Practice

The latest review seeking to reassure clinicians about the safety of switching their patients to biosimilars focuses on rheumatology indications.

The risk evaluation and mitigation strategy program for clozapine allows for patients to receive clozapine—even in the setting of moderate to severe neutropenia—if the benefit to psychiatric treatment outweighs the risk of recurrent neutropenia. However, literature that can guide appropriate treatment for such patients is limited. A recently published case report suggests that using filgrastim to control leukopenia and neutropenia could allow patients to continue to receive clozapine without interruption.

Treating ankylosing spondylitis (AS) is costly, even in high-income nations. In lower-income countries, patients may face serious challenges in accessing high-cost drugs, like anti–tumor necrosis factor agents, even when biosimilars are available.

During the 20th Asia Pacific League of Associations for Rheumatology (APLAR) Congress, held September 6 to 9 in Kaohsiung, Taiwan, researchers presented on real-world experience with switching to biosimilars in treating rheumatic diseases.

Rituximab-based immunochemotherapy can be safely applied in patients after obinutuzumab-associated anaphylaxis, but the existing risk of cross­reactivity should be considered, and careful monitoring of such patients during rituximab infusion is required.

A new study suggests that CD8+ natural killer cells are a biomarker that can predict therapeutic outcome for patients with ankylosing spondylitis who are administered anti–tumor necrosis factor agents because they are nonresponsive to conventional treatment.

Adherence and persistence rates for biologic drugs are still low in the United States, leading to suboptimal patient outcomes and putting a substantial burden on the healthcare system.

Two pivotal studies of biosimilar epoetin alfa (Retacrit) versus its reference (Epogen) in patients undergoing hemodialysis have shown that the biosimilar and the originator have comparable safety and efficacy. In the phase 3b PIEDA (Phase 3b Investigation of Erythropoietin Drugs Using a Specified Dosing Algorithm) study, investigators sought to further investigate how switching from the reference to the biosimilar affects maintenance of hemoglobin levels when using an erythropoiesis-stimulating agent dosing algorithm.

While both the biosimilar filgrastim and biosimilar pegfilgrastim were effective in reducing the incidence of neutropenia, adverse events related to granulocyte-colony stimulating factor therapy were significantly higher in patients who received pegfilgrastim.

Currently, UK eligibility criteria for starting biologics in patients with rheumatoid arthritis (RA) set a threshold of a disease activity score in a count of 28 joints of 5.1 or higher—the threshold for severe disease—on at least 2 occasions measured 1 month apart.

Pediatric Crohn disease (CD), which can have serious impacts on children’s growth, is increasing in incidence. Current treatments for pediatric patients with CD—such as corticosteroids or immunomodulators—may be particularly difficult for children to tolerate. Infliximab, however, has been shown to be effective and well tolerated in children, as a newly published phase 3 study in Japanese pediatric patients with CD found that infliximab improved clinical outcome measures from week 2 to week 56.

Regulators licensed the 3 etanercept biosimilars discussed for all of the indications of the reference drug on the basis of the extrapolation of indications, a practice that the authors say rheumatologists may find “anomalous and a source of debate.”

There was a significant difference observed in pain scores between pediatric patients receiving pegfilgrastim versus those receiving filgrastim after allogenic hematopoietic stem cell transplantation.

Because patients with rheumatoid arthritis may have compromised manual dexterity, they may have challenges with self-administering their biologic therapies. In the case of etanercept, which is typically administered once per week, device design that prioritizes ease of use can help improve patient adherence to treatment regimens.

The researchers concluded that rituximab should be considered as a preferred biologic treatment for rheumatoid arthritis (RA) therapy, though treatment of RA with any biologic medication improved quality of life significantly.

In analyzing the association between biologic-free remission maintenance and the type of biologic drugs that patients had used, a notable difference emerged between patients who used infliximab, adalimumab, or golimumab versus those who received etanercept and certolizumab pegol.

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.