natgillin/translations-raw huggingface dataset:
De i alt 334 patienter, der opnåede komplet eller partiel remission efter induktionsbehandlingen, blev efterfølgende randomiseret til MabThera - vedligeholdelsesbehandling (n=167) eller observation (n=167).
A total of 334 patients achieving a complete or partial remission following induction therapy were randomised in a second step to MabThera maintenance therapy (n=167) or observation (n=167).
MabThera vedligeholdelsesbehandling bestod af en enkelt infusion med MabThera på 375 mg/ m2 legemsoverflade administreret hver tredje måned indtil sygdomsprogression eller i en periode på højst to år.
MabThera maintenance treatment consisted of a single infusion of MabThera at 375 mg/ m2 body surface area given every 3 months until disease progression or for a maximum period of two years.
Den endelige effektanalyse inkluderede alle patienter randomiseret til begge dele af forsøget.
The final efficacy analysis included all patients randomized to both parts of the study.
Efter en median observationstid på 31 måneder for patienter randomiseret til induktionsfasen, forbedrede R- CHOP signifikant udfaldet af refraktær/ relaps af follikulært NHL i sammenligning med CHOP (se tabel 4).
After a median observation time of 31 months for patients randomised to the induction phase, R-CHOP significantly improved the outcome of patients with relapsed/ refractory follicular NHL when compared to CHOP (see Table 4).
19 Tabel 4
19 Table 4
Induktionsfase:
Induction phase: overview of efficacy results for CHOP vs.
Oversigt over effektdata for CHOP versus R- CHOP (31 måneders median observationstid)
R-CHOP (31 months median observation time)
Primært effektmål 1)
Primary Efficacy 1)
CHOP R- CHOP p- værdi Risikoreduktion1) ORR2) 74% 87% 0, 0003 na CR2) 16% 29% 0, 0005 na PR2) 58% 58% 0, 9449 na
74% 16% 58%
Estimater 2)
87% 29% 58%
beregnet ved hazard ratio
0.0003 0.0005 0.9449
Seneste tumorrespons bedømt af investigator.
Estimates were calculated by hazard ratios 2) Last tumour response as assessed by the investigator.
Forkortelser:
The “ primary” statistical test for “ response” was the trend test of CR versus PR versus non-response (p < 0.0001) Abbreviations:
NA, ikke tilgængelig; ORR: samlet responsrate; CR: fuldstændigt respons; PR: partielt respons
NA, not available; ORR: overall response rate; CR: complete response; PR: partial response
For patienter randomiseret til vedligeholdelsesdelen af forsøget var den mediane observationstid 28 måneder fra vedligeholdelsesrandomiseringen.
For patients randomized to the maintenance phase of the trial, the median observation time was 28 months from maintenance randomisation.
Vedligeholdelsesbehandling med MabThera gav en klinisk relevant og statistisk signifikant forbedring af det primære endpoint, PFS (tiden fra vedligeholdelsesrandomiseringen til relaps, sygdomsprogression eller død) sammenlignet med observation alene (p < 0, 0001 log rank test).
Maintenance treatment with MabThera led to a clinically relevant and statistically significant improvement in the primary endpoint, PFS, (time from maintenance randomisation to relapse, disease progression or death) when compared to observation alone (p < 0.0001 log-rank test). The median PFS was 42.2 months in the MabThera maintenance arm compared to 14.3 months in the observation arm.
Den mediane PFS var 42, 2 måneder i MabThera vedligeholdelsesarmen sammenlignet med 14, 3 måneder i observationsarmen.
Using a cox regression analysis, the risk of experiencing progressive disease or death was reduced by 61% with MabThera maintenance treatment when compared to observation (95% CI; 45 %-72%).
Ved anvendelse af Cox regressionsanalyse var risiko for forekomst af progressiv sygdom eller død reduceret med 61% med MabThera vedligeholdelsesbehandling sammenlignet med observation (95% konfidensinterval:
Kaplan-Meier estimated progression- free rates at 12 months were 78% in the MabThera maintenance group vs.
45% - 72%).
57% in the observation group.
En analyse af den samlede overlevelse bekræftede den signifikante fordel af MabThera vedligeholdelse fremfor observation (p=0, 0039 log- rank test).
An analysis of overall survival confirmed the significant benefit of MabThera maintenance over observation (p=0.0039 log-rank test).
22% - 75%).
MabThera maintenance treatment reduced the risk of death by 56% (95% CI; 22 %-75%).
Oversigt over effektdata for MabThera versus observation (28 måneders median observationstid)
Maintenance phase: overview of efficacy results MabThera vs. observation (28 months median observation time)
Kaplan- Meier estimat af den Risiko -
Median Time to Event (Months)
Effektparametre
Reduction
mediane periode til hændelse Observation MabThera (N = 167) (N=167)
Observation MabThera (N = 167) (N=167)
(måneder) Log- Rank p value
Log-Rank p value
42, 2
14.3 42.2
Varighed til ny lymfombehandling
Time to new lymphoma treatment
Sygdomsfri overlevelsea
Disease-free survivala
Analyse af undergrupper PFS
Subgroup Analysis PFS
NR: ikke opnået; a: kun gældende for patienter, der opnåede fuldstændigt respons
20 NR: not reached; a: only applicable to patients achieving a CR
Fordelen ved MabThera vedligeholdelsesbehandling blev bekræftet af alle undergruppeanalyser, uafhængigt af induktionsbehandlingen (CHOP eller R- CHOP) eller graden af respons på induktionsbehandlingen (CR eller PR) (tabel 5).
The benefit of MabThera maintenance treatment was confirmed in all subgroups analysed, regardless of induction regimen (CHOP or R-CHOP) or quality of response to induction treatment (CR or PR) (table 5).
MabThera- vedligeholdelsesbehandling forlængede signifikant den mediane PFS hos patienter, der responderede på CHOP- induktionsbehandling (median PFS 37, 5 måneder versus 11, 6 måneder, p < 0, 0001) såvel som hos dem, der responderede på R- CHOP induktionsbehandling (median PFS 51, 9 måneder versus 22, 1 måneder, p=0, 0071).
22.1 months, p=0.0071).
Selvom undergrupperne var små gav MabThera vedligeholdelsesbehandling en signifikant fordel i form af samlet overlevelse både for patienter, der responderede på CHOP og for patienter, der responderede på R- CHOP, dog er længere opfølgning nødvendig for at bekræfte denne observation.
Although subgroups were small, MabThera maintenance treatment provided a significant benefit in terms of overall survival for both patients responding to CHOP and patients responding to R-CHOP, although longer follow-up is required to confirm this observation.
Diffust storcellet B- celle non- Hodgkin lymfom
Diffuse large B cell non-Hodgkin’ s lymphoma
I et åbent, randomiseret studie fik 399 tidligere ubehandlede, ældre patienter (60 – 80 år) med diffust storcellet B- celle lymfom standard- CHOP kemoterapi (cyklophosphamid 750 mg/ m2, doxorubicin 50 mg/ m2, vinkristin 1, 4 mg/ m2 op til maksimalt 2 mg på dag 1 og prednison 40 mg/ m2 på dag 1- 5) hver 3. uge i otte serier eller MabThera 375 mg/ m2 plus CHOP (R- CHOP).
In a randomised, open-label trial, a total of 399 previously untreated elderly patients (age 60 to 80 years) with diffuse large B cell lymphoma received standard CHOP chemotherapy (cyclophosphamide 750 mg/ m2, doxorubicin 50 mg/ m2, vincristine 1.4 mg/ m2 up to a maximum of 2 mg on day 1, and prednisolone 40 mg/ m2/ day on days 1-5) every 3 weeks for eight cycles, or MabThera 375 mg/ m2 plus CHOP (R-CHOP).
31 måneder.
The final efficacy analysis included all randomised patients (197 CHOP, 202 R-CHOP), and had a median follow-up duration of approximately 31 months.
Den endelige analyse bekræftede, at R- CHOP behandlingen var forbundet med klinisk relevant og statistisk signifikant forbedring af længden af den progressionsfrie overlevelse (de primære effektparametre var død, relaps, forværring af lymfomet eller påbegyndelse af ny antilymfombehandling) (p=0, 0001).
The final analysis confirmed that R-CHOP treatment was associated with a clinically relevant and statistically significant improvement in the duration of event-free survival (the primary efficacy parameter; where events were death, relapse or progression of lymphoma, or institution of a new anti-lymphoma treatment) (p = 0.0001).
Dette repræsenterer en risikoreduktion på 41%.
Kaplan Meier estimates of the median duration of event-free survival were 35 months in the R-CHOP arm compared to 13 months in the CHOP arm, representing a risk reduction of 41%.
Estimaterne ved 24 måneders overlevelse var 68, 2% i R- CHOP armen sammenlignet med 57, 4% i CHOP armen.
At 24 months, estimates for overall survival were 68.2% in the R-CHOP arm compared to 57.4% in the CHOP arm.
En efterfølgende analyse af længden af overlevelsen, udført med en median opfølgningsperiode på 60 måneder, bekræftede fordelene ved R- CHOP behandlingen i forhold til CHOP behandlingen (p=0, 0071), hvilket svarer til en risikoreduktion på 32%.
A subsequent analysis of the duration of overall survival, carried out with a median follow-up duration of 60 months, confirmed the benefit of R-CHOP over CHOP treatment (p=0.0071), representing a risk reduction of 32%.
Analysen af alle sekundære parametre (responsrate, progresionssfri overlevelse, sygdomsfri overlevelse, varighed af respons) bekræftede behandlingseffekten af R- CHOP i forhold til CHOP.
The analysis of all secondary parameters (response rates, progression-free survival, disease-free survival, duration of response) verified the treatment effect of R-CHOP compared to CHOP.
Den samlede responsrate efter behandlingsserie 8 var 76, 2% i R- CHOP gruppen sammenlignet med 62, 4% i CHOP gruppen (p=0, 0028).
The complete response rate after cycle 8 was 76.2% in the R-CHOP group and 62.4% in the CHOP group (p=0.0028).
Risikoen for sygdomsprogression blev reduceret med 46% og risikoen for relaps med 51%.
The risk of disease progression was reduced by 46% and the risk of relapse by 51%.
I alle patientundergrupper (køn, alder, aldersjusteret IPI, Ann Arbor stadie, ECOG, β2- mikrobuglobulin, LDH, albumin, B- symptomer, udbredt sygdom, ekstranodale lymfomer, knoglemarvspåvirkning) var risikoratioen for hændelsesfri overlevelse og samlet
In all patients subgroups (gender, age, age adjusted IPI, Ann Arbor stage, ECOG, β 2 microglobulin, LDH, albumin, B symptoms, bulky disease, extranodal sites, bone marrow involvement), the risk ratios for event-free survival and overall survival (R-CHOP compared with CHOP) were less than 0.83 and 0.95 respectively.
R- CHOP var associeret med bedre udfald for både høj - og lavrisikopatienter i forhold til aldersjusteret IPI.
R-CHOP was associated with improvements in outcome for both high- and low-risk patients according to age adjusted IPI.
Kliniske laboratoriefund Af 67 patienter der blev vurderet for humant anti- mus antistof (HAMA) fandtes intet respons.
Clinical laboratory findings Of 67 patients evaluated for human anti-mouse antibody (HAMA), no responses were noted.
Af 356 patienter, der blev vurderet for HACA, var 1, 1% (4 patienter) positive.
Of 356 patients evaluated for HACA, 1.1% (4 patients) were positive.
I et ikke - placebokontrolleret, randomiseret studie blev 817 tidligere ubehandlede patienter med CLL randomiseret til enten FC- kemoterapi (fludarabin 25mg/ m2, cyclophosphamid 250 mg/ m2, på dag 1- 3) hver 4. uge i 6 serier eller MabThera i kombination med FC (R- FC).
In an open-label randomized trial, a total of 817 previously untreated patients with CLL were randomized to receive either FC chemotherapy (fludarabine 25 mg/ m2, cyclophosphamide 250 mg/ m2, days 1-3) every 4 weeks for 6 cycles or MabThera in combination with FC (R-FC).
MabThera blev givet i en dosis på 375 mg/ m2 i første serie en dag før kemoterapi og i en dosis på 500 mg/ m2 på dag 1 i hver af de efterfølgende behandlingsserier.
MabThera was administered at a dosage of 375 mg/ m2 during the first cycle one day prior to chemotherapy and at a dosage of 500 mg/ m2 on day 1 of each subsequent treatment cycle.
I alt blev 810 patienter analyseret for effekt (403 R- FC, 407 FC) (tabel 6).
A total of 810 patients (403 R-FC, 407 FC) were analyzed for efficacy (Table 6).
Medianen for det primære endepunkt, progressionsfri overlevelse, var 40 måneder i R- FC- gruppen og 32 måneder i FC- gruppen (p < 0, 0001, log- rank test).
The primary endpoint of progression-free survival was 40 months median in the R-FC group and 32 months in the FC group (p < 0.0001, log-rank test).
Analysen for den samlede overlevelse viste en bedret overlevelse i R- FC- armen (p = 0, 0427, log- rank test).
The analysis of overall survival showed an improved survival in favour of the R-FC arm (p=0.0427, log-rank test), however longer follow-up is
Det er dog nødvendigt med en længere follow- up- periode for at bekræfte denne observation.
21 needed to confirm this observation.
I forhold til sygdomsrisikoen ved baseline var fordelen for PFS konsistent i de fleste patientundergrupper, som blev analyseret.
The benefit in terms of PFS was consistently observed in most patient subgroups analyzed according to disease risk at baseline.
20, 7 måneder)
FC alone (20.7 months median observation time)
Kaplan- Meier estimat for
Kaplan-Meier Estimate of
den
Risk
mediane tid til hændelsen FC R- FC
Median Time to Event (Months) FC R-FC Log-Rank
reduktion
Reduction
= 407) (N=403)
(N = 407)
32, 2 39, 8
39.8
NR NR
NR
Event- fri overlevelse
Event Free Survival
Responsrate (CR, nPR eller PR)
Response rate (CR, nPR, or PR)
CR- rater
CR rates
Sygdomsfri overlevelse (DFS) **
Duration of response* Disease free survival (DFS)** Time to new treatment
NR: ikke nået; n. a.: ikke relevant *: gælder kun for patienter, som opnåede CR, nPR eller PR **: gælder kun for patienter, som opnåede CR
Response rate and CR rates analysed using Chi-squared Test. *: only applicable to patients achieving a CR, nPR, PR; applicable **: only applicable to patients achieving a CR;
22 Progressionsfri overlevelse ifølge Binet stage (ITT)
Progression-Free Survival according to Binet stage (ITT)
Hazard Ratio
Hazard Ratio (95% CI)
ikke justeret)
adjusted)
Resultater fra andre støttende studier, som anvendte MabThera i kombination med andre kemoterapiregimer (herunder CHOP, FCM, PC og PCM) til behandling af CLL- patienter, har også vist høje, totale responsrater med lovende PFS- rater uden relevant øgning af behandlingstoksiciteten.
Results from other supportive studies using MabThera in combination with other chemotherapy regimens (including CHOP, FCM, PC, PCM) for the treatment of CLL patients have also demonstrated high overall response rates with promising PFS rates without adding relevant toxicity to the treatment.
Kliniske erfaringer med reumatoid arthritis
Clinical Experience in Rheumatoid Arthritis
Effekt og sikkerhed af MabThera til lindring af symptomer og kliniske fund ved reumatoid arthritis blev vist i tre randomiserede, kontrollerede, dobbeltblindede, multicenter forsøg.
The efficacy and safety of MabThera in alleviating the symptoms and signs of rheumatoid arthritis was demonstrated in three randomized, controlled, double-blind, multicenter studies.
Forsøg 1 var et dobbeltblindet sammenlignende forsøg, der omfattede 517 patienter, som havde oplevet utilstrækkeligt respons eller intolerans over for behandling med en eller flere TNF- hæmmere.
22 Study 1 was a double blind comparative study which included 517 patients that had experienced an inadequate response or intolerance to one or more TNF inhibitor therapies.
Egnede patienter havde aktiv reumatoid arthritis i mindst 6 måneder, diagnosticeret ifølge kriterierne fra American College of Rheumatology (ACR), med antal hævede led (SJC) ≥ 8 (66 antal led) og antal ømme led (TJC) ≥ 8 (68 antal led) og forhøjet CRP eller ESR.
Eligible patients had active rheumatoid arthritis for at least 6 months, diagnosed according to the criteria of the American College of Rheumatology (ACR), with swollen joint count (SJC) (8 (66 joint count), and tender joint count (TJC) (8 (68 joint count) and elevated CRP or ESR.
Det primære endpoint var andelen af patienter, der opnåede ACR20 respons ved uge 24.
The primary endpoint was the percent of patients who achieved an ACR20 response at week 24.
Patienterne fik, med 15 dages interval to intravenøse infusioner med MabThera på 1000 mg, begge efter en intravenøs infusion med 100 mg methylprednison.
Patients received two 1000 mg intravenous infusions of MabThera, each following an intravenous infusion of 100 mg methylprednisone and separated by an interval of 15 days.
Alle patienter fik samtidig oral methotrexat (10- 25 mg/ uge) og 60 mg oral prednison på dagene 2- 7 og 30 mg på dagene 8- 14 efter den første infusion.
All patients received concomitant oral methotrexate (10-25 mg/ week) and 60 mg oral prednisone on days 2-7 and 30 mg on days 8-14 following the first infusion.
Patienterne blev fulgt efter uge 24 for langtidsendpoints, inklusiv en radiologisk vurdering i uge 56.
Patients were followed beyond week 24 for long term endpoints, including radiographic assessment at 56 weeks.
Dette skete i forbindelse med en åben protokol som forlængelse af forsøget.
During this time 81% of patients, from the original placebo group received rituximab between weeks 24 an 56, under an open label extension study protocol.
Forsøg 2 var et randomiseret, dobbeltblindet, double- dummy, kontrolleret, 3 x 3 multifaktorielt forsøg, som sammenlignede to forskellige doser af rituximab med eller uden en af to kortikosteriodregimer i kombination med ugentlig methotrexat hos patienter med aktiv reumatoid arthritis, som ikke havde responderet på behandling med 1- 5 andre DMARDs.
Study 2 was a randomized, double-blind, double-dummy, controlled, 3 x 3 multifactorial study which compared two different dose levels of rituximab given with or without one of two peri infusional corticosteroid regimens in combination with weekly methotrexate in patients with active rheumatoid arthritis which had not responded to treatment with 1 to 5 other DMARDs.
Forsøg 3 var et dobbeltblindet, dobbelt- dummy, kontrolleret forsøg, der evaluerede rituximab monoterapi og rituximab i kombination med enten cyclophosphamid eller methotrexat hos patienter med aktiv reumatoid arthritis, som ikke tidligere havde responderet på en eller flere DMARDs.
Study 3 was a double-blind, double-dummy, controlled study evaluating rituximab monotherapy, and rituximab in combination with either cyclophosphamide or methotrexate in patients with active rheumatoid arthritis which had not responded to one or more prior DMARDs
Sammenligningsgruppen i alle tre forsøg var ugentlig methotrexat (10- 25 mg ugentligt).
The comparator group in all three studies was weekly methotrexate (10-25 mg weekly).
Resultat for sygdomsaktivitet I alle tre forsøg, øgede rituximab 2 x 1000 mg signifikant andelen af patienter, der opnåede mindst 20% forbedring i ACR score, sammenlignet med patienter behandlet med methotrexat alene (tabel 7).
Disease activity outcomes In all three studies, rituximab 2 x 1000 mg significantly increased the proportion of patients achieving at least a 20% improvement in ACR score compared with patients treated with methotrexate alone (Table 7).
Effekten af behandlingen var sammenlignelig hos patienterne uafhængigt af reumafaktor status, alder, køn, legemsoverfladeareal, race, antal tidligere behandlinger eller sygdomsstatus.
The treatment effect was similar in patients independent of rheumatoid factor status, age, gender, body surface area, race, number of prior treatments or disease status.
Klinisk og statistisk signifikante forbedringer sås også på alle individuelle komponenter af ACR respons (antal ømme og hævede led, patientens og lægens overordnede bedømmelse, funktionsindex score (HAQ), smerteevaluering og C- reaktivt protein (mg/ dl)).
Clinically and statistically significant improvement was also noted on all individual components of the ACR response (tender and swollen joint counts, patient and physician global assessment, disability index scores (HAQ), pain assessment and C-Reactive Proteins (mg/ dL).
23 Tabel 7
Table 7
Sammenligning mellem studierne af ACR respons ved uge 24 (ITT populationen)
Cross-Study Comparison of ACR Responses at Week 24 (ITT Population)
ACR Respons Placebo+MTX Rituximab+MTX
ACR Response Placebo+MTX Rituximab+MTX
36 (18%)
Study 2
ACR70
ACR20 ACR50 ACR70
N= 143
36 (18%) 11 (5%) 3 (1%) N= 143
N= 185
153 (51%)1 80 (27%)1 37 (12%)1 N= 185
Forsøg 3
Study 3 1
ACR20
ACR20 ACR50 ACR70 ACR20 ACR50 ACR70
15 (38%)
45 (31%) 19 (13%) 6 (4%) N= 40 15 (38%) 5 (13%) 2 (5%)
28 (70%) 3
96 (52%)2 61 (33%)2 28 (15%)2 N= 40 28 (70%)3 17 (43%)3 9 (23%)3
17 (43%) 3
p ≤ 0.0001; p ≤ 0.001; 3 p < 0.05 2
p ≤ 0, 0001; 2 p ≤ 0, 001; 3 p < 0, 05 MTX – methotrexat
MTX – Methotrexate
I forsøg 3 var ACR20 respons 65% hos patienter behandlet med rituximab alene sammenlignet med 38% med methotrexat alene (p = 0, 025).
In study 3, the ACR20 response in patients treated with rituximab alone was 65% compared with 38% on methotrexate alone (p=0.025).
Patienter behandlet med rituximab havde en signifikant større reduktion i sygdomsaktivitetsscore (DAS28) end patienter behandlet med methotrexat alene (gennemsnitlig ændring i DAS28 fra baseline var henholdsvis - 1, 9 versus - 0, 4; p < 0, 0001).
23 Rituximab treated patients had a significantly greater reduction in disease activity score (DAS28) than patients treated with methotrexate alone (Mean change in DAS28 from baseline -1.9 vs. -0.4, p < 0.0001, respectively).
Et godt til moderat European League Against Rheumatism (EULAR) respons blev opnået af signifikant flere patienter behandlet med rituximab sammenlignet med patienter behandlet med methotrexat alene (tabel 9).
A good to moderate European League Against Rheumatism (EULAR) response was achieved by significantly more rituximab treated patients compared to patients treated with methotrexate alone (Table 9).
I dette forsøg blev strukturelle ledskader bedømt radiologisk og beskrevet ved ændringen i den modificerede totale Sharp score og komponenterne, erosionsscore og ledspalteafsmalningsscore.
Radiographic response In Study 1, conducted in patients with inadequate response or intolerance to one or more TNF inhibitor therapies, structural joint damage was assessed radiographically and expressed as change in modified total Sharp score and its components, the erosion score and joint space narrowing score.
Patienter, der havde fået rituximab/ MTX fra starten udviste i uge 56 signifikant mindre radiologisk progression end patienter, der i starten udelukkende havde fået methotrexat.
Patients originally receiving rituximab/ MTX demonstrated significantly less radiographic progression than patients originally receiving methotrexate alone at 56 weeks.
Af de patienter, der i starten udelukkende fik methotrexat, fik 81% rituximab enten som rescue behandling i ugerne 16- 24 eller i forlængelsen af forsøget inden uge 56.
Of the patients originally receiving methotrexate alone, 81% received rituximab either as rescue between weeks 16-24 or in the extension trial, before week 56.
En højere andel af patienter, der havde fået rituximab/ MTX fra starten, havde ingen erosionsprogression i løbet af de 56 uger (tabel 8).
A higher proportion of patients receiving the original rituximab/ MTX treatment also had no erosive progression over 56 weeks (Table 8).
24 Tabel 8
Table 8
Gennemsnitlige radiologiske forandringer over 56 uger i forsøg 1
56 weeks in Study 1
Placebo+MTX Rituximab +MTX 2 × 1g
Rituximab +MTX 2 × 1g
Forsøg 1 Total Sharp score
Study 1 Total Sharp score
p=0, 0046 Erosionsscore
p=0.0046 Erosion Score
p=0, 0114 Ledspalteafsmalningsscore
p=0.0114 Joint Space narrowing score
p=0, 0006 Andel af patienter uden
p=0.0006 Proportion of patients with no erosive
erosionsprogression i løbet af 56 uger
progression over 56 weeks
p=0, 0494
p=0.0494
Resultat for livskvalitet
Quality of life outcomes
Signifikante reduktioner i funktionsindex (HAQ- DI), træthed (FACIT- F) (tabel 8)
Significant reductions in disability index (HAQ-DI), fatigue (FACIT-F) (Table 9), and improvement in both the physical and mental health domains of the SF-36 were observed in patients treated with rituximab compared to patients treated with methotrexate alone (SF-36 Physical 5.8 vs.
og forbedringer i
0.9, SF-36 Mental 4.7 vs.
Resultater for sygdomsaktivitet og livskvalitet ved uge 24 i forsøg 1
Disease Activity and Quality of Life Outcomes at Week 24 in Study 1
Respons ved uge 24:
Week 24 response:
Placebo+MTX1 N= 201
Placebo+MTX1 N= 201 mean (SD)