TAKE CHARGE OF CD+UC FOR YOUR BIO-NAÏVE PATIENTS
STELARA® FOR LASTING* REMISSION
For the treatment of adult patients with moderately to severely active Crohn's disease or moderately to severely active ulcerative colitis.
*In both the CD and UC studies, many patients achieved clinical remission at 1 year with STELARA®.
Many patients achieved clinical response as early as Week 6 in CD and Week 8 in UC in clinical trials1†
Many patients achieved clinical remission at 1 year in the CD and UC clinical trials1‡
HISTO-ENDOSCOPIC MUCOSAL IMPROVEMENT (HEMI) IN UC
The first and only FDA-approved biologic treatment in UC to achieve HEMI1§
The relationship of HEMI to long-term outcomes was not studied in the clinical trials.
The overall 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®—3 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 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).
§HEMI was defined as combined endoscopic improvement (Mayo endoscopy subscore of 0 or 1) and histologic improvement of the colon tissue (neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions, ulcerations, or granulation tissue).
References: 1. STELARA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 2. Data on file. Janssen Biotech, Inc.