Patients with Painful Inflammatory Spinal Arthritis Showed Marked Improvements in Multiple Study Endpoints Following Treatment with SIMPONI ARIA®
WASHINGTON, DC, USA I November 14, 2016 I Janssen Research & Development, LLC (Janssen) announced today new findings from a pivotal Phase 3 study showing the efficacy and safety profile of the intravenously administered anti-tumor necrosis factor (TNF)-alpha therapy SIMPONI ARIA® (golimumab) in the treatment of active ankylosing spondylitis (AS). Data from the GO-ALIVE study showed that 73.3 percent of patients with active ankylosing spondylitis receiving SIMPONI ARIA® 2 mg/kg achieved the study’s primary endpoint of at least a 20 percent improvement in the Assessment in Ankylosing Spondylitis criteria (ASAS20) at week 16, compared with 26.2 percent of patients receiving placebo (P ≤ 0.001). Data from GO-ALIVE, which will be part of an upcoming submission to the U.S. Food and Drug Administration (FDA) seeking approval of SIMPONI ARIA® for the treatment of active ankylosing spondylitis, are being presented for the first time at the 2016 ACR/ARHP Annual Meeting. In July 2013, SIMPONI ARIA® received U.S. FDA approval as a 30-minute infusion for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate.
“Anti-TNF therapy remains the mainstay in the treatment of ankylosing spondylitis, a complex chronic inflammatory disease involving the spine, peripheral joints and multiple other organ systems,” said Atul Deodhar, M.D., MRCP, FACP, FACR, Professor of Medicine, Oregon Health & Science University and lead study author.* “The results reported from the GO-ALIVE study demonstrate significant improvement in signs and symptoms and physical function in patients with active ankylosing spondylitis receiving SIMPONI ARIA®, and these are important findings for patients living with this progressive, debilitating immune disease.”
In addition to meeting the primary endpoint of ASAS20 at week 16, all statistically-controlled secondary endpoints in the GO-ALIVE study were also met with statistical significance in comparisons of SIMPONI ARIA® versus placebo at week 16 (P < 0.05). Major secondary endpoints evaluated at week 16 were ASAS40, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI 50) score, an indicator of a major clinical response, and change in Bath Ankylosing Spondylitis Functional Index (BASFI) score, which measures improvements in physical function.
- 47.6 percent of patients receiving SIMPONI ARIA® achieved an ASAS40 response compared with 8.7 percent of patients receiving placebo (P < 0.001).
- 41.0 percent of SIMPONI ARIA® patients achieved a BASDAI 50 response compared with 14.6 percent of placebo patients (P < 0.001).
- Mean change from baseline in BASFI was -2.4 for the SIMPONI ARIA® group compared with -0.5 for the placebo group (P < 0.001).
Additional assessments in GO-ALIVE were ASAS partial remission, change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI), change in baseline measures of physical and mental health reported by patients through the Medical Outcomes Study Short Form-36 questionnaire (SF-36), and Ankylosing Spondylitis Quality of Life (ASQoL) patient-reported outcomes. Each of these demonstrated statistically significant superiority of SIMPONI ARIA® compared with placebo.
Through week 16, 32.4 percent of patients receiving SIMPONI ARIA® and 23.3 percent of patients receiving placebo had one or more adverse events (AEs). The most common type of AE was infection, 11.4 percent reported in the SIMPONI ARIA® group and 7.8 percent reported in the placebo group. At week 16, patients initially treated with placebo began to receive SIMPONI ARIA®. Through week 28, 34.8 percent of SIMPONI ARIA®-treated patients experienced one or more AEs, and nasopharyngitis was the most common AE reported (5.4 percent) and serious AEs reported in the SIMPONI ARIA® group included one case of pancreatitis and one case of pneumonia. There were no opportunistic infections, malignancies, or deaths through week 28. Infusion reactions were low (1.5 percent) among SIMPONI ARIA®-treated patients, with three patients reporting four reactions, none of which was serious or severe.
“We are very encouraged by these robust results, which show the potential of SIMPONI ARIA® in the treatment of ankylosing spondylitis, an immune-mediated disease that can severely impact the lives of patients,” said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC. “With the data from the GO-ALIVE Phase 3 study, we look forward to pursuing FDA approval of SIMPONI ARIA® for the treatment of active ankylosing spondylitis.”
About GO-ALIVE
GO-ALIVE is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of IV golimumab (SIMPONI ARIA®) in adult patients with active ankylosing spondylitis. Patients had a diagnosis of definite AS per modified New York criteria, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) greater than or equal to four, total back pain visual analogue scale greater than or equal to four, and C-reactive protein greater than or equal to 0.3 mg/dL. Up to 20 percent of patients could have had prior anti-TNF-alpha treatment with agents other than SIMPONI® (golimumab) and up to 10 percent of patients could have complete ankylosis of the spine. Patients (n=208) were randomized one-to-one to receive SIMPONI ARIA® 2 mg/kg at weeks 0, 4, and every 8 weeks or placebo at week 0, 4, and 12, with crossover to SIMPONI ARIA® at week 16. The study will continue through 52 weeks.
About Ankylosing Spondylitis
Ankylosing spondylitis is a chronic, immune-mediated disease that causes enthesitis, or inflammation where ligaments and muscles attach to bones, most commonly those within the spine. It is the primary disease in a group of arthritis-related diseases known as spondylitis, spondyloarthropathy or spondyloarthritis.1 The disease affects men more often than women and typically manifests in early adulthood.2 In contrast to mechanical low back pain, low back pain and stiffness with ankylosing spondylitis worsen after a period of rest or upon waking up in the morning and improve after exercise, a hot bath or a shower.1
About SIMPONI ARIA® (golimumab) infusion
SIMPONI ARIA® is an infusible, fully human anti-TNF-alpha monoclonal antibody that targets both soluble and transmembrane bioactive forms of TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. By binding with and blocking TNF-alpha, SIMPONI ARIA® helps control inflammation. SIMPONI ARIA® is approved for the treatment of adult patients with moderately to severely active RA with the medicine methotrexate.
About the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us on Twitter at https://twitter.com/JanssenGlobal.
SOURCE: Janssen
Post Views: 481
Patients with Painful Inflammatory Spinal Arthritis Showed Marked Improvements in Multiple Study Endpoints Following Treatment with SIMPONI ARIA®
WASHINGTON, DC, USA I November 14, 2016 I Janssen Research & Development, LLC (Janssen) announced today new findings from a pivotal Phase 3 study showing the efficacy and safety profile of the intravenously administered anti-tumor necrosis factor (TNF)-alpha therapy SIMPONI ARIA® (golimumab) in the treatment of active ankylosing spondylitis (AS). Data from the GO-ALIVE study showed that 73.3 percent of patients with active ankylosing spondylitis receiving SIMPONI ARIA® 2 mg/kg achieved the study’s primary endpoint of at least a 20 percent improvement in the Assessment in Ankylosing Spondylitis criteria (ASAS20) at week 16, compared with 26.2 percent of patients receiving placebo (P ≤ 0.001). Data from GO-ALIVE, which will be part of an upcoming submission to the U.S. Food and Drug Administration (FDA) seeking approval of SIMPONI ARIA® for the treatment of active ankylosing spondylitis, are being presented for the first time at the 2016 ACR/ARHP Annual Meeting. In July 2013, SIMPONI ARIA® received U.S. FDA approval as a 30-minute infusion for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate.
“Anti-TNF therapy remains the mainstay in the treatment of ankylosing spondylitis, a complex chronic inflammatory disease involving the spine, peripheral joints and multiple other organ systems,” said Atul Deodhar, M.D., MRCP, FACP, FACR, Professor of Medicine, Oregon Health & Science University and lead study author.* “The results reported from the GO-ALIVE study demonstrate significant improvement in signs and symptoms and physical function in patients with active ankylosing spondylitis receiving SIMPONI ARIA®, and these are important findings for patients living with this progressive, debilitating immune disease.”
In addition to meeting the primary endpoint of ASAS20 at week 16, all statistically-controlled secondary endpoints in the GO-ALIVE study were also met with statistical significance in comparisons of SIMPONI ARIA® versus placebo at week 16 (P < 0.05). Major secondary endpoints evaluated at week 16 were ASAS40, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI 50) score, an indicator of a major clinical response, and change in Bath Ankylosing Spondylitis Functional Index (BASFI) score, which measures improvements in physical function.
- 47.6 percent of patients receiving SIMPONI ARIA® achieved an ASAS40 response compared with 8.7 percent of patients receiving placebo (P < 0.001).
- 41.0 percent of SIMPONI ARIA® patients achieved a BASDAI 50 response compared with 14.6 percent of placebo patients (P < 0.001).
- Mean change from baseline in BASFI was -2.4 for the SIMPONI ARIA® group compared with -0.5 for the placebo group (P < 0.001).
Additional assessments in GO-ALIVE were ASAS partial remission, change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI), change in baseline measures of physical and mental health reported by patients through the Medical Outcomes Study Short Form-36 questionnaire (SF-36), and Ankylosing Spondylitis Quality of Life (ASQoL) patient-reported outcomes. Each of these demonstrated statistically significant superiority of SIMPONI ARIA® compared with placebo.
Through week 16, 32.4 percent of patients receiving SIMPONI ARIA® and 23.3 percent of patients receiving placebo had one or more adverse events (AEs). The most common type of AE was infection, 11.4 percent reported in the SIMPONI ARIA® group and 7.8 percent reported in the placebo group. At week 16, patients initially treated with placebo began to receive SIMPONI ARIA®. Through week 28, 34.8 percent of SIMPONI ARIA®-treated patients experienced one or more AEs, and nasopharyngitis was the most common AE reported (5.4 percent) and serious AEs reported in the SIMPONI ARIA® group included one case of pancreatitis and one case of pneumonia. There were no opportunistic infections, malignancies, or deaths through week 28. Infusion reactions were low (1.5 percent) among SIMPONI ARIA®-treated patients, with three patients reporting four reactions, none of which was serious or severe.
“We are very encouraged by these robust results, which show the potential of SIMPONI ARIA® in the treatment of ankylosing spondylitis, an immune-mediated disease that can severely impact the lives of patients,” said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC. “With the data from the GO-ALIVE Phase 3 study, we look forward to pursuing FDA approval of SIMPONI ARIA® for the treatment of active ankylosing spondylitis.”
About GO-ALIVE
GO-ALIVE is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of IV golimumab (SIMPONI ARIA®) in adult patients with active ankylosing spondylitis. Patients had a diagnosis of definite AS per modified New York criteria, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) greater than or equal to four, total back pain visual analogue scale greater than or equal to four, and C-reactive protein greater than or equal to 0.3 mg/dL. Up to 20 percent of patients could have had prior anti-TNF-alpha treatment with agents other than SIMPONI® (golimumab) and up to 10 percent of patients could have complete ankylosis of the spine. Patients (n=208) were randomized one-to-one to receive SIMPONI ARIA® 2 mg/kg at weeks 0, 4, and every 8 weeks or placebo at week 0, 4, and 12, with crossover to SIMPONI ARIA® at week 16. The study will continue through 52 weeks.
About Ankylosing Spondylitis
Ankylosing spondylitis is a chronic, immune-mediated disease that causes enthesitis, or inflammation where ligaments and muscles attach to bones, most commonly those within the spine. It is the primary disease in a group of arthritis-related diseases known as spondylitis, spondyloarthropathy or spondyloarthritis.1 The disease affects men more often than women and typically manifests in early adulthood.2 In contrast to mechanical low back pain, low back pain and stiffness with ankylosing spondylitis worsen after a period of rest or upon waking up in the morning and improve after exercise, a hot bath or a shower.1
About SIMPONI ARIA® (golimumab) infusion
SIMPONI ARIA® is an infusible, fully human anti-TNF-alpha monoclonal antibody that targets both soluble and transmembrane bioactive forms of TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. By binding with and blocking TNF-alpha, SIMPONI ARIA® helps control inflammation. SIMPONI ARIA® is approved for the treatment of adult patients with moderately to severely active RA with the medicine methotrexate.
About the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us on Twitter at https://twitter.com/JanssenGlobal.
SOURCE: Janssen
Post Views: 481
