New Data Demonstrates Long-Term Skin Clearance in Patients with Moderate to Severe Plaque Psoriasis Treated with Janssen’s TREMFYA® (guselkumab)

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new data that showed a vast majority of patients with moderate to severe plaque psoriasis receiving TREMFYA^® (guselkumab), who achieved at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) at week 28, maintained a PASI 90 response with continuous treatment through week 72.¹ Findings from the study also demonstrated that a vast majority of patients originally randomised to guselkumab, but withdrawn from treatment at week 28, regained a PASI 90 response within six months of initiating guselkumab retreatment.¹ These long-term findings from the Phase III VOYAGE 2 study were presented at the 2018 American Academy of Dermatology (AAD) Annual Meeting in San Diego, California, during a late-breaking abstract session at 1:00 PM PST (22:00 CET) on Saturday 17 February.

“The longer-term data from VOYAGE 2 shows promising results for guselkumab as both a continuous, long-term treatment for moderate to severe plaque psoriasis, and as an option for patients who have been withdrawn from therapy and retreated,” said study investigator Prof. Kristian Reich, M.D. of Dermatologikum Berlin and SCIderm Research Institute in Hamburg, Germany. “These data provide important information to dermatologists should they need to interrupt treatment with guselkumab for a period of time, as the findings demonstrate guselkumab quickly and robustly re-established a PASI 90 response within six months.”

Results from the trial demonstrated that among patients who achieved a PASI 90 response at week 28 with guselkumab, 86 percent who continued receiving guselkumab maintained a PASI 90 response through week 72, while only 11.5 percent of patients who were withdrawn from treatment maintained a PASI 90 response.¹ Of the 173 patients who were withdrawn from receiving guselkumab, 87.6 percent achieved a PASI 90 response within six months of commencing retreatment.¹

Adverse events reported in at least five percent of guselkumab-treated patients during the first 16 weeks of the VOYAGE 1 and 2 trials included: nasopharyngitis, upper respiratory tract infection, injection site erythema, headache, arthralgia, pruritus and back pain.^2,3 No new safety signals were observed with continuous treatment with guselkumab through week 100.⁴

* Ends *

About American Academy of Dermatology (AAD) Annual Meeting

The American Academy of Dermatology (AAD) Annual Meeting is taking place in San Diego, California from Friday 16 February to Tuesday 20 February 2018. For more information, visit: https://www.aad.org/meetings/annual-meeting

About TREMFYA ^® (guselkumab) ⁵

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

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.^2,3,6,7 Guselkumab is a 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.^2,3

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

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

About VOYAGE 2 study

• VOYAGE 2 is a Phase III, multicentre, randomised, double-blind, placebo- and active-comparator-controlled study designed to evaluate the safety and efficacy of guselkumab compared with placebo and adalimumab, and of guselkumab maintenance therapy compared with withdrawal of therapy, in adult patients with moderate to severe plaque psoriasis. Patients (n=992) were randomised to receive subcutaneous (SC) injections of guselkumab 100 mg at weeks 0, 4, 12 and 20; placebo at weeks 0, 4 and 12 with crossover to guselkumab at weeks 16 and 20 or adalimumab 80 mg at week 0, followed by 40 mg at week 1 and every two weeks through week 23.² Patients initially randomised to receive guselkumab who achieved a PASI 90 response (n=375) at week 28 were re-randomised to either continue treatment with guselkumab (n=193) or withdrawal to placebo (n=182) with retreatment upon a 50 percent or greater loss of PASI improvement at week 28 or week 72 if retreatment criteria were not met.¹

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.⁸ The inconsistent nature of psoriasis means that even when plaques appear to subside, patients can have ongoing concerns over their return.⁹

Impact

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.¹⁰

Psoriasis is also associated with several comorbidities including psoriatic arthritis, cardiovascular diseases, metabolic syndrome, chronic obstructive pulmonary disorder (COPD) and osteoporosis.^11,12

In addition, many individuals are faced with social exclusion, discrimination and stigma because of their disease.¹³

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 (“Janssen”) 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 and potential availability in Europe 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 or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges inherent in product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; 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 January 1, 2017, including under “Item 1A. Risk Factors,” its most recently filed Quarterly Report on Form 10-Q, including under the caption “Cautionary Note Regarding Forward-Looking Statements,” and 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 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.

1 Gordon K, Armstrong A, et al. American Academy of Dermatology (AAD) 2018 Annual Meeting 16–20 February 2018; San Francisco, USA, ID #6748. 2 Reich K and Armstrong AW, et al. J Am Acad Dermatol 2017;76(3):418–31. 3 Blauvelt A, Papp KA, et al. J Am Acad Dermatol 2017;76(3):405–17. 4 Reich K, Papp K, et al. 8th International Congress of Psoriasis from Gene to Clinic 30 November–2 December 2017; London, UK, ID #75. 5 European Medicines Agency. 2017. Available at: https://www.medicines.org.uk/emc/medicine/34321. Accessed February 2018. 6 Langley RG, Tsai TF, et al. Br J Dermatol 2017;178(1):114–23. 7 Bachelez H. The Lancet 2017;390(10091):208–10. 8 National Institute of Arthritis and Musculoskeletal and Skin Disorders. NIH Medline Plus 2003;12(1):20-1. 9 US Food and Drug Administration. 2016. Available at: https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM529856.pdf. Accessed February 2018. 10 Rapp SR, Feldman SR, et al. J Am Acad Dermatol 1999;41(3):401–7. 11 Nijsten T, Wakkee MJ. Invest Dermatol 2009;129(7):1601–3. 12 National Psoriasis Foundation. Available at: https://www.psoriasis.org/about-psoriasis/related-conditions. Accessed February 2018. 13 World Health Organization. 2016. Available at: apps.who.int/iris/bitstream/10665/204417/1/9789241565189_eng.pdf. Accessed February 2018.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

View source version on businesswire.com: http://www.businesswire.com/news/home/20180219005134/en/

Contact information

Janssen
Media Contact
Emily Bone
Mobile: +44 7876 394 360
ebone1@its.jnj.com
or
Media Contact
Kim Rotondo
Office: +1 215-628-7166
Mobile: +1 267-994-1169
krotondo@its.jnj.com
or
Investor Contact
Joseph J. Wolk
Johnson & Johnson
Office: +1 732-524-1142