Clinical trials of biosimilar treatments, including a phase 1 study of SB17, which is biosimilar to ustekinumab, and two phase 3 studies investigating of SB16, which is biosimilar to denosumab, are currently recruiting.
Denosumab Has Edge on Alendronate for Steroid-Induced Bone Loss
NEW YORK (Reuters Health)—Long-term glucocorticoid users see greater gains in spine bone-mineral density when treated with the monoclonal antibody denosumab vs. oral alendronate, a small clinical trial shows. The drug also proved superior at lowering bone-turnover markers at 12 months, researchers in Hong Kong report in Bone.1 “Denosumab may be considered as an alternative first-line…
Upadacitnib for RA: Researchers Compared Upadacitinib with Placebo & Adalimumab in Patients with RA & an Inadequate Response to Methotrexate
In phase 3 clinical trial, upadacitnib proved superior to placebo and adalimumab in improving the signs and symptoms of RA in patients on stable background methotrexate.
Health Canada Approves CT-P13 SC for RA; Plus Tofacitinib May Increase Cardiac & Cancer Risks
In Canada, a subcutaneous formulation of CT-P13, which is biosimilar to infliximab, was approved to treat rheumatoid arthritis.
Reassuring Data on Immune Checkpoint Inhibitors in Autoimmune Disease
NEW YORK (Reuters Health)—Patients with preexisting autoimmune disease (AIDs) are not at increased risk for immune-related adverse events from immune checkpoint inhibitor (ICI) therapy, although these adverse events may be more likely in patients with inflammatory bowel disease (IBD), new research indicates. “Therefore, we encourage physicians not to withhold ICI in most common AIDs. However,…
Immunosuppressive Medicines Do Not Worsen COVID-19 Outcomes
(Reuters)—Medications that suppress the immune system—necessary for many chronic diseases—do not worsen outcomes of COVID-19 cases, new data suggest. Researchers looked back at 2,121 adults hospitalized for COVID-19 between March and August, including 108 who were taking immunosuppressive drugs (primarily prednisone, tacrolimus or mycophenolate mofetil). After accounting for patients’ general baseline health status, researchers found…
The Unapproved-Drugs Initiative Is Coming to an End
On Friday, Nov. 20, 2020, the U.S. Department of Health and Human Services (HHS) published a Notice through the Federal Register announcing the withdrawal of guidance documents that established the Unapproved Drugs Initiative. This Notice brings to an end a 14-year-old program that has been blamed for significantly contributing to the rising cost of some…
Research Outlines Benefits of bDMARDs to Treat Early RA
Sapart et al. suggest a combination of methotrexate and biologic disease-modifying anti-rheumatic drugs as induction therapy for patients with early RA may lead to long-term remission.
UnitedHealthcare Designates Avsola, Inflectra Preferred Infliximab Products
On Feb. 1, UnitedHealthcare enacted a new policy designating Avsola and Inflectra as the preferred infliximab products for UHC commercial plans. ACR leaders have urged UHC to allow existing patients to continue on their current medication.
Study Examines Tofacitinib’s Long-Term Cardiovascular Risk & More
In a post-marketing safety study, tofacitinib did not prove non-inferior to tumor necrosis factor inhibitors when evaluated for its long-term effects on heart disease, malignancies and serious infections in RA patients.
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