarmene opstår oftest hos patienter, som også tager non-steroide antiinflammatoriske lægemidler (NSAID) eller kortikosteroider (f.eks. prednison).
Holes in stomach or intestines happen most often in people who also take nonsteroidal anti-inflammatory drugs or corticosteroids (e.g., prednisone).
XELJANZ kan også tages alene i de tilfælde, hvor behandling med methotrexat ikke tåles eller ikke tilrådes.
XELJANZ can also be taken on its own in those cases where methotrexate treatment is not tolerated or treatment with methotrexate is not advised.
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.
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.
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).
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).
Filmovertræk hypromellose 6cP (E464) titandioxid (E171) lactosemonohydrat macrogol 3350 triacetin (E1518)
Film coat hypromellose 6cP (E464) titanium dioxide (E171) lactose monohydrate macrogol 3350 triacetin (E1518)
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.
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.
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 %).
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%).
Lægen vil muligvis tage blodprøver og teste dig for hepatitis, før du påbegynder behandling med XELJANZ, og mens du tager XELJANZ.
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.
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.
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.
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.
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.