ROCKVILLE, Md.--(BUSINESS WIRE)--Human Genome Sciences, Inc. (Nasdaq: HGSI) announced today that several abstracts related to BENLYSTA® (belimumab) and systemic lupus erythematosus (SLE) will be presented at the annual meeting of the American College of Rheumatology/ Association of Rheumatology Health Professionals, being held in Chicago, IL from November 4 to November 9, 2011. A total of 13 abstracts - three oral presentations and 10 posters - have been accepted for presentation; seven in the Annual Scientific Sessions and six in the Health Economics Outcomes Research (HEOR) sessions.
BENLYSTA is the first in a class of drugs called BLyS-specific inhibitors. BENLYSTA was approved by the U.S. Food and Drug Administration (FDA) on March 9, 2011 for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy. Limitations of use: The efficacy of belimumab has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus, and has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of belimumab is therefore not recommended in these situations.
The scientific analyses examine the impact of BENLYSTA on patients with SLE, including its efficacy, safety profile and effect on specific organ systems. The HEOR analyses explore the manifestations of the disease and outcome predictors as well as the impact of lupus on healthcare utilization and work productivity
For complete information on all presentations and abstracts, please visit the American College of Rheumatology website at www.rheumatology.org.
ANNUAL SCIENTIFIC SESSIONS
Oral Presentation
Tuesday, November 8
Dooley,
M. et. al., Abstract #2472: Effect of Belimumab Treatment on
Renal Outcome: Results from BLISS-52/BLISS-76
Time/Location:
3:15 p.m. – 3:30 p.m., McCormick Place Convention Center: W 183 A
Poster Presentations
Time/Location for all: 9
a.m. – 6 p.m., McCormick Place Convention Center, Poster Hall
Monday, November 7
Furie,
R.A. et. al., Abstract #1367: Clinical and Laboratory Correlates
in Responders (by the SLE Responder Index) in Phase 3 Belimumab Clinical
Trials
HEALTH ECONOMICS OUTCOMES RESEARCH (HEOR) SESSION
Oral Presentations
Monday, November 7
Hill,
D et. al, Abstract #1712: SLE Disease Activity During a 12-Month
Period and Risk of New Onset Organ System Damage or Death: Observations
in a Single U.S. Academic Medical Center
Time/Location:
5:45 p.m. – 6:00 p.m., McCormick Place Convention Center: W 183 A
Tuesday, November 8
Watson,
P et. al., Abstract #2443: The Natural History and
Predictive Factors of Long-Term Outcomes in SLE
Time/Location:
3:30 p.m. – 3:45 p.m., McCormick Place Convention Center: W 194 B
Poster Presentations
Time/Location for all: 9
a.m. – 6 p.m., McCormick Place Convention Center, Poster Hall
Monday, November 7
Eudy,
A. et. al., Abstract #1392: Infections as Predictors of
Organ System Damage Accrual in SLE
Shah, M. et. al., Abstract #1379: Corticosteroid Use and Associated Risk of Adverse Events in Patients with SLE: A Retrospective Claims Analysis
Tuesday, November 8
Sulcs,
E et. al., Abstract #1855: Impact of SLE on Employment and Work
Productivity in the U.S.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATION
BENLYSTA is contraindicated in patients who have had anaphylaxis with belimumab.
WARNINGS AND PRECAUTIONS
MORTALITY
There were more deaths reported with BENLYSTA than with placebo during the controlled period of the clinical trials. Out of 2133 patients in 3 clinical trials, a total of 14 deaths occurred in the following groups: 3/675 in placebo, 5/673 in BENLYSTA 1 mg/kg, 0/111 in BENLYSTA 4 mg/kg, and 6/674 in BENLYSTA 10 mg/kg. No single cause of death predominated. Etiologies included infection, cardiovascular disease, and suicide.
SERIOUS INFECTIONS
Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents, including BENLYSTA. Caution should be exercised when considering use in patients with a history of chronic infections. Patients receiving therapy for a chronic infection should not receive BENLYSTA. Consider interrupting BENLYSTA therapy in patients who develop a new infection while receiving BENLYSTA. The most frequent serious infections included pneumonia, urinary tract infection, cellulitis, and bronchitis.
MALIGNANCY
The impact of treatment with BENLYSTA on the development of malignancies is not known. As with other immunomodulating agents, the mechanism of action of BENLYSTA could increase the risk of malignancies.
HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS) AND INFUSION REACTIONS
Healthcare providers should be aware of the risk of hypersensitivity reactions, which may present as infusion reactions, and monitor patients closely. Some patients received premedication; however, there is insufficient evidence to determine whether premedication diminishes the frequency or severity of these reactions. Patients should be informed of the signs and symptoms of a hypersensitivity reaction and instructed to seek immediate medical care should a reaction occur.
In clinical trials, hypersensitivity reactions, including anaphylaxis, were reported. Manifestations included hypotension, angioedema, urticaria or other rash, pruritus, and dyspnea. In the event of a serious hypersensitivity reaction, discontinue BENLYSTA immediately and administer appropriate medical therapy.
In clinical trials, infusion-associated adverse events were reported. Serious infusion reactions included bradycardia, myalgia, headache, rash, urticaria, and hypotension. In the event of an infusion reaction, the infusion rate may be slowed or interrupted.
DEPRESSION
In clinical trials, psychiatric events (primarily depression, insomnia, and anxiety) were reported more frequently with BENLYSTA than with placebo. Serious psychiatric events, serious depression, and two suicides were also reported. It is unknown if BENLYSTA treatment is associated with increased risk for these events. Instruct patients to contact their healthcare provider if they experience new or worsening depression, suicidal thoughts, or other mood changes.
IMMUNIZATION
Live vaccines should not be given for 30 days before or concurrently with BENLYSTA. BENLYSTA may interfere with the response to immunizations.
USE WITH BIOLOGIC THERAPIES OR IV CYCLOPHOSPHAMIDE
BENLYSTA has not been studied in combination with other biologic therapies, including B-cell targeted therapies, or IV cyclophosphamide. Therefore, use of BENLYSTA is not recommended in combination with these therapies.
ADVERSE REACTIONS
The most commonly reported adverse reactions (≥5%) were nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, and pharyngitis.
OTHER IMPORTANT INFORMATION
USE IN SPECIFIC POPULATIONS
Pregnancy: Category C. BENLYSTA should be used during pregnancy only if the potential benefit outweighs the risk. Women of childbearing potential should use adequate contraception during BENLYSTA treatment and for at least 4 months after the last dose.
Effect in black/African American Patients: In exploratory analyses of 2 Phase III trials, response rates were lower for black patients (N=148) in the BENLYSTA group relative to black patients in the placebo group. In the Phase II trial, black patients (N=106) in the BENLYSTA group did not appear to have a different response than the rest of the study population. Although no definitive conclusions can be drawn from these analyses, caution should be used when considering BENLYSTA for black/African American patients.
ABOUT THE GSK/HGS COLLABORATION
HGS and GlaxoSmithKline (GSK) are developing belimumab under a definitive co-development and co-commercialization agreement entered into in 2006. Under the agreement, HGS had responsibility for conducting the belimumab Phase 3 trials, with assistance from GSK. The companies share equally in Phase 3/4 development costs, sales and marketing expenses, and profits of any product commercialized under the current agreement.
ABOUT HUMAN GENOME SCIENCES
Human Genome Sciences exists to place new therapies into the hands of those battling serious disease. For more information about HGS, please visit the Company’s web site at www.hgsi.com. HGS, Human Genome Sciences and BENLYSTA are trademarks of Human Genome Sciences, Inc. Other trademarks referenced are the property of their respective owners.