New Data For Stelara®
RWE CONFIRMS RAPID RESPONSE FROM THE 1ST DOSE WITH STELARA®
HIGHLIGHTS
- SustAIN,* the largest study evaluating STELARA® in CD in clinical practice, showed that 58% of highly refractory patients demonstrated a response (including remission) at Week 8.†27
RWE CONFIRMS HIGH, LASTING EFFICACY WITH MINIMAL USE OF CORTICOSTEROIDS
HIGHLIGHTS
- The SustAIN and FINUSTE 2* studies demonstrated long-term durability and treatment persistence in patients with active CD.†‡2,4
- STELARA® monotherapy was as effective as combination therapy in terms of clinical and endoscopic improvement in patients with IBD.§28
RWE CONFIRMS THE REASSURING SAFETY PROFILE OF STELARA® IN IBD
- The safety profile and tolerability data in the real-world setting were consistent with the known profile of STELARA®.1,2,5,6,8,11-14,21,27,29
PRESCRIBING INFORMATION
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References
* This study is supported by Janssen.
† Patients with active CD (HBI>4) who received ≥1 dose of STELARA® before July 2018 were included; N = 463 patients; 96.5%
≤4, and clinical response as a decrease in HBI ≥3 points; dataset includes off-label dosing.
‡ N = 155 patients with highly refractory CD: 59% had prior CD-related surgeries; 97% had a treatment history of ≥1 biologic agent; 67% had used ≥2 biologics.
§ Clinical response: Decrease in HBI ≥3 or Simple Clinical Colitis Activity Index (SCCAI)/partial Mayo score ≥2; Clinical remission:
HBI ≤4 or SCCAI/Mayo <3; Endoscopic remission: Absence of ulcerations in CD, Mayo score 0 in UC. Colonoscopy 6–12 months.
steroids, IBD-related surgery/hospitalisation during 1-year follow-up.
CD: Crohn’s disease; HBI: Harvey-Bradshaw index; IBD: Inflammatory bowel disease; RCT: Randomised controlled trial; UC: Ulcerative colitis; UST: Ustekinumab.
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CP-246327
