New Analysis Presented by Janssen at United European Gastroenterology Week (UEGW) Demonstrates Long-Term Safety Profile for STELARA ® (ustekinumab) in Older Patients Across Approved Indications
SPRING HOUSE, PENNSYLVANIA, October 4, 2021 – Today, the Janssen Pharmaceutical Companies of Johnson &Johnson announced a new analysis of STELARA® (ustekinumab) pooled safety data from 13 clinical studies across approved indications, showing rates of key safety events among adults 60 years and older treated with STELARA for up to five yearsa were similar to rates observed with placebo during the control phase of these trials.1,b Approved indications included adults with moderately to severely active Crohn’s disease (CD), moderately to severely active ulcerative colitis (UC), moderate to severe plaque psoriasis (PsO) and active psoriatic arthritis (PsA) (Oral Presentation OP198).1 These data represent an important patient population as patients 60 years old and older are at a higher risk of disease and therapy-associated morbidity, which can result in disease management challenges.1“Little has been intentionally explored about the safety profile of biologics in patients aged 60 and older with inflammatory bowel disease, as this population is often limited in number in clinical trials,” said Professor Subrata Ghosh, Chair and Head of Department of Medicine, University College Cork, Ireland and lead study investigator of the pooled safety analysis.c “This analysis arms physicians with data to consider when treating older patients with STELARA given the safety profile observed across all approved indications.” Pooled Safety (Oral Presen...
ConclusionsOlanzapine use is associated with an increased risk of major congenital malformations and specifically, musculoskeletal malformations. Use during pregnancy should be restricted to situations where no safer alternatives exist.
ConclusionThe CYP2C19 IMs, PMs, and the number of targeted vessels are essential factors associated with MACE risk in dual clopidogrel-treated Uygur population with ACS following PCI. These data provide valuable insights into the genetic polymorphisms affecting clopidogrel response among minority groups in China.
ConclusionThe majority of patient-reported ADRs were non-serious. However, a relevant number of non-labelled even serious ADRs was reported for novel compounds by patients. Despite well-known limitations of patient-reported ADRs, this web-based ADR reporting system contributes to the identification of new ADRs and thus can help to improve patients ’ safety complementing other pharmacovigilance instruments.
ConclusionsThe results of our study suggest lack of statistically significant association between theCYB5A gene rs1790834 polymorphism and the response to leflunomide in women with RA.
AbstractPurposeThe trial aimed to investigate the effectiveness of exogenous melatonin as an adjuvant to pregabalin for relief of pain in patients suffering from painful diabetic neuropathy (PDN).Patients and methodsThis randomized, double-blind, placebo-controlled trial was carried out between October 2019 and December 2020 in an outpatient specialty clinic in Iran. One-hundred-three type 2 diabetic patients suffering from PDN were randomized into either the melatonin group (n = 52) or the placebo group (n = 51). Besides pregabalin at a dose of 150 mg per day, patients started with melato...
According to the American Cancer Society, about 1 in 5 cancers in the US and about 1 in 6 cancer deaths can be linked to poor nutrition, being overweight, not exercising, or alcohol.WebMD Health News
OHSU's vaccination results are in line with other major Portland health systems.
The FDA has followed the advice of its advisory panels, approving additional doses of Moderna and J&J vaccines, and opening up people's options by letting them switch vaccine type for their booster.FDA Approvals
Both Iterion and Moleculin are moving their drug candidates through the regulatory pipeline.
More News: Allergy | Allergy & Immunology | Arthritis | Babies | Babies Heart Conditions | Back Pain | Bleeding | Brain | Brain Cancers | Breast Needle Aspiration | Breastfed | Bronchitis | Canada Health | Cancer | Cancer & Oncology | Cancer Vaccines | Cardiology | Cardiovascular | Child Development | Children | Chronic Pain | Clinical Trials | Cold Sores | Colon Cancer | Colorectal Cancer | Complementary Medicine | Cough | Crohn's Disease | Diets | Emergency Medicine | ENT & OMF | Environmental Health | Food and Drug Administration (FDA) | Gastric (Stomach) Cancer | Gastroenteritis | Gastroenterology | Genetics | Headache | Health Management | Heart | Herbs | Herpes | Hospitals | Humira | Hypertension | Infectious Diseases | Inflammatory Bowel Disease | Ireland Health | Japan Health | Learning | Legislation | Lower Endoscopy | Marketing | Methotrexate | Migraine | Milk | Neurology | Neuroscience | Nurses | Nursing | Nutrition | Oral Cancer | Pain | Pain Management | Pharmaceuticals | Pregnancy | Profits and Losses | Psoriasis | Psoriatic Arthritis | Pulmonary Hypertension | Respiratory Medicine | Rheumatology | Science | Skin | Skin Cancer | Sore Throat | Stelara | Study | Training | Tuberculosis | Tuberculosis (BCG) Vaccine | Ulcerative Colitis | Universities & Medical Training | Upper Endoscopy | Urinary Tract Infections | USA Health | Vaccines | Vitamins | Weight Loss