natgillin/translations-raw huggingface dataset:
Data fra det åbne forlængelsesforsøg indikerer, at reduktionen i hastigheden af progression af strukturel ødelæggelse opretholdes i 60 måneder i en delmængde af patienterne.
44 the open-label extension phase indicate that the reduction in rate of progression of structural damage is maintained for 60 months in a subset of patients.
Tabel 5 Gennemsnitlige radiografiske ændringer gennem 12 måneder i RA- forsøg III
Table 5 Radiographic Mean Changes Over 12 Months in RA Study III
45 I RA- forsøg V blev strukturel ledskade vurderet radiografisk og udtrykt som ændringer i modificeret Total Sharp Score (se tabel 6).
In RA study V, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (see Table 6).
Efter henholdsvis 52 ugers og 104 ugers behandling, var procentdelen af patienter uden progression (ændring fra baseline i modificeret Total Sharp Score ≤ 0, 5) signifikant højere med Humira/ methotrexat- kombinationsterapi (henholdsvis 63, 8% og 61, 2%) sammenlignet med methotrexat- monoterapi (henholdsvis 37, 4% og 33, 5%, p < 0, 001) og Humira monoterapi (henholdsvis 50, 7%, p < 0, 002 og 44, 5%, p < 0, 001).
Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified Total Sharp Score ≤ 0.5) was significantly higher with Humira/ methotrexate combination therapy (63.8% and 61.2% respectively) compared to methotrexate monotherapy (37.4% and 33.5% respectively, p < 0.001) and Humira monotherapy (50.7%, p < 0.002 and 44.5%, p < 0.001 respectively).
Helbredsrelateret livskvalitet og fysisk funktion blev evalueret ud fra et fysisk funktionsevneindeks fra Health Assessment Questionnaire (HAQ) i de fire originale adækvate og velkontrollerede forsøg, som var et allerede specificeret primært end- point ved uge 52 i RA- forsøg III.
45 Health-related quality of life and physical function was assessed using the disability index of the Health Assessment Questionnaire (HAQ) in the four original adequate and well-controlled trials, which was a pre-specified primary endpoint at Week 52 in RA study III.
I RA- forsøg III blev forbedringer i fysisk funktion opretholdt gennem 260 uger (60 måneder) med åben behandling.
In RA study III, improvement in physical function was maintained through Week 260 (60 months) of open-label treatment.
I den åbne indkøringsfase blev patienterne stratificeret i to grupper – MTX- behandlede (methotrexat- behandlede) og ikke- MTX - behandlede.
In the open-label lead in phase (OL LI) patients were stratified into two groups, MTX (methotrexate)-treated or non-MTX- treated.
46 Patienterne fortsatte på faste doser NSAID’ er og/ eller prednison (≤ 0, 2 mg/ kg/ dag eller maksimalt 10 mg/ dag) I den åbne indkøringsfase fik alle patienter 24 mg/ m2 op til et maksimum på 40 mg Humira hver anden uge i 16 uger.
In the OL LI phase all patients received 24 mg/ m2 up to a maximum of 40 mg Humira every other week for 16 weeks.
Efter 32 uger eller ved opblussen af sygdommen var patienterne egnede til inklusion i den åbne forlængelsesfase.
After 32 weeks or at disease flare, patients were eligible to enroll into the open label extension phase
Tabel 8 Pædiatriske ACR- responser i JIA- forsøget
46 Table 8 Ped ACR Responses in the JIA study
47 resultater anbefales Humira til anvendelse i kombination med MTX og til anvendelse som monoterapi til patienter, som ikke egner sig til behandling med MTX (se afsnit 4. 2).
Taking these results into consideration, Humira is recommended for use in combination with MTX and for use as monotherapy in patients for whom MTX use is not appropriate (see section 4.2).
I PsA- forsøg II blev 100 patienter, som havde utilstrækkelig respons over for DMARD- terapi, behandlet i 12 uger.
PsA study II with 12-week duration, treated 100 patients who had an inadequate response to DMARD therapy.
Tabel 9 ACR respons i placebokontrollerede psoriasisartrit forsøg (Procentdel af patienter)
47 Table 9 ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients)
ACR 50
Week 12 Week 24 ACR 70
Uge 12
4% 6%
Uge 24
36%*** 39%***
Behandling med Humira reducerede den udviklingshastighed, hvormed de perifere led destrueredes, sammenlignet med behandling med placebo som målt ved ændring i forhold til baseline i mTSS (gennemsnit + SD) 0, 8 ± 2, 5 i placebogruppen (ved uge 24) sammenlignet med 0, 0 ±1, 9; (p < 0, 001). i Humira- gruppen (ved uge 48).
Humira treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS (mean ± SD) 0.8 ± 2.5 in the placebo group (at Week 24) compared with 0.0 ± 1.9; (p < 0.001) in the Humira group (at Week 48).
48 Patienter, der blev behandlet med Humira, viste en statistisk signifikant forbedring i den fysiske funktion, som målt ved hjælp af HAQ og Short Form Health Survey (SF 36), sammenlignet med placebo ved uge 24.
Humira treated patients demonstrated statistically significant improvement in physical function as assessed by HAQ and Short Form Health Survey (SF 36) compared to placebo at Week 24.
Nioghalvfjerds (20, 1%) af patienterne blev samtidigt behandlet med sygdomsmodificerende antireumatiske lægemidler, og 37 (9, 4%) af patienterne med glukokortikoider.
Seventy-nine (20.1%) patients were treated concomitantly with disease modifying anti − rheumatic drugs, and 37 (9.4%) patients with glucocorticoids.
Forsøgspersoner (n=215, 54, 7%), som ikke opnåede ASAS 20 ved uge 12, eller 16 eller 20 fik tidligere adgang til åben adalimumab 40 mg subkutant hver anden uge og blev efterfølgende behandlet som non- respondere i de dobbeltblindede statistiske analyser.
Subjects (n=215, 54.7%) who failed to achieve ASAS 20 at Weeks 12, or 16 or 20 received early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently treated as non-responders in the double-blind statistical analyses.
Tabel 10 - Effekt respons i placebo- kontrolleret AS forsøg – forsøg I Reduktion af tegn og symptomer
48 Table 10 – Efficacy Responses in Placebo-Controlled AS Study – Study I Reduction of Signs and Symptoms
49 Crohns sygdom
Crohn’ s disease
In CD- forsøg I, blev 299 TNF- antagonist- naive patienter randomiseret til en af fire behandlingsgrupper; placebo i uge 0 og 2, 160 mg Humira i uge 0 og 80 mg i uge 2, 80 mg i uge 0 og 40 mg i uge 2, og 40 mg i uge 0 og 20 mg i uge 2.
In CD Study I, 299 TNF-antagonist naive patients were randomised to one of four treatment groups; placebo at Weeks 0 and 2, 160 mg Humira at Week 0 and 80 mg at Week 2, 80 mg at Week 0 and 40 mg at Week 2, and 40 mg at Week 0 and 20 mg at Week 2.
I CD- forsøg II, blev 325 patienter, der ikke længere responderede eller var intolerante over for infliximab, randomiseret til at modtage enten 160 mg Humira i uge 0 og 80 mg i uge 2 eller placebo i uge 0 og 2.
In CD Study II, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg Humira at Week 0 and 80 mg at Week 2 or placebo at Weeks 0 and 2.
Vedligeholdelse af klinisk remission blev undersøgt i CD- forsøg III (CHARM).
Maintenance of clinical remission was evaluated in CD study III (CHARM).
Ved uge 4 blev patienterne randomiseret til 40 mg hver anden uge, 40 mg hver uge, eller placebo gennem hele forsøgsforløbet på 56 uger.
49 randomised to 40 mg every other Week, 40 mg every Week, or placebo with a total study duration of 56 Weeks.
Patienter i klinisk respons (nedgang i CDAI ≥ 70) i uge 4 blev stratificeret og analyseret adskilt fra dem, som ikke havde klinisk respons ved uge 4.
Patients in clinical response (decrease in CDAI ≥ 70) at Week 4 were stratified and analysed separately from those not in clinical response at Week 4.
Tabel 11 viser rater for induktion af remission og respons i CD- forsøg I og CD- forsøg II.
CD study I and CD study II induction of remission and response rates are presented in Table 11.
Table 11 Induktion af klinisk remission og respons (Procent af patienterne)
Table 11 Induction of Clinical Remission and Response (Percent of Patients) Week 4
80/ 40 mg N = 75
CDStudy I:
160/ 80 m g N=76
Infliximab Naive Patients Placebo Humira Humira N=74 80/ 40 mg 160/ 80 m N = 75 g N=76
36% * **
12% 24% 36%* **
49%
24% 37% 49%
I CD- forsøg III var 58% (499/ 854) af patienterne i klinisk respons i uge 4 og blev vurderet i den primære analyse.
InCD Study III, at Week 4, 58% (499/ 854) of patients were in clinical response and were assessed in the primary analysis.
Raterne for klinisk remission forblev forholdvis konstante uanset tidligere TNF- antagonist - eksposition.
Clinical remission results remained relatively constant irrespective of previous TNF-antagonist exposure.
50 Tabel 12 Vedligeholdelse af klinisk remission og respons (Procent af patienterne)
50 Table 12 Maintenance of Clinical Remission and Response (Percent of Patients)
4. 2).
Therapy continued beyond 12 Weeks did not result in significantly more responses (see section 4.2).
51 tilgængelig dokumentation, som sammenligner Humira og methotrexat i mere end 16 ugers behandling.
There are no data available comparing Humira and MTX beyond 16 weeks of therapy.
Tabel 13 Ps Forsøg I (REVEAL) Resultater af effekt ved uge 16 Humira 40 mg hver Placebo anden uge N=398 N=814 N (%) n (%) ≥PASI 75 a
≥ PASI 75
26 (6, 5)
26 (6.5)
578 (70, 9) b
578 (70.9)b
PASI 100 PGA:
PASI 100 PGA:
Klar/ minimal
Clear/ minimal
3 (0, 8) 17 (4, 3)
3 (0.8) 17 (4.3)
163 (20, 0) b 506 (62, 2) b
163 (20.0)b 506 (62.2)b
N=53
Placebo N=53 n (%)
N=110
MTX N=110 n (%)
N=108
Humira 40 mg eow N=108 n (%)
Klar/ minimal a p < 0. 001 Humira vs. placebo b p < 0. 001 Humira vs. methotrexat c p < 0. 01 Humira vs. placebo d p < 0. 05 Humira vs. methotrexat
Clear/ minimal a p < 0.001 Humira vs. placebo b p < 0.001 Humira vs. methotrexate c p < 0.01 Humira vs. placebo d p < 0.05 Humira vs. methotrexate
52 Immunogenicitet
52 Immunogenicity
Efter administration af 24 mg/ m2 (op til et maksimum på 40 mg) subkutant hver anden uge til patienter med polyartikulær juvenil idiopatisk artrit (JIA) var den gennemsnitligelaveste steady- state (værdier
Following the administration of 24 mg/ m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with polyarticular juvenile idiopathic arthritis (JIA) the mean trough steady-state (values measured from Week 20 to 48) serum adalimumab concentration was 5.6 ± 5.6 µg/ mL (102 %CV) Humira monotherapy and 10.9 ± 5.2 µg/ mL (47.7% CV) with concomitant methotrexate.
5, µg/ ml.
53 In patients with Crohn’ s disease, the loading dose of 80 mg Humira on Week 0 followed by 40 mg Humira on Week 2 achieves serum adalimumab trough concentrations of approximately 5.5 µg/ ml during the induction period.
12 µg/ ml i induktions- perioden.
A loading dose of 160 mg Humira on Week 0 followed by 80 mg Humira on Week 2 achieves serum adalimumab trough concentrations of approximately 12 µg/ ml during the induction period.
Gennemsnitlige steady- state laveste niveauer på omtrent 7 µg/ ml blev set hos patienter med Crohns sygdom, som modtog vedligeholdelsesdosis på 40 mg Humira 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 Humira every other week.
Hos patienter med psoriasis var laveste gennemsnitlige- steady- state- koncentration 5 µg/ ml ved behandling med adalimumab 40 mg i monoterapi hver anden uge.
In patients with psoriasis, the mean steady-state trough concentration was 5 µg/ mL during adalimumab 40 mg every other week monotherapy treatment.
Humira er ikke undersøgt hos patienter med nedsat lever - eller nyrefunktion.
Humira has not been studied in patients with hepatic or renal impairment.
Mannitol Citronsyremonohydrat Natriumcitrat Natriumdihydrogenfosfatdihydrat Dinatriumfosfatdihydrat Natriumchlorid Polysorbat 80 Natriumhydroxid Vand til injektionsvæske
Mannitol Citric acid monohydrate Sodium citrate Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Sodium chloride Polysorbate 80 Sodium hydroxide Water for injections
54 6. 5 Emballagetype og pakningsstørrelser
54 6.5 Nature and contents of container
Humira, 40 mg injektionsvæske, opløsning i fyldt engangssprøjte (type 1- glas) til patientbrug:
Humira 40 mg solution for injection in single-use pre-filled syringe (type I glass) for patient use:
Pakninger af: • 1 fyldt injektionssprøjte (0, 8 ml steril opløsning) med 1 alkoholserviet i en blisterpakning. • 2 fyldte injektionssprøjter (0, 8 ml steril opløsning) med 2 alkoholservietter i en blisterpakning. • 4 fyldte injektionssprøjter (0, 8 ml steril opløsning) med 4 alkoholservietter i en blisterpakning. • 6 fyldte injektionssprøjter (0, 8 ml steril opløsning) med 6 alkoholservietter i en blisterpakning.
Packs of: • 1 pre-filled syringe (0.8 ml sterile solution) with 1 alcohol pad in a blister. • 2 pre-filled syringes (0.8 ml sterile solution), each with 1 alcohol pad, in a blister. • 4 pre-filled syringes (0.8 ml sterile solution), each with 1 alcohol pad, in a blister. • 6 pre-filled syringes (0.8 ml sterile solution), each with 1 alcohol pad, in a blister.
DATO FOR FØRSTE TILLADELSE/ FORNYELSE AF TILLADELSEN
DATE OF FIRST AU`THORISATION/ RENEWAL OF THE AUTHORISATION
Humira, 40 mg injektionsvæske, opløsning i fyldt injektionssprøjte ½med beskyttelseshætte.
Humira 40 mg solution for injection in pre-filled syringe with needleguard
Injektionsvæske, klar opløsning i fyldt injektionssprøjte med beskyttelseshætte.
Clear solution for injection in pre-filled syringe with needleguard.
56 Ankyloserende spondylitis
56 Ankylosing spondylitis
57 Psoriasisartrit og ankyloserende spondylitis
Psoriatic arthritis and ankylosing spondylitis
Den anbefalede dosis af Humira til patienter med psoriaris artrit er 40 mg adalimumab givet som enkeltdosis subkutan injektion hver anden uge.
57 The recommended dose of Humira for patients with psoriatic arthritis or ankylosing spondylitis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Svækket nyre - og/ eller leverfunktion
Impaired renal and/ or hepatic function
58 4. 3 Kontraindikationer
58 4.3 Contraindications
Hos patienter, som har været eksponeret for tuberkulose, og patienter, som har rejst i områder med høj risiko for tuberkulose eller endemisk mykose, såsom histoplasmose, kokcidioidomykose, eller blastomykose, skal risiko og fordele ved behandling med Humira overvejes, inden behandlingen iværksættes (se Opportunistiske infektioner).
In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidiomycosis, or blastomycosis, the risk and benefits of treatment with Humira should be considered prior to initiating therapy (see Opportunistic infections).
Alvorlige infektioner, inklusive sepsis, som skyldes bakterielle, mykobakteriel, invasive virale svampe eller andre opportunistiske infektioner såsom listeriose og pneumocystis et blevet rapporteret hos patienter, som modtog Humira.
Serious infections including sepsis, due to bacterial, mycobacterial, invasive fungal viral, or other opportunistic infections such as listeriosis, and pneumocystis have been reported in patients receiving Humira.
Der er rapporteret om indlæggelse eller fatale udfald associeret med infektioner
Hospitalisation or fatal outcomes associated with infections have been reported.
Det anbefales, at disse undersøgelser registreres på
It is recommended that the conduct of these tests should be recorded in the patient alert card.
Den ordinerende læge bør være opmærksom på risikoen for falsk negative resultater af tuberkulinhudtest, særligt hos patienter, der er alvorligt syge eller immunkompromitterede.
59 If latent tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted.
Hvis der diagnosticeres aktiv tuberkulose, må Humira- terapi ikke påbegyndes (se punkt 4. 3).
In all situations described below, the benefit/ risk balance of therapy should be very carefully considered.
I alle disse situationer, der er beskrevet neden for, skal balancen mellem fordele/ ulemper ved behandling tages meget nøje i betragtning.
If inactive (‘ latent’) tuberculosis is diagnosed, appropriate treatment for latent tuberculosis must be started with anti-tuberculosis prophylaxis therapy before the initiation of Humira, and in accordance with local recommendations.
Hvis der diagnosticeres inaktiv (‘ latent ’) tuberkulose, skal der startes med anti- tuberkulose - behandling i overensstemmelse med lokale anbefalinger, inden behandling med Humira startes.
In patients who have several or significant risk factors for tuberculosis and have a negative test for latent tuberculosis, anti-tuberculosis therapy should also be considered before the initiation of Humira.
Anti- tuberkulose- behandling, skal også tages i betragtning hos patienter, der har flere eller betydelige risiko- faktorer for tuberkulose og har en negativ test for latent tuberkulose, inden behandling med Humira startes.
Use of anti-tuberculosis therapy should also be considered before the initiation of Humira in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
Anti- tuberkulose behandling, skal også tages i betragtning hos patienter, der tidligere har haft latent eller aktiv tuberkulose, hvor det ikke har kunnet bekræftes, at behandlingen har været tilstrækkelig, inden start af behandling med Humira. Nogle patienter, som tidligere har været behandlet mod latent eller aktiv tuberkulose, har udviklet aktiv tuberkulose, imens de har været i behandling med Humira.
Some patients who have previously received treatment for latent or active tuberculosis have developed active tuberculosis while being treated with Humira.
Disse infektioner er ikke konsekvent blevet erkendt hos patienter, som tager TNF - blokkere, hvorved iværksættelse af passende behandling er blevet forsinket, hvilket sommetider har resulteret i fatale udfald.
These infections have not consistently been recognised in patients taking TNF-blockers and this has resulted in delays in appropriate treatment, sometimes resulting in fatal outcomes.
Der er forekommet reaktivering af hepatitis B hos patienter, som er kroniske bærere af denne virus, der modtog TNF- antagonister inkluderende Humira.
Reactivation of hepatitis B has occurred in patients who are chronic carriers of this virus when receiving a TNF-antagonist including Humira.
60 Allergiske reaktioner
60 very rarely following Humira administration.
Sjældne tilfælde af pancytopeni herunder aplastisk anæmi er rapporteret efter behandling med TNF - antagonister.
Rare reports of pancytopenia including aplastic anaemia have been reported with TNF atagonists.
Hos patienter
Vaccinations Similar antibody responses to the standard 23-valent pneumococcal vaccine and the influenza trivalent virus vaccination were observed in a study in 226 adult subjects with rheumatoid arthritis who were
61 med bekræftede signifikante hæmatologiske abnormiteter bør det overvejes at afbryde behandlingen med Humira.
61 treated with adalimumab or placebo.
(Se punkt 4. 5)
(See section 4.5).
62 Tyndtarms- obstruktion
62 4.5 Interaction with other medicinal products and other forms of interaction
Svimmelhed (inklusive vertigo, synsforstyrrelser og træthed) kan forekomme efter administration af Humira se pkt 4. 8
Dizziness (including vertigo, vision disorder and fatigue) may occur following administration of Humira (see Section 4.8).
Disse forsøg omfattede både patienter med reumatoid artrit med kortere og længere sygdomsforløb, polyartikulær juvenil idiopatisk artritis og patienter med psoriasisartrit, ankyloserende spondylitis, Crohns sygdom og psoriasis.
These trials included rheumatoid arthritis patients with short term and long standing disease, polyarticular juvenile idiopathic arthritis as well as psoriatic arthritis, ankylosing spondylitis, Crohn’ s disease and psoriasis patients.
63 Den del af patienterne, som ophørte med behandling på grund af bivirkninger i løbet af den dobbeltblindede, kontrollerede del af de pivotale forsøg udgjorde 4, 5% for patienter, der fik Humira, og 4, 5% for kontrolbehandlede patienter.
The proportion of patients who discontinued treatment due to adverse events during the double-blind, controlled portion of pivotal studies was 4.5% for patients taking Humira and 4.5% for control treated patients.
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.
63 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.
64 Systemorganklasser Undersøgelser
System Organ Class Investigations
synsforstyrrelser, okulære føleforstyrrelser, infektion, irritation eller inflammation i øjet
vision disorder, ocular sensation disorders, infection, irriaation or inflammation of the eye
Sygdomme i åndedrætsorganer, brysthule og mediastinum
64 System Organ Class Respiratory, thoracic and mediastinal disorders
65 Systemorganklasser Gastrointestinale sygdomme
Gastrointestinal disorders
Infektiøse og parasitære sygdomme
65 System Organ Class Infections and infestations
66 Systemorganklasser Godartede, ondartede og uspecificerede svulster
Neoplasms benign, malignant and
(herunder cyster og polypper)
unspecified (including cysts and polyps)
Reaktioner ved injektionsstedet
66 Injection site reactions
67 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).
1. 000 patient- år blandt 3. 853 Humirabehandlede 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 3,853 Humira treated patients versus a rate of 4.3 (1.8, 10.4) per 1,000 patient-years among 2183 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 kontro- lbehandlede patienter).
The rate (95% confidence interval) of non-melanoma skin cancers was 8.8 (5.7, 13.5) per 1000 patient-years among Humira-treated patients and 2.6 (0.8, 8.0) per 1,000 patient-years among control patients.
Autoantistoffer
67 Autoantibodies
To patienter ud af 3441, 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.