Symptomatic Response
TREMFYA® separated from placebo in symptomatic response as early as Week 1
Post Hoc: Symptomatic Response1*†
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Ulcerative Colitis Specialist
*DATA LIMITATION:
Symptomatic response data through Week 12 were post hoc analyses and not adjusted for multiplicity. No statistical or clinical significance can be made.
†Symptomatic response was defined as a decrease from induction baseline in the symptomatic Mayo score by ≥30% and ≥1 point, with either a ≥1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1. The symptomatic Mayo score was defined as the sum of the stool frequency and the rectal bleeding subscores.1
CI=confidence interval; IV=intravenous.
Endoscopic Remission
Over 1/3 of all patients on TREMFYA® achieved complete endoscopic remission (MES=0) at 1 year*†‡
DATA LIMITATION SUBGROUP ANALYSIS1:
Endoscopic remission of the biologic/JAKi-naïve population at 1 year was a prespecified endpoint but not adjusted for multiplicity. No statistical or clinical significance can be made.
DATA LIMITATION SUBGROUP ANALYSIS1:
Endoscopic remission of the biologic/JAKi-naïve population at 1 year was a prespecified endpoint but not adjusted for multiplicity. No statistical or clinical significance can be made.
*Week 44 of the maintenance study was defined as 1 year.
†Endoscopic remission (normalization) was defined as an endoscopy subscore of 0.1
‡The modified Mayo score includes the 3-component Mayo score (stool frequency, rectal bleeding, and endoscopy subscores) without the physician’s global assessment.2
JAKi=Janus kinase inhibitor; MES=Mayo endoscopic subscore; q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous.
Endoscopic Remission
When in clinical remission at 1 year, 71% of biologic/
JAKi-naïve patients were in endoscopic remission1,2*†‡
Use the lowest effective recommended dosage to maintain therapeutic response.
*DATA LIMITATION:
*DATA LIMITATION SUBGROUP ANALYSIS1:
Endoscopic remission among clinical remitters (overall population and biologic/JAKi-naïve) at Week 44 was a post hoc analysis
and not adjusted for multiplicity. Clinical remission at Week 44 in the biologic/JAKi-naïve subgroup analysis was prespecified but
not controlled for multiplicity. No statistical or clinical significance can be made.
Endoscopic remission of the biologic/JAKi-naïve population at 1 year was a
prespecified endpoint but not adjusted for multiplicity. No statistical or clinical significance can be made.
†Week 44 of the maintenance study was defined as 1 year.
‡Of the 58% of patients who achieved clinical remission at Week 44 with TREMFYA® 200 mg SC q4w, 71% were also in endoscopic remission at Week 44.1
§Clinical remission was defined as a Mayo stool frequency subscore of 0 or 1 and not increased from baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.1
||Endoscopic remission (normalization) was defined as an endoscopy subscore of 0.1
¶The modified Mayo score includes the 3-component Mayo score (stool frequency, rectal bleeding, and endoscopy subscores) without the physician’s global assessment.1
JAKi=Janus kinase inhibitor; q4w=every 4 weeks; SC=subcutaneous.
Endoscopic Imagery
See the difference with endoscopic imagery
From a real patient on TREMFYA®
who was in endoscopic remission at
Weeks 12 and 441
Before TREMFYA®
Week 0, MES=3
After TREMFYA®
Week 12, MES=0
Endoscopic Remission (MES=0) at Week 12 for TREMFYA® 200 mg IV q4w 15%
(63/421) and patients who received
placebo 5% (14/280)2*
DATA LIMITATION: Endoscopic remission at Week 12 was a prespecified endpoint but not adjusted for multiplicity. No statistical or clinical significance can be made.
After TREMFYA®
Week 44, MES=0
Endoscopic Remission (MES=0) at Week 44 for TREMFYA® 200 mg SC q4w 34% (64/190), TREMFYA® 100 mg SC q8w 35% (65/188), and patients who received placebo 15% (29/190)1,2*
These images are of sections of an actual patient's colon from the QUASAR study. Individual results may vary.1
*Endoscopic remission (normalization) was defined as an endoscopy subscore of 0.2
IV=intravenous; MES=Mayo endoscopic subscore; q4w=every 4 weeks; q8w=every 8 weeks; SC=subcutaneous.
References: 1. Data on file. Janssen Biotech, Inc. 2. TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.