Web Exclusives

According to the authors of a recent study, although monitoring of anti-drug antibodies (ADAbs) or serum concentrations of biologicals in rheumatoid arthritis treatments could explain efficacy loss, and help with choosing subsequent medication, such monitoring of tumor necrosis factor (TNF)-α blockers is not generally done on a routine basis in current clinical practices. They have, however, demonstrated the cost-benefits of routine monitoring of drug levels and ADAbs in clinical practice, which they report can in turn improve the decision-making process of using TNF-α blockers.
Patients with rheumatoid arthritis who inadequately responded to methotrexate monotherapy and were treated with tocilizumab plus methotrexate experienced subdued radiographic progression and maintained improvements in signs and symptoms over 5 years, according to data from Joel Kremer, MD, Albany Medical College, NY, and colleagues.
Long-term follow-up of the French 1 Stop Imatinib Study (STIM1) in patients with chronic myeloid leukemia (CML) has demonstrated that imatinib (Gleevec) can be safely discontinued in patients with a deep molecular response (ie, lasting at least 2 years). According to data presented at ASH 2015, molecular relapse was very rare after 6 months of stopping imatinib, and no relapse was reported after 2 years.
Approximately 40% of children with acute lymphoblastic leukemia (ALL) fail to take 6-mercaptopurine (6-MP) as prescribed, and a sizable majority of parents and children with ALL overreport the intake of a critical drug for maintaining remission, according to a study reported by lead investigator Wendy Landier, PhD, RN, NP, Children’s of Alabama, Birmingham, and colleagues at ASH 2015. The study suggests that electronic reporting using TrackCap, a medication event monitoring system (MEMS), is more reliable than self-reports.
The U.S. Food and Drug Administration today approved Venclexta (venetoclax) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion and who have been treated with at least one prior therapy. Venclexta is the first FDA-approved treatment that targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with CLL.
The US Food and Drug Administration (FDA) announced the approval of Inflectra (infliximab-dyyb)—a biosimilar to Remicade (infliximab)—for patients with chronic severe plaque psoriasis, and active ankylosing spondylitis or psoriatic arthritis. The biosimilar is also indicated for adult patients with moderately to severely active ulcerative colitis who have inadequately responded to standard therapy; in combination with methotrexate for patients with moderately to severely active rheumatoid arthritis; and patients aged ≥6 years with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Inflectra is the second biosimilar approved by the FDA.
Ixekizumab (Taltz) has been approved by the US Food and Drug Administration (FDA) for use in patients with moderate-to-severe plaque psoriasis, the agency has announced. Administered as an injection, ixekizumab is an antibody that binds and inhibits the inflammatory response of the inflammation-causing interleukin-17A protein.
Immediate-release opioid analgesics will now require boxed warnings regarding the serious risks for abuse, addiction, overdose, neonatal opioid withdrawal syndrome (NOWS), and death associated with the drugs, according to an announcement by the US Food and Drug Administration (FDA). This is the latest in a number of steps recently outlined by the FDA in their bid to reassess their approach to opioid medications.
The U.S. Food and Drug Administration today approved Alecensa (alectinib) to treat people with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate treatment with, another therapy called Xalkori (crizotinib).
The U.S. Food and Drug Administration today approved Vistogard (uridine triacetate) for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these cancer treatments.
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