natgillin/translations-raw huggingface dataset:
The trials had either a double-blind, placebo-controlled period of 6 months (258 patients with abatacept, 133 with placebo) or 1 year (1,697 patients with abatacept, 856 with placebo).
Dvojno slepa s placebom nadzorovana preskušanja so trajala 6 mesecev (258 bolnikov je prejemalo abatacept, 133 placebo) ali 1 leto (1. 697 bolnikov je prejemalo abatacept, 856 placebo).
Other concomitant medications included:
V teh preskušanjih je večina bolnikov prejemala metotreksat (81, 9% skupaj z abataceptom, 83, 3% skupaj s placebom).
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).
Druga zdravila, ki so jih bolniki prejemali sočasno so: nesteroidna protivnetna zdravila (83, 9% z abataceptom, 85, 1% s placebom), sistemski kortikosteroidi (74, 7% z abataceptom, 75, 8% s placebom), nebiološka imunomodulirajoča protirevmatična zdravila, najpogosteje klorokin/ hidroksiklorokin, leflunomid in/ ali
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.
5 sulfasalazin (26, 9 z abataceptom, 32, 1% s placebom), zaviralci TNF, predvsem etanercept (9, 4% z abataceptom, 12, 3% s placebom) in anakinra (1, 1% z abataceptom, 1, 6% s placebom).
The most frequently reported adverse drug reactions (≥ 5%) among abatacept-treated patients were headache and nausea.
Pri bolnikih, ki so prejemali abatacept, so najpogosteje (≥ 5%) poročali o glavobolu in navzei.
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.
Zaradi neželenih učinkov zdravila je bilo zdravljenje prekinjeno pri 3, 4% bolnikov, ki so prejemali abatacept in 2, 2% bolnikov, ki so prejemali placebo.
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.
V tabeli 2 so navedeni neželeni učinki zdravila, ki so bili pri bolnikih, ki so prejemali abatacept pogostejši (razlika > 0, 2%) kot pri bolnikih, ki so prejemali placebo.
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).
Seznam je naveden po organskih sistemih in pogostnosti, pri čemer so uporabljene naslednje kategorije: zelo pogosti (≥ 1/ 10); pogosti (≥ 1/ 100 do < 1/ 10); občasni (≥ 1/ 1. 000 do < 1/ 100); redki (≥ 1/ 10. 000 do < 1/ 1. 000); zelo redki (< 1/ 10. 000).
Undesirable Effects in Placebo-Controlled Trials
Neželeni učinki v s placebom nadzorovanih preskušanjih
Common Blood pressure increased, liver function test abnormal (including transaminases increased) Uncommon Blood pressure decreased, weight increased
Pogosti Zvišanje krvnega tlaka, nenormalni izvidi testov jetrne funkcije (vključno z zvišanjem transaminaz) Občasni Znižanje krvnega tlaka, povečanje telesne mase
Tachycardia, bradycardia, palpitations
Tahikardija, bradikardija, palpitacije
Very Common Common Uncommon
Zelo pogosti Pogosti Občasni
Headache Dizziness Paraesthesia
Glavobol Omotica Parestezija
Conjunctivitis, visual acuity reduced
Konjunktivitis, zmanjšana ostrina vida
Abdominal pain, diarrhoea, nausea, dyspepsia Gastritis, mouth ulceration, aphthous stomatitis
Bolečina v trebuhu, driska, navzea, dispepsija Gastritis, razjede v ustni votlini, aftozni stomatitis
Rash (including dermatitis)
Bolezni kože in podkožja
Uncommon
Pogosti Občasni
Increased tendency to bruise, alopecia, dry skin
Izpuščaj (vključno z dermatitisom) Večja nagnjenost k modricam, alopecija, suha koža
Arthralgia, pain in extremity
Artralgija, bolečina v udih
Infections and infestations
6 Infekcijske in parazitske bolezni
Lower respiratory tract infection (including bronchitis), urinary tract infection, herpes simplex, upper respiratory tract infection (including tracheitis, nasopharyngitis), rhinitis
Okužba spodnjih dihal (vključno z bronhitisom), okužba sečil, herpes simpleks, okužba zgornjih dihal (vključno s traheitisom, nazofaringitisom), rinitis
Tooth infection, infected skin ulcer, onychomycosis
Okužba zoba, okužena kožna razjeda, onihomikoza
6 Neoplasms benign, malignant and unspecified (incl. cysts and polyps)
Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)
Hypertension, flushing Hypotension, hot flush
Splošne težave in spremembe na mestu aplikacije
General disorders and administration site conditions
Utrujenost, astenija
Fatigue, asthenia Influenza like illness
Gripi podobna bolezen
Depression, anxiety
Depresija, tesnoba
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:
Neželeni učinki zdravila, katerih pojavnost pri bolnikih, ki so prejemali abatacept, ni bila večja od pojavnosti (to je, če razlika ni bila > 0, 2%) pri placebu, vendar pa so bili ovrednoteni kot klinično pomembni so naslednji:
Common: herpes zoster; Uncommon: pneumonia, hypersensitivity, pyelonephritis, bronchospasm, urticaria, psoriasis, cystitis, migraine, throat tightness, dry eye; Rare: sepsis, bacteraemia.
Pogosti: herpes zoster; Občasni: pljučnica, preobčutljivost, pielonefritis, bronhospazem, urtikarija, psoriaza, cistitis, migrena, stiskanje v žrelu, suhe oči; Redki: sepsa, bakteriemija.
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.
Okužbe V s placebom nadzorovanih kliničnih preskušanjih so o okužbah, ki bi lahko bile povezane z zdravljenjem, poročali pri 23, 2% bolnikov, ki so prejemali abatacept, in 19, 5% bolnikov, ki so prejemali placebo.
Serious infections at least possibly related to treatment were reported in 1.8% of abatacept-treated patients and 1.0% of placebo-treated patients.
O resnih okužbah, ki bi lahko bile povezane z zdravljenjem, so poročali pri 1, 8% bolnikov, ki so prejemali abatacept, in 1, 0% bolnikov, ki so prejemali placebo.
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).
Resne okužbe, ki so se pojavile pri vsaj enem bolniku, ki je prejemal abatacept (0, 05% bolnikov) so naslednje: pljučnica, bronhitis, flegmona, akutni pielonefritis, okužba sečil, divertikulitis, intestinalni absces, lokalizirana okužba, kožni abscesi, mišično- skeletne okužbe, sepsa, empiem; hepatitis E in tuberkuloza (glejte poglavje 4. 4).
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.
Novotvorbe V s placebom nadzorovanih kliničnih preskušanjih so o novotvorbah poročali pri 27 od 1. 955 bolnikov, ki so prejemali abatacept in so jih spremljali 1. 687 bolniških let (“ patient- years ”) ter pri 11 od 989 bolnikov, ki so prejemali placebo in so jih spremljali 794 bolniških let.
In double-blind and open-label clinical trials, malignancies were reported in 66 of 2,688 abatacept-treated patients during 4,764 patient-years.
V dvojno slepih in odprtih kliničnih preskušanjih so o novotvorbah poročali pri 66 od 2. 688 bolnikov, ki so prejemali abatacept med 4. 764 bolniškimi leti.
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).
Poročila vključujejo 33 bolnikov z nemelanomskim kožnim rakom, 28 bolnikov s solidnim rakom na organih in 6 bolnikov s 7 hematološko obliko raka (4 bolniki z limfomi in 2 bolnika z mielodisplastičnim sindromom).
The most commonly reported solid organ cancer was lung cancer (11 cases).
Od solidnih oblik raka so najpogosteje poročali o pljučnem raku (11 primerov).
The number of observed malignancies was consistent with that expected in an age- and gender-matched rheumatoid arthritis population (see section 4.4).
Število opaženih novotvorb je bilo v skladu s po starosti in spolu pričakovanim številom pri populaciji z revmatoidnim artritisom (glejte poglavje 4. 4).
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
Neželeni učinki, povezani z infundiranjem V študijah II, III in IV (glejte poglavje 5. 1) so bili akutni učinki, povezani z infundiranjem (neželeni učinki, ki so se pojavili v 1 uri po začetku infundiranja), pogostejši pri bolnikih, ki so prejemali abatacept, kot pri bolnikih, ki so prejemali placebo (9, 8% za abatacept, 6, 7% za placebo).
The most frequently reported events with abatacept (1-2%) were dizziness, headache, and hypertension.
Pri bolnikih, ki so prejemali abatacept, so najpogosteje (1- 2%) poročali o omotici, glavobolu in hipertenziji.
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.
Akutni neželeni učinki, povezani z infundiranjem, o katerih so poročali pri > 0, 1% in ≤ 1% bolnikov, ki so prejemali abatacept, so vključevali kardiopulmonalne simptome, kot so hipotenzija, zvišanje krvnega tlaka, znižanje krvnega tlaka in dispneja, drugi simptomi so vključevali navzeo, zardevanje, urtikarijo, kašelj, preobčutljivost, srbenje, izpuščaj in sopenje.
Hypersensitivity reactions were uncommon.
Preobčutljivostne reakcije so bile občasne.
In 2,688 abatacept-treated patients during 4,764 patient-years, there was 1 case of anaphylaxis.
Pri 2. 688 bolnikih, ki so prejemali abatacept, se je med 4. 764 bolniškimi leti pojavil 1 primer anafilaksije.
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.
Drugi učinki, ki bi lahko bili povezani s preobčutljivostjo na zdravilo, kot so hipotenzija, urtikarija in dispneja, so se pojavili pri manj kot 0, 6% bolnikov, ki so prejemali abatacept.
Discontinuation due to an acute infusion-related reaction occurred in 0.4% of patients receiving abatacept and in 0.2% of placebo-treated patients.
Zaradi akutnih neželenih učinkov, povezanih z infundiranjem, je bilo zdravljenje prekinjeno pri 0, 4% bolnikov, ki so prejemali abatacept in 0, 2% bolnikov, ki so prejemali 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.
Neželeni učinki zdravila pri bolnikih s kronično obstrukcijsko pljučno boleznijo (KOPB) V študiji IV je 37 bolnikov s KOPB prejemalo abatacept, 17 pa placebo.
47.1%, respectively).
Pri bolnikih s KOPB, ki so prejemali abatacept, so bili neželeni učinki zdravila pogostejši kot pri bolnikih, ki so prejemali placebo (51, 4% v primerjavi s 47, 1%).
5.9%, respectively); these included COPD exacerbation, and dyspnea.
Bolezni dihal so bile pri bolnikih, ki so prejemali abatacept, pogostejše kot pri bolnikih, ki so prejemali placebo (10, 8% v primerjavi s 5, 9%), in so vključevale poslabšanje KOPB in dispnejo.
0%), including COPD exacerbation (1 of 37 patients [2.7%]) and bronchitis (1 of 37 patients [2.7%]).
Resni neželeni učinki so bili pri bolnikih s KOPB, ki so prejemali abatacept, pogostejši kot pri bolnikih, ki so prejemali placebo (5, 4% v primerjavi z 0%), vključevali so poslabšanje KOPB (1 od 37 bolnikov [2, 7%]) in bronhitis (1 od 37 bolnikov [2, 7%]).
Autoantibodies Abatacept therapy did not lead to increased formation of autoantibodies, i. e., antinuclear and anti- dsDNA antibodies, compared with placebo.
Avtoprotitelesa Pri zdravljenju z abataceptom tvorba avtoprotiteles, npr. protijedrna in anti- dsDNA protitelesa, ni bila večja kot pri placebu.
Immunogenicity Antibodies directed against the abatacept molecule were assessed by ELISA assays in rheumatoid arthritis patients treated for up to 3 years with abatacept.
Imunogenost Protitelesa proti molekuli abatacepta so z ELISA testi ugotavljali pri bolnikih z revmatoidnim artritisom, ki so do 3 leta prejemali abatacept.
Sixty-two of 2,237 (2.8%) patients developed binding antibodies.
Vezalna protitelesa so ugotovili pri dvainšestdesetih od 2. 237 (2, 8%) bolnikov.
In patients assessed for antibodies at least 56 days after discontinuation of abatacept, 15 of 203 (7.4%) developed antibodies.
Pri bolnikih, ki so bili preiskani na protitelesa vsaj 56 dni po prekinitvi zdravljenja z abataceptom, so protitelesa ugotovili pri 15 od 203 bolnikov (7, 4%).
Samples with confirmed binding activity to CTLA-4 were assessed for the presence of neutralizing antibodies.
Vzorci s potrjenim vezalnim delovanjem za CTLA- 4 so bili ovrednoteni na prisotnost nevtralizirajočih protiteles.
Eight of 13 evaluable patients were shown to possess neutralizing antibodies.
Nevtralizirajoča protitelesa so bila ugotovljena pri osmih od 13 ovrednotenih bolnikov.
The potential clinical relevance of neutralizing antibody formation is not known.
Možen klinični pomen razvoja nevtralizirajočih protiteles ni znan.
Safety information related to the pharmacological class Abatacept is the first selective co-stimulation modulator.
8 Informacije o varnosti, povezane s farmakološko skupino Abatacept je prvi selektivni modulator kostimulacije.
Information on the relative safety in a clinical trial versus infliximab is summarized in section 5.1.
Podatki o relativni varnosti v kliničnih preskušanjih v primerjavi z infliksimabom so povzeti v poglavju 5. 1.
Doses up to 50 mg/ kg have been administered without apparent toxic effect.
Uporabljeni so bili odmerki do 50 mg/ kg brez očitnih toksičnih učinkov.
Pharmacotherapeutic group: selective immunosuppressants, ATC code:
Zdravila za selektivno zaviranje imunske odzivnosti, oznaka ATC:
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 je fuzijski protein, sestavljen iz zunajcelične domene s humanim citotoksičnim limfocitom T povezanega antigena 4 (CTLA- 4; “ human cytotoxic T- lymphocyte- associated antigen 4 ”), vezane na modificirani Fc del humanega imunoglobulina G1 (IgG1).
Mechanism of action Abatacept selectively modulates a key costimulatory signal required for full activation of T lymphocytes expressing CD28.
Mehanizem delovanja Abatacept selektivno modulira ključni kostimulacijski signal, potreben za polno aktivacijo T limfocitne ekspresije CD28.
Abatacept decreases antigen specific TNFα, interferon-γ, and interleukin-2 production by T lymphocytes.
Abatacept zmanjša T limfocitno produkcijo antigensko specifičnega TNFα, interferona- γ in interlevkina- 2.
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.
Farmakodinamični učinki Opazili so od odmerka odvisno zmanjšanje topnega receptorja za interlevkin- 2 v serumu, označevalca aktivacije limfocitov T; serumskega interlevkina- 6, produkta aktiviranih sinovijskih makrofagov in fibroblastom podobnih sinoviocitov pri revmatoidnem artritisu; revmatoidnega faktorja, avtoprotiteles, ki jih proizvajajo plazmatke in C- reaktivnega proteina, reaktanta akutne faze vnetja.
In addition, serum levels of matrix metalloproteinase-3, which produces cartilage destruction and tissue remodelling, were decreased.
Zmanjšale so se tudi serumske vrednosti matriks metaloproteinaze- 3, ki povzroča poškodbe hrustanca in preoblikovanje tkiva.
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.
Klinična učinkovitost in varnost Učinkovitost in varnost abatacepta so vrednotili v randomiziranih, dvojno slepih, s placebom nadzorovanih kliničnih preskušanjih pri odraslih bolnikih z aktivnim revmatoidnim artritisom, diagnosticiranim po kriterijih Ameriškega združenja za revmatologijo (ACR; “ American College of Rheumatology ”).
Studies I, II, III, and V required patients to have at least 12 tender and 10 swollen joints at randomization.
V študije I, II, III in V so bili vključeni bolniki, ki so ob randomizaciji imeli vsaj 12 občutljivih in 10 oteklih sklepov.
In Studies I, II, and V the efficacy and safety of abatacept compared to placebo were assessed in patients with an inadequate response to methotrexate and who continued on their stable dose of methotrexate.
Bolniki so še naprej prejemali stabilni odmerek metotreksata.
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.
V študiji III so učinkovitost in varnost abatacepta vrednotili pri bolnikih z
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.
Študija IV je predvsem vrednotila varnost pri bolnikih z aktivnim revmatoidnim artritisom, ki so potrebovali dodatno ukrepanje kljub trenutnemu zdravljenju z nebiološkimi in/ ali biološkimi imunomodulirajočimi protirevmatičnimi zdravili.
Study I patients were randomized to receive abatacept 2 or 10 mg/ kg or placebo for 12 months.
V študiji I so bili bolniki za 12 mesecev randomizirani na abatacept v odmerku 2 ali 10 mg/ kg ali placebo.
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).
V študijah II, III in IV so bili bolniki randomizirani tako, da so 12 mesecev (študiji II in IV) ali 6 mesecev (študija III) prejemali fiksni odmerek približno 10 mg/ kg abatacepta ali placeba.
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.
Pri bolnikih s telesno maso, manjšo od 60 kg, je bil odmerek abatacepta 500 mg, pri bolnikih s telesno maso od 60 do 100 kg 750 mg, pri bolnikih s telesno maso, večjo od 100 kg, pa 1 gram.
Study V patients were randomized to receive this same fixed dose of abatacept or 3 mg/ kg infliximab or placebo for 6 months.
V študiji V so bili bolniki randomizirani tako, da so 6 mesecev prejemali ta isti fiksni odmerek abatacepta, 3 mg/ kg infliksimaba ali placebo.
9 Studies I, II, III, IV, and V evaluated 339, 638, 389, 1,441, and 431 patients, respectively.
V študijo I je bilo vključenih 339, v študijo II 638, v študijo III 389, v študijo IV 1. 441 in v študijo V 431 bolnikov.
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.
ACR odziv Odstotek odzivov ACR 20, 50 in 70 pri bolnikih, ki so prejemali abatacept v študiji II (bolniki z nezadostnim odzivom na metotreksat) in študiji III (bolniki z nezadostnim odzivom na zaviralec TNF), je prikazan v tabeli 3.
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.
Izboljšanje je ostalo pomembno ves čas trajanja študij.
Table 3:
10 Tabela 3:
ACR
ACR
Responses in Placebo-Controlled Trials
odziv v s placebom nadzorovanih preskušanjih
Percent of Patients Inadequate Response to Inadequate Response to Methotrexate (MTX) TNF Blocking Agent Study II Study III a
Odstotek bolnikov Nezadosten odziv na Nezadosten odziv na zaviralec metotreksat (MTX) TNF Študija II Študija III Abatacepta Abatacepta
Abatacept Placebo Abatacepta +MTX +MTX + DMARDsb +
Placebo + DMARDsb + +MTX +MTX
Response Rate ACR 20
Obseg odziva ACR 20
n = 424 n = 214 n = 256
n = 424 n = 214 n = 256 23% * 18% **
Day 15 Month 6 Month 12 ACR 50
6. mesec 12. mesec ACR 50
23%* 14% 18%** 68%*** 40% 50%*** 73%*** 40% NAd
40% 73% *** NAd 40% 40% *** 20% ***
5% 20% NAd
20% NAd
Month 6 Month 12 ACR 70
6. mesec
Month 6 Month 12 Major Clinical
6. mesec
20%*** 7% 10%** 29%*** 6% NAd
7%
Responsec *
odzivc *
14%*** 2% NAd
14% *** NAd 2%
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.
p < 0, 05, abatacept v primerjavi s placebom. ** p < 0, 01, abatacept v primerjavi s placebom. *** p < 0, 001, abatacept v primerjavi s placebom. a Fiksni odmerek približno 10 mg/ kg (glejte poglavje 4. 2). b Sočasna imunomodulirajoča protirevmatična zdravila (DMARDs; “ disease- modifying anti- rheumatic drugs ”) so vključevala enega ali več naslednjih: metotreksat, klorokin/ hidroksiklorokin, sulfasalazin, leflunomid, azatioprin, zlato in anakinro. c Večji klinični odziv je definiran kot dosežen odziv ACR 70, ki je trajal neprekinjeno 6 mesecev. d Po 6 mesecih so imeli bolniki možnost vključitve v odprto študijo.
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.
Trajanje in ohranitev odzivov ACR 20, 50 in 70 so v odprtem podaljšku študije I spremljali 48 mesecev zdravljenja z abataceptom, v odprtem podaljšku študije II 24 mesecev zdravljenja z abataceptom, v odprtem podaljšku študije III pa 18 mesecev zdravljenja z abataceptom.
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.
V študiji I so po 48 mesecih odziv ACR 20 ugotovili pri 71% (42/ 59) bolnikov, ACR 50 pri 41% (24/ 59) in ACR 70 pri 31% (18/ 58) bolnikov.
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.
V študiji II so po 24 mesecih odziv ACR 20 ugotovili pri 88% (291/ 332) bolnikov, ACR 50 pri 62% (205/ 332) in ACR 70 pri 38% (127/ 334) bolnikov.
In study III, ACR 20 responses were observed in 70% (118/ 167) of patients, ACR 50 in 43% (73/ 168), and ACR 70 in 22% (37/ 169) at 18 months.
V študiji III so po 18 mesecih odziv ACR 20 ugotovili pri 70% (118/ 167) bolnikov, ACR 50 pri 43% (73/ 168) in ACR 70 pri 22% (37/ 169) bolnikov.