New Three-Year Data for Janssen’s TREMFYA®▼ (Guselkumab) Demonstrates Well Maintained Rates of Skin Clearance in Patients with Moderate to Severe Plaque Psoriasis
October 22, 2018
-
82.8 percent of patients maintained a Psoriasis Area Severity Index
(PASI) 90 score (near complete skin clearance) at Week 156 -
82.1 percent of patients maintained an Investigator’s Global
Assessment (IGA) score of cleared (0) or minimal disease (1), at Week
156
LAS VEGAS–(BUSINESS WIRE)–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 37th
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
#ENDS#
*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.
# # #
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.
PHEM/IMM/0918/0023
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