natgillin/translations-raw huggingface dataset:
(1) Evaluators samlede vurdering, (2) patientens samlede vurdering, (3) funktions/ handicap mål, (4) visuel analog smerteskala og (5) erytrocyt - sedimentationshastighed eller C- reaktiv protein.
(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.
ACR- N anvender de samme kriterier som ACR20, beregnet ved at tage den laveste procentvise forbedring i antallet af hævede led, antallet af ømme led og medianen af de sidste 5 komponenter af ACR responset.
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.
Strukturel ledskade (erosioner og forsnævring af ledspalte) i begge hænder og fødder blev målt som ændringen fra baseline i total van der Heijde- modified Sharp score (0- 440).
Structural joint damage (erosions and joint space narrowing) in both hands and feet was measured by the change from baseline in the total van der Heijde-modified Sharp score (0-440).
Health Assessment Questionnaire (HAQ; scale 0- 3) blev anvendt til at måle patienternes gennemsnitlige ændring i fysisk funktionsevne fra baseline scores over tiden.
The Health Assessment Questionnaire (HAQ; scale 0-3) was used to measure patients’ average change from baseline scores over time, in physical function.
ATTRACT undersøgelsen evaluerede responset ved ugerne 30, 54 og 102 i en placebokontrolleret undersøgelse hos 428 patienter med aktiv rheumatoid arthrit på trods af behandling med methotrexat.
The ATTRACT study evaluated responses at 30, 54 and 102 weeks in a placebo-controlled study of 428 patients with active rheumatoid arthritis despite treatment with methotrexate.
Patienterne fik placebo, 3 mg/ kg eller 10 mg/ kg infliximab i ugerne 0, 2 og 6, samt hver 4. eller 8. uge herefter.
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.
Alle patienterne fik konstante methotrexat doser (median 15 mg/ uge) i 6 måneder før inklusionen og skulle fortsætte med konstante doser under hele undersøgelsen.
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.
Resultater fra uge 54 (ACR20, total van der Heijde- modified Sharp score og HAQ) er vist i tabel 3.
Results from week 54 (ACR20, total van der Heijde-modified Sharp score and HAQ) are shown in Table 3.
Højere grader af klinisk respons (ACR50 og ACR70) blev set i alle infliximabgrupper ved 30 og 54 uger sammenlignet med methotrexat alene.
Higher degrees of clinical response (ACR50 and ACR70) were observed in all infliximab groups at 30 and 54 weeks compared with methotrexate alone.
En reduktion i hastigheden af progressionen af strukturel ledskade (erosioner og forsnævring af ledspalte) blev set i alle infliximabgrupper ved 54 uger (tabel 3).
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).
17 De virkninger, der sås ved 54 uger, blev opretholdt i 102 uger.
The effects observed at 54 weeks were maintained through 102 weeks.
Tabel 3 Virkninger på ACR20, strukturel ledskade og fysisk funktionsevne ved uge 54, ATTRACT infliximabb 3 mg/ kg 3 mg/ kg 10 mg/ kg 10 mg/ kg Alle
18 Table 3 Effects on ACR20, Structural Joint Damage and Physical Function at week 54, ATTRACT infliximabb
Kontrola
3 mg/ kg 3 mg/ kg
hver 8. uge
10 mg/ kg
hver 4. uge
10 mg/ kg
hver 8. uge
Controla
hver 4. uge
q 8 wks q 4 wks
infliximabb
infliximabb
Patienter med ACR20 respons / patienter evalueret (%) c
Patients with ACR20 response/ Patients evaluated (%)c
Total scored (van der Heijde- modified Sharp score) Ændring fra baseline
Total scored (van der Heijde-modified Sharp score)
(Gennemsnit ± SDc)
Change from baseline (Mean ± SDc) c
- 0, 7 ± 3, 8 0, 6 ± 5, 9
-0.7 ± 3.8
Medianc
0.6 ± 5.9
4, 0
Median
0, 5
4.0 0.5
(Interkvartil interval)
(Interquartile range)
(0, 5; 9, 7)
(0.5,9.7)
(- 1, 5; 3, 0) (- 2, 5; 3, 0) (- 1, 5; 2, 0) (- 3, 0; 1, 5) (- 1, 8; 2, 0)
(-1.5,3.0) (-2.5,3.0) (-1.5,2.0) (-3.0,1.5)
Patienter uden forværring/ patienter evalueret (%) c
Patients with no deterioration/ patients evaluated (%)c
34/ 71 35/ 71 37/ 77 44/ 66 (48%) (49%) (48%) (67%)
34/ 71 35/ 71 37/ 77 (48%) (49%) (48%)
HAQ ændring fra baseline over tidene
HAQ change from baseline over timee
86 85 87 81
81
0, 4 ± 0, 3 0, 5 ± 0, 4 0, 5 ± 0, 5 0, 4 ± 0, 4
0.4 ± 0.3 0.5 ± 0.4 0.5 ± 0.5
a:
0.4 ± 0.4
Kontrol = Alle patienter havde aktiv RA på trods af behandling med stabile methotrexat doser i 6 måneder før inklusion og skulle fortsætte på stabile doser gennem undersøgelsen.
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.
Større værdier indikerer mere uarbejdsdygtighed. e:
Concurrent use of stable doses of oral corticosteroids (≤ 10 mg/ day) and/ or NSAIDs was permitted, and folate supplementation was given. b: all infliximab doses given in combination with methotrexate and folate with some on corticosteroids and/ or NSAIDs c: p < 0.001, for each infliximab treatment group vs. control d: greater values indicate more joint damage. e:
ASPIRE undersøgelsen evaluerede respons ved uge 54 hos 1004 methotrexat naive patienter med tidlig (≤3 års sygdomsvarighed, median 0, 6 år) aktiv rheumatoid arthrit (median antallet af hævede og ømme led var henholdsvis 19 og 31).
The ASPIRE study evaluated responses at 54 weeks in 1004 methotrexate naive patients with early (≤ 3 years disease duration, median 0.6 years) active rheumatoid arthritis (median swollen and tender joint count of 19 and 31, respectively).
Alle patienter fik methotrexat (optimeret til 20 mg/ uge ved uge 8) og enten placebo, 3 mg/ kg eller 6 mg/ kg infliximab i ugerne 0, 2 og 6 samt hver 8. uge derefter.
All patients received methotrexate (optimised to 20 mg/ wk by week 8) and either placebo, 3 mg/ kg or 6 mg/ kg infliximab at weeks 0, 2, and 6 and every 8 weeks thereafter.
Tabel 4 Effekter på ACRn, strukturel ledskade og fysisk funktion ved uge 54, ASPIRE Infliximab + MTX
19 Table 4 Effects on ACRn, Structural Joint Damage and Physical Function at week 54, ASPIRE Infliximab + MTX Subjects randomised Percentage ACR improvement
+ MTX 282
+ MTX 282
3 mg/ kg 359
3 mg/ kg 359
6 mg/ kg 363
6 mg/ kg 363
Kombineret 722
Combined 722
Gennemsnit ± SDa Ændring fra baseline i total van der Heijde modificeret Sharp scoreb
Mean ± SDa Change from baseline in total van der Heijde modified Sharp scoreb
Gennemsnit ± SDa Median Forbedring fra baseline i HAQ gennemsnitligt over tid fra uge 30 til uge 54c
Mean ± SDa Median Improvement from baseline in HAQ averaged over time from week 30 to week 54c
a: p < 0, 001, for hver infliximab behandlingsgruppe mod kontrol b: højere værdier indikerer mere ledskade. c:
a: p < 0.001, for each infliximab treatment group vs. control b: greater values indicate more joint damage. c:
HAQ = Health Assessment Questionnaire; højere værdier indikerer mindre handicap. d: p = 0, 030 og < 0, 001 for henholdsvis 3 mg/ kg og 6 mg/ kg behandlingsgruppen mod placebo + MTX.
HAQ = Health Assessment Questionnaire; greater values indicate less disability. d: p = 0.030 and < 0.001 for the 3mg/ kg and 6mg/ kg treatment groups respectively vs. placebo + MTX.
Data, som underbygger dosistitrering ved rheumatoid arthritis, stammer fra ATTRACT, ASIPRE og START undersøgelserne.
Data to support dose titration in rheumatoid arthritis come from ATTRACT, ASPIRE and the START study.
START var en randomiseret, multicenter, dobbelblindt, 3- armet, parallel - gruppe sikkerhedsundersøgelse.
START was a randomised, multicenter, double-blind, 3-arm, parallel-group safety study.
I en af armene (gruppe 2, n=329) blev patienter med utilstrækkeligt respons tilladt dosisjutering med 1, 5 mg/ kg intervaller fra 3 op til 9 mg/ kg.
In one of the study arms (group 2, n=329), patients with an inadequate response were allowed to dose titrate with 1.5 mg/ kg increments from 3 up to 9 mg/ kg.
Af de patienter som behøvede dosisjustering opnåede 80% klinisk respons og størstedelen af disse (64%) behøvede kun en justering med 1, 5 mg/ kg.
Of the patients who required a dose titration, 80% achieved clinical response and the majority (64%) of these required only one adjustment of 1.5 mg/ kg.
Crohns sygdom, voksne
Adult Crohn’ s disease
Induktionsbehandling af svær, aktiv Crohns sygdom Effekten af en éndosis behandling med infliximab blev vurderet hos 108 patienter med aktiv Crohns sygdom (Crohn’ s Disease Activity Index (CDAI) ≥ 220 ≤ 400) i en randomiseret, dobbeltblind, placebokontrolleret, dosis- virknings undersøgelse.
Induction treatment in severe active Crohn’ s disease The efficacy of a single dose treatment with infliximab was assessed in 108 patients with active Crohn’ s disease (Crohn’ s Disease Activity Index (CDAI) ≥ 220 ≤ 400) in a randomised, double- blinded, placebo-controlled, dose-response study.
Af disse 108 patienter blev 27 behandlet med den anbefalede dosis på 5 mg/ kg infliximab.
Of these 108 patients, 27 were treated with the recommended dosage of infliximab 5 mg/ kg.
Det primære endpoint var andelen af patienter, der oplevede en klinisk effekt, bestemt som en nedgang i CDAI på ≥ 70 point fra baseline ved 4- ugers evalueringen og uden stigning i brugen af lægemidler eller kirurgiske indgreb for Crohns sygdom.
The primary endpoint was the proportion of patients who experienced a clinical response, defined as a decrease in CDAI by ≥ 70 points from baseline at the 4-week evaluation and without an increase in the use of medicinal products or surgery for Crohn’ s disease.
Sekundære endpoints omfattede andelen af patienter i klinisk remission i uge 4 (CDAI < 150) og den kliniske respons på længere sigt.
Secondary endpoints included the proportion of patients in clinical remission at week 4 (CDAI < 150) and clinical response over time.
I uge 4 efter indgivelse af en enkelt dosis opnåede 22/ 27 (81%) af de infliximabbehandlede patienter, der fik 5 mg/ kg dosen en klinisk effekt mod 4/ 25 (16%) af placebopatienterne (p < 0, 001).
4/ 25 (16%) of the placebo-treated patients (p < 0.001).
I uge 4 opnåede endvidere 13/ 27 (48%) af infliximabbehandlede patienter en klinisk remission (CDAI < 150) i forhold til 1/ 25 (4%) af placebobehandlede patienter.
1/ 25 (4%) of placebo-treated patients.
Ved den sidste observation efter 12 uger sås stadig effekt hos 13/ 27 (48%) af patienterne behandlet med infliximab.
At the last observation at 12 weeks, 13/ 27 (48%) of infliximab- treated patients were still responding.
Vedligeholdelsesbehandling af svær, aktiv Crohns sygdom Effekten af gentagne infusioner med infliximab blev undersøgt i en 1- års klinisk undersøgelse (ACCENT I).
Maintenance treatment in severe active Crohn’ s disease The efficacy of repeated infusions with infliximab was studied in a 1-year clinical study (ACCENT I).
I alt 573 patienter med moderat til svær aktiv Crohns sygdom (CDAI ≥ 220 ≤ 400) fik en enkelt infusionsdosis på 5 mg/ kg ved uge 0.
A total of 573 patients with moderately to severely active Crohn’ s disease (CDAI ≥ 220 ≤ 400) received a single infusion of 5 mg/ kg at week 0.
178 af de 580 inkluderede patienter (30, 7%) blev defineret som havende svær sygdom (CDAI score > 300 og samtidig kortikoid og/ eller immunsupprimerende behandling) svarende til populationen defineret i indikationen (se pkt.
178 of the 580 enrolled patients (30.7%) were defined as having severe disease (CDAI score > 300 and concomitant corticosteroid and/ or
4. 1).
20 immunosuppressants) corresponding to the population defined in the indication (see section 4.1).
I uge 2 blev alle patienter bedømt til klinisk respons og randomiseret til en af 3 behandlingsgrupper; en placebo - vedligeholdelsesgruppe, en 5 mg/ kg vedligeholdelsesgruppe og en 10 mg/ kg vedligeholdelsesgruppe.
At week 2, all patients were assessed for clinical response and randomised to one of 3 treatment groups; a placebo maintenance group, 5 mg/ kg maintenance group and 10 mg/ kg maintenance group.
Disse patienter blev klassificeret som Uge- 2 responderende og blev inkluderet i den primære analyse (se tabel 5).
These patients were classified as Week-2 responders and were included in the primary analysis (see Table 5).
Blandt patienter klassificeret som non- responderende ved uge 2, opnåede 32% (26/ 81) i placebo - vedligeholdelsesgruppen og 42% (68/ 163) i infliximabgruppen klinisk respons ved uge 6.
Among patients classified as non-responders at week 2, 32% (26/ 81) in the placebo maintenance group and 42% (68/ 163) in the infliximab group achieved clinical response by week 6.
De co- primære endpoints var forholdet af patienter i klinisk remission (CDAI < 150) ved uge 30 og tiden til tab af respons efter uge 54.
The co-primary endpoints were the proportion of patients in clinical remission (CDAI < 150) at week 30 and time to loss of response through week 54.
19 Tabel 5:
Table 5:
Effekter på respons og remissionshastighed, data fra ACCENT I (Uge- 2 responderende) ACCENT I (Uge- 2 responderende)% Patienter
Effects on response and remission rate, data from ACCENT I (Week-2 responders) ACCENT I (Week-2 responders)% of Patients
Placebo -
Placebo
Infliximab -
Infliximab
vedligeholdelse vedligeholdelse (n=110) 5 mg/ kg (n=113) (p- værdi)
Maintenance (n=110)
vedligeholdelse 10 mg/ kg (n=112) (p- værdi)
Maintenance 10 mg/ kg (n=112) (p value)
Median tid til tab af respons frem til uge 54 Uge 30
Median time to loss of response through week 54 Week 30
19 uger 38 uger (0, 002)
38 weeks (0.002)
> 54 uger (< 0, 001)
> 54 weeks (< 0.001)
27, 3 51, 3 (< 0, 001)
51.3 (< 0.001)
20, 9 38, 9 (0, 003)
38.9 (0.003)
Steroidfri remission Uge 54
Steroid-Free Remission Week 54
10, 7 (6/ 56) 31, 0 (18/ 58) (0, 008)
31.0 (18/ 58) (0.008)
15, 5 38, 1 (< 0, 001)
38.1 (< 0.001)
Klinisk remission b
Clinical Remission
13, 6 28, 3 (0, 007)
28.3 (0.007)
Vedblivende steroidfri remission
Sustained Steroid-Free Remissionb
17, 9 (10/ 56) 5, 7 (3/ 53)
5.7 (3/ 53)
Reduktion i CDAI ≥25% og ≥70 point.
Reduction in CDAI ≥ 25% and ≥ 70 points.
De patienter, der fik kortikosteroider ved baseline, fik ikke kortikosteroider i de 3 måneder forud for uge 54.
CDAI < 150 at both Week 30 and 54 and not receiving corticosteroids in the 3 months prior to Week 54 among patients who were receiving corticosteroids at baseline.
I begyndelsen af uge 14 fik patienter, der havde responderet på behandling, men efterfølgende mistet deres kliniske fordel, lov til at krydse over til en infliximab dosis på 5 mg/ kg højere end den dosis hvortil de oprindeligt var randomiseret.
Beginning at week 14, patients who had responded to treatment, but subsequently lost their clinical benefit, were allowed to cross over to a dose of infliximab 5 mg/ kg higher than the dose to which they were originally randomised.
Otteoghalvfems procent (50/ 56) af patienterne, der mistede klinisk respons på infliximab 5 mg/ kg vedligeholdelsesbehandling efter uge 14, responderede på behandling med infliximab 10 mg/ kg.
Eighty-nine percent (50/ 56) of patients who lost clinical response on infliximab 5 mg/ kg maintenance therapy after week 14 responded to treatment with infliximab 10 mg/ kg.
Forbedring af målene for livskvalitet, reduktion i sygdomsrelateret hospitaliseringer og brug af kortikosteroid sås for infliximab- vedligeholdelsesgrupperne sammenlignet med placebo - vedligeholdelsesgruppen ved ugerne 30 og 54.
Improvements in quality of life measures, a reduction in disease-related hospitalizations and corticosteroid use were seen in the infliximab maintenance groups compared with the placebo maintenance group at weeks 30 and 54.
Induktionsbehandling af fistulerende, aktiv Crohns sygdom Effekten blev også vurderet i en randomiseret, dobbeltblind, placebokontrolleret undersøgelse hos 94 patienter med fistulerende Crohns sygdom, som havde fistler af mindst 3 måneders varighed.
21 The efficacy was assessed in a randomised, double-blinded, placebo-controlled study in 94 patients with fistulising Crohn’ s disease who had fistulae that were of at least 3 months’ duration.
Enogtredive af disse patienter blev behandlet med infliximab 5 mg/ kg.
Thirty-one of these patients were treated with infliximab 5 mg/ kg.
Samtidig brug af stabile doser af konventionel behandling var tilladt, og 83% af patienterne fortsatte brugen af mindst et af disse behandlinger.
Concurrent use of stable doses of conventional therapies was permitted, and 83% of patients continued to receive at least one of these therapies.
Det primære endpoint var andelen af patienter, der oplevede en klinisk effekt, bestemt som ≥ 50% reduktion fra basislinien i antallet af fistler, drænet ved forsigtigt tryk, ved mindst to på hinanden følgende besøg (med 4 ugers mellemrum) uden øget brug af lægemidler eller kirurgisk indgreb for Crohns sygdom.
The primary endpoint was the proportion of patients who experienced a clinical response, defined as ≥ 50% reduction from baseline in the number of fistulae draining upon gentle compression on at least two consecutive visits (4 weeks apart), without an increase in the use of medicinal products or surgery for Crohn’ s disease.
Otteogtres procent (21/ 31) af patienter behandlet med infliximab, der fik et 5 mg/ kg doseringsregimen, opnåede en klinisk effekt mod 26% (8/ 31) af placebobehandlede patienter (p = 0, 002).
Sixty-eight percent (21/ 31) of infliximab-treated patients receiving a 5 mg/ kg dose regimen achieved a clinical response vs.
Median tiden til der registreredes en effekt i gruppen behandlet med infliximab var 2 uger.
26% (8/ 31) placebo-treated patients (p = 0.002).
Median varigheden af
The median time to onset of response in the infliximab-treated group was 2 weeks.
20 respons var 12 uger.
The median duration of response was 12 weeks.
Det lykkedes desuden at lukke alle fistler hos 55% af infliximab- behandlede patientersammenlignet med 13% af patienter behandlet med placebo (p = 0, 001).
Additionally, closure of all fistulae was achieved in 55% of infliximab-treated patients compared with 13% of placebo-treated patients (p = 0.001).
Vedligeholdelsesbehandling af fistulerende, aktiv Crohns sygdom Effekten af gentagne infusioner med infliximab hos patienter med fistulerende Crohns sygdom blev undersøgt i en 1- års klinisk undersøgelse (ACCENT II).
Maintenance treatment in fistulising active Crohn’ s disease The efficacy of repeated infusions with infliximab in patients with fistulising Crohn’ s disease was studied in a 1-year clinical study (ACCENT II).
I alt 306 patienter fik 3 doser infliximab på 5 mg/ kg i ugerne 0, 2 og 6.
A total of 306 patients received 3 doses of infliximab 5 mg/ kg at week 0,2 and 6.
Ved baseline havde 87% af patienterne perianale fistler, 14% havde abdominale fistler, 9% havde rectovaginale fistler.
At baseline, 87% of the patients had perianal fistulae, 14% had abdominal fistulae, 9% had rectovaginal fistulae.
Ved uge 14 blev 282 patienter bedømt til klinisk respons og randomiseret til at få enten placebo eller 5 mg/ kg infliximab hver 8. uge til og med uge 46.
At week 14, 282 patients were assessed for clinical response and randomised to receive either placebo or 5 mg/ kg infliximab every 8 weeks through week 46.
Uge 14 - responderende (195/ 282) blev analyseret for det primære endpoint, som var tiden fra randomisering til tab af respons (se tabel 6).
Week-14 responders (195/ 282) were analyzed for the primary endpoint, which was time from randomisation to loss of response (see Table 6).
Effekter på responshastighed, data fra ACCENT II (Uge 14 - responderende) ACCENT II (Uge 14 - responderende)
Effects on response rate, data from ACCENT II (Week-14 responders) ACCENT II (Week-14 responders)
n=99)
Maintenance (n=99)
5 mg/ kg) (n=96)
Maintenance (5 mg/ kg) (n=96)
Median tid til tab af respons uge 54 Uge 54
Median time to loss of response through week 54 Week 54
Fistula Respons (%) a
Fistula Response (%) a Complete fistula response (%) b
A ≥50% reduktion fra baseline i antallet af drænede fistulaer over en periode på ≥4 uger b:
A ≥ 50% reduction from baseline in the number of draining fistulas over a period of ≥ 4 weeks b:
Fravær af alle drænede fistulaer
Absence of any draining fistulas
I begyndelsen af uge 22 blev patienter, der initialt responderede på behandling og efterfølgende mistede deres respons, kvalificeret til at krydse over til aktiv genbehandling hver 8. uge på en infliximabdosis 5 mg/ kg højere end den dosis, hvortil de oprindeligt blev randomiseret.
Beginning at week 22, patients who initially responded to treatment and subsequently lost their response were eligible to cross over to active re-treatment every 8 weeks at a dose of infliximab 5 mg/ kg higher than the dose to which they were originally randomised.
Blandt patienter i infliximabgruppen 5 mg/ kg, der krydsede over på grund af tab af fistula respons efter uge 22, responderede 57% (12/ 21) på genbehandling med infliximab 10 mg/ kg hver 8. uge.
Among patients in the infliximab 5 mg/ kg group who crossed over because of loss of fistula response after week 22, 57% (12/ 21) responded to re-treatment with infliximab 10 mg/ kg every 8 weeks.
Vedligeholdelsesbehandling med infliximab hver 8. uge reducerede sygdomsrelateret hospitalisering og kirurgiske indgreb signifikant sammenlignet med placebo.
22 Maintenance therapy with infliximab every 8 weeks significantly reduced disease-related hospitalisations and surgeries compared with placebo.
Crohns sygdom, børn (6 til 17 år)
Paediatric Crohn’ s disease (6 to17 years)
I REACH undesøgelsen fik 112 patienter (6 til 17 år, median alder 13, 0 år) med moderat til svær aktiv Crohns sygdom (median PCDAI 40) og utilstrækkelig respons på konventionel behandling 5 mg/ kg infliximab i ugerne 0, 2 og 6.
In the REACH study, 112 patients (6 to 17 years, median age 13.0 years) with moderate to severe, active Crohn’ s disease (median PCDAI of 40) and an inadequate response to conventional therapies were to receive 5 mg/ kg infliximab at weeks 0, 2, and 6.
Alle patienterne skulle være på en stbil dosis af 6- MP, AZA eller MTX (35% fik også kortiokosteroid ved baseline).
All patients were required to be on a stable dose of 6-MP, AZA or MTX (35% were also receiving corticosteroids at baseline).
Patienter, som blev vurderet af investigator til at have et klinisk respons i uge 10 blev randomiseret og fik 5 mg/ kg infliximab enten hver 8. eller hver 12. uge som et vedligeholdelsesbehandlingsprogram.
Patients assessed by the investigator to be in clinical response at week 10 were randomized and received 5 mg/ kg infliximab at either q8 weeks or q12 weeks as a maintenance treatment regimen.
Hvis respons forsvandt under vedligeholdelsesbehandlingen var cross- over til en højere dosis (10 mg/ kg) og/ eller kortere doseringsinterval (hver 8. uge) tilladt.
If response was lost during maintenance treatment, crossing over to a higher dose (10 mg/ kg) and/ or shorter dosing interval (q8 weeks) was allowed.
Toogtredive (32) evaluerbare patienter crossed over (9 personer i 8. ugers gruppen og 23 i 12 ugers gruppen).
Thirty-two (32) evaluable paediatric patients crossed over (9 subjects in the q8 weeks and 23 subjects in the q12 weeks maintenance groups).
Fireogtyve af disse patienter (75, 0%) genvandt klinisk respons efter cross over.
Twenty-four of these patients (75.0%) regained clinical response after crossing over.
Fordelingen af personer med klinisk respons i uge 10 var 88, 4% (99/ 112).
The proportion of subjects in clinical response at week 10 was 88.4% (99/ 112).
Fordelingen af personer som opnåede klinisk remission i uge 10 var 58, 9% (66/ 112).
The proportion of subjects achieving clinical remission at week 10 was 58.9% (66/ 112).
21 I uge 30 var fordelingen af personer med klinisk remission højere i 8 ugers gruppen (59, 6%, 31/ 52) end i 12 ugers gruppen (35, 3%, 18/ 51; p=0, 013).
At week 30, the proportion of subjects in clinical remission was higher in the q8 week (59.6%, 31/ 52) than the q12 week maintenance treatment group (35.3%, 18/ 51; p=0.013).