LONDON, Dec. 17, 2020 /PRNewswire/
-- GlaxoSmithKline plc (LSE/NYSE: GSK) announced the US Food
and Drug Administration (FDA) has approved BENLYSTA (belimumab) for
the treatment of adult patients with active lupus nephritis (LN)
who are receiving standard therapy. Lupus nephritis is a serious
inflammation of the kidneys caused by systemic lupus erythematosus
(SLE), the most common form of lupus, which can lead to end-stage
kidney disease, requiring dialysis or a kidney transplant. The
approval extends the current indication in the US to include both
SLE and LN for both the intravenous and subcutaneous
formulations.
Dr. Hal Barron, Chief Scientific
Officer and President R&D, GSK said: "Approximately 40% of
patients with systemic lupus erythematosus develop lupus nephritis,
which causes inflammation in the kidneys and can lead to end-stage
kidney disease. BENLYSTA is the first medicine approved to
treat systemic lupus and adults with active lupus nephritis, an
important treatment advance for patients with this incurable
autoimmune disease."
The FDA approval for adult patients with active LN follows a
Breakthrough Therapy Designation and Priority Review and is based
on the positive results of the BLISS-LN (Efficacy and Safety of
Belimumab in Adult Patients with Active Lupus Nephritis) study and
the unmet need in this patient population. The BLISS-LN study is
the largest and longest phase 3 study conducted in active LN,
involving 448 adult patients. The study met its primary endpoint
demonstrating that a statistically significant greater number of
patients achieved Primary Efficacy Renal Response (PERR) at two
years (or 104 weeks) when treated with BENLYSTA plus standard
therapy compared to placebo plus standard therapy in adults with
active LN (43% vs 32%, odds ratio (95% CI) 1.55 (1.04, 2.32),
p=0.0311). Statistical significance compared to placebo across all
four major secondary endpoints was achieved, including Complete
Renal Response and Time to Renal-Related Event or Death. The safety
results are consistent with the known safety profile of
BENLYSTA.
Dr. Richard Furie, Chief of the
Division of Rheumatology and Professor at the Feinstein Institutes
for Medical Research at Northwell Health and Lead Investigator of
the BLISS-LN study, commented: "We have long aspired to enhance
outcomes for patients with lupus nephritis. In the four decades I
have been caring for people with lupus, we have not been able to
achieve remission in more than just one-third of patients with
lupus nephritis and, despite all of our efforts, 10% to 30% of
patients with lupus kidney disease still progress to end-stage
kidney disease. The data from the BLISS-LN study show that BENLYSTA
added to standard therapy not only increased response rates over
two years, but it also prevented worsening of kidney disease in
patients with active lupus nephritis compared to standard
therapy alone. Therefore, it is gratifying to see the rewards of
decades of research."
Dr. Brad Rovin, Director of the
Division of Nephrology and Medical Director of the Center for
Clinical Research Management at the Ohio State
University Wexner Medical Center, commented: "The
overarching goal in the management of patients with lupus nephritis
is to delay the need for kidney replacement therapies, such as
dialysis and transplantation. The BLISS-LN study not only
demonstrated that the addition of BENLYSTA to standard therapy
significantly increased the PERR, but also showed that patients had
a 49% decrease in risk for experiencing a renal-related event. I'm
encouraged by the progress we're making in lupus nephritis."
About the BLISS-LN study
BLISS-LN is a phase 3,
104-week, randomised, double-blind, placebo-controlled,
post-approval commitment study to evaluate the efficacy and safety
of intravenous (IV) BENLYSTA 10 mg/kg plus standard therapy
(mycophenolate mofetil for induction and maintenance, or
cyclophosphamide for induction followed by azathioprine for
maintenance, plus steroids) compared to placebo plus standard
therapy in adult patients with active LN. Active LN was confirmed
by renal biopsy during screening visit using the 2003 International
Society of Nephrology/Renal Pathology Society criteria within the
past 6 months, and clinically active kidney disease requiring
induction therapy.
For US Patients: Making our products affordable and
accessible
GSK is actively involved in creating solutions
that allow patients to have access to new scientific breakthroughs.
We remain committed to helping patients access GSK medications and
have a long history of providing patient assistance programs.
Patients and healthcare professionals who need help with
prescription coverage should visit www.BENLYSTA.com or call
1-877-4-BENLYSTA (1-877-423-6597) for eligibility
information.
About lupus nephritis (LN)
Systemic lupus
erythematosus (SLE), the most common form of lupus, is a chronic,
incurable, autoimmune disease associated with a range of symptoms
that can fluctuate over time including painful or swollen joints,
extreme fatigue, unexplained fever, skin rashes and organ damage.
In lupus nephritis (LN), SLE causes kidney inflammation (swelling
or scarring) of the small blood vessels that filter wastes in your
kidney (glomeruli) and sometimes the kidneys, by attacking them
like they would attack a disease1. LN can lead to
end-stage kidney disease, which requires kidney dialysis or a
transplant. Despite improvements in both diagnosis and treatment
over the last few decades, LN remains an indicator of poor
prognosis.2,3 Manifestations of LN include proteinuria,
elevations in serum creatinine and the presence of urinary
sediment.
About BENLYSTA (belimumab)
BENLYSTA, a BLyS-specific
inhibitor, is a human monoclonal antibody that binds to soluble
BLyS. BENLYSTA does not bind B cells directly. By binding BLyS,
BENLYSTA inhibits the survival of B cells, including autoreactive B
cells, and reduces the differentiation of B cells into
immunoglobulin-producing plasma cells. First approved in 2011, it
is the first and only approved biologic for both SLE and LN in more
than 50 years.
The following information is based on the US Prescribing
Information for BENLYSTA in licensed indications only. Please
consult the full Prescribing Information for all the labelled
safety information for BENLYSTA.
INDICATION
BENLYSTA is indicated for patients aged ≥5
years with active, autoantibody-positive systemic lupus
erythematosus (SLE) who are receiving standard therapy and patients
aged ≥18 with active lupus nephritis who are receiving standard
therapy. The subcutaneous (SC) formulation is approved for patients
aged ≥18 years. BENLYSTA is not recommended in patients with
severe active central nervous system lupus or in combination with
other biologics.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATION
Previous anaphylaxis with
BENLYSTA.
WARNINGS AND PRECAUTIONS
Serious Infections:
Serious and sometimes fatal infections have been reported in
patients receiving immunosuppressive agents, including BENLYSTA.
The incidence of serious infections was similar in patients
receiving BENLYSTA versus placebo, whereas fatal infections
occurred more frequently with BENLYSTA. The most frequent
serious infections in adults with SLE treated with BENLYSTA IV
included pneumonia, urinary tract infection, cellulitis, and
bronchitis. Use caution in patients with severe or chronic
infections and consider interrupting therapy in patients with
a new infection.
Progressive Multifocal Leukoencephalopathy (PML): Cases of JC
virus-associated PML resulting in neurological deficits, including
fatal cases, have been reported in patients with SLE receiving
immunosuppressants, including BENLYSTA. If PML is confirmed,
consider stopping immunosuppressant therapy, including
BENLYSTA.
Hypersensitivity Reactions (Including Anaphylaxis): Acute
hypersensitivity reactions, including anaphylaxis (eg, hypotension,
angioedema, urticaria or other rash, pruritus, and dyspnea) and
death, have been reported, including in patients who have
previously tolerated BENLYSTA. Generally, reactions occurred within
hours of the infusion but may occur later. Non-acute
hypersensitivity reactions (eg, rash, nausea, fatigue, myalgia,
headache, and facial edema) typically occurred up to a week after
infusion. Patients with a history of multiple drug allergies or
significant hypersensitivity may be at increased risk. With
BENLYSTA SC, systemic hypersensitivity reactions were similar to
those in IV trials.
Healthcare providers (HCPs) should monitor patients during and
after IV administration and be prepared to manage anaphylaxis;
discontinue immediately in the event of a serious reaction.
Premedication may mitigate or mask a hypersensitivity response.
Advise patients about hypersensitivity symptoms and instruct them
to seek immediate medical care if a reaction occurs.
Infusion Reactions: Serious infusion reactions (eg,
bradycardia, myalgia, headache, rash, urticaria, and hypotension)
were reported in adults. HCPs should monitor patients and manage
reactions if they occur. Premedication may mitigate or mask a
reaction. If an infusion reaction develops, slow or interrupt the
infusion.
Depression and Suicidality: In adult trials,
psychiatric events were reported more frequently with BENLYSTA IV
related primarily to depression-related events, insomnia, and
anxiety; serious psychiatric events included serious depression and
suicidality, including 2 completed suicides. No serious
depression-related events or suicides were reported in
the BENLYSTA SC trial. Before adding BENLYSTA,
assess patients' risk of depression and suicide and
monitor them during treatment. Instruct
patients/caregivers to contact their HCP if they experience
new/worsening depression, suicidal thoughts, or other mood
changes.
Malignancy: The impact of BENLYSTA on the
development of malignancies is unknown; its mechanism of action
could increase the risk for malignancies.
Immunization: Live vaccines should not be given for
30 days before or concurrently with BENLYSTA as clinical safety has
not been established.
Use With Biologic Therapies: BENLYSTA has not been
studied and is not recommended in combination with other biologic
therapies, including B-cell targeted therapies.
ADVERSE REACTIONS:
The most common serious adverse
reactions in adult SLE clinical trials were serious infections,
BENLYSTA IV 6.0% (placebo 5.2%), some of which were fatal
infections BENLYSTA IV 0.3% (placebo 0.1%). Adverse reactions
occurring in ≥3% of adults and ≥1% more than placebo: nausea 15%
(12%); diarrhea 12% (9%); pyrexia 10% (8%); nasopharyngitis 9%
(7%); bronchitis 9% (5%); insomnia 7% (5%); pain in extremity
6% (4%); depression 5% (4%); migraine 5% (4%); pharyngitis 5% (3%);
cystitis 4% (3%); leukopenia 4% (2%); viral gastroenteritis 3%
(1%).
In adult patients with active lupus nephritis, serious
infections occurred in 14% of patients receiving BENLYSTA IV
(placebo 17%), some of which were fatal infections, BENLYSTA 0.9%
(placebo 0.9%). Adverse reactions occurring in ≥3% of adults
and ≥1% more than placebo were consistent with the known safety
profile of BENLYSTA IV in SLE patients.
Adverse reactions in pediatric patients aged ≥5 years receiving
BENLYSTA IV were consistent with those observed in adults.
The safety profile observed for BENLYSTA SC in adults was
consistent with the known safety profile of BENLYSTA IV with the
exception of local injection site reactions.
USE IN SPECIFIC
POPULATIONS
Pregnancy: There are insufficient
data in pregnant women to establish whether there is
drug-associated risk for major birth defects or miscarriage. After
a risk/benefit assessment, if prevention is warranted, women of
childbearing potential should use contraception during treatment
and for ≥4 months after the final treatment.
Pregnancy Registry: HCPs are encouraged to register patients and
pregnant women are encouraged to enroll themselves by calling
1-877-681-6296.
Lactation: No information is available
on the presence of belimumab in human milk, the effects on the
breastfed infant, or the effects on milk production. Consider
developmental and health benefits of breastfeeding with the
mother's clinical need for BENLYSTA and any potential adverse
effects on the breastfed child or from the underlying maternal
condition.
Pediatric Use: The safety and
effectiveness have not been established for BENLYSTA IV in SLE
patients <5 years of age, and in active LN patients <18 years
of age, and for BENLYSTA SC in SLE and LN patients <18 years of
age.
GSK's commitment to immunology
GSK is focused on the
research and development of medicines for immune-mediated diseases,
such as lupus and rheumatoid arthritis, that are responsible for a
significant health burden to patients and society. Our
world-leading scientists are focusing research on the biology of
the immune system with the aim to develop immunological-based
medicines that have the potential to alter the course of
inflammatory disease. As the only company with a biological
treatment approved for adult and pediatric lupus, GSK is leading
the way to help patients and their families manage this chronic,
inflammatory autoimmune disease. Our aim is to develop
transformational medicines that can alter the course of
inflammatory disease to help people live their best day, every
day.
About GSK
GSK is a science-led global healthcare
company with a special purpose: to help people do more, feel
better, live longer. For further information please visit
www.gsk.com/about-us.
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1 National Kidney Foundation, Lupus and Kidney
Disease (Lupus Nephritis). Available at
https://www.kidney.org/atoz/content/lupus
2 Gordon C, Hayne D, Pusey C, et al. European
Consensus Statement on the Terminology used in the Management of
Lupus Glomerulonephritis. Lupus 2009;18:257-26.
3 Waldman M and Appel GB. Update of the Treatment
of Lupus Nephritis. Kidney International 2006;70:1403-1412.
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