JANSSEN

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced 18 company-sponsored abstracts will be presented at the 14^th  Congress of the European Crohn’s and Colitis Organisation (ECCO) taking place in Copenhagen, Denmark from 6-9 March. Highlights include six company-sponsored oral or digital oral presentations, including new data from the Phase 3 UNIFI study evaluating the efficacy and safety of STELARA^® (ustekinumab) maintenance therapy in patients with moderate to severe ulcerative colitis (UC), which will be presented during the Plenary Session on 9 March.

“This year marks the largest showing of data from our inflammatory bowel disease portfolio of products at ECCO, a reflection of our continued leadership and unwavering commitment to addressing unmet needs for people living with IBD ,” said Scott E Plevy, MD, Gastroenterology Disease Area and IL-23 Pathway Leader, Janssen Research & Development, LLC^* “We are excited to present new Phase 3 maintenance data for STELARA in ulcerative colitis which are the basis of our pending regulatory applications in the European Union, US and Canada.”

A listing of abstracts is provided in the table below. Notable data presentations at ECCO include the following:

New ustekinumab data in ulcerative colitis

• Results from the Phase 3 UNIFI study evaluating the efficacy and safety of ustekinumab as maintenance therapy in patients with moderate to severe UC who were in clinical response to a single intravenous induction of ustekinumab will be presented during a plenary session. These data were included in the recent Group Type II Variation Application to the European Medicines Agency and supplemental Biologics License Application submission to the U.S. Food and Drug Administration. (Abstract OP37 )
• Additional data from the same Phase 3 UNIFI study evaluating the effects of ustekinumab induction therapy on endoscopic healing (EH), histologic healing (HH) and combined histo-endoscopic mucosal healing (HEMH), in patients with moderate to severe UC will be presented as a digital oral. UNIFI is the first Phase 3 study to measure the effects of biologic therapy on EH and HEMH endpoint in patients with UC. Mucosal healing assesses how the colon is responding both histologically and endoscopically to therapy and both have been associated with improved, long-term clinical outcomes and a major therapeutic goal in treating patients with UC. (Abstract DOP71 )

New ustekinumab data in Crohn’s disease (CD)

• Results from the Phase 3 IM-UNITI maintenance study evaluating efficacy of ustekinumab after one year of maintenance therapy (i.e. at week 56, rather than the original week 44 primary endpoint) in patients with moderate to severe CD will be shared as a poster presentation. (Abstract P343 )

Abstract No.		Title		Date/Time
OP13		Molecular response to ustekinumab in moderate-to-severe ulcerative colitis by serum protein and biopsy gene expression analysis: Results from the UNIFI Phase 3 induction study		Oral presentation Friday, March 8, 2019 8:30 AM - 10:30 AM
P406		General health status in patients with moderate to severe ulcerative colitis receiving ustekinumab: results from the Phase 3 UNIFI induction and maintenance studies		Poster presentation Friday, March 8, 2019 12:30 PM - 1:30 PM
P681		Ustekinumab therapy induced clinically meaningful improvement and remission as measured by the Inflammatory Bowel Disease Questionnaire: Results from the phase 3 UNIFI induction and maintenance studies		Poster presentation Friday, March 8, 2019 12:30 PM - 1:30 PM
P312		Efficacy in biologic failure and non-biologic-failure populations in a Phase 3 study of ustekinumab in moderate–severe ulcerative colitis: UNIFI		Poster presentation Friday, March 8, 2019 12:30 PM - 1:30 PM
P477		Clinical remission by legacy vs. FDA definitions: definition justification and results from UNIFI Study		Poster presentation Friday, March 8, 2019 12:30 PM - 1:30 PM
P317		Characterisation of patients with delayed response to ustekinumab for Crohn’s disease		Poster presentation Friday, March 8, 2019 12:30 PM - 1:30 PM
P680		Long-term efficacy of ustekinumab with and without concomitant immunosuppressants for Crohn’s disease: results from IM-UNITI long-term extension through 2 years		Poster presentation Friday, March 8, 2019 12:30 PM - 1:30 PM
P343		Efficacy of ustekinumab in Crohn’s disease at maintenance Week 56: IM-UNITI study		Poster presentation Friday, March 8, 2019 12:30 PM - 1:30 PM
P311		Pharmacokinetics and exposure–response relationships of intravenously administered ustekinumab during induction treatment in patients with ulcerative colitis: Results from the UNIFI induction study		Poster presentation Friday, March 8, 2019 12:30 PM - 1:30 PM
DOP47		Sustained remission in patients with moderate to severe ulcerative colitis: Results from the Phase 3 UNIFI maintenance study		Digital oral presentation Friday, March 8, 2019 5:20 PM - 6:20 PM
DOP71		Effects of ustekinumab induction therapy on endoscopic and histological healing in the UNIFI Phase 3 study in ulcerative colitis		Digital oral presentation Friday, March 8, 2019 5:20 PM - 6:20 PM
DOP54		Efficacy and safety of ustekinumab through Week 16 in patients with moderate-to-severe ulcerative colitis randomised to ustekinumab: results from the UNIFI induction trial		Digital oral presentation Friday, March 8, 2019 5:20 PM - 6:20 PM
OP36		A colonic gene expression signature predicts non-response to anti-inflammatory therapies in inflammatory bowel disease		Oral presentation Saturday, March 9, 2019 10:50 AM - 12:20 PM
OP37		Efficacy and safety of ustekinumab as maintenance therapy in ulcerative colitis: Week 44 results from UNIFI		Oral presentation Saturday, March 9, 2019 10:50 AM - 12:20 PM

The common (≥ 1/100) adverse reactions reported in controlled periods of the adult psoriasis, psoriatic arthritis and CD 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.¹

About ulcerative colitis

Ulcerative colitis affects up to 2.6 million people in Europe.² It is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus. Ulcerative colitis is the result of an abnormal response by the body's immune system. Symptoms vary, but may include loose and more urgent bowel movements, persistent diarrhoea, abdominal pain, bloody stool, loss of appetite, weight loss and fatigue.³

About the UNIFI trial

UNIFI is a Phase 3 protocol, designed to evaluate the safety and efficacy of ustekinumab induction and maintenance dosing for the treatment of moderate to severe UC in adults who demonstrated an inadequate response to, or were unable to tolerate, conventional (i.e., corticosteroids, immunomodulators) or biologic (i.e., one or more TNF blockers and/or vedolizumab) therapies. Both the induction and maintenance studies are randomised, double-blind, placebo-controlled, parallel group, multicentre studies. The induction study was conducted over a duration of at least 8 weeks for each participant. Participants achieving clinical response in the induction study were eligible for the maintenance study. The maintenance study was 44 weeks in duration. The primary endpoint of the induction study was clinical remission at week 8, and the primary endpoint for the maintenance study was clinical remission at week 44 among responders to a single intravenous ustekinumab infusion. After completion of the maintenance study, a long-term extension study will follow eligible participants for an additional three years.

About Crohn’s disease

Up to 1.7 million people across Europe are living with CD.² Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet or other environmental factors. Symptoms of CD can vary but often include abdominal pain and tenderness, frequent diarrhoea, rectal bleeding, weight loss and fever. There is currently no cure for CD.⁴

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 CD. 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 ustekinumab 90 mg every 8 or 12 weeks, or placebo. In patients who met loss of response criteria between weeks 8–32, a one-time dose adjustment to 90 mg every 8 weeks occurred. All patients completing week 44 were eligible to enter the long-term extension programme, continuing their current regimen up to week 252.

About STELARA ^® (ustekinumab) ¹

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, and is also indicated for the treatment of moderate to severe plaque psoriasis in adolescent patients aged 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 therapy has been inadequate. In November 2016, the European Commission approved ustekinumab for the treatment of adult patients with moderately to severely active CD 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. In December 2018, a Group Type II Variation Application to the European Medicines Agency (EMA) was submitted, which seeks approval of ustekinumab for the treatment of adults with moderately to severely active UC.

About the Janssen Pharmaceutical Companies of Johnson & Johnson

At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Learn more at www.janssen.com/EMEA . Follow us on Twitter: @JanssenEMEA. Janssen Research & Development, LLC is one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

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References

1. European Medicines Agency. (2016) Ustekinumab Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000958/WC500058513.pdf . Accessed February 2019

2. Ng SC, Shi HY, Underwood FE, et al . Worldwide incidence and prevalence of inflammatory bowel disease in the 21^st century: a systematic review of population-based studies. Lancet 2017;390:2769-78.

3. Crohn’s and Colitis UK. Ulcerative colitis. Available at: https://www.crohnsandcolitis.org.uk/about-inflammatory-bowel-disease/ulcerative-colitis . Accessed February 2019.

4. Crohn’s and Colitis UK. Crohn’s disease. Available at http://www.crohnsandcolitis.org.uk/about-inflammatory-bowel-disease/crohns-disease . Accessed February 2019.

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