%)ab
PGA of cleared (0), minimal (1), or mild (2)
14 (18.2%)
275 (94.2%)ab
Week 24
N
77
276
90% improvement
1 (1.3%)
161 (58.3%)a
75% improvement
3 (3.9%)
227 (82.2%)a
50% improvement
5 (6.5%)
248 (89.9%)
PGA of cleared (0) or minimal (1)
2 (2.6%)
203 (73.6%)a
PGA of cleared (0), minimal (1), or mild (2)
15 (19.5%)
246 (89.1%)a
Week 50
N
68
281
90% improvement
34 (50.0%)
127 (45.2%)
75% improvement
52 (76.5%)
170 (60.5%)
50% improvement
61 (89.7%)
193 (68.7%)
PGA of cleared (0) or minimal (1)
46 (67.6%)
149 (53.0%)
PGA of cleared (0), minimal (1), or mild (2)
59 (86.8%)
189 (67.3%)
All nails cleared c
Week 10
1/65(1.5%)
16/235 (6.8% )
Week 24
3/65 (4.6%)
58/223 (26,0%) a
Week 50
27/64 (42.2%)
92/226 (40.7%)
a: p < 0.001, for each infliximab treatment group vs. control
b: n = 292
c: Analysis was based on subjects with nail psoriasis at baseline (81.8% of subjects). Mean baseline NAPSI scores were 4.6 and 4.3 in infliximab and placebo group.
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).
Paediatric population
Paediatric Crohn's disease (6 to17 years)
In the REACH study, 112 patients (6 to 17 years, median age 13.0 years) with moderate to severe, active Crohn's disease (median paediatric CDAI of 40) and an inadequate response to conventional therapies were to receive 5 mg/kg infliximab at weeks 0, 2, and 6. All patients were required to be on a stable dose of 6-MP, AZA or MTX (35% were also receiving corticosteroids at baseline). 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. 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. Thirty-two (32) eva luable paediatric patients crossed over (9 subjects in the q8 weeks and 23 subjects in the q12 weeks maintenance groups). Twenty-four of these patients (75.0%) regained clinical response after crossing over.
The proportion of subjects in clinical response at week 10 was 88.4% (99/112). The proportion of subjects achieving clinical remission at week 10 was 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). 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 about fistulas were derived from PCDAI scores. 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.
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.
Other paediatric indications
The European Medic |
