natgillin/translations-raw huggingface dataset:
Bivirkninger hos pædiatriske patienter med polyartikulær juvenil idiopatisk artrit
Undesirable effects in paediatric patients with polyarticular juvenile idiopathic arthritis
Bivirkninger, hvor kausaliteten i det mindste er muligt relateret til adalimumab for de pivotale forsøg, både klinisk og laboratoriemæssigt, er opført efter organklassesystem og hyppighed (meget almindelig ≥ 1/ 10; almindelig ≥ 1/ 100 til < 1/ 10; usædvanlig ≥ 1/ 1. 000 til < 1/ 100 og sjælden ≥ 1/ 10. 000 til < 1/ 1000) i tabel 1 nedenfor.
Adverse events at least possibly causally-related to adalimumab for pivotal studies, both clinical and laboratory, are displayed by system organ class and frequency (very common ≥ 1/ 10; common ≥ 1/ 100 to < 1/ 10; uncommon ≥ 1/ 1,000 to < 1/ 100 and rare ≥ 1/ 10,000 to < 1/ 1,000) in Table 1 below.
10 Systemorganklasser Undersøgelser
System Organ Class Investigations
Hyppighed Usædvanlig
Frequency Uncommon
Bivirkning forhøjet blod- keratin- fosforkinase, forlænget aktiveret partiel tromboplastintid, tilstedeværelse af autoantistoffer
Adverse Reaction blood creatine phosphokinase increased, activated partial thromboplastin time prolonged, autoantibodies present
arytmier, takykardi
arrhythmias, tachycardia
hjertestop, koronar arteriel insufficiens, angina pectoris, pericardieekssudat, hjerteinsufficiens, palpitationer
cardiac arrest, coronary artery insufficiency, angina pectoris, pericardial effusion, congestive cardiac failure, palpitations
Sygdomme i blod - og lymfesystem
Blood and the lymphatic system disorders
neutropeni (herunder agranulocytosis), leukopeni, trombocytopeni, anæmi, lymfadenopati, leukocytose, lymfopeni
neutropaenia (including agranulocytosis), leucopaenia, thrombocytopaenia, anaemia, lymphadenopathy, leucocytosis, lymphopaenia
pancytopeni, idiopatisk trombocytopenisk purpura
pancytopaenia, idiopathic thrombocytopaenic purpura
omtågethed (herunder vertigo), hovedpine, forstyrrelse af nerve- følsomhed (herunder paræstesi)
dizziness (including vertigo), headache, neurologic sensation disorders (including paraesthesias)
synkope, migræne, tremor, søvnforstyrrelser
syncope, migraine, tremor, sleep disturbances
dissemineret sclerose, ansigtslammelse
multiple sclerosis, facial palsy
synsforstyrrelser, okulære føleforstyrrelser, infektion, irritation eller inflammation i øjet
vision disorder, ocular sensation disorders, infection, irritation or inflammation of the eye
Sygdomme i det ydre og det indre øre
10 System Organ Class Ear and labyrinth disorders
Usædvanlig
Frequency Uncommon
øre- ubehag (herunder smerte og hævelse)
Adverse Reaction ear discomfort (including pain and swelling)
høre- tab, tinnitus
hearing loss, tinnitus
hoste, nasopharyngeal smerte
cough, nasopharyngeal pain
11 Systemorganklasser Gastrointestinale sygdomme
Gastrointestinal disorders
Hyppighed Almindelig
Common
Bivirkning diarré, mavesmerter, stomatitis og sår i munden, kvalme
diarrhoea, abdominal pain, stomatitis and mouth ulceration, nausea
rektal blødning, opkastning, dyspepsi, opsvulmet mave, konstipation
rectal haemorrhage, vomiting, dyspepsia, abdominal bloating, constipation
pancreatitis, intestinal stenose, colitis, enteritis, oesophagitis, gastritis
pancreatitis, intestinal stenosis, colitis, enteritis, oesophagitis, gastritis
haematuri, nyresvækkelse, blære - og urinrørs - symptomer
haematuria, renal impairment, bladder and urethral symptoms
proteinurea, nyresmerter
proteinuria, renal pain
urtikaria, psoriasis, ekkymose og øget tendens til blå mærker, purpura, dermatitis og eksem, hårtab
urticaria, psoriasis, ecchymosis and increased bruising, purpura, dermatitis and eczema, hair loss
Sygdomme i bevægeapparatet og
Musculoskeletal, connective tissue and
smerter i skeletmuskulaturen
musculoskeletal pain
bindevæv
bone disorders
rhabdomyolysis
Rhabdomyolysis
hypokaliæmi, forhøjede lipider, appetitforstyrrelser (herunder anorexi), hyperuricaemia
hypokalaemia, lipids increased, appetite disorders (including anorexia), hyperuricaemia
hypercalcæmi, hypocalcæmi
hypercalcaemia, hypocalcaemia
Infektiøse og parasitære sygdomme
11 System Organ Class Infections and infestations
Almindelig
Frequency Common
nedre luftvejsinfektioner (herunder pneumoni, bronkitis), virusinfektioner (herunder influenza, herpesinfektioner), candidiasis, bakterielle infektioner (herunder urinvejsinfektioner), øvre luftvejsinfektioner
Adverse Reaction lower respiratory infections (including pneumonia, bronchitis), viral infections (including influenza, herpes infections), candidiasis, bacterial infections (including urinary tract infections), upper respiratory infection
sepsis, opportunistiske infektioner (inklusive tuberkulose eller histoplasmose) abscesser, ledinfektion, hudinfektion (herunder cellulitis og impetigo), superficielle svampeinfektioner (herunder i hud, negle og fødder)
opportunistic infections (including tuberculosis, histoplasmosis), sepsis, abscess, joint infection, skin infection (including cellulitis and impetigo), superficial fungal infections (including skin, nail and foot)
nekrotiserende fascitis, viral meningitis, diverticulitis, sårinfektion
necrotising fasciitis, viral meningitis, diverticulitis, wound infection
12 Systemorganklasser Godartede, ondartede og uspecificerede svulster
Neoplasms benign, malignant and unspecified
Hyppighed Usædvanlig
Uncommon
Bivirkning hudpapillom
skin papilloma
(herunder cyster og polypper)
(including cysts and polyps)
lymfomer, faste organtumorer (herunder i bryst, ovarie og testikler), malignt melanom, spinocellulært karcinom
lymphoma, solid organ tumours (including breast, ovarian, testicular), malignant melanoma, squamous cell carcinoma of the skin
hypertension, rødmen, hæmatom
hypertension, flushing, haematoma
pyreksi, træthed (herunder asteni og utilpashed)
pyrexia, fatigue (including asthenia and malaise)
systemisk lupus erythematosus, angioødem, lægemiddel- allergi
systemic lupus erythematosus, angioedema, drug hypersensitivity
serumsyge, sæsonbestemt allergi
serum sickness, seasonal allergy
forhøjede leverenzymer
hepatic enzymes increased
hepatisk nekrose, hepatitis, hepatisk steatose, cholelithiasis, forhøjet serumbilirubin
hepatic necrosis, hepatitis, hepatic steatosis, cholelithiasis, blood bilirubin increased
Reaktioner ved injektionsstedet
12 Injection site reactions
I de pivotale kontrollerede forsøg havde 15% af de patienter, som blev behandlet med Humira, reaktioner ved injektionsstedet (erythem og/ eller kløe, blødning, smerter eller hævelse) sammenlignet med 9% af de patienter, som fik placebo eller aktiv kontrol.
In the pivotal controlled trials, 15% of patients treated with Humira developed injection site reactions (erythema and/ or itching, haemorrhage, pain or swelling), compared to 9% of patients receiving placebo or active control.
I de pivotale kontrollerede forsøg var infektionshyppigheden 1, 58 pr. patientår hos Humira - behandlede patienter og 1, 42 pr. patientår hos placebo - og aktiv kontrolbehandlede patienter.
In the pivotal controlled trials, the rate of infection was 1.58 per patient year in the Humira treated patients and 1.42 per patient year in the placebo and active control-treated patients.
Infektionerne var primært nasofaryngitis, øvre luftvejsinfektioner, og sinusitis.
The infections consisted primarily of nasopharyngitis, upper respiratory tract infection, and sinusitis.
Incidensen af alvorlige infektioner var 0, 04 pr. patientår hos Humira- behandlede patienter og 0, 03 pr. patientår hos placebo - og aktiv kontrolbehandlede patienter.
The incidence of serious infections was 0.04 per patient year in Humira treated patients and 0.03 per patient year in placebo and active control − treated patients.
13 I kontrollerede og åbne forsøg med Humira blev der rapporteret alvorlige infektioner (herunder dødelige infektioner, som forekom sjældent), inklusive rapporter om tuberkulose (herunder miliærtuberkulose og ekstra- pulmonær tuberkulose) og invasive opportunistiske infektioner (f. eks. dissemineret eller ekstrapulmonal histoplasmose, blastomykose, kokcidioimykose, pneumocytis, candidiasis, aspergillose og listeriose).
In controlled and open label studies with Humira, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e. g. disseminated or extrapulmonary histoplasmosis, blastomycosis, coccidioidomycosis, pneumocystis, candidiasis, aspergillosis and listeriosis).
Der blev ikke observeret nogen maligniteter hos 171 patienter med en eksposition på 192, 5 patientår i et Humira- forsøg med juvenile idiopatisk artrit patienter.
No malignancies were observed in 171 patients with an exposure of 192.5 patient years during a Humira trial in juvenile idiopathic arthritis patients.
1. 000 patient- år blandt 3. 853 Humira - behandlede patienter mod en hyppighed på 4, 3 (1, 8, 10, 4) pr.
During the controlled portions of pivotal Humira trials at least 12 weeks in duration in patients with moderately to severely active rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’ s disease and psoriasis, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95% confidence interval) of 5.9 (3.5, 9.9) per 1,000 patient-years among 3853 Humira treated patients versus a rate of 4.3 (1.8, 10.4) per 1,000 patient-years among 2,183 control patients (median duration of treatment was 5.5 months for Humira and 3.9 months for control-treated patients).
1. 000 patient- år blandt 2. 183 kontrolpatienter (gennemsnitlig varighed af behandlingen var 5, 5 måneder for Humira og 3, 9 måneder for de kontrol- behandlede patienter).
The rate (95% confidence interval) of non-melanoma skin cancers was 8.8 (5,7, 13.5) per 1,000 patient-years among Humira-treated patients and 2.6 (0.8, 8.0) per 1,000 patient-years among control patients.
1. 000 patient- år blandt Humira- behandlede patienter og 2, 6 (0, 8, 8, 0) pr.
Of these skin cancers, squamous cell carcinomas occurred at rates (95% confidence interval) of 2.5 (1.1, 5.6) per 1,000 patient-years among Humira-treated patients and 0 per 1,000 patient-years among control patients.
Hos disse hudkræfttilfælde forekom planocellulært karcinom med en hyppighed (95% konfidensinterval) på 2, 5 (1, 1, 5, 6) pr.
The rate (95% confidence interval) of lymphomas was 0.8 (0.2, 3.3) per 1,000 patient-years among Humira-treated patients and 0.9 (0.1, 6.1) per 1,000 patient-years among control patients.
Når de kontrollerede dele af disse forsøg og igangværende åbne opfølgningsforsøg kombineres med en gennemsnitlig varighed på omkring 1, 7 år, inklusive 6. 539 patienter og over 16. 000 patient- års behandling, er den observerede hyppighed af maligniteter, fraset lymfomer og ikke- melanom hudkræft, cirka 10, 1 pr.
When combining controlled portions of these trials and ongoing open label extension studies with a median duration of approximately 1.7 years including 6,539 patients and over 16,000 patient-years of therapy, the observed rate of malignancies, other than lymphoma and non-melanoma skin cancers is approximately 10.1 per 1,000 patient years.
1. 000 patient- år.
The observed rate of non-melanoma skin cancers is approximately 9.0 per 1,000 patient years, and the observed rate of lymphomas is approximately 1.1 per 1000 patient years.
1. 000 patient- år.
In post-marketing experience from January 2003, predominately in patients with rheumatoid arthritis, the reported rate of malignancies other than lymphomas and non-melanoma skin cancers is approximately 1.7 per 1,000 patient years.
4. 4).
The reported rates for non-melanoma skin cancers and lymphomas are approximately 0.2 and 0.4 per 1,000 patient years, respectively (see section 4.4).
Post- marketing er der rapporteret om sjældne tilfælde af hepatosplenisk T- celle lymfom hos patienter i behandling med adalimumab (se punk 4. 4).
Rare post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with adalimumab (see section 4.4).
Autoantistoffer
13 Autoantibodies
Patienter fik testet serumprøver for autoantistoffer på forskellige tidspunkter i reumatoid artrit forsøgne I- V.
Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis Studies I − V.
I disse havde 11, 9% af de Humira- behandlede patienter og 8, 1% af de placebo - og aktiv kontrolbehandlede patienter med negative antinukleære antistoftitere ved baseline positive titere efter 24 uger.
In these trials, 11.9% of patients treated with Humira and 8.1% of placebo and active control − treated patients that had negative baseline anti-nuclear antibody titres reported positive titres at Week 24.
To patienter ud af 3. 441, som blev behandlet med Humira i alle reumatoid artrit og psoriasisartrit forsøg, udviklede kliniske tegn, der tydede på et nyopstået lupuslignende syndrom.
Two patients out of 3,441 treated with Humira in all rheumatoid arthritis and psoriatic arthritis studies developed clinical signs suggestive of new-onset lupus-like syndrome.
I de kontrollerede kliniske reumatoid artrit- forsøg (RA- forsøg I- IV) var forhøjelsen i ALAT- værdierne hos patienter behandlet med adalimumab og placebo ens.
Rheumatoid arthritis clinical trials: in controlled rheumatoid arthritis clinical trials (RAstudies I − IV), elevations of ALT were similar in patients receiving adalimumab or placebo.
Hos patienter med tidlig reumatoid artrit (sygdomsvarighed på mindre end 3 år) (RA- forsøg V) forekom forhøjede ALAT- værdier oftere i kombinationsarmen (Humira/ methotrexat) end i methotrexat- monoterapiarmen
In patients with early rheumatoid arthritis (disease duration of less than 3 years) (RA study V), elevations of ALT were more common in the combination arm (Humira / methotrexate) compared to the methotrexate monotherapy arm or the Humira monotherapy arm.
I JIA- forsøget var de få transaminase- stigninger små og ens hos placebo - og adalimumab- eksponerede patienter, og de fleste forekom i kombination med methotrexat.
In the JIA trial the few transaminase elevations were small and similar in the placebo and adalimumab exposed patients, and mostly occurred in combination with methotrexate.
Forhøjede ALAT- værdier forekom oftere hos patienter med psoriasisartrit (PsA- forsøg I- II) end hos patienter med reumatoid artrit i kliniske forsøg.
Psoriatic arthritis clinical trials: elevations in ALT were more common in psoriatic arthritis patients (PsA studies I - II) compared with patients in rheumatoid arthritis clinical studies.
I alle reumatoid artrit, polyartikulær juvenil idiopatisk artrit og psoriasisartrit forsøg var patienter med forhøjede ALAT- værdier asymptomatiske, og i de fleste tilfælde var forhøjelserne forbigående og forsvandt ved fortsat behandling.
In all rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis studies, patients with raised ALT were asymptomatic and in most cases elevations were transient and resolved on continued treatment.
Kliniske forsøg med Crohns sygdom: i kontrollererde kliniske forsøg var forhøjelse af ALAT sammenlignelig hos patienter, der modtog adalimumab eller placebo.
Crohn’ s disease clinical trials: in controlled clinical trials, elevations of ALT were similar in patients receiving adalimumab or placebo.
Forhøjelsen af ALAT var sammenlignelig hos patienter, der modtog adalimumab eller placebo i de kontrollerede kliniske forsøg for psoriasis.
Psoriasis clinical trials: in controlled psoriasis clinical trials, elevations of ALT were similar in patients receiving adalimumab or placebo.
Yderligere bivirkninger fra overvågning efter markedsføring og kliniske fase IV- forsøg
Additional Adverse Reactions from Postmarketing Surveillance or Phase IV Clinical Trials
I tabel 2 ses de yderligere bivirkninger, som er rapporteret fra overvågning efter markedsføring eller kliniske fase IV- forsøg:
The additional adverse reactions in Table 2 have been reported from postmarketing surveillance or Phase IV clinical trials:
Tabel 2 Uønskede virkninger i overvågning efter markedsføring og kliniske fase IV- forsøg
Table 2 Undesirable Effects in Postmarketing Surveillance and Phase IV Clinical Studies
Systemorganklasse Gastrointestinale sygdomme Sygdomme i lever og galdeveje Sygdomme i nervesystemet
System Organ Class Gastrointestinal disorders Hepatobiliary disorders Nervous system disorders
Bivirkning Tarmperforation reaktivering af hepatitis B demyeliniserende sygdomme (f. eks. opticus neuritis, Guillain- Barré syndrom)
Adverse Reaction intestinal perforation reactivation of hepatitis B demyelinating disorders (e. g. optic neuritis, Guillian-Barré syndrome)
Sygdomme i åndedrætsorganer, brysthule og mediastinum Sygdomme i hud og subkutant væv Forstyrrelser i immunsystemet Benigne, maligne og uspecificerede tumorer (inkl. cyster og polypper)
Skin and subcutaneous tissue disorders Immune system disorders Neoplasma benign, malignant and unspecified (including cysts and polyps)
interstitiel lungesygdom, herunder pulmonal fibrose kutan vaskulitis anafylaksi hepatosplenisk T- celle lymfom
cutaneous vasculitis anaphylaxis hepatosplenic T-cell lymphoma
4. 9 Overdosering
14 4.9 Overdose
Det højeste dosisniveau, som er evalueret, har været adskillige intravenøse doser på 10 mg/ kg, hvilket er næsten 15 gange den anbefalede dosis..
The highest dose level evaluated has been multiple intravenous doses of 10 mg/ kg, which is approximately 15 times the recommended dose.
Selektive immunsuppressive stoffer.
Selective immunosuppressive agents.
Adalimumab binder specifikt til TNF og neutraliserer dennes biologiske funktion ved at blokere dens interaktion med celleoverflade- TNF- receptorerne p55 og p75.
Adalimumab binds specifically to TNF and neutralizes the biological function of TNF by blocking its interaction with the p55 and p75 cell surface TNF receptors.
15 Adalimumab modulerer også de biologiske responser, som induceres eller reguleres af TNF, herunder ændringer i niveauerne af de adhæsionsmolekyler, som er ansvarlige for leukocytmigrationen (ELAM - 1, VCAM- 1 og ICAM- 1 med en IC50 på 0, 1- 0, 2 nM)
Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of0.1-0.2 nM).
Efter behandling med Humira blev der hos patienter med reumatoid artrit observeret et hurtigt fald i niveauet af inflammatoriske akutfasereaktanter (C- reaktivt protein (CRP) og erytrocytsænkningshastighed (ESR)) og serumcytokiner (IL- 6) sammenholdt med baseline.
After treatment with Humira, a rapid decrease in levels of acute phase reactants of inflammation (C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)) and serum cytokines (IL-6) was observed compared to baseline in patients with rheumatoid arthritis.
Serumniveauer af matrixmetalloproteinaser (MMP- 1 og MMP- 3), som forårsager vævsomdannelse, der er ansvarlig for bruskdestruktionen, var også nedsatte efter Humira- administration.
Serum levels of matrix metalloproteinases (MMP-1 and MMP-3) that produce tissue remodelling responsible for cartilage destruction were also decreased after Humira administration.
Der blev også fundet et hurtigt fald i CRP hos patienter med Crohns sygdom.
A rapid decrease in CRP levels was also observed in patients with Crohn’ s disease.
Et hurtigt fald i CRP- niveau blev også observeret hos patienter med polyartikulær juvenil idiopatisk artrit.
A rapid decrease in CRP levels was also observed in patients with polyarticular juvenile idiopathic arthritis.
Humira er vurderet hos mere end 3. 000 patienter i de kliniske reumatoid artrit forsøg.
Humira was evaluated in over 3,000 patients in all rheumatoid arthritis clinical trials.
Humiras virkning og bivirkningsprofil ved behandling af reumatoid artrit blev vurderet i fem randomiserede, dobbeltblindede og velkontrollerede forsøg.
The efficacy and safety of Humira for the treatment of rheumatoid arthritis were assessed in five randomised, double-blind and well-controlled studies.
RA- forsøg 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 effekt, og hvor methotrexat- dosen forblev konstant på 10 til 25 mg hver uge.
RAstudy 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.
RA- forsøg II evaluerede 544 patienter, der var ≥ 18 år, med moderat til alvorlig aktiv reumatoid artrit, hvor behandling var mislykket med mindst ét sygdomsmodificerende antireumatisk lægemiddel.
RA study II evaluated 544 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old and had failed therapy with at least one disease-modifying, anti-rheumatic drugs.
RA- forsøg III evaluerede 619 patienter, der var ≥ 18 år, med moderat til alvorlig aktiv reumatoid artrit, som havde haft et ikke- effektivt respons på methotrexat i doser på 12, 5 til 25 mg eller som var intolerante over for 10 mg methotrexat hver uge.
RA study III evaluated 619 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, and who had an ineffective response to methotrexate at doses of 12.5 to 25 mg, or
Derefter blev patienterne optaget i et åbent forlængelsesforsøg hvor 40 mg Humira blev administreret hver anden uge i op til 60 måneder.
Thereafter, patients enrolled in an open-label extension phase in which 40 mg of Humira was administered every other week up to 60 months.
RA- forsøg IV vurderede primært sikkerheden hos 636 patienter, der var ≥ 18 år, med moderat til alvorlig aktiv reumatoid artrit.
RA study IV primarily assessed safety in 636 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old.
Disse terapier omfatter methotrexat, leflunomid, hydrozychloroquine, sulfasalazin og/ eller guldsalte.
These therapies include methotrexate, leflunomide, hydroxychloroquine, sulfasalazine and/ or gold salts.
RA- forsøg V vurderede 799 methotrexat- naive voksne patienter med moderat til alvorlig aktiv reumatoid artrit i tidligt stadium (gennemsnitlig sygdomsvarighed på mindre end 9 måneder).
RA study V evaluated 799 methotrexate-naïve, adult patients with moderate to severely active early rheumatoid arthritis (mean disease duration less than 9 months).
Dette forsøg vurderede virkningen af Humira 40 mg hver anden uge/ methotrexat- kombinationsterapi, Humira monoterapi 40 mg hver anden uge og methotrexat- monoterapi med hensyn til reduktion af tegn, symptomer og hastigheden af progressionen af ledskader ved reumatoid artrit i 104 uger.
This study evaluated the efficacy of Humira 40 mg every other week/ methotrexate combination therapy, Humira 40 mg every other week monotherapy and methotrexate monotherapy in reducing the signs and symptoms and rate of progression of joint damage in rheumatoid arthritis for 104 weeks.
16 Det primære end- point i RA- forsøg I, II og III og det sekundære end- point i RA- forsøg IV var den procentdel af patienter, som fik ACR 20- respons i uge 24 eller 26.
The primary end point in RA studies I, II and III and the secondary endpoint in RA study IV was the percent of patients who achieved an ACR 20 response at Week 24 or 26.
Det primære end- point i RA- forsøg V var procentdelen af patienter, som opnåede et ACR 50 respons i uge 52.
The primary endpoint in RA study V was the percent of patients who achieved an ACR 50 response at Week 52.
Forsøgne III og V havde yderligere primære end- points i uge 52 med forsinket sygdomsprogression (bestemt ud fra røntgenresultater).
RA studies III and V had an additional primary endpoint at 52 weeks of retardation of disease progression (as detected by X-ray results).
RA- forsøg III havde også et primært end- point, som var ændringer i livskvalitet.
RA study III also had a primary endpoint of changes in quality of life.