qanastek/EMEA-V3 huggingface dataset:
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.
Minn ġimgħa 14, il- pazjenti li kellhom rispons għall- kura, iżda li imbagħad tilfu l- benefiċċju kliniku tagħhom, tħallew jaqilbu għal doża ta ’ infliximab ta ’ 5 mg/ kg ogħla mid- doża li kienu randomised fuqha oriġinarjament.
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.
Disa u tmenin fil mija (50/ 56) tal- pazjenti li tilfu r- rispons kliniku fuq infliximab 5 mg/ kg bħala terapija ta ’ manteniment wara ġimgħa 14 kellhom rispons għal kura b’ infliximab 10 mg/ kg.
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.
Titjib fil- miżuri tal- kwalità tal- ħajja, tnaqqis fil- każijiet li kienu jeħtieġu jmorru l- isptar minħabba l - marda u l- użu tal- kortikosterojdi dehru fil- gruppi ta ’ manteniment b’ infliximab meta mqabbel mal - grupp ta ’ manteniment bi plaċebo f’ ġimgħa 30 u 54.
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.
Kura ta ’ induzzjoni għal marda ta ’ Crohn fistulzzanti attiva L- effikaċja kien ukoll studjat fi studju randomised, double- blinded, ikkontrollat bi plaċebo f’ 94 pazjent bil- marda ta ’ Crohn fistulizzanti li kellhom fistli li kienu ilhom mill- inqas 3 xhur.
Thirty-one of these patients were treated with infliximab 5 mg/ kg.
Wieħed u tletin minn dawn il- pazjenti kienu trattati b’ infliximab 5 mg/ kg.
Approximately 93% of the patients had previously received antibiotic or immunosuppressive therapy.
Madwar 93% tal- pazjenti qabel kienu ngħataw antibjotiċi jew terapija immunosoppressiva.
Concurrent use of stable doses of conventional therapies was permitted, and 83% of patients continued to receive at least one of these therapies.
L- użu fl- istess waqt ta ’ dożi stabbli ta ’ terapiji konvenzjonali kien permess, u 83% mill- pazjenti baqgħu jingħataw mill- inqas waħda minn dawn it- terapiji.
Patients received three doses of either placebo or infliximab at weeks 0, 2 and 6.
Il- pazjenti ngħataw tliet dożi jew ta ’ plaċebo jew ta ’ infliximab f ’ ġimgħat 0, 2 u 6.
Patients were followed up to 26 weeks.
Il- pazjenti kienu segwiti sas- 26 ġimgħa.
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.
Il- fini ewlieni kien il- proporzjoni ta ’ pazjenti li kellhom rispons kliniku, definit bħala tnaqqis ta ’ ≥ 50% mil- linja bażi fin- numru ta ’ fistli li jnixxu meta jkunu magħfusa bil- mod mill- inqas f’ żewġ eżamijiet wara xulxin (b’ 4 ġimgħat bejniethom), mingħajr żieda fl- użu tal- prodotti mediċinali jew kirurġija għal marda ta ’ Crohn.
26% (8/ 31) placebo-treated patients (p = 0.002).
Tmienja u sittin fil- mija (21/ 31) tal- pazjenti li ngħataw infliximab b’ reġim b’ doża ta ’ 5 mg/ kg kellhom reazzjoni klinika kontra 26% (8/ 31) tal- pazjenti li ngħataw plaċebo (p = 0. 002).
The median time to onset of response in the infliximab-treated group was 2 weeks.
Iż- żmien medjan sakemm beda r- rispons fil- grupp li ngħata infliximab kien ta ’ ġimgħatejn.
The median duration of response was 12 weeks.
Id- dewmien medju tar - rispons kien ta ’ 12- il ġimgħa.
Additionally, closure of all fistulae was achieved in 55% of infliximab-treated patients compared with 13% of placebo-treated patients (p = 0.001).
Barra dan, kien hemm għeluq tal- fistli kollha f’ 55% tal- pazjenti li ngħataw infliximab meta mqabbel ma ’ 13% tal- pazjenti li ngħataw plaċebo (p = 0. 001).
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).
Kura ta ’ manteniment fil- marda ta ’ Crohn fistulzzanti attiva L- effikaċja ta ’ infużjonijiet ripetuti ta ’ infliximab f’ pazjenti bil- marda ta ’ Crohn fistulizzanti kienet studjati fi studju kliniku ta ’ sena (ACCENT II).
A total of 306 patients received 3 doses of infliximab 5 mg/ kg at week 0,2 and 6.
B’ kollox 306 pazjent ngħataw 3 dożi ta ’ 5 mg/ kg infliximab f’ ġimgħat 0, 2 u 6.
At baseline, 87% of the patients had perianal fistulae, 14% had abdominal fistulae, 9% had rectovaginal fistulae.
Fil- linja bażi, 87% tal- pazjenti kellhom fistli peri- anali, 14% kellhom fistli fl- addome, 9% kellhom fistli rektovaġinali.
The median CDAI score was 180.
Il- punteġġ CDAI medjan kien 180.
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.
F’ ġimgħa 14, 282 pazjent kienu evalwati għar- rispons kliniku u tqassmu b’ mod randomised biex jingħataw plaċebo jew 5 mg/ kg infliximab kull 8 ġimgħat sas- 46 ġimgħa.
Week-14 responders (195/ 282) were analyzed for the primary endpoint, which was time from randomisation to loss of response (see Table 6).
Rispondituri ta ’ Ġimgħa- 14 (195/ 282) kienu analizatti għall- fini ewlieni, li kien iż- żmien minn meta ġew randomised sakemm tilfu r- rispons (ara Tabella 6).
Corticosteroid tapering was permitted after week 6.
It- tnaqqis gradwali tal- kortikosterojdi kien permess wara ġimgħa 6.
Effects on response rate, data from ACCENT II (Week-14 responders) ACCENT II (Week-14 responders)
Effetti fuq ir- rata ta ’ rispons, dejta minn ACCENT II (Rispondituri ta ’ Ġimgħa- 14)
Infliximab
21 ACCENT II (Rispondituri ta ’ Ġimgħa- 14)
Maintenance (n=99)
Manteniment bi Plaċebo (n=99)
Maintenance (5 mg/ kg) (n=96)
Manteniment b’ Infliximab (5 mg/ kg) (n=96)
Median time to loss of response through week 54 Week 54
Medja taż- żmien sakemm intilef ir - rispons għal ġimgħa 54 Ġimgħa 54
> 40 weeks
> 40 ġimgħa
Fistula Response (%) a Complete fistula response (%) b
Rispons Fistula (%) a Rispons fistula komplet (%) b
23.5 19.4
23. 5 19. 4
46.2 36.3
46. 2 36. 3
0.001 0.009
0. 001 0. 009
A ≥ 50% reduction from baseline in the number of draining fistulas over a period of ≥ 4 weeks b:
Tnaqqis ta ’ ≥50% mill- linja bażi fin- numru ta ’ fistli li kienu qed inixxu fuq perijodu ta ’ ≥4 ġimgħat b:
Absence of any draining fistulas
Ma kien hemm l- ebda fistula li tnixxi
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.
Minn ġimgħa 22, pazjenti li fil- bidu kellhom rispons għall- kura u imbagħad tilfu r- rispons tagħhom kienu eliġibbli biex jinqalbu għall- kura mill- ġdid attiva kull 8 ġimgħat b’ doża ta ’ infliximab 5 mg/ kg ogħla mid- doża li fuqha kienu randomised oriġinarjament.
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.
Fost il- pazjenti fil- grupp fuq infliximab 5 mg/ kg li qalbu minħabba li l- fistula tilfet ir- rispons wara gimgħa 22, 57% (12/ 21) kellhom rispons għall- kura mill- ġdid b’ infliximab 10 mg/ kg kull 8 ġimgħat.
There was no significant difference between placebo and infliximab for the proportion of patients with sustained closure of all fistulas through week 54, for symptoms such as proctalgia, abscesses and urinary tract infection or for number of newly developed fistulas during treatment.
Ma kien hemm l- ebda differenza sinifikanti bejn plaċebo u infliximab fil- proporzjon ta ’ pazjenti li l - fistli tagħhom baqgħu kollha magħluqa sal- 54 ġimgħa, għal sintomi bħal proktalġja, qradi u infezzjonijiet fis- sistema awrinarja jew fin- numru ta ’ fistli ġodda li jiżviluppaw waqt it- trattament.
22 Maintenance therapy with infliximab every 8 weeks significantly reduced disease-related hospitalisations and surgeries compared with placebo.
It- terapija ta ’ manteniment b’ infliximab kull 8 ġimgħat naqqset b’ mod sinifikanti n- numru ta ’ każijiet li kienu jeħtieġu li jmorru l- isptar jew jiġu operati minħabba l- marda meta mqabbla mal- plaċebo.
Furthermore, a reduction in corticosteroid use and improvements in quality of life were observed.
Minbarra hekk, deher tnaqqis fl- użu tal- kortikosterojde u titjib fil- kwalità tal- ħajja.
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.
Marda ta ’ Crohn fit- tfal (6 sa 17- il sena) Fl- istudju REACH, 112- il pazjent (6 sa 17- il sena, età medjana 13. 0- il sena) b’ marda ta ’ Crohn attiva moderata għal severa (PCGAI medjan ta ’ 40) u rispons mhux xieraq għal terapiji konvenzjonali kellhom jirċievu 5 mg/ kg infliximab ma ’ ġimgħa 0, 2, u 6.
All patients were required to be on a stable dose of 6-MP, AZA or MTX (35% were also receiving corticosteroids at baseline).
Kien meħtieġ li l- pazjenti kollha jkunu fuq doża stabbli ta ’ 6- MP, AZA jw MTX (35% kienu qed jingħataw ukoll kortikosterojdi mal- linja bażi).
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.
Pazjenti li kienu evalwati mill- investigatur li kellhom rispons kliniku ma ’ ġimgħa 10 kienu randomised u rċevew 5 mg/ kg infliximab f’ ġimgħat q8 jew ġimgħat q12 bħala kors għat- trattament ta ’ manteniment..
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.
Meta r- rispons intilef waqt it- trattament ta ’ manteniment, kien permess li jinqalbu għal doża ogħla (10 mg/ kg) u/ jew li jkollhom intervall iqsar (q8 ġimgħat).
Thirty-two (32) evaluable paediatric patients crossed over (9 subjects in the q8 weeks and 23 subjects in the q12 weeks maintenance groups).
Tnejn u tletin (32) pazjenti tfal li setgħu jiġu evalwati qalbu (9 individwi f’ ġimgħa q8 u 23 individwu fil- grupp ta ’ manteniment f’ ġimgħa q12).
Twenty-four of these patients (75.0%) regained clinical response after crossing over.
Erbgħa u għoxrin minn dawn il- pazjenti (75. 0%) reġgħu kisbu rispons kliniku wara li qalbu.
The proportion of subjects in clinical response at week 10 was 88.4% (99/ 112).
Il- proporzjoni ta ’ individwi li kellhom rispons kliniku ma ’ ġimgħa 10 kien 88. 4% (99/ 112).
The proportion of subjects achieving clinical remission at week 10 was 58.9% (66/ 112).
Il - proporzjon ta ’ individwi li fiequ b’ mod kliniku ma ’ ġimgħa 10 kien 58. 9% (66/ 112).
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).
Ma ’ ġimgħa 30, il- proporzjon ta ’ individwi li fiequ b’ mod kliniku kienu ogħla fil- ġimgħa q8 (59. 6%, 31/ 52) milli fil- grupp ta ’ manteniment f’ ġimgħa q12 (35. 3%, 18/ 51; p=0. 013).
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).
Ma ’ ġimgħa 54, il - figuri kienu 55. 8% (29/ 52) u 23. 5% (12/ 51) fil- ġimgħat q8 u fil- gruppi ta ’ manteniment f’ ġimgħa q12, rispettivament (p < 0. 001).
Data about fistulas were derived from PCDAI scores.
Tagħrif dwar fistuli inkisbu mill- punteġġi PCDAI.
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.
Minn 22 individwu li kellhom fistuli mal- linja bażi, 63. 6% (14/ 22), 59. 1% (13/ 22) u 68. 2% (15/ 22) kellhom rispons tal- fistula ma ’ ġimgħa 10, 30 u 54, rispettivament, fil- gruppi ta ’ manteniment kombinati ġimgħat q8 u ġimgħat q12.
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.
Minbarra hekk, titjib statistiku u kliniku fil- kwalità tal- ħajja u t- tul, kif ukoll tnaqqis sinifikanti fl- użu ta ’ kortikosterojd, deher kontra l- linja bażi.
Ulcerative Colitis
Infjammazzjoni ta ’ l- Imsaren
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)].
22 Is- sigurtà u l- effikaċja ta ’ Remicade kienu evalwati f’ żewġ (ACT 1 u ACT 2) studji kliniċi randomized, double blind, kontrollati bi plaċebo f’ pazjenti adulti b’ infjammazzjoni ta ’ l- imsaren attiva b’ mod moderat għal sever (Punteġġ Mayo 6 sa 12; Sottopunteġġ bl- endoskopija 2) b’ rispons mhux xieraq għat- terapiji konvenzjonali [kortikosterojdi orali, aminosalicylates u/ jew immunomodulaturi (6 - MP, AZA)].
Concomitant stable doses of oral aminosalicylates, corticosteroids, and/ or immunomodulatory agents were permitted.
Dożi stabbli ta ’ aminosalicylates orali, kortikosterojdi, u/ jew aġenti immunomodulaturi mogħtija fl- istess ħin kienu permessi.
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.
Fiż- żewġ studji, pazjenti kienu randomized biex jirċievu plaċebo, jew 5 mg/ kg Remicade, jew 10 mg/ kg Remicade ma ’ ġimgħa 0, 2, 6, 14 u 22, u fl- ACT 1 ma ’ ġimgħa 30, 38 u 46.
Corticosteroid taper was permitted after week 8.
It- tnaqqis fix- xejn ta ’ kortikosterojdi kien permess wara ġimgħa 8.
23 Table 7 Effects on clinical response, clinical remission and mucosal healing at Weeks 8 and 30.
Tabella 7 Effetti fuq ir- rispons kliniku, tnaqqis kliniku u fejqan tal- mukuża ma ’ Ġimgħa 8 u 30.
Combined data from ACT 1 & 2.
Dejta kollettiva minn ACT1 u 2.
Infliximab Subjects randomized
Infliximab
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
Perċentwali ta ’ individwi f’ rispons kliniku u f’ rispons kliniku sostnut Rispons kliniku ma ’ ġimgħa 8a Rispons kliniku ma ’ ġimgħa 30a Rispons sostnut (rispons kliniku ma ’ ġimgħa 8
33.2% 27.9%
33. 2% 27. 9%
66.9% 49.6%
66. 9% 49. 6%
65.3% 55.4%
65. 3% 55. 4%
66.1% 52.5%
66. 1% 52. 5%
Week 8 and Week 30)a
kif ukoll ma ’ ġimgħa 30) a
19.3%
19. 3%
45.0%
45. 0%
49.6%
49. 6%
47.3%
47. 3%
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
Perċentwali ta ’ individwi li kellhom tnaqqis kliniku u tnaqqis li baqa ’ Rispons kliniku ma ’ ġimgħa 8a
10.2% 13.1%
36. 4%
36.4% 29.8%
29. 8%
29.8% 36.4%
33. 1%
33.1% 33.1%
13. 1%
Week 8 and Week 30)a
29. 8%
5.3%
5. 3%
19.0%
19. 0%
24.4%
24. 4%
21.7%
21. 7%
Percentage of subjects with mucosal healing Mucosal healing at Week 8a
Perċentwali ta ’ individwi b’ fejqan tal- mukuża Fejqan tal- mukuża ma ’ Ġimgħa 8a Fejqan tal- mukuża ma ’
32.4%
32. 4%
61.2%
61. 2%
60.3%
60. 3%
60.7%
60. 7%
Mucosal healing at Week 30
Ġimgħa 30a
27.5%
27. 5%
48.3%
48. 3%
52.9%
52. 9%
50.6%
50. 6%
a: p < 0.001, for each infliximab treatment group vs. placebo
a: p < 0. 001, għal kull grupp ta ’ vs. plaċebo
The efficacy of Remicade through week 54 was assessed in the ACT 1 study.
L- effikaċja ta ’ Remicade fil- 54 ġimgħa kienet evalwata mill- istudju ACT 1.
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).
Wara 54 ġimgħa, 44. 9% tal- pazjenti fil- grupp ta ’ kura b’ infliximab kombinat kellhom rispons kliniku meta mqabbla ma ’ 19. 8% fil- grupp ta ’ plaċebo (p < 0. 001).
18.2%, p < 0.001, respectively).
Tnaqqis kliniku u fejqan tal- mukuża seħħew f’ proporzjon akbar ta ’ pazjenti fil- grupp ta ’ kura li kienu fuq infliximab kombinat meta mqabbla mal- grupp ta ’ kura fuq il - plaċebo ma ’ ġimgħa 54 (34. 6% vs 16. 5%, p < 0. 001 u 46. 1% vs 18. 2%, p < 0. 001, rispettivament).
The proportions of patients in sustained response and sustained remission at week 54 were greater in the combined infliximab treatment group than in the placebo treatment group (37.9% vs.
Il - proporzjonijiet tal- pazjenti f’ rispons li baqa ’ u tnaqqis li baqa ’ ma ’ ġimgħa 54 kien akbar fil- grupp ta ’ kura b’ infliximab milli fil- grupp ta ’ kura bil- plaċebo (37. 9% vs.
6.6%, p < 0.001, respectively).
14. 0%, p < 0. 001, u 20. 2% vs 6. 6%, p < 0. 001, rispettivament).
7.2%, p < 0.001, pooled ACT 1 & ACT 2 data) and week 54 (21.0% vs.
Proporzjon akbar ta ’ pazjenti fil- grupp ta ’ kura b’ infliximab kombinat setgħu jwaqqfu l- kortikosterojdi fil- waqt li baqgħu bi tnaqqis kliniku meta mqabbla ma ’ grupp ta ’ kura bi plaċebo kemm f’ ġimgħa 30 (22. 3% vs 7. 2%, p < 0. 001, dejta ACT1 u ACT2 mgħaqqdin flimkien) u ġimgħa 54 (21. 0% vs.
8.9%, p=0.022, ACT1 data).
8. 9%, p=0. 022, dejta ACT1).
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.
L- analiżi tad- dejta miġbura flimkien mill- istudji ACT1 u ACT2 u l- estenzjonijiet tagħhom, analizzati mill- linja bażi tul l- 54 ġimgħa, wriet tnaqqis fin- numru tal- pazjenti li ddaħħlu l- isptar minħabba każijiet relatati ma ’ l- infjammazzjoni ta ’ l- imsaren u operazzjonijiet kirurġiċi bil- kura b’ infiximab.
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:
In - numru ta ’ dawk li kellhom imorru l- isptar minħabba l- UC kien aktar baxx b’ mod sinifikanti fil- gruppi ta ’ kura b’ 5 u 10 mg/ kg infliximab milli fil- grupp tal- plaċebo (il- medja tan- numru ta ’ dawk li marru l - isptar għal kull 100 sena- individwu:
21 and 19 vs 40 in the placebo group; p=0.019 and p=0.007, respectively).
21 u 19 kontra 40 fil- grupp tal- plaċebo; p=0. 019 u p=0. 007,
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:
In- numru ta ’ operazzjonijiet kiruġiċi relatati ma ’ l- UC kien ukoll aktar baxx fil- gruppi ikkurati b’ 5 u 10 mg/ kg infliximab milli fil- grupp tal- plaċebo (il- medja tan- numru ta ’ dawk li kellhom operazzjonijiet kirurġiċi għal kull 100 sena- individwu:
22 and 19 vs 34; p=0.145 and p=0.022, respectively).
22 u 19 kontra 34; p=0. 145 u p=0. 022, rispettivament).
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.
Il- proporzjon ta ’ l- individwi li għamlu kolektomija f’ kwalunkwe ħin tul il- 54 ġimgħa wara l- ewwel infużjoni ta ’ l- istudju kienu miġbura u mgħaqqdin mill- istudji ACT 1 u ACT 2 u l- estenzjonijiet tagħhom.
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%).
Kien hemm anqas individwi li għamlu kolektomija fil grupp ta ’ 5 mg/ kg infliximab (28/ 242 jew 11. 6% [N. S.]) u l- grupp ta ’ 10 mg/ kg infliximab (18/ 242 jew 7. 4% [p=0. 011]) milli fil- grupp tal - plaċebo (36/ 244; 14. 8%).
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
It- tnaqqis fl- inċidenza tal- kolektomija kienet eżaminata wkoll fi studju ieħor randomised, double blind (C0168Y06) f’ pazjenti fl- isptar (n=45) b’ infjammazzjoni ta ’ l- imsaren moderata għal severa li ma kellhomx rispons għal kortekosterojdi IV u li għalhekk kellhom riskju akbar li jkollhom kolektomija.
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).
Kien hemm numru anqas b’ mod sinifikanti ta ’ kolektomiji fit- 3 xhur ta ’ l- istudju f’ pazjenti li rċievew doża waħda ta ’ 5 mg/ kg infliximab meta mqabbla ma ’ pazjenti li rċievew plaċebo (29. 2% kontra 66. 7% rispettivament, p=0. 017).
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.
F’ ACT 1 u ACT 2, infliximab tejjeb il- kwalità tal- ħajja, konfermata b’ titjib statistikament sinifikanti kemm f’ kejl speċifiku għall- marda, IBDQ, kif ukoll f’ titjib f’ SF- 36 formula ta ’ servej ġeneriku qasir ta ’ 36- punt.
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).
Ankylosing spondylitis L- effikaja u s- sigurtà ta ’ infliximab kienu evalwati f’ żewġ studji multiċentriċi, double- blind, kontrollati bi plaċebo f’ pazjenti b’ ankylosing spondylitis attiva (Indiċi tal- Marda Ankylosing Spondylitis ta ’ Bath [BASDAI] punteġġ ≥ 4 u uġigħ fis- sinsla ≥ 4 fuq skala minn 1 – 10).
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).
Fl- ewwel studju (P01522), li kellu fażi ta 3 xhur double- blind, 70 pazjent irċevew jew 5 mg/ kg infliximab jew plaċebo f’ ġimgħat 0, 2, 6 (35 pazjent f’ kull grupp).
At week 12, placebo patients were switched to infliximab 5 mg/ kg every 6 weeks up to week 54.
F’ ġimgħa 12, pazjenti fuq plaċebo inqalbu fuq infliximab 5 mg/ kg kull 6 ġimgħat sa ’ ġimgħa 54.
After the first year of the study, 53 patients continued into an open-label extension to week 102.
Wara l- ewwel sena ta ’ l- istudju, 53 pazjent komplew fuq estensjoni open- label sa ’ ġimgħa 102.
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.
Fit- tieni studju (ASSERT), 279 pazjent kienu randomized sabiex jirċievu plaċebo (Grupp 1, n=78) jew 5 mg/ kg infliximab (Grupp 2, n=201) f’ ġimgħa 0, 2 u 6 u kull 6 ġimgħat sa ġimgħa 24.
Thereafter, all subjects continued on infliximab every 6 weeks to week 96.
Minn hemm ‘ l quddiem, kull individwu komplew fuq infliximab kull 6 ġimgħat sa ġimgħa 96.
Group 1 received 5 mg/ kg infliximab.
Grupp 1 irċevew 5 mg/ kg infliximab.
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.
Fi grupp 2, mis- 36 ġimgħa, pazjenti li kellhom BASDAI ≥ 3 wara żewġ żjajar wara xulxin, irċievew 7. 5 mg/ kg infliximab kull 6 ġimgħat minn hemm ‘ l quddiem sa ’ ġimgħa 96.
In ASSERT, improvement in signs and symptoms was observed as early as week 2.
F’ titjib ASSERT, titjib fis- sinjali u s- sintomi dehru sa mit- 2 ġimgħa.
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).
Ma ’ l- 24 ġimgħa, in- numru ta ’ persuni li rrispondew għal ASAS 20 kienu 15/ 78 (19%) fil- grupp tal- plaċebo, u 123/ 201 (61) fil- grupp fuq 5 mg/ kg infliximab (p < 0. 001).
There were 95 subjects from group 2 who continued on 5 mg/ kg every 6 weeks.
Kien hemm 95 individwu minn grupp 2 li komplew fuq il- 5 mg/ kg kull 6 ġimgħat.
At 102 weeks there were 80 subjects still on infliximab treatment and among those, 71 (89%) were ASAS 20 responders.
Ma ’ ġimgħa 102 kien hemm 80 individwu li kienu għadhom fuq il- kura b’ infliximab u fost dawk, 71 (89%) irrispondew għal ASAS 20.
In P01522, improvement in signs and symptoms was also observed as early as week 2.
F’ P01522, titjib fis- sinjali u s- sintomi deher ukoll sa mit- 2 ġimgħa.
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).
Ma ’ ġimgħa 12, in- numru ta ’ dawk li kellhom rispons BASDAI 50 kienu 3. 35 (9%) fil- grupp tal- plaċebo, u 20/ 35 (57%) fil- grupp tal- 5 mg/ kg (p < 0. 01).
There were 53 subjects who continued on 5 mg/ kg every 6 weeks.
Kien hemm 53 individwu li komplew fuq 5 mg/ kg kull 6 ġimgħat.
At 102 weeks there were 49 subjects still on infliximab treatment and among those, 30 (61%) were BASDAI 50 responders.
Ma ’ ġimgħa 102 kien hemm 49 individwu li kienu għadhom fuq il- kura b’ infliximab u fost dawk, 30 (61%) kellhom rispons BASDAI 50.
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.
Fiż- zewġ studji, il- funzjoni fiżika u l- kwalità tal- ħajja hekk kif imkejjla bil- BASFI u l- punteġġ tal - komponent fiżiku ta ’ l- SF- 36 tjeibu wkoll b’ mod sinifikanti.
Psoriatic Arthritis
Artrite bi Psorajiżi
Efficacy and safety were assessed in two multicenter, double-blind, placebo-controlled studies in patients with active psoriatic arthritis.
24 L- effikaċja u s- sigurtà kienu evalwati f’ żewġ studji multiċentriċi, double- blind, kontrollati bi plaċebo f’ pazjenti b’ artrite bi psorajiżi attiva.
In the first clinical study (IMPACT), efficacy and safety of infliximab were studied in 104 patients with active polyarticular psoriatic arthritis.
Fl- ewwel studju kliniku (IMPACT), l- effikaċja u s- sigurtà ta ’ infliximab kienu studjati f’ 104 pazjenti b’ artrite bi psorajiżi li teffettwa ħafna ġogi.
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).
Waqt is- 16- il ġimgħa tal- fażi double- blind, il- pazjenti rċevew 5 mg/ kg infliximab jew plaċebo f’ ġimgħa 0, 2, 6, 14 (52 pazjent f’ kull grupp).
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.
Ma ’ ġimgħa 16, il- pazjenti fuq plaċebo inqalbu għal infliximab u minn hemm ’ l quddiem ingħataw 5 mg/ kg infliximab kull 8 ġimgħat sa ġimgħa 46.
After the first year of the study, 78 patients continued into an open-label extension to week 98.
Wara l- ewwel sena ta ’ l- istudju, 78 pazjent komplew f’ estenzjoni open - lavel għal ġimgħa 98.
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).
Fit- tieni studju kliniku (IMPACT 2), l- effikaċja u s- sigurtà ta ’ infliximab kienu studjati f’ 200 pazjent b’ artrite psorjatika attiva (≥ 5 ġogi minfuħin u ≥ 5 ġogi teneri).
Forty-six percent of patients continued on stable doses of methotrexate (≤ 25 mg/ week).
Sitta u erbgħin fil- mija tal- pazjenti komplew fuq dożi stabbli ta ’ methotrexate (≤25 mg/ ġimgħa).
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
Waqt l- 24- ġimgħa tal- fażi double- blind, pazjenti rċevew 5 mg/ kg infliximab jew placebo f’ ġimgħa 0, 2, 6, 14 u 22 (100 pazjent f’ kull grupp).
At week 16, 47 placebo patients with < 10% improvement from baseline in both swollen and tender joint counts were switched to infliximab induction (early escape).
Ma ’ ġimgħa 16, 47 pazjent fuq plaċebo b ’ < 10% titjib mil- linja bażi kemm fl- għadd ta ’ dawk b’ ġogi minfuħin kif ukoll b’ dawk teneri kienu maqluba għall- induzzjoni fuq infliximab (ħarba bikrija).
At week 24, all placebo-treated patients crossed over to infliximab induction.
Ma ’ ġimgħa 24, il- pazjenti kullha trattati bi plaċebo qalbu għall- induzzjoni fuq infliximab.
Dosing continued for all patients through week 46.
Id- dożi komplew jingħataw lill- pazjenti kollha matul ġimgħa 46.
Key efficacy results for IMPACT and IMPACT 2 are shown in Table 8 below:
Ir- riżultati kruċjali għal IMPACT u IMPACT 2 qed jintwerew f’ Tabella 8 hawn taħt.
Effects on ACR and PASI in IMPACT and IMPACT 2
Effetti fuq l- ACR u PASI f’ IMPACT u IMPACT 2
Infliximab Infliximab Placebo Infliximab
Infliximab Infliximab
(Week 16) (Week 16)
(Ġimgħa 16)
(Week 98)
(Ġimgħa 16) (Ġimgħa 98)
(Week 24) (Week 24)
(Ġimgħa 24) (Ġimgħa 24)
(Week 54)
(Ġimgħa 54)
Patients randomized
Pazjenti randomized
ACR response (% of patients)
ACR rispons (% ta ’ pazjenti)
ACR 20
ACR 20 rispons *
ACR 50
ACR 50 rispons *
ACR 70
ACR 70 rispons *
response* PASI response (% of patients)b
Rispons PASI (% ta ’ pazjenti) b
PASI 75 response**
Rispons PASI 75 **
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
* Analiżi- ITT fejn l- individwi b’ dejta nieqsa kienu meqjusa ma ’ dawk li ma kellhomx rispons a Dejta ta ’ Ġimgħa 98 għal IMPACT jinkludi plaċebo kombinat crossover u pazjenti fuq infliximab li daħlu għall- estensjoni open- label b Bażata fuq pazjenti li kellhom PASI > 2. 5 mal- linja bażi għal IMPACT, u pazjenti b ’ > 3% BSA kellhom ukoll ġilda bi psorajiżi mal- linja bażi f’ IMPACT 2 ** Rispons PASI 75 għal IMPACT mhux inkluż minħabba N baxx; p < 0. 001 għal infliximab vs plaċebo ma ’ ġimgħa 24 għal IMPACT 2
In IMPACT and IMPACT 2, clinical responses were observed as early as week 2 and were maintained through week 98 and week 54 respectively.
F’ IMPACT u IMPACT 2, rispons kliniċi kienu diġà bdew jidhru mat- 2 ġimgħa u baqgħu sa ġimgħa 98 u ġimgħa 54 rispettivament.
Efficacy has been demonstrated with or without concomitant use of methotrexate.
L- effikaċja ntweriet bl- użu fl- istess ħin ta ’ methotrexate kif ukoll mingħajru.
Decreases in parameters of peripheral activity characteristic of psoriatic arthritis (such as number of swollen joints, number of painful/ tender joints, dactylitis and presence of enthesopathy) were seen in the infliximab-treated patients.
Tnaqqis fil- parametri ta ’ attività periferali karatteristika ta ’ artrite bi psorajiżi (bħan - numru ta ’ ġogi minfuħin, numru ta ’ ġogi bl- uġigħ/ teneri, daktilite u preżenza ta ’ entesopatija) dehru f’ pazjenti trattati b’ infliximab.
Radiographic changes were assessed in IMPACT 2.
Bidliet radjugrafiċi kienu evalwati f’ IMPACT 2.
Radiographs of hands and feet were collected at baseline, weeks 24 and 54.
Radjugrafi ta ’ l- idejn u s- saqajn inġabru mal- linja bażi, ġimgħa 24 u 54.
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).
Il- kura b’ infliximab naqset r- rata ta ’ l- avvanz tal- ħsara periferali fil- ġogi meta mqabbla mal- kura bi plaċebo fil- fini ewlieni ta ’ ġimgħa 24 hekk kif imkejla mill- bidla mill- linja bażi fil- punteġġ vdH- S modifikat totali (medja ± punteġġ SD kien 0. 82 ± 2. 62 fil- grupp fuq plaċebo
In the infliximab group, the mean change in total modified vdH-S score remained below 0 at the week 54 timepoint.
Fil- grupp fuq infliximab, il- medja tal - bidla fil- punteġġ vdH- S modifikat baqa taħt 0 mal- 54 ġimgħa.
Infliximab-treated patients demonstrated significant improvement in physical function as assessed by HAQ.
Pazjenti li kienu kkurati b’ infliximab urew titjib sinifikanti fil- funzjoni fiżika kif imkejla b’ HAQ.
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.
Titjib sinifikanti fil- kwalità tal- ħajja relatata mas- saħħa intwerew ukoll bil- kejl tal- punteġġi tas - sommarju tal- komponent fiżiku u mentali ta ’ SF- 36 f’ IMPACT 2.
The efficacy of infliximab was assessed in two multicenter, randomised, double blind studies:
Psorajiżi L- effikaċja ta ’ infliximab kienet evalwata f’ żewġ studji multiċentriċi, randomised, double- blind:
SPIRIT and EXPRESS.
SPIRIT u EXPRESS.
Patients in both studies had plaque psoriasis (Body Surface Area [BSA] ≥ 10% and Psoriasis Area and Severity Index [PASI] score ≥ 12).
Il- pazjenti fiż- żewġ studji kellhom psorajiżi bi plakka (Erja tas- Superfiċje tal - Ġisem [BSA] ≥10% u punteġġ ta ’ l- Indiċi tas- Severità u l- Erja tal- Psorajiżi [PASI] ≥12).
The primary endpoint in both studies was the percent of patients who achieved ≥ 75% improvement in PASI from baseline at week 10.
Il- fini primarju fiż- żewġ studji kien il- perċentwali tal- pazjenti li kisbu ≥75% titjib fil- PASI mil- linja bażi ma ’ ġimgħa 10.
26 SPIRIT evaluated the efficacy of infliximab induction therapy in 249 patients with plaque psoriasis that had previously received PUVA or systemic therapy.
SPIRIT evalwa l- effikaċja tat- terapija ta ’ induzzjoni b’ infliximab f’ 249 pazjent bi psorajiżi li qabel kienu rċevew PUVA jew terapija sistemika.
Patients received either 3 or 5 mg/ kg infliximab or placebo infusions at weeks 0, 2 and 6.
Il- pazjenti rċevew 3 jew 5 mg/ kg infliximab jew infużjonijiet ta ’ plaċebo ma ’ ġimgħat 0, 2 u 6.
Patients with a PGA score ≥ 3 were eligible to receive an additional infusion of the same treatment at week 26.
Pazjenti b’ punteġġ PGA ≥3 kienu eliġibbli li jirċievu infużjoni oħra bl- istess trattament ma ’ ġimgħa 26.
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).
Fi SPIRIT, il- proporzjon ta ’ pazjenti li kisbu PASI 75 ma ’ ġimgħa 10 kien 71. 7% fil- grupp fuq 3 mg/ kg infliximab, 87. 9% fil- grupp fuq 5 mg/ kg infliximab, u 5. 9% fil- grupp fuq plaċebo (p < 0. 001)..
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.
Ma ’ ġimgħa 26, għoxrin ġimgħa wara l- aħħar doża ta ’ induzzjoni, 30% tal- pazjenti fil - grupp fuq 5 mg/ kg u 13. 8% fil- grupp fuq 3 mg/ kg urew rispons skond PASI 75.
Between weeks 6 and 26, symptoms of psoriasis gradually returned with a median time to disease relapse of > 20 weeks.
Bejn ġimgħa 6 u 26, is- sintomi ta ’ psorajiżi bil- mod reġgħu dehru b’ ħin medjan biex terġa tirkadi l- marda ta ’ > 20 ġimgħa.
No rebound was observed.
Ma dehrx effett rebound.
EXPRESS evaluated the efficacy of infliximab induction and maintenance therapy in 378 patients with plaque psoriasis.
EXPRESS evalwa l- effikaċja tat- terapija ta ’ induzzjoni b’ infliximab u terapija ta ’ manteniment f’ 378 pazjent bi psorajiżi bil- plakka.
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.
Il- pazjenti rċevew 5 mg/ kg bħala infużjonijiet ta ’ infliximab jew plaċebo ma ’ ġimgħa 0, 2 u 6 segwiti b’ terapija ta ’ manteniment kull 8 ġimgħat sa ’ ġimgħa 22 għal grupp fuq plaċebo u sa ġimgħa 46 fil- grupp fuq infliximab.
At week 24, the placebo group crossed over to infliximab induction therapy (5 mg/ kg) followed by infliximab maintenance therapy (5 mg/ kg).
Ma ’ ġimgħa 24, il- grupp fuq plaċebo inqaleb fuq it- terapija ta ’ induzzjoni b’ infliximab (5 mg/ kg) segwit b’ terpija ta ’ manteniment b’ infliximab (5 mg/ kg).
Nail psoriasis was assessed using the Nail Psoriasis Severity Index (NAPSI).
Il- psorajiżi fid- dwiefer kienet evalwata permezz ta ’ L- Indiċi tas- Severità tal - Psorajiżi tad- Dwiefer (NAPSI).
Prior therapy with PUVA, methotrexate, cyclosporin, or acitretin had been received by 71.4% of patients, although they were not necessarily therapy resistant.
Qabel kienet ingħatat terapija b’ PUVA, methotrexate, cyclosporin jew acitretin lill- 71. 4% tal- pazjenti, għalkemm ma kienux bil- fors reżistenti għat- terapija.
Key results are presented in Table 9.
Ir- riżultati kruċjali qed jidhru f’ Tabella 9.
In infliximab treated subjects, significant PASI 50 responses were apparent at the first visit (week 2) and PASI 75 responses by the second visit (week 6).
F’ individwi ttrattati b’ infliximab, rispons PASI 50 sinifikanti kienu evidenti ma ’ l- ewwel żjara (ġimgħa 2) u rispons PASI 75 mat- tieni żjara (ġimgħa 6).
Efficacy was similar in the subgroup of patients that were exposed to previous systemic therapies compared to the overall study population.
L- effikaċja kienet simili fis- sottogrupp ta ’ pazjenti li qabel kienu esposti għall- terapiji sistemiċi meta mqabbla mal- popolazzjoni globali li ħadet sehem fl- istudju.
Table 9 Summary of PASI response, PGA response and percent of patients with all nails cleared at Weeks 10, 24 and 50.
Tabella 9 Sommarju tar- rispons PASI, rispons PGA u perċentwali tal- pazjenti li fiequlhom difrejhom ma ’ ġimgħat 10, 24 u 50.
Placebo → Infliximab
Plaċebo → Infliximab
Week 10
Ġimgħa 10
(at week
(ma ’
24)
ġimgħa 24)
301
301 172 (57. 1%) a
≥ 90% improvement ≥ 75% improvement ≥ 50% improvement PGA of cleared (0) or minimal (1)
≥ 75% titjib
1 (1.3%) 2 (2.6%) 6 (7.8%) 3 (3.9%)
6 (7. 8%)
PGA of cleared (0), minimal (1), or mild (2) Week 24
PGA ta ’ l- imneħħi (0) jew minimu (1)
14 (18.2%)
3 (3. 9%)
275 (94.2%)ab
275 (94. 2%) ab
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
PGA ta ’ l- imneħħi (0), minimu (1), jew ħafif (2)
77 1 (1.3%) 3 (3.9%) 5 (6.5%) 2 (2.6%) 15 (19.5%)
PGA ta ’ l- imneħħi (0) jew minimu (1)
276 161 (58.3%)a 227 (82.2%)a 248 (89.9%) 203 (73.6%)a 246 (89.1%)a
PGA ta ’ l- imneħħi (0), minimu (1), jew ħafif (2) Ġimgħa 50
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
≥ 90% titjib ≥ 75% titjib ≥ 50% titjib PGA ta ’ l- imneħħi (0) jew minimu (1) PGA ta ’ l- imneħħi (0), minimu (1), jew ħafif (2) c Dwiefer kollha fiequ
1/ 65(1.5%)
1/ 65( 1. 5%)
16/ 235 (6.8%)
16/ 235 (6. 8%)
Week 24
58/ 223 (26, 0%) a Ġimgħa 24
3/ 65 (4.6%)
3/ 65 (4. 6%)
Week 50 a: p < 0.001, for each infliximab treatment group vs. control b: n = 292
Ġimgħa 50 a: p < 0. 001, għal kull grupp ta ’ kura b’ infliximab vs il- kontroll b: n = 292
27/ 64 (42.2%)
27/ 64 (42. 2%)
92/ 226 (40.7%)
92/ 226 (40. 7%)
Analysis was based on subjects with nail psoriasis at baseline (81.8% of subjects).
Analiżi kienet ibbażata fuq individwi bi prorajiżi tad- dwiefer mal- linja bażi (81. 8% ta ’ l - individwi).
Mean baseline NAPSI scores were 4.6 and 4.3 in infliximab and placebo group.
Punteġġi medji mal- linja bażi kienu 4. 6 u 4. 3 fil- grupp fuq infliximab u fuq il- plaċebo.
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).
Titjib sinifikanti mill- linja bażi dehru fil- DLQI (p < 0. 001) u l- punteġġi fiżiċi u mentali tal- komponenti tal- SF 36 (p < 0. 001 għat- tqabbil ta ’ kull component).
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).
Infużjonijiet ġol- vina ta ’ darba ta ’ 1, 3, 5, 10 jew 20 mg/ kg ta ’ infliximab irriżultaw f’ żidiet tal - konċentrazzjoni massima fis- serum (Cmax) u fl- erja taħt il- kurva tal- konċentrazzjoni mal- ħin (AUC) proporzjonali mad- dożi.
The volume of distribution at steady state (median Vd of 3.0 to 4.1 litres) was not dependent on the administered dose and indicated that infliximab is predominantly distributed within the vascular compartment.
Il- volum ta ’ distribuzzjoni fi stat fiss (Vd medjan ta ’ 3. 0 sa 4. 1 litri) ma kienx jiddependi fuq id- doża mogħtija u wera li infliximab huwa distribwit l- aktar fil- kompartiment vaskulari.
No time-dependency of the Pharmacokinetics was observed.
Il- farmakokinetiċi ma dehrux likienu jiddependu fuq il- ħin.
The elimination pathways for infliximab have not been characterised.
Il- mezzii kif jitneħħa infliximab għadhom mhux magħrufa.
Unchanged infliximab was not detected in urine.
Ma kienx osservat infliximab mhux mibdul fl- awrina.
No major age- or weight-related differences in clearance or volume of distribution were observed in rheumatoid arthritis patients.
Ma dehrux differenzi kbar relatati ma ’ l- età jew mal- piż fit- tneħħija jew fil- volum ta ’ distribuzzjoni f’ pazjenti b’ sintomi ta ’ artrite rewmatika.
The pharmacokinetics of infliximab in elderly patients has not been studied.
Il- farmakokinetiċi ta ’ infliximab f’ pazjenti anzjani ma kienetx studjata.
Studies have not been performed in patients with liver or renal disease.
Ma sarux studji f’ pazjenti b’ mard tal- fwied jew tal- kliewi.
At single doses of 3, 5, or 10 mg/ kg, the median Cmax values were 77, 118 and 277 micrograms/ ml, respectively.
F’ dożi waħidhom ta ’ 3, 5, jew 10 mg/ kg, il- valuri Cmax medjani kienu 77, 118 u 277 mikrogrammi/ ml rispettivament.
The median terminal half-life at these doses ranged from 8 to 9.5 days.
Il- half- life terminali medjan ta ’ infliximab b’ dawn id- dożi jvarja bejn 8 u 9. 5 ijiem.
In most patients, infliximab could be detected in the serum for at least 8 weeks after the recommended single dose of 5 mg/ kg for Crohn’ s disease and the rheumatoid arthritis maintenance dose of 3 mg/ kg every 8 weeks.
Fil - biċċa l- kbira tal- pazjenti, infliximab seta ’ jitkejjel fis- serum għal mill- anqas 8 ġimgħat wara d- doża waħidha rakkomandata għal marda ta ’ Crohn ta ’ 5 mg/ kg u d- doża ta ’ manteniment ta ’ 3 mg/ kg kull 8 ġimgħat għas- sintomi ta ’ l- artrite rewmatika.
Repeated administration of infliximab (5 mg/ kg at 0, 2 and 6 weeks in fistulising Crohn´s disease, 3 or 10 mg/ kg every 4 or 8 weeks in rheumatoid arthritis) resulted in a slight accumulation of infliximab in serum after the second dose.
L- għotja ripetuta ta ’ infliximab (5 mg/ kg f’ ġimgħat 0, 2 u 6 għall- marda ta ’ Crohn fistulizzanti, 3 jew 10 mg/ kg kull 4 jew 8 ġimgħat għal artrite rewmatika) irriżultat f ’ akkumulazzjoni żgħira ta ’ infliximab fis- serum wara t- tieni doża.
No further clinically relevant accumulation was observed.
L- ebda akkumulazzjoni oħra li kienet klinikament relevanti ma dehret.
In most fistulising Crohn’ s disease patients, infliximab was detected in serum for 12 weeks (range 4-28 weeks) after administration of the regimen.
Fil- biċċa l- kbira tal- pazjenti bil- marda ta ’ Crohn fistulizzanti, infliximab deher fis- serum għal 12- il ġimgħa (b’ medda ta ’ 4- 28 ġimgħa) wara li ngħata l- kors.
Overall, serum levels in paediatric patients with Crohn's disease (53 patients aged 6 to 17 years old; 8 patients aged 6 to 10 years old) were similar to those in adult Crohn's disease patients.
B’ mod ġenerali, il- livelli fis- serum f’ pazjenti tfal bil- marda ta ’ Crohn (53 pazjent ta ’ etajiet bejn 6 u 17- il sena; 8 pazjenti ta ’ etajiet bejn 6 u 10 snin) kienu simili għal dawk f’ pazjenti adulti bil- marda ta ’
The median terminal half-life for the 5 mg/ kg dose in paediatric patients with Crohn's disease is 10.9 days.
Il- medjan tal- half life terminali għall- pazjenti tfal bid- doża ta ’ 5 mg/ kg bil- marda ta ’ Crohn huwa 10. 9 jiem.
5.3 Preclinical safety data
5. 3 Studju qabel l- użu kliniku dwar is- sigurta ’ tal- medicina
Infliximab does not cross react with TNFα from species other than human and chimpanzees.
Infliximab ma jagħmilx cross reaction ma ’ TNFα minn speċji oħra barra mill- bniedem u x- ximpanżì.
Therefore, conventional preclinical safety data with infliximab are limited.
Għalhekk, dejta preklinika konvenzjonali dwar s- sigurtà ta ’ infliximab hija limitata.
In a developmental toxicity study conducted in mice using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, there was no indication of maternal toxicity, embryotoxicity or teratogenicity.
Fi studju dwar tossiċità fl- iżvilupp li sar fi ġrieden billi ntuża antikorp analogu li jinibixxi l- attività funzjonali ta ’ TNFα tal- ġrieden b’ mod silettiv, ma kien hemm l- ebda indikazzjoni ta ’ tossiċità fl- omm, embrijutossiċità jew teratoġeniċità.
In a fertility and general reproductive function study, the number of pregnant mice was reduced following administration of the same analogous antibody.
Fi studju dwar il- fertilità u l- funzjoni riproduttiva ġenerali, in - numru ta ’ ġrieden bi tqala naqas wara l- għotja ta ’ l- istess antikorp analogu.
It is not known whether this finding was due to effects on the males and/ or the females.
Mhux magħruf jekk din is - sejba kienetx minħabba effetti fuq il- ġrieden irġiel u/ jew in- nisa.
In a 6-month repeated dose toxicity study in mice, using the same analogous antibody against mouse TNFα, crystalline deposits were observed on the lens capsule of some of the treated male mice.
Fi studju ta ’ 6- xhur dwar tossiċità b’ dożi ripetuti li sar fil- ġrieden, fejn intuża l- istess antikorp analogu kontra TNFα tal- ġrieden, depożiti kristallini kienu osservati fuq il- kapsula tal- lenti ta ’ wħud mil- ġrieden irġiel ittrattati.
No specific ophthalmologic examinations have been performed in patients to investigate the relevance of this finding for humans.
Ma saru l- ebda studji speċifiċi fl- għajnejn tal- pazjenti biex tiġi mistħarrġa r- rilevanza ta ’ din is- sejba għal- bnedmin.
Long-term studies have not been performed to evaluate the carcinogenic potential of infliximab.
Ma sarux studji fit- tul biex issir evalwazzjoni dwar jekk infliximab jistax jikkawża kanċer.
Studies in mice deficient in TNFα demonstrated no increase in tumours when challenged with known tumour initiators and/ or promoters.
Studji fi ġrieden nieqsa minn TNFα ma wrew l- ebda żieda ta ’ tumuri meta ġew stimulati b ’ sustanzi li huma magħrufin li jikkawżaw tumuri u/ jew promoturi.
28 6.1 List of excipients
6. 1 Lista ta ’ sustanzi mhux attivi
Sucrose Polysorbate 80 Monobasic sodium phosphate Dibasic sodium phosphate
Sucrose Polysorbate 80 Monobasic sodium phosphate Dibasic sodium phosphate.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Fin- nuqqas ta ’ studji dwar kompatibilità, dan il- prodott mediċinali mgħandux jitħallat ma ’ prodotti mediċinali oħra.
Chemical and physical in use stability of the reconstituted solution has been demonstrated for 24 hours at 25°C.
L- istabilità kimika u fiżika waqt l- użu tas- soluzzjoni rikostitwita f’ temperatura ta ’ 25°C kienet aċċertata għal 24 siegħa.
From a microbiological point of view, the product should be used as soon as possible but within 3 hours of reconstitution and dilution.
Mil- lat mikrobijoloġiku, il- prodott għandu jintuża kemm jista ’ jkun malajr iżda fi żmien tliet sigħat wara li jkun rikostitwit u dilwit.
If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2 to 8°C.
Jekk ma jintużax mill- ewwel, iż- żmien tal - ħażna waqt l- użu u l- kundizzjonijiet qabel l- użu huma r- responsabbiltà ta ’ min qed jużah u m’ għandhomx ikunu iktar minn 24 siegħa f’ temperatura ta ’ 2 sa 8°C.