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Amjevita OK'd to Treat Inflammatory Diseases

Posted 27 Sep 2016 by Drugs.com

MONDAY, Sept. 26, 2016 – Amjevita (adalimumab-atto) – a biosimilar drug similar to the popular anti-inflammatory drug Humira – has been approved by the U.S. Food and Drug Administration. Amjevita has been approved for moderate-to-severe rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis (an arthritis that affects the spine); Crohn's disease; ulcerative colitis; plaque psoriasis and juvenile idiopathic arthritis, the FDA said in a news release. Biological drugs are generally derived from a living organism and can come from many sources, including humans, animals, microorganisms or yeast, the FDA said. A biosimilar drug is a biological product that's sanctioned after its maker proves it is "highly similar" to an already-approved biologic drug. The manufacturer of the biosimilar drug must prove that the product has "no clinically meaningful differences" in safety, purity ... Read more

Related support groups: Rheumatoid Arthritis, Humira, Crohn's Disease, Psoriatic Arthritis, Ulcerative Colitis, Ankylosing Spondylitis, Crohn's Disease - Maintenance, Plaque Psoriasis, Ulcerative Colitis - Active, Crohn's Disease - Acute, Ulcerative Colitis - Maintenance, Juvenile Idiopathic Arthritis, Adalimumab, Amjevita

FDA Approves Amjevita (adalimumab-atto), a Biosimilar to Humira

Posted 26 Sep 2016 by Drugs.com

September 23, 2016 – The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases. Amjevita is approved for the following indications in adult patients: moderately to severely active rheumatoid arthritis; active psoriatic arthritis; active ankylosing spondylitis (an arthritis that affects the spine); moderately to severely active Crohn’s disease; moderately to severely active ulcerative colitis; and moderate to severe plaque psoriasis. Amjevita is also indicated for moderately to severely active polyarticular juvenile idiopathic arthritis in patients four years of age and older. Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses. “This is the fourth FDA-approved biosimilar. The biosimilar pathway is still a new fr ... Read more

Related support groups: Rheumatoid Arthritis, Psoriasis, Humira, Crohn's Disease, Psoriatic Arthritis, Ulcerative Colitis, Ankylosing Spondylitis, Crohn's Disease - Maintenance, Plaque Psoriasis, Ulcerative Colitis - Maintenance, Adalimumab, Amjevita

Vitamin A Compound Might Aid in Colon Cancer Fight

Posted 30 Aug 2016 by Drugs.com

TUESDAY, Aug. 30, 2016 – Retinoic acid, a compound derived in the body from vitamin A, might have a role in suppressing colon cancer, new animal research suggests. "Retinoic acid has been known for years to be involved in suppressing inflammation in the intestine," said study senior author Dr. Edgar Engleman, professor of pathology and medicine at Stanford University School of Medicine in Palo Alto, Calif. Meanwhile, the development of colon cancer has been linked to inflammation. For example, inflammatory bowel disease, such as ulcerative colitis, has been associated with colon cancer, he said in a university news release. "We wanted to connect the dots and learn whether and how retinoic acid levels directly affect cancer development," Engleman added. When the researchers looked at mice with colon cancer, they saw lower levels of retinoic acid in the intestines of the mice. The ... Read more

Related support groups: Cancer, Ulcerative Colitis, Colorectal Cancer, Ulcerative Colitis - Active, A-25, Ulcerative Colitis - Maintenance, Vitamin A, Diagnosis and Investigation, Familial Adenomatous Polyposis, A/Fish Oil, Retinol, Aquasol A, Vitamin A Topical

Stool Transplant Soothes Tough-to-Treat Colitis in Study

Posted 23 May 2016 by Drugs.com

MONDAY, May 23, 2016 – Stool transplants helped ease debilitating symptoms and heal the colons of tough-to-treat ulcerative colitis patients, new research shows. Australian scientists said the findings could pave the way for such transplants to be used on a more widespread basis. Transferring fecal matter from healthy donors into these patients alters the composition of their gut bacteria, circumventing one of the drivers of ulcerative colitis, experts said. "We were not completely surprised by the study findings, as . . . smaller studies along with unpublished experience suggested repeated fecal microbiota transplantation may be an effective treatment for ulcerative colitis," said study author Dr. Sudarshan Paramsothy, a gastroenterologist at University of New South Wales. "This study shows that [stool transplant] is a very promising therapeutic option for ulcerative colitis ... Read more

Related support groups: Ulcerative Colitis, Ulcerative Colitis - Active, Ulcerative Colitis - Maintenance, Diagnosis and Investigation, Fecal Incontinence

Inflectra Approved as 'Biosimilar' to Remicade

Posted 7 Apr 2016 by Drugs.com

WEDNESDAY, April 6, 2016 – The U.S. Food and Drug Administration has approved its second-ever "biosimilar" drug, Inflectra, for adults with Crohn's disease, rheumatoid arthritis or chronic plaque psoriasis, among other prescribed uses. In a media release, the agency said Inflectra was biosimilar to Janssen Biotech's Remicade (infliximab), first licensed in 1998. A biosimilar drug is sanctioned based on its maker's ability to show that it is "highly similar" to an already-approved biological drug that is generally derived from a living organism, such as a person, animal, microorganism or yeast, the FDA said. The maker of a biosimilar drug also must prove that the product has no "clinically meaningful difference" in safety and effectiveness from the original drug, and that the newer product has only "minor differences in clinically inactive components" from the original. Inflectra's most ... Read more

Related support groups: Rheumatoid Arthritis, Psoriasis, Crohn's Disease, Remicade, Psoriatic Arthritis, Ulcerative Colitis, Ankylosing Spondylitis, Crohn's Disease - Maintenance, Plaque Psoriasis, Ulcerative Colitis - Active, Crohn's Disease - Acute, Ulcerative Colitis - Maintenance, Infliximab, Inflectra

FDA Approves Inflectra (infliximab-dyyb) a Biosimilar to Remicade

Posted 7 Apr 2016 by Drugs.com

April 5, 2016 – The U.S. Food and Drug Administration today approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA. Inflectra is biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab), which was originally licensed in 1998. Inflectra is approved and can be prescribed by a health care professional for the treatment of: adult patients and pediatric patients (ages six years and older) with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy; adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy; patients with moderately to severely active rheumatoid arthritis in combination with methotrexate; patients with active ankylosing spondylitis (arthritis of ... Read more

Related support groups: Rheumatoid Arthritis, Psoriasis, Crohn's Disease, Remicade, Psoriatic Arthritis, Ulcerative Colitis, Ankylosing Spondylitis, Plaque Psoriasis, Infliximab, Inflectra

Ultrasound Might Speed Up Digestive Drug Delivery: Animal Study

Posted 21 Oct 2015 by Drugs.com

WEDNESDAY, Oct. 21, 2015 – Ultrasound waves could be used to rapidly deliver drugs to the digestive system, new animal research suggests. This new approach to drug delivery might potentially benefit people with inflammatory bowel disease (IBD), such as Crohn's disease and ulcerative colitis. However, this new method of drug delivery hasn't yet been tested in humans. "With additional research, our technology could prove invaluable in both clinical and research settings, enabling improved therapies and expansion of research techniques applied to the [gastrointestinal] tract," said co-senior study author Daniel Blankschtein, a professor of chemical engineering at Massachusetts Institute of Technology (MIT) in Cambridge. "[Our study] demonstrates for the first time the active administration of drugs, including biologics, through the GI tract," he said in an MIT news release. The ... Read more

Related support groups: Crohn's Disease, Colitis, Ulcerative Colitis, Crohn's Disease - Maintenance, Ulcerative Colitis - Active, Inflammatory Bowel Disease, Crohn's Disease - Acute, Ulcerative Colitis - Maintenance, Diagnosis and Investigation

More Evidence High-Fiber, Mediterranean Diet Is Good for You

Posted 29 Sep 2015 by Drugs.com

TUESDAY, Sept. 29, 2015 – Numerous studies have extolled the health benefits of the Mediterranean diet. Now, research suggests the regimen may also boost levels of beneficial fatty acids. These so-called "short chain fatty acids" are produced by bacteria in the intestine during fermentation of insoluble fiber from fruits, vegetables and legumes. The fatty acids are believed to provide a number of health benefits, including a lower risk of diabetes, heart disease and inflammatory diseases, an Italian team reports in the Sept. 29 issue of the journal Gut. "We provide here tangible evidence of the impact of a healthy diet and a Mediterranean dietary pattern," wrote the team led by Danilo Ercolini, a professor of microbiology at the University of Naples in Italy. The study of 153 Italian adults found higher levels of short chain fatty acids in vegans, vegetarians and those who closely ... Read more

Related support groups: Diabetes, Type 2, Heart Disease, Crohn's Disease, Ulcerative Colitis, Fish Oil, Lovaza, Inflammatory Bowel Disease, Omega-3, Dietary Fiber Supplementation, Omacor, MaxEPA, Omega-3 Polyunsaturated Fatty Acids, EPA Fish Oil, Restora, Animi-3, Marine Lipid Concentrate, Omega 3-6-9 Complex, MegaKrill, Omega-500, Lactobacillus Casei/omega-3 Polyunsaturated Fatty Acids

Childhood Abuse Linked to Ulcerative Colitis Later in Life

Posted 11 Sep 2015 by Drugs.com

FRIDAY, Sept. 11, 2015 – Adults who were physically or sexually abused as children may be at increased risk for the inflammatory bowel disease ulcerative colitis, a new study finds. University of Toronto researchers analyzed data from nearly 22,000 Canadians aged 18 and older. They found that those with a history of childhood abuse were nearly twice as likely to have ulcerative colitis as those who hadn't suffered abuse. In ulcerative colitis, inflammation and sores develop in the innermost lining of the large intestine, according to the Crohn's & Colitis Foundation of America. Symptoms include diarrhea, bloody stools and abdominal pain. "We found that one-quarter of adults with ulcerative colitis reported they had been physically abused during their childhood, compared to one in 10 of those without inflammatory bowel disease," study lead author Esme Fuller-Thomson, a professor in the ... Read more

Related support groups: Ulcerative Colitis, Ulcerative Colitis - Active, Ulcerative Colitis - Maintenance

Crohn's Disease, Colitis Tied to Anxiety in Study

Posted 4 Aug 2015 by Drugs.com

TUESDAY, Aug. 4, 2015 – People with inflammatory bowel disease, such as Crohn's disease or ulcerative colitis, have an increased risk for an anxiety disorder, especially women, a new study suggests. Inflammatory bowel disease (IBD) is a group of disorders that cause chronic inflammation of the digestive tract. "Patients with IBD face substantial chronic physical problems associated with the disease," lead author Esme Fuller-Thomson, a professor from the University of Toronto, said in a university news release. "The additional burden of anxiety disorders makes life much more challenging so this 'double jeopardy' must be addressed." The study authors looked at 269 Canadian adults who had been diagnosed with an inflammatory bowel disease. The researchers found that these patients were two times more likely to have had generalized anxiety disorder at some point in their lives than adults ... Read more

Related support groups: Anxiety, Generalized Anxiety Disorder, Anxiety and Stress, Panic Disorder, Post Traumatic Stress Disorder, Social Anxiety Disorder, Crohn's Disease, Colitis, Ulcerative Colitis, Crohn's Disease - Maintenance, Ulcerative Colitis - Active, Crohn's Disease - Acute, Performance Anxiety, Ulcerative Colitis - Maintenance, Lymphocytic Colitis, Allergic Colitis

Surgery May Beat Drugs for Ulcerative Colitis: Study

Posted 13 Jul 2015 by Drugs.com

MONDAY, July 13, 2015 – Surgery may extend the lives of older adults with the inflammatory bowel disease ulcerative colitis, new research suggests. A study of thousands of adults with the condition compared results of surgery to those of long-term drug treatment. It found that surgery's survival benefit was greatest for those 50 and older who had advanced disease. "Surgery has always been an option," said study leader Dr. Meenakshi Bewtra, but many experts look at it as a last resort. Bewtra, assistant professor of medicine and epidemiology at the University of Pennsylvania Perelman School of Medicine, used data from Medicare and Medicaid for the study. She and her colleagues followed 830 patients who had elective surgery – known as colectomy – and more than 7,500 who took medicine to manage the condition. Surgery involves removal of the colon, sometimes followed by additional ... Read more

Related support groups: Surgery, Ulcerative Colitis, Ulcerative Colitis - Active, Ulcerative Colitis - Maintenance, Gastrointestinal Surgery

Viruses May Play Role in Crohn's Disease, Colitis: Study

Posted 23 Jan 2015 by Drugs.com

FRIDAY, Jan. 23, 2015 – Viruses may play a role in inflammatory bowel diseases, including the two most common types, Crohn's disease and ulcerative colitis, a new study reveals. Previous research has linked these bowel diseases with a lower variety of bacteria in the gut, according to the researchers. In this new study, people with inflammatory bowel disease had a greater variety of viruses in their digestive systems compared to healthy people, the investigators found. The findings suggest that viruses, as well as bacteria, are a factor in inflammatory bowel disease, according to the study published online Jan. 22 in the journal Cell. The findings are the "tip of the iceberg," said study senior author Dr. Herbert Virgin IV, a professor of pathology and head of the department of pathology and immunology at Washington University School of Medicine in St. Louis. Much more research is ... Read more

Related support groups: Crohn's Disease, Colitis, Ulcerative Colitis

Sleep Duration Linked to Ulcerative Colitis Risk in Study

Posted 24 Oct 2014 by Drugs.com

FRIDAY, Oct. 24, 2014 – Not getting the right amount of sleep might raise your risk of ulcerative colitis, a new study suggests. Those who sleep less or more than the recommended seven to eight hours per night may be more prone to developing the chronic condition, which causes inflammation in the intestines, researchers report. The study authors concluded that duration and quality of sleep are key factors to be considered among patients with inflammatory bowel diseases. "Both short and long durations of sleep have important health implications, and are associated with increased overall mortality, cardiovascular disease and cancer," study author Dr. Ashwin Ananthakrishnan, of Massachusetts General Hospital in Boston, said in an American Gastroenterological Association news release. "Our findings indicate that ulcerative colitis may potentially be added to this list," he said. "We found ... Read more

Related support groups: Sleep Disorders, Ulcerative Colitis

FDA Approves Uceris (budesonide) Rectal Foam for Ulcerative Colitis

Posted 10 Oct 2014 by Drugs.com

RALEIGH, N.C., October 8, 2014 – Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced that the Food and Drug Administration (FDA) has granted final approval for Uceris (budesonide) rectal foam for the induction of remission in patients with active mild-to-moderate distal ulcerative colitis (UC) extending up to 40cm from the anal verge. The foam is a rectally administered corticosteroid that overcomes treatment limitations associated with currently approved therapies which are often ineffective due to insufficient distribution of active drug to the distal colon. On September 15, 2014 the FDA tentatively approved Uceris rectal foam pending expiration of the 45-day waiting period described in section 505( c )(3)( C ) of the Federal Food, Drug and Cosmetic Act. The waiting period has expired and the FDA has granted Uceris rectal foam final approval as of October 7, 2014. About ... Read more

Related support groups: Ulcerative Colitis, Ulcerative Colitis - Active, Budesonide, Ulcerative Colitis - Maintenance, Uceris

Certain Autoimmune Drugs in Pregnancy May Up Newborn Infection Risk: Study

Posted 3 Oct 2014 by Drugs.com

FRIDAY, Oct. 3, 2014 – When given to pregnant women, a common treatment for ulcerative colitis may inadvertently lower their baby's ability to fight off infections at birth, new French research suggests. The treatment, called anti-TNF therapy, is an injected, artificial antibody. This type of medication is widely seen as a safe and effective way to tackle a wide range of autoimmune disorders, such as rheumatoid arthritis and inflammatory bowel conditions that include ulcerative colitis and Crohn's disease. It's not unusual for pregnant women to receive the treatment, given that inflammatory bowel diseases often strike women of childbearing age. However, this type of drug can cross the placenta and reach the fetus, the study authors said. And four French cases – all involving babies born to women exposed to Remicade (infliximab) during pregnancy – suggest the therapy may cause newborn ... Read more

Related support groups: Rheumatoid Arthritis, Humira, Crohn's Disease, Enbrel, Remicade, Ulcerative Colitis, Inflammatory Bowel Disease, Cimzia, Simponi, Infliximab, Adalimumab, Etanercept, Golimumab, Certolizumab

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