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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
lp-stelara-weeks

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

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.

1. Iborra M, et al. Aliment Pharmacol Ther. 2020; 52: 1017-1030.
2. Chaparro, M, et al. Poster P0507 presented at United European Gastroenterology Week (UEGW), 11–13 October 2020, virtual event.
3. Chaparro M, et al. Poster 0434 presented at European Crohn’s and Colitis Organisation (ECCO) 15th Congress, 12–15 February 2020, Vienna, Austria.
4. Af Björkesten CG, et al. Eur J Gastroenterol Hepatol. 2020; 32(12): 1507-1513.
5. Alric H, et al. Aliment Pharmacol Ther. 2020; 51: 948-957.
6. Biemans VBC, et al. J Crohns Colitis. 2020; 14: 33-45.
7. Pauwels A, et al. Poster P0414 presented at European Crohn’s and Colitis Organisation (ECCO) 14th Congress, 6–9 March 2019, Copenhagen, Denmark.
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19. Parra RS, et al. Poster P0429 presented at United European Gastroenterology Week (UEGW), 19–23 October 2019, Barcelona, Spain.
20. Viola A, et al. Poster 0717 presented at European Crohn’s and Colitis Organisation (ECCO) 15th Congress, 12–15 February 2020, Vienna, Austria.
21. Biemans VBC, et al. Aliment Pharmacol Ther. 2020; 52: 123-134.
22. Townsend T, et al. Poster P586 presented at European Crohn’s and Colitis Organisation (ECCO) 14th Congress, 6–9 March 2019, Copenhagen, Denmark.
23. Ahmed Z, et al. Gastroenterol Res. 2019; 12: 245-251.
24. Bokemeyer B, et al. Poster P728 presented at European Crohn’s and Colitis Organisation (ECCO) 14th Congress, 6–9 March 2019, Copenhagen, Denmark.
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26. Suvarna VR. Perspect Clin Res. 2018; 9(2): 61-63.
27. Chaparro M, et al. Poster presentation P0506 presented at United European Gastroenterology Week (UEGW), 11–13 October 2020, virtual event.
28. Hu A, et al. Gastroenterol Hepatol. 202012: S1542-3565(20)30973-3.
29. Iborra M, et al. Aliment Pharmacol Ther. 2019; 50: 278-288.
30. Panaccione R, et al. Aliment Pharmacol Ther. 2020; 52: 1658-1675.
31. Sandborn WJ, et al. Oral presentation OP110 presented at United European Gastroenterology Week (UEGW), 11–13 October 2020, virtual event.
32. STELARA® 130 mg concentrate solution for infusion. 90 mg / 45 mg solution for injection. EU Summary of Product Characterist ics, November 2020.

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