New Janssen Initiative Aims to Advance Equitable Care and Address Hidden Threat of Amputation Related to Peripheral Artery Disease (PAD)

TITUSVILLE, N.J., March 31, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the launch of Save Legs. Change Lives.™ Spot Peripheral Artery Disease Now, a multi-year initiative aimed at creating urgency and action to address the hidden threat of peripheral artery disease (PAD)-related amputation, with an initial focus on reaching Black Americans, who are more than twice as likely to be impacted by PAD.¹ Janssen has joined forces with leading professional associations, healthcare systems and community organizations to advance equitable care for individuals and communities placed at an increased risk for cardiovascular disease in the U.S.

Cardiovascular disease – also known as heart disease – is the leading cause of death in the U.S.² and can affect more than just the heart.³ One serious condition that often goes underdiagnosed and undertreated is PAD,⁴ a common circulatory condition that causes blood vessels to narrow and reduces blood flow to the limbs, most often the legs.⁵ PAD affects an estimated 20 million Americans,⁶ yet only approximately 8.5 million are diagnosed.⁷ If left untreated, PAD can lead to serious events including heart attack, stroke, acute limb ischemia or amputation.⁵

Black Americans experience disproportionate rates of cardiovascular disease,⁸ and – as a result of higher rates of asymptomatic PAD,⁹ less access to quality vascular care¹⁰ and greater risk for delays in care⁹ – are up to four times more likely than white Americans to have a PAD-related amputation.¹⁰

“While health inequities have long existed, the last several years have brought them to the forefront of our collective consciousness. Black Americans are placed at disproportionate risk of losing legs and lives – a reality we all must actively address,” said Dr. Pernessa Seele*, Founder and CEO, The Balm in Gilead, Inc., a faith-based organization engaged in eliminating health disparities. “We believe the most effective way to eliminate the alarming health disparities within Black populations is for intentional, sustained and compassionate action by the healthcare industry, public health and faith communities.”

PAD is a leading cause of amputations in the U.S.,¹⁰ with rates continuing to rise.¹¹ Amputations are a devastating complication of PAD and are associated with high mortality, despite being largely preventable.¹⁰ Tragically, PAD-related amputations are directly correlated to an increased risk of death, with 70 percent of patients with PAD who have a leg amputation dying within three years.¹²

Save Legs. Change Lives.™ has three main areas of focus: driving research, collaborating with powerful partners, and empowering individuals and communities.

Research to Break Down Barriers to PAD Screening and Increase Equitable Care

As part of the initiative, Janssen is supporting, sponsoring and promoting evidence-based research to uncover systemic bias, identify unmet patient needs, and propel healthcare systems toward change. Groundbreaking research already underway includes a data-based tool to help health systems identify groups of patients with inadequate PAD care and better direct efforts toward those placed at the highest risk of amputation, as well as a series of white papers that highlight best practices of leading limb salvage programs for people at risk for amputation.

“Everyone deserves a chance to avoid an amputation. I grew up in my dad’s podiatry practice and I saw from a young age what a difference you can make in simply helping people move through the world,” said David G. Armstrong**, Ph.D., D.P.M., Professor of Surgery and Director of the Southwestern Academic Limb Salvage Alliance (SALSA), at Keck School of Medicine, University of Southern California, and President of the American Limb Preservation Society (ALPS). “Limb preservation is of paramount importance, and I believe in the big idea that, together, we can eliminate limb amputations over the next generation. The inspiring thing is that – even with so many factors collectively stacked against our patients, ongoing research, awareness and sharing of best practices is vital to ensure we help people with PAD protect their legs and avoid the devastating consequences of amputation.”

Collaboration to Unlock Better PAD Care and Improve Outcomes

Through Save Legs. Change Lives.™ Janssen is collaborating with powerful partners, including universities, health systems, non-governmental organizations and change makers to break down barriers to equitable and inclusive care, ranging from access and health literacy to health-care provider diversity.

The Company, through Janssen Scientific Affairs, LLC, is proud to help support the American Heart Association’s PAD National Action Plan, which aims to reduce PAD-related amputation. Additionally, Janssen is sponsoring the American College of Cardiology Foundation’s “Change the FIELD” initiative, a major multi-year effort to foster inclusivity, equity, leadership and diversity in the field of cardiology.

Education, Awareness and Screening to Reach Individuals Placed at Greatest Risk

Janssen is supporting grassroots PAD awareness, education and screening that empowers individuals and communities to change the trajectory of their health. These efforts include:

• empower™ PAD: a traveling mobile health unit that brings PAD screening and education directly to communities across the nation;
• The Change Network: a steering committee that convenes healthcare thought leaders and patient advocates to fuel discussion and inform the development of patient-friendly PAD resources, including ArteryAware.com;
• Healthy Directions: a community education program designed to raise awareness about PAD with Black Americans and in communities of color; and
• The Balm in Gilead, Inc.: supporting the creation of culturally tailored PAD educational resources and awareness programming for faith-based institutions in the Chicago area serving individuals of African descent with the goals of preventing diseases, improving health outcomes and eliminating health disparities.

“Save Legs. Change Lives.™ sets in motion a vision for more relevant, trusted and inclusive care for everyone affected by PAD,” said Avery Ince, M.D., Ph.D., Vice President, Medical Affairs, Janssen Cardiovascular & Metabolism, Janssen Scientific Affairs, LLC. “As part of Johnson & Johnson, Janssen believes that major corporations have the power – and therefore the responsibility – to tackle pressing health challenges and make good health a reality for all people. We hope our efforts will inspire action to reduce amputations among people living with PAD.”

Save Legs. Change Lives.™ is part of Johnson & Johnson’s broader initiative, Our Race to Health Equity (ORTHE) – a $100 million commitment to help eradicate racial and social injustice as a public health threat. In the inaugural year of Save Legs. Change Lives.™, Janssen aims to reach Americans who unknowingly live with PAD through local screening and educational events, grassroots community activations, and a comprehensive online destination of patient-friendly PAD resources, ultimately elevating awareness and action among communities placed at an increased risk of the disease and the healthcare providers and systems that serve them.

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/JanssenUS and https://twitter.com/JanssenGlobal. Janssen Scientific Affairs, LLC, is 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. 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 Scientific Affairs, LLC, 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 2, 2022, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other 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. National Heart, Lung, and Blood Institute. Facts About Peripheral Arterial Disease (P.A.D.) for African Americans. Accessed March 10, 2022 from https://www.nhlbi.nih.gov/files/docs/public/heart/pad_extfactsheet_aa_508.pdf
2. Centers for Disease Control and Prevention. Heart Disease Facts. Accessed March 16, 2022 from https://www.cdc.gov/heartdisease/facts.htm
3. Cleveland Clinic. Cardiovascular Disease. Accessed March 16, 2022 from https://my.clevelandclinic.org/health/diseases/21493-cardiovascular-disease
4. Afzal N, Sohn S, Scott CG, Liu H, Kullo IJ, Arruda-Olson AM. Surveillance of Peripheral Arterial Disease Cases Using Natural Language Processing of Clinical Notes. AMIA Jt Summits Transl Sci Proc. 2017;2017:28-36. Accessed March 16, 2022 from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5543345/#r2-2609862
5. National Heart, Lung, and Blood Institute. Peripheral Artery Disease. Accessed March 10, 2022 from https://www.nhlbi.nih.gov/health-topics/peripheral-artery-disease
6. Cardiovascular Coalition. Racial Disparities in Vascular Care. (n.d.). Accessed March 11, 2022 from https://cardiovascularcoalition.com/our-patients/racial-disparities-in-vascular-care/
7. American Heart Association. PAD Toolkit for Health Care Professionals. Accessed March 11, 2022, from https://www.heart.org/en/health-topics/peripheral-artery-disease/pad-toolkit
8. Centers for Disease Control and Prevention. African American Health. Accessed March 16, 2022 from https://www.cdc.gov/vitalsigns/aahealth/index.html
9. Winta Ghidei, Tracie C. Collins, “African Americans and Peripheral Arterial Disease: A Review Article”, International Scholarly Research Notices, vol. 2012, Article ID 165653, 9 pages, 2012. https://doi.org/10.5402/2012/165653
10. Creager MA, Matsushita K, Arya S, et al. Reducing nontraumatic lower-extremity amputations by 20% by 2030: time to get to our feet: a policy statement from the American Heart Association. Circulation. 2021;143(17):e875-e891. doi:10.1161/CIR.0000000000000967
11. Schuivens PME, Buijs M, Boonman-de Winter L, et al. Impact of the COVID-19 lockdown strategy on vascular surgery practice: more major amputations than usual. Ann Vasc Surg. 2020;69:74-79. doi:10.1016/j.avsg.2020.07.025. Retrieved June 2, 2021 from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7402273/
12. Jones WS, Patel M, et al. High mortality risks after major lower extremity amputation in Medicare patients with peripheral artery disease. Am Heart J. 2013 May;165(5):809-15, 815.e1. doi:10.1016/j.ahj.2012.12.002

*The Balm in Gilead, Inc. was provided a grant to help support their PAD disease awareness program.
**Dr. Armstrong has served as a paid consultant to Janssen.