A new UC treatment is here
For the treatment of adult patients with moderately to severely active Crohn’s disease (CD) or ulcerative colitis (UC).
*In both the CD and UC studies, many patients achieved clinical remission at 1 year with STELARA®.
RAPID RESPONSE:
Clinical response† was achieved
as early as Week 6 in CD and
Week 8 in UC1
†In CD, clinical response was defined as reduction in CDAI score of ≥100 points or CDAI score of <150. In UC, clinical response was defined as a decrease from baseline in the modified Mayo score by ≥30% and ≥2 points, with either a decrease from baseline in the rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0 or 1.
LASTING REMISSION:
Many patients achieved clinical remission‡ at 1 year in the CD and UC clinical trials. In CD, the majority of those patients remained in clinical remission at ≈5 years.§ In UC, the majority of those patients remained in symptomatic remissionII at ≈4 years1,2¶
‡In CD, clinical remission was defined as a CDAI score of <150. In UC, clinical remission was defined as Mayo stool frequency subscore of 0 or 1, Mayo rectal bleeding subscore of 0, and Mayo endoscopy subscore of 0 or 1 (modified so that 1 does not include friability).
§53% (68/128) of patients were in clinical remission at 1 year; of these patients, 59% (40/68) were in clinical remission at 5 years.
IISymptomatic remission was defined as a Mayo stool frequency subscore of 0 or 1 and a Mayo rectal bleeding subscore of 0.
¶45% (79/176) of patients were in clinical remission at 1 year; of these patients, 69% (53/77) were in symptomatic remission at 4 years.
SAFETY PROFILE:
The safety profile in CD and UC studies through 1 year was consistent with that seen in other approved indications1
Commercial Formulary Coverage Look-up
Enter Your ZIP Code to View Coverage Results
All information is subject to change. Actual benefits determined by health plan. We strongly recommend you call the health plan for its reimbursement policies. This information does not advise on or guarantee coverage or payment.
In the phase 3 clinical trials and open-label LTE1,2
In the phase 3 clinical trials and open-label LTE
STELARA withMe provides a range of dedicated support and resources to help make it easier for patients as they begin, and continue, their STELARA® treatment journey.
Visit stelarawithme.com/HCP
CD=Crohn’s disease; CDAI=Crohn's Disease Activity Index; FDA=Food and Drug Administration;HEMI=histo-endoscopic mucosal improvement; LTE=long-term extension; UC=ulcerative colitis.
†In CD, clinical response was defined as reduction in CDAI score of ≥100 points or CDAI score of <150. In UC, clinical response was defined as a decrease from baseline in the modified Mayo score by ≥30% and ≥2 points, with either a decrease from baseline in the rectal bleeding subscore of ≥1 or a rectal bleeding subscore of 0 or 1.
‡In CD, clinical remission was defined as a CDAI score of <150. In UC, clinical remission was defined as Mayo stool frequency subscore of 0 or 1, Mayo rectal bleeding subscore of 0, and Mayo endoscopy subscore of 0 or 1 (modified so that 1 does not include friability).
References: 1. STELARA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.
© Janssen Biotech, Inc. 2024. All rights reserved.
cp-210102v8
Last Updated September 2024
© Janssen Biotech, Inc. 2024 09/24 cp-460750v1