5 mg/kg infliximab giveneither every 8 weeks or every 12 weeks.
At Week 10, 88% of patients were in clinical response (defined as a decrease from baseline inthe PCDAI score of ≥ 15 points and total PCDAI score of ≤ 30 points), and 59% were inclinical remission (defined as PCDAI score of ≤ 10 points).
The proportion of pediatric patients achieving clinical response at Week 10 comparedfavorably with the proportion of adults achieving a clinical response in Study Crohn’s I. Thestudy definition of clinical response in Study Peds Crohn’s was based on the PCDAI score,whereas the CDAI score was used in the adult Study Crohn’s I.
At both Week 30 and Week 54, the proportion of patients in clinical response was greater inthe every 8-week treatment group than in the every 12-week treatment group (73% vs. 47% atWeek 30, and 64% vs. 33% at Week 54). At both Week 30 and Week 54, the proportion ofpatients in clinical remission was also greater in the every 8-week treatment group than in theevery 12week treatment group (60% vs. 35% at Week 30, and 56% vs. 24% at Week 54),(Table 4).
For patients in Study Peds Crohn’s receiving corticosteroids at baseline, the proportion ofpatients able to discontinue corticosteroids while in remission at Week 30 was 46% for theevery 8-week maintenance group and 33% for the every 12-week maintenance group. AtWeek 54, the proportion of patients able to discontinue corticosteroids while in remission was46% for the every 8-week maintenance group and 17% for the every 12-week maintenancegroup.
Table 4 Response and remission in study peds Crohn’s
5 mg/kg infliximab
Every 8 Week Every 12 Week
Treatment Group Treatment Group
Patients randomized 52 51
Clinical Responsea
Week 30 73%d 47%
Week 54 64%d 33%
Clinical Remission b
Week 30 60%C 35%
Week 54 56%d 24%
a Defined as a decrease from baseline in the PCDAI score of ≥15 points and total score of ≤ 30 points.
b Defined as a PCDAI score of ≤ 10 points. c P-value < 0.05
d P-value < 0.01
14.3 Ulcerative Colitis
The safety and efficacy of infliximab were assessed in 2 randomized, double-blind, placebocontrolledclinical studies in 728 patients with moderately to severely active ulcerative colitis(UC) (Mayo score5 6 to 12 [of possible range 0 to 12], Endoscopy subscore ≥ 2) with aninadequate response to conventional oral therapies (Studies UC I and UC II). Concomitanttreatment with stable doses of aminosalicylates, corticosteroids and/or immunomodulatoryagents was permitted. Corticosteroid taper was permitted after Week 8. Patients wererandomized at week 0 to receive either placebo, 5 mg/kg infliximab or 10 mg/kg infliximab atWeeks 0, 2, 6, and every 8 weeks thereafter through Week 46 in Study UC I, and at Weeks 0,2, 6, and every 8 weeks thereafter through Week 22 in Study UC II. In Study UC II, patients
were allowed to continue blinded therapy to Week 46 at the investigator’s discretion.
Patients in Study UC I had failed to respond or were intolerant to oral corticosteroids, 6-MP,or AZA. Patients in Study UC II had failed to respond or were intolerant to the abovetreatments and/or aminosalicylates. Similar proportions of patients in Studies UC I and UC IIwere receiving corticosteroids (61% and 51%, respectively), 6-MP/AZA (49% and 43%) andaminosalicylates (70% and 75%) at baseline. More patients in Study UC II than UC I weretaking solely aminosalicylates for UC (26% vs. 11%, respectively). Clinical response wasdefined as a decrease from baseli |
