New Analysis Shows High Rates of Skin Clearance as Measured by Absolute PASI in Patients With Moderate to Severe Plaque Psoriasis Treated With Janssen's TREMFYA® (guselkumab)

LONDON, December 2, 2017 /PRNewswire/ --

FOR MEDICAL AND TRADE MEDIA ONLY  

• Absolute PASI analysis from the VOYAGE 1 trial shows a high level of skin responses were maintained through two years in patients treated with guselkumab   
• Additional new data show a consistent safety profile for guselkumab through two years  

Janssen-Cilag International NV ("Janssen") presented a new analysis from VOYAGE 1 assessing efficacy responses based on absolute Psoriasis Area and Severity Index score (PASI), as reported through two years of TREMFYA^® (guselkumab) treatment in adult patients with moderate to severe psoriasis.^[1] The data, presented at the 8^th International Congress of Psoriasis from Gene to Clinic, showed that guselkumab treatment led to significantly higher rates of skin clearance vs Humira^® (adalimumab) through one year, as measured by absolute PASI (p <0.001). In patients who received continuous treatment with guselkumab, high level PASI responses were also maintained through the two years.^[1]

"The chronicity and often unpredictable nature of psoriasis mean that percentage improvements in signs and symptoms don't always translate into improvements in quality of life for patients," said Dr Kim Papp, K Papp Clinical Research and Probity Medical Research, Waterloo, Canada and study lead investigator. "By directly analysing PASI values in this trial, we focused on a direct and objective measurement of disease severity, not just the percentage of improvement. Results from VOYAGE 1 demonstrate that treatment with guselkumab translates into clinically meaningful improvements for patients."

The aim of this post-hoc analysis was to objectively measure the area of the body affected by the reddening, scaling and thickening associated with psoriasis plaques, rather than reporting on the relative percentage improvement in PASI score from baseline seen with treatment. Efficacy through to two years (week 100) was analysed based on absolute PASI responses of 0, ?1 and ?3 on a scale of 0 to 72, with higher scores indicating greater disease severity.^[1],[2] The results showed that at week 48, 72.0% of patients treated with guselkumab had a PASI score of ?1 vs 43.4% of patients treated with adalimumab (p <0.001). Furthermore, 47.4% of guselkumab treated patients had clear skin (PASI 0) vs 23.4% of those treated with adalimumab (p <0.001).^[1] After 2 years (week 100) high skin clearance rates continued to be seen among patients receiving guselkumab, 68.6% had a PASI score of ?1 and nearly half (49%) had clear skin (PASI score of 0).^{[1][see Information for Editors section for study design]}

Janssen also presented new two-year data from VOYAGE 1 and VOYAGE 2, evaluating the safety of guselkumab in adult patients with moderate to severe plaque psoriasis.^[3] The analysis considered patients who were initially randomised to guselkumab and those randomised to placebo and crossed over to guselkumab at week 16. The results showed that safety event rates for both groups of guselkumab-treated patients were comparable between year 1 and year 2. In addition, the safety data for patients who were initially randomised to adalimumab and later crossed over to receive guselkumab were consistent with overall guselkumab safety data, with no additional safety signals identified.^[3]

Adverse events reported in at least five percent of guselkumab-treated patients during the first 16 weeks in the VOYAGE 1 and 2 trials included: nasopharyngitis, upper respiratory tract infection, injection site erythema, headache, arthralgia, pruritus and back pain. The types of adverse events reported remained generally consistent through 48 weeks of treatment,^[4],[5] and through to week 100.^[3]

Information for Editors  

About the International Congress of Psoriasis from Gene to Clinic  

The 8^th International Congress of Psoriasis from Gene to Clinic is taking place in London from Thursday 30^th November to Saturday 2^nd December. For more information, visit: http://www.psoriasisg2c.com

About TREMFYA^® (guselkumab)^[6]

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.^{[4],[5],[7],[8]} 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.^[4],[5]

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

VOYAGE 1, VOYAGE 2 studies   

• VOYAGE 1 is a Phase III, 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] At week 48, patients randomised to guselkumab at week 0 and those who crossed over from placebo to guselkumab at week 16 continued to receive guselkumab q8w; patients randomised to adalimumab at week 0 also switched to guselkumab q8w at week 48.^[9] Beginning at week 52, all patients began receiving open-label guselkumab. This study will continue for a total of 5 years.
• VOYAGE 2 is a Phase III, multicentre, randomised, double-blind, placebo- and active comparator-controlled study, including 992 patients. It consisted of a placebo-controlled period (weeks 0-16), an active comparator-controlled period (weeks 0-28), and a randomised withdrawal and retreatment period (weeks 28-72).^[4] Beginning at week 76, all patients began receiving open-label guselkumab. This study will also continue for a total of 5 years.

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.^[10] The inconsistent nature of psoriasis means that even when plaques appear to subside, patients can have ongoing concerns over their return.^[11]

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.^[12]

Psoriasis is also associated with several comorbidities including psoriatic arthritis, cardiovascular diseases, metabolic syndrome, chronic obstructive pulmonary disorder (COPD) and osteoporosis.^[13],[14]

In addition, many individuals are faced with social exclusion, discrimination, and stigma because of their disease.^[15]

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 http://www.janssen.com/emea. Follow us on Twitter: @JanssenEMEA.

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 http://www.sec.gov, http://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.

References 

1. Papp K, Griffiths CEM, et al. 8th International Congress of Psoriasis from Gene to Clinic 30 November - 2 December, 2017; London, UK, ID #77.

2. Poulin Y, Sheth P, et al. Dermatol Ther (Heidelb). 2014 Jun;4(1):33-42.

3. Reich K, Papp K et al. 8th International Congress of Psoriasis from Gene to Clinic 30 November - 2 December, 2017; London, UK, ID #75.

4. Reich K and Armstrong AW, et al. J Am Acad Dermatol 2017;76(3):418-31.

5. Blauvelt A, Papp KA, et al. J Am Acad Dermatol 2017;76(3):405-17.

6. European Medicines Agency. 2017. Available at: https://www.medicines.org.uk/emc/medicine/34321 . Accessed November 2017.

7. Langley RG, Tsai TF, et al. Br J Dermatol 2017; Jun 21 [Epub ahead of print].

8. Bachelez H. The Lancet 2017;390:208-10.

9. Griffiths E, Papp K, et al. 26th European Academy of Dermatology and Venereology Congress (EADV 2017) 13-17 Sept, 2017; Geneva, Switzerland;D3T01.1I.

10. National Institute of Arthritis and Musculoskeletal and Skin Disorders. NIH Medline Plus 2003;12(1):20-1.

11. US Food and Drug Administration. 2016. Available at: https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM529856.pdf . Accessed November 2017.

12. Rapp SR, Feldman SR, et al. J Am Acad Dermatol 1999;41(3):401-7.

13. Nijsten T, Wakkee MJ. Invest Dermatol 2009;129(7):1601-3.

14. National Psoriasis Foundation. Available at: psoriasis.org/about-psoriasis/related-conditions. Accessed November 2017.

15. World Health Organization. 2016. Available at: apps.who.int/iris/bitstream/10665/204417/1/9789241565189_eng.pdf. Accessed November 2017