Janssen Pharmaceutica

Janssen to highlight data from broad rheumatology portfolio at the 2018 Annual meeting of the American College of Rheumatology

Beerse, Belgium (ots/PRNewswire) -

- One-year results from  the  Phase 2  study evaluating  STELARA® 
  (ustekinumab)  in patients  with active systemic lupus 
  erythematosus featured in a plenary presentation 
- 13  presentations from approved and pipeline products provide 
  real-world treatment and disease insights across multiple 
  immune-mediated diseases  

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that it will be presenting results from 13 abstracts across the company's rheumatology portfolio and pipeline products during the 2018 American College of Rheumatology (ACR) / Association for Rheumatology Health Professionals (ARHP) Annual Meeting taking place in Chicago, IL, from 19-24 October. New results from a Phase 2 trial evaluating STELARA®* (ustekinumab) in patients with active systemic lupus erythematosus (SLE) treated through one year will be presented in a plenary presentation on Tuesday, 23 October, with additional data from that study also featured as an oral presentation.

These results highlight the depth and breadth of the Janssen rheumatology portfolio and advance the understanding of the safety and efficacy of ustekinumab and TREMFYA®** (guselkumab) across multiple immune-mediated diseases, including SLE, moderate-to-severe plaque psoriasis (PsO) and active psoriatic arthritis (PsA).

"The broad range of data being presented at this year's annual meeting spans the spectrum from clinical investigational studies to real world evidence about our marketed products, such as ustekinumab and guselkumab, in clinical practice settings," said Jaime Oliver Vigueras, Europe, Middle East and Africa Immunology Therapeutic Area Lead, Janssen-Cilag AG. "These studies build on our longstanding heritage of innovation in rheumatology and help further our understanding of potential new treatment pathways in diseases like lupus, where there is significant unmet patient need."

Janssen abstracts to be presented during ACR include:

Abstracts can be accessed on the ACR 2018 Annual Meeting website at: http://acrabstracts.org/.



Abstract No.    Title                                 Date/Time
Ustekinumab                                                      
   
Abstract 636    Remission/low disease activity is a   Poster 
presentation
reasonable treatment target in PsA:   Sunday, 21 
October 2018;
Results from a routine care European  9:00-11:00
cohort of PsA patients treated with  
ustekinumab or TNF inhibitors      

Abstract 2557   Efficacy of ustekinumab on            Poster 
presentation
spondylitis-associated endpoints in   Tuesday, 23
October 2018;
TNF-naïve active psoriatic arthritis  9:00-11:00
patients with physician-reported
spondylitis

Abstract 2658   Real world medication use in incident Poster 
presentation
systemic lupus erythematosus and      Tuesday, 23
October 2018;
lupus nephritis patients              9:00-11:00

Abstract 2785   Efficacy and safety of ustekinumab,   Plenary 
presentation
an interleukin-12/23 inhibitor, in    Tuesday, 23
October 2018;
patients with active systemic lupus   11:00-12:30
erythematosus: 1-year results of a
phase 2, randomised
placebo-controlled, crossover study

Abstract 2643   SLEDAI-2K responder index-50 is       Poster 
presentation
effective in demonstrating partial    Tuesday, 23
October 2018;
response in a phase 2, randomised     9:00-11:00
placebo-controlled study of
ustekinumab in patients with active
systemic lupus erythematosus                     
                                   

Abstract 2951   Ustekinumab treatment response in SLE Oral 
presentation
is associated with changes in type II Wednesday, 
24 October 2018;
but not type I interferons            11:00-12:30


Guselkumab                                                       
  
Abstract 633    The effect of guselkumab on           Poster 
presentation
dactylitis: results from a phase 2    Sunday, 21 
October 2018;
study in patients with active         9:00-11:00
psoriatic arthritis                  

Abstract 1657   The effect of guselkumab on           Poster 
presentation
enthesitis: results from a phase 2    Monday, 22 
October 2018;
study in patients with active         9:00-11:00
psoriatic arthritis

Abstract 989    Reduction of serum IL17F and IL22 by  Poster 
presentation
IL23p19 blockade with guselkumab is   Monday, 22 
October 2018;
associated with improvement in joint  9:00-11:00
symptoms in psoriatic arthritis

Abstract 2560   Efficacy of guselkumab in psoriasis   Poster 
presentation
patients with self-reported psoriatic Tuesday, 23
October 2018;
arthritis with involvement of the     9:00-11:00
scalp, nails, hands, and feet: a
pooled analysis from 2 pivotal Phase
3 psoriasis studies

Abstract 2566   Impact of guselkumab versus placebo   Poster 
presentation
and adalimumab on patient reported    Tuesday, 23
October 2018;
outcomes in patients with and without 9:00-11:00
psoriatic arthritis in a phase 3
pivotal psoriasis study

Abstract 2600   Clinically meaningful improvement in  Poster 
presentation
health-related quality of life and    Tuesday, 23
October 2018;
the association with disease activity 9:00-11:00
in psoriatic arthritis after
treatment with guselkumab: results
from a randomised placebo-controlled
phase II clinical trial
IBD and PsO
Abstract 367    Incidence of inflammatory bowel       Poster 
presentation
disease (IBD) among patients (Pts)    Sunday, 21 
October 2018;
with other chronic inflammatory       9:00-11:00
diseases (CID) treated with
interleukin-17a (IL-17a) or
phosphodiesterase 4 (PDE4) inhibitors 

ENDS

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.[1] 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).[2] The disease most often affects women and disproportionately affects women of African American, Hispanic, Asian and Native American descent compared to Caucasian women.[3] Incidence rates vary across European countries, ranging from 2.2 cases/100,000 in Spain to 5 cases/100,000 in France.[4] Lupus is estimated to affect at least 5 million people worldwide.[5]

About psoriatic arthritis

Psoriatic arthritis is a chronic immune-mediated inflammatory disease characterised by both joint inflammation and the skin lesions associated with psoriasis.[6] It is estimated that one third of the 125 million people who are living with psoriasis worldwide will also develop psoriatic arthritis.[7] The disease causes pain, stiffness and swelling in and around the joints and commonly appears between the ages of 30 and 50, but can develop at any time.[6] Though the exact cause of psoriatic arthritis is unknown, genes, the immune system, and environmental factors are all believed to play a role in the onset of the disease.[8]

About psoriasis

The most common form of psoriasis is plaque psoriasis, usually resulting in areas of thick, red or inflamed skin covered with silvery scales which are known as plaques.[9] The inconsistent nature of psoriasis means that even when plaques appear to subside, many patients still live in fear of their return.[10]

Psoriasis can cause great physical and psychological burden. A study comparing psoriasis to other prominent conditions found its mental and physical impact comparable to that seen in cancer, heart disease and depression.[11] Psoriasis is also associated with several comorbidities including psoriatic arthritis, cardiovascular diseases, metabolic syndrome, chronic obstructive pulmonary disorder (COPD) and osteoporosis.[12] In addition, many individuals are faced with social exclusion, discrimination, and stigma because of their disease.[10]

About ustekinumab[13]

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.[13] 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.[13] 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.[13]

*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 (>=1/100) 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.[13]

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® (ustekinumab) is a registered trademark of Johnson & Johnson.

Important Safety Information

For complete European Union (EU) prescribing information, please visit: www.medicines.org.uk/emc/product/4413/smpc.

About guselkumab[14]

Guselkumab is a human monoclonal antibody developed by Janssen that selectively blocks the protein interleukin (IL)-23. Guselkumab received marketing authorisation from the European Commission in November 2017 for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.[14] In May 2018, the National Institute for Health and Care Excellence (NICE) issued its Final Appraisal Determination (FAD) recommending guselkumab for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.[15]

**Guselkumab is currently under investigation and is not approved for active psoriatic arthritis. A Phase 3 programme evaluating guselkumab in the treatment of adults with active psoriatic arthritis is ongoing.

The most common side effects of guselkumab include upper respiratory infections, headache, injection site reactions, joint pain (arthralgia), diarrhoea, stomach flu (gastroenteritis), fungal skin infections, urticaria and herpes simplex infections.

TREMFYA® (guselkumab) 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/tremfya-epar-product-information_en.pdf

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. Follow us on Twitter at twitter.com/JanssenEMEA (https://twitter.com/JanssenEMEA). Janssen-Cilag International NV 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 regarding ongoing and planned development efforts involving ustekinumab and guselkumab 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 materialize, 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, 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.

###

Date of preparation: October 2018

PHEM/IMM/1018/0003

1. Mayo Clinic. Lupus. Available at: http://www.mayoclinic.org/diseases-conditions/lupus/symptoms-causes/syc-20365789. Accessed Oct 2018.

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

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

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

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

6. Arthritis Research UK. Psoriatic Arthritis. Available at: http://www.arthritisresearchuk.org/arthritis-information/conditions/psoriatic-arthritis.aspx. Accessed Oct 2018.

7. International Federation of Psoriasis Associations. Our Cause: Psoriasis. Available at: https://ifpa-pso.com/our-cause/. Accessed Oct 2018.

8. National Psoriasis Foundation. About Psoriatic Arthritis. Available at: http://www.psoriasis.org/psoriatic-arthritis. Accessed Oct 2018.

9. British Skin Foundation. Psoriasis. Available at: http://www.britishskinfoundation.org.uk/SkinInformation/AtoZofSkindisease/Psoriasis.aspx. Accessed Oct 2018.

10. World Health Organization (2016) Global Report on Psoriasis. Available at: apps.who.int/iris/bitstream/10665/204417/1/9789241565189_eng.pdf. Accessed Oct 2018.

11. Rapp S.R, et al . Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol. 1999;41(3):401-7.

12. Nijsten T et al . Complexity of the association between psoriasis and comorbidities. J Invest Dermatol. 2009; 129(7):1601-1603.

13. EMC. STELARA 45 mg solution for injection (vials) SmPC. Available at: http://www.medicines.org.uk/emc/product/4413/smpc. Accessed Oct 2018.

14. European Medicines Agency. Tremfya Summary of Product Characteristics. Janssen-Cilag International NV. Available at: http://www.ema.europa.eu/documents/product-information/tremfya-epar-product-information_en.pdf. Accessed Oct 2018.

15. National Institute of Health and Care Excellence (NICE). Final Appraisal Determination: Guselkumab for treating moderate to severe plaque psoriasis. Available at: http://www.nice.org.uk/guidance/ta521/documents/final-appraisal-determination-document. Accessed Oct 2018.

Contact:

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



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