Efficacy and Safety Results from Second STELARA® Phase 3 Induction Study (UNITI-1), the Largest Conducted to Date in Patients Refractory to TNF Inhibitors, Presented at the 11th Congress of ECCO
AMSTERDAM, The Netherlands I March 18, 2016 I Phase 3 data presented at the 11th Congress of the European Crohn’s and Colitis Organisation (ECCO) showed that treatment with STELARA® (ustekinumab) induced clinical response and clinical remission in adult patients with moderate to severe Crohn’s disease who had previously failed or were intolerant to treatment with one or more anti-tumor necrosis factor (TNF)-alpha therapies. The Janssen Phase 3 UNITI-1 study, which included 741 patients, achieved its primary endpoint with STELARA® treatment groups demonstrating significantly higher rates of clinical response at week 6 when compared with the placebo group. Major secondary endpoints of clinical response and clinical remission at week 8 were also significantly higher among patients receiving STELARA® compared with patients receiving placebo.
These latest findings follow Phase 3 results from the UNITI-2 study, which demonstrated the efficacy and safety of STELARA® in patients who had previously failed conventional therapy, the majority of whom were naïve to treatment with anti-TNF-alpha therapy. Applications seeking approval of STELARA® for the treatment of moderately to severely active Crohn’s disease are currently under review in Europe and the United States. STELARA®, approved for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in many countries, is a monoclonal antibody that targets interleukin (IL)-12 and IL-23 cytokines, which are believed to play a role in immune-mediated diseases, including Crohn’s disease.
“Results from the UNITI-1 study show that ustekinumab therapy induced clinical response and remission in patients with moderate to severe Crohn’s disease who had previously failed treatment with TNF inhibitors,” said Paul Rutgeerts, M.D., Professor Emeritus of Medicine and Former Director of the Multidisciplinary Department of Endoscopy, Catholic University of Leuven, Belgium, and ustekinumab Crohn’s disease steering committee member. “With two Phase 3 induction studies demonstrating the efficacy and safety of ustekinumab in anti-TNF-alpha naïve, exposed and failure patient populations, we look forward to the forthcoming maintenance study findings. The need to induce and maintain control of disease symptoms is paramount in the treatment of Crohn’s disease.”
Patients participating in the Phase 3 UNITI-1 study received a single intravenous (I.V.) infusion of placebo, STELARA® 130 mg or STELARA® ~6 mg/kg (weight-tiered dosing: patients weighing less than or equal to 55 kg received 260 mg; patients weighing more than 55 kg and less than or equal to 85 kg received 390 mg; and patients weighing more than 85 kg received 520 mg) at week 0. All enrolled patients had previously failed or were intolerant to treatment with at least one anti-TNF-alpha therapy, and half of the enrolled patients had failed two or more anti-TNF-alpha therapies.
At week 6, 34 percent of patients receiving STELARA® 130 mg and 34 percent of patients receiving STELARA® ~6 mg/kg achieved clinical response, as defined by a reduction from baseline in the Crohn’s Disease Activity Index (CDAI) score of at least 100 points, compared with 22 percent of patients receiving placebo (P = 0.002 for STELARA® 130 mg; P = 0.003 for STELARA® ~6 mg/kg). CDAI is a symptom-based disease assessment tool commonly used in clinical trials to quantify Crohn’s disease activity.
At week 8, 34 percent and 38 percent of patients receiving STELARA® 130 mg and STELARA® ~6 mg/kg, respectively, achieved clinical response, compared with 20 percent of patients receiving placebo (P < 0.001). In addition, 16 percent of patients receiving STELARA® 130 mg and 21 percent of patients receiving STELARA® ~6 mg/kg achieved clinical remission at week 8, as defined by a CDAI score of less than 150 points, compared with 7 percent of patients receiving placebo (P = 0.003 for STELARA® 130 mg; P < 0.001 for STELARA® ~6 mg/kg).
In addition to significant improvements in signs and symptoms as measured by CDAI, both doses of STELARA® resulted in significant improvements in the Inflammatory Bowel Disease Questionnaire (IBDQ), a health-related quality of life measure for patients with IBD, as well as significant reduction in markers of inflammation, including C-reactive protein (CRP), fecal lactoferrin and calprotectin.
Through week 8 (placebo-controlled period), adverse events (AEs), serious AEs and infections were reported in similar proportions across STELARA® and placebo treatment groups. One case of Listeria meningitis infection was reported in the STELARA® ~6 mg/kg group. No malignancies, deaths, cases of tuberculosis or major adverse cardiovascular events (MACE) were observed in patients treated with STELARA®.
“We are pleased to share these important results from the Phase 3 UNITI-1 induction study, which complement Phase 3 results from the UNITI-2 study and further support regulatory applications submitted seeking approval of STELARA® for the treatment of moderately to severely active Crohn’s disease,” said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC. “Janssen Immunology remains committed to the continued development of STELARA® and the discovery of innovative medicines for the treatment of immune-mediated diseases.”
Additional data from the STELARA® Phase 3 Crohn’s disease clinical development program being presented at the 11th Congress of ECCO include:
Assessment of Serum C-reactive Protein, Fecal Lactoferrin, and Fecal Calprotectin in Patients with Crohn’s Disease: Results from the UNITI-1 and UNITI-2 Ustekinumab Induction Studies
Pharmacokinetics And Exposure-Response Relationships of Intravenously Administered Ustekinumab During Induction Treatment in Patients with Crohn’s Disease: Results from the UNITI-1 and UNITI-2 Studies
Molecular Response to Ustekinumab in Moderate-to-Severe Crohn’s Disease by Serum Protein Analysis: Results from the UNITI-1 and UNITI-2 Phase 3 Induction Studies
About the UNITI-1 Trial
UNITI-1, a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study, evaluated the efficacy and safety of STELARA® induction therapy in adult patients with moderate to severe Crohn’s disease. Patients (n=741) were randomized equally to receive a single I.V. infusion of placebo, STELARA® 130 mg or STELARA® ~6 mg/kg (weight-tiered dosing: patients weighing less than or equal to 55 kg received 260 mg; patients weighing more than 55 kg and less than or equal to 85 kg received 390 mg; and patients weighing more than 85 kg received 520 mg) at week 0. All participating patients had previously failed or were intolerant to treatment with at least one anti-TNF-alpha therapy. The primary endpoint was clinical response at week 6, measured by the proportion of patients who achieved at least a 100-point reduction from baseline CDAI scores. Major secondary endpoints at week 8 included clinical response and clinical remission (defined by CDAI scores less than 150 points). At week 8, patients either transitioned to the IM-UNITI maintenance study or were to complete a safety follow-up period through week 20.
UNITI-1 is part of a comprehensive Phase 3 clinical development program investigating STELARA® for the treatment of moderate to severe Crohn’s disease. Data from the UNITI-2 induction study evaluating STELARA® for the treatment of patients who had previously failed conventional therapy, the majority of whom were naïve to treatment with anti-TNF-alpha therapy, were presented in 2015 at the American College of Gastroenterology (ACG) Annual Meeting and United European Gastroenterology (UEG) Week. Results from the IM-UNITI maintenance study will be presented at a future medical congress.
About Crohn’s Disease
More than five million people worldwide are living with Crohn’s disease and ulcerative colitis—collectively known as inflammatory bowel disease (IBD).1 Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract that affects approximately 700,000 Americans2 and nearly 250,000 Europeans.3 The cause of Crohn’s disease is not known, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition or diet and other environmental factors. Symptoms of Crohn’s disease can vary but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss and fever. There is currently no cure for Crohn’s disease.2
About STELARA® (ustekinumab)
STELARA®, a human IL-12 and IL-23 antagonist, is approved in the United States for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. STELARA® is also approved for the treatment of adult patients (18 years or older) with active psoriatic arthritis and can be used alone or in combination with methotrexate (MTX).
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people with serious diseases throughout the world. Beyond its innovative medicines, Janssen is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and healthcare professionals have access to the latest treatment information, support services and quality care.
Janssen Research & Development, LLC is one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssen.com for more information. Follow us on Twitter at https://twitter.com/JanssenGlobal.
SOURCE: Janssen
Post Views: 249
Efficacy and Safety Results from Second STELARA® Phase 3 Induction Study (UNITI-1), the Largest Conducted to Date in Patients Refractory to TNF Inhibitors, Presented at the 11th Congress of ECCO
AMSTERDAM, The Netherlands I March 18, 2016 I Phase 3 data presented at the 11th Congress of the European Crohn’s and Colitis Organisation (ECCO) showed that treatment with STELARA® (ustekinumab) induced clinical response and clinical remission in adult patients with moderate to severe Crohn’s disease who had previously failed or were intolerant to treatment with one or more anti-tumor necrosis factor (TNF)-alpha therapies. The Janssen Phase 3 UNITI-1 study, which included 741 patients, achieved its primary endpoint with STELARA® treatment groups demonstrating significantly higher rates of clinical response at week 6 when compared with the placebo group. Major secondary endpoints of clinical response and clinical remission at week 8 were also significantly higher among patients receiving STELARA® compared with patients receiving placebo.
These latest findings follow Phase 3 results from the UNITI-2 study, which demonstrated the efficacy and safety of STELARA® in patients who had previously failed conventional therapy, the majority of whom were naïve to treatment with anti-TNF-alpha therapy. Applications seeking approval of STELARA® for the treatment of moderately to severely active Crohn’s disease are currently under review in Europe and the United States. STELARA®, approved for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in many countries, is a monoclonal antibody that targets interleukin (IL)-12 and IL-23 cytokines, which are believed to play a role in immune-mediated diseases, including Crohn’s disease.
“Results from the UNITI-1 study show that ustekinumab therapy induced clinical response and remission in patients with moderate to severe Crohn’s disease who had previously failed treatment with TNF inhibitors,” said Paul Rutgeerts, M.D., Professor Emeritus of Medicine and Former Director of the Multidisciplinary Department of Endoscopy, Catholic University of Leuven, Belgium, and ustekinumab Crohn’s disease steering committee member. “With two Phase 3 induction studies demonstrating the efficacy and safety of ustekinumab in anti-TNF-alpha naïve, exposed and failure patient populations, we look forward to the forthcoming maintenance study findings. The need to induce and maintain control of disease symptoms is paramount in the treatment of Crohn’s disease.”
Patients participating in the Phase 3 UNITI-1 study received a single intravenous (I.V.) infusion of placebo, STELARA® 130 mg or STELARA® ~6 mg/kg (weight-tiered dosing: patients weighing less than or equal to 55 kg received 260 mg; patients weighing more than 55 kg and less than or equal to 85 kg received 390 mg; and patients weighing more than 85 kg received 520 mg) at week 0. All enrolled patients had previously failed or were intolerant to treatment with at least one anti-TNF-alpha therapy, and half of the enrolled patients had failed two or more anti-TNF-alpha therapies.
At week 6, 34 percent of patients receiving STELARA® 130 mg and 34 percent of patients receiving STELARA® ~6 mg/kg achieved clinical response, as defined by a reduction from baseline in the Crohn’s Disease Activity Index (CDAI) score of at least 100 points, compared with 22 percent of patients receiving placebo (P = 0.002 for STELARA® 130 mg; P = 0.003 for STELARA® ~6 mg/kg). CDAI is a symptom-based disease assessment tool commonly used in clinical trials to quantify Crohn’s disease activity.
At week 8, 34 percent and 38 percent of patients receiving STELARA® 130 mg and STELARA® ~6 mg/kg, respectively, achieved clinical response, compared with 20 percent of patients receiving placebo (P < 0.001). In addition, 16 percent of patients receiving STELARA® 130 mg and 21 percent of patients receiving STELARA® ~6 mg/kg achieved clinical remission at week 8, as defined by a CDAI score of less than 150 points, compared with 7 percent of patients receiving placebo (P = 0.003 for STELARA® 130 mg; P < 0.001 for STELARA® ~6 mg/kg).
In addition to significant improvements in signs and symptoms as measured by CDAI, both doses of STELARA® resulted in significant improvements in the Inflammatory Bowel Disease Questionnaire (IBDQ), a health-related quality of life measure for patients with IBD, as well as significant reduction in markers of inflammation, including C-reactive protein (CRP), fecal lactoferrin and calprotectin.
Through week 8 (placebo-controlled period), adverse events (AEs), serious AEs and infections were reported in similar proportions across STELARA® and placebo treatment groups. One case of Listeria meningitis infection was reported in the STELARA® ~6 mg/kg group. No malignancies, deaths, cases of tuberculosis or major adverse cardiovascular events (MACE) were observed in patients treated with STELARA®.
“We are pleased to share these important results from the Phase 3 UNITI-1 induction study, which complement Phase 3 results from the UNITI-2 study and further support regulatory applications submitted seeking approval of STELARA® for the treatment of moderately to severely active Crohn’s disease,” said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC. “Janssen Immunology remains committed to the continued development of STELARA® and the discovery of innovative medicines for the treatment of immune-mediated diseases.”
Additional data from the STELARA® Phase 3 Crohn’s disease clinical development program being presented at the 11th Congress of ECCO include:
Assessment of Serum C-reactive Protein, Fecal Lactoferrin, and Fecal Calprotectin in Patients with Crohn’s Disease: Results from the UNITI-1 and UNITI-2 Ustekinumab Induction Studies
Pharmacokinetics And Exposure-Response Relationships of Intravenously Administered Ustekinumab During Induction Treatment in Patients with Crohn’s Disease: Results from the UNITI-1 and UNITI-2 Studies
Molecular Response to Ustekinumab in Moderate-to-Severe Crohn’s Disease by Serum Protein Analysis: Results from the UNITI-1 and UNITI-2 Phase 3 Induction Studies
About the UNITI-1 Trial
UNITI-1, a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study, evaluated the efficacy and safety of STELARA® induction therapy in adult patients with moderate to severe Crohn’s disease. Patients (n=741) were randomized equally to receive a single I.V. infusion of placebo, STELARA® 130 mg or STELARA® ~6 mg/kg (weight-tiered dosing: patients weighing less than or equal to 55 kg received 260 mg; patients weighing more than 55 kg and less than or equal to 85 kg received 390 mg; and patients weighing more than 85 kg received 520 mg) at week 0. All participating patients had previously failed or were intolerant to treatment with at least one anti-TNF-alpha therapy. The primary endpoint was clinical response at week 6, measured by the proportion of patients who achieved at least a 100-point reduction from baseline CDAI scores. Major secondary endpoints at week 8 included clinical response and clinical remission (defined by CDAI scores less than 150 points). At week 8, patients either transitioned to the IM-UNITI maintenance study or were to complete a safety follow-up period through week 20.
UNITI-1 is part of a comprehensive Phase 3 clinical development program investigating STELARA® for the treatment of moderate to severe Crohn’s disease. Data from the UNITI-2 induction study evaluating STELARA® for the treatment of patients who had previously failed conventional therapy, the majority of whom were naïve to treatment with anti-TNF-alpha therapy, were presented in 2015 at the American College of Gastroenterology (ACG) Annual Meeting and United European Gastroenterology (UEG) Week. Results from the IM-UNITI maintenance study will be presented at a future medical congress.
About Crohn’s Disease
More than five million people worldwide are living with Crohn’s disease and ulcerative colitis—collectively known as inflammatory bowel disease (IBD).1 Crohn’s disease is a chronic inflammatory condition of the gastrointestinal tract that affects approximately 700,000 Americans2 and nearly 250,000 Europeans.3 The cause of Crohn’s disease is not known, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition or diet and other environmental factors. Symptoms of Crohn’s disease can vary but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss and fever. There is currently no cure for Crohn’s disease.2
About STELARA® (ustekinumab)
STELARA®, a human IL-12 and IL-23 antagonist, is approved in the United States for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. STELARA® is also approved for the treatment of adult patients (18 years or older) with active psoriatic arthritis and can be used alone or in combination with methotrexate (MTX).
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people with serious diseases throughout the world. Beyond its innovative medicines, Janssen is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and healthcare professionals have access to the latest treatment information, support services and quality care.
Janssen Research & Development, LLC is one of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssen.com for more information. Follow us on Twitter at https://twitter.com/JanssenGlobal.
SOURCE: Janssen
Post Views: 249
