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®.
FAST
RAPID RESPONSE:
Clinical response† was achieved
as early as Week 6 in CD and
Week 8 in UC1
LASTS
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¶
PROVEN
SAFETY PROFILE:
The safety profile in CD and UC studies through 1 year was consistent with that seen in other approved indications1
STELARA®—5 YEARS OF EFFICACY AND SAFETY DATA IN CROHN’S DISEASE (CD)
In the phase 3 clinical trials and open-label LTE1,2
STELARA®—4 YEARS OF EFFICACY AND SAFETY DATA IN ULCERATIVE COLITIS (UC)2
In the phase 3 clinical trials and open-label LTE
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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.