A yearlong pilot study that evaluated the safety and efficacy of belimumab in a small group of patients with early diffuse systemic sclerosis found no significant difference in the number of adverse events between those treated with the drug and those who received a placebo. Currently, no drugs are approved specifically for the treatment of…
Drug Safety: Fasinumab Evaluated in Clinical Trials, Plus Celecoxib May Not Pose Increased Heart Attack or Stroke Risk
After an independent review, ongoing clinical trials investigating the safety of fasinumab for treating hip or knee OA will discontinue the use of higher fasinumab doses…
Romosozumab Has Biggest BMD Benefit in First Year of Treatment
NEW YORK (Reuters Health)—Romosozumab shows smaller benefits for increasing bone mineral density (BMD) in the second year of treatment compared to the first, new research suggests. The extension of a phase 2 study in postmenopausal women with low bone mass also found BMD decreased sharply when patients on romosozumab were switched to placebo after two…
FDA Update: Committee Recommends 2 mg Baricitinib Approval; HLH Identified as Serious Adverse Event for Lamotrigine
The FDA Arthritis Advisory Committee has recommended the approval of 2 mg baricitinib (but not in a 4 mg dose) for treating adults with moderate to severe active RA…
International Approvals for Guselkumab & Anakinra; Plus Adalimumab Biosimilar in Europe
In Japan the use of guselkumab to treat erythrodermic, plaque and pustular psoriasis is approved, and anakinra is now indicated for Still’s disease in the E.U…
FDA Staff Raises Safety Concerns Over Arthritis Drug Baricitinib
(Reuters)—An experimental rheumatoid arthritis drug developed by Eli Lilly and Co. and Incyte Corp. poses serious risks of deadly blood clots at higher doses, U.S. Food and Drug Administration staff says, the latest setback to a treatment regulators declined to approve last year. New data provided by the companies in a resubmission of their marketing…
Denosumab May Work Better Than Risedronate for Steroid-Induced Osteoporosis
NEW YORK (Reuters Health)—The RANKL inhibitor denosumab is superior to the bisphosphonate risedronate in increasing bone-mineral density (BMD) at the lumbar spine in patients just starting or continuing steroid therapy, according to 12-month results of a 24-month randomized controlled study. “Glucocorticoid-induced osteoporosis is the most common form of secondary osteoporosis and increases the risk of…
Upadacitinib Proves Superiority to Adalimumab in Phase 3 RA Study
Initial results from an ongoing trial show that upadacitinib outperforms adalimumab in achieving ACR20 in patients with rheumatoid arthritis…
FDA Expands Label for Insulin Degludec; Adalimumab Biosimilar Moves Forward After Legal Battle
The FDA has expanded the label for insulin degludec to include data on improved cardiovascular outcomes and deceased severe hypoglycemia…
Nonopioid Medication May Be as Effective as Opioids for Chronic Pain
A recent study compared the efficacy of opioids with nonopioid pain treatments in patients with chronic back pain and hip or knee osteoarthritis. After 12 months, researchers found that treatment with opioids was not superior to treatment with nonopioid medication, with only minor differences in patients’ functional responses to the medications…
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