New Phase 2 Data Show Stelara® (ustekinumab) Sustained Improvement in Disease Activity in Adults With Systemic Lupus Ery

About systemic lupus erythematosus (SLE)       Lupus is a chronic, inflammatory autoimmune disease that can affect many different body systems, including joints, skin, heart, lungs, kidneys and brain.[2] SLE can range from mild to severe and is characterised by inflammation of any organ system and complex auto-antibody production (antibodies directed against normal human tissue).[3] The disease most often affects women and disproportionately affects women of African American, Hispanic, Asian and Native American descent compared to Caucasian women.[4] Incidence rates vary across European countries, ranging from 2.2 cases/100,000 in Spain to 5 cases/100,000 in France.[5] Lupus is estimated to affect at least 5 million people worldwide.[6]

About ustekinumab[7]      In the European Union, ustekinumab is approved for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or psoralen plus ultraviolet A (PUVA), and is also indicated for the treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years and older who are inadequately controlled by or are intolerant to other systemic therapies or phototherapies.[7] In addition, ustekinumab is approved alone or in combination with MTX for the treatment of active psoriatic arthritis in adult patients when the response to previous non-biological disease-modifying antirheumatic drug (DMARD) therapy has been inadequate.[7] Ustekinumab is approved by the European Commission for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF-alpha antagonist or have medical contraindications to such therapies.[7]

*Ustekinumab is currently under investigation and is not approved for SLE. A Phase 3 programme evaluating ustekinumab in the treatment of adults with active SLE is ongoing.

The common (greater than or equal to1/100) adverse reactions reported in controlled periods of the adult psoriasis, psoriatic arthritis and Crohn's disease clinical studies with ustekinumab as well as post-marketing experience were: upper respiratory tract infection, arthralgia, back pain, diarrhoea, dizziness, fatigue, headache, injection site pain, injection site erythema, myalgia, nasopharyngitis, nausea, oropharyngeal pain, pruritus and vomiting.[7]

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to ustekinumab, which is currently approved for the treatment of moderate to severe plaque psoriasis in 90 countries, paediatric psoriasis in 43 countries, psoriatic arthritis in 83 countries and Crohn's disease in 62 countries.

STELARA(R) (ustekinumab) is a registered trademark of Johnson & Johnson.

Important Safety Information  For complete European Union (EU) prescribing information, please visit: www.ema.europa.eu/documents/product-information/stelara-epar... n.pdf [https://www.ema.europa.eu/documents/product-information/stel... ] .

About the Janssen Pharmaceutical Companies of Johnson & Johnson  At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.

We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com/emea [https://www.janssen.com/emea ]. Follow us on Twitter at www.twitter.com/JanssenEMEA [http://www.twitter.com/JanssenEMEA ]. Janssen-Cilag International NV, marketing authorisation holder for ustekinumab in the European Union, and Janssen-Cilag AG are 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 new study data on ustekinumab in Europe. 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 materialise, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV, 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 or 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 behaviour 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 December 31, 2017, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," in the company's most recently filed Quarterly Report on Form 10-Q and in the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov [https://www.sec.gov ], www.jnj.com [https://www.jnj.com ] or on request from Johnson & Johnson. Neither 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. 

**Dr. van Vollenhoven is a paid consultant for Janssen. He was not compensated for any media work.     

Date of preparation: October 2018  PHGB/IMM/1018/0006    

1. Van Vollenhoven, R. F., et al (2018). Efficacy and Safety of Ustekinumab, an Interleukin-12/23 Inhibitor, in Patients with Active Systemic Lupus Erythematosus: 1-Year Results of a Phase 2, Randomized Placebo-Controlled, Crossover Study. 2018 American College of Rheumatology Annual Meeting, Abstract no. 2785. 

2. Mayo Clinic. Lupus. Available at: http://www.mayoclinic.org/diseases-conditions/lupus/symptoms.... Accessed Oct 2018. 

3. Moulton, V. R., Suarez-Fueyo, A., Meidan, E., Li, H., Mizui, M., & Tsokos, G. C. Pathogenesis of human systemic lupus erythematosus: a cellular perspective. Trends in molecular medicine 2017;23(7), 615-635. 

4. Lupus Research Alliance. About Lupus. Available at: http://www.lupusresearch.org/understanding-lupus/what-is-lup.... Accessed Oct 2018. 

5. Danchenko N, Satia JA and Anthony MS. Epidemiology of systemic lupus erythematosus: a comparison of worldwide disease burden. Lupus 2006;15:308-318. 

6. Lupus UK. World Lupus Day 2018 Survey Findings. Available at: http://www.lupusuk.org.uk/wld-survey-2018. Accessed Oct 2018. 

7. EMC. STELARA 45 mg solution for injection (vials) SmPC. Available at: http://www.medicines.org.uk/emc/product/.... Accessed Oct 2018.

CONTACT: Media contacts: Kathleen Provinciael, +32-497-33-26-87,kprovinc@its.jnj.com. Investor contacts, Christopher DelOreficeJohnson & Johnson, +1-732-524-2955. Lesley Fishman, Johnson & Johnson,+1-732-524-3922