New analyses of Phase II trial demonstrate improvement
of symptoms in multiple organ domains including skin and joints
8 June 2016
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that they will present positive new data on anifrolumab, an investigational monoclonal antibody that blocks all type 1 interferons, being developed to treat moderate to severe systemic lupus erythematosus (SLE, or lupus), at the Annual European Congress of Rheumatology (EULAR 2016), taking place in London, U.K. from 8-11 June, 2016.
In five presentations — three oral and two posters — AstraZeneca and MedImmune will present results from the positive Phase II anifrolumab trial (known as MUSE) for the first time outside of the United States, as well as new analyses of the Phase II data demonstrating the broad effects of anifrolumab on multiple organ domains and on biomarkers of SLE, and other clinical evidence in lupus.1-5
Results from the Phase II MUSE trial in moderate to severe SLE demonstrate that anifrolumab reduced lupus disease activity across a wide range of clinical endpoints. In the analysis of the primary endpoint, significantly more anifrolumab-treated patients achieved an SLE Responder Index [SRI(4)] response at Day 169 with sustained reduction of oral corticosteroids (OCS) (<10 mg/day and =Day 1 dose from Day 85 to 169) compared to patients receiving placebo.1 Even greater effect sizes were observed in the 75% of patients who had a high type I interferon gene signature at baseline (Abstract OP0291, 11 June 2016, 09:47 am GMT).1
A new analysis of the Phase II trial revealed a greater reduction in disease activity with anifrolumab treatment versus placebo in individual organ domains frequently involved in lupus.2 At Week 52, changes in skin and joint activity (the mucocutaneous and musculoskeletal domains) were observed using the British Isles Lupus Assessment Group (BILAG) and SLE Disease Activity Index 2000 (SLEDAI-2K), with higher percentages of patients in the anifrolumab-treated groups showing improvement.2 Trends suggesting potential benefits were also observed in most of the other less frequently active organ domains, including cardiorespiratory, vascular, hematological and constitutional.2 (Abstract THU0295, 09 June 2016, 11:45 am–13:30 pm GMT).
Additional Company presentations at EULAR include:
• An additional analysis of the Phase II trial evaluating the effects of anifrolumab on immune cell dysregulation and complement system abnormalities of SLE.3 Results show that anifrolumab administration elicits a widespread impact on selected, peripheral biomarkers of patients with moderate to severe SLE. (Abstract OP0165, 10 June 2016, 11:20 am GMT).3
• Association between Systemic Lupus Erythematosus (SLE) Responder Index(4) (SRI4) and global, clinically-important benefit in patients with moderate-to-severe SLE, including broad improvements in clinical, laboratory and patient-reported outcome measures (Abstract OP0044, 09 June 2016, 11:10 am GMT).4
• Key factors for patient engagement in SLE and lupus nephritis trials in African-Americans, based on a clinical trial simulation (Abstract THU0355, 09 June 2016, 11:45 am–13:30 pm).5 Bing Yao, Senior Vice President, Research and Development for Respiratory, Inflammation and Autoimmunity, MedImmune, said: “Our Phase II trial has provided a strong foundation from which our Phase III trials were designed. We are actively enrolling in those Phase III trials now, and we look forward to further exploring the role of type I interferons in the treatment of lupus and building on these promising results.”
Principal Investigator Richard A. Furie, MD, Chief, Division of Rheumatology, Northwell Health, said: “Although there have been many recent treatment advances for autoimmune conditions, innovations in lupus therapies have lagged behind, leaving a significant need as most current options have limited efficacy or undesired side effects. I am excited to share compelling evidence that blocking type 1 interferons is a promising strategy for the treatment of SLE, providing needed hope for the lupus community.”
In the Phase II trial, anifrolumab treatment was well tolerated, and serious adverse events reported were similar across the three treatment groups.1 A dosage-dependent increase in Herpes zoster cases (Placebo: 2.0%; 300mg: 5.1%; 1000mg: 9.5%) and a greater number of events reported as influenza (placebo: 2.0%; 300mg: 6.1%; 1,000 mg: 7.6%) were observed for patients receiving anifrolumab.1
8 June 2016
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that they will present positive new data on anifrolumab, an investigational monoclonal antibody that blocks all type 1 interferons, being developed to treat moderate to severe systemic lupus erythematosus (SLE, or lupus), at the Annual European Congress of Rheumatology (EULAR 2016), taking place in London, U.K. from 8-11 June, 2016.
In five presentations — three oral and two posters — AstraZeneca and MedImmune will present results from the positive Phase II anifrolumab trial (known as MUSE) for the first time outside of the United States, as well as new analyses of the Phase II data demonstrating the broad effects of anifrolumab on multiple organ domains and on biomarkers of SLE, and other clinical evidence in lupus.1-5
Results from the Phase II MUSE trial in moderate to severe SLE demonstrate that anifrolumab reduced lupus disease activity across a wide range of clinical endpoints. In the analysis of the primary endpoint, significantly more anifrolumab-treated patients achieved an SLE Responder Index [SRI(4)] response at Day 169 with sustained reduction of oral corticosteroids (OCS) (<10 mg/day and =Day 1 dose from Day 85 to 169) compared to patients receiving placebo.1 Even greater effect sizes were observed in the 75% of patients who had a high type I interferon gene signature at baseline (Abstract OP0291, 11 June 2016, 09:47 am GMT).1
A new analysis of the Phase II trial revealed a greater reduction in disease activity with anifrolumab treatment versus placebo in individual organ domains frequently involved in lupus.2 At Week 52, changes in skin and joint activity (the mucocutaneous and musculoskeletal domains) were observed using the British Isles Lupus Assessment Group (BILAG) and SLE Disease Activity Index 2000 (SLEDAI-2K), with higher percentages of patients in the anifrolumab-treated groups showing improvement.2 Trends suggesting potential benefits were also observed in most of the other less frequently active organ domains, including cardiorespiratory, vascular, hematological and constitutional.2 (Abstract THU0295, 09 June 2016, 11:45 am–13:30 pm GMT).
Additional Company presentations at EULAR include:
• An additional analysis of the Phase II trial evaluating the effects of anifrolumab on immune cell dysregulation and complement system abnormalities of SLE.3 Results show that anifrolumab administration elicits a widespread impact on selected, peripheral biomarkers of patients with moderate to severe SLE. (Abstract OP0165, 10 June 2016, 11:20 am GMT).3
• Association between Systemic Lupus Erythematosus (SLE) Responder Index(4) (SRI4) and global, clinically-important benefit in patients with moderate-to-severe SLE, including broad improvements in clinical, laboratory and patient-reported outcome measures (Abstract OP0044, 09 June 2016, 11:10 am GMT).4
• Key factors for patient engagement in SLE and lupus nephritis trials in African-Americans, based on a clinical trial simulation (Abstract THU0355, 09 June 2016, 11:45 am–13:30 pm).5 Bing Yao, Senior Vice President, Research and Development for Respiratory, Inflammation and Autoimmunity, MedImmune, said: “Our Phase II trial has provided a strong foundation from which our Phase III trials were designed. We are actively enrolling in those Phase III trials now, and we look forward to further exploring the role of type I interferons in the treatment of lupus and building on these promising results.”
Principal Investigator Richard A. Furie, MD, Chief, Division of Rheumatology, Northwell Health, said: “Although there have been many recent treatment advances for autoimmune conditions, innovations in lupus therapies have lagged behind, leaving a significant need as most current options have limited efficacy or undesired side effects. I am excited to share compelling evidence that blocking type 1 interferons is a promising strategy for the treatment of SLE, providing needed hope for the lupus community.”
In the Phase II trial, anifrolumab treatment was well tolerated, and serious adverse events reported were similar across the three treatment groups.1 A dosage-dependent increase in Herpes zoster cases (Placebo: 2.0%; 300mg: 5.1%; 1000mg: 9.5%) and a greater number of events reported as influenza (placebo: 2.0%; 300mg: 6.1%; 1,000 mg: 7.6%) were observed for patients receiving anifrolumab.1
