New Analyses Suggest Favorable Results for STELARA® (ustekinumab) When Used as a First-Line Therapy for Bio-Naïve Patients with Moderately to Severely Active Crohn’s Disease and Ulcerative Colitis


SPRING HOUSE, Pa., Oct. 25, 2021 /PRNewswire/ — The Janssen Pharmaceutical Corporations of Johnson & Johnson at the moment introduced knowledge from two new analyses of STELARA® (ustekinumab) for the therapy of adults with reasonably to severely energetic Crohn’s illness (CD) and ulcerative colitis (UC).1,2 In a modelled evaluationa targeted on therapy sequencing utilizing knowledge from randomized managed trials, community meta-analysis and literature, outcomes confirmed affected person time spent in scientific remission or response was highest when STELARA was used as a first-line superior remedy for bio-naïve sufferers with reasonably to severely energetic UC relative to outcomes related to second- or third-line use (P0540).1 Moreover, in a separate real-world claims evaluation, a better proportion of bio-naïve sufferers who began biologic remedy with STELARA (n=948) for reasonably to severely energetic CD confirmed persistence at 12 months versus adalimumab (n=4,143) (P0525).2 These knowledge are amongst 16 abstracts, together with one oral presentation, introduced on the 2021 American Faculty of Gastroenterology Annual Scientific Assembly, which is going down October 22-27 in Las Vegas, Nevada.1,2

Janssen Pharmaceutical Companies of Johnson & Johnson logo (PRNewsfoto/Janssen Pharmaceutical...
Janssen Pharmaceutical Corporations of Johnson & Johnson emblem (PRNewsfoto/Janssen Pharmaceutical Companie)

“Information rising from these analyses inform physicians with extra proof to help STELARA as a first-line possibility for sufferers with reasonably to severely energetic Crohn’s illness and ulcerative colitis,” stated Christopher Gasink, M.D., Head of Immunology Medical Affairs, Gastroenterology, Janssen Scientific Affairs, LLC. “Many sufferers dwelling with inflammatory bowel illness can cycle via totally different therapies on account of loss or lack of therapy response. Research like these are vital in serving to information physicians to pick an applicable therapeutic possibility for his or her sufferers in a first-line setting.”

“Figuring out the Optimum Remedy Sequence for STELARA in Remedy Algorithms for Superior Therapies in UC (P0540)” Outcomes Advised:
Initiating STELARA as a first-line superior remedy for UC in a hybrid choice tree mannequin resulted in additional favorable affected person outcomes when it comes to elevated period of time spent in remission or response and the suspending of surgical procedure in contrast with second-line and third-line use.1

  • When used first-line, STELARA-treated sufferers within the cohort mannequin spent on common:
  • When STELARA was used within the second-line setting, sufferers spent on common:
  • Modelled use of STELARA within the first- versus second-line diminished time affected by energetic UC by 0.6, 8.3, and 13.8 months over one, three, and 5 years, respectively. When in comparison with third-line, first-line use of STELARA advised even better reductions on the one-year (0.9 months), three-year (9 months), and five-year (14.5 months) timepoints.1
  • Future analysis is required to generate long-term scientific knowledge to substantiate these outcomes.1

“Remedy Persistence Amongst Bio-Naïve Sufferers with CD Initiated on STELARA or adalimumab (P0525)” Outcomes Advised:
A better proportion of bio-naive sufferers chosen from the IQVIA PharMetrics® Plus claims database who began on STELARA (n=948) had been persistent on remedy at 12 months, together with persistent and corticosteroid-free and protracted and on monotherapy versus sufferers who began on adalimumab (n=4,143).2 Particularly, sufferers within the STELARA versus adalimumab cohort confirmed:

  • 50 p.c increased fee of persistence on biologic (hazard ratio [HR] 1.50; 95% confidence interval [CI]: 1.29-1.74).2
  • 17 p.c increased fee of persistence and being corticosteroid-free (HR: 1.17; 95% CI: 1.04-1.31).2
  • 47 p.c increased fee of persistence on monotherapy (HR: 1.47; 95% CI: 1.30-1.65).2

“These analyses in ulcerative colitis and Crohn’s illness broaden the physique of knowledge for STELARA and provides us perception into therapy sequencing and persistence charges, that are vital when assessing biologic remedy choices for sufferers. The info are informative as a result of sufferers with inflammatory bowel illness can display a short-term scientific response and enchancment with remedy after which lose response,” stated Jan Wehkamp, M.D., Vice President, Gastroenterology Illness Space Chief, Janssen Analysis & Growth, LLC. “Janssen is dedicated to conducting analyses that present extra perception when treating sufferers with inflammatory bowel illness.”

Editor’s Notice:

About (P0540): Figuring out the Optimum Remedy Sequence for STELARA in Remedy Algorithms for Superior Therapies in UC1
Within the hybrid mannequin described within the editor’s observe, the therapy basket for first- and second-line UC was represented by infliximab (33 p.c), adalimumab (33 p.c), and vedolizumab (33 p.c), and third-line therapy was comprised of vedolizumab (50 p.c) and tofacitinib (50 p.c). Sufferers moved to subsequent line of therapy upon lack of response, and people failing the primary three strains of superior remedy moved to standard therapy (e.g., aminosalicylates and/or immunosuppressants, corticosteroids). The mannequin estimated time spent in remission, response, energetic UC (Mayo rating 6-12), surgical procedure, in addition to occurrences of loss of life over one, three and 5 years. Transition chances for remission, response and surgical procedure had been derived from randomized managed trials, community meta-analysis, and the literature. These are modelled outcomes primarily based on enter assumptions largely from scientific trials and a community meta-analysis.

About (P0525): Remedy Persistence Amongst Bio-Naïve Sufferers 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 had been chosen from a de-identified medical insurance claims knowledge from the IQVIA PharMetrics® Plus. Bio-naïve sufferers had been outlined as sufferers with no medical or pharmacy declare for biologics indicated for CD throughout the baseline interval (12 months earlier than the initiation of the index agent). Baseline traits had been balanced in weighted STELARA (n=948) and adalimumab (n=4,143) cohorts utilizing inverse likelihood of therapy weights. Persistence on index agent was outlined as absence of gaps >120 days (STELARA) or >60 days (adalimumab) between days of remedy provide. Composite endpoints of being persistent on index biologic and corticosteroid-free (

Modeling and Actual-World Information Limitations
Modeling and real-world knowledge have the potential to complement randomized managed trial knowledge by offering extra details about how a drugs performs throughout all accessible Part 2 and three scientific trials and in routine scientific observe. There are limitations, nevertheless, and these knowledge can’t be used as stand-alone proof to validate the efficacy or security of a therapy.

About Ulcerative Colitis (UC)
Greater than 5 million folks worldwide reside with CD and UC—generally generally known as inflammatory bowel illness. UC impacts almost 907,000 folks within the U.S., with roughly 38,000 new circumstances recognized every year.3 UC is a power illness of the big gut, often known as the colon, wherein the liner of the colon turns into infected and develops tiny open sores, or ulcers, that produce pus and mucus.4 It’s the results of an irregular response by the physique’s immune system.4 Signs range, however could embrace unfastened and extra pressing bowel actions, persistent diarrhea, belly ache, bloody stool, lack of urge for food, weight reduction, and fatigue.5

About Crohn’s Illness (CD)
CD is among the two predominant types of inflammatory bowel illness, which impacts an estimated three million People.6 CD is a power inflammatory situation of the gastrointestinal tract with no identified trigger, however the illness is related to abnormalities of the immune system that may very well be triggered by a genetic predisposition, eating regimen or different environmental elements.7 Signs of CD can range, however typically embrace belly ache and tenderness, frequent diarrhea, rectal bleeding, weight reduction, and fever.8 There’s at present no remedy for CD.9

About STELARA® (ustekinumab)10
STELARA® (ustekinumab) is a completely human monoclonal antibody and is the primary biologic therapy to selectively inhibit the interleukin (IL)-12 and IL-23 pathways. STELARA is accepted in the US for the therapy of: 1) adults and kids six years and older with average to extreme plaque psoriasis who’re candidates for phototherapy or systemic remedy; 2) grownup sufferers (18 years or older) with energetic psoriatic arthritis, used alone or together with methotrexate (MTX); 3) grownup sufferers (18 years and older) with reasonably to severely energetic CD; 4) grownup sufferers (18 years and older) with reasonably to severely energetic UC.

The Janssen Pharmaceutical Corporations of Johnson & Johnson preserve unique worldwide advertising and marketing rights to STELARA®.

STELARA® (ustekinumab) IMPORTANT SAFETY INFORMATION
STELARA® is a prescription medication that impacts your immune system. STELARA® can enhance your likelihood of getting severe negative effects together with:

Critical Infections
STELARA® could decrease your capability to combat infections and should enhance your danger of infections. Whereas taking STELARA®, some folks have severe infections, which can require hospitalization, together with tuberculosis (TB), and infections brought on by micro organism, fungi, or viruses.

  • Your physician ought to verify you for TB earlier than beginning STELARA® and watch you carefully for indicators and signs of TB throughout therapy with STELARA®.
  • In case your physician feels that you’re in danger for TB, it’s possible you’ll be handled for TB earlier than and through therapy with STELARA®.

You shouldn’t begin taking STELARA® when you have any form of an infection until your physician says it’s okay.

Earlier than beginning STELARA®, inform your physician in the event you:

  • suppose you might have an an infection or have signs of an an infection similar to:
  • are being handled for an an infection.
  • get numerous infections or have infections that maintain coming again.
  • have TB or have been in shut contact with somebody with TB.

After beginning STELARA®, name your physician instantly when you have any signs of an an infection (see above). STELARA® could make you extra prone to get infections or make an an infection that you’ve worse. Individuals who have a genetic drawback the place the physique doesn’t make any of the proteins interleukin 12 (IL–12) and interleukin 23 (IL–23) are at a better danger for sure severe infections that may unfold all through the physique and trigger loss of life. Individuals who take STELARA® can also be extra prone to get these infections.

Cancers
STELARA® could lower the exercise of your immune system and enhance your danger for sure forms of most cancers. Inform your physician when you have ever had any kind of most cancers. Some individuals who had danger elements for pores and skin most cancers developed sure forms of pores and skin cancers whereas receiving STELARA®. Inform your physician when you have any new pores and skin growths.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
RPLS is a uncommon situation that impacts the mind and may trigger loss of life. The reason for RPLS is just not identified. If RPLS is discovered early and handled, most individuals get better. Inform your physician instantly when you have any new or worsening medical issues together with: headache, seizures, confusion, and imaginative and prescient issues.

Critical Allergic Reactions
Critical allergic reactions can happen. Cease utilizing STELARA® and get medical assist instantly when you have any signs of a severe allergic response similar to: feeling faint, swelling of your face, eyelids, tongue, or throat, chest tightness, or pores and skin rash.

Lung Irritation
Circumstances of lung irritation have occurred in some individuals who obtain STELARA® and could also be severe. These lung issues could have to be handled in a hospital. Inform your physician instantly in the event you develop shortness of breath or a cough that does not go away throughout therapy with STELARA®.

Earlier than receiving STELARA®, inform your physician about all your medical circumstances, together with in the event you:

  • have any of the circumstances or signs listed above for severe infections, cancers, or RPLS.
  • ever had an allergic response to STELARA® or any of its components. Ask your physician if you’re unsure.
  • are allergic to latex. The needle cowl on the prefilled syringe accommodates latex.
  • have just lately acquired or are scheduled to obtain an immunization (vaccine). Individuals who take STELARA® mustn’t obtain stay vaccines. Inform your physician if anybody in your own home wants a stay vaccine. The viruses utilized in some forms of stay vaccines can unfold to folks with a weakened immune system, and may trigger severe issues. You shouldn’t obtain the BCG vaccine throughout the one 12 months earlier than receiving STELARA® or one 12 months after you cease receiving STELARA®.
  • have any new or altering lesions inside psoriasis areas or on regular pores and skin.
  • are receiving or have acquired allergy pictures, particularly for severe allergic reactions.
  • obtain or have acquired phototherapy in your psoriasis.
  • are pregnant or plan to develop into pregnant. It’s not identified if STELARA® can hurt your unborn child. You and your physician ought to resolve if you’ll obtain STELARA®.
  • are breastfeeding or plan to breastfeed. It’s thought that STELARA® passes into your breast milk. Speak to your physician about one of the best ways to feed your child in the event you obtain STELARA®.

Inform your physician about all of the medicines you’re taking, together with prescription and over–the–counter medicines, nutritional vitamins, and natural dietary supplements. Know the medicines you’re taking. Hold an inventory of them to point out your physician and pharmacist while you get a brand new medication.

When prescribed STELARA®:

  • Use STELARA® precisely as your physician tells you to.
  • STELARA® is meant to be used below the steering and supervision of your physician. In kids 6 years and older, it is suggested that STELARA® be administered by a healthcare supplier. In case your physician decides that you simply or a caregiver could give your injections of STELARA® at residence, it’s best to obtain coaching on the precise strategy to put together and inject STELARA®. Your physician will decide the precise dose of STELARA® for you, the quantity for every injection, and the way typically it’s best to obtain it. Don’t attempt to inject STELARA® your self till you or your caregiver have been proven the right way to inject STELARA® by your physician or nurse.

Frequent negative effects of STELARA® embrace: nasal congestion, sore throat, and runny nostril, higher respiratory infections, fever, headache, tiredness, itching, nausea and vomiting, redness on the injection web site, vaginal yeast infections, urinary tract infections, sinus an infection, abdomen ache, diarrhea, and joint ache. These usually are not the entire potential negative effects with STELARA®. Inform your physician about any facet impact that you simply expertise. Ask your physician or pharmacist for extra data.

Please learn the total Prescribing Information and Medication Guide for STELARA® and focus on any questions you might have along with your physician.

You might be inspired to report destructive negative effects of prescribed drugs to the FDA. Go to www.fda.gov/medwatch or name 1800FDA1088.

cp-113880v1

About REMICADE® (infliximab)11
REMICADE was the primary anti-TNF-alpha therapy accepted in the US in August 1998 and the primary TNF inhibitor to be accepted in three totally different therapeutic areas: gastroenterology, rheumatology, and dermatology. REMICADE has demonstrated broad scientific utility with indications in Crohn’s illness, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, ulcerative colitis, pediatric Crohn’s illness and psoriasis. The protection and efficacy of REMICADE have been properly established in scientific trials over the previous 17 years and thru business expertise with greater than 2.7 million sufferers handled worldwide.

Within the U.S., REMICADE is accepted for the next indications:

Crohn’s Illness:

  • Can scale back indicators and signs and induce and preserve remission in grownup sufferers with reasonably to severely energetic Crohn’s illness who have not responded properly to different therapies.

Pediatric Crohn’s Illness:

  • Can scale back indicators and signs and induce and preserve remission in kids (ages 6-17) with reasonably to severely energetic Crohn’s illness who have not responded properly to different therapies.

Ulcerative Colitis:

  • Can scale back indicators and signs, induce and preserve remission, promote intestinal therapeutic, and scale back or cease the necessity for steroids in grownup sufferers with reasonably to severely energetic ulcerative colitis who have not responded properly to different therapies.

Pediatric Ulcerative Colitis:

  • Can scale back indicators and signs and induce and preserve remission in kids (ages 6-17) with reasonably to severely energetic ulcerative colitis who have not responded properly to different therapies.

Rheumatoid Arthritis:

  • Can scale back indicators and signs, assist cease additional joint injury, and enhance bodily operate in grownup sufferers with reasonably to severely energetic rheumatoid arthritis, together with methotrexate.

Ankylosing Spondylitis:

  • Can scale back indicators and signs in grownup sufferers with energetic ankylosing spondylitis.

Psoriatic Arthritis:

  • Can scale back indicators and signs of energetic arthritis, assist cease additional joint injury, and enhance bodily operate in grownup sufferers with psoriatic arthritis.

Plaque Psoriasis:

  • Authorized for the therapy of grownup sufferers with power extreme (in depth and/or disabling) plaque psoriasis below the care of a doctor who will decide if REMICADE® is suitable contemplating different accessible therapies.

Janssen Biotech, Inc. found and developed REMICADE and markets the product in the United States. The Janssen Pharmaceutical Corporations market REMICADE in Canada, Central and South America, the Center East, Africa and Asia Pacific.

In Japan, Indonesia, and Taiwan, Janssen Biotech, Inc. licenses distribution rights to REMICADE to Mitsubishi Tanabe Pharma Company. In Europe, Russia and Turkey, Janssen Biotech, Inc. licenses distribution rights to REMICADE to Schering-Plough (Eire) Firm, a subsidiary of Merck & Co, Inc.

REMICADE® (INFLIXIMAB) IMPORTANT SAFETY INFORMATION
Solely your physician can suggest a course of therapy after checking your well being situation. REMICADE® (infliximab) may cause severe negative effects similar to decreasing your capability to combat infections. Some sufferers, particularly these 65 years and older, have had severe infections which embrace tuberculosis (TB) and infections brought on by viruses, fungi, or micro organism which have unfold all through the physique or precipitated infections in sure areas (similar to pores and skin). A few of these infections have been deadly. Your physician ought to monitor you carefully for indicators and signs of TB throughout therapy with REMICADE®.

Uncommon cancers have been reported in kids and teenage sufferers taking tumor necrosis issue (TNF) blocker medicines. Hepatosplenic T-cell lymphoma, a uncommon type of deadly lymphoma, has occurred largely in male youngsters or younger males with Crohn’s illness or ulcerative colitis who had been taking REMICADE® and azathioprine or 6-mercaptopurine. For youngsters and adults taking TNF blockers, together with REMICADE®, the possibilities of getting lymphoma or different cancers could enhance. It is best to focus on any considerations about your well being and medical care along with your physician.

It’s not identified if REMICADE® is secure and efficient in kids below 6 years of age.

What ought to I inform my physician earlier than I take REMICADE®?

It is best to let your physician know when you have or ever had any of the next:

  • Tuberculosis (TB) or have been close to somebody who has TB. Your physician will verify you for TB with a pores and skin take a look at. You probably have latent (inactive) TB, you’ll start TB therapy earlier than you begin REMICADE®.
  • Lived in a area the place sure fungal infections like histoplasmosis or coccidioidomycosis are widespread.
  • Infections that maintain coming again, have diabetes or an immune system drawback.
  • Any kind of most cancers or a danger issue for growing most cancers, for instance, power obstructive pulmonary illness (COPD) or had phototherapy for psoriasis.
  • Coronary heart failure or any coronary heart situation. Many individuals with coronary heart failure mustn’t take REMICADE®.
  • Hepatitis B virus (HBV) an infection or suppose it’s possible you’ll be a service of HBV. Your physician will take a look at you for HBV.
  • Nervous system issues (like a number of sclerosis or Guillain-Barré syndrome).

Additionally inform your physician in the event you:

  • Use the medicines Kineret® (anakinra), Orencia® (abatacept) or Actemra® (tocilizumab) or different medicines known as biologics used to deal with the identical issues as REMICADE®.
  • Are pregnant, plan to develop into pregnant, are breast-feeding or plan to breastfeed, or have a child and had been utilizing REMICADE® throughout your being pregnant. Inform your child’s physician about your REMICADE® use. In case your child receives a stay vaccine inside 6 months after start, your child could develop infections with severe issues that may result in loss of life.
  • Lately acquired or are scheduled to obtain a vaccine. Adults and kids taking REMICADE® mustn’t obtain stay vaccines or therapy with a weakened micro organism (similar to BCG for bladder most cancers) whereas taking REMICADE®.

What ought to I look ahead to and speak to my physician about earlier than or whereas taking REMICADE®?

The next severe (generally deadly) negative effects have been reported in folks taking REMICADE®.

It is best to inform your physician instantly when you have any of the indicators listed beneath:

  • Critical infections (like TB, blood infections, pneumonia)—fever, tiredness, cough, flu-like signs, or heat, purple or painful pores and skin or any open sores. REMICADE® could make you extra prone to get an an infection or make any an infection that you’ve worse.
  • Reactivation of HBV—feeling unwell, poor urge for food, tiredness, fever, pores and skin rash and/or joint ache.
  • Lymphoma, or another cancers in adults and kids.
  • Pores and skin most cancers—any adjustments in or growths in your pores and skin.
  • Cervical most cancers—your physician could suggest that you simply be repeatedly screened. Some ladies with rheumatoid arthritis, significantly these over 60, have developed cervical most cancers.
  • Coronary heart failure—new or worsening signs, similar to shortness of breath, swelling of ankles or toes, or sudden weight achieve.
  • Different coronary heart issues inside 24 hours of infusion, together with coronary heart assault, low blood circulation to the center, or irregular coronary heart rhythm—chest discomfort or ache, arm ache, abdomen ache, shortness of breath, nervousness, lightheadedness, dizziness, fainting, sweating, nausea, vomiting, fluttering or pounding in your chest, and/or a quick or a gradual heartbeat.
  • Liver harm—jaundice (yellow pores and skin and eyes), darkish brown urine, ache on the precise facet of your abdomen space, fever, or extreme tiredness.
  • Blood issues—fever that does not go away, bruising, bleeding or extreme paleness.
  • Nervous system issues—adjustments in your imaginative and prescient, numbness or tingling in any a part of your physique, seizures, or weak spot in your arms or legs.
  • Stroke inside 24 hours of infusion—numbness or weak spot of the face, arm or leg, particularly on one facet of the physique; sudden confusion, hassle talking or understanding; sudden hassle seeing in a single or each eyes; sudden hassle strolling; dizziness; lack of stability or coordination; or a sudden, extreme headache.
  • Allergic reactions throughout or after infusion—hives, issue respiratory, chest ache, excessive or low blood stress, and fever or chills.
  • Delayed allergic reactions (3 to 12 days after infusion)—fever, rash, headache, sore throat, muscle or joint ache, swelling of the face and fingers, or issue swallowing.
  • Lupus-like syndrome—chest discomfort or ache that doesn’t go away, shortness of breath, joint ache, rash on the cheeks or arms that will get worse within the solar.
  • Psoriasis—new or worsening psoriasis similar to purple scaly patches or raised bumps on the pores and skin which can be crammed with pus.

The extra widespread negative effects of REMICADE® embrace respiratory infections (similar to sinus infections and sore throat), headache, coughing and abdomen ache.

Please learn the total Prescribing Information and Medication Guide for REMICADE® and focus on any questions you might have along with your physician.

You might be inspired to report destructive negative effects of prescribed drugs to the FDA. Go to www.fda.gov/medwatch, or name 1-800-FDA-1088.

Concerning the Janssen Pharmaceutical Corporations of Johnson & Johnson
At Janssen, we’re making a future the place illness is a factor of the previous. We are the Pharmaceutical Corporations of Johnson & Johnson, working tirelessly to make that future a actuality for sufferers in every single place by combating illness with science, enhancing entry with ingenuity, and therapeutic hopelessness with coronary heart. We deal with areas of medication the place we are able to make the largest distinction: Cardiovascular & Metabolism, Immunology, Infectious Ailments & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

Study extra at www.janssen.com. Observe us at www.twitter.com/JanssenGlobal.

Janssen Analysis & Growth, LLC and Janssen Scientific Affairs, LLC are every a part of the Janssen Pharmaceutical Corporations of Johnson & Johnson.

Cautions Regarding Ahead-Trying Statements
This press launch accommodates “forward-looking statements” as outlined within the Personal Securities Litigation Reform Act of 1995 relating to STELARA® (ustekinumab) product improvement. The reader is cautioned to not depend on these forward-looking statements. These statements are primarily based on present expectations of future occasions. If underlying assumptions show inaccurate or identified or unknown dangers or uncertainties materialize, precise outcomes may range materially from the expectations and projections of Janssen Analysis & Growth, LLC, and any of the opposite Janssen Pharmaceutical Corporations and/or Johnson & Johnson. Dangers and uncertainties embrace, however usually are not restricted to: challenges and uncertainties inherent in product analysis and improvement, together with the uncertainty of scientific success and of acquiring regulatory approvals; uncertainty of business success; manufacturing difficulties and delays; competitors, together with technological advances, new merchandise and patents attained by opponents; challenges to patents; product efficacy or security considerations leading to product recollects or regulatory motion; adjustments in conduct and spending patterns of purchasers of well being care services and products; adjustments to relevant legal guidelines and laws, together with international well being care reforms; and developments towards well being care price containment. An extra checklist and descriptions of those dangers, uncertainties and different elements may be present in Johnson & Johnson’s Annual Report on Type 10-Ok for the fiscal 12 months ended January 3, 2021, together with within the sections captioned “Cautionary Notice Concerning Ahead-Trying Statements” and “Merchandise 1A. Danger Components,” and within the firm’s most just lately filed Quarterly Report on Type 10-Q, and the corporate’s subsequent filings with the Securities and Alternate Fee. Copies of those filings can be found on-line at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Not one of the Janssen Pharmaceutical Corporations nor Johnson & Johnson undertakes to replace any forward-looking assertion on account of new data or future occasions or developments.

References

  1. Zhang S, et al. Figuring out the Optimum Remedy Sequence for Ustekinumab in Remedy Algorithms for Superior Therapies in Ulcerative Colitis (Summary P0540). Introduced on the American Faculty of Gastroenterology (ACG) Annual Scientific Assembly, October 22-27, 2021.
  2. Pilon D, et al. Remedy persistence amongst bio-naïve sufferers with Crohn’s illness initiated on ustekinumab or adalimumab (Summary P0525). Introduced on the ACG Annual Scientific Assembly, October 22-27, 2021.
  3. The Information About Inflammatory Bowel Ailments. Crohn’s & Colitis Basis of America. Accessed September 22, 2021, from https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf
  4. What’s Ulcerative Colitis? Crohn’s & Colitis Basis. Accessed September 22, 2021, from https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis
  5. Indicators and Signs of Ulcerative Colitis. Crohn’s & Colitis Basis. Accessed September 22, 2021 from https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis/symptoms
  6. Overview of Crohn’s Illness. Crohn’s & Colitis Basis. Accessed September 22, 2021, from https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview
  7. Causes of Crohn’s Illness. Crohn’s & Colitis Basis. Accessed September 22, 2021, from https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes
  8. Indicators and Signs of Crohn’s Illness. Crohn’s & Colitis Basis. Accessed September 22, 2021, from https://www.crohnscolitisfoundation.org/what-is-crohns-disease/symptoms
  9. Crohn’s illness – Signs 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 Data. Obtainable at: http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/STELARA-pi.pdf. Accessed September 22, 2021.
  11. REMICADE® Prescribing Data. Obtainable at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/REMICADE-pi.pdf Accessed October 2021.

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