Practice

With patents on reference products that treat multiple sclerosis (MS) set to expire soon in the region, a panel of experts in Latin America recently published a set of recommendations regarding the efficacy, safety, and quality of biosimilars in these countries.

“Our results suggest that in patients with a contraindication to immunotherapy, such as connective tissue, rheumatologic, or interstitial lung disease, bevacizumab may be a reasonable alternative, instead of pembrolizumab, to add to carboplatin-pemetrexed,” said lead author, Stephen J. Bagley, MD, MSCE, assistant professor of hematology-oncology at Abramson Cancer Center, in a statement.

Infliximab and its biosimilars are often used as a treatment for ulcerative colitis (UC), and recent years have seen the collection of real-world data on the use of biosimilar CT-P13 (Inflectra, Remsima) that confirm the product’s equivalent efficacy to that of the reference, Remicade. One newly published study, which assessed patient data from a French nationwide health administrative database, found that not only is biosimilar CT-P13 as effective as the reference product in treating UC, it may also have a lower risk of serious infections.

In its May 2019 network bulletin, UnitedHealthcare announced that, as of July 1, it will prefer the use of brand-name pegfilgrastim, Amgen’s Neulasta, over biosimilar options.

All children with inflammatory bowel disease (IBD) who were receiving maintenance infliximab at a single center between 2017 and 2018 were included in the study.

A study presented at the recent ISPOR 2019 meeting assessed both the cost associated with treatment with infliximab for patients at US hospitals as well as reasons for discontinuation of therapy during follow-up, and it found that insurance coverage status is one factor that plays a role in discontinuation of this therapy that rose consistently in price over the study period.

Extended stability data for the reference Herceptin have been published, supporting advanced preparation and dose banding. Given stability data for SB3 are limited, a new study sought to assess the extended physiochemical stability and bioactivity of the biosimilar and to evaluate the advanced preparation of the reconstituted and diluted product.

Patients with rheumatoid arthritis (RA) have similar rates of infection after total knee or hip replacement no matter which biologic they take, but those using glucocorticoids, even moderate doses, appear to have an increased risk of postoperative infections, according to a study published today.

Despite their benefits to patients, innovative treatments, including biologics, come at a high cost to the healthcare system, and those in a position to make coverage decisions for these products must grapple with these therapies’ affordability. During the ISPOR 2019 meeting, researchers presented findings on how health plan restrictions could limit orphan drug coverage—and encourage biosimilar use—as a means to manage their budgets.

Research presented at this week’s ISPOR 2019 meeting sheds important light on the impact of biologics on the use of other healthcare resources.

The FDA this week approved Regeneron’s aflibercept (Eylea) to treat all stages of diabetic retinopathy. The regulatory decision makes aflibercept the only anti–vascular endothelial growth factor therapy approved for 2 dosing regimens in this indication: every 8 weeks or every 4 weeks.

Patients with psoriasis taking new prescriptions of apremilast, etanercept, and ustekinumab had a decreased rate of serious infection compared with those taking methotrexate, according to an analysis of medical records from 2 large US claims databases.

A phase 3 trial of eculizumab found the drug reduced the frequency of relapse neuromyelitis optica spectrum disorder (NMOSD), an autoimmune, inflammatory disorder that typically affects the optic nerves and spinal cord.

Despite potential benefits of biosimilar adoption in terms of both patient access and healthcare system sustainability, and despite ongoing efforts at patient and provider education on biosimilars, stakeholders may continue to have concerns about perceived risks with switching. A new review of the available literature on switching—from randomized controlled trials and real-world evidence—sought to address those concerns, and said that additional education and ongoing real-world evidence collection will be necessary to increasing stakeholder comfort with these agents.

During this week’s Association for Research in Vision and Ophthalmology 2019 Annual Meeting, researchers presented new findings on the utility—and the delivery—of bevacizumab in eye disorders.

Dupuytren disease (DD), a common, fibroproliferative condition of the hand that can cause contracture of the fingers, currently has no approved treatment for its early stages, and surgical intervention is often required as the disease progresses.

The authors concluded that the physiochemical and biological analyses demonstrated that the biosimilar is not affected by reconstitution, dilution, and extended storage in infusion bags. These findings, they write, provide added reassurance to healthcare providers that the biosimilar is safe and effective under extended in-use conditions.

The American College of Rheumatology (ACR) and the Arthritis Foundation (AF) released guidelines for treating 2 subtypes of juvenile idiopathic arthritis (JIA), which affects nearly 300,000 children in the United States. One guideline discusses therapeutic approaches for non-systemic polyarthritis, sacroiliitis, and enthesitis; the other focuses on the screening, monitoring, and treatment of JIA with associated uveitis. The second guideline focuses on uveitis, which can be a chronic or acute disease.

The researchers wrote that that a numerically larger proportion of patients with myasthenia gravis (MG) stopped or reduced their doses of immunosuppressive therapies than started or increased, and that symptom improvement or worsening were the main reasons for changes to concomitant therapy.

Functional disabilities start to appear in patients with rheumatoid arthritis (RA) 1 to 2 years before diagnosis, signaling that earlier diagnosis and more aggressive treatment may lessen the burden of disease, according to a study released today.

A recent exploratory study found signs that retail pharmacies may be associated with higher nonadherence to rheumatoid arthritis (RA) medications.

This week, dermatology experts are gathering in Paris, France, for the 6th Congress of Skin Inflammation and Psoriasis International Network to discuss advances in the treatment of inflammatory skin diseases. During the congress, researchers from the University of Verona in Verona, Italy, will report findings from a study in which patients were switched between 2 different biosimilar infliximab products during treatment of chronic plaque psoriasis.

Myelodysplastic syndromes, which are a diverse group of neoplasms that arise from hematopoietic stem cells, are characterized by ineffective hematopoiesis, leading to cytopenias such as anemia and neutropenia.

Adalimumab and infliximab showed the highest discontinuation rate due to patient remission, followed by golimumab, in the study of patients with rheumatoid arthritis (RA).

After treatment withdrawal, 58.3% of patients with ankylosing spondylitis (AS) had relapsed. Half of the relapses appeared within 6 months.

During this week’s 21st Congress of the Asia Pacific League of Associations for Rheumatology and Australian Rheumatology Association, held April 8-11 in Brisbane, Australia, multiple groups of researchers are reporting on the real-world use of biosimilars in rheumatology. According to these research teams, biosimilars are proving to be effective in the real-world clinical setting.

This week, rheumatology experts will gather in Brisbane, Australia, for the 21st Congress of the Asia Pacific League of Associations for Rheumatology (APLAR) and Australian Rheumatology Association (ARA), held April 8-11. During the meeting, several groups of researchers will discuss real-world experience with biosimilar infliximab in Asia.

Intravenous golimumab and infliximab are both widely used in the treatment of rheumatoid arthritis (RA) in the United States, though these anti–tumor necrosis factor agents have markedly different dosing recommendations; patients who receive golimumab may receive 7 infusions during year 1, while patients who receive infliximab may receive between 8 and 14 infusions during year 1.

Next week, researchers from around the globe will gather in Geneva, Switzerland, for the 2019 European Lung Cancer Congress. During the meeting, multiple research teams will discuss new findings from research into the use of bevacizumab—which now has approved biosimilars that promise cost savings and expanded patient access—in nonsquamous non–small-cell lung cancer (NSCLC).

A new consensus report calls the nocebo effect underrecognized in the area of biosimilars and says that more research is needed on this important topic.