REMICADE®
CLINICAL INFORMATION

For pediatric patients with moderately to severely active ulcerative colitis

REMICADE®
CLINICAL INFORMATION

For pediatric patients with moderately to severely active ulcerative colitis

For pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy1

CLINICAL DATA

Clinical response and remission
Clinical response at Week 8, the primary endpoint of the Pediatric UC Trial, was achieved in 44 out of 60 (73%) patients after induction dosing of REMICADE® 5 kg/mg IV at Weeks 0, 2, and 6.*1,5


The pediatric UC trial was a multicenter, phase 3, randomized, open-label, parallel-group trial to evaluate the safety and efficacy of REMICADE® in pediatric patients aged 6 to 17 years with moderately to severely active UC.

remission in PEDIATRIC UC trial1,5
REMICADE® 5 mg/kg IV
Week 8 n/N(%)
Clinical remission
(Mayo score)
24/60 (40%)
Remission (PUCAI) 17/51 (33%)
Week 54 Every 8 Weeks Treatment Group Every 12 Weeks Treatment Group§
n/N (%) n/N (%)
Remission (PUCAI) 8/21 (38%) 4/22 (18%)

*Mayo clinical response was defined by a decrease in Mayo score of 30% and 3 points, with a decrease in the rectal bleeding subscore of 1 or a rectal bleeding subscore of 0 or 1.1,5

†Mayo clinical remission was defined as a Mayo score of 2 points, with no individual subscore >1 point.1,5

‡Pediatric Ulcerative Colitis Activity Index (PUCAI) remission was defined as a PUCAI <10 points.1,5 The PUCAI is comprised of 6 subscores: rectal bleeding (0 to 30 points), number of stools in a 24-hour period (0 to 15 points), stool consistency (0 to 10 points), abdominal pain (0 to 10 points), nocturnal bowel movements (0 to 10 points), and activity level (0 to 10 points). The total score ranges from 0 to 85. Higher scores represent more severe disease.5

§REMICADE® 5 mg/kg IV every 12 weeks is not an approved maintenance dose for pediatric patients with moderately to severely active UC.1


References: 1. REMICADE® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. FDA approves Inflectra, a biosimilar to Remicade [news release]. Silver Spring, MD: US Food and Drug Administration; April 5, 2016. https://www.fda.gov/news-events/press-announcements/fda-approves-inflectrabiosimilar-remicade. Accessed August 2, 2019. 3. Biologics License Application approval for Renflexis [approval letter]. Silver Spring, MD; US Food and Drug Administration; April 21, 2017. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761054Orig1s000ltr.pdf. Accessed August 2, 2019. 4. Biologics License Application (BLA) clinical review for Renflexis. Silver Spring, MD; US Food and Drug Administration; March 21, 2016. 5. Hyams J, Damaraju L, Blank M, et al; for the T72 Study Group. Induction and maintenance therapy with infliximab for children with moderate to severe ulcerative colitis. Clin Gastroenterol Hepatol. 2012;10(4):391-399.

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