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. 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. 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.
| Ustekinumab | is | currently | under | investigation | and | is | not | approved | for | SLE. | A | Phase | 3 | program | 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, infection site pain, injection site erythema, myalgia, nasopharyngitis, nausea, oropharyngeal pain, pruritus and vomiting.
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 54 countries.
Stelara(R) is a registered trademark of Janssen Biotech, Inc.
Important Safety Information
For complete European Union (EU) prescribing information, please visit: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_... .
About guselkumab[21]
Guselkumab is a human monoclonal antibody developed by Janssen that selectively blocks the protein interleukin (IL)-23. 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.[22] Guselkumab received marketing authorization from the European Commission in November 2017 for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy.
**Guselkumab is currently under investigation and is not approved for active psoriatic arthritis. A Phase 3 program 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(R) (guselkumab) is a registered trademark of Janssen Biotech, Inc.
Important Safety Information
For complete European Union (EU) prescribing information, please visit: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_... .
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 https://twitter.com/JanssenEMEA. Janssen Pharmaceutica 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 development of 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 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 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 December 31, 2017, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company'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 [http://www.sec.gov ], www.jnj.com [http://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.
References
1. Vollenhoven RV, et al. Efficacy and safety of ustekinumab in patients with active systemic lupus erythematosus: results of a Phase 2, randomized placebo-controlled study. 2018 Annual European Congress of Rheumatology; Abstract no. FRI0303.
2. Touma Z, et al. SLEDAI-2K Responder Index-50 is effective in demonstrating partial response in a Phase 2, randomized placebo-controlled study of ustekinumab in patients with active systemic lupus erythematosus. 2018 Annual European Congress of Rheumatology; Abstract no. FRI0339.
3. Gladman D, et al. The effect of guselkumab on dactylitis: results from a Phase 2 study in patients with active psoriatic arthritis. 2018 Annual European Congress of Rheumatology; Abstract no. SAT0322.
4. Helliwell P, et al. The effect of guselkumab on enthesitis: results from a Phase 2 study in patients with active psoriatic arthritis. 2018 Annual European Congress of Rheumatology; Abstract no. SAT0344.
5. Deodhar A, et al. Efficacy and safety results of guselkumab in patients with active psoriatic arthritis over 56 weeks from a Phase 2a, randomized, double-blind, placebo-controlled study. 2018 Annual European Congress of Rheumatology; Abstract no. OP0308.
6. Li K, et al. Comparative evaluation of cellular and molecular changes associated with response to selective IL-23 blockade vs dual IL-12/23 blockade in psoriasis skin. 2018 Annual European Congress of Rheumatology; Abstract no. OP0166.
7. Griffiths CE, et al. Two-year efficacy and safety of guselkumab for treatment of moderate-to-severe psoriasis: Phase 3 VOYAGE 1 trial. 2018 Annual European Congress of Rheumatology; Abstract no. AB0912.
8. Mayo Clinic. Lupus. Available at: https://www.mayoclinic.org/diseases-conditions/lupus/symptom.... Accessed May 2018.
9. Arthritis Research UK. Lupus (SLE). Available at: https://www.arthritisresearchuk.org/arthritis-information/co.... Accessed May 2018.
10. Lupus Research Alliance. About Lupus. Available at: http://www.lupusresearch.org/understanding-lupus/what-is-lup.... Accessed May 2018.
11. Danchenko N, Satia JA and Anthony MS. Epidemiology of systemic lupus erythematosus: a comparison of worldwide disease burden. Lupus 2006;15:308-318.
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