SAN DIEGO, November 7, 2017 /PRNewswire/ --
GSK today announced results from BLISS-SC, a 52-week study for BENLYSTA (belimumab) for subcutaneous use (SC) in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving Standard of Care (SoC). The data being presented at the 2017 American College of Rheumatology/Association for Rheumatology Health Professionals Annual Meeting (ACR/AHRP) show that weekly treatment with BENLYSTA SC 200mg reduced the need to increase the dose of corticosteroid (one standard of care medication for patients with SLE). The subcutaneous (autoinjector) formulation of BENLYSTA was approved for use in the U.S. on July 20, 2017 and in Japan on September 27, 2017. The efficacy of BENLYSTA has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. BENLYSTA has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of BENLYSTA is not recommended in these situations. Findings are consistent with previous studies for BENLYSTA for intravenous use (IV).
SLE, the most common form of lupus, affects many organ systems; common organ manifestations involve the skin, kidney, haematological and musculoskeletal systems. Corticosteroid use in SLE is an important contributor to long-term organ damage.
April Thompson, PhD, Scientific Director, Global Immunology and study author said: "Reducing reliance on corticosteroids to treat symptoms of SLE is a key treatment goal for patients and physicians. The findings reported here suggest that BENLYSTA SC added to standard of care may prove beneficial by reducing the need for an increase in corticosteroid dose."
BLISS-SC was conducted to assess the safety and efficacy of BENLYSTA SC plus SoC in adult patients with active, autoantibody-positive SLE. Efficacy and safety data have been published. The overall incidence of treatment-related adverse events (AEs) was 31.3% with BENLYSTA SC plus SoC vs 26.1% with placebo plus SoC. The percentage of patients experiencing a serious AE was 10.8% with BENLYSTA SC plus SoC compared with 15.7% with placebo plus SoC. A total of five deaths were reported: three in BENLYSTA SC plus SoC, and two with placebo plus SoC. Here, the effects on corticosteroid use are reported:
Additional analyses show that at Week 52 fewer patients in the BENLYSTA SC group versus the placebo group required ?50% increase in dose or any increase in corticosteroid from Weeks 20-28 and 36-52. The percentage of patients with ?50% reduction in corticosteroid dose by Week 52 was similar in the BENLYSTA SC and placebo groups.
Most patients entered the study receiving corticosteroid, with the majority receiving >7.5 mg/day (60.2%). Patients receiving BENLYSTA SC and this amount of corticosteroid also showed a reduction in their corticosteroid use by 25% versus placebo use. This major secondary endpoint was not statistically significant.
About the Study
BLISS-SC (GSK study BEL112341; NCT01484496) was a 52-week, Phase III, multicenter, randomized, double-blind, placebo-controlled study conducted in 177 centers in 30 countries across North, Central and South America, Western and Eastern Europe and Asia. Patients were ?18 years of age, receiving SoC, with a clinical diagnosis of SLE according to American College of Rheumatology (ACR) criteria and SELENA-SLEDAI score of ?8 at screening. Patients were randomized (2:1) to receive weekly belimumab 200 mg SC or placebo, plus SoC for 52 weeks.
The primary endpoint was the SLE Responder Index 4 (SRI4; ?4-point decrease in SELENA-SLEDAI, <0.3 increase in Physician's Global Assessment, and no new British Isles Lupus Assessment Group (BILAG) A or ?1 B organ domain scores, from baseline) at Week 52.
About systemic lupus erythematosus (SLE)
Systemic lupus erythematosus (SLE) is the most common form of lupus, affecting approximately 70 percent of an estimated 5 million people with lupus worldwide. Approximately 170,000-200,000 Americans live with SLE. It is a chronic, incurable autoimmune disease producing autoantibodies that can attack almost any system in the body.
About BENLYSTA
BENLYSTA is currently the only medicine specifically developed and approved for SLE. 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.
BENLYSTA is indicated in the US 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 BENLYSTA has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. BENLYSTA has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of BENLYSTA is not recommended in these situations.
How supplied: BENLYSTA (belimumab) for intravenous (IV) use is available as 120 mg in a 5-mL single-dose vial and 400 mg in a 20-mL single-dose vial. BENLYSTA (belimumab) for subcutaneous use (SC) is available as 200 mg in a 1-mL single-dose prefilled autoinjector and 200 mg in a 1-mL single-dose prefilled glass syringe.
Important Safety Information for belimumab
Please consult the full Prescribing Information for all the labelled safety information for Benlysta (belimumab).
CONTRAINDICATION
Previous anaphylaxis with BENLYSTA.
WARNINGS AND PRECAUTIONS
MORTALITY
In controlled clinical trials, death occurred in 0.8% (11/1,458) of patients treated with BENLYSTA IV and in 0.4% (3/675) of patients receiving placebo. Etiologies included infection, cardiovascular disease, and suicide.
In the controlled trial (N=836), death occurred in 0.5% (3/556) of patients receiving BENLYSTA SC and 0.7% (2/280) of patients receiving placebo. Infection was the most common cause of death.
SERIOUS INFECTIONS
Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents, including BENLYSTA. The most frequent serious infections were pneumonia, including bacterial pneumonia, urinary tract infection, cellulitis, herpes zoster, and bronchitis. Use caution in patients with severe or chronic infections. Consider interrupting therapy with BENLYSTA in patients who develop 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) AND INFUSION REACTIONS
Acute hypersensitivity reactions, including anaphylaxis and death, have been reported in association with infusions and injections of BENLYSTA, including in patients who have previously tolerated BENLYSTA. These events generally occurred within hours of the infusion; however, they may occur later. Non-acute hypersensitivity reactions including rash, nausea, fatigue, myalgia, headache, and facial edema, have been reported and typically occurred up to a week following the most recent infusion. Patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk. Premedication may mitigate or mask an infusion reaction or hypersensitivity response. In the controlled trial of BENLYSTA SC, systemic hypersensitivity reactions were similar to those observed in the IV clinical trials. Anaphylaxis was observed in 0.6% and 0.4% of patients receiving BENLYSTA and placebo, respectively. Manifestations included hypotension, angioedema, urticaria or other rash, pruritus, and dyspnea.
Serious infusion reactions (excluding hypersensitivity reactions) were reported in 0.5% and 0.4% of patients receiving BENLYSTA and placebo, respectively and included bradycardia, myalgia, headache, rash, urticaria, and hypotension. BENLYSTA IV should be administered by healthcare providers prepared to manage infusion reactions and anaphylaxis. The infusion rate may be slowed or interrupted if the patient develops an infusion reaction. In the event of a serious reaction, administration of BENLYSTA must be discontinued immediately and appropriate medical therapy administered. Patients should be closely monitored during and for an appropriate period of time after IV administration of BENLYSTA. Patients receiving BENLYSTA should be informed of the signs and symptoms of hypersensitivity reactions and seek immediate medical care should a reaction occur.
DEPRESSION
In the controlled clinical trials of BENLYSTA IV, psychiatric events were reported more frequently with BENLYSTA than with placebo, related primarily to depression-related events, insomnia and anxiety. Serious psychiatric events were reported in trials with BENLYSTA. Serious depression and suicidality (including two completed suicides) were reported in trials with BENLYSTA IV. There were no serious depression-related events or suicides reported in the BENLYSTA SC trials. Instruct patients to contact their healthcare provider if they experience new or worsening depression, suicidal thoughts, or other mood changes.
MALIGNANCY
The impact of treatment with BENLYSTA on the development of malignancies is not known. The mechanism of action of BENLYSTA could increase the risk for the development of malignancies.
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 common serious adverse reactions were serious infections (6.0% and 5.2% in patients receiving BENLYSTA IV and placebo, respectively), some of which were fatal. Adverse reactions, regardless of causality, occurring in at least 3% of patients with SLE who received BENLYSTA 10 mg/kg and placebo respectively and, at an incidence at least 1% greater than that observed with placebo in the 3 controlled studies, were: nausea 15% and 12%; diarrhea 12% and 9%; pyrexia 10% and 8%; nasopharyngitis 9% and 7%; bronchitis 9% and 5%; insomnia 7% and 5%; pain in extremity 6% and 4%; depression 5% and 4%; migraine 5% and 4%; pharyngitis 5% and 3%; cystitis 4% and 3%; leukopenia 4% and 2%; viral gastroenteritis 3% and 1%.
The safety profile observed for BENLYSTA SC plus standard therapy was consistent with the known safety profile of BENLYSTA IV plus standard therapy, with the exception of local injection site reactions.
OTHER IMPORTANT INFORMATION FOR BENLYSTA
USE IN SPECIFIC POPULATIONS
Pregnancy: There are insufficient data on use of BENLYSTA in pregnant women to establish whether there is drug-associated risk for major birth defects or miscarriage. Following an assessment of benefit versus risk, if prevention is warranted, women of childbearing potential should use effective contraception during treatment and for at least 4 months after the final treatment.
Pregnancy Registry: Healthcare professionals are encouraged to register patients and pregnant women are encouraged to enroll themselves by calling 1-877-681-6296.
Lactation: There is no information available on the presence of belimumab in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BENLYSTA and any potential adverse effects on the breastfed child from BENLYSTA or from the underlying maternal condition.
Black/African American Patients: In clinical studies, there have been mixed results regarding how well BENLYSTA works in black/African American patients. Consider the risks and benefits when prescribing BENLYSTA in black/African American patients.
GSK - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit http://www.gsk.com.
Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2016.
Registered in England & Wales: No. 3888792
Registered Office: 980 Great West Road Brentford, Middlesex TW8 9GS
SOURCE GSK
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GSK today announced results from BLISS-SC, a 52-week study for BENLYSTA (belimumab) for subcutaneous use (SC) in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving Standard of Care (SoC). The data being presented at the 2017 American College of Rheumatology/Association for Rheumatology Health Professionals Annual Meeting (ACR/AHRP) show that weekly treatment with BENLYSTA SC 200mg reduced the need to increase the dose of corticosteroid (one standard of care medication for patients with SLE). The subcutaneous (autoinjector) formulation of BENLYSTA was approved for use in the U.S. on July 20, 2017 and in Japan on September 27, 2017. The efficacy of BENLYSTA has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. BENLYSTA has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of BENLYSTA is not recommended in these situations. Findings are consistent with previous studies for BENLYSTA for intravenous use (IV).
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SLE, the most common form of lupus, affects many organ systems; common organ manifestations involve the skin, kidney, haematological and musculoskeletal systems. Corticosteroid use in SLE is an important contributor to long-term organ damage.
April Thompson, PhD, Scientific Director, Global Immunology and study author said: "Reducing reliance on corticosteroids to treat symptoms of SLE is a key treatment goal for patients and physicians. The findings reported here suggest that BENLYSTA SC added to standard of care may prove beneficial by reducing the need for an increase in corticosteroid dose."
BLISS-SC was conducted to assess the safety and efficacy of BENLYSTA SC plus SoC in adult patients with active, autoantibody-positive SLE. Efficacy and safety data have been published. The overall incidence of treatment-related adverse events (AEs) was 31.3% with BENLYSTA SC plus SoC vs 26.1% with placebo plus SoC. The percentage of patients experiencing a serious AE was 10.8% with BENLYSTA SC plus SoC compared with 15.7% with placebo plus SoC. A total of five deaths were reported: three in BENLYSTA SC plus SoC, and two with placebo plus SoC. Here, the effects on corticosteroid use are reported:
Additional analyses show that at Week 52 fewer patients in the BENLYSTA SC group versus the placebo group required ?50% increase in dose or any increase in corticosteroid from Weeks 20-28 and 36-52. The percentage of patients with ?50% reduction in corticosteroid dose by Week 52 was similar in the BENLYSTA SC and placebo groups.
Most patients entered the study receiving corticosteroid, with the majority receiving >7.5 mg/day (60.2%). Patients receiving BENLYSTA SC and this amount of corticosteroid also showed a reduction in their corticosteroid use by 25% versus placebo use. This major secondary endpoint was not statistically significant.
About the Study
BLISS-SC (GSK study BEL112341; NCT01484496) was a 52-week, Phase III, multicenter, randomized, double-blind, placebo-controlled study conducted in 177 centers in 30 countries across North, Central and South America, Western and Eastern Europe and Asia. Patients were ?18 years of age, receiving SoC, with a clinical diagnosis of SLE according to American College of Rheumatology (ACR) criteria and SELENA-SLEDAI score of ?8 at screening. Patients were randomized (2:1) to receive weekly belimumab 200 mg SC or placebo, plus SoC for 52 weeks.
The primary endpoint was the SLE Responder Index 4 (SRI4; ?4-point decrease in SELENA-SLEDAI, <0.3 increase in Physician's Global Assessment, and no new British Isles Lupus Assessment Group (BILAG) A or ?1 B organ domain scores, from baseline) at Week 52.
About systemic lupus erythematosus (SLE)
Systemic lupus erythematosus (SLE) is the most common form of lupus, affecting approximately 70 percent of an estimated 5 million people with lupus worldwide. Approximately 170,000-200,000 Americans live with SLE. It is a chronic, incurable autoimmune disease producing autoantibodies that can attack almost any system in the body.
About BENLYSTA
BENLYSTA is currently the only medicine specifically developed and approved for SLE. 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.
BENLYSTA is indicated in the US 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 BENLYSTA has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. BENLYSTA has not been studied in combination with other biologics or intravenous cyclophosphamide. Use of BENLYSTA is not recommended in these situations.
How supplied: BENLYSTA (belimumab) for intravenous (IV) use is available as 120 mg in a 5-mL single-dose vial and 400 mg in a 20-mL single-dose vial. BENLYSTA (belimumab) for subcutaneous use (SC) is available as 200 mg in a 1-mL single-dose prefilled autoinjector and 200 mg in a 1-mL single-dose prefilled glass syringe.
Important Safety Information for belimumab
Please consult the full Prescribing Information for all the labelled safety information for Benlysta (belimumab).
CONTRAINDICATION
Previous anaphylaxis with BENLYSTA.
WARNINGS AND PRECAUTIONS
MORTALITY
In controlled clinical trials, death occurred in 0.8% (11/1,458) of patients treated with BENLYSTA IV and in 0.4% (3/675) of patients receiving placebo. Etiologies included infection, cardiovascular disease, and suicide.
In the controlled trial (N=836), death occurred in 0.5% (3/556) of patients receiving BENLYSTA SC and 0.7% (2/280) of patients receiving placebo. Infection was the most common cause of death.
SERIOUS INFECTIONS
Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents, including BENLYSTA. The most frequent serious infections were pneumonia, including bacterial pneumonia, urinary tract infection, cellulitis, herpes zoster, and bronchitis. Use caution in patients with severe or chronic infections. Consider interrupting therapy with BENLYSTA in patients who develop 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) AND INFUSION REACTIONS
Acute hypersensitivity reactions, including anaphylaxis and death, have been reported in association with infusions and injections of BENLYSTA, including in patients who have previously tolerated BENLYSTA. These events generally occurred within hours of the infusion; however, they may occur later. Non-acute hypersensitivity reactions including rash, nausea, fatigue, myalgia, headache, and facial edema, have been reported and typically occurred up to a week following the most recent infusion. Patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk. Premedication may mitigate or mask an infusion reaction or hypersensitivity response. In the controlled trial of BENLYSTA SC, systemic hypersensitivity reactions were similar to those observed in the IV clinical trials. Anaphylaxis was observed in 0.6% and 0.4% of patients receiving BENLYSTA and placebo, respectively. Manifestations included hypotension, angioedema, urticaria or other rash, pruritus, and dyspnea.
Serious infusion reactions (excluding hypersensitivity reactions) were reported in 0.5% and 0.4% of patients receiving BENLYSTA and placebo, respectively and included bradycardia, myalgia, headache, rash, urticaria, and hypotension. BENLYSTA IV should be administered by healthcare providers prepared to manage infusion reactions and anaphylaxis. The infusion rate may be slowed or interrupted if the patient develops an infusion reaction. In the event of a serious reaction, administration of BENLYSTA must be discontinued immediately and appropriate medical therapy administered. Patients should be closely monitored during and for an appropriate period of time after IV administration of BENLYSTA. Patients receiving BENLYSTA should be informed of the signs and symptoms of hypersensitivity reactions and seek immediate medical care should a reaction occur.
DEPRESSION
In the controlled clinical trials of BENLYSTA IV, psychiatric events were reported more frequently with BENLYSTA than with placebo, related primarily to depression-related events, insomnia and anxiety. Serious psychiatric events were reported in trials with BENLYSTA. Serious depression and suicidality (including two completed suicides) were reported in trials with BENLYSTA IV. There were no serious depression-related events or suicides reported in the BENLYSTA SC trials. Instruct patients to contact their healthcare provider if they experience new or worsening depression, suicidal thoughts, or other mood changes.
MALIGNANCY
The impact of treatment with BENLYSTA on the development of malignancies is not known. The mechanism of action of BENLYSTA could increase the risk for the development of malignancies.
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 common serious adverse reactions were serious infections (6.0% and 5.2% in patients receiving BENLYSTA IV and placebo, respectively), some of which were fatal. Adverse reactions, regardless of causality, occurring in at least 3% of patients with SLE who received BENLYSTA 10 mg/kg and placebo respectively and, at an incidence at least 1% greater than that observed with placebo in the 3 controlled studies, were: nausea 15% and 12%; diarrhea 12% and 9%; pyrexia 10% and 8%; nasopharyngitis 9% and 7%; bronchitis 9% and 5%; insomnia 7% and 5%; pain in extremity 6% and 4%; depression 5% and 4%; migraine 5% and 4%; pharyngitis 5% and 3%; cystitis 4% and 3%; leukopenia 4% and 2%; viral gastroenteritis 3% and 1%.
The safety profile observed for BENLYSTA SC plus standard therapy was consistent with the known safety profile of BENLYSTA IV plus standard therapy, with the exception of local injection site reactions.
OTHER IMPORTANT INFORMATION FOR BENLYSTA
USE IN SPECIFIC POPULATIONS
Pregnancy: There are insufficient data on use of BENLYSTA in pregnant women to establish whether there is drug-associated risk for major birth defects or miscarriage. Following an assessment of benefit versus risk, if prevention is warranted, women of childbearing potential should use effective contraception during treatment and for at least 4 months after the final treatment.
Pregnancy Registry: Healthcare professionals are encouraged to register patients and pregnant women are encouraged to enroll themselves by calling 1-877-681-6296.
Lactation: There is no information available on the presence of belimumab in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BENLYSTA and any potential adverse effects on the breastfed child from BENLYSTA or from the underlying maternal condition.
Black/African American Patients: In clinical studies, there have been mixed results regarding how well BENLYSTA works in black/African American patients. Consider the risks and benefits when prescribing BENLYSTA in black/African American patients.
GSK - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit http://www.gsk.com.
Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2016.
Registered in England & Wales: No. 3888792
Registered Office: 980 Great West Road Brentford, Middlesex TW8 9GS
SOURCE GSK
