Data from GALAXI 2 & 3 showed TREMFYA® was
superior to STELARA ® in all pooled endoscopic
endpoints
WASHINGTON, May 21, 2024
/PRNewswire/ -- Johnson & Johnson today announced the
first Phase 3 results for TREMFYA® (guselkumab) in adult
patients with moderately to severely active Crohn's disease (CD),
which demonstrated superiority of both subcutaneous (SC)
maintenance doses (200 mg every 4 weeks [q4w] and 100 mg every 8
weeks [q8w]) versus placebo and ustekinumab.1 Data
showed that both maintenance doses of TREMFYA® met the
composite co-primary endpoints compared to placebo in each
individual study.1,b In results versus ustekinumab, both
doses of TREMFYA® demonstrated statistically significant
and clinically meaningful differences on all prespecified pooled
endoscopic endpoints.1 These findings were featured as a
late-breaking oral presentation (Abstract #1057b) at Digestive
Disease Week (DDW) 2024.1
The GALAXI 2 (n=508) and GALAXI 3 (n=513) studies were the
first-ever double-blind registrational head-to-head clinical trials
to demonstrate superiority versus ustekinumab in CD. A summary of
select data from the 48-week pooled, multiplicity-controlled
endpoints is as follows:1
|
Endpoint
|
TREMFYA® 200mg SC
q4w
versus ustekinumab
|
TREMFYA® 100mg SC
q8w versus
ustekinumab
|
Ustekinumab
|
Endoscopic
endpoints
|
Endoscopic
responsed
|
52.7%
(p<0.001)
|
47.9%
(p=.009)
|
37.1 %
|
Endoscopic
remissione
|
37.2%
(p=0.001)
|
33.2%
(p=0.024)
|
24.7 %
|
Clinical remission
and
endoscopic response
|
47.3%
(p<0.001)
|
41.6%
(p=0.049)
|
33.7 %
|
Deep
remissionf
|
33.8%
(p=0.002)
|
29.7%
(p=0.040)
|
22.3 %
|
Clinical
endpoint
|
Clinical
remissiong
|
70.3%
(p=.058)
|
65.4%
(p=.512)
|
62.9 %
|
"These results are promising for those who continue to
experience persistent and debilitating symptoms and offer the
possibility of guselkumab as a future-first advanced therapy
or after failure of other advanced therapies that may deliver the
lasting remission patients deserve to relieve the burden of
disease," said Remo Panaccione,
M.D., Professor of Medicine, University of
Calgary and lead study investigator.a "The GALAXI
program demonstrates the potential of guselkumab and this targeted
IL-23 approach for rapid and sustained efficacy in the treatment of
Crohn's disease."
TREMFYA® has a well-studied safety profile and
years of patient experience in approved indications and earlier
inflammatory bowel disease trials. In the GALAXI program, the
safety profile was consistent with that of the currently approved
indications.1 Through Week 48, the number of
patients with at least one or more (≥1) adverse events (AE), ≥1
serious AEs, and AEs leading to discontinuation were similar across
patients who received TREMFYA®, placebo, or
ustekinumab.1 The proportions of patients with
serious infections and AEs of interest were
low.1
"The Phase 3 GALAXI program, comprised of two rigorous,
double-blind studies with secondary endpoints comparing TREMFYA to
ustekinumab, reiterate our dedication to addressing the needs of
patients with Crohn's disease and our deep scientific expertise in
inflammatory bowel disease and focused innovation in the IL-23
pathway," said David Lee, M.D.,
Ph.D., Global Therapeutic Area Head Immunology, Johnson &
Johnson Innovative Medicine. "These findings demonstrate the
promise of TREMFYA for patients living with moderately to severely
active Crohn's disease compared to conventional and advanced
therapies."
This year, Janssen-Cilag International NV, a Johnson &
Johnson company, announced submission of applications to the
European Medicines Agency (EMA) seeking to expand the Marketing
Authorization Application for TREMFYA® to include the
treatment of adult patients with moderately to severely active
ulcerative colitis (UC) and moderately to severely active CD.
Additionally, Johnson & Johnson submitted regulatory
applications seeking the approval of TREMFYA® for the
treatment of adults with moderately to severely active UC in
countries or regions including the United
States and Europe.
Editor's Notes:
a. Dr. Panaccione is a paid consultant for Johnson &
Johnson. He has not been compensated for any media work.
b. TREMFYA® is not currently approved to treat
Crohn's disease.
c. Design in which patients in the active treatment arms
remained on the therapy to which they were initially randomized,
regardless of clinical response at Week 12, with the exception of
nonresponders in the placebo arm, who crossed over to blinded
ustekinumab treatment.1
d. Endoscopic response
is defined as ≥50 percent improvement from baseline in the Simple
Endoscopic Score in Crohn's disease (SES-CD) (primary efficacy
analysis set (nonresponder imputation)).1
e.
Endoscopic remission is defined as an endoscopy subscore of
0.1
f. Deep remission endpoint consists of
clinical remission and endoscopic remission
together.1
g. Clinical remission is defined as
a Crohn's Disease Activity Index (CDAI) score of <150 (primary
efficacy analysis set (nonresponder imputation)).1
ABOUT THE GALAXI PROGRAM (NCT03466411)
GALAXI is a randomized, double-blind, placebo-controlled,
active-controlled (ustekinumab), global, multicenter Phase 2/3
program designed to evaluate the efficacy and safety of guselkumab
in participants with moderately to severely active Crohn's disease
with inadequate response/intolerance to conventional therapies
(immunomodulators, corticosteroids) and/or biologics (TNF
antagonists, vedolizumab).2 GALAXI includes a Phase
2 dose-ranging study (GALAXI 1) and two independent, identically
designed confirmatory Phase 3 studies (GALAXI 2 and
3).1 Each GALAXI study employed a treat-through
design in which participants remained on the treatment to which
they were initially randomized, reflecting real-world clinical
practice, and includes a long-term extension study that will assess
clinical, endoscopic, and safety outcomes with guselkumab through a
total of five years.1
ABOUT CROHN'S DISEASE
Crohn's disease is one of the two main forms of inflammatory
bowel disease, which affects an estimated three million Americans
and an estimated four million people across Europe.3,4 Crohn's
disease is a chronic inflammatory condition of the gastrointestinal
tract with no known cause, but the disease is associated with
abnormalities of the immune system that could be triggered by a
genetic predisposition, diet, or other environmental
factors.5 Symptoms of Crohn's disease can vary, but
often include abdominal pain and tenderness, frequent diarrhea,
rectal bleeding, weight loss, and fever. There is currently no cure
for Crohn's disease.6
ABOUT TREMFYA® (guselkumab)
Developed by Johnson & Johnson, TREMFYA® is the first
approved fully-human, dual-acting monoclonal antibody that blocks
IL-23 by binding to the p19 subunit of IL-23 and binding to CD64, a
receptor on cells that produce IL-23.7 IL-23 is an
important driver of the pathogenesis of inflammatory
diseases.8 Findings for dual acting are limited to
in vitro studies that demonstrate guselkumab binds to CD64, which
is expressed on the surface of IL-23 producing cells in an
inflammatory monocyte model. The clinical significance of this
finding is not known.8,9,10,11
TREMFYA® is approved in the U.S.,8
Canada,12 Japan13 and a number of other
countries for the treatment of adults with moderate-to-severe
plaque psoriasis (PsO) who are candidates for injections or pills
(systemic therapy) or phototherapy (treatment using ultraviolet
light) and for the treatment of adult patients with active
psoriatic arthritis (PsA).8 It is also approved in
the EU for the treatment of moderate-to-severe plaque PsO in adults
who are candidates for systemic therapy and for the treatment of
active PsA in adult patients who have had an inadequate response or
who have been intolerant to a prior disease-modifying antirheumatic
drug therapy.14
Johnson & Johnson maintains exclusive worldwide marketing
rights to TREMFYA®.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about
TREMFYA® (guselkumab)?
TREMFYA® is a prescription medicine that may
cause serious side effects, including:
- Serious Allergic Reactions. Stop using
TREMFYA® and get emergency medical help right away
if you develop any of the following symptoms of a serious allergic
reaction:
- fainting, dizziness, feeling lightheaded (low blood
pressure)
- swelling of your face, eyelids, lips, mouth, tongue, or
throat
- trouble breathing or throat tightness
- chest tightness
- skin rash, hives
- itching
- Infections. TREMFYA® may lower the
ability of your immune system to fight infections and may increase
your risk of infections. Your healthcare provider should check you
for infections and tuberculosis (TB) before starting treatment with
TREMFYA® and may treat you for TB before you begin
treatment with TREMFYA® if you have a history of TB
or have active TB. Your healthcare provider should watch you
closely for signs and symptoms of TB during and after treatment
with TREMFYA®.
Tell your healthcare provider right away if you have an infection
or have symptoms of an infection, including:
- fever, sweats, or chills
- muscle aches
- weight loss
- cough
- warm, red, or painful skin or sores on your body different from
your psoriasis
- diarrhea or stomach pain
- shortness of breath
- blood in your phlegm (mucus)
- burning when you urinate or urinating more often than
normal
Do not use TREMFYA® if you have had a
serious allergic reaction to guselkumab or any of the ingredients
in TREMFYA®.
Before using TREMFYA®, tell your healthcare
provider about all of your medical conditions, including if
you:
- have any of the conditions or symptoms listed in the
section "What is the most important information I should
know about TREMFYA®?"
- have an infection that does not go away or that keeps coming
back.
- have TB or have been in close contact with someone with
TB.
- have recently received or are scheduled to receive an
immunization (vaccine). You should avoid receiving live vaccines
during treatment with TREMFYA®.
- are pregnant or plan to become pregnant. It is not known if
TREMFYA® can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if
TREMFYA® passes into your breast milk.
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements.
What are the possible side effects of
TREMFYA®?
TREMFYA® may cause serious side effects. See
"What is the most important information I should know about
TREMFYA®?"
The most common side effects of
TREMFYA® include: upper respiratory
infections, headache, injection site reactions, joint pain
(arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin
infections, herpes simplex infections, and bronchitis.
These are not all the possible side effects of
TREMFYA®. Call your doctor for medical advice about side
effects.
Use TREMFYA® exactly as your healthcare provider
tells you to use it.
Please read the full Prescribing Information,
including Medication Guide for
TREMFYA®, and discuss any questions that you have with
your doctor.
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call
1–800–FDA–1088.
ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build
a world where complex diseases are prevented, treated, and
cured, where treatments are smarter and less invasive,
and solutions are personal. Through our expertise in
Innovative Medicine and MedTech, we are uniquely positioned to
innovate across the full spectrum of healthcare solutions today to
deliver the breakthroughs of tomorrow, and profoundly impact health
for humanity. Learn more at https://www.jnj.com/ or at
www.janssen.com/johnson-johnson-innovative-medicine. Follow us at
@JNJInnovMed. Janssen Research & Development, LLC and Janssen
Biotech, Inc. are Johnson & Johnson companies.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995
regarding TREMFYA®. 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
materialize, actual results could vary materially from the
expectations and projections of Janssen Research & Development,
LLC, Janssen Biotech, Inc. and/or Johnson & Johnson. Risks and
uncertainties include, but are not limited to: challenges and
uncertainties inherent in product research and development,
including the uncertainty of clinical success and of obtaining
regulatory approvals; uncertainty of commercial success;
manufacturing difficulties and delays; competition, including
technological advances, new products and patents attained by
competitors; challenges to patents; product efficacy or safety
concerns resulting in product recalls or regulatory action; changes
in behavior 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, 2023, including in the
sections captioned "Cautionary Note Regarding Forward-Looking
Statements" and "Item 1A. Risk Factors," and in Johnson &
Johnson'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 Janssen Research
& Development, LLC, Janssen Biotech, Inc. nor Johnson &
Johnson undertakes to update any forward-looking statement as a
result of new information or future events or developments.
1 Panaccione, R et al. Efficacy and safety of
guselkumab therapy in patients with moderately to severely active
Crohn's disease: results of the GALAXI 2 & 3 phase 3 studies.
Oral presentation (Abstract #1057b) at Digestive Disease Week (DDW)
2024. May 2024.
2 National Institutes of Health:
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/study/NCT03466411. Accessed April 2024.
3 Crohn's & Colitis Foundation. Overview of
Crohn's disease. Available at:
https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview.
Accessed May 2024.
4 Ng SC, et al. Worldwide incidence and prevalence
of inflammatory bowel disease in the 21st century: a systematic
review of population-based studies. The Lancet.
2017;390:2769-78.
5 Crohn's & Colitis Foundation. What is Crohn's
disease? Available at:
https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes.
Accessed May 2024
6 Crohn's & Colitis Foundation. Signs and
Symptoms of Crohn's Disease. Available at:
https://www.crohnscolitisfoundation.org/what-is-crohns-disease/symptoms.
Accessed May 2024.
7 TREMFYA® Prescribing Information.
Available at:
https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf.
Accessed May 2024.
8 Mehta H, et al. Differential Changes in
inflammatory mononuclear phagocyte and T-Cell profiles within
psoriatic skin during treatment with guselkumab vs. secukinumab. J
Invest Dermatol 2021;141(7):1707-1718. Available at:
https://pubmed.ncbi.nlm.nih.gov/33524368/. Accessed April 2024.
9 Wang Y, et al. Monocytes/Macrophages play a
pathogenic role in IL-23 mediated psoriasis-like skin inflammation.
Sci Rep. 2019;9(1):5310. Available at:
https://pubmed.ncbi.nlm.nih.gov/30926837/. Accessed May 2024.
10 Matt P, et al. Up-regulation of CD64-expressing
monocytes with impaired FcγR function reflects disease activity in
polyarticular psoriatic arthritis. Scand J Rheumatol 2015;
44(6):464-473. Available at:
https://pubmed.ncbi.nlm.nih.gov/26084203/. Accessed May 2024.
11 McGonagle D, et al. Guselkumab, an IL-23p19
subunit–specific monoclonal antibody, binds CD64+ myeloid cells and
potently neutralises IL-23 produced from the same cells. Presented
at EULAR 2023, May 31-June 3.
12 The Canadian Agency for Drugs & Technologies
in Health. TREMFYA Prescribing Information. Available at:
https://pdf.hres.ca/dpd_pm/00042101.pdf. Accessed May 2024.
13 Japan Pharmaceuticals and Medical Devices
Agency. Tremfya Report on the Deliberation Results. Available at:
https://www.pmda.go.jp/files/000234741.pdf. Accessed May 2024.
14 European Commission: Tremfya (guselkumab).
Available at:
http://ec.europa.eu/health/documents/community-register/html/h1234.htm.
Accessed May 2024.
|
Media
contact:
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+1
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cstoltz@its.jnj.com
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contact:
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investor-relations@its.jnj.com
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