Practice

One week after intravitreal bevacizumab injection, corneal endothelial cells showed no sign of inflammation or any other complications, according to a study published in BMC Ophthalmology.

Although corticosteroids are a mainstay of treatment for immune reconstitution inflammatory syndrome (IRIS), some patients with HIV are refractory to corticosteroid therapy. Infliximab may be useful in treating IRIS, but little is known about patients who are also refractory to infliximab therapy.

A multi-center retrospective study of Japanese patients, newly published in PLOS One, sought to describe treatment persistence and reasons for discontinuation among patients who were treating their rheumatoid arthritis with 1 of 7 biologic agents: adalimumab, etanercept, infliximab, golimumab, certolizumab pegol, tocilizumab, and abatacept.

Biosimilars of eculizumab, which have the potential to reduce costs for both patients and the healthcare system, have been eagerly awaited, yet many drug makers are developing novel anti-C5 agents.

Data on the use of rituximab in treating patients with systemic lupus erythematosus (SLE) has been far from clear; 2 randomized controlled trials of rituximab in patients with SLE failed to meet their primary endpoints, while open-label trials have reported the drug’s efficacy in this indication.

Patients without comorbidities who received subcutaneous trastuzumab with their chemotherapy and endocrine therapy showed a significant improvement in emotional function, and reported that they were less upset by hair loss than the patients in the control group.

Randomized controlled trials have established the clinical efficacy and safety of infliximab in treating fistulizing Crohn disease (CD), and while evidence for adalimumab and vedolizumab in this indication is weaker, these drugs are also used in clinical practice, sometimes in treatment sequences of biologics, to treat fistulizing CD. In Europe, where access to biologic drugs is largely driven by budgetary considerations, biosimilars have the potential to improve access to treatment.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of March 5, 2018.

Anti–tumor necrosis factor (anti-TNF) treatment has revolutionized the management of ankylosing spondylitis (AS), but 20% to 30% of patients discontinue treatment due to failure or inadequate response to treatment. That being said, anti-TNF therapies are structurally different and have different mechanisms of action; consequently, unsuccessful treatment with 1 anti-TNF drug does not determine a patient’s potential response to another.

Gillian Woollett, MA, DPhil, senior vice president of Avalere and leader of the company’s FDA practice, told The Center for Biosimilars® in an interview that a study she co-authored is aimed at reassuring all biosimilar stakeholders that, “even though no clinical differences are expected when patients are switched from a reference product to a biosimilar, indeed none are found. Hence, we confirm the expectation already established through the application of sound regulatory science.”

A recent study analyzed the long-term efficacy and safety profile of anti–tumor necrosis factor (anti-TNF) treatment in 15 patients with rhupus, a rare association defined by the coexistence of both systemic lupus erythematosus and rheumatoid arthritis (RA) in the same patient.

To determine whether a course of 300 ug of filgrastim, administered daily for 2 days, achieves the same clinical outcomes that have been reported with the recommended dosage, and whether such a dose could provide cost savings, investigators from Marshall University performed a retrospective chart review to identify all patients at their institution with chemotherapy-induced neutropenia who were treated with 2 consecutive doses of 300 ug of filgrastim between September 2011 and September 2016.

In an effort to evaluate whether switching from a reference biologic to a biosimilar could lead to altered clinical outcomes—such as enhanced immunogenicity, compromised safety, or reduced efficacy—a research team, led by Hillel Cohen, PhD, conducted a systematic literature review of all available switching studies.

The proposed biosimilar references Genentech’s Pulmozyme, a biologic first approved in the early 1990s in both the European Union and the United States. Pulmozyme is used in conjunction with other therapies to improve pulmonary function in patients with cystic fibrosis.

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of February 26, 2018.

February 2018 saw a number of developments for biosimilars that treat inflammatory bowel disease, with new studies from around the globe adding to the body of data on these therapies.

In a recently published editorial in The Official Journal of the World Federation of Hemophilia, author Angela Thomas, MB, PhD, discusses the advancements in hemophilia treatment as well as the place biosimilars may or may not have in reducing the cost of care.

The American College of Rheumatology (ACR) has updated its health policy statements for 2018, and biosimilars featured heavily in the organization’s concerns for the year ahead.

A recently published editorial linked to a previous switching study for patients who had been receiving reference infliximab (Remicade) to biosimilar infliximab (Inflectra) argues that the positive results of the trial “apparently settles the case in favor of unrestricted switching of 'expensive' originator to 'cheap' biosimilar infliximab. Yet, the devil is the details."

The Center for Biosimilars recaps the top 5 biosimilars articles for the week of February 19, 2018.

A study published in Alimentary Pharmacology Therapeutics in December 2017 compared the outcomes, pharmacokinetics, and immunogenicity of treatment intensification strategies in patients with Crohn disease (CD) who have lost clinical response to the anti–tumor necrosis factor (anti-TNF) therapy infliximab.

In an animal model of bleomycin-induced lung toxicity, filgrastim increased alveolar neutrophil recruitment, pulmonary edema, and lung myeloperoxidase activity. That finding led to concerns about whether filgrastim could increase pulmonary toxicity when used together with adriamycin, bleomycin, vinblastine, and dacarbazine regimens.

Patients with rheumatoid arthritis (RA) who use corticosteroids can delay the initiation of biologic disease-modifying antirheumatic drugs (DMARDs), have higher incidence of adverse events (AEs), and have more healthcare costs before the initiation of biologic DMARDs than patients who do not use corticosteroids.

Last week, at the European Crohn's and Colitis Organisation's 13th annual congress in Vienna, Austria, researchers presented data from the NOR-SWITCH EXTENSION trial—a 26-week open label extension of the NOR-SWITCH trial—concerning the inflammatory bowel disease (IBD) subgroup.

At the recent European Crohn's and Colitis Organisation’s 13th Congress in Vienna, Austria, several studies investigated the efficacy of infliximab biosimilars in treating Crohn disease (CD), ulcerative colitis (UC), and rheumatoid arthritis (RA).

While corticosteroids are a common treatment for uveitis, effective corticosteroid-sparing therapies are necessary to maintain disease control without risking corticosteroid-related adverse events.

At the European Crohn’s and Colitis Organisation’s 13th annual congress, held in Vienna, Austria, a number of studies explored switching from reference infliximab to its biosimilar.

Today, at the 13th Congress of the European Crohn’s and Colitis Organisation (ECCO), researchers released 12-month data from the Personalized Anti–Tumor Necrosis Factor (anti-TNF) Therapy in Crohn Disease (CD) Study (PANTS).

This week, the American Society of Clinical Oncology (ASCO) released a new statement that seeks to offer clinicians guidance on the use of biosimilars in oncology as a wave of patent expirations is expected to bring more anti-cancer and supportive care biosimilars to the US market.

The TITRATE study is designed to investigate whether intensive management of RA leads to a greater number of remissions at 12 months, in addition to examining levels of disability, quality of life and acceptability, and cost-effectiveness.