AMSTERDAM, March 18, 2016 /PRNewswire/ -- Phase 3 data presented at the 11th Congress of the European Crohn's and Colitis Organisation (ECCO) showed that treatment with STELARA® (ustekinumab) induced clinical response and clinical remission in adult patients with moderate to severe Crohn's disease who had previously failed or were intolerant to treatment with one or more anti-tumor necrosis factor (TNF)-alpha therapies. The Janssen Phase 3 UNITI-1 study, which included 741 patients, achieved its primary endpoint with STELARA® treatment groups demonstrating significantly higher rates of clinical response at week 6 when compared with the placebo group. Major secondary endpoints of clinical response and clinical remission at week 8 were also significantly higher among patients receiving STELARA® compared with patients receiving placebo.
These latest findings follow Phase 3 results from the UNITI-2 study, which demonstrated the efficacy and safety of STELARA® in patients who had previously failed conventional therapy, the majority of whom were naïve to treatment with anti-TNF-alpha therapy. Applications seeking approval of STELARA® for the treatment of moderately to severely active Crohn's disease are currently under review in Europe and the United States. STELARA®, approved for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in many countries, is a monoclonal antibody that targets interleukin (IL)-12 and IL-23 cytokines, which are believed to play a role in immune-mediated diseases, including Crohn's disease.
"Results from the UNITI-1 study show that ustekinumab therapy induced clinical response and remission in patients with moderate to severe Crohn's disease who had previously failed treatment with TNF inhibitors," said Paul Rutgeerts, M.D., Professor Emeritus of Medicine and Former Director of the Multidisciplinary Department of Endoscopy, Catholic University of Leuven, Belgium, and ustekinumab Crohn's disease steering committee member. "With two Phase 3 induction studies demonstrating the efficacy and safety of ustekinumab in anti-TNF-alpha naïve, exposed and failure patient populations, we look forward to the forthcoming maintenance study findings. The need to induce and maintain control of disease symptoms is paramount in the treatment of Crohn's disease."
Patients participating in the Phase 3 UNITI-1 study received a single intravenous (I.V.) infusion of placebo, STELARA® 130 mg or STELARA® ~6 mg/kg (weight-tiered dosing: patients weighing less than or equal to 55 kg received 260 mg; patients weighing more than 55 kg and less than or equal to 85 kg received 390 mg; and patients weighing more than 85 kg received 520 mg) at week 0. All enrolled patients had previously failed or were intolerant to treatment with at least one anti-TNF-alpha therapy, and half of the enrolled patients had failed two or more anti-TNF-alpha therapies.
At week 6, 34 percent of patients receiving STELARA® 130 mg and 34 percent of patients receiving STELARA® ~6 mg/kg achieved clinical response, as defined by a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of at least 100 points, compared with 22 percent of patients receiving placebo (P = 0.002 for STELARA® 130 mg; P = 0.003 for STELARA® ~6 mg/kg). CDAI is a symptom-based disease assessment tool commonly used in clinical trials to quantify Crohn's disease activity.
At week 8, 34 percent and 38 percent of patients receiving STELARA® 130 mg and STELARA® ~6 mg/kg, respectively, achieved clinical response, compared with 20 percent of patients receiving placebo (P < 0.001). In addition, 16 percent of patients receiving STELARA® 130 mg and 21 percent of patients receiving STELARA® ~6 mg/kg achieved clinical remission at week 8, as defined by a CDAI score of less than 150 points, compared with 7 percent of patients receiving placebo (P = 0.003 for STELARA® 130 mg; P < 0.001 for STELARA® ~6 mg/kg).
In addition to significant improvements in signs and symptoms as measured by CDAI, both doses of STELARA® resulted in significant improvements in the Inflammatory Bowel Disease Questionnaire (IBDQ), a health-related quality of life measure for patients with IBD, as well as significant reduction in markers of inflammation, including C-reactive protein (CRP), fecal lactoferrin and calprotectin.
Through week 8 (placebo-controlled period), adverse events (AEs), serious AEs and infections were reported in similar proportions across STELARA® and placebo treatment groups. One case of Listeria meningitis infection was reported in the STELARA® ~6 mg/kg group. No malignancies, deaths, cases of tuberculosis or major adverse cardiovascular events (MACE) were observed in patients treated with STELARA®.
"We are pleased to share these important results from the Phase 3 UNITI-1 induction study, which complement Phase 3 results from the UNITI-2 study and further support regulatory applications submitted seeking approval of STELARA® for the treatment of moderately to severely active Crohn's disease," said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC. "Janssen Immunology remains committed to the continued development of STELARA® and the discovery of innovative medicines for the treatment of immune-mediated diseases."
Additional data from the STELARA® Phase 3 Crohn's disease clinical development program being presented at the 11th Congress of ECCO include:
- Assessment of Serum C-reactive Protein, Fecal Lactoferrin, and Fecal Calprotectin in Patients with Crohn's Disease: Results from the UNITI-1 and UNITI-2 Ustekinumab Induction Studies
- Pharmacokinetics And Exposure-Response Relationships of Intravenously Administered Ustekinumab During Induction Treatment in Patients with Crohn's Disease: Results from the UNITI-1 and UNITI-2 Studies
- Molecular Response to Ustekinumab in Moderate-to-Severe Crohn's Disease by Serum Protein Analysis: Results from the UNITI-1 and UNITI-2 Phase 3 Induction Studies
About the UNITI-1 Trial
UNITI-1, a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study, evaluated the efficacy and safety of STELARA® induction therapy in adult patients with moderate to severe Crohn's disease. Patients (n=741) were randomized equally to receive a single I.V. infusion of placebo, STELARA® 130 mg or STELARA® ~6 mg/kg (weight-tiered dosing: patients weighing less than or equal to 55 kg received 260 mg; patients weighing more than 55 kg and less than or equal to 85 kg received 390 mg; and patients weighing more than 85 kg received 520 mg) at week 0. All participating patients had previously failed or were intolerant to treatment with at least one anti-TNF-alpha therapy. The primary endpoint was clinical response at week 6, measured by the proportion of patients who achieved at least a 100-point reduction from baseline CDAI scores. Major secondary endpoints at week 8 included clinical response and clinical remission (defined by CDAI scores less than 150 points). At week 8, patients either transitioned to the IM-UNITI maintenance study or were to complete a safety follow-up period through week 20.
UNITI-1 is part of a comprehensive Phase 3 clinical development program investigating STELARA® for the treatment of moderate to severe Crohn's disease. Data from the UNITI-2 induction study evaluating STELARA® for the treatment of patients who had previously failed conventional therapy, the majority of whom were naïve to treatment with anti-TNF-alpha therapy, were presented in 2015 at the American College of Gastroenterology (ACG) Annual Meeting and United European Gastroenterology (UEG) Week. Results from the IM-UNITI maintenance study will be presented at a future medical congress.
About Crohn's Disease
More than five million people worldwide are living with Crohn's disease and ulcerative colitis—collectively known as inflammatory bowel disease (IBD).1 Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract that affects approximately 700,000 Americans2 and nearly 250,000 Europeans.3 The cause of Crohn's disease is not known, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition or diet and other environmental factors. Symptoms of Crohn's disease can vary but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss and fever. There is currently no cure for Crohn's disease.2
About STELARA® (ustekinumab)
STELARA®, a human IL-12 and IL-23 antagonist, is approved in the United States for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. STELARA® is also approved for the treatment of adult patients (18 years or older) with active psoriatic arthritis and can be used alone or in combination with methotrexate (MTX).
The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA®, which is currently approved for the treatment of moderate to severe plaque psoriasis in 87 countries and psoriatic arthritis in 71 countries.
Important Safety Information (U.S.) |
STELARA® is a prescription medicine that affects your immune system. STELARA® can increase your chance of having serious side effects including:
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
- shortness of breath
- blood in your 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 who has 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. It is not known if people who take STELARA® will get any of these infections because of the effects of STELARA® on these proteins.
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. Get medical help right away if you have any symptoms such as: feeling faint, swelling of your face, eyelids, tongue, or throat, trouble breathing, throat or chest tightness, or skin rash.
Before receiving STELARA®, tell your doctor 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 vaccine. The viruses used in some types of 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 taking STELARA® or one year after you stop taking 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
- have any other medical conditions
- are pregnant or plan to become pregnant. It is not known if STELARA® will harm your unborn baby. You and your doctor should decide if you will take STELARA®.
- are breast-feeding or plan to breast-feed. It is thought that STELARA® passes into your breast milk. You should not breast-feed while taking STELARA® without first talking to your doctor.
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 prescribed by your doctor
- 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®. Do not try to inject STELARA® yourself until you or your caregiver has been shown how to inject STELARA® by your doctor or nurse.
Common side effects of STELARA® include: upper respiratory infections, headache, tiredness, joint pain and nausea. 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.
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.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people with serious diseases throughout the world. Beyond its innovative medicines, Janssen is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and healthcare professionals have access to the latest treatment information, support services and quality care.
Janssen Research & Development, LLC is one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssen.com for more information. Follow us on Twitter at https://twitter.com/JanssenGlobal.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development. 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/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges inherent in new product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new products; 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 description 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 3, 2016, including in Exhibit 99 thereto, 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 or Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
1. World IBD Day. Home. Available at http://www.worldibdday.org/index.html. Accessed February 3, 2016.
2. Crohn's & Colitis Foundation of America. What is Crohn's Disease?. Available at http://www.ccfa.org/what-are-crohns-and-colitis/what-is-crohns-disease/. Accessed February 3, 2016.
3. European Federation of Pharmaceutical Industries and Associations. Inflammatory Bowel Disease. Available at http://www.efpia.eu/diseases/78/59/Inflammatory-Bowel-Disease. Accessed February 3, 2016.
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