natgillin/translations-raw huggingface dataset:
RA-studie I evaluerede 271 patienter, der var ≥ 18 år, med moderat til alvorlig aktiv reumatoid artrit, hvor behandling var mislykket med mindst ét sygdomsmodificerende antireumatisk lægemiddel, hvor methotrexat i doser på 12,5 til 25 mg (10 mg ved methotrexat-intolerans) hver uge havde haft utilstrækkelig virkning, og hvor methotrexat-dosen forblev konstant på 10 til 25 mg hver uge. 
RA study I evaluated 271 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, had failed therapy with at least one disease-modifying, anti rheumatic drug and had insufficient efficacy with methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexate-intolerant) every week and whose methotrexate dose remained constant at 10 to 25 mg every week.
Hyppigheden (95 % konfidensinterval) af ikkemelanom hudkræft var 8,8 (6,0-13,0) pr. 1.000 patientår blandt adalimumab-behandlede patienter og 3,2 (1,3-7,6) pr. 1.000 patientår blandt kontrolpatienterne. 
The rate (95 % confidence interval) of non-melanoma skin cancers was 8.8 (6.0, 13.0) per 1,000 patient-years among adalimumab-treated patients and 3.2 (1.3, 7.6) per 1,000 patient-years among control patients.
Den forbedrede fysiske funktion fortsatte i den åbne forlængelse frem til 
Improved physical function continued during the open label extension up to week 136.
ACR-respons i placebokontrollerede psoriasisartrit-studier (Procentdel af 
ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients)
I RA-studie V var forbedringen i HAQ funktionsevneindeks og den fysiske komponent fra SF 36 større (p < 0,001) for adalimumab/methotrexat-kombinationsterapi end for methotrexat-monoterapi og adalimumab-monoterapi efter 52 uger. 
In RA study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p < 0.001) for adalimumab/methotrexate combination therapy versus methotrexate monotherapy and adalimumab monotherapy at week 52, which was maintained through week 104.
Resultaterne i uge 12 viste statististisk signifikante forbedringer på tegn og symptomer på aktiv nr-axSpA hos patienter i behandling med adalimumab sammenlignet med placebo (tabel 14). 
week 12 results showed statistically significant improvement of the signs and symptoms of active nr-axSpA in patients treated with adalimumab compared to placebo (Table 14).
Patienter, der udviste pædiatrisk ACR 30-respons ved uge 16, var egnede til randomisering i den dobbeltblindede fase og fik enten adalimumab 24 mg/m2 op til maksimalt 40 mg eller placebo hver anden uge i yderligere 32 uger eller indtil opblussen af sygdommen. 
Patients demonstrating a Paediatric ACR 30 response at week 16 were eligible to be randomised into the double blind (DB) phase and received either adalimumab 24 mg/m² up to a maximum of 40 mg, or placebo every other week for an additional 32 weeks or until disease flare.
Den ordinerende læge bør være opmærksom på risikoen for falsk negative resultater af tuberkulinhudtest, særligt hos patienter, der er alvorligt syge eller immunkompromitterede. 
It is recommended that the conduct and results of these tests are recorded in the patient alert card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Cyltezo-dosis til patienter med polyartikulær juvenil idiopatisk artrit 
Cyltezo dose for patients with polyarticular juvenile idiopathic arthritis
I den åbne indkøringsfase fik alle patienter 24 mg/m2 op til maksimalt 40 mg adalimumab hver anden uge i 16 uger. 
In the OL LI phase all patients received 24 mg/m² up to a maximum of 40 mg adalimumab every other week for 16 weeks.
Forbedring af tegn og symptomer blev opretholdt med adalimumab-behandling i den åbne 
In the open-label extension, improvement in the signs and symptoms was maintained with adalimumab
I en analyse af non-respondenter, defineret som patienter, som udgik af studiet på grund af bivirkninger eller manglende virkning, eller hvor dosis blev trappet op var PASI 75- og PGA clear/minimal responserater henholdvis 69,6 % og 55,7 % efter yderligere 108 ugers åben-behandling (i alt 160 uger). 
In an analysis in which all patients who dropped out of the study for adverse events or lack of efficacy, or who dose-escalated, were considered non-responders, PASI 75 and PGA of clear or minimal response rates in these patients were 69.6 % and 55.7 %, respectively, after an additional 108 weeks of open-label therapy (total of 160 weeks).
Ca. dobbelt så mange patienter i placebogruppen som i adalimumabgruppen oplevede forværring af abscesser (henholdvis 23,0 % vs 11,4 %) og suppurerende fistler (henholdvis 30,0 % vs 13,9 %) i de første 12 uger af HS-studie I og II. 
Approximately twice the proportion of patients in the placebo group in the first 12 weeks of Studies HS-I and HS-II, compared with those in the adalimumab group experienced worsening of abscesses (23.0 % vs 11.4 %, respectively) and draining fistulas (30.0 % vs 13.9 %, respectively).
Patientkortet skal indeholde de følgende vigtige oplysninger: 
The patient alert card shall contain the following key messages:
Dine symptomer kan komme igen efter behandlingen stopper. 
Your symptoms may return upon
• Brug ikke den 40 mg fyldte pen, hvis der anbefales andre doser end 40 mg Brug af anden medicin sammen med Cyltezo 
• Do not use the 40 mg pre-filled pen, if doses other than 40 mg are recommended.
I studie nr-axSpA I blev adalimumab 40 mg hver anden uge er vurderet hos 185 patienter i et randomiseret, 12 ugers dobbeltblindet, placebokontrolleret studie hos patienter med aktiv nr-axSpA (gennemsnitlig baseline score for sygdomsaktivitet [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] var 6,4 for patienter i behandling med adalimumab og 6,5 for patienter i placeboarmen), som havde haft utilstrækkeligt respons på eller var intolerante over for ≥ 1 NSAID eller havde 
In Study nr-axSpA I, adalimumab 40 mg every other week was assessed in 185 patients in a randomised, 12 week double-blind, placebo-controlled study in patients with active nr-axSpA (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.4 for patients treated with adalimumab and 6.5 for those on placebo) who have had an inadequate response to or intolerance to ≥ 1 NSAIDs, or a contraindication for NSAIDs.
, arytmi, kongestiv hjertesvigt 
Myocardial infarction arrhythmia, congestive heart failure
Blandt disse havde 154 patienter (90,6 %) ACR 20-respons, 127 patienter (74,7 %) ACR 50-respons og 102 patienter (60,0 %) ACR 70-respons. 
Among those, 154 patients (90.6 %) had ACR 20 responses; 127 patients (74.7 %) had ACR 50 responses; and 102 patients (60.0 %) had ACR 70 responses.
Kombination af Cyltezo og anakinra anbefales ikke (se pkt. 
The combination of Cyltezo and anakinra is not recommended (see section 4.4 “Concurrent administration of
Hvis disse lægemidler ikke virker godt nok, vil du blive tilbudt Cyltezo til reduktion af sygdomstegn og symptomer på din Crohns sygdom. 
If these medicines do not work well enough, you will be given Cyltezo to reduce the signs and symptoms of your Crohn's disease.
Adalimumabs virkning er undersøgt i et randomiseret, dobbeltblindet kontrolleret studie med 114 pædiatriske patienter fra 4 år med svær kronisk plaque-psoriasis (defineret ved PGA (physician global assessment) ≥ 4 eller > 20% BSA (body surface area)-involvering eller > 10 % BSA-involvering med meget tykke læsioner eller PASI (psoriasis area and severity index) ≥ 20 eller ≥ 10 med klinisk relevante manifestioner i ansigt, på kønsorganer eller hånd/fod), som ikke havde opnået tilstrækkelig kontrol med topikal behandling og helioterapi eller lysbehandling. 
The efficacy of adalimumab was assessed in a randomised, double-blind, controlled study of 114 paediatric patients from 4 years of age with severe chronic plaque psoriasis (as defined by a PGA ≥ 4 or > 20 % BSA involvement or > 10 % BSA involvement with very thick lesions or PASI ≥ 20 or ≥ 10 with clinically relevant facial, genital, or hand/ foot involvement) who were inadequately controlled with topical therapy
Cyltezo kan nedsætte hastigheden for ødelæggelse af brusk og knogler i leddene forårsaget af sygdommen og forbedre de fysiske funktioner. 
Cyltezo can slow down the damage to the cartilage and bone of the joints caused by the disease and improve physical function.
Det anbefales, at fordelen og risikoen ved fortsat langvarig behandling vurderes årligt (se pkt. 
It is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly
Hvis du holder op med at bruge Cyltezo 
How to use Cyltezo
De hyppigst rapporterede bivirkninger er infektioner (såsom nasopharyngitis, øvre luftvejsinfektioner og sinuitis), reaktioner på injektionsstedet (erytem, kløe, blødning, smerter eller hævelse), hovedpine 
The most commonly reported adverse reactions are infections (such as nasopharyngitis, upper respiratory tract infection and sinusitis), injection site reactions (erythema, itching, haemorrhage, pain or swelling),
Efter subkutan administration af 40 mg adalimumab hver anden uge hos voksne patienter med rheumatoid artrit (RA) var middel steady state-koncentrationerne på henholdsvis cirka 5 µg/ml (uden kombination med methotrexat) og 8-9 µg/ml (i kombination med methotrexat). 
Following subcutaneous administration of 40 mg of adalimumab every other week in adult rheumatoid arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 μg/mL (without concomitant methotrexate) and 8 to 9 μg/mL (with concomitant methotrexate), respectively.
Samtidig behandling med azathioprin/6-mercaptopurin I studier hos voksne med Crohns sygdom blev der set en højere forekomst af maligne og alvorlige infektionsrelaterede bivirkninger ved kombination af adalimumab og azathioprin/6-mercaptopurin end med adalimumab alene. 
In adult Crohn's disease studies, higher incidences of malignant and serious infection-related adverse events were seen with the combination of adalimumab and azathioprine/6-mercaptopurine compared with
Hjælpestoffer: natriumacetattrihydrat, koncentreret eddikesyre, trehalosedihydrat, polysorbat 80 og vand til injektionsvæsker. 
Excipients: sodium acetate trihydrate, glacial acetic acid, trehalose dihydrate, polysorbate 80 and water for injections.
Fortsat behandling med Cyltezo anbefales ikke til patienter, der ikke responderer inden for denne tidsperiode. 
Cyltezo therapy should not be continued in patients failing to respond within this time period.
Der foreligger ingen data vedrørende den sekundære overførsel af infektion med levende vacciner hos patienter, der modtager adalimumab. 
No data are available on the secondary transmission of infection by live vaccines in
*** p < 0,001 for alle sammenligninger mellem adalimumab og placebo * p < 0,05 for alle sammenligninger mellem adalimumab og placebo 
*** p < 0.001 for all comparisons between adalimumab and placebo * p < 0.05 for all comparisons between adalimumab and placebo
Cyltezo bruges til at behandle ankyloserende spondylitis og aksial spondyloartritis uden radiografiske tegn på ankyloserende spondylitis hos voksne. 
Cyltezo is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults.
Efter behandling med adalimumab blev der også observeret et hurtigt fald i CRP-niveau hos patienter med polyartikulær juvenil idiopatisk artrit, Crohns sygdom, colitis ulcerosa og hidrosadenitis suppurativa. 
A rapid decrease in CRP levels was also observed in patients with polyarticular juvenile idiopathic arthritis, Crohn's disease, ulcerative colitis and hidradenitis suppurativa after treatment with adalimumab.
Studiets primære endepunkt var klinisk remission ved uge 26, defineret som PCDAI score ≤ 10. Rater for klinisk remission og klinisk respons (defineret som reduktion i PCDAI-score på mindst 15 point fra baseline) er vist i tabel 26. 
Clinical remission and clinical response (defined as reduction in PCDAI score of at least 15 points from Baseline) rates are presented in Table 26.
• nedsat antal hvide blodlegemer, røde blodlegemer og blodplader 
• low blood measurements for white blood cells, red blood cells and platelet count.
• En vejledning til læger og sundhedspersonale 
• The Summary of Product Characteristics • Guide for healthcare professionals
Cyltezo er indiceret til behandling af voksne med alvorlig aksial spondyloartritis uden radiografiske tegn på AS, men med objektive tegn på inflammation ved forhøjet CRP og/eller MRI, som ikke har responderet tilstrækkeligt på eller er intolerante over for NSAID. 
Cyltezo is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.
Hos patienter med polyartikulær JIA, som var 2 til < 4 år eller 4 år og derover med en vægt < 15 kg, som blev doseret med adalimumab 24 mg/m2, var den gennemsnitlige dal-serumkoncentration af adalimumab ved steady state 6,0 ± 6,1 µg/ml (101 % CV) uden samtidig methotrexat og 7,9 ± 5,6 µg/ml (71,2 % CV) med samtidig methotrexat. 
In patients with polyarticular JIA who were 2 to < 4 years old or aged 4 and above weighing < 15 kg dosed with adalimumab 24 mg/m² , the mean trough steady-state serum adalimumab concentrations was 6.0 ± 6.1 μg/mL (101 % CV) for adalimumab without concomitant methotrexate and 7.9 ± 5.6 μg/mL (71.2 % CV) with concomitant methotrexate.
Fordelingen af patienter i henhold til alder og modtaget adalimumab-dosis i den 
Distribution of patients by age and adalimumab dose received during the OL LI phase
Adalimumabs sikkerhed og virkning ved induktions- og vedligeholdelsesbehandling med doser afhængige af legemsvægt (< 40 kg eller ≥ 40 kg) er undersøgt i et multicenter, randomiseret, dobbeltblindet klinisk studie med 192 pædiatriske patienter i alderen 6 til 17 (inklusive) år med moderat til svær Crohns sygdom (CD), defineret som Paediatric Crohn's Disease Activity Index (PCDAI) score > 30. 
Adalimumab was assessed in a multicentre, randomised, double-blind clinical trial designed to evaluate the efficacy and safety of induction and maintenance treatment with doses dependent on body weight (< 40 kg or ≥ 40 kg) in 192 paediatric subjects between the ages of 6 and 17 (inclusive) years, with moderate to severe Crohn´s disease (CD) defined as Paediatric Crohn's Disease Activity Index (PCDAI) score > 30.
På tværs af alle behandlingsgrupper var den gennemsnitlige baseline-PASI-score 18,9, og baseline-PGAscore varierede fra “moderat” (53 % af de inkluderede patienter) til “alvorlig” (41 %) og 
Across all treatment groups, the mean baseline PASI score was 18.9 and the baseline Physician's Global Assessment (PGA) score ranged from “moderate” (53 % of subjects included) to “severe” (41 %) to “very severe” (6 %).
Hos patienter i adalimumab-behandling blev signifikant forbedring af tegn på inflammation, målt ved hs-CRP og MRI af både sakroiliakaleddene og rygsøjlen, opretholdt frem til henholdvis uge 156 og 
Significant improvement of signs of inflammation as measured by hs-CRP and MRI of both Sacroiliac Joints and the Spine was maintained in adalimumab-treated patients through week 156 and week 104, respectively.
• Beholderen til ”kanyleaffald” skal altid opbevares utilgængeligt for børn. 
• Always keep “sharps” container out of sight and reach of children.
Cyltezo er indiceret til behandling af voksne med non-infektiøs intermediær, posterior og pan-uveitis, som har haft utilstrækkeligt respons på kortikosteroider, som har behov for steroidbesparende behandling, eller som ikke er egnet til behandling med kortikosteroider. 
Cyltezo is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.
Sikkerhedsprofilen hos patienter med uveitis, som behandles med adalimumab hver anden uge, var den samme som den kendte sikkerhedsprofil for adalimumab. 
The safety profile for patients with uveitis treated with adalimumab every other week was consistent with the
Stemplet skal nå ned i bunden af injektionssprøjten. 
Plunger should reach bottom of syringe.
Gennemsnitlige dal-niveauer på omtrent 7 µg/ml ved steady state blev set hos patienter med Crohns sygdom, som fik vedligeholdelsesdosis på 40 mg adalimumab hver anden uge. 
Mean steady-state trough levels of approximately 7 μg/mL were observed in Crohn's disease patients who received a maintenance dose of 40 mg adalimumab every other week.
Hvis injektionen på nogen måde går galt, må der ikke anvendes endnu en Cyltezo fyldt injektionssprøjte. 
If something goes wrong with the injection, do not use another Cyltezo pre-filled syringe.
Hos voksne patienter med psoriasis var den gennemsnitlige dal-koncentration af adalimumab ved steady state 5 µg/ml ved monoterapibehandling med 40 mg adalimumab hver anden uge. 
In adult patients with psoriasis, the mean steady-state trough concentration was 5 μg/mL during adalimumab 40 mg every other week monotherapy treatment.
Efter subkutan administration af 0,8 mg/kg (op til maksimalt 40 mg) hver anden uge til pædiatriske patienter med kronisk plaque-psoriasis var den gennemsnitlige dal-koncentration af adalimumab ved steady state 7,4 ± 5,8 µg/ml (± SD) (79 % CV). 
Following the administration of 0.8 mg/kg (up to a maximum of 40 mg) subcutaneously every other week to paediatric patients with chronic plaque psoriasis, the mean ± SD steady-state adalimumab trough concentration was approximately 7.4 ± 5.8 μg/mL (79 % CV).
Når injektionssprøjten er taget ud af køleskabet og har været opbevaret ved stuetemperatur, skal injektionssprøjten bruges indenfor 14 dage eller kasseres, også selv om den lægges tilbage i 
Once removed from the refrigerator for room temperature storage, the syringe must be used within 14 days or discarded, even if it is returned to the refrigerator.
Adalimumabs sikkerhed og virkning blev undersøgt hos voksne patienter med kronisk plaque-psoriasis (≥ 10 % BSA-involverering og PASI ≥ 12 eller ≥ 10), som var kandidater til systemisk behandling eller lysbehandling i randomiserede, dobbeltblindede studier. 
The safety and efficacy of adalimumab were studied in adult patients with chronic plaque psoriasis (≥ 10 % BSA involvement and Psoriasis Area and Severity Index (PASI) ≥ 12 or ≥ 10) who were candidates for systemic therapy or phototherapy in randomised, double-blind studies.
I kliniske studier er der observeret alvorlige infektioner i forbindelse med samtidig administration af anakinra og en anden TNF-antagonist, etanercept, uden yderligere klinisk virkning end ved anvendelse af etanercept alene. 
Concurrent administration of biologic DMARDS or TNF-antagonists Serious infections were seen in clinical studies with concurrent use of anakinra and another TNF-antagonist, etanercept, with no added clinical benefit compared to etanercept alone.
Kaplan-Meier kurver opsummerende tid til opblussen af sygdom i studie nr axSpA II 
Kaplan-Meier Curves Summarizing Time to Flare in Study nr-axSpA II
• Brug ikke den 40 mg fyldte injektionssprøjte, hvis der anbefales andre doser end 40 mg Brug af anden medicin sammen med Cyltezo 
• Do not use the 40 mg pre-filled syringe, if doses other than 40 mg are recommended.
I studie I var der også signifikante forbedringer i den fysiske og mentale komponent i den sammensatte SF-36-score 
In Study I, improvements in the physical and mental component summary scores of the SF-36 were also significant compared to placebo.
Cyltezo kan leveres i en fyldt injektionssprøjte og/eller en fyldt pen. 
Cyltezo may be available as a pre-filled syringe and/or a pre-filled pen.
Efter afslutningen af begge studier blev 383 patienter inkluderet i et åbent forlængelsesstudie, hvor 40 mg adalimumab blev 
Upon completion of both studies, 383 patients enrolled in an open-label extension study, in which 40 mg adalimumab was administered every other week.
Meget almindelig (kan forekomme hos mere end 1 ud af 10 personer): 
Very common (may affect more than 1 in 10 people):
Cyltezo fyldt injektionssprøjte er fremstillet af glas. 
The Cyltezo pre-filled syringe is made of glass.
p-værdi a p-værdi b p-værdi p-værdien for den parvise sammenligning af methotrexat-monoterapi og adalimumab/methotrexatkombinationsbehandling ved anvendelse af Mann-Whitney U test. p-værdien for den parvise sammenligning af adalimumab-monoterapi og adalimumab/methotrexatkombinationsbehandling ved anvendelse af Mann-Whitney U test p-værdien for den parvise sammenligning af adalimumab-monoterapi og methotrexat-monoterapi ved anvendelse af 
p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test. p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy
Ikke almindelig Nykturi 
Very Common Uncommon
***, **, * Statistisk signifikant ved henholdvis p < 0,001, < 0,01 og < 0,05 for alle sammenligninger mellem adalimumab og 
***, **, * Statistically significant at p < 0.001, < 0.01, and < 0.05, respectively, for all comparisons between
• lungesygdom som forårsager kortåndethed (inklusive inflammation/vævsirritation) 
• lung diseases causing shortness of breath (including inflammation);
De gennemsnitlige dal-serumkoncentrationer (± SD) af adalimumab, som blev opnået ved uge 4, var 15,7 ± 6,6 µg/ml for patienter ≥ 40 kg (160/80 mg) og 10,6 ± 6,1 µg/ml for patienter < 40 kg (80/40 mg). 
The mean (± SD) serum adalimumab trough concentrations achieved at week 4 were 15.7±6.6 μg/mL for patients ≥ 40 kg (160/80 mg) and 10.6 ± 6.1 μg/mL for patients
Adalimumab er ikke undersøgt hos patienter med nedsat lever- eller nyrefunktion. 
Adalimumab has not been studied in patients with hepatic or renal impairment
Cyltezo er indiceret til behandling af moderat til svær kronisk plaque-psoriasis hos voksne patienter, 
Cyltezo is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are
2) Inspicer den fyldte injektionssprøjte 
2) Inspect pre-filled syringe
MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER INJEKTIONSSPRØJTEETIKET 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SYRINGE LABEL
Ikke-infektiøs uveitis er en betændelseslignende (inflammatorisk) sygdom, som påvirker bestemte dele af øjet. 
Non-infectious uveitis in adults and children Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye. Cyltezo works by
Blandt patienter, som fik afbrudt behandlingen med adalimumab ved uge 12 i HS-studie I og II, var HiSCR-raten 12 uger efter genoptagelse af behandling med adalimumab 40 mg ugentlig tilbage på samme niveau, som før behandlingsafbrydelsen (56,0 %). 
Among patients whose adalimumab treatment was withdrawn at week 12 in Studies HS-I and HS-II, the HiSCR rate 12 weeks after re-introduction of adalimumab 40 mg weekly returned to levels similar to that
Cyltezo dosis til patienter med entesopati relateret artrit 
Cyltezo dose for patients with enthesitis-related arthritis
I kontrollerede fase 3-studier af adalimumab hos patienter med Crohns sygdom og colitis ulcerosa med en kontrolperiode på 4 til 52 uger forekom ALAT-stigninger ≥ 3 x ULN hos 0,9 % af de adalimumabbehandlede patienter og 0,9% af de kontrol-behandlede patienter. 
In controlled Phase 3 trials of adalimumab in patients with Crohn's disease and ulcerative colitis with a control period ranging from 4 to 52 weeks, ALT elevations ≥ 3 x ULN occurred in 0.9 % of adalimumabtreated patients and 0.9 % of controlled-treated patients.