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Janssen’s STELARA® (ustekinumab) Demonstrates Sustained Efficacy in Improving Clinical Remission Rates in Patients with Moderate to Severe Crohn’s Disease Throughout Three Years

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new three-year data from the IM-UNITI study, which demonstrates the continued efficacy of ustekinumab in improving clinical remission rates and shows ustekinumab to be generally well-tolerated in patients with Crohn’s disease.1 The data from the IM-UNITI trial, which will continue for a further two years, are being presented today at the 26th United European Gastroenterology Week (UEGW) congress in Vienna, Austria.

These new three-year results from IM-UNITI are encouraging because they show the important role that treatment with ustekinumab can have in helping Crohn’s disease patients to achieve long-term clinical remission ,” said Professor William Sandborn, Director, Inflammatory Bowel Disease Center, University of California, San Diego, USA.* “Clinical remission is an important goal during treatment as patients have an improved quality of life and wellbeing when they do not need to worry about a flare up .”

These data are the first to be presented from the three-year assessment of subcutaneously (SC) administered 90 mg ustekinumab in Crohn’s disease. Overall efficacy assessments at week 152 demonstrated that 60.3% of all randomised ustekinumab-treated patients who entered the long-term extension study were in clinical remission. Furthermore, 68.8% of these randomised ustekinumab treated patients had demonstrated a clinical response.1

The key study findings for different dosing regimens found that 61.9% of patients who were randomised to receive 90 mg ustekinumab SC every 12 weeks (q12w) and continued to receive this dose in the study extension were in clinical remission. For those patients who were randomised to receive 90 mg ustekinumab SC in the every eight week dosing regimen group (q8w) and continued to receive this dose, 69.5% of patients were in clinical remission.1

The study also found that, of those patients who were naïve to TNF antagonist therapy and treated with ustekinumab, 67.6% were in clinical remission at week 156.1 This demonstrates that patients who have not yet received TNF antagonist therapy (the most commonly prescribed class of biologic treatments)2 could benefit from ustekinumab treatment. Further to this, of those ustekinumab treated patients who had previously failed (i.e. who were refractory to) or who were intolerant to TNF antagonist therapy, 48.4% were in clinical remission.1

Dr Jaime Oliver, MD, Janssen Therapeutic Area Lead, Immunology, Europe, Middle East & Africa, Cilag GmbH International said, “Janssen is dedicated to helping improve the lives of people living with Crohn’s disease. With that mission in mind, we are pleased that these study findings indicate that ustekinumab can help a substantial proportion of people with moderate to severe Crohn’s disease achieve clinical remission. The IM-UNITI study will continue to explore ustekinumab for a further two years, as part of our ongoing commitment to our patients, innovation and scientific leadership .”

Safety events (per hundred patient years) were not higher amongst all ustekinumab treated patients entering the long-term extension study compared to placebo from week 44 through to week 156. No new safety signals were observed.1

Between weeks 96 and 156, three deaths were reported (one each of acute myocardial infarction, kidney failure and sepsis).1 Additionally, two cases of non-melanoma skin cancers (adenocarcinoma of the small intestine and chronic myeloid leukaemia [CML]) were seen in these ustekinumab treated groups.1

The common (≥1/100) adverse reactions reported in controlled periods of the adult psoriasis, psoriatic arthritis and Crohn's disease clinical studies with ustekinumab as well as post-marketing experience are: arthralgia (joint pain), back pain, diarrhoea, dizziness, fatigue, headache, infection site pain, injection site erythema, myalgia (muscle pain), nasopharyngitis, nausea, oropharyngeal pain, pruritus (itching of the skin), upper respiratory tract infection and vomiting.3

Janssen is presenting a total of four abstracts at this year’s UEGW congress, including further data from the UNITI clinical trial programme, as well as a late breaking abstract presenting data from the UNIFI clinical trial programme assessing ustekinumab’s efficacy in moderate to severe ulcerative colitis patients.4

#ENDS#

*Professor William Sandborn is a paid consultant for Janssen. He was not compensated for any media work.

About UEGW

The United European Gastroenterology Week (UEGW) congress is taking place in Vienna, Austria from Saturday 20th to Wednesday 24th October 2018. For more information, visit: https://www.ueg.eu/week/ .

About Crohn’s disease

Up to one million people across Europe are living with Crohn’s disease, and nearly 33,000 new cases are diagnosed each year.5 Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet or other environmental factors. Symptoms of Crohn’s disease can vary but often include abdominal pain and tenderness, frequent diarrhoea, rectal bleeding, weight loss and fever. There is currently no cure for Crohn’s disease.6

About the IM-UNITI trial

IM-UNITI, a Phase 3, multicentre, randomised, double-blind, placebo-controlled, parallel group study, evaluated the efficacy and safety of ustekinumab maintenance therapy in adult patients with moderate-to-severe Crohn’s disease. Patients who had responded to a single intravenous dose of ustekinumab in the UNITI-1 or UNITI-2 induction studies were randomised equally to receive maintenance subcutaneous (SC) ustekinumab 90mg q8w or q12w, or placebo. In patients who met loss of response criteria between weeks 8–32, a one-time dose adjustment to 90mg q8w occurred. All patients completing week 44 were eligible to enter the long-term extension programme, continuing their current regimen up to week 152. Patients will continue in the IM-UNITI trial up to week 252.

About STELARA ® (ustekinumab) 3

In the European Union, ustekinumab is approved for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or psoralen plus ultraviolet A (PUVA), and is also indicated for the treatment of moderate-to-severe plaque psoriasis in adolescent patients from the age of 12 years and older who are inadequately controlled by or are intolerant to other systemic therapies or phototherapies. In addition, ustekinumab is approved alone or in combination with MTX for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate. In November 2016, the European Commission approved ustekinumab for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-alpha antagonist or have medical contraindications to such therapies.

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.

We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com/EMEA . Follow us on Twitter: @JanssenEMEA.

Janssen-Cilag International NV and Cilag GmbH International are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

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References

1. Sandborn W, Rutgeerts P, et al. Efficacy and safety of ustekinumab for Crohn’s disease: Results from IM-UNITI long-term extension through 3 years. United European Gastroenterology Week (UEGW 2018) 20–24 October, 2018;Vienna, Austria.

2. Crohn’s & Colitis UK. Biological drugs: Information sheet. Available at: http://s3-eu-west-1.amazonaws.com/files.crohnsandcolitis.org.uk/Publications/Biologic-drugs-in-ibd . Last accessed October 2018.

3. European Medicines Agency. (2018) Ustekinumab Summary of Product Characteristics. Available at: https://www.ema.europa.eu/documents/product-information/stelara-epar-product-information_en.pdf . Accessed October 2018.

4. Sands B, Sandborn W, et al . Safety and efficacy of ustekinumab induction therapy in patients with moderate to severe ulcerative colitis: results from the Phase 3 UNIFI study. United Europe Gastroenterology Week (UEGW) 2018 20–24 Oct 2018;Vienna, Austria:LB01.

5. Janssen Disease Lens. Ulcerative colitis. Available at: https://www.crohnsandcolitis.org.uk/about-inflammatory-bowel-disease/ulcerative-colitis . Accessed October 2018.

6. Crohn’s and Colitis UK. Crohn’s disease. Available at: http://www.crohnsandcolitis.org.uk/about-inflammatory-bowel-disease/crohns-disease . Accessed October 2018.

Contact:

Media Enquiries: Emily Bone Mobile: +44 7876 394 360 Email: ebone1@ITS.JNJ.com or Investor Relations: Christopher DelOrefice Phone: +1 732-524-2955 or Lesley Fishman Phone: +1 732-524-3922

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