- New data from VOYAGE 2 trial shows high
efficacy response rates were achieved with continuous guselkumab
treatment versus withdrawal
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patients originally randomised to guselkumab, but withdrawn from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been withdrawn from therapy and retreated,” said study investigator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withdrawn from treatment maintained a PASI 90 response.1 Of the 173
patients who were withdrawn from receiving guselkumab, 87.6 percent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.
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ContactKim RotondoOffice: +1 215-628-7166Mobile: +1
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