Rheumatology

Using the same dosing as treatment for lymphoma and older age were linked with higher odds of complete remission off therapy.

Study findings in patients with rheumatoid arthritis (RA), write the authors, suggest “that potentially more aggressive treatment is needed across the entire population of patients with RA."

The pan-Canadian Pharmaceutical Alliance engaged the Canadian Agency for Drugs and Technologies in Health to lead a multiphase stakeholder consultation process to encourage biosimilar uptake.

In May of 2018, drug maker Lupin announced that the European Medicines Agency would review its application for YLB113, a proposed etanercept biosimilar referencing Enbrel. This week, results of a phase 3 study of the biosimilar in patients with rheumatoid arthritis (RA) revealed the similarity of the product with its reference, and also demonstrated that the product has lower immunogenicity than the reference drug.

Increased spending on new oncology and autoimmune drugs was partially offset by a decline in price growth and the continued increase in the use of generic drugs, according to a recent report from CMS about national healthcare spending in 2018.

Drug developer Biocad received approval for its rituximab biosimilar, BCD-020 (Acellbia) in Russia in 2014, and since that time, the drug has been launched in Russia and in multiple other markets around the world. While Biocad has not specified whether it plans to pursue regulatory approval for the biosimilar in the European Union, the company has announced ambitions to enter the EU market with some of its products, and researchers have published new data for the biosimilar in both oncology and rheumatology indications.

Amgen and pharmacy benefit manager (PBM) Abarca this week announced that they have entered into an outcomes-based contract for brand-name etanercept, Enbrel.

A recent study assessed tofacitinib versus anti–tumor necrosis factor (anti-TNF) agents using data from the Corrona registry, a large, prospective, observational database of patients with rheumatoid arthritis (RA) in more than 174 practices in 41 US states.

The issue of whether to switch patients currently taking biologics to biosimilars has been playing out in Canada over the past week, as mandated switching begins in British Columbia, while a reference product maker fights against a possible similar change in 2 other provinces.

Celltrion Healthcare announced that the European Commission has authorized Remsima SC, a subcutaneously administered formulation of its biosimilar infliximab, CT-P13, for the treatment of rheumatoid arthritis. The product is the first subcutaneous infliximab option to be approved in any regulatory territory.

Nordic countries have had some of the highest rates of biosimilar use, and extensive registry data in these countries also allow for observational studies of biosimilar use in real-world clinical practice. A new study used data from 5 such registries—which included more than 2000 patients with spondyloarthritis—to assess retention rates for those treated with biosimilars or reference products of etanercept and infliximab.

Biosimilar infliximab CT-P13 (Inflectra, Remsima) has been the subject of numerous studies since its authorization in multiple regulatory territories, and this month, data from the Korean College of Rheumatology Biologics (KOBIO) registry add to the growing body of knowledge about this biosimilar’s use in patients with rheumatoid arthritis in routine clinical practice.

A recent review explored the evidence of monoclonal antibodies (mAb) and fusion proteins (FP) to examine their safety and efficacy in the most common chronic inflammatory diseases in children—bronchial asthma, psoriasis, juvenile idiopathic arthritis (JIA), and chronic inflammatory bowel diseases (IBD).

The FDA has approved Pfizer’s adalimumab biosimilar, Abrilada (adalimumab-afzb), referencing Humira.

As the only anti–tumor necrosis factor therapies currently available to US patients with inflammatory diseases, biosimilars of infliximab are increasingly used to treat diseases like rheumatoid arthritis. While there are a wealth of data on real-world use of these products in territories like the European Union, less research has examined their use in the United States. During the American College of Rheumatology’s 2019 meeting, held this week in Atlanta, Georgia, researchers reported on the results of 3 studies that assessed real-world use of biosimilar infliximab in the US context.

The lead author said the results indicate that biologics can be used in older patients with rheumatoid arthritis (RA) as effectively as in those who are younger.

While US patients continue to wait for a biosimilar etanercept to become commercially available, real-world data continue to amass for Samsung Bioepis’ biosimilar, SB4, in European clinical practice. The biosimilar, sold as Benepali in the European context, was the subject of several studies presented this week at the American College of Rheumatology’s 2019 meeting, held in Atlanta, Georgia.

Among the first biosimilars to gain US approval was Sandoz’s etanercept biosimilar, GP2015, or Erelzi. The product was authorized by the FDA in 2016, but it has not yet launched in the US market due to long-running patent disputes related to Amgen’s innovator product, Enbrel. In other markets, however, the biosimilar is a widely used treatment option, and data presented at the American College of Rheumatology’s 2019 meeting, held this week in Atlanta, Georgia, show that not only is the biosimilar safe and effective in real-world practice in ex-US markets, but it could also bring about substantial savings in the United States once it becomes available.

Elaine Husni, MD, MPH, vice chair and director of the Arthritis and Musculoskeletal Center in the Orthopedic and Rheumatologic Institute at the Cleveland Clinic, discusses how comfortable rheumatologists are with using biosimilars.

The results will inform will inform counseling and management of pregnant women with inflammatory diseases who need tofacitinib or non-tumor necrosis factor inhibitors during pregnancy, said the author.

Improvements in biosimilars—ones that may give them an advantage such as lower immunogenicity or a new route of administration—may be the key to unlocking a better patient experience, according to Celltrion. In fact, pursuing such so-called “biobetters” may prove to be more important for the drug maker than pursuing interchangeable biosimilars.

Postmarket drug price changes alone accounted for most of the recent spending growth on biologics, and manufacturers’ rebates had little impact, according to an abstract presented at the American College of Rheumatology’s 2019 meeting, being held in Atlanta, Georgia, this week.

Over the past few years, awareness of biosimilars has been increasing; however, research presented at the American College of Rheumatology’s 2019 meeting, being held in Atlanta, Georgia, shows that while US rheumatologists hold growing awareness of biosimilars, hesitancy remains around such issues as switching stable patients and the extrapolation of indications.

On Sunday, during the American College of Rheumatology (ACR)’s 2019 meeting, being held in Atlanta, Georgia, researchers reported on the safety and efficacy of the proposed infliximab biosimilar ABP 710 in a phase 3 study of patients with rheumatoid arthritis (RA). Researchers also reported on a phase 1 and 3 study of the proposed rituximab biosimilar, ABP 798, in patients with RA.

A recent study from Romania examined the efficacy and safety of biosimilar etanercept SB4 (Benepali) compared to originator etanercept in a real-life cohort of patients with rheumatoid arthritis (RA).

Novartis Friday announced results from a head-to-head trial of its secukinumab (Cosentyx) versus adalimumab in patients with active psoriatic arthritis (PsA), saying its therapy missed statistical significance for its primary end point.

Researchers reported on 1-year follow-up among patients at 2 centers, all of whom had psoriasis or psoriatic arthritis, after Brazilian health authorities issued a 2017 mandate that patients being treated with the reference infliximab be switched to CT-P13, and that new starts be given the biosimilar instead of the reference.

The Japanese Adverse Drug Event Report (JADER) database, a large, published database managed by the Pharmaceuticals and Medical Devices Agency for pharmacovigilance, collects spontaneous reports as a means to detect adverse events (AEs) related to drugs, and a newly published study used the JADER data to assess AEs related to the reference infliximab and to the biosimilar, CT-P13.

The Institute for Clinical and Economic Review (ICER), a nonprofit health technology assessment body, has issued an updated report on treatments for rheumatoid arthritis (RA) in which it says that the Janus kinase (JAK) inhibitor upadacitinib has a marginal clinical benefit over adalimumab and an "incremental cost-utility ratio falling below commonly cited thresholds.”

In treating patients with moderate to severe psoriasis, Samsung Bioepis’ etanercept biosimilar, approved in the European Union as Benepali and in the United States as Eticovo, was shown to be effective in a registry study.