Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

Remission Noted After 2 Years for Patients with Crohn’s Disease

By Janssen Pharmaceutical Companies | February 17, 2017

New data shows Stelara (ustekinumab) maintained clinical response and remission after two years of treatment in patients with moderate to severe Crohn’s disease.

Janssen-Cilag International NV announced today new two-year data from the ongoing IM-UNITI long-term extension (LTE) study evaluating the efficacy and safety of subcutaneous (SC) Stelara (ustekinumab) in patients with moderate to severe Crohn’s disease. The data presented at the 12th Congress of the European Crohn’s and Colitis Organization (ECCO) showed that treatment with ustekinumab maintained clinical response and remission for up to two years with no new safety signals observed.1

“Maintaining control of disease symptoms is paramount in the treatment of Crohn’s disease. The two-year clinical response and remission rates from the IM-UNITI study provide further evidence that ustekinumab can be an effective therapeutic option for people living with this chronic and often debilitating disease,” said Professor William Sandborn, MD, UC San Diego Health System, Gastroenterology Chief.

Of the 1,281 patients enrolled in the maintenance study, 397 patients who achieved a response to ustekinumab at week 8 following an induction phase were randomized to receive SC ustekinumab 90mg every 8 weeks (Q8W) or every 12 weeks (Q12W), or placebo during a maintenance (0–44 week) period, before entering the LTE (44–252 week) period.

A one-time dose adjustment to ustekinumab 90mg Q8W was permitted in patients in the randomized group who met loss of response criteria between weeks 8–32. Clinical efficacy data were collected every 12 weeks and safety data were collected every 4 weeks from the end of the maintenance trial (week 44) until the maintenance study was unblinded and then at Q8W or Q12W dosing visits during the LTE period; data at week 92 are reported here.

Among randomized patients who entered the LTE period and continued to receive ustekinumab through week 96, 79.2% of patients receiving ustekinumab Q12W and 87.1% of patients receiving ustekinumab Q8W were in remission, while 90.9% of patients and 94.3% of patients showed clinical response at week 92, respectively. Among all ustekinumab-treated patients who continued to receive ustekinumab through week 96, remission and response rates at week 92 were 70.7% and 84.7%, respectively (as observed).

Safety event rates per hundred years of follow up were comparable in ustekinumab-treated patients compared to placebo-treated patients from week 44 through to week 96. Among all ustekinumab-treated patients, there were two deaths (sudden death, asphyxia). There were two NMSC (non-melanoma skin cancer) malignancies reported between weeks 44 and 96, a seminoma in a ustekinumab-treated patient and a papillary thyroid cancer in a placebo-only-treated patient.1

“The 96 week data from the IM-UNITI study complement data previously presented from the UNITI program. We look forward to sharing future results from the UNITI program, and remain committed to improving overall outcomes for people living with Crohn’s disease,” said Frederic Lavie, EMEA Therapeutic Area Leader Immunology, Cardiovascular and Metabolics, Janssen.
__________________________________________________

Reference:

1 Sandborn W, Rutgeerts P, Gasink C et al. Long term efficacy and safety of ustekinumab for Crohn’s disease: Results from IM-UNITI Long-Term Extension through 2 years. Annual Congress of the European Crohn’s and Colitis Organization (ECCO 2017); 15-18 February, 2017; Barcelona, Spain; Abstract A-1285.

(Source: Business Wire)


Filed Under: Drug Discovery

 

Related Articles Read More >

FDA approved ENFLONSIA for the prevention of RSV in Infants
First clinical study results of Dupixent for atopic dermatitis in patients with darker skin tones 
Labcorp widens precision oncology toolkit, aims to speed drug-trial enrollment
Lokavant’s Spectrum v15 uses AI to cut trial-feasibility modeling from weeks to minutes
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE