natgillin/translations-raw huggingface dataset:
Cases of tuberculosis, sometimes fatal, including miliary tuberculosis and tuberculosis with extrapulmonary location have been reported (see section 4.4).
Poročali so tudi o primerih tuberkuloze, včasih celo s smrtnim izidom, vključno z miliarno tuberkulozo in tuberkulozo izven pljuč (glejte poglavje 4. 4).
Malignancies and lymphoproliferative disorders:
Maligne in limfoproliferativne bolezni:
In clinical studies with infliximab in which 5780 patients were treated, representing 5494 patient years, 5 cases of lymphomas and 26 non-lymphoma malignancies were detected as compared with no lymphomas and 1 non-lymphoma malignancy in 1600 placebo-treated patients representing 941 patient years.
V kliničnih študijah z infliksimabom, v katerih je bilo zdravljenih 5780 bolnikov, to pomeni skupaj 5494 bolnikov x let, so odkrili 5 primerov limfoma in 26 nelimfomskih rakavih bolezni, pri 1600 s placebom zdravljenih bolnikih, to pomeni skupaj 941 bolnikih x letih, pa nič limfomov in 1 nelimfomsko rakavo bolezen.
In long-term safety follow-up of clinical studies with infliximab of up to 5 years, representing 6234 patients-years (3210 patients), 5 cases of lymphoma and 38 cases of non-lymphoma malignancies were reported.
Pri spremljanju dolgoročne varnosti infliksimaba do 5 let po kliničnih študijah, to pomeni pri skupaj 6234 bolnikih x letih (3210 bolnikov), pa so poročali o 5 primerih limfoma in 38 primerih nelimfomskih rakavih bolezni.
From August 1998 to August 2005, 1909 cases of suspected malignancies have been reported from post-marketing, clinical studies and registries (321 in Crohn’ s disease patients, 1302 in rheumatoid arthritis patients and 286 in patients with other or unknown indications).
Od avgusta 1998 do avgusta 2005 so na podlagi post- marketinških izkušenj, kliničnih študij in registrov poročali o 1909 primerih suma na maligno bolezen( 321 pri bolnikih s Crohnovo boleznijo, 1302 pri bolnikih z revmatoidnim artritisom in 286 pri bolnikih z drugimi neznanimi indikacijami).
Among those there were 347 lymphoma cases.
Od tega je bilo 347 primerov limfoma.
During this period, the estimated exposure is 1,909,941 patient years since first exposure (see section 4.4:
Ocenjujejo, da je bilo v tem času približno 1. 909. 941 bolnikov x let zdravljenih z infliksimabom od prvega zdravljenja (glejte poglavje 4. 4.
Special Warnings and Special Precautions for Use - "Malignancies").
Posebna opozorila in previdnostni ukrepi – "Maligne bolezni").
In an exploratory clinical study involving patients with moderate to severe COPD who were either current smokers or ex-smokers, 157 patients were treated with Remicade at doses similar to those used in RA and Crohn’ s disease.
V poskusnem kliničnem preskušanju pri bolnikih z zmerno do hudo KOPB, ki so bili bodisi aktivni kadilci ali bivši kadilci, je bilo 157 bolnikov zdravljenih z zdravilom REMICADE v odmerkih, podobnih tistim, ki se uporabljajo pri revmatoidnem artritisu in pri Crohnovi bolezni.
The median duration of follow-up was 0.8 years (incidence 5.7% [95% CI 2.65% - 10.6%].
Mediana dolžina spremljanja bolnikov je bila 0, 8 let (incidenca 5, 7% [95% IZ 2, 65% - 10, 6%].
There was one reported malignancy amongst 77 control patients (median duration of follow-up 0.8 years; incidence 1.3% [95% CI 0.03% - 7.0%]).
Pri 77 bolnikih iz kontrolne skupine so poročali o enem malignomu (mediana dolžina spremljanja bolnikov je bila 0, 8 let, incidenca pa 1, 3% [95% IZ 0, 03% - 7, 0%]).
Rare post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients with Crohn’ s disease and ulcerative colitis treated with Remicade, the majority of whom were adolescent or young adult males (see section 4.4).
Ti bolniki so večinoma sodili med mladostnike ali mlajše odrasle moške (glejte poglavje 4. 4).
In a phase II study aimed at evaluating Remicade in congestive heart failure (CHF), higher incidence of mortality due to worsening of heart failure were seen in patients treated with Remicade, especially those treated with the higher dose of 10 mg/ kg (i. e. twice the maximum approved dose).
V študiji faze II, katere cilj je bil ovrednotiti zdravilo Remicade pri kongestivnem srčnem popuščanju (CHF- congestive heart failure), so pri bolnikih, zdravljenih s tem zdravilom, ugotavljali večjo incidenco smrtnosti zaradi poslabšanja srčnega popuščanja, še posebej pri tistih, ki so prejemali večji odmerek 10 mg/ kg (dvakrat več od največjega odobrenega odmerka).
In this study 150 patients with NYHA Class III-IV CHF (left ventricular ejection fraction ≤ 35%) were treated with 3 infusions of Remicade 5 mg/ kg, 10 mg/ kg, or placebo over 6 weeks.
V tej študiji je bilo 150 bolnikov s srčnim popuščanjem stopnje III do IV po NYHA (iztisni delež levega ventrikla < 35%) zdravljenih s tremi infuzijami: dveh z zdravilom Remicade v odmerkih 5 mg/ kg in 10 mg/ kg in eni s placebom 6 tednov.
At 38 weeks, 9 of 101 patients treated with Remicade (2 at 5 mg/ kg and 7 at 10 mg/ kg) died compared to one death among the 49 patients on placebo.
Po 38 tednih je umrlo 9 od 101 bolnikov, zdravljenih z zdravilom Remicade (2 z odmerkom 5 mg/ kg in 7 z odmerkom 10 mg/ kg), v primerjavi z eno smrtjo pri 49 bolnikih, ki so prejemali placebo.
There have been post-marketing reports of worsening heart failure, with and without identifiable precipitating factors, in patients taking Remicade.
14 Obstajajo postmarketinška poročila o poslabševanju srčnega popuščanja pri bolnikih, ki so jemali zdravilo Remicade, z ali brez ugotovljivih dejavnikov, ki bi lahko poslabšali stanje.
There have also been rare post-marketing reports of new onset heart failure, including heart failure in patients without known pre-existing cardiovascular disease.
Obstaja tudi nekaj redkih postmarketinških poročil o novonastalem srčnem popuščanju, vključno s srčnim popuščanjem pri bolnikih brez znane predhodne oz. obstoječe srčnožilne bolezni.
Hepatobiliary events:
Sopojavi na jetrih, žolčniku in žolčevodih:
Elevations of ALT ≥ 5 x ULN have been observed (see Table 2).
Opazili so zvišanje vrednosti ALT na ≥5- kratnik zgornje meje normalnih vrednosti (glejte preglednico 2).
In post- marketing surveillance, very rare cases of jaundice and hepatitis, some with features of autoimmune hepatitis, have been reported in patients receiving Remicade (see section 4.4)
V okviru postmarketinških izkušenj so pri bolnikih, ki so prejemali zdravilo Remicade, poročali o zelo redkih primerih zlatenice in hepatitisa, pri nekaterih tudi z znaki avtoimunskega hepatitisa (glejte poglavje 4. 4).
14 Table 2:
Preglednica 2:
Proportion of patients with increased ALT activity in Clinical Studies
Delež bolnikov s povišano vrednostjo ALT v kliničnih preskušanjih.
Indication
Število bolnikov3
Number of patients3
Indikacija
Median follow-up (wks)4
Mediana dolžina spremljanja bolnikov (tedni) 4
≥ 3 x ULN
≥5- kratnik ZMN
≥ 5 x ULN
placebo
Crohn’ s disease2
Crohnova bolezen2
Pediatric Crohn’ s disease
Pediatrična Crohnova bolezen
Ankylosing spondylitis
Ankiloziraj oči spondilitis
2 Placebo patients in the 2 Phase III studies in Crohn’ s disease, ACCENT I and ACCENT II, received an initial dose of 5 mg/ kg infliximab at study start and were on placebo in the maintenance phase.
2 V dveh preskušanjih tretje faze pri Crohnovi bolezni, ACCENT I in ACCENT II, so bolniki iz placebo skupine na začetku obeh študij prejeli začetni odmerek infliksimaba 5 mg/ kg telesne mase, v fazi vzdrževalnega zdravljenja pa so prejemali placebo.
Patients who were randomized to the placebo maintenance group and then later crossed over to infliximab are included in the infliximab group in the ALT analysis.
Bolniki, ki so jih naključno razporedili v skupino za vzdrževalno zdravljenje s placebom in so potem prešli v skupino za zdravljenje z infliksimabom, so bili pri analizi ALT vključeni v infliksimabovo skupino.
4 Median follow-up is based on patients treated.
Mediana dolžina spremljanja bolnikov je bila določena samo z upoštevanjem zdravljenih bolnikov.
Antinuclear antibodies (ANA)/ Anti-double-stranded DNA (dsDNA) antibodies:
Protitelesa proti celičnemu jedru (ANA- anticelular antibodies) / protitelesa proti dvojnoverižni DNA (dsDNA):
Approximately half of infliximab-treated patients in clinical studies who were ANA negative at baseline developed a positive ANA during the study compared with approximately one-fifth of placebo-treated patients.
Približno polovica bolnikov, zdravljenih z infliksimabom v kliničnih študijah, ki so imeli na začetku negativen izvid na ANA, je imelo med študijo pozitiven izvid na ANA, v primerjavi s približno eno petino bolnikov, ki so prejemali placebo.
Anti- dsDNA antibodies were newly detected in approximately 17% of infliximab-treated patients compared with 0% of placebo-treated patients.
Protitelesa anti- dsDNA so na novo ugotovili pri približno 17% bolnikov, zdravljenih z infliksimabom, v primerjavi z 0% bolnikov, ki so prejemali
At the last evaluation, 57% of infliximab-treated patients remained anti-dsDNA positive.
Ob zadnji oceni je bilo 57% bolnikov, zdravljenih z infliksimabom, še vedno pozitivnih na anti- dsDNA.
Reports of lupus and lupus-like syndromes, however, remain uncommon.
Poročila o pojavu lupusa in lupusu podobnih sindromov, pa so še vedno občasna.
Additional information on special populations
Dodatne informacije za posebno skupino bolnikov
Juvenile Rheumatoid Arthritis patients:
Bolniki z juvenilnim revmatoidnim artritisom:
4-17 years old) with active JRA despite methotrexate.
Zdravilo Remicade so proučevali v preskušanju pri 120 bolnikih (razpon starosti od 4 do 17 let), ki so imeli aktivni JRA kljub zdravljenju z metotreksatom.
Patients received 3 or 6 mg/ kg infliximab as a 3-dose induction regimen (weeks 0, 2, 6 or weeks 14, 16, 20 respectively) followed by maintenance therapy every 8 weeks, in combination with methotrexate.
Ti bolniki so prejemali uvodno shemo iz treh odmerkov infliksimaba 3 mg/ kg oziroma 6 mg/ kg (v tednih 0, 2 in 6 oziroma v tednih 14, 16 in 20), potem pa je sledilo vzdrževalno zdravljenje na vsakih 8 tednov, v kombinaciji z metotreksatom.
Infusion reactions Infusion reactions occurred in 35% of patients with JRA receiving 3 mg/ kg compared with 17.5% of patients receiving 6 mg/ kg.
Infuzijske reakcije Infuzijske reakcije so se pojavile pri 35% bolnikov z JRA, ki so prejemali odmerek 3 mg/ kg, v primerjavi s 17, 5% tistih, ki so prejemali odmerek 6 mg/ kg.
In the 3 mg/ kg Remicade group, 4 out of 60 patients had a serious infusion reaction and 3 patients reported a possible anaphylactic reaction (2 of which were among the serious infusion reactions).
V skupini, ki je zdravilo Remicade prejemala v odmerku 3 mg/ kg, so imeli 4 od 60- tih bolnikov resno infuzijsko reakcijo, pri 3 pa so poročali o možni anafilaktični reakciji (od tega sta 2 sodili med resne infuzijske reakcije).
In the 6 mg/ kg group, 2 out of 57 patients had a serious infusion reaction, one of whom had a possible anaphylactic reaction.
V skupini, ki je zdravilo prejemala v odmerku 6 mg/ kg, pa sta imela 2 od 57- tih bolnikov resno infuzijsko reakcijo in eden od njiju je morda imel anafilaktično reakcijo.
Immunogenicity Antibodies to infliximab developed in 38% of patients receiving 3 mg/ kg compared with 12% of patients receiving 6 mg/ kg.
Imunogenost Protitelesa proti infliksimabu so se pojavila pri 38% bolnikov, ki so prejemali odmerek 3 mg/ kg, v primerjavi z 12% bolnikov, ki so prejemali odmerek 6 mg/ kg.
The antibody titers were notably higher for the 3 mg/ kg compared to the 6 mg/ kg group.
Titri protiteles v skupini, ki je prejemala odmerek 3 mg/ kg, so bili opazno višji kot v tisti, ki je prejemala 6 mg/ kg.
15 Infections Infections occurred in 68% (41/ 60) of children receiving 3 mg/ kg over 52 weeks, 65% (37/ 57) of children receiving infliximab 6 mg/ kg over 38 weeks and 47% (28/ 60) of children receiving placebo over 14 weeks.
Okužbe Okužbe so se pojavile pri 68% (41/ 60) otrok, ki so prejemali infliksimab v odmerku 3 mg/ kg v času 52 tednov, pri 65% (37/ 57) otrok, ki so prejemali infliksimab v odmerku 6 mg/ kg v času 38 tednov, in pri 47% (28/ 60) otrok, ki so prejemali placebo v času 14 tednov.
Paediatric Crohn’ s disease patients:
Crohnova bolezen pri pediatričnih bolnikih:
The following adverse events were reported more commonly in paediatric Crohn’ s disease patients in the REACH study (see section 5.1) than in adult Crohn’ s disease patients: anaemia (10.7%), blood in stool (9.7%), leukopenia (8.7%), flushing (8.7%), viral infection (7.8%), neutropenia (6.8%), bone fracture (6.8%), bacterial infection (5.8%), and respiratory tract allergic reaction (5.8%).
Naslednje neželene učinke so v preskušanju REACH prijavljali pogosteje pri pediatričnih bolnikih s Crohnovo boleznijo (glejte poglavje 5. 1) kot pri odraslih bolnikih s Crohnovo boleznijo: anemija (10, 7%), kri v blatu (9, 7%), levkopenija (8, 7%), pordelost (8, 7%), virusne okužbe (7, 8%), nevtropenija (6, 8%), zlomi kosti (6, 8%), bakterijske okužbe (5, 8%), alergijske reakcije dihal (5, 8%).
Infusion-related reactions Overall, in REACH, 17.5% of randomized patients experienced 1 or more infusion reactions.
Infuzijske reakcije V preskušanju REACH se je pri skupaj 17, 5% naključno razvrščenih bolnikov pojavila ena oziroma več infuzijskih reakcij.
There were no serious infusion reactions, and 2 subjects in REACH had non-serious anaphylactic reactions.
Ni bilo nobene resne infuzijske reakcije, dva preiskovanca v preskušanju REACH pa sta imela anafilaktično reakcijo, ki ni bila resna.
Immunogenicity Antibodies to infliximab were detected in 3 (2.9%) paediatric patients.
Okužbe V preskušanju REACH so o okužbah poročali pri 56, 3% randomiziranih preiskovancih, zdravljenih z infliksimabom.
Infections In the REACH study, infections were reported in 56.3% of randomized subjects treated with infliximab.
O okužbah so pogosteje poročali pri tistih preiskovancih, ki so prejemali infuzije na vsakih 8 tednov, kot pa pri tistih, ki so jih prejemali na vsakih 12 tednov (73, 6% prvih in 38, 0% drugih).
Post-marketing spontaneous serious adverse events with infliximab in the paediatric population have included malignancies including hepatosplenic T-cell lymphomas, transient hepatic enzyme abnormalities, lupus-like syndromes, and positive autoantibodies (see sections 4.4 and 4.8: ‘ Malignancies and lymphoproliferative disorders’).
16 Med spontano prijavljenimi resnimi neželenimi učinki v okviru postmarketinških izkušenj z uporabo infliksimaba pri pediatričnih bolnikih so bili tudi malignomi, vključno s T- celičnimi limfomi jeter in vranice, prehodno nenormalnimi izvidi jetrnih encimov, lupusu podobnimi sindromi in pozitivnimi izvidi na avtoprotitelesa (glejte poglavji 4. 4 in 4. 8 Malignomi in limfoproliferativne bolezni).
Single doses up to 20 mg/ kg have been administered without toxic effects.
Uporabljeni so bili enkratni odmerki infliksimaba do 20 mg/ kg in ti niso povzročili toksičnih učinkov.
L04AB02.
Farmakoterapevtska skupina: zdravila za selektivno zaviranje imunske odzivnosti, oznaka ATC: L04AB02.
Pharmacodynamic properties:
Farmakodinamične lastnosti:
Infliximab is a chimeric human-murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of TNFα but not to lymphotoxin α (TNFß).
Infliksimab je himerno človeško- mišje monoklonsko protitelo, ki se z veliko afiniteto veže tako na topne kot na transmembranske oblike TNFα, ne pa tudi na limfotoksin α (TNFß).
Infliximab prevented disease in transgenic mice that develop polyarthritis as a result of constitutive expression of human TNFα and when administered after disease onset, it allowed eroded joints to heal.
Če so ga dali kmalu po nastopu bolezni, je celo omogočil celjenje erozij sklepov.
In rheumatoid arthritis, treatment with infliximab reduced
V sklepih bolnikov z revmatoidnim artritisom so ugotavljali povečano koncentracijo TNFα in ta je bila v korelaciji s povečano aktivnostjo bolezni.
16 infiltration of inflammatory cells into inflamed areas of the joint as well as expression of molecules mediating cellular adhesion, chemoattraction and tissue degradation.
Pri revmatoidnem artritisu je zdravljenje z infliksimabom zmanjšalo infiltracijo vnetnih celic v vnete dele sklepov, pa tudi ekspresijo molekul, ki sodelujejo pri celični adheziji, kemotaksi in razgradnji tkiva.
After infliximab treatment, patients exhibited decreased levels of serum interleukin 6 (IL-6) and C-reactive protein (CRP), and increased haemoglobin levels in rheumatoid arthritis patients with reduced haemoglobin levels, compared with baseline.
Po zdravljenju z infliksimabom se je pri bolnikih zmanjšala serumska koncentracija interlevkina 6 (IL- 6) in C- reaktivnega proteina (CRP) v primerjavi z izhodiščno vrednostjo.
Infliximab treatment of Crohn’ s disease patients was also associated with a substantial reduction of the commonly elevated serum inflammatory marker, CRP.
Pri bolnikih s Crohnovo boleznijo je bilo zdravljenje z infliksimabom tudi povezano z znatnim zmanjšanjem običajno zvišane serumske koncentracije vnetnega pokazatelja CRP in zviša nivo hemoglobina pri bolnikih z revmatoidnim artritisom, ki imajo ta nivo sicer znižan.
Total peripheral white blood cell counts were minimally affected in infliximab-treated patients, although changes in lymphocytes, monocytes and neutrophils reflected shifts towards normal ranges.
Na celotno število levkocitov v periferni krvi je zdravilo vplivalo le minimalno, četudi so ugotavljali pomik števila limfocitov, monocitov in nevtrofilcev v smeri proti normalnim vrednostim.
Peripheral blood mononuclear cells (PBMC) from infliximab-treated patients showed undiminished proliferative responsiveness to stimuli compared with untreated patients, and no substantial changes in cytokine production by stimulated PBMC were observed following treatment with infliximab.
Prav tako niso opazili bistvenih sprememb v tvorbi citokinov v stimuliranih mononuklearnih celicah iz periferne krvi po zdravljenju z infliksimabom.
Clinical Efficacy
Pri bolnikih, ki so se zdravili z zdravilom infliksimab, so v endoskopskih študijah opazili znake celjenja črevesne sluznice.
Rheumatoid arthritis
Klinična učinkovitost
The efficacy of infliximab was assessed in two multicentre, randomised, double-blind, pivotal clinical studies:
17 Revmatoidni artritis Učinkovitost infliksimaba so ocenjevali v dveh multicentričnih, randomiziranih, dvojno slepih osrednjih preskušanjih:
ATTRACT and ASPIRE.
ATTRACT in ASPIRE.
In both studies concurrent use of stable doses of folic acid, oral corticosteroids (≤ 10 mg/ day) and/ or non-steroidal anti-inflammatory drugs (NSAIDs) was permitted.
V obeh študijah je bilo dovoljeno sočasno jemanje stalnih odmerkov folne kisline, peroralnih kortikosteroidov (≤ 10 mg/ dan) in/ ali nesteroidnih protivnetnih zdravil (NSAID).
The primary endpoints were the reduction of signs and symptoms as assessed by the American College of Rheumatology criteria (ACR20 for ATTRACT, landmark ACR-N for ASPIRE), the prevention of structural joint damage, and the improvement in physical function.
Primarni cilji študije so bili zmanjšanje znakov in simptomov bolezni, kar so ocenjevali po merilih Ameriškega revmatološkega združenja (ACR - American College of Rheumatology criteria) (ACR 20 za ATTRACT, mejna vrednost ACR- N za ASPIRE), preprečevanje strukturne okvare sklepov in izboljšanje njihove funkcije.
A reduction in signs and symptoms was defined to be at least a 20% improvement (ACR20) in both tender and swollen joint counts, and in 3 of the following 5 criteria:
Zmanjšanje znakov in simptomov so opredelili kot najmanj 20% izboljšanje (ACR 20) števila bolečih in oteklih sklepov ter 3 od naslednjih 5 meril:
(1) evaluator’ s global assessment, (2) patient’ s global assessment, (3) functional/ disability measure, (4) visual analogue pain scale and (5) erythrocyte sedimentation rate or C-reactive protein.
(1) zdravnikove splošne ocene, (2) bolnikove splošne ocene, (3) merila funkcionalne prizadetosti/ neprizadetosti, (4) vizualne analogne lestvice bolečine in (5) hitrosti sedimentacije eritrocitov ali C- reaktivnega proteina.
ACR-N uses the same criteria as the ACR20, calculated by taking the lowest percent improvement in swollen joint count, tender joint count, and the median of the remaining 5 components of the ACR response.
ACR- N temelji na istih merilih kot ACR 20, kar se izračuna z upoštevanjem najmanjšega odstotnega izboljšanja števila oteklih sklepov, števila bolečih sklepov in mediane vrednosti preostalih 5 komponent odziva ACR.
The Health Assessment Questionnaire (HAQ; scale 0-3) was used to measure patients’ average change from baseline scores over time, in physical function.
Vprašalnik za oceno zdravstvenega stanja (HAQ - Health Assessment Questionnaire, lestvica 0 - 3) so uporabljali za merjenje povprečne spremembe vrednosti za funkcijo sklepov s časom, v primerjavi z začetnimi vrednostmi.
Approximately 50% of patients were in functional Class III.
Približno 50% teh bolnikov je bilo v funkcijskem razredu III.
Patients received placebo, 3 mg/ kg or 10 mg/ kg infliximab at weeks 0, 2 and 6, and then every 4 or 8 weeks thereafter.
Bolniki so prejemali bodisi placebo v odmerku 3 mg/ kg ali infliksimab v odmerku 10 mg/ kg v tednih 0, 2 in 6, potem pa na vsake 4 tedne do 8 tednov.
All patients were on stable methotrexate doses (median 15 mg/ wk) for 6 months prior to enrolment and were to remain on stable doses throughout the study.
Vsi bolniki so prejemali stalne odmerke metotreksata (mediani odmerek 15 mg/ teden) že 6 mesecev pred vključitvijo v študijo in ves čas študije.
Higher degrees of clinical response (ACR50 and ACR70) were observed in all infliximab groups at 30 and 54 weeks compared with methotrexate alone.
Izrazitejši klinični odziv (ACR 50 in ACR 70) so opažali v 30. in 54. tednu v vseh skupinah, ki so prejemale infliksimab, v primerjavi z bolniki, ki so prejemali le metotreksat.
17 A reduction in the rate of the progression of structural joint damage (erosions and joint space narrowing) was observed in all infliximab groups at 54 weeks (Table 3).
V 54. tednu so v vseh skupinah, ki so prejemale infliksimab, ugotavljali zmanjšanje hitrosti napredovanja strukturne okvare sklepov (erozije in zožitev sklepne špranje) (preglednica 3).
18 Table 3 Effects on ACR20, Structural Joint Damage and Physical Function at week 54, ATTRACT infliximabb
Učinki na ACR 20, strukturno okvaro sklepov in funkcijo sklepov v 54. tednu, študija ATTRACT infliksimabb
10 mg/ kg
10 mg/ kg skupaj za
All
15/ 88
Controla
36/ 86
q 8 wks q 4 wks
41/ 86
q 8 wks
51/ 87
q 4 wks
48/ 81
infliximabb
176/ 340
Patients with ACR20 response/ Patients evaluated (%)c
ACR 20 / pregledani bolniki (%) c
15/ 88 (17%)
(17%)
36/ 86 41/ 86 (42%) (48%)
(42%)
51/ 87 (59%)
(48%)
48/ 81 (59%)
(59%) (59%)
Total scored (van der Heijde-modified Sharp score)
skupni rezultatd (po metodi van modificirani po Sharpu)
Change from baseline (Mean ± SDc) c
sprememba glede na začetno vrednost (srednja vr. ± SDc)
7.0 ± 10.3 1.3 ± 6.0
± 10, 3
1.6 ± 8.5
1, 3 ± 6, 0
-0.7 ± 3.8
- 0, 7 ± 3, 8
0.6 ± 5.9
0, 6 ± 5, 9
(Interquartile range)
(- 1, 5; 3, 0) 34/ 71 18
(0.5,9.7)
(- 2, 5; 3, 0) 35/ 71
(-1.5,3.0) (-2.5,3.0) (-1.5,2.0) (-3.0,1.5)
(- 1, 5; 2, 0) 37/ 77
(-1.8,2.0)
(- 3, 0; 1, 5) 44/ 66
Patients with no deterioration/ patients evaluated (%)c
pregledani bolniki (%) c spreminjanje HAQ glede
13/ 64 (20%)
(20%)
34/ 71 35/ 71 37/ 77 (48%) (49%) (48%)
(48%)
44/ 66 (67%)
(67%)
150/ 285 (53%)
(53
HAQ change from baseline over timee
na začetno vrednost s časome (pregledani bolniki)
a: control = All patients had active RA despite treatment with stable methotrexate doses for 6 months prior to enrolment and were to remain on stable doses throughout the study.
Vsi bolniki so imeli aktivni revmatoidni artritis kljub zdravljenju s stalnimi odmerki metotreksata že 6 mesecev pred vključitvijo v študijo; te odmerke so prejemali še naprej ves čas študije.