New Three-Year Data for Janssen’s TREMFYA®▼ (Guselkumab) Demonstrates Well Maintained Rates of Skin Clearance in Patients with Moderate to Severe Plaque Psoriasis

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new long-term data from the open-label period of the VOYAGE 1 clinical study. The data demonstrate well maintained rates of skin clearance with TREMFYA^®▼ (guselkumab) treatment at Week 52 (1 year) and Week 156 (3 years) among adult patients with moderate to severe plaque psoriasis.¹ The findings, presented at the 37^th Fall Clinical Dermatology Conference in Las Vegas, USA, showed nearly 83 percent of patients receiving guselkumab in the Phase 3 VOYAGE 1 study maintained at least a 90 percent improvement in the Psoriasis Area Severity Index (PASI 90), or near complete skin clearance, and an Investigator’s Global Assessment (IGA) score of cleared (0) or minimal disease (1) at Week 156.¹

“These findings are impressive as they demonstrate consistency in high rates of skin clearance with guselkumab treatment at Weeks 48, 100 and 156, with every eight-week maintenance therapy,” said Andrew Blauvelt, MD, MBA, President, Oregon Medical Research Center, and VOYAGE 1 study steering committee member.* “In the management of moderate to severe plaque psoriasis, including symptom relief as well as skin clearance, it is essential that we continue to evaluate the impact of treatments with long-term data like those presented today. The VOYAGE 1 findings help further our understanding of the long-term impact of targeting IL-23 with guselkumab in the treatment of plaque psoriasis.”

Results from the open-label extension of the VOYAGE 1 Phase 3 clinical study showed that at Week 156, in the combined group of patients initially randomised to guselkumab, or to placebo with crossover to guselkumab at Week 16, 82.1 percent achieved an IGA score of 0/1 (cleared or minimal disease), 96.4 percent achieved a PASI 75 score, and 82.8 percent achieved a PASI 90 score (near complete skin clearance).¹

At Week 156, 53.1 percent of patients achieved an IGA score of 0 and 50.8 percent of patients achieved a PASI 100 response. These measures represent skin completely cleared of psoriasis plaques (except for residual discoloration) and are consistent with the PASI 100 and IGA 0 results demonstrated at Week 100.¹

Responses based on the Psoriasis Symptoms and Signs Diary (PSSD) were also consistent at Week 100 and Week 156. This tool evaluates patient-reported symptoms (i.e., itch, pain, stinging, burning and skin tightness) and signs (i.e., skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding).² The percentage of patients receiving a PSSD symptom score of 0 was 40.2 percent at Week 100 and 40.4 at Week 156.¹

“We are very pleased and excited by these results. The data adds to the growing body of safety and efficacy evidence with the use of guselkumab over a three-year period,” said Newman Yeilding, MD, Head of Immunology Development, Janssen Research & Development, LLC. “As a part of our commitment to developing innovative therapies for chronic, immune-mediated diseases like psoriasis, we have been focusing on generating long-term data so that patients and physicians can be more informed when making treatment decisions.”

The findings follow the first two positive Health Technology Appraisals in Europe for guselkumab since marketing authorisation was granted in November 2017; the United Kingdom’s National Institute for Health and Care Excellence (NICE), and Germany’s drug reimbursement body, The Federal Joint Committee (Gemeinsamer Bundesausschuss; G-BA).^3,4

During clinical development, guselkumab was generally well tolerated by patients with psoriasis.^5,6,7 The very common and common adverse events associated with guselkumab are as follows: upper respiratory infection (very common, ≥1/10) and arthralgia, diarrhoea, gastroenteritis, headache, herpes simplex infections, injection site erythema, tinea infections and urticaria (common, ≥1/100 to <1/10). Injection site pain has been reported as an uncommon adverse event (≥1/1,000 to <1/100).⁸ In this study, the types of adverse events reported remained consistent through 156 weeks of treatment.^1,5,6

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

About psoriasis

What it is

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, patients can have ongoing concerns over their return.

Impact

Psoriasis can cause great physical and psychological burden. Mental health issues are common among people with psoriasis, and the impact it can have on quality of life is comparable to diabetes and cancer.¹⁰ Psoriasis is also associated with several comorbidities including psoriatic arthritis, cardiovascular diseases, metabolic syndrome, chronic obstructive pulmonary disorder (COPD) and osteoporosis.¹¹ In addition, many individuals are faced with social exclusion, discrimination and stigma because of their disease.¹²

About TREMFYA ^® (guselkumab) ⁸

On 10 November 2017, TREMFYA^® (guselkumab) was granted market authorisation in the European Union for the treatment of adult patients with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy).⁸

Guselkumab is the first psoriasis treatment licensed in the European Union to selectively target IL-23, a key driver of the immune inflammatory response in psoriasis.^5,6,7,13 It is a subcutaneous, self-injectable treatment for psoriasis (following training). Treatment requires two starter doses, one initially and the other four weeks later, followed by a maintenance dose once every eight weeks (q8w) thereafter.^5,6,14

The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to guselkumab, which is currently approved in the US, Canada and the European Union.

VOYAGE 1 study

• VOYAGE 1 is a Phase 3, multicentre, randomised, double-blind, placebo- and active comparator-controlled study, including 837 patients. It included a placebo-controlled period (Weeks 0–16), after which patients taking placebo crossed over to receive guselkumab through Week 48, and an active comparator-controlled period comparing guselkumab with adalimumab (Week 0-48).^5,6,14 Patients randomised to guselkumab at Week 0 and those who crossed over from placebo to guselkumab at Week 16 continued to receive guselkumab q8w at Week 48.^5,14 Beginning at Week 52, all patients began receiving open-label guselkumab. This study will continue for a total of 5 years. Results presented to date include findings through Week 156 of the study. Through Week 48, non-responder imputation rules were used for missing data, while after Week 48 no missing data were imputed after the application of treatment failure rules.

Prescribing and safety information

For complete European Union (EU) prescribing and safety information, please visit: https://www.medicines.org.uk/emc/medicine/34321

▼Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Janssen-Cilag Ltd on 01494 567447.

Clinical development programme

Phase 3 studies are being undertaken to evaluate the efficacy and safety of guselkumab for patients with psoriatic arthritis and Crohn’s disease.^15,16 A Phase 3 comparator study (the ECLIPSE study) is underway to evaluate the efficacy of guselkumab versus Cosentyx^® (secukinumab), an IL-17A inhibitor, in patients with moderate to severe plaque psoriasis.¹⁴

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: @JanssenEMEA.

Janssen-Cilag International NV, the marketing authorisation holder for TREMFYA^® in the European Union, Janssen-Cilag Ltd, and Janssen Research & Development, LLC, 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 development and potential availability in the European Union of guselkumab. 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, Janssen-Cilag Ltd, Janssen Research & Development, LLC, or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; 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,” 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, 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. Griffiths et al. Maintenance of response with guselkumab for up to 3 years’ treatment in the Phase 3 VOYAGE 1 trial of patients with plaque psoriasis. Falls Clinical Dermatology Conference 2018 18–12 Oct, 2018;Las Vegas, USA.

2. Armstrong, A et al. Validation of psychometric properties and development of response criteria for the Psoriasis Symptoms and Signs Diary (PSSD): Results from a Phase III clinical trial. J Dermatol Treat 2017;11:1–31.

3. National Institute of Health and Care Excellence (NICE). Guselkumab for treating moderate to severe plaque psoriasis [TA521]. Available at: www.nice.org.uk/guidance/TA521. Last accessed October 2018.

4. Gemeinsamer Bundesausschuss. Reasons for the decision of the Common Federal Committee on an amendment to the Medicinal Products Directive (AM-RL): Annex XII -Decisions on the benefit assessment of Medicines containing new active substances according to § 35a SGB V - Guselkumab. Available at: https://www.g-ba.de/downloads/40-268-4987/2018-05-17_AM-RL-XII_Guselkumab_D-330_TrG.pdf. Last accessed October 2018.

5. Blauvelt A, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the continuous treatment of patients with moderate to severe psoriasis: Results from the phase III, double-blinded, placebo- and active comparator-controlled VOYAGE 1 trial. J Am Acad Dermatol 2017;76(3):405–17.

6. Reich K, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: Results from the Phase III, double-blind, placebo- and active comparator-controlled VOYAGE 2 trial. J Am Acad Dermatol 2017;76(3):418–31.

7. Langley R, et al. Efficacy and safety of guselkumab in patients with psoriasis who have an inadequate response to ustekinumab: results of the randomized, double-blind, phase III NAVIGATE trial. Br J Dermatol 2018;178(1):114–23.

8. European Medicines Agency. Tremfya 100mg solution for injection. 2017. Available at: https://www.medicines.org.uk/emc/medicine/34321. Accessed October 2018.

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

10. Bajorek Z, et al. The impact of long term conditions on employment and the wider UK economy. The Work Foundation. 2016. Available at: http://www.theworkfoundation.com/wp-content/uploads/2016/11/397_The-impact-of-long-term-conditions-on-the-economy.pdf. Accessed October 2018.

11. Nijsten T, et al. Complexity of the association between psoriasis and comorbidities. Journal of Investigative Dermatology 2009;129(7):1601–03.

12. World Health Organization (2016) Global Report on Psoriasis. Available at: apps.who.int/iris/bitstream/10665/204417/1/9789241565189_eng.pdf. Last accessed October 2018.

13. Bachelez, H. Interleukin 23 inhibitors for psoriasis: not just another number. The Lancet 2017;390(10091):208–10.

14. ClinicalTrials.gov. A study to evaluate the comparative efficacy of CNTO 1959 (guselkumab) and secukinumab for the treatment of moderate to severe plaque-type psoriasis (ECLIPSE). Identifier NCT03090100. Available at: https://clinicaltrials.gov/ct2/show/NCT03090100. Accessed October 2018.

15. ClinicalTrials.gov. A study evaluating the efficacy and safety of guselkumab administered subcutaneously in participants with active psoriatic arthritis. Identifier NCT03158285. Available at: https://clinicaltrials.gov/ct2/show/NCT03158285. Accessed October 2018.

16. ClinicalTrials.gov. A study of the efficacy and safety of guselkumab in participants with moderately to severely active crohn's disease (GALAXI). Identifier NCT03466411. Available at: https://clinicaltrials.gov/ct2/show/NCT03466411. Accessed October 2018.

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