- 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-conditio
ns/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.arthriti
sresearchuk.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.britishskinfound
ation.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-de
termination-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
Original-Content von: Janssen Pharmaceutica, übermittelt durch news aktuell
