natgillin/translations-raw huggingface dataset:
Forbedring i søvn blev vurderet ved måned 3 i alle studierne ved hjælp af skemaerne Sleep Problems Index I og II fra studiet Medical Outcomes Study Sleep (MOS-Sleep).
Improvement in sleep was assessed using the Sleep Problems Index I and II summary scales of the Medical Outcomes Study Sleep (MOS-Sleep) measure at month 3 in all studies.
Behandlingssvigt blev defineret som en stigning i Mayo-scoren på ≥ 3 point fra vedligeholdelsesstudiets baseline, ledsaget af en stigning i subscoren for rektal blødning med ≥ 1 punkt og en stigning i den endoskopiske subscore på ≥ 1 point, hvilket giver en absolut endoskopisk subscore på ≥ 2 efter en minimumsbehandling på 8 uger i studiet.
Treatment failure was defined as an increase in Mayo score of ≥ 3 points from maintenance study baseline, accompanied by an increase in rectal bleeding subscore by ≥ 1 point, and an increase of endoscopic subscore of ≥ 1 point yielding an absolute endoscopic subscore of ≥ 2 after a minimum treatment of 8 weeks in the study.
CYP3A-hæmmer Ketoconazol
CYP3A Inhibitor Ketoconazole
Generelt var den sikkerhedsprofil, der blev observeret hos patienter med UC behandlet med tofacitinib, konsistent med sikkerhedsprofilen for tofacitinib ved RA-indikationen.
Overall, the safety profile observed in patients with UC treated with tofacitinib was consistent with the safety profile of tofacitinib in the RA indication.
Der er visse typer vaccine, du ikke må få, når du tager XELJANZ.
Certain types of vaccines should not be given when taking XELJANZ.
Efter yderligere 8 uger med XEJLANZ 10 mg to gange 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.
Der er rapporteret alvorlige og til tider dødelige infektioner forårsaget af bakterielle og mykobakterielle patogener, invasive svampepatogener, virale patogener eller andre opportunistiske patogener hos patienter, der får tofacitinib.
Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving tofacitinib.
Studie III (ORAL Standard
Study III (O RAL Standard)
Tabletterne findes som blisterkort med 14 tabletter.
The tablets are provided in blisters containing 14 tablets.
Da incidensen af infektioner generelt er højere hos ældre mennesker og hos diabetikere, skal der udvises forsigtighed ved behandling af ældre mennesker og diabetikere (se pkt.
As there is a higher incidence of infections in the elderly and in the diabetic populations in general, caution should be used when treating the elderly and patients with diabetes (see section 4.8).
HDPE-beholdere med silicagel som tørremiddel og børnesikker lukning i polypropylenindeholdende 60 eller 180 filmovertrukne tabletter.
HDPE bottles with silica gel desiccant and child-resistant polypropylene closure containing 60 or 180 film-coated tablets.
• Din læge kan beslutte at forlænge den indledende behandling på 10 mg to gange dagligt med yderligere 8 uger (16 uger i alt) efterfulgt af 5 mg to gange dagligt.
• Your doctor may decide to extend the initial 10 mg twice a day treatment by an additional 8 weeks (16 weeks in total), followed by 5 mg twice a day.
• Malignitet
• Malignancy
6 månede
6 months
Ikke almindelig ≥ 1/1.000 til
Uncommon ≥1/1,000 to
Hvis du tager XELJANZ og ammer, skal du holde op med at amme, indtil du har talt med lægen om at standse behandlingen med XELJANZ.
If you are taking XELJANZ and breast-feeding, you must stop breast-feeding until you talk to your doctor about stopping treatment with XELJANZ.
Hvis der er sket en reduktion i respons, kan det overvejes at genintroducere tofacitinib 10 mg to gange dagligt.
If there has been a loss of response, reinduction with tofacitinib 10 mg twice daily may be considered.
For patienter, der ikke opnår tilstrækkelig god terapeutisk effekt efter 8 uger, kan induktionsdosis på 10 mg to gange dagligt forlænges i yderligere 8 uger (16 uger i alt), efterfulgt af 5 mg to gange dagligt som vedligeholdelse.
For patients who do not achieve adequate therapeutic benefit by week 8, the induction dose of 10 mg twice daily can be extended for an additional 8 weeks (16 weeks total), followed by 5 mg twice daily for maintenance.
For tofacitinib 5 mg 2 gange dagligt plus MTX var der en lignende effekt på gennemsnitlig progression af strukturel skade (ikke statistisk signifikant).
When given at a dose of 5 mg twice daily, tofacitinib plus MTX exhibited similar effects on mean progression of structural damage (not statistically significant).
Administration af tofacitinib 11 mg depottabletter samtidigt med et fedtholdigt måltid medførte ingen ændringer i AUC, hvorimod Cmax blev øget med 27 %.
Coadministration of tofacitinib 11 mg prolonged-release tablet with a high-fat meal resulted in no changes in AUC while Cmax was increased by 27%.
Kriterierne for behandlingsafbrydelse og monitorering for lymfopeni diskuteres i pkt.
Discontinuation and monitoring criteria for lymphopenia are discussed in section 4.2.
Tofacitinib blev udskilt i mælken hos diegivende rotter ved koncentrationer, der var cirka 2 gange højere end serumkoncentrationerne 18 timer efter dosering.
Tofacitinib was secreted in milk of lactating rats at concentrations approximately 2-fold those in serum from 1 to 8 hours postdose.
XELJANZ indeholder lactose
XELJANZ contains lactose
Hos RA-patienter nedsatte samtidig administration af tofacitinib og MTX 15-25 mg ugentlig AUC og Cmax af MTX med henholdsvis 10 % og 13 %.
In RA patients, coadministration of tofacitinib with MTX 15-25 mg once weekly decreased the AUC and Cmax of MTX by 10% and 13%, respectively.
Tabel 1: Lavt absolut lymfocyttal Lavt absolut lymfocyttal (ALC) (se pkt.
Table 1: Low absolute lymphocyte count Low absolute lymphocyte count (ALC) (see section 4.4)
Kortikosteroidfri remission hos patienter, der tager kortikosteroider ved baseline a,g
Corticosteroid-free remission among patients taking corticosteroids at baselinea,g
NA ORAL Sync: Patienter med utilstrækkeligt respons på DMARD
NA ORAL Sync: DMARD inadequate responders
Studier
Studies
Tofacitinib er ikke en hæmmer eller inducer af CYPerne (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 og CYP3A4) og ikke en hæmmer af UGTerne (UGT1A1, UGT1A4, UGT1A6, UGT1A9 og UGT2B7).
Tofacitinib is not an inhibitor or inducer of CYPs (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) and is not an inhibitor of UGTs (UGT1A1, UGT1A4, UGT1A6, UGT1A9, and UGT2B7).
N=antal forsøgspersoner analyseret, ACR20/50/70=American College of Rheumatology ≥ 20, 50, 70 % forbedring; MTX=methotrexat.
QOW=every other week, N=number of subjects analysed, ACR20/50/70=American College of Rheumatology ≥20, 50, 70% improvement, NA=not applicable, MTX=methotrexate.
Tofacitinib blev udskilt i mælken hos diegivende rotter (se pkt.
Tofacitinib was secreted in the milk of lactating rats (see section 5.3).
Ved måned 12 havde 96 % og 98 % af de patienter, som fik hhv. Tofacitinib 5 mg 2 gange dagligt og adalimumab 40 mg subkutant hver anden uge, ingen radiografisk progression (mTSS-stigning fra baseline på mindre end eller lig med 0,5).
At month 12, 96% and 98% of patients receiving tofacitinib 5 mg twice daily, and adalimumab 40 mg subcutaneously every 2 weeks, respectively, did not have radiographic progression (mTSS increase from baseline less than or equal to 0.5).
Røntgen TNFi-IR Monotera pi, aktiv komparator (MTX), røntgen
TNFi-IR Monotherapy, Active comparator (MT X),
I et kontrolleret klinisk RA-studie returnerede det forhøjede LDL-kolesterol og ApoB til niveauet før behandling som respons på statinbehandling.
In an RA controlled clinical trial, elevations in LDL cholesterol and ApoB decreased to pretreatment levels in response to statin therapy.
Risikoen for NMSC kan være højere hos patienter, der behandles med tofacitinib 10 mg to gange dagligt end hos patienter, der behandles med 5 mg to gange dagligt.
The risk of NMSC may be higher in patients treated with tofacitinib 10 mg twice daily than in patients treated with 5 mg twice daily.
Vaccination med levende vacciner anbefales ikke under tofacitinib-behandling.
It is recommended that live vaccines not be given concurrently with tofacitinib.
Tabel 11: Gennemsnitlig ændring (LS) fra baseline i HAQ-DI ved 3 måneder Placebo + MTX
Table 11: LS mean change from baseline in HAQ-DI at month 3 Placebo + MTX
Du må ikke skifte mellem XELJANZ 5 mg filmovertrukne tabletter og XELJANZ 11 mg depottabletter, medmindre det sker efter lægens anvisninger.
You should not switch between the XELJANZ 5 mg film-coated tablet and the XELJANZ 11 mg prolonged-release tablet unless instructed by your doctor.
Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 118,88 mg lactose.
Excipient with known effect Each film-coated tablet contains 118.88 mg of lactose.
Slug XELJANZ 11 mg depottabletter hele for at sikre, at den samlede dosis indgives korrekt.
Swallow XELJANZ 11 mg prolonged-release tablets whole in order to ensure the entire dose is delivered correctly.
Der var ingen evidens for en sammenhæng mellem alvorlige eller opportunistiske infektioner eller herpes zoster og lymfocytundergruppe-tal (se pkt.
There was no evidence of a relationship between serious or opportunistic infections or herpes zoster and lymphocyte subset counts (see section 4.2 for absolute lymphocyte count monitoring).
Tofacitinib 5 mg tabletter kan knuses og indtages med vand.
Tofacitinib tablets may be crushed and taken with water.
Behandling med tofacitinib var forbundet med forhøjede lipidparametre, såsom total-kolesterol, LDLkolesterol og HDL-kolesterol.
Treatment with tofacitinib was associated with increases in lipid parameters such as total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol.
Efter 8 uger på tofacitinib 10 mg to gange dagligt i OCTAVE Open, blev remission opnået hos 35 % (20/58) patienter, der fik tofacitinib 5 mg to gange dagligt i OCTAVE Sustain og 40 % (40/99) patienter med dosisafbrydelse i OCTAVE Sustain.
After 8 weeks on tofacitinib 10 mg twice daily in OCTAVE Open, remission was achieved in 35% (20/58) patients who received tofacitinib 5 mg twice daily in OCTAVE Sustain and 40% (40/99) patients with dose interruption in OCTAVE Sustain.
I alle studier havde patienter, der blev behandlet med 5 mg eller 10 mg tofacitinib 2 gange dagligt, statistisk signifikante ACR20-, ACR50- og ACR70-responsrater ved måned 3 og måned 6 versus placebogruppen (eller versus MTX i ORAL Start).
In all studies, patients treated with either 5 mg or 10 mg twice daily tofacitinib had statistically significant ACR20, ACR50 and ACR70 response rates at month 3 and month 6 versus placebo (or versus MTX in ORAL Start) treated patients.
Malignitet og lymfoproliferative forstyrrelser
Malignancy and lymphoproliferative disorder
Bivirkningsfrekvensen var højere for kombinationen tofacitinib plus MTX end for tofacitinib som monoterapi i kliniske RA-studier.
There was a higher incidence of adverse events for the combination of tofacitinib with MTX versus tofacitinib as monotherapy in RA clinical studies.
Vedvarende kortikosteroidfri remission hos patienter i remission ved baseline
Sustained corticosteroidfree remission among patients in remission at baseline
o Kontaktinfo for lægen.
o Contact details of the prescriber
I løbet af studiet ORAL Strategy var respons på tofacitinib 5 mg to gange dagligt + MTX numerisk ens sammenlignet med adalimumab 40 mg + MTX og begge var numerisk højere end tofacitinib 5 mg to gange dagligt.
Over the course of ORAL Strategy, responses with tofacitinib 5 mg twice daily + MTX were numerically similar compared to adalimumab 40 mg + MTX and both were numerically higher than tofacitinib 5 mg twice daily.
Der er observeret viral reaktivering og tilfælde med reaktivering af herpes-virus (fx herpes zoster) i kliniske studier med tofacitinib.
Viral reactivation and cases of herpes virus reactivation (e.g., herpes zoster) were observed in clinical studies with tofacitinib.
Der blev observeret statistisk signifikante ACR20-responsrater med tofacitinib 5 mg 2 gange dagligt i begge studier så tidligt som i uge 2 (første vurdering efter baseline) sammenlignet med placebo.
Statistically significant ACR20 response rates were observed with tofacitinib 5 mg BID in both studies as early as week 2 (first post-baseline assessment) in comparison to placebo.
Måned 6: ACR50
Month 6: ACR50
Hver pakning indeholdende 56, 112 eller 182 filmovertrukne tabletter.
Each pack contains 56, 112, or 182 film-coated tablets.
Måned 6: mTSS ACR70
Month 6: mT SS ACR70
• Patientinformationspakken skal indeholde: o Indlægsseddel o Patientinformationskort
• The patient information pack should contain: o Patient information leaflet o The patient alert card
Ved baseline havde 80,7 % og 49,2 % af patienterne hhv. enthesitis og dactylitis.
80.7% and 49.2% of patients had enthesitis and dactylitis, respectively.
Tofacitinib 11 mg depottabletter indeholder sorbitol.
Tofacitinib 11 mg prolonged-release tablets contains sorbitol.
Hvid, rund tablet med en diameter på 7,9 mm, med “Pfizer” indgraveret på den ene side og “JKI 5” på den anden.
White, round tablet of 7.9 mm diameter, debossed “Pfizer” on one side and “JKI 5” on the other.
Samtidig administration af MTX 15-25 mg en gang om ugen påvirkede ikke tofacitinibs farmakokinetik hos RA-patienter (se figur 1).
Concomitant administration with MTX 15-25 mg once weekly had no effect on the PK of tofacitinib in RA patients (see Figure 1).
Blandt opportunistiske infektioner blev TB og andre mykobakterielle infektioner, kryptokokinfektion, histoplasmose, øsofageal candidiasis, multidermatomal herpes zoster, cytomegalovirus-infektion, BK-virus-infektioner og listeriose rapporteret for tofacitinib.
Among opportunistic infections, TB and other mycobacterial infections, cryptococcus, histoplasmosis, oesophageal candidiasis, multidermatomal herpes zoster, cytomegalovirus, BK virus infections and listeriosis were reported with tofacitinib.
Patienter, der fuldførte ét af induktionsstudierne (OCTAVE Induction 1 eller OCTAVE Induction 2), men ikke opnåede klinisk respons, eller patienter, der fuldførte eller udgik tidligt pga. behandlingssvigt i vedligeholdelsesstudiet (OCTAVE Sustain), var egnede til OCTAVE Open.
Patients who completed 1 of the induction studies (OCTAVE Induction 1 or OCTAVE Induction 2) but did not achieve clinical response or patients who completed or withdrew early due to treatment failure in the maintenance study (OCTAVE Sustain) were eligible for OCTAVE Open.
Der er rapporteret om lymfom og andre former for kræft (såsom lunge-, bryst- og prostatakræft, melanom og kræft i bugspytkirtlen) hos patienter, der blev behandlet med XELJANZ.
Lymphoma and other cancers (such as lung, breast, melanoma, prostate and pancreatic) have been reported in patients treated with XELJANZ.
N=59 for placebo, N=65 for tofacitinib 5 mg to gange dagligt, N=55 for tofacitinib 10 mg to gange dagligt.
N=59 for placebo, N=65 for tofacitinib 5 mg twice daily, N=55 for tofacitinib 10 mg twice daily.
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).
The HAQ-DI responder rate (response defined as having decrease from baseline of ≥ 0.35) at month 3 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).
Denne behandlingsforskel fra placebo var ens for både tofacitinib 5 mg to gange dagligt og tofacitinib 10 mg to gange dagligt i undergruppen af patienter uden tidligere svigt af TNF-hæmmer.
This treatment difference from placebo was similar between tofacitinib 5 mg twice daily and tofacitinib 10 mg twice daily in the subgroup of patients without prior TNF inhibitor failure.
Den anbefalede dosis er 10 mg, som indgives oralt to gange dagligt til induktion i 8 uger og 5 mg, som indgives to gange dagligt til vedligeholdelse.
The recommended dose is 10 mg given orally twice daily for induction for 8 weeks and 5 mg given twice daily for maintenance.
Mindste kvadraters gennemsnitlige ændring fra baseline i HAQ-DI Konventionel syntetisk DMARD Patienter med utilstrækkeligt respons a (TNFi naive)
Least squares mean change from baseline in HAQ-DI Conventional synthetic DMARD inadequate responders a
Lokal endoskopivurdering
Local endoscopy read
Det er vist, at tofacitinib er teratogent hos rotter og kaniner, og at det påvirker fødslen og den peri-/postnatale udvikling (se pkt.
Tofacitinib has been shown to be teratogenic in rats and rabbits, and to affect parturition and peri/postnatal development (see section 5.3).
DAS28-4(ESR)-respons
DAS28-4(ESR) response
HDPE-beholdere med 2 silicagel som tørremiddel og børnesikker lukning i polypropylen indeholdende 30 eller 90 depottabletter.
HDPE bottles with 2 silica gel desiccants and child-resistant, polypropylene closure containing 30 or 90 prolonged-release tablets.
Hvis du lider af leddegigt, kan din læge ændre dine tabletter fra XELJANZ 5 mg filmovertrukne tabletter to gange dagligt til XELJANZ 11 mg depottabletter én gang dagligt.
If you suffer from rheumatoid arthritis, your doctor may switch your tablets from XELJANZ 5 mg film-coated tablets twice daily to XELJANZ 11 mg prolonged-release tablets once daily.
I undergruppen af patienter med tidligere svigt af TNF-hæmmer var den observerede behandlingsforskel fra placebo numerisk større for tofacitinib 10 mg to gange dagligt i forhold til tofacitinib 5 mg to gange dagligt med 9,7 til 16,7 procentpoint på tværs af de primære og vigtige, sekundære effektmål.
In the subgroup of patients with prior TNF inhibitor failure, the observed treatment difference from placebo was numerically greater for tofacitinib 10 mg twice daily than tofacitinib 5 mg twice daily by 9.7 to 16.7 percentage points across the primary and key secondary endpoints.
Eksponeringen for tofacitinib nedsættes, når det administreres samtidigt med potente CYP-induktorer (f.eks. rifampicin).
Tofacitinib exposure is decreased when coadministered with potent CYP inducers (e.g., rifampicin).
• Vejledningen til sundhedsprofessionelle skal omfatte følgende nøgleinformationer: o Relevant information om sikkerhedsproblemer, som er omtalt i yderligere risikominimeringstiltag (aRMM) (fx alvorlighed, sværhedsgrad, frekvens, tid til indtræden, reversibilitet af den pågældende bivirkning) o Detaljer vedrørende den population, som har højere risiko for de sikkerhedsproblemer, der er omtalt i aRMM (fx kontraindikationer, risikofaktorer, øget risiko for interaktioner med visse lægemidler) o Detaljer om, hvordan sikkerhedsproblemerne i aRMM kan minimeres ved passende monitorering og håndtering (fx hvad man bør gøre, hvad man ikke bør gøre, og hvem der har størst sandsynlighed for at blive påvirket ved forskellige scenarier, for eksempel hvornår ordinering/indtagelse bør begrænses eller ophøre, hvordan lægemidlet skal tages, hvornår dosis bør øges/reduceres på baggrund af laboratorietal og symptomer) o Nøgleinformation, som skal gives ved rådgivning af patienten o Instruktioner i, hvordan bivirkninger håndteres o Information om BSRBR-, ARTIS-, RABBIT- og BIODABASER-registrene for RA og UC og vigtigheden af at bidrage til disse
• The Guide for healthcare professionals shall contain the following key elements: o Relevant information of the safety concerns addressed by the aRMM (e.g. seriousness, severity, frequency, time to onset, reversibility of the AE as applicable) o Details of the population at higher risk for the safety concern addressed by the aRMM (i.e. contraindications, risk factors, increased risk by interactions with certain medicine) o Details on how to minimise the safety concern addressed by the aRMM through appropriate monitoring and management (i.e. what to do, what not do, and who is most likely be impacted according to different scenarios, like when to limit or stop prescribing/ingestion, how to administer the medicine, when to increase/decrease the dosage according to laboratory measurements, signs and symptoms) o Key message to convey in patients counselling o Instructions on how to handle possible adverse events o Information about the BSRBR, ARTIS, RABBIT and BIODABASER and UC registries and the importance of contributing to these
Hvis du får kræft, mens du tager XELJANZ, vil din læge overveje, om behandlingen skal stoppes.
If you develop cancer while taking XELJANZ your doctor will review whether to stop XELJANZ treatment.
- Øvrige indholdstoffer: sorbitol (E420) (se afsnit 2), hydroxyethylcellulose, copovidon, magnesiumstearat, celluloseacetat, hydroxypropylcellulose (E463), hypromellose (E464), titandioxid (E171), triacetin (E1518), rød jernoxid (E172), shellak (E904), ammoniumhydroxid (E527), propylenglycol (E1520) og sort jernoxid (E172).
- The other ingredients are sorbitol (E420) (see section 2), hydroxyethyl cellulose, copovidone, magnesium stearate, cellulose acetate, hydroxypropyl cellulose (E463), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), red iron oxide (E172), shellac (E904), ammonium hydroxide (E527), propylene glycol (E1520) and black iron oxide (E172).
N=101 for placebo, N=101 for tofacitinib 5 mg to gange dagligt, N=87 for tofacitinib 10 mg to gange dagligt.
N=101 for placebo, N=101 for tofacitinib 5 mg twice daily, N=87 for tofacitinib 10 mg twice daily.
De co-primære effektmål var følgende: Gennemsnitlig ændring fra baseline i mTSS, procent forsøgspersoner, der opnåede ACR20- eller ACR70-respons, gennemsnitlig ændring fra baseline i HAQ-DI, procent forsøgspersoner, der opnåede DAS28-4(ESR) < 2,6 (remission).
Co-primary endpoints as follows: mean change from baseline in mTSS; percent of subjects achieving ACR20 or ACR70 responses; mean change from baseline in HAQ-DI; percent of subjects achieving a DAS28-4(ESR) <2.6 (remission).
HAQDI
HAQ-DI
* p<0,0001; **p<0,001; †p<0,05 for XELJANZ versus placebo.
* p<0.0001; **p<0.001; †p<0.05 for tofacitinib versus placebo.
OCTAVE Induction 2-studiet Central endoskopivurdering Lokal endoskopivurdering
OCTAVE induction study 2 Central endoscopy read
XELJANZ kan nedsætte kroppens evne til at reagere på infektioner og kan forværre en eksisterende infektion eller øge risikoen for at få en ny infektion.
XELJANZ can reduce your body's ability to respond to infections and may make an existing infection worse or increase the chance of getting a new infection - if you have or have a history of tuberculosis or have been in close contact with someone with tuberculosis.
Patienter, der opnåede klinisk respons i ét af induktionsstudierne (OCTAVE Induction 1 eller OCTAVE Induction 2) med tofacitinib 10 mg to gange dagligt, men oplevede behandlingssvigt efter, at deres dosis blev reduceret til tofacitinib 5 mg to gange dagligt eller efter behandlingsafbrydelse i OCTAVE Sustain (dvs. blev randomiseret til placebo), fik deres dosis øget til tofacitinib 10 mg to gange dagligt i OCTAVE Open.
Patients who achieved clinical response in 1 of the induction studies (OCTAVE Induction 1 or OCTAVE Induction 2) with tofacitinib 10 mg twice daily but experienced treatment failure after their dose was reduced to tofacitinib 5 mg twice daily or following treatment interruption in OCTAVE Sustain (i.e., were randomised to placebo), had their dose increased to tofacitinib 10 mg twice daily in OCTAVE Open.
Urosepsis Dissemineret TB
Urosepsis Disseminated TB Necrotizing fasciitis