Practice

While the United States is still awaiting the launch of the first FDA-approved biosimilar epoetin alfa, erythropoiesis-stimulating agents were among the first biosimilars to become available in Europe. This month, Italian researchers published a post-authorization observational study that compared the efficacy and safety of 2 European biosimilars and the reference epoetin alfa in patients undergoing dialysis at 26 hospitals in 4 regions in Italy, and they concluded that their results support the comparable safety profiles of the originator and biosimilar products.

This Psoriasis Awareness Month, a new review of real-world experience with adalimumab (Humira) in patients with psoriasis finds that adalimumab is slightly less safe, but has better effectiveness and drug survival, than other biologic treatment options.

Combination treatment is typically more effective than treatment with methotrexate alone, but some patients may experience adverse events with methotrexate that make monotherapy desirable.

Teva announced this week that the FDA has approved its tbo-filgrastim (Granix), a follow-on product referencing Neupogen, to reduce the duration of severe neutropenia in patients as young as 1 month old who have nonmyeloid malignancies and are receiving myelosuppressive chemotherapy.

The Institute for Clinical and Economic Review (ICER) explains that, compared with anti–tumor necrosis factor (anti-TNF) drugs, both guselkumab and risankizumab offered a superior benefit based on currently available data.

During the 2018 annual conference of the United Kingdom and Ireland’s Prescribing and Research in Medicines Management, investigators reported on 2 questionnaire-based studies that highlighted the critical importance of provider education in the prescribing of biologics and biosimilars.

Pfizer’s Ixifi, a biosimilar infliximab product that was approved for all indications of its reference in the United States in December 2017, received FDA clearance with a data package that included findings from a phase 3, randomized, double-blind, active-controlled, multinational study comparing the biosimilar with the reference infliximab in combination with methotrexate in patients with rheumatoid arthritis (RA). The data were presented in an abstract at the American College of Rheumatology’s annual meeting in 2017, and the results for the initial 30-week treatment period have now been published in Arthritis Research and Therapy.

The updated treatment approach will allow clinicians, based on individual patients’ outcomes, to lengthen the intervals between injections for patients with neovascular age-related macular degeneration (AMD) who are already in the first year of treatment. That could mean fewer injections and fewer trips to the clinic for patients with AMD.

While data are becoming more numerous on the feasibility of withdrawing a biologic from a patient who has reached low disease activity (LDA) on combination therapy, data concerning the ability to maintain a treatment target on biologic monotherapy are fewer. A new, post-hoc study reported that adalimumab, used as monotherapy, led to positive clinical, functional, and radiographic outcomes in patients with RA for up to 3 years in more than half of patients who reached LDA after combination therapy.

Rituximab, primarily used as a second-line biologic therapy, was used in a cost-saving and adverse-event reducing on-demand schedule in 94.6% of patients; these patients were assessed for signs of relapse and the need for another rituximab infusion at their regularly scheduled visits, and they also had the option of contacting a healthcare provider by phone if they felt that they were relapsing.

Six months after patients switched from reference infliximab to biosimilar infliximab, there was no meaningful increase in patients’ outpatient healthcare use, according to a new study.

In a recent study, only 44.5% of patients with psoriatic arthritis (PsA) persisted with their index biologic for 12 months or more.

At the American Diabetes Association’s 78th Scientific Sessions, researchers presented ways in which education—for both patients and providers—can help improve the care of patients with diabetes who use biosimilar or follow-on insulins.

Biosimilars of anticancer monoclonal antibodies are emerging in the therapeutic landscape, and while the body of evidence concerning switching to supportive care biosimilars—epoetin and filgrastim biosimilars—is robust, there are fewer data available concerning a switch to biosimilars of products such as rituximab, trastuzumab, and bevacizumab.

Transitioning from reference adalimumab (Humira) to Amgen’s FDA- and EU-approved adalimumab biosimilar ABP 501 (Amgevita) was not associated with increased immunogenicity over an observation period of 72 weeks in patients with rheumatoid arthritis, according to the results of a study presented at the European Congress of Rheumatology.

Italian researchers report that 72% of their trial participants being treated for psoriatic arthritis achieved sustained remission with ETN 25 mg biweekly, which was maintained a year after treatment initiation.

A survey of German patients who used a prefilled pen for subcutaneous delivery of biosimilar etanercept SB4 has reported a very high level of patient satisfaction with the product following an interim analysis.

Catch up on the week’s top rheumatology, gastroenterology, clinical practice, regulatory, policy, and business news from the world of biosimilars.

In the short term, nonmedical switching (NMS) of stable patients with a rheumatic condition from originator biologics to biosimilars could have “considerable” short-term costs for a rheumatology medical center, according to a study presented at the annual European Congress of Rheumatology.

Intravenous administration of the anti–vascular endothelial growth factor treatment bevacizumab at high doses can result in serious, systemic adverse events (AEs). Additionally, tumors can become resistant to therapy and adopt a more invasive growth pattern. Thus, delivering bevacizumab for the treatment of cancer at a lower dose in a manner that avoids systemic AEs is necessary.

Eales disease (ED) is a common, idiopathic, inflammatory retinal vasculitis that particularly affects young adults. Current treatments available for ED include corticosteroids, laser photocoagulation, retinal cryotherapy, and surgery, but a recent study found that using intravitreal bevacizumab injections may produce better outcomes and reduce the need for surgery.

This month saw a variety of developments in the world of biosimilar drugs for the treatment of rheumatic diseases.

While managing costs is extremely important to physicians and their patients, achieving and maintaining disease control without increasing the risk of complications or toxicities must remain the primary goal in the treatment of chronic inflammatory diseases.

Here are the top 5 biosimilars articles for the week of June 25.

Intestinal Behçet disease (BD), which is an immune-mediated, chronic, inflammatory intestinal disease, can be difficult to treat, in part because the pathogenesis of intestinal BD is unclear. However, as data for using anti–tumor necrosis factor (anti-TNF) drugs have been accumulating in the treatment of inflammatory bowel disease (IBD), which has a similar clinical presentation, the potential to treat BD with these agents is under investigation.

New International League of Associations for Rheumatology (ILAR) recommendations are now available for the treatment of patients with psoriatic arthritis living in resource-poor regions, including Central and South America and Africa.

Catch up on the week’s top rheumatology, gastroenterology, neurology, clinical practice, advocacy, regulatory, policy, and business news from the world of biosimilars.

During the fourth congress of the European Academy of Neurology, held in Lisbon, Portugal, from June 16 to 19, researchers presented on the roles of both existing and investigational anti-CD20 drugs in treating neurological diseases.

Anti–tumor necrosis factor (TNF) agents, widely used in rheumatology and gastroenterology, carry some safety risks. While the risk of infection or malignancy are common concerns, neurological complications, while rare, are also possible.

A new study, published in Alimentary Pharmacology and Therapeutics, sought to test antigenic comparability between the reference infliximab and the biosimilar.