STELARA® (ustekinumab) Data Demonstrate Long-Term Efficacy and Safety Results in Adults with Moderately to Severely Active Ulcerative Colitis in Phase 3 Extension Trial

BARCELONA, Spain, Oct. 21, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new two-year data from the long-term extension of the Phase 3 UNIFI study. The data demonstrated that the majority of adult patients with moderately to severely active ulcerative colitis who achieved symptomatic remission¹ with STELARA^® (ustekinumab) were able to sustain remission through week 92. These data are being presented today as a late-breaking data presentation (LB01) at the 27th United European Gastroenterology Week (UEGW) congress.

These data include 399 participants who were in clinical response eight weeks after receiving a single intravenous (IV) induction dose of STELARA and who were then randomized to receive STELARA subcutaneous (SC) 90mg injections every 12 weeks (q12w), STELARA SC 90mg injections every 8 weeks (q8w), or placebo, and who entered the long-term extension. Results presented showed that the majority of patients who achieved symptomatic remission¹ with STELARA were able to sustain symptomatic remission through week 92.

• The percentage of patients receiving STELARA SC q12w who were in symptomatic remission between weeks 44 to 92 ranged between 81 to 90 percent, and those receiving STELARA SC q8w ranged between 83 and 91 percent.
• Among patients who had achieved clinical remission at maintenance baseline, 69 percent of patients receiving STELARA q8w and 80 percent of patients receiving STELARA q12w maintained symptomatic remission at both weeks 44 and 92.
• Additional analyses demonstrated that approximately two-thirds of patients receiving STELARA q8w and q12w achieved corticosteroid-free symptomatic remission at week 92.²

"Ulcerative colitis is a life-long and debilitating inflammatory bowel disease, interrupting the daily lives of millions of people around the world who may still be searching for an effective treatment option," said lead study investigator Bruce E. Sands, M.D., Icahn School of Medicine, Mt. Sinai, New York, who will be delivering the oral presentation³. "It's encouraging to see data from long-term extension trials that can offer symptom relief and remission over time to those struggling with UC."

Through two years, the proportions of patients with adverse events (AEs), serious AEs, and serious infections in the STELARA groups were generally comparable to the placebo group. No new safety signals were observed.

"The Phase 3 UNIFI two-year data underscore our commitment to advancing research and development in inflammatory bowel diseases," said Jan Wehkamp, M.D., Vice President, Gastroenterology Disease Area Leader, Janssen Research & Development, LLC. "We are proud to present these results for the first time at UEGW because we recognize the significant unmet needs that continue to persist in treating the life-altering symptoms of moderately to severely active UC."   

Janssen is presenting a total of 17 abstracts at this year's UEGW congress of which seven are oral presentations, including further data from the UNIFI UC clinical trials program.

STELARA is currently approved for the treatment of adults with moderately to severely active ulcerative colitis in the U.S. and European Union.

About the UNIFI Trial
UNIFI is a Phase 3 protocol designed to evaluate the safety and efficacy of STELARA induction and maintenance dosing for the treatment of moderately to severely active ulcerative colitis 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 or vedolizumab) therapies. Both the induction and maintenance studies are randomized, double-blind, placebo-controlled, parallel group, multi-center studies.

The induction study was of at least 8 weeks duration for each participant. Participants achieving clinical response in the induction study were eligible for the maintenance study. The maintenance study was 44 weeks duration. The primary endpoint of the induction study is clinical remission at week 8, and the primary endpoint for the maintenance study is clinical remission at week 44 among responders to a single IV STELARA infusion. A long-term extension of UNIFI is ongoing and is following eligible participants for an additional three years upon completion of the maintenance study.

About Ulcerative Colitis
Ulcerative Colitis (UC) is a chronic, progressive inflammatory bowel disease (IBD) that causes ulcerations and inflammation in the large intestine (colon and rectum).^4,5 UC affects approximately 910,000 adults in the U.S. and men are approximately 1.5 times more likely than women to be diagnosed.⁶ The disease is more common among Caucasian people, although it can affect people of any racial or ethnic group. Diagnosis tends to peak between the ages of 15 and 35, although the disease itself can occur at any age.⁷ Symptoms of ulcerative colitis can vary but may include looser and more urgent bowel movements, bloody stool, crampy abdominal pain, loss of appetite and fatigue. There is currently no cure for ulcerative colitis.⁸

About STELARA^® (ustekinumab)
STELARA^® (ustekinumab), a human IL-12 and IL-23 antagonist, is approved in the United States for the treatment of: 1) adults and children 12 years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; 2) adult patients (18 years or older) with active psoriatic arthritis, used alone or in combination with methotrexate (MTX); 3) adult patients (18 years and older) with moderately to severely active Crohn's disease; 4) adult patients (18 years and older) with moderately to severely active ulcerative colitis.

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA^®.

IMPORTANT SAFETY INFORMATION
STELARA^® is a prescription medicine that affects your immune system. STELARA^® can increase your chance of having serious side effects including:

Serious Infections
STELARA^® may lower your ability to fight infections and may increase your risk of infections. While taking STELARA^®, some people have serious infections, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.

• Your doctor should check you for TB before starting STELARA^® and watch you closely for signs and symptoms of TB during treatment with STELARA^®.
• If your doctor feels that you are at risk for TB, you may be treated for TB before and during treatment with STELARA^®.

You should not start taking STELARA^® if you have any kind of infection unless your doctor says it is okay.

Before starting STELARA^®, tell your doctor if you:

• think you have an infection or have symptoms of an infection such as:
• fever, sweats, or chills
• muscle aches
• cough
• shortness of breath
• blood in phlegm
• weight loss
• warm, red, or painful skin or sores on your body
• diarrhea or stomach pain
• burning when you urinate or urinate more often than normal
• feel very tired
• are being treated for an infection.
• get a lot of infections or have infections that keep coming back.
• have TB, or have been in close contact with someone with TB.

After starting STELARA^®, call your doctor right away if you have any symptoms of an infection (see above). STELARA^® can make you more likely to get infections or make an infection that you have worse. People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL‐12) and interleukin 23 (IL‐23) are at a higher risk for certain serious infections that can spread throughout the body and cause death. People who take STELARA^® may also be more likely to get these infections.

Cancers
STELARA^® may decrease the activity of your immune system and increase your risk for certain types of cancer. Tell your doctor if you have ever had any type of cancer. Some people who had risk factors for skin cancer developed certain types of skin cancers while receiving STELARA^®. Tell your doctor if you have any new skin growths.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
RPLS is a rare condition that affects the brain and can cause death. The cause of RPLS is not known. If RPLS is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including: headache, seizures, confusion, and vision problems.

Serious Allergic Reactions
Serious allergic reactions can occur. Stop using STELARA^® and get medical help right away if you have any symptoms of a serious allergic reaction such as: feeling faint, swelling of your face, eyelids, tongue, or throat, chest tightness, or skin rash.

Lung Inflammation
Cases of lung inflammation have happened in some people who receive STELARA^® and may be serious. These lung problems may need to be treated in a hospital. Tell your doctor right away if you develop shortness of breath or a cough that doesn't go away during treatment with STELARA^®.

Before receiving STELARA^®, tell your doctor about all of your medical conditions, including if you:

• have any of the conditions or symptoms listed above for serious infections, cancers, or RPLS.
• ever had an allergic reaction to STELARA^® or any of its ingredients. Ask your doctor if you are not sure.
• are allergic to latex. The needle cover on the prefilled syringe contains latex.
• have recently received or are scheduled to receive an immunization (vaccine). People who take STELARA^® should not receive live vaccines. Tell your doctor if anyone in your house needs a live vaccine. The viruses used in some types of live vaccines can spread to people with a weakened immune system, and can cause serious problems. You should not receive the BCG vaccine during the one year before receiving STELARA^® or one year after you stop receiving STELARA^®.
• have any new or changing lesions within psoriasis areas or on normal skin.
• are receiving or have received allergy shots, especially for serious allergic reactions.
• receive or have received phototherapy for your psoriasis.
• are pregnant or plan to become pregnant. It is not known if STELARA^® can harm your unborn baby. You and your doctor should decide if you will receive STELARA^®.
• are breastfeeding or plan to breastfeed. It is thought that STELARA^® passes into your breast milk. Talk to your doctor about the best way to feed your baby if you receive STELARA^®.

Tell your doctor about all the medicines you take, including prescription and over‐the‐counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

When prescribed STELARA^®:

• Use STELARA^® exactly as your doctor tells you to.
• STELARA^® is intended for use under the guidance and supervision of your doctor. In children 12 years and older, it is recommended that STELARA^® be administered by a healthcare provider. If your doctor decides that you or a caregiver may give your injections of STELARA^® at home, you should receive training on the right way to prepare and inject STELARA^®. Your doctor will determine the right dose of STELARA^® for you, the amount for each injection, and how often you should receive it. Do not try to inject STELARA^® yourself until you or your caregiver have been shown how to inject STELARA^® by your doctor or nurse.

Common side effects of STELARA^® include: nasal congestion, sore throat, and runny nose, upper respiratory infections, fever, headache, tiredness, itching, nausea and vomiting, redness at the injection site, vaginal yeast infections, urinary tract infections, sinus infection, stomach pain, diarrhea, and joint pain. These are not all of the possible side effects with STELARA^®. Tell your doctor about any side effect that you experience. Ask your doctor or pharmacist for more information.

Please read the full Prescribing Information and Medication Guide for STELARA^® and discuss any questions you have with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‐800‐FDA‐1088.

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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. Follow us at www.twitter.com/JanssenGlobal. Janssen Research & Development, LLC is one 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 the US of STELARA^® (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 materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, and any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; 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 December 30, 2018, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, 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. None of 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.

1. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0. Patients who had both stool frequency and rectal bleeding subscores missing at a visit were considered not to be in symptomatic remission at that visit.
2. Sands, B., et. Al. Efficacy and Safety of Ustekinumab for Ulcerative Colitis through 2 Years: UNIFI Long-Term Extension [Presentation for LB01] Presented at the 27th United European Gastroenterology Week (UEGW) congress 19-23 October 2019; Madrid, Spain.
3. Prof Bruce Sands is a paid consultant for Janssen. He has not been compensated for any media work.
4. Hendrickson BA, Gokhale R, Cho JH. Clinical aspects and pathophysiology of inflammatory bowel disease. Clin Microbiol Rev. 2002;15(1):79-94.
5. Crohn's & Colitis Foundation of America. Inflammatory bowel disease and irritable bowel syndrome: similarities and differences. www.crohnscolitisfoundation.org/assets/pdfs/ibd-and-irritable-bowel.pdf. Published July 2014. Accessed July 7, 2019.
6. Kappelman MD, Rifas–Shiman SL, Kleinman K, Ollendorf D, Bousvaros A, Grand RJ, Finkelstein, JA. The prevalence and geographic distribution of Crohn's disease and ulcerative colitis in the United States. Clin Gastroenterol Hepatol. 2007;5(12):1424-1429.
7. Kornbluth A, Sachar DB. Ulcerative colitis practice guidelines in adults: American College of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2010;105(3):501-523.
8. Crohn's & Colitis Foundation of America. What is Ulcerative Colitis? http://www.crohnscolitisfoundation.org/what-are-crohns-and-colitis/what-is-ulcerative-colitis/. Accessed February 1, 2019.

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SOURCE Janssen Pharmaceutical Companies of Johnson & Johnson

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