natgillin/translations-raw huggingface dataset:
I uge 54 var tallene 55, 8% (29/ 52) og 23, 5% (12/ 51) for henholdsvis 8 ugers gruppen og 12 ugers gruppen (p < 0, 001).
At week 54, the figures were 55.8% (29/ 52) and 23.5% (12/ 51) in the q8 weeks and q12 weeks maintenance groups, respectively (p < 0.001).
Data om fistler blev uddraget fra PCDAI score.
Data about fistulas were derived from PCDAI scores.
Af de 22 personer som havde fistler ved baseline, var henholdsvis 63, 6% (14/ 22), 59, 1% (13/ 22) og 68, 2% (15/ 22) i fuldstændig fistelrespons i uge 10, 30 og 54 i de kombinerede 8 ugers og 12 ugers vedligeholdelsesgrupper.
Of the 22 subjects that had fistulas at baseline, 63.6% (14/ 22), 59.1% (13/ 22) and 68.2% (15/ 22) were in complete fistula response at week 10, 30 and 54, respectively, in the combined q8 weeks and q12 weeks maintenance groups.
Derudover blev der obseveret statistiske og kliniske signifikante forbedringer af livskvalitet og højde såvel som en signifikant reduktion i brug af kortikosteroid i forhold til baseline.
In addition, statistically and clinically significant improvements in quality of life and height, as well as a significant reduction in corticosteroid use, were observed versus baseline.
Colitis ulcerosa
Ulcerative Colitis
Sikkerhed og effekt ved Remicade blev vurderet i to (ACT 1 og ACT 2) randomiserede, dobbeltblinde, placebokontrollerede kliniske undersøgelser hos voksne patienter med moderat til svær, aktiv colitis ulcerosa (Mayo score 6 til 12; Endoskopi subscore 2) med et utilstrækkeligt respons på konventionel behandling [orale kortikosteroider, aminosalicylater og/ eller immunmodulatorer (6- MP, AZA)].
The safety and efficacy of Remicade were assessed in two (ACT 1 and ACT 2) randomized, double- blind, placebo-controlled clinical studies in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore 2) with an inadequate response to conventional therapies [oral corticosteroids, aminosalicylates and/ or immunomodulators (6-MP, AZA)].
Samtidig anvendelse af stabile doser af orale aminosalicylater, kortikosteroider og/ eller immunmodulatorer var tilladt.
Concomitant stable doses of oral aminosalicylates, corticosteroids, and/ or immunomodulatory agents were permitted.
I begge undersøgelser var patienterne randomiseret til at få enten placebo, 5 mg/ kg Remicade eller 10 mg/ kg Remicade i uge 0, 2, 6, 14 og 22, og i ACT 1 i uge 30, 38 og 46.
In both studies, patients were randomized to receive either placebo, 5 mg/ kg Remicade, or 10 mg/ kg Remicade at weeks 0, 2, 6, 14 and 22, and in ACT 1 at weeks 30, 38 and 46.
Tabel 7 Effekt på klinisk respons, klinisk remission og slimhindeheling i uge 8 og 30.
23 Table 7 Effects on clinical response, clinical remission and mucosal healing at Weeks 8 and 30.
Kombinerede resultater fra ACT 1 & 2.
Combined data from ACT 1 & 2.
Infliximab Randomiserede forsøgspersoner
Infliximab Subjects randomized
Placebo 244
Placebo 244
Kombineret 484
Combined 484
Procent forsøgspersoner i klinisk respons og i vedvarende klinisk respons Klinisk respons i uge 8a
Percentage of subjects in clinical response and in sustained clinical response Clinical response at Week 8a Clinical response at Week 30a Sustained response (clinical response at both
27, 9%
33.2% 27.9%
49, 6%
66.9% 49.6%
55, 4%
65.3% 55.4%
52, 5%
66.1% 52.5%
(klinisk respons både i uge 8 og uge 30) a
Week 8 and Week 30)a
10, 2%
19.3%
36, 4%
45.0%
29, 8%
49.6%
33, 1%
47.3%
Klinisk remission i uge 30 Vedvarende remission (i remission både i uge 8 og
Percentage of subjects in clinical remission and sustained remission Clinical remission at Week 8a Clinical remission at Week 30 a Sustained remission (in remission at both
13, 1%
10.2% 13.1%
29, 8%
36.4% 29.8%
36, 4%
29.8% 36.4%
33, 1%
33.1% 33.1%
uge 30) a
Week 8 and Week 30)a
Procent forsøgspersoner med slimhindeheling Slimhindeheling i uge 8a
Percentage of subjects with mucosal healing Mucosal healing at Week 8a
Slimhindeheling i uge 30
Mucosal healing at Week 30
a: p < 0, 001, for hver infliximabbehandlingsgruppe mod placebo
a: p < 0.001, for each infliximab treatment group vs. placebo
Effekten af Remicade i uge 54 blev undersøgt i ACT 1 undersøgelsen.
The efficacy of Remicade through week 54 was assessed in the ACT 1 study.
Ved 54 uger var 44, 9% af patienterne i den kombinerede infliximabbehandlingsgruppe i klinisk respons sammenlignet med 19, 8% i placebobehandlingsgruppen (p < 0, 001).
At 54 weeks, 44.9% of patients in the combined infliximab treatment group were in clinical response compared to 19.8% in the placebo treatment group (p < 0.001).
Klinisk remission og slimhindeheling forekom i en større andel af patienterne i den kombinerede infliximabbehandlingsgruppe sammenlignet med placebobehandlingsgruppen i uge 54 (henholdsvis 34, 6% mod 16, 5%, p < 0, 001 og 46, 1% mod 18, 2%, p < 0, 001).
16.5%, p < 0.001 and 46.1% vs.
Andelene af patienter i vedvarende respons og vedvarende remission i uge 54 var større i den kombinerede infliximabbehandlingsgruppe end i placebobehandlingsgruppen (henholdsvis 37, 9% mod 14, 0%, p < 0, 001 og 20, 2% mod 6, 6%, p < 0, 001).
6.6%, p < 0.001, respectively).
22 En større andel patienter i den kombinerede infliximabbehandlingsgruppe var i stand til at afbryde kortikosteroider og stadig blive i klinisk remission sammenlignet med placebobehandlingsgruppen i både uge 30 (22, 3% mod 7, 2%, p < 0, 001, samlede ACT 1 & ACT 2 data) og uge 54 (21, 0% mod 8, 9%, p=0, 022, ACT 1 data).
8.9%, p=0.022, ACT1 data).
Den samlede data analyse for ACT 1 og ACT 2 undersøgelserne og deres forlængelser, som blev analyseret fra baseline til uge 54, viste en reduktion af colitis ulcerosa - relaterede hospitalsindlæggelser og kirurgiske indgreb med infliximabbehandling.
The pooled data analysis from the ACT 1 and ACT 2 studies and their extensions, analysed from baseline through 54 weeks, demonstrated a reduction of ulcerative colitis related hospitalisations and surgical procedures with infliximab treatment.
Antallet af UC relaterede hospitalsindlæggelser var signifikant lavere i 5 og 10 mg/ kg infliximabbehandlingsgrupperne end i placebogruppen (gennemsnitligt antal hospitalsindlæggelser per 100 forsøgsperson- år:
The number of UC-related hospitalisations was significantly lower in the 5 and 10 mg/ kg infliximab treatment groups than in the placebo group (mean number of hospitalisations per 100 subject-years:
21 og 19 mod 40 i placebogruppen; h. h. v. p=0, 019 og p=0, 007).
21 and 19 vs 40 in the placebo group; p=0.019 and p=0.007, respectively).
Antallet af UC - relaterede kirurgiske indgreb var også lavere i 5 og 10 mg/ kg infliximabbehandlingsgrupperne end i placebogruppen (gennemsnitligt antal kirurgiske indgreb per 100 forsøgsperson- år:
The number of UC-related surgical procedures was also lower in the 5 and 10 mg/ kg infliximab treatment groups than in the placebo group (mean number of surgical procedures per 100 subject-years:
22 og 19 mod 34; h. h. v. p=0, 145 og p=0, 022).
22 and 19 vs 34; p=0.145 and p=0.022, respectively).
Andelen af forsøgspersoner, som fik foretaget kolektomi på et hvilket som helst tidspunkt indenfor 54 uger efter den første infusion af studiemedicin, blev samlet fra ACT 1 og ACT 2 undersøgelserne og deres forlængelser.
The proportion of subjects who underwent colectomy at any time within 54 weeks following the first infusion of study agent were collected and pooled from the ACT 1 and ACT 2 studies and their extensions.
Der var færre forsøgspersoner, som fik foretaget kolektomi i 5 mg/ kg infliximabgruppen (28/ 242 eller 11, 6% [N. S.] og 10 mg/ kg infliximabgruppen (18/ 242 eller 7. 4% [p=0, 011]) end i placebogruppen (36/ 244; 14, 8%).
Fewer subjects underwent colectomy in the 5 mg/ kg infliximab group (28/ 242 or 11.6% [N. S.]) and the 10 mg/ kg infliximab group (18/ 242 or 7.4% [p=0.011]) than in the placebo group (36/ 244; 14.8%).
Reduktionen i hyppigheden af kolektomi blev også undersøgt i en anden randomiseret, dobbelblind undersøgelse (C0168Y06) af hospitaliserede patienter (n=45) med moderat til svær aktiv colitis ulcerosa, som ikke responderede på IV kortikosteroider, og som derfor havde større risiko for kolektomi.
The reduction in incidence of colectomy was also examined in another randomised, double-blind study (C0168Y06) in hospitalised patients (n= 45) with moderately to severely active ulcerative colitis who
29, 2% og 66, 7%, p=0, 017).
Significantly fewer colectomies occurred within 3 months of study infusion in patients who received a single dose of 5 mg/ kg infliximab compared to patients who received placebo (29.2% vs 66.7% respectively, p=0.017).
Infliximab forbedrede livskvaliteten i ACT 1 og ACT 2, hvilket bekræftedes ved statistisk signifikant forbedring i både et sygdomsspecifikt mål, IBDQ, og ved forbedring i den almindelige 36- punkt korte udgave af spørgeskema SF- 36.
In ACT 1 and ACT 2, infliximab improved quality of life, confirmed by statistically significant improvement in both a disease specific measure, IBDQ, and by improvement in the generic 36-item short form survey SF-36.
Infliximabs effekt og sikkerhed blev undersøgt i to multicenter, dobbelblind, placebokontrollerede undersøgelser hos patienter med aktiv ankyloserende spondylitis (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] score≥4 og spinalsmerte ≥ 4 på en skala på 1- 10)
Efficacy and safety of infliximab were assessed in two multicenter, double-blind, placebo-controlled studies in patients with active ankylosing spondylitis (Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] score ≥ 4 and spinal pain ≥ 4 on a scale of 1-10).
I den første undesøgelse (P01522), som havde en dobbelblind fase på 3 måneder, modtog 70 patienter enten 5 mg/ kg infliximab eller placebo i uge 0, 2, 6 (35 patienter i hver gruppe).
In the first study (P01522), which had a 3 month double-blind phase, 70 patients received either 5 mg/ kg infliximab or placebo at weeks 0, 2, 6 (35 patients in each group).
I uge 12 blev placebopatienter skiftet over til infliximab 5 mg/ kg hver 6. uge indtil uge 54.
At week 12, placebo patients were switched to infliximab 5 mg/ kg every 6 weeks up to week 54.
Efter undersøgelsens første år fortsatte 53 patienter i en open- label fortsættelse til uge 102.
After the first year of the study, 53 patients continued into an open-label extension to week 102.
I den anden kliniske undersøgelse (ASSERT) blev 279 patienter randomiseret til behandling med enten placebo (gruppe 1, n=78) eller 5 mg/ kg infliximab (gruppe 2, n=201) i uge 0, 2 og 6 og derefter hver 6. uge indtil uge 24.
In the second clinical study (ASSERT), 279 patients were randomized to receive either placebo (Group 1, n=78) or 5 mg/ kg infliximab (Group 2, n=201) at 0, 2 and 6 weeks and every 6 weeks to week 24.
Gruppe 1 fik 5 mg/ kg infliximab.
Group 1 received 5 mg/ kg infliximab.
Patienter i gruppe 2, som havde en BASDAI ≥3 ved 2 på hinanden følgende konsultationer, fik 7, 5 mg/ kg infliximab hver 6. uge startende med uge 36 og frem til uge 96.
In group 2, starting with the week-36 infusion, patients who had a BASDAI ≥ 3 at 2 consecutive visits, received 7.5 mg/ kg infliximab every 6 weeks thereafter through week 96.
I uge 24 var antallet af ASAS 20 responders 15/ 78 (19%) i placebogruppen og 123/ 201 (61%) i gruppen, der fik 5 mg/ kg infliximab (p < 0, 001).
At week 24, the number of ASAS 20 responders was 15/ 78 (19%) in the placebo group, and 123/ 201 (61%) in the 5 mg/ kg infliximab group (p < 0.001).
Der var 95 patienter fra gruppe 2, som fortsatte på 5 mg/ kg hver 6. uge.
There were 95 subjects from group 2 who continued on 5 mg/ kg every 6 weeks.
I 102. uge var 80 patienter stadig på infliximabbehandling og blandt disse var 71 (89%) ASAS 20 responders.
At 102 weeks there were 80 subjects still on infliximab treatment and among those, 71 (89%) were ASAS 20 responders.
I uge 12 var antallet af BASDAI 50 responders 3/ 35 (9%) i placebogruppen og 20/ 35 (57%) i 5 mg/ kg gruppen (p < 0, 01).
At week 12, the number of BASDAI 50 responders were 3/ 35 (9%) in the placebo group, and 20/ 35 (57%) in the 5 mg/ kg group (p < 0.01).
Der var 53 patienter, som fortsatte på 5 mg/ kg hver 6. uge.
There were 53 subjects who continued on 5 mg/ kg every 6 weeks.
I 102. uge var 49 patienter stadig på infliximabbehandling, og blandt disse var 30 (61%) BASDAI 50 responders.
At 102 weeks there were 49 subjects still on infliximab treatment and among those, 30 (61%) were BASDAI 50 responders.
23 I begge undersøgelser blev fysisk funktion og livskvalitet målt ved BASFI og den fysiske delscore af SF- 36 blev også signifikant forbedret.
In both studies, physical function and quality of life as measured by the BASFI and the physical component score of the SF-36 were also improved significantly.
Psoriasis arthritis
Psoriatic Arthritis
Effekt og sikkerhed blev vurderet i to dobbeltblinde, placebokontrollerede multicenterundersøgelser hos patienter med aktiv psoriasis arthritis.
Efficacy and safety were assessed in two multicenter, double-blind, placebo-controlled studies in patients with active psoriatic arthritis.
I den første kliniske undersøgelse (IMPACT) blev effekt og sikkerhed af infliximab undersøgt hos 104 patienter med aktiv polyartikulær psoriasis arthritis.
In the first clinical study (IMPACT), efficacy and safety of infliximab were studied in 104 patients with active polyarticular psoriatic arthritis.
Under den 16 uger lange dobbeltblinde fase fik patienterne enten 5 mg/ kg infliximab eller placebo i uge 0, 2, 6 og 14 (52 patienter i hver gruppe).
During the 16-week double-blind phase, patients received either 5 mg/ kg infliximab or placebo at weeks 0, 2, 6, and 14 (52 patients in each group).
Startende i uge 16 blev placebobehandlede patienter skiftet til infliximab, og alle patienter fik herefter 5 mg/ kg infliximab hver 8. uge frem til uge 46.
Starting at week 16, placebo patients were switched to infliximab and all patients subsequently received 5 mg/ kg infliximab every 8 weeks up to week 46.
Efter undersøgelsens første år fortsatte 78 patienter i en åben undersøgelse til uge 98.
After the first year of the study, 78 patients continued into an open-label extension to week 98.
I den anden kliniske undersøgelse (IMPACT 2) blev effekt og sikkerhed af infliximab undersøgt hos 200 patienter med aktiv psoriasis arthritis (≥5 hævede led og ≥5 ømme led).
In the second clinical study (IMPACT 2), efficacy and safety of infliximab were studied in 200 patients with active psoriatic arthritis (≥ 5 swollen joints and ≥ 5 tender joints).
Seksogfyrre procent af patienterne fortsatte på stabile doser methotrexat (≤25 mg/ uge).
Forty-six percent of patients continued on stable doses of methotrexate (≤ 25 mg/ week).
Under den 24 uger dobbeltblinde fase modtog patienterne enten 5 mg/ kg infliximab eller placebo i ugerne 0, 2, 6, 14 og 22 (100 patienter i hver gruppe).
During the 24-week double-blind phase, patients received either 5 mg/ kg infliximab or placebo at weeks 0, 2, 6, 14, and 22 (100 patients
De vigtigste resultater for effekt i IMPACT og IMPACT 2 er vist i tabel 8 nedenfor:
Key efficacy results for IMPACT and IMPACT 2 are shown in Table 8 below:
Infliximab Infliximab (uge 16) (uge 98)
(Week 16) (Week 16)
Placebo Infliximab (uge 24) (uge 24)
(Week 24) (Week 24)
Infliximab (uge 54)
(Week 54)
Randomiserede patienter
Patients randomized
52 Ikke aktuel
N/ Aa
ACR 20 respons *
ACR 20
5( 10%)
5(10%)
34 (65%)
34 (65%)
48 (62%)
48 (62%)
16 (16%)
16 (16%)
54 (54%)
54 (54%)
53 (53%)
53 (53%)
ACR 50 respons *
ACR 50
0( 0%)
0(0%)
24 (46%)
24 (46%)
35 (45%)
35 (45%)
4 (4%)
4 (4%)
41( 41%)
41(41%)
33 (33%)
33 (33%)
ACR
response*
70 respons *
ACR 70
15 (29%)
15 (29%)
27 (35%)
27 (35%)
2 (2%)
2 (2%)
27 (27%)
27 (27%)
20 (20%)
20 (20%)
PASI respons (% of patienter) b
response* PASI response (% of patients)b
PASI 75 respons **
PASI 75 response**
40 (48. 8%)
40 (48.8%)
* ITT- analyser med emner med manglende data blev inkluderet som ikke- responderende a Uge 98 data for IMPACT inkluderer kombineret placebo crossover og infliximab patienter, der deltog i den åbne undersøgelse b Baseret på patienter med PASI > 2. 5 ved baseline for IMPACT, og patienter med > 3% BSA psoriasis hud påvirkning ved baseline af IMPACT 2 ** PASI 75 respons for IMPACT ikke inkluderet som følge af lav N; p < 0. 001 for infliximab vs. placebo i uge 24 for IMPACT 2
a Week 98 data for IMPACT includes combined placebo crossover and infliximab patients who entered the open-label extension b Based on patients with PASI > 2.5 at baseline for IMPACT, and patients with > 3% BSA psoriasis skin involvement at baseline in IMPACT 2 ** PASI 75 response for IMPACT not included due to low N; p < 0.001 for infliximab vs. placebo at week 24 for IMPACT 2
Effekten har været demonstreret med eller uden samtidig
Efficacy has been demonstrated with or without concomitant use of methotrexate.
24 brug af methotrexat.
Radiographs of hands and feet were collected at baseline, weeks 24 and 54.
Endpoint blev målt ved ændring fra baseline i samlet modificeret vdH- S score (middel ± SD score var 0, 82 ± 2, 62 i placebogruppen sammenlignet med - 0, 70 ± 2, 53 i infliximabgruppen; p < 0, 001.
Infliximab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment at the week 24 primary endpoint as measured by change from baseline in total modified vdH-S score (mean ± SD score was 0.82 ± 2.62 in the placebo group compared with -0.70 ± 2.53 in the infliximab group; p < 0.001).
I infliximabgruppen forblev middelændringen i samlet modificeret vdH- S score under 0 i uge 54.
In the infliximab group, the mean change in total modified vdH-S score remained below 0 at the week 54 timepoint.
Infliximabbehandlede patienter viste signifikant forbedring i fysisk funktionsevne, vurderet ved HAQ.
Infliximab-treated patients demonstrated significant improvement in physical function as assessed by HAQ.
Signifikant forbedring i helbredsrelateret livskvalitet blev også påvist, målt med den fysiske og mentale component summary score af SF- 36 i IMPACT 2.
Significant improvements in health-related quality of life were also demonstrated as measured by the physical and mental component summary scores of the SF-36 in IMPACT 2.
Effekten af infliximab blev vurderet i to multicenter, randomiserede, dobbeltblinde undersøgelser:
The efficacy of infliximab was assessed in two multicenter, randomised, double blind studies:
SPIRIT og EXPRESS.
SPIRIT and EXPRESS.
Patienter i begge undersøgelser havde plaque psoriasis (Body Surface Area [BSA] ≥ 10% og Psoriasis Area and Severity Index [PASI] score ≥ 12).
Patients in both studies had plaque psoriasis (Body Surface Area [BSA] ≥ 10% and Psoriasis Area and Severity Index [PASI] score ≥ 12).
Det primære endpoint i begge undersøgelser var procenten af patienter, som opnåede ≥ 75% forbedring i PASI fra baseline i uge 10.
The primary endpoint in both studies was the percent of patients who achieved ≥ 75% improvement in PASI from baseline at week 10.
SPIRIT vurderede effekten af infliximab induktionsbehandling hos 249 patienter med plaque psoriasis, som tidligere havde fået PUVA eller systemisk behandling.
26 SPIRIT evaluated the efficacy of infliximab induction therapy in 249 patients with plaque psoriasis that had previously received PUVA or systemic therapy.
Patienterne fik enten 3 eller, 5 mg/ kg infliximab eller placeboinfusioner i uge 0, 2 og 6.
Patients received either 3 or 5 mg/ kg infliximab or placebo infusions at weeks 0, 2 and 6.
I SPIRIT var andelen af patienter, der opnåede PASI 75 i uge 10 71, 7% i 3 mg/ kg infliximabgruppen, 87, 9% i 5 mg/ kg infliximabgruppen og 5, 9% i placebogruppen (p < 0, 001).
In SPIRIT, the proportion of patients achieving PASI 75 at week 10 was 71.7% in the 3 mg/ kg infliximab group, 87.9% in the 5 mg/ kg infliximab group, and 5.9% in the placebo group (p < 0.001).
I uge 26, tyve uger efter den sidste induktionsdosis, var 30% af patienterne i 5 mg/ kg gruppen og 13, 8% af patienterne i 3 mg/ kg gruppen PASI 75 respondere.
By week 26, twenty weeks after the last induction dose, 30% of patients in the 5mg/ kg group and 13.8% of patients in the 3mg/ kg group were PASI 75 responders.
EXPRESS vurderede effekten af infliximab induktions - og vedligeholdelsesbehandling hos 378 patienter med plaque psoriasis.
EXPRESS evaluated the efficacy of infliximab induction and maintenance therapy in 378 patients with plaque psoriasis.
Patienterne fik 5 mg/ kg infliximab eller placebo infusioner i uge 0, 2 og 6 efterfulgt af vedligeholdelsesbehandling hver 8. uge indtil uge 22 i placebogruppen og indtil uge 46 i infliximabgruppen.
Patients received 5 mg/ kg infliximab or placebo infusions at weeks 0, 2 and 6 followed by maintenance therapy every 8 weeks through week 22 in the placebo group and through week 46 in the infliximab group.
I uge 24 krydsede placebogruppen over til infliximab induktionsbehandling (5 mg/ kg) efterfulgt af infliximab vedligeholdelsesbehandling (5 mg/ kg).
At week 24, the placebo group crossed over to infliximab induction therapy (5 mg/ kg) followed by infliximab maintenance therapy (5 mg/ kg).
Tidligere behandling med PUVA, methotrexate, ciclosporin eller acitretin var modtaget af 71, 4% af patienterne, selv om de ikke nødvendigvis var behandlingsresistente.
Prior therapy with PUVA, methotrexate, cyclosporin, or acitretin had been received by 71.4% of patients, although they were not necessarily therapy resistant.
Nøgleresultater præsenteres i tabel 9.
Key results are presented in Table 9.
Effekten var den samme i undergruppen af patienter, der var eksponeret for tidligere systemiske behandlinger sammenlignet med den totale undersøgelsespopulation.
Efficacy was similar in the subgroup of patients that were exposed to previous systemic therapies compared to the overall study population.
Tabel 9 Resumé af PASI respons, PGA- respons og andel patienter, hvis negle alle var fri for psoriasis i uge 10, 24 og 50.
Table 9 Summary of PASI response, PGA response and percent of patients with all nails cleared at Weeks 10, 24 and 50.
Placebo →
Placebo → Infliximab
Infliximab
Week 10
Uge 10
(at week
5 mg/ kg (i uge 24)
24)
N ≥ 90% forbedring
N
77 1 (1, 3%)
77
301 172 (57, 1%) a
301
25 ≥ 75% forbedring ≥ 50% forbedring PGA helt væk (0) eller minimale (1)
≥ 90% improvement ≥ 75% improvement ≥ 50% improvement PGA of cleared (0) or minimal (1)
2 (2, 6%) 6 (7, 8%) 3 (3, 9%)
1 (1.3%) 2 (2.6%) 6 (7.8%) 3 (3.9%)
242 (80, 4%) a 274 (91, 0%) 242 (82, 9%) ab
172 (57.1%)a 242 (80.4%)a 274 (91.0%) 242 (82.9%)ab
PGA helt væk (0), minimale (1) eller lette (2) Uge 24
PGA of cleared (0), minimal (1), or mild (2) Week 24
N ≥ 90% forbedring ≥ 75% forbedring ≥ 50% forbedring PGA helt væk (0) eller minimale (1) PGA helt væk (0), minimale (1) eller lette (2) Uge 50
N ≥ 90% improvement ≥ 75% improvement ≥ 50% improvement PGA of cleared (0) or minimal (1) PGA of cleared (0), minimal (1), or mild (2) Week 50
N ≥ 90% forbedring ≥ 75% forbedring ≥ 50% forbedring PGA helt væk (0) eller minimale (1) PGA helt væk (0), minimale (1) eller lette (2) Alle negle fri for psoriasisc
N ≥ 90% improvement ≥ 75% improvement ≥ 50% improvement PGA of cleared (0) or minimal (1) PGA of cleared (0), minimal (1), or mild (2) All nails cleared c
N = 292
Week 50 a: p < 0.001, for each infliximab treatment group vs. control b: n = 292
Analysen var baseret på patienter med neglepsoriasis ved baseline (81, 8% af patienterne).
Analysis was based on subjects with nail psoriasis at baseline (81.8% of subjects).
4, 6 og 4, 3 i infliximab - og placebogruppen.
Mean baseline NAPSI scores were 4.6 and 4.3 in infliximab and placebo group.
Der blev registreret signifikante forbedringer fra baseline i DLQI (p < 0, 001) og de fysiske og mentale del- scorer af SF 36 (p < 0, 001 for hver enkelt delsammenligning).
Significant improvements from baseline were demonstrated in DLQI (p < 0.001) and the physical and mental component scores of the SF 36 (p < 0.001 for each component comparison).
Enkelte intravenøse infusioner på 1, 3, 5, 10 eller 20 mg/ kg infliximab udviste dosis- proportionale stigninger i den maksimale serumkoncentration (Cmax) samt området under koncentrationstidskurven (AUC).
Single intravenous infusions of 1, 3, 5, 10 or 20 mg/ kg of infliximab yielded dose proportional increases in the maximum serum concentration (Cmax) and area under the concentration-time curve (AUC).