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Janssen Announces FDA Approval of Stelara (ustekinumab) for the Treatment of Adolescents with Moderate to Severe Plaque Psoriasis

Posted 18 Oct 2017 by

Horsham, Pa., October 13, 2017 ― Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Stelara (ustekinumab) for the treatment of adolescents (12 years of age or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Today’s approval marks a significant milestone for this age group as approximately one-third of individuals who develop plaque psoriasis do so before 20 years of age, and there are limited treatment options for adolescents.[1] Since receiving approval in September 2009 for the treatment of adults living with moderate to severe plaque psoriasis, Stelara has become a leading therapeutic option for dermatologists and their patients, with only four doses a year after two starter doses. “Psoriasis can affect many aspects of everyday life and the visible pla ... Read more

Related support groups: Psoriasis, Plaque Psoriasis, Stelara, Ustekinumab

New Meds Make Inroads Against Crohn's Disease

Posted 13 Apr 2017 by

THURSDAY, April 13, 2017 – Fewer Americans with Crohn's disease are ending up in the hospital than in the past, according to a new federal study. Crohn's is a chronic inflammatory bowel disorder that often leads to surgery for most with the disease. Hospitalization rates for Crohn's disease remained stable in the United States between 2003 and 2013. That's a change from a study done from 1998 to 2004 that saw more than 4 percent increases in Crohn's hospitalizations each year, researchers with the U.S. Centers for Disease Control and Prevention said. The stable hospital rates are likely due to the 1998 introduction of a new class of biologic drugs. Examples of these medications used to treat Crohn's disease include: adalimumab (Humira), infliximab (Remicade), certolizumab (Cimzia) and ustekinumab (Stelara), according to the U.S. National Institute of Diabetes and Digestive and Kidney ... Read more

Related support groups: Humira, Crohn's Disease, Remicade, Ulcerative Colitis, Crohn's Disease - Maintenance, Inflammatory Bowel Disease, Ulcerative Colitis - Active, Stelara, Crohn's Disease - Acute, Cimzia, Ulcerative Colitis - Maintenance, Infliximab, Adalimumab, Inflectra, Certolizumab, Ustekinumab, Amjevita

Drug Stelara May Ease Crohn's Disease

Posted 18 Nov 2016 by

THURSDAY, Nov. 17, 2016 – People with moderate to severe Crohn's disease who haven't responded to other treatments may benefit from the drug ustekinumab (Stelara), a new study suggests. Stelara is a monoclonal antibody that blocks the action of the inflammatory agents interleukin-12 and interleukin-23. The drug had been approved for the treatment of psoriasis and is now approved for treating Crohn's disease as well. Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract. Crohn's usually affects the end of the small bowel and the beginning of the colon. But it may affect any part of the gastrointestinal tract, from the mouth to the anus, according to the Crohn's and Colitis Foundation of America (CCFA). Crohn's can cause diarrhea, rectal bleeding, an urgent need to move the bowels, stomach cramps, pain and constipation, the CCFA says. "Stelara is effective for ... Read more

Related support groups: Humira, Crohn's Disease, Remicade, Crohn's Disease - Maintenance, Stelara, Crohn's Disease - Acute, Cimzia, Ustekinumab

Study Identifies Genetic Subtypes of Crohn's Disease

Posted 14 Oct 2016 by

FRIDAY, Oct. 14, 2016 – Crohn's disease appears to have at least two distinct genetic subtypes, which could explain why the condition is so hard to treat, a new study suggests. "The one-treatment-fits-all approach doesn't seem to be working for Crohn's patients," said study co-senior author Dr. Shehzad Sheikh. He's an assistant professor in the departments of medicine and genetics at the University of North Carolina School of Medicine. "It's plausible that this is because only a subset of patients has the type of disease that responds to standard therapy, whereas, for the rest of the patients, we're really not hitting the right targets," Sheikh said in a university news release. Crohn's is a chronic inflammatory disorder of the intestinal tract. The most common symptoms are diarrhea, stomach cramps and weight loss. The course and severity of the disease vary widely from patient to ... Read more

Related support groups: Humira, Crohn's Disease, Crohn's Disease - Maintenance, Asacol, Sulfasalazine, Stelara, Inflammatory Bowel Disease, Pentasa, Lialda, Crohn's Disease - Acute, Apriso, Mesalamine, Canasa, Delzicol, Asacol HD, Azulfidine, Diagnosis and Investigation, Sulfazine, Rowasa, Salofalk

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

Posted 27 Sep 2016 by

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

Stelara (ustekinumab) Receives FDA Approval to Treat Active Psoriatic Arthritis

Posted 23 Sep 2013 by

HORSHAM, Pa., Sept. 23, 2013 /PRNewswire/ – Janssen Biotech, Inc., announced today that the U.S. Food and Drug Administration (FDA) has approved Stelara (ustekinumab) alone or in combination with methotrexate for the treatment of adult patients (18 years or older) with active psoriatic arthritis. It is estimated that more than two million people in the U.S. are living with psoriatic arthritis1, a chronic autoimmune disease characterized by both joint inflammation and psoriasis skin lesions. "It is critical for dermatologists and rheumatologists to be able to offer new and novel treatment options to our adult patients living with psoriatic arthritis, a disease where additional biologic options are very much needed," said investigator and Steering Committee member Alice B. Gottlieb, triple board certified in dermatology, rheumatology and internal medicine, M.D., Ph.D, Chief and ... Read more

Related support groups: Psoriatic Arthritis, Stelara, Ustekinumab

Psoriasis Drug May Help People With Crohn's Disease: Study

Posted 17 Oct 2012 by

WEDNESDAY, Oct. 17 – The drug Stelara, used to treat the skin condition psoriasis, may also be effective against Crohn's disease, according to a new study. Researchers from the University of California, San Diego School of Medicine found Stelara (ustekinumab) blocks two proteins known to cause inflammation. Crohn's disease patients with moderate-to-severe cases of the debilitating inflammatory bowel disease experienced improvements after six weeks of treatment, the team noted. One specialist not connected to the study welcomed the results. "This study confirms an earlier study showing that ustekinumab can be an effective therapy," said Dr. Bruce Sands, professor of medicine at the Mount Sinai School of Medicine in New York City. "Given the large unmet need for these individuals with refractory [hard-to-treat] Crohn's disease, these results are a great step forward," he said. Roughly ... Read more

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

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