natgillin/translations-raw huggingface dataset:
NSAID (83, 9% med abatacept, 85, 1% med placebo); systemiske kortikosteroider (74, 7% med abatacept, 75, 8% med placebo); non- biologisk DMARD- behandling, hyppigst chloroquin/ hydroxychloroquin, leflunomid og/ eller sulfasalazin (26, 9% med abatacept, 32, 1% med placebo); TNF- hæmmende midler, primært etanercept, (9, 4% med abatacept, 12, 3% med placebo) og anakinra (1, 1% med abatacept, 1, 6% med placebo).
NSAIDs (83.9% with abatacept, 85.1% with placebo); systemic corticosteroids (74.7% with abatacept, 75.8% with placebo); non-biological DMARD therapy, most commonly chloroquine/ hydroxychloroquine, leflunomide and/ or sulfasalazine (26.9% with abatacept, 32.1% with placebo); TNF blocking agents, mainly etanercept (9.4% with abatacept, 12.3% with placebo); and anakinra (1.1% with abatacept, 1.6% with placebo).
I placebo- kontrollerede kliniske forsøg med abatacept indberettedes bivirkninger hos 52, 2% af de abataceptbehandlede patienter og hos 46, 1% af de placebobehandlede.
In placebo-controlled clinical trials with abatacept, adverse drug reactions (ADRs) were reported in 52.2% of abatacept-treated patients and 46.1% of placebo-treated patients.
De hyppigst indberettede
The most frequently reported adverse drug reactions (≥ 5%) among abatacept-treated patients were headache and nausea.
Andelen af patienter som seponerede behandling på grund af bivirkninger, var 3, 4% for abataceptbehandlede patienter og 2, 2% for placebobehandlede.
5 The proportion of patients who discontinued treatment due to ADRs was 3.4% for abatacept-treated patients and 2.2% for placebo-treated patients.
Tabel 2 angiver de bivirkninger, der forekom med større hyppighed (forskel > 0, 2%) i gruppen af abataceptbehandlede patienter end blandt de placebobehandlede patienter.
Listed in Table 2 are adverse drug reactions that occurred with greater frequency (difference > 0.2%) in abatacept-treated patients than in placebo-treated patients.
Meget almindelig (≥ 1/ 10); Almindelig (≥ 1/ 100 til, < 1/ 10); Ikke almindelige (≥ 1/ 1. 000 til, < 1/ 100); Sjælden (≥ 1/ 10. 000 til, < 1/ 1. 000); Meget sjælden (< 1/ 10. 000).
The list is presented by system organ class and frequency, using the following categories: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000).
Bivirkninger i placebo- kontrollerede forsøg
Undesirable Effects in Placebo-Controlled Trials
Forhøjet blodtryk, forhøjede levertal (inklusive forhøjede transaminaser)
Common Blood pressure increased, liver function test abnormal (including transaminases increased) Uncommon Blood pressure decreased, weight increased
Takykardi, bradykardi, palpitationer
Tachycardia, bradycardia, palpitations
Meget almindelig Almindelig Ikke almindelig
Very Common Common Uncommon
Hovedpine Svimmelhed Paræstesier
Headache Dizziness Paraesthesia
Konjunktivitis, nedsat syn
Conjunctivitis, visual acuity reduced
Abdominalsmerter, diarré, kvalme, dyspepsi Gastritis, mundsår, aftøs stomatitis
Abdominal pain, diarrhoea, nausea, dyspepsia Gastritis, mouth ulceration, aphthous stomatitis
Hud og subkutane væv
Rash (including dermatitis)
Udslæt (inklusive dermatitis) Øget tendens til blå mærker, alopeci, tør hud
Increased tendency to bruise, alopecia, dry skin
Artralgi, ekstremitetssmerter
Arthralgia, pain in extremity
Nedre luftvejsinfektion (inklusive bronkitis), urinvejsinfektion, herpes simplex, øvre luftvejsinfektion (inklusive tracheitis, nasopharyngitis), rhinitis
Lower respiratory tract infection (including bronchitis), urinary tract infection, herpes simplex, upper respiratory tract infection (including tracheitis, nasopharyngitis), rhinitis
Tandinfektion, inficerede hudsår, onychomycosis
Tooth infection, infected skin ulcer, onychomycosis
6 Benigne, maligne og uspecificerede tumorer (inkl. cyster og polypper)
6 Neoplasms benign, malignant and unspecified (incl. cysts and polyps)
Basalcelle- carcinom
Basal cell carcinoma
Hypertension, rodmen Hypotension, hedeture
Hypertension, flushing Hypotension, hot flush
Influenzalignende sygdom
Fatigue, asthenia Influenza like illness
De bivirkninger, der blev rapporteret for gruppen af abataceptbehandlede patienter, og som ikke forekom med en større hyppighed (dvs. forskellen var ikke > 0, 2%) end med placebo, men som alligevel betragtes som medicinsk relevante omfatter følgende hændelser:
ADRs reported in abatacept-treated patients which did not occur with an excess incidence (i. e. the difference was not > 0.2%) over placebo but were considered to be medically relevant include the following events:
Almindelig: herpes zoster; Ikke almindelig: pneumoni, hypersensitivitet, pyelonefritis, bronkospasme, urticaria, psoriasis, cystitis, migræne, synkebesvær, tørre øjne; Sjælden: sepsis, bakteriæmi.
Common: herpes zoster; Uncommon: pneumonia, hypersensitivity, pyelonephritis, bronchospasm, urticaria, psoriasis, cystitis, migraine, throat tightness, dry eye; Rare: sepsis, bacteraemia.
Infektioner I de placebo- kontrollerede kliniske forsøg rapporteredes infektioner, der som minimum var muligt relateret til behandling hos 23, 2% af de abataceptbehandlede patienter og hos 19, 5% af de placebobehandlede.
Infections In the placebo-controlled clinical trials, infections at least possibly related to treatment were reported in 23.2% of abatacept-treated patients and 19.5% of placebo-treated patients.
Alvorlige infektioner, der som minimum muligvis var relateret til behandling, rapporteredes hos 1, 8% af de abataceptbehandlede patienter og hos 1, 0% af de placebobehandlede.
Serious infections at least possibly related to treatment were reported in 1.8% of abatacept-treated patients and 1.0% of placebo-treated patients.
4. 4).
Serious infections reported in at least one patient treated with abatacept (0.05% of patients) included the following: pneumonia; bronchitis; cellulitis; acute pyelonephritis; urinary tract infection; diverticulitis, intestinal abscess; localised infection; skin abscess; musculoskeletal infections; sepsis; empyema; hepatitis E; and tuberculosis (see section 4.4).
For gruppen af placebobehandlede patienter er der tilsvarende rapporter for 11 ud af 989 patienter, observeret gennem 794 patientår.
Malignancies In placebo-controlled clinical trials, malignancies were reported in 27 of 1,955 abatacept-treated patients observed during 1,687 patient-years, and in 11 of 989 placebo-treated patients observed during 794 patient-years.
Der er i dobbeltblinde og åbne kliniske forsøg rapporteret maligniteter hos 66 ud af 2. 688 abataceptbehandlede patienter gennem 4. 764 patientår.
In double-blind and open-label clinical trials, malignancies were reported in 66 of 2,688 abatacept-treated patients during 4,764 patient-years.
Dette omfatter 33 patienter med non- melanom hudkræft, 28 med solid organcancer og 6 med hæmatologiske maligniteter (4 med lymfomer og 2 med myelodysplastiske syndromer).
This included 33 patients with non-melanoma skin cancers, 28 with solid organ cancers, and 6 with hematologic malignancies (4 with lymphomas and 2 with myelodysplastic syndromes).
Den hyppigst rapporterede solide organcancer var lungecancer (11 tilfælde).
The most commonly reported solid organ cancer was lung cancer (11 cases).
4. 4).
The number of observed malignancies was consistent with that expected in an age- and gender-matched rheumatoid arthritis population (see section 4.4).
Infusionsrelaterede reaktioner Akutte infusionsrelaterede hændelser (bivirkninger der opstod inden for 1 time efter påbegyndelse af infusionen) i studie II, III og IV (se pkt.
Infusion-related reactions Acute infusion-related events (adverse reactions occurring within 1 hour of the start of the infusion) in Studies II, III, and IV (see section 5.1) were more common in the abatacept-treated patients than the
5. 1) var hypiggere hos de abataceptbehandlede patienter end hos de placebobehandlede (9, 8% for abatacept, 6, 7% for placebo).
7 placebo-treated patients (9.8% for abatacept, 6.7% for placebo).
De hyppigst rapporterede hændelser med abatacept (1- 2%) var svimmelhed, hovedpine og hypertension.
The most frequently reported events with abatacept (1-2%) were dizziness, headache, and hypertension.
Andre symptomer inkluderede kvalme, rødmen, urticaria, hoste, hypersensitivitet, pruritus, udslæt og pulmonelle bilyde.
Acute infusion-related events that were reported in > 0.1% and ≤ 1% of patients treated with abatacept included cardiopulmonary symptoms such as hypotension, increased blood pressure, decreased blood pressure, and dyspnea; other symptoms included nausea, flushing, urticaria, cough, hypersensitivity, pruritus, rash, and wheezing.
Hypersensitivitetsreaktioner var ikke almindelige.
Hypersensitivity reactions were uncommon.
Blandt 2. 688 abataceptbehandlede patienter gennem 4. 764 patientår sås 1 anafylaktisk tilfælde.
In 2,688 abatacept-treated patients during 4,764 patient-years, there was 1 case of anaphylaxis.
Andre hændelser der kan være forbundet med overfølsomhed over for lægemidlet som hypotension, urticaria og dyspnø, sås hos færre end 0, 6% af de abataceptbehandlede patienter.
Other events potentially associated with hypersensitivity to the medicinal product, such as hypotension, urticaria, and dyspnea, each occurred in less than 0.6% of abatacept-treated patients.
Seponering på grund af akut infusionsrelateret reaktion forekom hos 0, 4% af de abataceptbehandlede patienter og hos 0, 2% af de placebobehandlede.
Discontinuation due to an acute infusion-related reaction occurred in 0.4% of patients receiving abatacept and in 0.2% of placebo-treated patients.
Bivirkninger hos patienter med kronisk obstruktiv lungesygdom (KOL) I studie IV blev 37 patienter med KOL behandlet med abatacept, og 17 med placebo.
Adverse drug reactions in patients with chronic obstructive pulmonary disease (COPD) In Study IV, there were 37 patients with COPD treated with abatacept and 17 treated with placebo.
KOL- patienter behandlet med abatacept udviklede hyppigere bivirkninger end dem, der blev behandlet med placebo (henholdsvis 51, 4% og 47, 1%).
47.1%, respectively).
Respiratoriske forstyrrelser forekom oftere hos abataceptbehandlede patienter end placebobehandlede (henholdsvis 10, 8% og 5, 9%).
Respiratory disorders occurred more frequently in abatacept-treated patients than in placebo-treated patients (10.8% vs.
Disse omfattede KOL- exacerbation og dyspnø.
5.9%, respectively); these included COPD exacerbation, and dyspnea.
En større procentdel af de abataceptbehandlede end de placebobehandlede patienter med KOL udviklede alvorlig bivirkning (5, 4% vs.
A greater percentage of abatacept- than placebo-treated patients with COPD developed a serious adverse reaction (5.4% vs.
0%), inklusive KOL- exacerbation (1 ud af 37 patienter [2, 7%]) og bronkitis (1 ud af 37 patienter [2, 7%]).
0%), including COPD exacerbation (1 of 37 patients [2.7%]) and bronchitis (1 of 37 patients [2.7%]).
Autoantistoffer Abataceptbehandling medførte ikke øget dannelse af autoantistoffer dvs. antinukleære og anti- dsDNA - antistoffer, sammenlignet med placebo.
Autoantibodies Abatacept therapy did not lead to increased formation of autoantibodies, i. e., antinuclear and anti- dsDNA antibodies, compared with placebo.
Immunogenicitet Antistoffer rettet mod abataceptmolekylet vurderedes ved ELISA- analyse hos patienter med reumatoid artritis, der fik behandling med abatacept i op til 3 år.
Immunogenicity Antibodies directed against the abatacept molecule were assessed by ELISA assays in rheumatoid arthritis patients treated for up to 3 years with abatacept.
62 ud af 2. 237 patienter (2, 8%) udviklede bindende antistoffer.
Sixty-two of 2,237 (2.8%) patients developed binding antibodies.
Blandt patienter, der blev vurderet for antistoffer mindst 56 dage efter seponering af abatacept, udviklede 15 ud af 203 (7, 4%) antistoffer.
In patients assessed for antibodies at least 56 days after discontinuation of abatacept, 15 of 203 (7.4%) developed antibodies.
Prøver med bekræftet bindingsaktivitet til CTLA- 4 vurderedes for tilstedeværelse af neutraliserende antistoffer.
Samples with confirmed binding activity to CTLA-4 were assessed for the presence of neutralizing antibodies.
Otte ud af 13 evaluérbare patienter viste sig at have neutraliserende antistoffer.
Eight of 13 evaluable patients were shown to possess neutralizing antibodies.
Potentiel klinisk relevans af dannelsen af neutraliserende antistoffer er ukendt.
The potential clinical relevance of neutralizing antibody formation is not known.
Analyser af immungenicitet er produkt- specifikke, og derfor er sammenligning med antistof - tal for andre produkter ikke hensigtsmæssige.
Because immunogenicity analyses are product-specific, comparison of antibody rates with those from other products is not appropriate.
Sikkerhedsoplysninger relateret til den farmakologiske klasse Abatacept er den første, selektive co- stimulerende modulator.
Safety information related to the pharmacological class Abatacept is the first selective co-stimulation modulator.
5. 1.
Information on the relative safety in a clinical trial versus infliximab is summarized in section 5.1.
Der er administreret doser på op til 50 mg/ kg uden åbenlys toksisk effekt.
Doses up to 50 mg/ kg have been administered without apparent toxic effect.
Farmakoterapeutisk klassifikation: selektive immunsuppressiva, ATC- kode:
Pharmacotherapeutic group: selective immunosuppressants, ATC code:
Abatacept er et fusionsprotein bestående af det ekstracellulære domæne af humant cytotoksisk T - lymfocyt- associeret antigen 4 (CTLA- 4) forbundet med en modificeret Fc- del af humant immunoglobulin G1 (IgG1).
Abatacept is a fusion protein that consists of the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) linked to a modified Fc portion of human immunoglobulin G1 (IgG1).
Abatacept fremstilles ved rekombinant DNA- teknologi i OHC- celler (Chinese hamster ovarian cells).
Abatacept is produced by recombinant DNA technology in Chinese hamster ovary cells.
Virkningsmekanisme Abatacept modulerer selektivt et primært co- stimulerende signal, der er nødvendigt for fuld aktivering af de T- lymfocytter, hvor CD28- receptoren er til stede.
Mechanism of action Abatacept selectively modulates a key costimulatory signal required for full activation of T lymphocytes expressing CD28.
Fuld aktivering af T- lymfocytter kræver 2 signaler fra celler med antigener: genkendelse af et specifikt antigen af en T- cellereceptor (signal 1) og et andet co- stimulatorisk signal.
Full activation of T lymphocytes requires two signals provided by antigen presenting cells: recognition of a specific antigen by a T cell receptor (signal 1) and a second, costimulatory signal.
Et væsentligt co- stimulatorisk led involverer binding af CD80 - og CD86- molekyler på overfladen af celler med antigener for CD28- receptoren på T- lymfocytter (signal 2).
A major costimulatory pathway involves the binding of CD80 and CD86 molecules on the surface of antigen presenting cells to the CD28 receptor on T lymphocytes (signal 2).
Abatacept hæmmer selektivt denne co- stimulation ved specifikt at bindes til CD80 og CD86.
Abatacept selectively inhibits this costimulatory pathway by specifically binding to CD80 and CD86.
Forsøg indikerer, at det naive T- lymfocytrespons påvirkes mere af abatacept end memory T - lymfocytresponset.
Studies indicate that naive T lymphocyte responses are more affected by abatacept than memory T lymphocyte responses.
In vitro- forsøg og dyremodeller har vist, at abatacept modulerer det T- lymfocytafhængige antistofrespons og inflammation.
Studies in vitro and in animal models demonstrate that abatacept modulates T lymphocyte-dependent antibody responses and inflammation.
In vitro svækker abatacept human T- lymfocytaktivering målt ved nedsat proliferation og cytokinproduktion.
In vitro, abatacept attenuates human T lymphocyte activation as measured by decreased proliferation and cytokine production.
Abatacept hæmmer antigenspecifik dannelse af TNFα, interferon- γ og interleukin- 2 fra T- lymfocytter.
Abatacept decreases antigen specific TNFα, interferon-γ, and interleukin-2 production by T lymphocytes.
Farmakodynamisk effekt Med abatacept sås derdosisafhængige fald i serumniveauer af opløselig interleukin- 2- receptor, en markør for T- lymfocytaktivering; serum interleukin- 6 (et produkt af aktiverede synovia- makrofager og fibroblast- lignende synoviocytter i reumatoid artritis); reumatoid faktor (et autoantistof dannet af plasmaceller) samt C- reaktivt protein (en akutfase- reaktant for inflammation).
Pharmacodynamic effects Dose-dependent reductions were observed with abatacept in serum levels of soluble interleukin-2 receptor, a marker of T lymphocyte activation; serum interleukin-6, a product of activated synovial macrophages and fibroblast-like synoviocytes in rheumatoid arthritis; rheumatoid factor, an autoantibody produced by plasma cells; and C-reactive protein, an acute phase reactant of inflammation.
Derudover faldt serumniveauer af matrix metalloproteinase- 3, som inducerer nedbrydning af brusk og remodellering af væv.
In addition, serum levels of matrix metalloproteinase-3, which produces cartilage destruction and tissue remodelling, were decreased.
Der sås ligeledes fald i serum- TNFα.
Reductions in serum TNFα were also observed.
Klinisk effekt og sikkerhed Effekt og sikkerhed af abatacept er undersøgt i randomiserede, dobbeltblinde, placebo- kontrollerede kliniske forsøg med voksne patienter med aktiv reumatoid arthritis diagnosticeret i overensstemmelse med ACR- kriterier (American College of Rheumatology).
Clinical efficacy and safety The efficacy and safety of abatacept were assessed in randomised, double-blind, placebo-controlled clinical trials in adult patients with active rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria.
I studie I, II, III og V skulle patienterne have mindst 12 ømme og 10 hævede led ved randomisering.
Studies I, II, III, and V required patients to have at least 12 tender and 10 swollen joints at randomization.
Studie III vurderede effekt og sikkerhed af abatacept hos patienter med utilstrækkeligt respons på et TNF - hæmmende middel, hvor TNF- hæmmeren seponeredes inden randomisering; andre DMARD var tilladt.
In Study III the efficacy and safety of abatacept were assessed in patients with an inadequate response to a TNF blocking agent, with the TNF blocking agent discontinued prior to randomization; other DMARDs were permitted.
Studie IV vurderede primært sikkerhed hos patienter med aktiv reumatoid arthritis med behov for yderligere intervention på trods af aktuel behandling med non- biologisk og/ eller biologisk DMARD; alle DMARD anvendt ved inklusion blev fortsat.
Study IV primarily assessed safety in patients with active rheumatoid arthritis requiring additional intervention in spite of current therapy with non-biological and/ or biological DMARDs; all DMARDs used at enrollment were continued.
9 Patienterne i studie I randomiseredes til abatacept 2 eller 10 mg/ kg eller placebo i 12 måneder.
Study I patients were randomized to receive abatacept 2 or 10 mg/ kg or placebo for 12 months.
10 mg/ kg, eller placebo i 12 (studie II og IV) eller 6 måneder (studie III).
Study II, III, and IV patients were randomized to receive a fixed dose approximating 10 mg/ kg of abatacept or placebo for 12 (Studies II and IV) or 6 months (Study III).
Abataceptdosis var 500 mg for patienter, der vejede mindre end 60 kg, 750 mg for patienter, der vejede 60- 100 kg og 1 gram for patienter, der vejede mere end 100 kg.
The dose of abatacept was 500 mg for patients weighing less than 60 kg, 750 mg for patients weighing 60 to 100 kg, and 1 gram for patients weighing greater than 100 kg.
Patienterne i studie V randomiseredes til samme faste abataceptdosis eller 3 mg/ kg infliximab eller placebo i 6 måneder.
Study V patients were randomized to receive this same fixed dose of abatacept or 3 mg/ kg infliximab or placebo for 6 months.
Studie V fortsatte i yderligere 6 måneder med kun abatacept - og infliximabgruppen.
Study V continued for an additional 6 months with the abatacept and infliximab groups only.
Studie I, II, III, IV og V evaluerede henholdsvis 339, 638, 389, 1. 441 og 431 patienter.
9 Studies I, II, III, IV, and V evaluated 339, 638, 389, 1,441, and 431 patients, respectively.
ACR- respons Tabel 3 angiver procentdelene af de abataceptbehandlede patienter der opnåede ACR 20, 50 og 70 respons i studie II (patienter med utilstrækkeligt respons på methotrexat) og studie III (patienter med utilstrækkeligt respons på TNF- hæmmer).
ACR response The percent of abatacept-treated patients achieving ACR 20, 50, and 70 responses in Study II (patients with inadequate response to methotrexate) and Study III (patients with inadequate response to TNF blocking agent) are shown in Table 3.
Hos abataceptbehandlede patienter i studie II og III sås en statistisk signifikant forbedring i ACR 20 - respons versus placebo efter administration af første dosis (dag 15), og denne forbedring forblev signifikant igennem hele studiet.
In abatacept-treated patients in Studies II and III, statistically significant improvement in the ACR 20 response versus placebo was observed after administration of the first dose (day 15), and this improvement remained significant for the duration of the studies.
I studie II udviklede 43% af de patienter, som ikke opnåede et ACR 20 respons ved 6 måneder, ACR 20- respons ved 12 måneder.
In Study II, 43% of the patients who had not achieved an ACR 20 response at 6 months developed an ACR 20 response at 12 months.
ACR- respons i placebo- kontrollerede forsøg
Responses in Placebo-Controlled Trials
Procentdel af patienter Utilstrækkeligt respons på Utilstrækkeligt respons på methotrexat (MTX) TNF- hæmmer Studie II Studie III a
Percent of Patients Inadequate Response to Inadequate Response to Methotrexate (MTX) TNF Blocking Agent Study II Study III a
Abatacept Placebo Abatacepta +MTX +MTX + DMARDb +
Abatacept Placebo Abatacepta +MTX +MTX + DMARDsb +
Placebo DMARDb
Placebo DMARDsb
Responsrater ACR 20
Response Rate ACR 20
n = 424 n = 214 n = 256
n = 424 n = 214 n = 256
n = 133
n = 133
Dag 15 Måned 6 Måned 12 ACR 50
Day 15 Month 6 Month 12 ACR 50
23% * 14% 18% ** 68% *** 40% 50% *** 73% *** 40% NAd
23%* 14% 18%** 68%*** 40% 50%*** 73%*** 40% NAd
5% 20% NAd
5% 20% NAd
Måned 6 Måned 12 ACR 70
Month 6 Month 12 ACR 70
40% *** 17% 20% *** 48% *** 18% NAd
40%*** 17% 20%*** 48%*** 18% NAd
4% NAd
4% NAd
Måned 6 Måned 12 Større klinisk
Month 6 Month 12 Major Clinical
20% *** 7% 10% ** 29% *** 6% NAd
20%*** 7% 10%** 29%*** 6% NAd
2% NAd
2% NAd
responsc *
Responsec *
14% *** 2% NAd
14%*** 2% NAd
NAd
NAd
10 mg/ kg (se pkt 4. 2). b Samtidig DMARD dækker en eller flere af følgende: methotrexat, chloroquin/ hydroxychloroquin, sulfasalazin, leflunomid, azathioprin, guld og anakinra. c Større klinisk respons defineres som opnåelse af ACR 70 respons over en 6- måneders periode. d Efter 6 måneder fik patienterne mulighed for at indgå i et åbent forsøg.
p < 0.05, abatacept vs. placebo. ** p < 0.01, abatacept vs. placebo. *** p < 0.001, abatacept vs. placebo. a Fixed dose approximating 10 mg/ kg (see section 4.2). b Concurrent DMARDs included one or more of the following: methotrexate, chloroquine/ hydroxychloroquine, sulfasalazine, leflunomide, azathioprine, gold, and anakinra. c Major clinical response is defined as achieving an ACR 70 response for a continuous 6-month period. d After 6 months, patients were given the opportunity to enter an open-label study.
I studie I sås ACR 20- respons hos 71% af
In the open-label extension of Studies I, II, and III durable and sustained ACR 20, 50, and 70 responses have been observed through 48, 24, and 18 months, respectively, of abatacept treatment.
10 patienterne (42/ 59), ACR 50 hos 41% (24/ 59) og ACR 70 hos 31% (18/ 58) ved 48 måneder.
In study I, ACR 20 responses were observed in 71% (42/ 59) of patients, ACR 50 in 41% (24/ 59), and ACR 70 in 31% (18/ 58) at 48 months.
I studie II sås ACR 20 respons hos 88% af patienterne (291/ 332), ACR 50 hos 62% (205/ 332) og ACR 70 hos 38% (127/ 334) ved 24 måneder.
In study II, ACR 20 responses were observed in 88% (291/ 332) of patients, ACR 50 in 62% (205/ 332), and ACR 70 in 38% (127/ 334) at 24 months.