natgillin/translations-raw huggingface dataset:
c SELECT-EARLY, SELECT-NEXT, SELECT-COMPARE, SELECT-BEYOND d SELECT-MONOTHERAPY e SELECT-EARLY f SELECT-COMPARE g multiplicitetskontrolleret ≤ 0,001 upadacitinib vs. placebo eller MTX-sammenligning h nominel p ≤ 0,001 upadacitinib vs. placebo eller MTX-sammenligning i nominel p ≤ 0,01 upadacitinib vs. adalimumab-sammenligning 
c SELECT-EARLY, SELECT-NEXT, SELECT-COMPARE, SELECT-BEYOND d SELECT-MONOTHERAPY e SELECT-EARLY f SELECT-COMPARE g multiplicity controlled p≤0.001 upadacitinib vs placebo or MTX comparison h nominal p≤0.001 upadacitinib vs placebo or MTX comparison i nominal p≤0.01 upadacitinib vs adalimumab comparison
Der er rapporteret om NMSC hos patienter i behandling med upadacitinib. 
NMSCs have been reported in patients treated with upadacitinib.
Vigtige resultater 
Key outcome measures
AbbVie AB Sími: +46 (0)8 684 44 600 
AbbVie AB Tel: +46 (0)8 684 44 600
Multipakning: 84 depottabletter (3 pakker af 28) 
Multipack: 84 (3 packs of 28) prolonged-release tablets
• Risiko for MACE-hændelser o En tekst om den øgede risiko for MACE hos RA patienter og behovet for at overveje typiske CV-risikofaktorer (f.eks hypertension, hyperlipidæmi) ved behandling af RApatienter o En tekst om risikoen for MACE under behandling med upadacitinib o Tekst om risikoen for hyperlipidæmi under behandling med upadacitinib o Oplysninger om overvågning af lipidniveauer og håndtering af forhøjede lipidniveauer i henhold til kliniske retningslinjer 
• Risk of MACE o Language on the increased risk of MACE in RA patients and the need to consider typical CV risk factors (e.g., hypertension, hyperlipidaemia) when treating RA patients o Language on the risk of MACE during treatment with upadacitinib o Language on the risk of hyperlipidaemia during upadacitinib therapy o Details on monitoring of lipid levels and management of elevated lipid levels per clinical guidelines
RINVOQ fås i pakninger med 28 eller 98 depottabletter og i multipakninger med 84 depottabletter fordelt i 3 æsker, der hver indeholder 28 depottabletter. 
RINVOQ is available in packs containing 28 or 98 prolonged-release tablets and in multipacks of 84 comprising 3 cartons, each containing 28 prolonged-release tablets.
Dosisjustering er ikke nødvendigt hos patienter med let (Child Pugh A) eller moderat (Child Pugh B) nedsat leverfunktion (se pkt. 
No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment (see section 5.2).
• hvis du har en infektion (feber, svedtendens eller kulderystelser, åndenød, varmefølelse, rød eller øm hud eller sår på kroppen, træthed, hoste, brændende fornemmelse ved vandladning eller hyppigere vandladning end normalt, svær hovedpine med nakkestivhed), eller hvis du har haft en infektion, der bliver ved at komme tilbage. 
• you have an infection (fever, sweating, or chills, shortness of breath, warm, red, or painful skin or sores on your body, feeling tired, cough, burning sensation when you pass urine or passing urine more often than normal, severe headache with stiff neck), or if you have ever had an infection that keeps coming back - RINVOQ can reduce your body's ability to fight infections and so may worsen an infection that you already have, or make it more likely for you to get a new infection
Tlf.: +48 22 372 78 00 
Tel.: +48 22 372 78 00
Hvis du har glemt at tage RINVOQ 
If you forget to take RINVOQ
I kliniske studier er der rapporteret om virus-reaktivering, herunder tilfælde af herpesvirusreaktivering (f.eks. herpes zoster) (se pkt. 
Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), was reported in clinical studies (see section 4.8).
SELECT NEXT csDMARD-UR 
SELECT NEXT csDMARD-IR
Brug ikke lægemidlet efter den udløbsdato, der står på blisterpakningen etiketten og æsken efter EXP. Der er ingen særlige krav vedrørende opbevaringstemperaturer for dette lægemiddel. 
Do not use this medicine after the expiry date which is stated on the blister label and carton after ‘EXP'.
AbbVie GmbH Sími: +43 1 20589-0 
AbbVie GmbH Tel: +43 1 20589-0
RINVOQ fås i beholdere (med tørremiddel), der indeholder 30 depottabletter, idet en pakning enten indeholder 1 beholder (pakning med 30 tabletter) eller 3 beholdere (pakning med 90 tabletter). 
RINVOQ is available in bottles with desiccant containing 30 prolonged-release tablets, each pack contains 1 bottle (30 tablet pack) or 3 bottles (90 tablet pack).
Cmax for upadacitinib var den samme hos patienter med normal og nedsat nyrefunktion. 
Upadacitinib Cmax was similar in subjects with normal and impaired renal function.
• Lavt antal hvide blodlegemer (påvises i blodprøver) 
• low white blood cell counts shown in blood tests
AbbVie Limited Sími: +353 (0)1 4287900 
AbbVie Limited Tel: +353 (0)1 4287900
Cmax for upadacitinib var uændret hos patienter med let nedsat leverfunktion og 43 % højere hos patienter med moderat nedsat leverfunktion sammenholdt med patienter med normal leverfunktion. 
Upadacitinib Cmax was unchanged in subjects with mild hepatic impairment and 43% higher in subjects with moderate hepatic impairment compared to subjects with normal liver function.
RINVOQ 15 mg depottabletter upadacitinib 
RINVOQ 15 mg prolonged-release tablets upadacitinib
Upadacitinib bør anvendes med forsigtighed hos patienter, der er i kronisk behandling med stærke CYP3A4-hæmmere. 
Upadacitinib should be used with caution in patients receiving chronic treatment with strong CYP3A4 inhibitors.
Andre lægemidler, der kan påvirke upadacitinibs farmakokinetik 
Potential for other medicinal products to affect the pharmacokinetics of upadacitinib
• En generel introduktion med vigtige oplysninger, som sundhedspersonen kan benytte under drøftelsen med patienten ved ordinering af upadacitinib. 
• General introductory language that the HCP measure contains important information to assist the discussion with patients when prescribing upadacitinib.
• Lav sygdomsaktivitet (DAS28-CRP) 
• Low disease activity (DAS28-CRP)
Der er rapporteret om alvorlige infektioner, herunder tilfælde med dødelig udgang, hos patienter i behandling med upadacitinib. 
Serious and sometimes fatal infections have been reported in patients receiving upadacitinib.
Sådan åbner du folien 
How to puncture the foil
Samtidig administration af CYP3A4-inducere 
Coadministration with CYP3A4 inducers
Behandling bør ikke indledes hos patienter med et absolut lymfocyttal (ALC) på < 500 celler/mm3, et absolut neutrofiltal (ANC) på < 1.000 celler/mm3 eller et hæmoglobinniveau (Hb) på < 8 g/dl (se pkt. 
Treatment should not be initiated in patients with an absolute lymphocyte count (ALC) that is < 500 cells/mm3, an absolute neutrophil count (ANC) that is < 1,000 cells/mm3 or who have haemoglobin (Hb) levels that are < 8 g/dL (see sections 4.4 and 4.8).
Der foreligger kun begrænsede data om anvendelse af upadacitinib hos patienter med svært nedsat nyrefunktion (se pkt. 
There are limited data on the use of upadacitinib in subjects with severe renal impairment (see section 5.2).
Den samlede langsigtede forekomst af infektioner for de grupper, der fik upadacitinib 15 mg, i alle fem kliniske fase 3-studier (2.630 patienter), var 93,7 hændelser pr. 100 patientår. 
The overall long-term rate of infections for the upadacitinib 15 mg group across all five Phase 3 clinical studies (2,630 patients) was 93.7 events per 100 patient-years.
Hvis en patient udvikler en alvorlig infektion, bør behandlingen afbrydes, indtil infektionen er under kontrol. 
Treatment should be interrupted if a patient develops a serious infection until the infection is controlled.
I baggrundsbehandling med csDMARD's 
On background csDMARDs
bDMARD-URe 
bDMARD-IRe
Tabletkerne: 
Tablet contents:
AbbVie Ltd Sími: +44 (0)1628 561090 
AbbVie Ltd Tel: +44 (0)1628 561090
baseline frem til uge 36; ALC-værdien vendte gradvist tilbage til eller tæt på baseline-niveauet ved fortsat behandling. 
Treatment with upadacitinib was associated with a small, transient increase in mean ALC from baseline up to Week 36 which gradually returned to at or near baseline levels with continued treatment.
Vandfri kolloid silica Magnesiumstearat 
Silica, colloidal anhydrous Magnesium stearate
Tabel 2: Bivirkninger Systemorganklasse Meget almindelig 
Adverse reactions System Organ Class
Hvis der ses kliniske tegn på dyb venetrombose/lungeemboli, bør behandlingen med upadacitinib afbrydes, og patienten bør undersøges med det samme og have relevant behandling. 
If clinical features of DVT/PE occur, upadacitinib treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment.
• Oplysning om, hvordan digitale oplysninger til sundhedspersoner tilgås. 
• Instructions for how to access digital HCP information
Navn og adresse på de fremstillere, der er ansvarlige for batchfrigivelse AbbVie S.r.l. 
Name and address of the manufacturers responsible for batch release
Brug af anden medicin sammen med RINVOQ 
Other medicines and RINVOQ
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Indre æske med 49 tabletter (for 98 stk. pakningen) 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Inner carton of 49 tablets (for the 98 pack)
Upadacitinib er ikke undersøgt hos patienter med svært nedsat leverfunktion (Child-Pugh C). 
Upadacitinib was not studied in patients with severe (Child-Pugh C) hepatic impairment.
2), moderat nedsat nyrefunktion (estimeret glomerulær filtrationshastighed 60-89 ml/min/1,73 m glomerulær filtrationshastighed 30-59 ml/min/1,73 m2) og svært nedsat nyrefunktion (estimeret glomerulær filtrationshastighed 15-29 ml/min/1,73 m2), sammenholdt med patienter med normal nyrefunktion. 
Upadacitinib AUC was 18%, 33%, and 44% higher in subjects with mild (estimated glomerular filtration rate 60 to 89 mL/min/1.73 m2), moderate (estimated glomerular filtration rate 30 to 59 mL/min/1.73 m2), and severe (estimated glomerular filtration rate 15 to 29 mL/min/1.73 m2) renal impairment, respectively, compared to subjects with normal renal function.
KG Sími: 00800 222843 33 (gebührenfrei) Sími: +49 (0) 611 / 1720-0 
AbbVie Deutschland GmbH & Co. KG Tel: 00800 222843 33 (gebührenfrei) Tel: +49 (0) 611 / 1720-0
• hvis du har kræft, da lægen så skal vurdere, om du er egnet til at få RINVOQ på trods af din kræftsygdom 
• you have cancer - because your doctor will have to decide if you can still be given RINVOQ
98 depottabletter. 
98 prolonged-release tablets.
Du kan finde flere oplysninger om anvendelse af RINVOQ på www.rinvoq.eu 
QR code to be included For more information and support on taking RINVOQ go to www.rinvoq.eu
Den samlede langsigtede forekomst af alvorlige infektioner for de grupper, der fik upadacitinib 15 mg, i alle fem kliniske fase 3-studier, var 3,8 hændelser pr. 100 patientår. 
The overall long-term rate of serious infections for the upadacitinib 15 mg group across all five Phase 3 clinical studies was 3.8 events per 100 patient-years.
Hvis du holder op med at tage RINVOQ 
If you stop taking RINVOQ
Kontakt lægen eller apotekspersonalet, før du tager RINVOQ, eller mens du tager det: 
Talk to your doctor or pharmacist before and during treatment with RINVOQ if:
I et klinisk studie sås en stigning i Cmax og AUC for upadacitinib på hhv. 70 % og 75 % ved samtidig administration af upadacitinib og ketoconazol. 
In a clinical study, coadministration of upadacitinib with ketoconazole resulted in 70% and 75% increases in upadacitinib Cmax and AUC, respectively.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske med beholder(e) (30 og 90 tabletter) 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Bottle Carton (30 and 90 pack)
Upadacitinib bør anvendes med forsigtighed hos patienter med svært nedsat nyrefunktion. 
Upadacitinib should be used with caution in patients with severe renal impairment.
• Patientkortet skal indeholde følgende centrale punkter: o Kontaktoplysninger på den læge, der har ordineret upadacitinib o En tekst om, at patienterne altid skal have PK på sig, så de kan vise det til sundhedspersoner, som de behandles af (dvs. sundhedspersoner, der ikke har ordineret upadacitinib, sundhedspersoner på skadestuer osv.) o En beskrivelse af tegn/symptomer på infektioner, som patienterne skal være opmærksomme på, så de om nødvendigt kan kontakte egen læge: 
• The patient alert card shall contain the following key messages: o Contact details of the upadacitinib prescriber o Language that the PAC should be carried by the patient at any time and to share it with HCPs involved in their care (i.e., non-upadacitinib prescribers, emergency room HCPs, etc.) o Description of signs/symptoms of infections the patient needs to be aware of, so that they can seek attention from their HCP:
Der er også rapporteret om opportunistiske infektioner ved anvendelse af upadacitinib, herunder tuberkulose, herpes zoster i flere dermatomer, oral/øsofageal candidiasis og cryptokokkose. 
Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, oral/oesophageal candidiasis, and cryptococcosis were reported with upadacitinib.
Sådan skal du tage RINVOQ 4. 
How to store RINVOQ 6.
(DAS28-CRP) i uge 24 
(DAS28-CRP) at week 24
(DAS28-CRP) i uge 14 
(DAS28-CRP) at week 14
Tabel 3: Oversigt over kliniske studier Studietitel 
Table 3: Clinical trials summary Study name Population (n) Treatment arms
• Forhøjet kolesterol (en type fedtstof i blodet (påvises i blodprøver)) 
• increased levels of cholesterol (a type of fat in the blood) as shown in tests
• Forhøjede triglycerider (en type fedtstof i blodet (påvises i blodprøver)) 
• increased levels of triglycerides (a type of fat in the blood) as shown in tests
ACR20 (%-del af patienterne) 
ACR20 (% of patients)
(DAS28-CRP) i uge 12 
(DAS28-CRP) at week 12
≥ 50 % eller ≥ 70 %); ADA = adalimumab; CDAI = klinisk sygdomsaktivitetsindeks; CR = klinisk remission; CRP = C-reaktivt protein, DAS28 = sygdomsaktivitetsscore for 28 led; UR = tilstrækkelige respondere; LDA = lav sygdomsaktivitet; MTX = methotrexat; PBO = placebo; UPA= upadacitinib a SELECT-NEXT, SELECT-EARLY, SELECT-COMPARE, SELECT-BEYOND b SELECT-MONOTHERAPY c SELECT-EARLY d SELECT-COMPARE e multiplicitetskontrolleret p ≤ 0,001 upadacitinib vs. placebo eller MTX-sammenligning f multiplicitetskontrolleret p ≤ 0,01 upadacitinib vs. placebo eller MTX-sammenligning g nominel p ≤ 0,001 upadacitinib vs. placebo eller MTX-sammenligning h nominel p ≤ 0,001 upadacitinib vs. adalimumab-sammenligning i nominel p ≤ 0,01 upadacitinib vs. adalimumab-sammenligning j nominal p ≤ 0,05 upadacitinib vs. adalimumab-sammenligning k nominel p ≤ 0,01 upadacitinib vs. placebo eller MTX-sammenligning l nominal p<0,05 upadacitinib vs. MTX sammenligning Note: Uge 48-data afledt fra analyse på FAS (Fulde analysesæt) af randomiseret gruppe ved anvendelse af Non-Responder Imputation 
improvement; ADA = adalimumab; CDAI = Clinical Disease Activity Index; CR = Clinical Remission; CRP = C-Reactive Protein, DAS28 = Disease Activity Score 28 joints; IR = inadequate responder; LDA = Low Disease Activity; MTX = methotrexate; PBO = placebo; UPA= upadacitinib a SELECT-NEXT, SELECT-EARLY, SELECT-COMPARE, SELECT-BEYOND b SELECT-MONOTHERAPY c SELECT-EARLY d SELECT-COMPARE e multiplicity controlled p≤0.001upadacitinib vs placebo or MTX comparison f multiplicity controlled p≤0.01 upadacitinib vs placebo or MTX comparison g nominal p≤0.001 upadacitinib vs placebo or MTX comparison h nominal p≤0.001upadacitinib vs adalimumab comparison i nominal p≤0.01 upadacitinib vs adalimumab comparison j nominal p<0.05 upadacitinib vs adalimumab comparison k nominal p≤0.01 upadacitinib vs placebo or MTX comparison l nominal p<0.05 upadacitinib vs MTX comparison
Infektioner i de øvre luftveje* 
Upper respiratory tract infections (URTI)*
I alle fase 3-studierne var virkningen ved upadacitinib 15 mg én gang dagligt generelt sammenlignelig med virkningen ved upadacitinib 30 mg én gang dagligt. 
Across the Phase 3 studies, the efficacy seen with upadacitinib 15 mg QD was generally similar to that observed with upadacitinib 30 mg QD.
Der er rapporteret om tilfælde af dyb venetrombose og lungeemboli hos patienter i behandling med JAK-hæmmere, herunder upadacitinib. 
Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving JAK inhibitors including upadacitinib.
I MTX-kontrollerede studier sås forhøjede ALAT- og ASAT-værdier på ≥ 3 x ULN over op til 12/14 uger i mindst én måling hos hhv. 0,8 % og 0,4 % af de patienter, der fik upadacitinib 15 mg, sammenholdt med hhv. 1,9 % og 0,9 % af de patienter, der fik MTX. 
In MTX-controlled studies, for up to 12/14 weeks, ALT and AST elevations ≥ 3 x ULN in at least one measurement were observed in 0.8% and 0.4% of patients treated with upadacitinib 15 mg, compared to 1.9% and 0.9%, respectively, of patients treated with MTX.
Afbrydelse af behandlingen 
Dose interruption
Behandlingen bør ikke påbegyndes eller bør afbrydes midlertidigt hos patienter, hvor der ved den rutinemæssige patientbehandling ses et ANC på < 1 x 109 celler/l, et ALC på < 0,5 x 109 celler/l eller et hæmoglobinniveau på < 8 g/dl (se pkt. 
Treatment should not be initiated, or should be temporarily interrupted, in patients with an ANC < 1 x 109 cells/L, ALC < 0.5 x 109 cells/L or haemoglobin < 8 g/dL observed during routine patient management (see section 4.2).
Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 patienter) 
Uncommon (may affect up to 1 in 100 people)
• Forhøjede leverenzymer (påvises i blodprøver (tegn på leverproblemer)) 
• increased levels of liver enzymes, shown by blood tests (sign of liver problems)
MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Beholder etiket 
PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING Bottle Label
ACR70 (%-del af patienterne) 
ACR70 (% of patients)
Hver depottablet indeholder 15 mg upadacitinib (som upadacitinibhemihydrat). 
Each prolonged-release tablet contains 15 mg of upadacitinib (as upadacitinib hemihydrate).
• Patientkort (PK) 
• Patient Alert Card (PAC)
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre æske til multipakning med 84 tabletter (med blue box) 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for 84 tablet multipack (with Blue Box)
• En advarsel til patienter og sundhedspersoner om risikoen ved levende vacciner, hvis de gives under behandling med upadacitinib o Beskrivelse af udvalgte risici for at gøre patienter og sundhedspersoner opmærksomme på væsentlige bivirkninger, herunder: 
• Language to advise patients and their HCPs about the risk of live vaccinations when given during upadacitinib therapy o Description of targeted risks for awareness by the patient and for HCPs involved in their care including:
Den samlede langsigtede forekomst af opportunistiske infektioner for de grupper, der fik upadacitinib 15 mg, i alle fem kliniske fase 3studier, var 0,6 hændelser pr. 100 patientår. 
The overall longterm rate of opportunistic infections for the upadacitinib 15 mg group across all five Phase 3 clinical studies was 0.6 events per 100 patient-years.
49 depottabletter. 
49 prolonged-release tablets.
RINVOQ 15 mg depottabletter 
RINVOQ 15 mg prolonged-release tablets
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Blister karton (én blisterpakning) 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Blister Carton (Individual carton)
FACIT-F-score (Functional Assessment of Chronic Illness Therapy-Fatigue), sammenholdt med placebo. 
Moreover, upadacitinib treated patients reported significant improvements in fatigue, as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue score (FACIT-F) compared to placebo.
Tryk skæret nedad, så der kommer hul på folien, og før det rundt langs hele foliekanten. 
Push down to make a hole in the foil and move the cutting tool round the edge of the foil to continue cutting the foil.
I baggrundsbehandling med MTX 
On background MTX
28 depottabletter 
28 prolonged-release tablets
Lilla, aflange, bikonvekse depottabletter på 14 x 8 mm og præget med "a15" på den ene side. 
Purple 14 x 8 mm, oblong biconvex prolonged-release tablets imprinted on one side with ‘a15'.
I kliniske studier sås et absolut neutrofiltal (ANC) på < 1 x 109 celler/l, et absolut lymfocyttal (ALC) på < 0,5 x 109 celler/l og et hæmoglobinniveau på < 8 g/dl hos ≤ 1 % af patienterne (se pkt. 
Absolute Neutrophil Count (ANC) < 1 x 109 cells/L, Absolute Lymphocyte Count (ALC) < 0.5 x 109 cells/L and haemoglobin < 8 g/dL were reported in ≤1 % of patients in clinical trials (see section 4.8).
Forkortelser: ACR20 (eller 50) = forbedring iht. 
Abbreviations: ACR20 (or 50) = American College of Rheumatology ≥20% (or ≥50%) improvement;
SF-36-scoren (Short Form (36) Health Survey Physical Component) sammenlignet med placebo og MTX. 
In the clinical studies, upadacitinib treated patients reported significant improvements in patientreported quality of life, as measured by the Short Form (36) Health Survey (SF-36) Physical Component Score compared to placebo and MTX.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Indre æske (i multipakning) med 84 tabletter (uden blue box) 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Intermediate carton of 84 tablet multipack (without Blue Box)
28 depottabletter. 
28 prolonged-release tablets.
ACR50 (%-del af patienterne) 
ACR50 (% of patients)
• medicin til behandling af krampeanfald (f.eks. phenytoin) 
• medicines to treat seizures or fits (such as phenytoin)
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre æske med 98 tabletter 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton of 98 tablets
Upadacitinib bør ikke anvendes hos patienter med svært nedsat leverfunktion (Child Pugh C) (se pkt. 
Upadacitinib should not be used in patients with severe (Child Pugh C) hepatic impairment (see section 4.3).
• Forhøjet niveau af enzymet kreatinkinase (påvises i blodprøver) 
• increase in an enzyme called creatine kinase, shown by blood tests
Behandling med upadacitinib 15 mg, alene eller i kombination med csDMARD's, gav en signifikant større forbedring af fysisk funktionsevne sammenholdt med alle komparatorer iht. 
Physical function response and health-related outcomes Treatment with upadacitinib 15 mg, alone or in combination with csDMARDs, resulted in a significantly greater improvement in physical function compared to all comparators as measured by HAQ-DI (see Table 6).
I placebo-kontrollerede studier, hvor patienterne fik baggrundsbehandling med DMARD's, sås forhøjet alaninaminotransferase (ALAT) og forhøjet aspartataminotransferase (ASAT) på ≥ 3 x ULN (øvre normalgrænse) over op til 12/14 uger i mindst én måling hos hhv. 2,1 % og 1,5 % af de patienter, der fik upadacitinib 15 mg, sammenholdt med hhv. 1,5 % og 0,7 % af de patienter, der fik placebo. 
In placebo-controlled studies with background DMARDs, for up to 12/14 weeks, alanine transaminase (ALT) and aspartate transaminase (AST) elevations ≥ 3 x upper limit of normal (ULN) in at least one measurement were observed in 2.1% and 1.5% of patients treated with upadacitinib 15 mg, compared to 1.5% and 0.7%, respectively, of patients treated with placebo.
Der blev rapporteret om forhøjet kreatininfosfokinase > 5 x ULN (øvre normalgrænse) efter 12/14 uger hos 1,0 % og 0,3 % af patienterne i hhv. upadacitinib 15 mg-gruppen og placebo-gruppen. 
CPK elevations > 5 x upper limit of normal (ULN) were reported in 1.0% and 0.3% of patients over 12/14 weeks in the upadacitinib 15 mg and placebo groups, respectively.
Upadacitinib bør anvendes med forsigtighed hos patienter med høj risiko for dyb venetrombose/lungeemboli. 
Upadacitinib should be used with caution in patients at high risk for DVT/PE.
Tabletterne må ikke tygges, knuses eller deles. 
Do not chew, crush or break the tablet.
Forkortelser: ACR20 (eller 50 eller 70) = forbedring iht. 
47h Abbreviations: ACR20 (or 50 or 70) = American College of Rheumatology ≥20% (or ≥50% or ≥70%)
baseline allerede i uge 1; den nedsatte hsCRP-værdi forblev på det lave niveau ved fortsat behandling. 
Treatment with upadacitinib was associated with decreases from baseline in mean hsCRP levels as early as Week 1 which were maintained with continued treatment.
• Triglycerider ≥ 2,26 mmol/l (200 mg/dl): 25 % vs. 15 % hos hhv. upadacitinib 15 mg-gruppen og placebo-gruppen 
• Triglycerides ≥ 2.26 mmol/L (200 mg/dL): 25% vs. 15%, in the upadacitinib 15 mg and placebo groups, respectively