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

Published: 2021-10-26 04:53:09 ET JNJ

SPRING HOUSE, PENNSYLVANIA - The Janssen Pharmaceutical Companies of Johnson & Johnson 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-naive 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-naive 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

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.

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Janssen Research & Development, LLC and 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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