Rheumatology

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.

As legislators consider policy and regulatory options to lower the cost of prescription drugs, the American College of Rheumatology (ACR) is calling for an end to step therapy (or sometimes called “fail first” policies) as well as the switching of medications in stable patients purely for cost reasons.

Fresenius Kabi announced today that it has received its first European marketing authorization for a biosimilar. The European Commission granted the drug developer approval for its adalimumab biosimilar, Idacio, for all indications of the reference product, Humira.

Recently, a study sought to determine whether dose reductions of anti–tumor necrosis factor (anti-TNF) therapies are possible for long-term treatment of spondyloarthritis, and found that a reduced dose is noninferior to a full dose in patients in sustained clinical remission.

Like all biologics, infliximab has the potential for immunogenicity, and the development of antidrug antibodies (ADAs) can lead to loss of response or hypersensitivity reactions. A newly published paper sought to evaluate the development of a cellular response to infliximab and whether such a response could predict ADA development.

In a paper published last week in ACR Open Rheumatology, researchers reported that although patients had some concerns about safety and efficacy, overall, they were satisfied with the switch to a biosimilar.

Recently, a new study sought to examine treatment patterns in US patients new to anti–tumor necrosis factor (anti-TNF) therapy, and it found that a majority of patients, particularly women, do not remain on their first anti-TNF after 2 years.

In February, the FDA issued a drug safety communication on tofacitinib (Xeljanz), an oral, small-molecule Janus kinase (JAK) inhibitor. According to the FDA communication, a clinical trial in patients with rheumatoid arthritis who were taking an as-yet unapproved 10-mg dose of tofacitinib twice each day found an increased risk of blood clots and death.

AbbVie has announced that the FDA has accepted for priority review its New Drug Application for upadacitinib for the treatment of rheumatoid arthritis (RA). Upadacitinib is a proposed once-daily, small-molecule, oral Janus kinase inhibitor that, if approved, could be an alternative to therapy with such injectable biologics as AbbVie’s flagship RA treatment, adalimumab (Humira), which will face biosimilar competition in the United States by 2023.

While the United States continues to await the launch of the first FDA-approved biosimilar etanercept (Erelzi), in other parts of the world biosimilars of the reference etanercept (Enbrel) are being widely used in clinical practice, and recent research reports on the role that biosimilar etanercept plays in the treatment of ankylosing spondylitis (AS).

GP2013, a biosimilar rituximab developed by Sandoz and licensed in the European Union under the brand names Rixathon and Riximyo, is used to treat both malignant and inflammatory diseases. A recently published paper, appearing in Arthritis Care and Research, says that researchers detected no safety risks when switching patients with rheumatoid arthritis from reference rituximab (Rituxan) to the biosimilar.

New research, published in BioDrugs, underscores the long-term efficacy and safety of treating rheumatoid arthritis (RA) with biosimilar rituximab, CT-P10.

In a newly published correspondence, Italian rheumatology providers called into question whether recently published results from the DANBIO registry can be used to guide non-medical switching from reference etanercept (Enbrel) to biosimilar SB4 (Benpali) in patients with inflammatory diseases.

The assumption that Medicare Part B payment rates lead providers to create higher drug utilization for costlier treatments in order to benefit from larger add-on payments is not correct, a recent white paper said. The paper from Xcenda, a part of AmerisourceBergen, also found similar results when looking at physician-administered drugs in the hospital outpatient setting.

Biosimilar adalimumab is making its way to patients, some of whom have expressed concerns about the presence of citrate in some of the available biosimilars.

In observational studies of patients who have switched treatment from a reference biologic to a biosimilar, some higher rates of discontinuation have been observed when these studies are compared with blinded switching studies.

Bio-Thera Solutions, a China-based biosimilar developer, announced that it has dosed the first patients in its phase 3 clinical study of BAT1806, a proposed biosimilar tocilizumab referencing Actemra, an interleukin-6 inhibitor.

Amgen and Allergan today announced positive topline results of a combined phase 1 and phase 3 study evaluating ABP 798, a proposed biosimilar rituximab, in comparison with the reference Rituxan in patients with rheumatoid arthritis.

Despite the fact that biosimilars have a longer history in the European Union than in the United States, many European patients still lack awareness of these medicines, and data suggest that a lack of awareness may be keeping patients from adhering to their therapies.

Sandoz’s biosimilar etanercept, Erelzi, referencing the brand-name Enbrel, has been granted an indication for the treatment of psoriatic arthritis by Health Canada.

In a recent comparability analysis, a proposed biosimilar to etanercept (that the developers hope to sell as Altebrel) underwent direct comparison to the reference and was found to have a high similarity in terms of glycosylation, primary structure, and in-vitro functionality.

Researchers recently sought to evaluate the efficacy and safety of infliximab biosimilar CT-P13 in the treatment of Takayasu arteritis (TAK), a granulomatous inflammatory vasculitis that affects the aorta and can cause aneurysms to form. Some patients with TAK benefit from corticosteroids or second-line, small-molecule immunosuppressive agents, but there is a demand for more effective therapeutic options.

When Celltrion and Teva’s biosimilar rituximab, CT-P10, earned FDA approval under the brand name Truxima in late 2018, it was authorized only for oncology indications, as the drug’s sponsors did not seek indications in inflammatory diseases because of issues related to patent exclusivity on some indications. However, the biosimilar has shown efficacy in treating rheumatoid arthritis (RA), and a European analysis found that the budget impact of introducing CT-P10 could dramatically reduce the cost to treat severe RA.

Drug maker Mycenax has reported positive phase 1 data for its proposed biosimilar tocilizumab, referencing Actemra.

Drug maker Amgen announced this week that it has submitted a Biologics License Application (BLA) for ABP 710, a proposed infliximab biosimilar referencing Remicade.

This week, the American College of Rheumatology and the National Psoriasis Foundation released a new treatment guideline for psoriatic arthritis (PsA) that contains evidence-based recommendations on caring for patients with this inflammatory disease.

Celltrion has announced that the European Medicines Agency (EMA) has accepted for review an extension marketing authorization application for a subcutaneous formulation of the company’s biosimilar infliximab, CT-P13 (sold in Europe as Remsima and in the United States as Inflectra).

This morning, the United Kingdom’s National Health Service (NHS) announced that it has completed negotiations over using the best-value adalimumab product, and it has arrived at a plan whereby it will save £300 million (approximately $386 million) of its current £400 million-per-year (approximately $514 million) spending on adalimumab.

Despite the extensive body of literature on rheumatoid arthritis (RA), the exact causes of the disease are not fully understood. Tumor necrosis factor alpha (TNF) is known to play a key role in the disease by stimulating catabolic processes and causing inflammation, and important elements of inflammation include changes in extracellular matrix compounds and their constituents, such as glycosaminoglycans.

As more biosimilars make their way to patients in the United States and Europe, stakeholders seek reassurance on switching to these products. A newly published systematic review sought to investigate the safety and efficacy of switching between reference and biosimilar infliximab in patients with inflammatory disorders.