10/25/2021 | Press release | Distributed by Public on 10/25/2021 07:32
SPRING HOUSE, PENNSYLVANIA, October 25, 2021 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced data from two new analyses of STELARA® (ustekinumab) for the treatment of adults with moderately to severely active Crohn's disease (CD) and ulcerative colitis (UC).1,2 In a modelled analysisa focused on treatment sequencing using data from randomized controlled trials, network meta-analysis and literature, results showed patient time spent in clinical remission or response was highest when STELARA was used as a first-line advanced therapy for bio-naïve patients with moderately to severely active UC relative to outcomes associated with second- or third-line use (P0540).1 Additionally, in a separate real-world claims analysis, a greater proportion of bio-naïve patients who started biologic therapy with STELARA (n=948) for moderately to severely active CD showed persistence at 12 months versus adalimumab (n=4,143) (P0525).2 These data are among 16 abstracts, including one oral presentation, presented at the 2021 American College of Gastroenterology Annual Scientific Meeting, which is taking place October 22-27 in Las Vegas, Nevada.1,2
"Data emerging from these analyses inform physicians with additional evidence to support STELARA as a first-line option for patients with moderately to severely active Crohn's disease and ulcerative colitis," said Christopher Gasink, M.D., Head of Immunology Medical Affairs, Gastroenterology, Janssen Scientific Affairs, LLC. "Many patients living with inflammatory bowel disease can cycle through different therapies as a result of loss or lack of treatment response. Studies like these are important in helping guide physicians to select an appropriate therapeutic option for their patients in a first-line setting."
"Identifying the Optimal Treatment Sequence for STELARA in Treatment Algorithms for Advanced Therapies in UC (P0540)" Results Suggested:
Initiating STELARA as a first-line advanced therapy for UC in a hybrid decision tree model resulted in more favorable patient outcomes in terms of increased amount of time spent in remission or response and the postponing of surgery compared with second-line and third-line use.1
When used first-line, STELARA-treated patients in the cohort model spent on average:
"Treatment Persistence Among Bio-Naïve Patients with CD Initiated on STELARA or adalimumab (P0525)" Results Suggested:
A higher proportion of bio-naive patients selected from the IQVIA PharMetrics® Plus claims database who started on STELARA (n=948) were persistent on therapy at 12 months, including persistent and corticosteroid-free and persistent and on monotherapy versus patients who started on adalimumab (n=4,143).2 Specifically, patients in the STELARA versus adalimumab cohort showed:
"These analyses in ulcerative colitis and Crohn's disease expand the body of data for STELARA and give us insight into treatment sequencing and persistence rates, which are important when assessing biologic therapy options for patients. The data are informative because patients with inflammatory bowel disease can demonstrate a short-term clinical response and improvement with therapy and then lose response," said Jan Wehkamp, M.D., Vice President, Gastroenterology Disease Area Leader, Janssen Research & Development, LLC. "Janssen is committed to conducting analyses that provide additional insight when treating patients with inflammatory bowel disease."
Editor's Note:
a. A hybrid model with decision tree for induction and a Markov cohort model for maintenance was developed to assess clinical efficacy of STELARA therapy when used 1st, 2nd, or 3rd line. Transition probabilities for remission, response and surgery were derived from randomized controlled trials, network meta-analysis, and the literature. Full details are available in the poster.1
About (P0540): Identifying the Optimal Treatment Sequence for STELARA in Treatment Algorithms for Advanced Therapies in UC1
In the hybrid model described in the editor's note, the treatment basket for first- and second-line UC was represented by infliximab (33 percent), adalimumab (33 percent), and vedolizumab (33 percent), and third-line treatment was comprised of vedolizumab (50 percent) and tofacitinib (50 percent). Patients moved to next line of treatment upon loss of response, and those failing the first three lines of advanced therapy moved to conventional treatment (e.g., aminosalicylates and/or immunosuppressants, corticosteroids). The model estimated time spent in remission, response, active UC (Mayo score 6-12), surgery, as well as occurrences of death over one, three and five years. Transition probabilities for remission, response and surgery were derived from randomized controlled trials, network meta-analysis, and the literature.These are modelled results based on input assumptions largely from clinical trials and a network meta-analysis.
About (P0525): Treatment Persistence Among Bio-Naïve Patients with CD Initiated on STELARA or adalimumab2
Bio-naïve adults with CD initiated on STELARA or adalimumab between September 23, 2016 and August 1, 2019 were selected from a de-identified health insurance claims data from the IQVIA PharMetrics® Plus. Bio-naïve patients were defined as patients with no medical or pharmacy claim for biologics indicated for CD during the baseline period (12 months before the initiation of the index agent). Baseline characteristics were balanced in weighted STELARA (n=948) and adalimumab (n=4,143) cohorts using inverse probability of treatment weights. Persistence on index agent was defined as absence of gaps >120 days (STELARA) or >60 days (adalimumab) between days of therapy supply. Composite endpoints of being persistent on index biologic and corticosteroid-free (<14 days of supply after day 90 post-index) and persistent and on monotherapy (no immunomodulators or non-index biologics) were assessed. All endpoints were estimated at 12 months post-index using weighted Kaplan-Meier and Cox's proportional hazards model analyses. Analyses of claims database depend on correct diagnosis, procedure, and drug codes, and misclassification may have occurred. All patients are assumed to have moderate to severe disease since they started biologic treatment.
Modeling and Real-World Data Limitations
Modeling and real-world data have the potential to supplement randomized controlled trial data by providing additional information about how a medicine performs across all available Phase 2 and 3 clinical trials and in routine clinical practice. There are limitations, however, and these data cannot be used as stand-alone evidence to validate the efficacy or safety of a treatment.
About Ulcerative Colitis (UC)
More than five million people worldwide are living with CD and UC-commonly known as inflammatory bowel disease. UC affects nearly 907,000 people in the U.S., with approximately 38,000 new cases diagnosed each year.3 UC 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.4 It is the result of an abnormal response by the body's immune system.4 Symptoms vary, but may include loose and more urgent bowel movements, persistent diarrhea, abdominal pain, bloody stool, loss of appetite, weight loss, and fatigue.5
About Crohn's Disease (CD)
CD is one of the two main forms of inflammatory bowel disease, which affects an estimated three million Americans.6 CD 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.7 Symptoms of CD can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever.8 There is currently no cure for CD.9
About STELARA® (ustekinumab)10
STELARA® (ustekinumab) is a fully human monoclonal antibody and is the first biologic treatment to selectively inhibit the interleukin (IL)-12 and IL-23 pathways. STELARA is approved in the United States for the treatment of: 1) adults and children six 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 CD; 4) adult patients (18 years and older) with moderately to severely active UC.
The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA®.
STELARA® (ustekinumab) 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.
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:
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:
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®:
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 REMICADE® (infliximab)11
REMICADE was the first anti-TNF-alpha treatment approved in the United States in August 1998 and the first TNF inhibitor to be approved in three different therapeutic areas: gastroenterology, rheumatology, and dermatology. REMICADE has demonstrated broad clinical utility with indications in Crohn's disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, pediatric Crohn's disease and psoriasis. The safety and efficacy of REMICADE have been well established in clinical trials over the past 17 years and through commercial experience with more than 2.7 million patients treated worldwide.
In the U.S., REMICADE is approved for the following indications:
Crohn's Disease:
Pediatric Crohn's Disease:
Ulcerative Colitis:
Pediatric Ulcerative Colitis:
Rheumatoid Arthritis:
Ankylosing Spondylitis:
Psoriatic Arthritis:
Plaque Psoriasis:
Janssen Biotech, Inc. discovered and developed REMICADE and markets the product in the United States. The Janssen Pharmaceutical Companies market REMICADE in Canada, Central and South America, the Middle East, Africa and Asia Pacific.
In Japan, Indonesia, and Taiwan, Janssen Biotech, Inc. licenses distribution rights to REMICADE to Mitsubishi Tanabe Pharma Corporation. In Europe, Russia and Turkey, Janssen Biotech, Inc. licenses distribution rights to REMICADE to Schering-Plough (Ireland) Company, a subsidiary of Merck & Co, Inc.
REMICADE® (INFLIXIMAB) IMPORTANT SAFETY INFORMATION
Only your doctor can recommend a course of treatment after checking your health condition. REMICADE® (infliximab) can cause serious side effects such as lowering your ability to fight infections. Some patients, especially those 65 years and older, have had serious infections which include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body or caused infections in certain areas (such as skin). Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with REMICADE®.
Unusual cancers have been reported in children and teenage patients taking tumor necrosis factor (TNF) blocker medicines. Hepatosplenic T-cell lymphoma, a rare form of fatal lymphoma, has occurred mostly in male teenagers or young men with Crohn's disease or ulcerative colitis who were taking REMICADE® and azathioprine or 6-mercaptopurine. For children and adults taking TNF blockers, including REMICADE®, the chances of getting lymphoma or other cancers may increase. You should discuss any concerns about your health and medical care with your doctor.
It is not known if REMICADE® is safe and effective in children under 6 years of age.
What should I tell my doctor before I take REMICADE®?
You should let your doctor know if you have or ever had any of the following:
Also tell your doctor if you:
What should I watch for and talk to my doctor about before or while taking REMICADE®?
The following serious (sometimes fatal) side effects have been reported in people taking REMICADE®.
You should tell your doctor right away if you have any of the signs listed below:
The more common side effects of REMICADE® include respiratory infections (such as sinus infections and sore throat), headache, coughing and stomach pain.
Please read the full Prescribing Information and Medication Guide for REMICADE® 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.
About the Janssen Pharmaceutical Companies of Johnson & JohnsonAt 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, LLCand Janssen Scientific Affairs, LLC are each 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 STELARA® (ustekinumab) 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 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 January 3, 2021, 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.
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References
1. Zhang S, et al. Identifying the Optimal Treatment Sequence for Ustekinumab in Treatment Algorithms for Advanced Therapies in Ulcerative Colitis (Abstract P0540). Presented at the American College of Gastroenterology (ACG) Annual Scientific Meeting, October 22-27, 2021.
2. Pilon D, et al. Treatment persistence among bio-naïve patients with Crohn's disease initiated on ustekinumab or adalimumab (Abstract P0525). Presented at the ACG Annual Scientific Meeting, October 22-27, 2021.
3. The Facts About Inflammatory Bowel Diseases. Crohn's & Colitis Foundation of America. Accessed September 22, 2021, from https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf
4. What is Ulcerative Colitis? Crohn's & Colitis Foundation. Accessed September 22, 2021, from https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis
5. Signs and Symptoms of Ulcerative Colitis. Crohn's & Colitis Foundation. Accessed September 22, 2021 from https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis/symptoms
6. Overview of Crohn's Disease. Crohn's & Colitis Foundation. Accessed September 22, 2021, from https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview
7. Causes of Crohn's Disease. Crohn's & Colitis Foundation. Accessed September 22, 2021, from https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes
8. Signs and Symptoms of Crohn's Disease. Crohn's & Colitis Foundation. Accessed September 22, 2021, from https://www.crohnscolitisfoundation.org/what-is-crohns-disease/symptoms
9. Crohn's disease - Symptoms and causes. (2020, October 13). Mayo Clinic. Accessed September 22, 2021 from https://www.mayoclinic.org/diseases-conditions/crohns-disease/symptoms-causes/syc-20353304
10. STELARA® Prescribing Information. Available at: http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/STELARA-pi.pdf. Accessed September 22, 2021.
11. REMICADE® Prescribing Information. Available at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/REMICADE-pi.pdf Accessed October 2021.
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