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FDA Approves Stelara (ustekinumab) for Treatment of Adults with Moderately to Severely Active Crohn's Disease

Posted 2 hours 23 minutes ago by Drugs.com

HORSHAM, Pa., Sept. 26, 2016 /PRNewswire/ – Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved Stelara (ustekinumab) for the treatment of moderately to severely active Crohn's disease in adults (18 years or older) who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor (TNF) blocker, or who failed or were intolerant to treatment with one or more TNF blockers. Stelara is the first biologic therapy for Crohn's disease targeting interleukin (IL)-12 and IL-23 cytokines, which play a key role in inflammatory and immune responses. "Crohn's disease is a complex condition to treat, and not all therapies work for every patient," said William J. Sandborn, MD, Chief, Division of Gastroenterology, and Professor of Medicine, UC San Diego School of Medicine, and ... Read more

Related support groups: Crohn's Disease, Stelara, Ustekinumab

Amjevita OK'd to Treat Inflammatory Diseases

Posted 5 hours ago 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, Ulcerative Colitis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease - Maintenance, Ulcerative Colitis - Active, Plaque Psoriasis, Crohn's Disease - Acute, Ulcerative Colitis - Maintenance, Juvenile Idiopathic Arthritis, Adalimumab, Amjevita

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

Posted 6 hours ago 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, Ulcerative Colitis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease - Maintenance, Plaque Psoriasis, Ulcerative Colitis - Maintenance, Adalimumab, Amjevita

Smoking Linked to Higher Relapse Risk After Surgery for Crohn's

Posted 2 Sep 2016 by Drugs.com

THURSDAY, Sept. 1, 2016 – Smoking increases the risk that Crohn's disease patients will have relapses after bowel surgery, new research suggests. The study included 240 Crohn's disease patients in the United Kingdom who were followed for three years after bowel surgery. Crohn's disease occurs when the immune system attacks the lining of the gut and bowel, and causes severe inflammation, the study authors noted. This can result in diarrhea, abdominal pain, nausea and reduced appetite. Patients are usually initially treated with drugs to suppress their immune system. But the study authors said that more than half of Crohn's patients eventually have surgery to remove the affected section of their bowel. However, surgery does not cure Crohn's, and relapses are common. According to the researchers from the University of Edinburgh in Scotland, smokers were much more likely than nonsmokers to ... Read more

Related support groups: Surgery, Smoking, Crohn's Disease, Smoking Cessation, Crohn's Disease - Maintenance, Crohn's Disease - Acute

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, Ulcerative Colitis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease - Maintenance, Ulcerative Colitis - Active, Plaque Psoriasis, 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, Ulcerative Colitis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Infliximab, Inflectra

Health Tip: Get Enough Nutrients

Posted 14 Jan 2016 by Drugs.com

-- A nutritious diet is especially important for people with irritable bowel disease (IBD), since they may be at increased risk of malnutrition. The Crohn's and Colitis Foundation of America says possible benefits of a nutritious diet include: Fewer symptoms of IBD. Reduced risk of iron or calcium deficiency. Improved bone health. Healthier body weight. Better regulation of hormone levels in girls and women. Read more

Related support groups: Irritable Bowel Syndrome, Crohn's Disease, Crohn's Disease - Maintenance, Crohn's Disease - Acute

Stem Cell Transplants May Not Help Tough-to-Treat Crohn's, Study Says

Posted 15 Dec 2015 by Drugs.com

TUESDAY, Dec. 15, 2015 – Stem cell transplants seem no better than conventional therapy for Crohn's disease that hasn't responded to other treatments, a new study finds. The European study also found that for patients who cannot undergo surgery for the condition, stem cell transplants resulted in serious side effects, including infections. "In this group of the most resistant cases of Crohn's disease, stem cell transplant was an effective treatment, but it is not a miracle cure that could be applied to anyone with Crohn's disease, because it only seems to work in a minority of patients and the treatment is challenging and hazardous," said lead researcher Christopher Hawkey. He is a professor of gastroenterology at Queen's Medical Centre in Nottingham, England. For the study, Hawkey and colleagues randomly assigned 45 patients with Crohn's disease to transplants with their own stem ... Read more

Related support groups: Crohn's Disease, Asacol, Crohn's Disease - Maintenance, Sulfasalazine, Pentasa, Lialda, Crohn's Disease - Acute, Apriso, Canasa, Mesalamine, Azulfidine, Asacol HD, Delzicol, Sulfazine, Diagnosis and Investigation, Rowasa, Azulfidine EN-tabs, Canasa Pac, Salofalk, FIV-ASA

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

Crohn's Disease Treatments for Kids May Not Get Gut Back to Normal

Posted 14 Oct 2015 by Drugs.com

WEDNESDAY, Oct. 14, 2015 – Current therapies for children with Crohn's disease don't fully restore healthy bacteria and fungi populations in their digestive systems, a new study shows. These findings suggest that treatments don't have to bring bacteria and other microbe levels back to normal levels in the gut to be useful. This knowledge could lead to new approaches for diagnosing and treating inflammatory bowel disease, according to the Oct. 14 study in the journal Cell Host & Microbe. "We show that microbes in the gut respond to treatment of inflammatory bowel disease in a much more complex way than has been previously appreciated," co-principal investigator Gary Wu, from the University of Pennsylvania in Philadelphia, said in a journal news release. "The results of our study provide information that could be used to track or predict disease, as well as new diet-based therapeutic ... Read more

Related support groups: Prednisone, Methylprednisolone, Crohn's Disease, Prednisolone, Hydrocortisone, Medrol, Cortisone, Dexamethasone, Triamcinolone, Asacol, Crohn's Disease - Maintenance, Betamethasone, Sulfasalazine, Pentasa, Budesonide, Lialda, Decadron, Crohn's Disease - Acute, Entocort, Solu-Medrol

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, Omega-3 Polyunsaturated Fatty Acids, MaxEPA, Marine Lipid Concentrate, Omega 3-6-9 Complex, EPA Fish Oil, Restora, Animi-3, Prenatal DHA, Sea-Omega 30, Super-EPA

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, Panic Disorder, Anxiety and Stress, 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

Stem Cells, Fecal Transplants Show Promise for Crohn's Disease

Posted 10 Apr 2015 by Drugs.com

FRIDAY, April 10, 2015 – Two experimental therapies might help manage the inflammatory bowel disorder Crohn's disease, if this early research pans out. In one study, researchers found that a fecal transplant – stool samples taken from a healthy donor – seemed to send Crohn's symptoms into remission in seven of nine children treated. In another, a separate research team showed that stem cells can have lasting benefits for a serious Crohn's complication called fistula. According to the Crohn's & Colitis Foundation, up to 700,000 Americans have Crohn's – a chronic inflammatory disease that causes abdominal cramps, diarrhea, constipation and rectal bleeding. It arises when the immune system mistakenly attacks the lining of the digestive tract. A number of drugs are available to treat Crohn's, including drugs called biologics, which block certain immune-system proteins. But fecal ... Read more

Related support groups: Crohn's Disease, Crohn's Disease - Maintenance, Crohn's Disease - Acute

New Drug for Crohn's Disease Shows Early Promise

Posted 18 Mar 2015 by Drugs.com

WEDNESDAY, March 18, 2015 – An experimental drug may quickly quash symptoms of the digestive disorder Crohn's disease – at least for the short term, an early clinical trial finds. The study, of more than 150 adults with Crohn's, found that just two weeks of treatment sent many into remission – meaning they had few to no symptoms of the inflammatory bowel disease 28 days after the study began. Experts said the findings are encouraging. For one, the drug is a pill, whereas the current "biologic" drugs for Crohn's – such as Remicade and Humira – are given by injection or IV. And the drug worked quickly. "There was a pretty high remission rate in a short period of time. That's impressive," said Dr. Raymond Cross, a gastroenterologist at the University of Maryland Medical Center, who was not involved in the study. In theory, the new drug – dubbed mongersen – could be safer than ... Read more

Related support groups: Crohn's Disease, Crohn's Disease - Acute

Slowed Growth Could Signal Crohn's Disease in Kids

Posted 18 Mar 2015 by Drugs.com

WEDNESDAY, March 18, 2015 – A lag in growth could be a sign that a child might suffer from undiagnosed inflammatory bowel disease (IBD), especially Crohn's disease, one pediatric doctor says. "Growth charts are one of the most important things we look at with children because sometimes a slower growth rate is the only sign of IBD, especially with Crohn's disease," Dr. Marc Schaefer, a pediatric gastroenterologist, said in a Penn State University news release. Other symptoms of inflammatory bowel disease in children include not wanting to eat, persistent stomach pains, and diarrhea or bloody stools, said Schaefer, who works at Penn State Hershey Children's Hospital in Hershey, Pa. Children with these symptoms should be evaluated, he suggested. Blood tests and endoscopy are also used to diagnose and to distinguish Crohn's from ulcerative colitis, another type of inflammatory bowel ... Read more

Related support groups: Crohn's Disease, Inflammatory Bowel Disease, Growth Retardation

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