TREMFYA® Phase 3 Crohn's disease study achieves
all primary and secondary endpoints
SPRING
HOUSE, Pa., June 20,
2024 /PRNewswire/ -- Johnson & Johnson (NYSE:
JNJ) today announced positive topline results from the pivotal
Phase 3 GRAVITI investigational study of TREMFYA®
(guselkumab) subcutaneous (SC) induction therapy in adult patients
with moderately to severely active Crohn's disease.1 The
study met both co-primary endpoints, achieving statistically
significant and clinically meaningful outcomes for clinical
remission at Week 12 as well as endoscopic response at Week 12. All
remaining multiplicity-controlled secondary endpoints at Week 12,
Week 24 and Week 48 were statistically significant compared to
placebo. GRAVITI adds to the robust results demonstrated
in GALAXI 2 and GALAXI 3, the first-ever double-blind
registrational head-to-head clinical trials to demonstrate
superiority versus STELARA® (ustekinumab) in key
endoscopic endpoints in Crohn's disease, which together show the
potential of TREMFYA® to become the only IL-23 inhibitor
to offer both SC or IV induction options.3,4 Safety data
from GRAVITI were consistent with the well-characterized safety
profile of TREMFYA® in its approved
indications.2,a
"The Phase 3 GRAVITI study showed promising results with SC
induction and provides similar clinical benefit to what was seen
with IV induction in the GALAXI studies," said David Lee, M.D., Ph.D., Global Therapeutic Area
Head Immunology, Johnson & Johnson Innovative Medicine. "Having
both SC and IV induction options provides choice and versatility
for patients and providers. TREMFYA is poised to be the only IL-23
inhibitor to offer a full SC therapy for both induction and
maintenance in Crohn's disease."
Results from the GRAVITI study are being prepared for
presentation at upcoming medical meetings and will be shared with
health authorities in planned submissions. A separate Johnson &
Johnson study evaluating the efficacy and safety of
TREMFYA® SC induction therapy in ulcerative colitis is
ongoing.
Editor's Notes:
a. TREMFYA® is not approved for
the treatment of ulcerative colitis or Crohn's disease.
ABOUT THE GRAVITI PROGRAM (NCT05197049)
GRAVITI is a randomized, double-blind, placebo-controlled Phase
3 study to evaluate guselkumab SC induction therapy (400 mg at
Weeks 0, 4, and 8) in patients with moderately to severely active
Crohn's disease who experienced an inadequate response or failed to
tolerate conventional therapy (i.e., corticosteroids or
immunomodulators) or biologic therapy (TNF antagonists or
vedolizumab).1 The maintenance doses in GRAVITI are the
same as those evaluated in GALAXI (200 mg SC q4w and 100 mg SC
q8w).1 The study employed a treat-through design, in
which patients are randomized to guselkumab at Week 0 and remain on
that regimen throughout the study, regardless of clinical response
status at the end of induction.1 Participants randomized
to placebo were able to receive guselkumab (400 mg SC q4w x3
➔ 100 mg SC q8w) if rescue criteria were met at Week
16.1
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
(corticosteroids or immunomodulators) and/or biologics (TNF
antagonists or vedolizumab).3 GALAXI includes a
Phase 2 dose-ranging study (GALAXI 1) and two independent,
identically designed confirmatory Phase 3 studies (GALAXI 2 and
3).3 Each GALAXI study employed a treat-through design
in which participants remained on the treatment to which they were
initially randomized and includes a long-term extension study that
will assess clinical, endoscopic, and safety outcomes with
guselkumab through a total of five years. Participants randomized
to placebo were able to receive ustekinumab if clinical response
was not met at Week 12. 3
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.5,6 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.7 Symptoms of Crohn's disease can vary, but
often include abdominal pain and tenderness, frequent diarrhea,
rectal bleeding, weight loss, and fever. Currently no cure is
available for Crohn's disease.8
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-23.9 IL-23 is an important driver of the
pathogenesis of inflammatory diseases.10 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.11,12,13,14
TREMFYA® is approved in the
U.S.,9 Canada,15 Japan16 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).17 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.17
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 STELARA® (ustekinumab)
STELARA® (ustekinumab), a human interleukin (IL)-12
and IL-23 antagonist, is approved in the
United States for the treatment of: 1) adults and children
six years and older with moderate to severe plaque psoriasis who
are candidates for phototherapy or systemic therapy; 2) adults and
children six years and older with active psoriatic arthritis; 3)
adult patients (18 years and older) with moderately to severely
active Crohn's disease; 4) adult patients (18 years and older) with
moderately to severely active ulcerative
colitis.18
The Janssen Pharmaceutical Companies of Johnson &
Johnson maintain exclusive worldwide marketing rights to
STELARA®.
IMPORTANT SAFETY INFORMATION
STELARA® is a prescription medicine that affects your
immune system. STELARA® can increase your chance of
having serious side effects including:
Serious Infections
STELARA® may lower your ability to fight infections
and may increase your risk of infections. While taking
STELARA®, some people have serious infections, which may
require hospitalization, including tuberculosis (TB), and
infections caused by bacteria, fungi, or viruses.
- Your doctor should check you for TB before starting
STELARA® and watch you closely for signs and symptoms of
TB during treatment with STELARA®.
- If your doctor feels that you are at risk for TB, you may be
treated for TB before and during treatment with
STELARA®.
You should not start taking STELARA® if you have any
kind of infection unless your doctor says it is okay.
Before starting STELARA®, tell your doctor if
you:
- think you have an infection or have symptoms of an infection
such as:
- fever, sweats, or chills
- muscle aches
- cough
- shortness of breath
- blood in phlegm
- weight loss
- warm, red, or painful skin or sores on your body
- diarrhea or stomach pain
- burning when you urinate or urinate more often than normal
- feel very tired
- are being treated for an infection or have any open
cuts.
- get a lot of infections or have infections that keep coming
back.
- have TB, or have been in close contact with someone with
TB.
After starting STELARA®, call your doctor right
away if you have any symptoms of an infection (see above).
These may be signs of infections such as chest infections, or skin
infections or shingles that could have serious complications.
STELARA® can make you more likely to get infections or
make an infection that you have worse. People who have a genetic
problem where the body does not make any of the proteins
interleukin 12 (IL–12) and interleukin 23 (IL–23) are at a higher
risk for certain serious infections that can spread throughout the
body and cause death. People who take STELARA® may also
be more likely to get these infections.
Cancers
STELARA® may decrease the activity of your immune
system and increase your risk for certain types of cancer. Tell
your doctor if you have ever had any type of cancer. Some people
who had risk factors for skin cancer developed certain types of
skin cancers while receiving STELARA®. Tell your doctor
if you have any new skin growths.
Posterior Reversible Encephalopathy Syndrome
(PRES)
PRES is a rare condition that affects the brain and can cause
death. The cause of PRES is not known. If PRES is found early and
treated, most people recover. Tell your doctor right away if you
have any new or worsening medical problems including: headache,
seizures, confusion, and vision problems.
Serious Allergic Reactions
Serious allergic reactions can occur. Stop using
STELARA® and get medical help right away if you have any
symptoms of a serious allergic reaction such as: feeling faint,
swelling of your face, eyelids, tongue, or throat, chest tightness,
or skin rash.
Lung Inflammation
Cases of lung inflammation have happened in some people who
receive STELARA® and may be serious. These lung problems
may need to be treated in a hospital. Tell your doctor right away
if you develop shortness of breath or a cough that doesn't go away
during treatment with STELARA®.
Before receiving STELARA®, tell your doctor about
all of your medical conditions, including if you:
- have any of the conditions or symptoms listed above for serious
infections, cancers, or PRES.
- ever had an allergic reaction to STELARA® or any of
its ingredients. Ask your doctor if you are not sure.
- are allergic to latex. The needle cover on the prefilled
syringe contains latex.
- have recently received or are scheduled to receive an
immunization (vaccine). People who take STELARA® should
not receive live vaccines. Tell your doctor if anyone in your house
needs a live vaccine. The viruses used in some types of live
vaccines can spread to people with a weakened immune system, and
can cause serious problems. You should not receive the BCG
vaccine during the one year before receiving STELARA® or
one year after you stop receiving
STELARA®.
- have any new or changing lesions within psoriasis areas or on
normal skin.
- are receiving or have received allergy shots, especially for
serious allergic reactions.
- receive or have received phototherapy for your
psoriasis.
- are pregnant or plan to become pregnant. It is not known if
STELARA® can harm your unborn baby. You and your doctor
should decide if you will receive STELARA® if you are
breastfeeding or plan to breastfeed. It is thought that
STELARA® passes into your breast milk.
- talk to your doctor about the best way to feed your baby if you
receive STELARA®.
Tell your doctor about all the medicines you take,
including prescription and over–the–counter medicines, vitamins,
and herbal supplements. Know the medicines you take. Keep a list of
them to show your doctor and pharmacist when you get a new
medicine.
When prescribed STELARA®:
- Use STELARA® exactly as your doctor tells you
to.
- STELARA® is intended for use under the guidance and
supervision of your
doctor. In children 6 years and older, it is recommended that
STELARA® be administered by a healthcare provider. If
your doctor decides that you or a caregiver may give your
injections of STELARA® at home, you should receive
training on the right way to prepare and inject
STELARA®. Your doctor will determine the right dose of
STELARA® for you, the amount for each injection, and how
often you should receive it. Do not try to inject
STELARA® yourself until you or your caregiver have been
shown how to inject STELARA® by your doctor or
nurse.
Common side effects of STELARA® include: nasal
congestion, sore throat, and runny nose, upper respiratory
infections, fever, headache, tiredness, itching, nausea and
vomiting, redness at the injection site, vaginal yeast infections,
urinary tract infections, sinus infection, bronchitis, diarrhea,
stomach pain, and joint pain. These are not all of the possible
side effects with STELARA®. Tell your doctor about any
side effect that you experience. Ask your doctor or pharmacist for
more information.
Please click to read the full Prescribing
Information and Medication Guide for
STELARA® and discuss any questions 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.
|
National Institutes of
Health: Clinicaltrials.gov. A study of guselkumab subcutaneous
therapy in participants with moderately to severely active Crohn's
disease (GRAVITI). Identifier: NCT05197049. Available at:
https://classic.clinicaltrials.gov/ct2/show/NCT05197049. Accessed
June 2024.
|
2.
|
Data on file.
Guselkumab. Clinical study report CNTO1959CRD3004
(GRAVITI).
|
3.
|
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 June
2024.
|
4.
|
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.
|
5.
|
Crohn's & Colitis
Foundation. Overview of Crohn's disease. Available at:
https://www.crohnscolitisfoundation.org/what-is-crohns-disease/overview.
Accessed June 2024.
|
6.
|
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.
|
7.
|
Crohn's & Colitis
Foundation. What is Crohn's disease? Available at:
https://www.crohnscolitisfoundation.org/what-is-crohns-disease/causes.
Accessed June 2024.
|
8.
|
Crohn's & Colitis
Foundation. Signs and symptoms of Crohn's disease. Available at:
https://www.crohnscolitisfoundation.org/what-is-crohns-disease/symptoms.
Accessed June 2024.
|
9.
|
US Food and Drug
Administration. TREMFYA® prescribing information.
Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761061s007lbl.pdf.
Accessed June 2024.
|
10.
|
Schinocca, C. et al.
Role of the IL-23/IL-17 pathway in rheumatic diseases: an overview.
Frontiers in immunology. 2021 Feb 22;12:321. Available at:
https://doi.org/10.3389/fimmu.2021.637829. Accessed June
2024.
|
11.
|
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 June
2024.
|
12.
|
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
June 2024.
|
13.
|
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 June
2024.
|
14.
|
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.
|
15.
|
The Canadian Agency for
Drugs & Technologies in Health. TREMFYA® prescribing
information. Available at:
https://dhpp.hpfb-dgpsa.ca/review-documents/resource/RDS00697.
Accessed June 2024.
|
16.
|
Japan Pharmaceuticals
and Medical Devices Agency. Tremfya report on the deliberation
results. Available at: https://www.pmda.go.jp/files/000234741.pdf.
Accessed June 2024.
|
17.
|
European Commission:
Tremfya (guselkumab). Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/tremfya.
Accessed June 2024.
|
18.
|
US Food and Drug
Administration. STELARA® prescribing information. Available
at: https://www.stelarahcp.com/. Accessed June 2024
|
Media
contact:
Craig Stoltz
+1
215-779-9396
|
|
|
Investor
contact:
Raychel Kruper
investor-relations@its.jnj.com
|
View original content to download
multimedia:https://www.prnewswire.com/news-releases/tremfya-guselkumab-studies-underscore-its-potential-to-be-the-only-il-23-inhibitor-to-offer-both-subcutaneous-and-intravenous-induction-302177102.html
SOURCE Johnson & Johnson