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New Two-Year Data Show Treatment with Janssen’s Stelara® (Ustekinumab) Reduced Rates of Hospitalisation and Surgery in Patients with Moderate-to-Severe Crohn’s Disease, Compared with Placebo

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today a new analysis looking at two-year data from the IM-UNITI long-term extension (LTE) STELARA® (ustekinumab) programme, which demonstrated that two dosing regimens of ustekinumab (90mg administrated every 12 [q12w] and 8 [q8w] weeks), can decrease the risk of Crohn’s disease (CD) related hospitalisation, surgery and the need for alternative biologic treatment in patients with moderate-to-severe CD, when compared to placebo.1 Janssen presented these long-term findings from the Phase III IM-UNITI study (abstract #2913377), alongside 14 other abstracts, at Digestive Disease Week® (DDW) 2018 in Washington DC on Saturday 2 June.

“Crohn’s disease can have a significant impact on patients, with most having multiple relapses and many experiencing complications that require intervention. These long-term data from IM-UNITI are particularly encouraging for clinicians as they demonstrate that treatment with ustekinumab reduced the need for hospitalisation, surgery, or a switch to another treatment,” said study investigator Professor William Sandborn, MD, UC San Diego Health System, Gastroenterology Chief.

This analysis included patients with moderate-to-severe CD from the UNITI-1 and UNITI-2 trials who had achieved clinical response after a single intravenous (IV) dose of ustekinumab and entered five years of long-term observation. Patients were randomised to receive either placebo or subcutaneous (SC) ustekinumab 90mg q12w or q8w. Incidences of hospitalisation, surgery or initiation of an alternative biologic (TNF-antagonist or anti-integrin therapy) were assessed at 96 weeks.1 The IM-UNITI LTE trial is ongoing.

Patients receiving ustekinumab q12w through to two-years were 52% less likely to be admitted to hospital or require surgery than patients treated with placebo (ustekinumab q12w HR=0.477 [0.238, 0.957], p=0.033). Patients receiving ustekinumab q8w were 40% less likely to experience either of these endpoints (ustekinumab q8w HR=0.601 [0.411, 0.879], p=0.006).1

Hospitalisation accounts for ~50–80% of the healthcare costs associated with inflammatory bowel disease (Crohn’s disease and ulcerative colitis), and ~40–60% of these inpatient costs can be attributed to surgery.2 CD patients may require surgery due to the damage that the disease causes to the bowel, presenting as ulcers, scarring, narrowing of the gastrointestinal (GI) tract (strictures) and abnormal connections between different parts of the GI tract (fistulas).3

Patients in the q8w group were 53% less likely to switch to an alternative biologic than the placebo group (ustekinumab q8w HR=0.473 [0.215, 1.040], p=0.042). The q12w group also saw a risk reduction of 33%, however, significance was not reached (ustekinumab q12w HR=0.667 [0.223, 1.999], p=0.467).1

Janssen also presented a new analysis from the UNITI-1 and 2 and IM-UNITI trials assessing which quality of life measures had the greatest impact on health-related quality of life after induction of therapy (abstract #2914355). Quality of life impact was measured via a questionnaire. At the start of the trials factors such as fatigue, sleep, loose stools and emotional and social effects such as feeling unwell and impact on leisure activity were seen to have the greatest negative impact on quality of life, with mean scores of <3.5. 8 by week significant improvements were seen for these measures in patients receiving ustekinumab vs>4

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 were: upper respiratory tract infection, arthralgia, back pain, diarrhoea, dizziness, fatigue, headache, infection site pain, injection site erythema, myalgia, nasopharyngitis, nausea, oropharyngeal pain, pruritus and vomiting.5

Janssen presented a total of 15 abstracts at this year’s DDW annual meeting.

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About Digestive Disease Week (DDW)

Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place June 2–5, 2018, at Walter E. Washington Convention Center. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org .

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.6 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.7

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 92. Patients will continue in the IM-UNITI trial up to week 252.

About STELARA ® (ustekinumab) 5

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.

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to ustekinumab, which is currently approved for the treatment of moderate to severe plaque psoriasis in 90 countries, paediatric psoriasis in 43 countries, psoriatic arthritis in 83 countries and Crohn’s disease in 54 countries.

Important Safety Information

For complete European Union (EU) prescribing information, please visit: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000958/human_med_001065.jsp&mid=WC0b01ac058001d124

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 (“Janssen”) is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Cautions Concerning Forward-Looking Statements

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development and potential availability in Europe of ustekinumab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges inherent in product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including under “Item 1A. Risk Factors,” its most recently filed Quarterly Report on Form 10-Q, including under the caption “Cautionary Note Regarding Forward-Looking Statements,” and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson. Neither the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

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References

1. Sandborn WJ, Sands B, Gasink C et al. Reduced rates of Crohn’s-related surgeries, hospitalizations and alternate biologic initiation with ustekinumab in the IM-UNITI study through 2 years. Digestive Disease Week ® (DDW) 2018: 2-5 June 2018. Abstract #2913377. Presentation #Sa1743.

2. Petryszyn PW & Witczak I. Costs in inflammatory bowel diseases. Przegla̜d Gastroenterologiczny . 2016;11(1):6–13.

3. NHS. Crohn’s disease. NHS Choices. Available from: https://www.nhs.uk/conditions/crohns-disease/living-with/#possible-complications (Last accessed May 2018).

4. Sands BE, Pires A, Gasink C et al. Post hoc analysis of the impact of ustekinumab treatment on specific items of the inflammatory bowel disease questionnaire in the UNITI-1&2 programs. Digestive Disease Week ® (DDW) 2018: 2-5 June 2018. Abstract #2914355. Presentation #Mo1811.

5. Ustekinumab Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000958/WC500058513.pdf (Last accessed May 2018).

6. Janssen Disease Lens. Available at https://www.diseaselens.com/v2/index.php (Last accessed May 2018).

7. Crohn’s and Colitis UK. Crohn’s disease. Available at http://www.crohnsandcolitis.org.uk/about-inflammatory-bowel-disease/crohns-disease (Last accessed May 2018).

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