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Golimumab significantly reduced signs and symptoms of ankylosing spondylitis
November 08, 2007More than half of patients receiving monthly subcutaneous (SC) injections of golimumab (CNTO 148) 50 mg and 100 mg experienced significant and sustained improvements in the signs and symptoms of active ankylosing spondylitis, according to Phase 3 study results presented at the American College of Rheumatology (ACR) annual meeting. At week 14 of the study, 59 percent of patients receiving golimumab 50 mg and 60 percent of patients receiving golimumab 100 mg achieved at least 20 percent improvement in the Assessment in Ankylosing Spondylitis criteria (ASAS 20) compared with 22 percent of patients receiving placebo (P < 0.001). Investigators also reported that study subjects receiving golimumab 50 mg or golimumab 100 mg showed significant, sustained improvements in physical function through six months as measured by the Bath Ankylosing Spondylitis Functional Index (BASFI).
Golimumab, Centocor Inc. and Schering-Plough Corporation's next-generation human anti-tumor necrosis factor (TNF)-alpha monoclonal antibody, is currently in the most comprehensive Phase 3 development program to date for an anti-TNF-alpha biologic therapy. With ongoing studies for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, golimumab is being studied as a monthly SC injection and an every twelve-week intravenous (IV) infusion (approximately 30-minutes) therapy.
"The rapid and significant effects of golimumab as demonstrated by these study findings are encouraging for the rheumatology community and for the patients living with this debilitating disease," said Jurgen Braun, MD, lead physician at the Rheumatological Center in Herne, Germany, professor at the Ruhr-Universitat of Bochum, Germany, and lead study investigator. "Anti-TNF therapies have dramatically advanced our approach to the management of this disease, and these data demonstrate the potential of golimumab as a new efficacious anti-TNF-alpha treatment option."
According to findings from the Golimumab - A Randomized Study in Ankylosing Spondylitis Subjects of a Novel Anti-TNF mAB Injection (SC) Given Every Four Weeks (GO-RAISE) trial, 59 percent of patients receiving golimumab 50 mg and 60 percent of patients receiving golimumab 100 mg achieved the primary endpoint of the study, ASAS 20 at week 14, compared with 22 percent of patients receiving placebo (P < 0.001 for both comparisons). Clinical benefit was demonstrated as early as week four after one dose and was maintained through week 24. At six months, 56 percent of patients receiving golimumab 50 mg and 66 percent of patients receiving golimumab 100 mg achieved ASAS 20 compared with 23 percent of patients receiving placebo (P < 0.001 for both comparisons). Furthermore, at six months, 44 percent of patients receiving golimumab 50 mg and 54 percent of patients receiving golimumab 100 mg achieved ASAS 40, defined as 40 percent improvement in ankylosing spondylitis signs and symptoms, compared with 15 percent of patients receiving placebo (P < 0.001 for both comparisons).
Importantly, at six months, 51 percent of patients receiving golimumab 50 mg and 48 percent of patients receiving golimumab 100 mg achieved a 50 percent reduction in disease activity as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI 50), a standard measure for assessing ankylosing spondylitis disease activity, compared with 15 percent of patients receiving placebo (P < 0.001). The BASDAI measures important markers of disease activity, including pain, morning stiffness and joint swelling.
"When treating this potentially progressive and debilitating disease, we attempt to reduce pain and other symptoms so that patients can maintain or improve physical function," said Atul Deodhar, MD, associate professor of medicine, Oregon Health and Science University, Portland, Oregon. "These findings show that golimumab improved both the signs and symptoms of ankylosing spondylitis and patients' physical function, which is promising in the treatment of this systemic inflammatory disease."
Findings from the GO-RAISE study showed that golimumab-treated patients experienced significant functional improvements as measured by the BASFI, a 1 to 10 scale (1 representing no impairment and 10 representing severe impairment), which measures physical function and impairment due to the disease and subsequent improvements as a result of treatment. Patients receiving golimumab 50 mg and 100 mg experienced an average decrease of 1.4 and 1.5 units from baseline in BASFI score, respectively, at week 14, compared with an average increase of 0.1 units among patient receiving placebo (P < 0.001 for both comparisons).
"We are encouraged by the findings from this Phase 3 trial evaluating golimumab as a treatment for ankylosing spondylitis," said Jerome A. Boscia, MD, senior vice president, Clinical Research and Development, Centocor, Inc. "These data suggest golimumab may be an effective treatment option for patients with this chronic, progressive spondyloarthropathy."
About the GO-RAISE Trial
The GO-RAISE trial included 356 patients with active ankylosing spondylitis. Subjects were randomized to receive subcutaneous injections of golimumab 50 mg or 100 mg or placebo every four weeks. The primary endpoint was the proportion of patients achieving ASAS 20 at week 14. At week 16, patients in the placebo or 50 mg group demonstrating less than 20 percent improvement from baseline in both total back pain and morning stiffness measures were switched to either golimumab 50 mg (previously receiving placebo) or golimumab 100 mg (previously receiving golimumab 50 mg).
Through week 24, golimumab was generally well tolerated with four percent of patients receiving golimumab 50 mg and six percent of patients receiving golimumab 100 mg experiencing a serious adverse event. Seven percent of patients receiving placebo experienced serious adverse events. Adverse events were reported in 80 percent of patients receiving golimumab and 77 percent of patients receiving placebo, with an increased incidence of infections, primarily upper respiratory infections, in patients treated with golimumab. Antibodies to golimumab were detected in four percent of patients through week 24.
Centocor, Inc.
According to findings from the Golimumab - A Randomized Study in Ankylosing Spondylitis Subjects of a Novel Anti-TNF mAB Injection (SC) Given Every Four Weeks (GO-RAISE) trial, 59 percent of patients receiving golimumab 50 mg and 60 percent of patients receiving golimumab 100 mg achieved the primary endpoint of the study, ASAS 20 at week 14, compared with 22 percent of patients receiving placebo (P < 0.001 for both comparisons). Clinical benefit was demonstrated as early as week four after one dose and was maintained through week 24. At six months, 56 percent of patients receiving golimumab 50 mg and 66 percent of patients receiving golimumab 100 mg achieved ASAS 20 compared with 23 percent of patients receiving placebo (P < 0.001 for both comparisons). Furthermore, at six months, 44 percent of patients receiving golimumab 50 mg and 54 percent of patients receiving golimumab 100 mg achieved ASAS 40, defined as 40 percent improvement in ankylosing spondylitis signs and symptoms, compared with 15 percent of patients receiving placebo (P < 0.001 for both comparisons).
Importantly, at six months, 51 percent of patients receiving golimumab 50 mg and 48 percent of patients receiving golimumab 100 mg achieved a 50 percent reduction in disease activity as measured by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI 50), a standard measure for assessing ankylosing spondylitis disease activity, compared with 15 percent of patients receiving placebo (P < 0.001). The BASDAI measures important markers of disease activity, including pain, morning stiffness and joint swelling.
"When treating this potentially progressive and debilitating disease, we attempt to reduce pain and other symptoms so that patients can maintain or improve physical function," said Atul Deodhar, MD, associate professor of medicine, Oregon Health and Science University, Portland, Oregon. "These findings show that golimumab improved both the signs and symptoms of ankylosing spondylitis and patients' physical function, which is promising in the treatment of this systemic inflammatory disease."
Findings from the GO-RAISE study showed that golimumab-treated patients experienced significant functional improvements as measured by the BASFI, a 1 to 10 scale (1 representing no impairment and 10 representing severe impairment), which measures physical function and impairment due to the disease and subsequent improvements as a result of treatment. Patients receiving golimumab 50 mg and 100 mg experienced an average decrease of 1.4 and 1.5 units from baseline in BASFI score, respectively, at week 14, compared with an average increase of 0.1 units among patient receiving placebo (P < 0.001 for both comparisons).
"We are encouraged by the findings from this Phase 3 trial evaluating golimumab as a treatment for ankylosing spondylitis," said Jerome A. Boscia, MD, senior vice president, Clinical Research and Development, Centocor, Inc. "These data suggest golimumab may be an effective treatment option for patients with this chronic, progressive spondyloarthropathy."
About the GO-RAISE Trial
The GO-RAISE trial included 356 patients with active ankylosing spondylitis. Subjects were randomized to receive subcutaneous injections of golimumab 50 mg or 100 mg or placebo every four weeks. The primary endpoint was the proportion of patients achieving ASAS 20 at week 14. At week 16, patients in the placebo or 50 mg group demonstrating less than 20 percent improvement from baseline in both total back pain and morning stiffness measures were switched to either golimumab 50 mg (previously receiving placebo) or golimumab 100 mg (previously receiving golimumab 50 mg).
Through week 24, golimumab was generally well tolerated with four percent of patients receiving golimumab 50 mg and six percent of patients receiving golimumab 100 mg experiencing a serious adverse event. Seven percent of patients receiving placebo experienced serious adverse events. Adverse events were reported in 80 percent of patients receiving golimumab and 77 percent of patients receiving placebo, with an increased incidence of infections, primarily upper respiratory infections, in patients treated with golimumab. Antibodies to golimumab were detected in four percent of patients through week 24.
Centocor, Inc.
Ankylosing Spondylitis Current Events and Ankylosing Spondylitis News RSSStudy aims to induce recovery from ankylosing spondylitis
Chinese patients will soon have the opportunity to take part in a study of a novel therapy aimed at reversing the autoimmune disease, ankylosing spondylitis.
Diagnosis of arthritis 5 years earlier in childless women compared to those with children
Nulliparous women (those who have not given birth to children) are diagnosed with chronic arthritides (including ankylosing spondylitis, psoriatic arthritis and rheumatoid arthritis (RA) an average of 5.2 years before parous women (those who have given birth to children).
CV risk management should be mandatory in RA and other types of inflammatory rheumatic disease
Rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA) patients should undergo compulsory cardiovascular (CV) risk management and existing CV risk calculators should be adapted to the increased CV risk in inflammatory rheumatic disease patients.
New findings show Enbrel significantly reduced levels of C-reactive protein
Amgen (NASDAQ: AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced findings from a retrospective analysis, which demonstrated that ENBREL reduced C-reactive protein (CRP), a marker of inflammation, in patients with moderate to severe plaque psoriasis following 12 weeks of treatment.
Phase 3 data show golimumab improved psoriatic arthritis symptoms
Patients with active psoriatic arthritis receiving monthly subcutaneous (SC) injections of golimumab (CNTO 148) experienced significant and sustained improvements in the joint and skin manifestations of the disease.
Study reveals 2 genes linked to disabling arthritis
An international team of researchers led by a Fred Hutchinson Cancer Research Center geneticist has discovered two genes linked to a disabling form of arthritis called ankylosing spondylitis, a painful and progressive disease in which some or all of the spine's vertebrae fuse together.
Major genetic breakthrough for ankylosing spondylitis brings treatment hope
Research funded by the Wellcome Trust and the Arthritis Research Campaign has identified two genes implicated in the disease ankylosing spondylitis, a common disease primarily causing back pain and progressive stiffness.
UT Rheumatologists Discover Two Genes
Work done in part by researchers at The University of Texas Medical School at Houston has led to the discovery of two genes that cause ankylosing spondylitis, an inflammatory and potentially disabling disease. The findings are published in the Oct. 21 online edition of Nature Genetics, a journal that emphasizes research on the genetic basis for common and complex diseases.
Clinical studies show REMICADE reduces incidence of bowel surgeries in ulcerative colitis patients
Clinical data presented today at the annual meeting of the American College of Gastroenterology (ACG) show that REMICADE significantly reduces the incidence of colectomy surgeries for patients with moderately to severely active ulcerative colitis (UC).
Largest ever study of genetics of common diseases published today
The Wellcome Trust Case Control Consortium, the largest ever study of the genetics behind common diseases such as diabetes, rheumatoid arthritis and coronary heart disease, today publishes its results in the journals Nature and Nature Genetics.
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