Practice

One of the main concerns attributed to anti–tumor necrosis factor (anti-TNF) treatment during pregnancy is the ability for the therapy to be transferred to the fetus. Complete immunoglobulin G (IgG) antibodies, both maternal and therapeutic, are delivered to the placenta during pregnancy naturally. This fact is important for patients who are treated with adalimumab, golimumab, and infliximab, which are complete IgG1 anti-TNF antibodies, and therefore transferred easily to the placenta.

Researchers involved in the Persephone phase 3 randomized clinical trial of 4089 women with HER2-positive early breast cancer found that 6 months of trastuzumab treatment was not inferior to the current standard.

Although the benefits of originator infliximab have been deemed to outweigh the potential harm during pregnancy, in a recent observational study, researchers looked to evaluate whether biosimilar infliximab therapy was associated with any new safety risks.

At the 58th Annual Scientific Meeting of the British Society for Haematology, held from April 16-18, 2018, in Liverpool, United Kingdom, researchers from 2 hospitals reported on the use of biosimilar rituximab in real-world settings.

In an effort to accurately predict an individual patient’s response after starting or tapering an anti–tumor necrosis factor (anti-TNF) agent, researchers from the Netherlands, reporting findings in Rheumatic and Musculoskeletal Diseases, explain that calprotectin has some predictive value for clinical response in patients starting anti-TNF treatment, although it was not predictive of clinical response after tapering.

In treating ankylosing spondylitis, anti–tumor necrosis factor (anti-TNF) drugs produce a response in approximately 60% of patients. For the 40% of patients who do not respond to treatment, previous studies have suggested that patient characteristics, including sex, may play a role.

The Center for Biosimilars® recaps the top 5 articles for the week of May 7, 2018.

In an interview with The Center for Biosimilars®, Dennis Cryer, MD, physician co-convener of the Biologics Prescribers Collaborative (BPC), said, "We still feel that much of the effectiveness of therapy is the relationship and the trust that can be developed between the physician and the patient."

Antibodies that deplete B cells, including rituximab, have demonstrated efficacy in the treatment of neurological conditions such as progressive multiple sclerosis and neuromyelitis optica spectrum disorder. The efficacy of these treatments hinges on adequate B-cell depletion, but there is a lack of standardization in treatment and monitoring protocols to guide clinical practice.

Though the use of biosimilars is becoming more common in the adult arthritis space, there has been little research on their use in pediatric patients. Identifying the need for further analysis in this population, researchers conducted a study investigating biosimilar use in children and young adults with juvenile idiopathic arthritis (JIA). The results were presented last week at the British Society for Rheumatology’s Annual Conference held in Liverpool, United Kingdom.

Some cervical cancer patients with advanced or recurrent disease suffer from anaphylaxis after taxane- or platinum-based therapy, and there is no standard treatment for progressive disease that develops during or shortly after platinum-based chemotherapy. Doctors and patients have therefore sought the development of a non-taxane, non-platinum regimen for recurrent cervical cancer.

Yesterday, at the British Society for Rheumatology’s Annual Conference held in Liverpool, United Kingdom, researchers presented a study that investigated the clinical outcomes of a multi-disciplinary switch to biosimilar etanercept from the reference product in patients with rheumatoid arthritis.

While treatment with trastuzumab is the standard of care for HER2-positive locally advanced or metastatic breast cancer and gastric cancer, data on long-term use of the biologic are lacking, and cardiac risk related to trastuzumab has posed concerns.

The Center for Biosimilars® recaps the top 5 articles for the week of April 30, 2018.

Filgrastim, used to prevent febrile neutropenia (FN) in patients undergoing chemotherapy, is the first drug in the United States to have a biosimilar approved. While the biosimilar filgrastim was approved in 2015, few studies have compared the real-world incidence of FN, healthcare resource utilization, and costs among US patients using the reference product (Neupogen) and those using the approved biosimilar (Zarxio).

While systemic inflammation is a potential biological mechanism underlying both Parkinson disease (PD) and inflammatory bowel disease (IBD), clinical data on comorbid PD and IBD are few. In a new study published in JAMA Neurology, researchers report on a retrospective cohort study that assessed the incidence of PD among patients with IBD and sought to identify whether anti–tumor necrosis factor (anti-TNF) therapy for IBD alters the risk of PD.

At the Academy of Managed Care Pharmacy’s Managed Care & Specialty Pharmacy Annual Meeting, held April 23 to 26, in Boston, Massachusetts, several research teams presented posters relevant to the US adoption of biosimilars.

Retinal vein occlusion (RVO) is a prevalent, vision-threatening disease, of which macular edema is a common complication. Standard treatment for RVO-associated macular edema involves intravitreal treatment with anti–vascular endothelial growth factor (anti-VEGF) agents such as ranibizumab, bevacizumab, or aflibercept. Despite success with these agents in clinical trials, anti-VEGF agents may be administered less frequently in clinical practice than in studies.

A case series was recently published in CNS Oncology that investigated whether adult pilocytic astrocytoma—a rare and highly vascular tumor—is responsive to bevacizumab treatment.

After spinal cord injury, oxidative stress, inflammation, and mitochondrial dysfunction can cause neural damage that was once believed to be both immediate and irreversible. However, neuronal death is now believed to proceed over a period of several days after initial trauma, and to include cellular, molecular, and biochemical cascades, including local inflammatory responses. Tumor necrosis factor is believed to be involved in the local production of cytokines at the site of the injury.

At the American College of Rheumatology (ACR)’s State-of-the-Art (SOTA) Symposium, held last week in Chicago, Illinois, Judith James, MD, PhD, chair of arthritis and clinical immunology at Oklahoma Medical Research Foundation, presented a talk on precision medicine in rheumatology.

The Center for Biosimilars® recaps the top 5 biosimilars articles for the week of April 16, 2018.

Rheumatologists gathered from across the country last week to discuss the latest approaches in the treatment of rheumatoid arthritis (RA) and other inflammatory diseases at the American College of Rheumatology’s (ACR) 2018 State-of-the-Art (SOTA) Clinical Symposium held in Chicago, Illinois.

Canadian patients who receive brand-name adalimumab (Humira) to treat ankylosing spondylitis (AS) are eligible for a patient support program, provided by drug maker AbbVie, that includes personalized services such as coaching phone calls before and after initiating treatment.

Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care, told The Center for Biosimilars® in an interview that, as his practice has begun to implement the Oncology Care Model, it has moved 100% of its patients to biosimilar filgrastim, Zarxio, from the reference filgrastim, Neupogen.

AbbVie reports that the trial of 15 mg of orally-administered, once-daily upadacitinib met its primary endpoints, with 71% of patients achieving 20% improvement based on American College of Rheumatology criteria (ACR20), and 29% achieving clinical remission.

Researchers demonstrated that trastuzumab increased progression-free survival (PFS) in patients with uterine serous carcinoma.

Sanofi’s list prices for Admelog are approximately 15% lower than the originator Humalog’s prices.

A recent study concludes that both hypertension and proteinuria, which are considered to be interrelated with the pharmacological action of bevacizumab, have the potential to indicate greater likelihood of therapeutic efficacy.

Data suggest that intravitreal bevacizumab increases the risk of thromboembolism, and some studies have raised the possibility of a link between bevacizumab and myocardial infarction (MI), while other studies did not find such a relationship.