Rheumatology

One recent paper analyzed data from 3 studies on down-titration of etanercept in patients with rheumatoid arthritis (RA) and concluded that patients who have achieved disease control according to a stringent definition have a greater likelihood of remaining in remission after reducing their dose or withdrawing etanercept.

Results of a phase 3 trial of IBI303, a proposed adalimumab biosimilar referencing Humira, showed that it is therapeutically equivalent in terms of efficacy, safety, and immunogenicity to the originator product, according to a study published in the first issue of The Lancet Rheumatology.

A new paper published this month may help to allay some concerns that US providers may have about using FDA-approved biosimilar rituximab.

Amgen announced yesterday that it will acquire apremilast (Otezla) from Celgene. The small-molecule drug, which inhibits phosphodiesterase 4, specific for cyclic adenosine monophosphate, is an orally administered therapy for patients with psoriatic arthritis and patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.

Along with innovations in design comes the question of patients’ willingness to pay for features that differentiate self-injection devices from one another.

Fewer than one-third of patients newly diagnosed with rheumatoid arthritis (RA) used anti–tumor necrosis factors agents, other biologics, Janus kinase inhibitors, or conventional disease-modifying antirheumatic drugs in 2014.

Upadacitinib is expected to help AbbVie continue to lead in the immunology market after biosimilar competition emerges for adalimumab in 2023. The approval for the treatment of RA is one of 6 indications that AbbVie’s chief executive officer, Richard Gonzalez, said in a 2018 presentation that the company expects to have approved and launched by 2022.

LG Chem’s biosimilar etanercept, LBEC0101, referencing Enbrel, recently gained approval in Japan and the Republic of Korea. Among the data that led to its authorization were those deriving from a phase 3 study that demonstrated the biosimilar had equivalent efficacy and a comparable safety profile to the reference product. Recently, researchers reported on a single-arm, open-label extension study in patients with rheumatoid arthritis (RA) who completed the 52-week phase 3 study.

Bio-Thera Solutions, a global biotechnology company based in Guangzhou, China, says it began a phase 1 study of BAT2506, a proposed golimumab biosimilar referencing Simponi.

This month, researchers published data from a phase 3 study of the biosimilar in patients with moderate to severe rheumatoid arthritis (RA) after previous phase 3 data were reported for a study in patients with severe plaque psoriasis.

Among the patients who viewed positively framed video explanations of biosimilars, 67% were willing to switch.

The study was conducted in patients with moderately to severely active rheumatoid arthritis who previously completed the VOLTAIRE-RA study.

Anti–tumor necrosis factor medicines are one of the costliest drugs for many health systems, and in the United Kingdom, a recent article described how one clinical commissioning group managed the switch of patients on the originator etanercept (Enbrel) to a biosimilar (Benepali) using a fixed-price model.

Samsung Bioepis’ etanercept biosimilar, SB4, has been available in multiple markets since it was authorized by the European Commission in 2016, and this week, a new systematic review reported on real-world evidence on the use of the biosimilar in treating inflammatory diseases.

Data continue to accrue on the use of biosimilar infliximab, CT-P13 (Inflectra, Remsima), in a variety of disease states, and a recent study among patients with ankylosing spondylitis (AS) who were treated with the biosimilar demonstrated infrequent discontinuation of therapy.

Celltrion announced that it has begun recruiting patients with inflammatory bowel disease in Ohio for a phase 3 clinical trial of its subcutaneous formulation of biosimilar infliximab, CT-P13 (Inflectra, Remsima). The study is intended to support an application for the formulation to the FDA.

Mixed cryoglobulinemic vasculitis—a rare disorder that is characterized by the presence of abnormal proteins in the blood that become insoluble at low temperatures and restrict blood flow—may be successfully managed with the use of rituximab as a generally well tolerated, glucocorticoid-sparing therapy.

A patient-level simulation model using real-world data from Finland evaluated the cost-effectiveness of abatacept, tocilizumab, and anti–tumor necrosis factor (anti-TNF) therapies as compared with rituximab in patients with rheumatoid arthritis (RA) who received previous treatment with an anti-TNF agent.

The FDA has approved Pfizer’s rituximab biosimilar, Ruxience (rituximab-pvvr), referencing Rituxan. The biosimilar was approved to treat non-Hodgkin lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis.

Celltrion formed Vcell Healthcare Limited with Nan Fung Group with the aim of commercializing 3 biosimilars in China.

Patients with inflammatory diseases in the United States continue to wait for the availability of a biosimilar etanercept, despite the 2016 approval of Erelzi and the 2019 approval of Eticovo. However, in the European context, biosimilar etanercept is already available, and recently presented data demonstrate that, in some countries, use of the biosimilar is high and making an impact on healthcare costs.

A variety of policy proposals have been put forward to help spur the US uptake of biosimilars, from legislative solutions to regulatory changes, but some providers are taking the matter into their own hands with concerted efforts to bring biosimilars to the clinic.

As more health systems seek to make use of the cost savings associated with biosimilars, data continue to accrue to support switching patients to these products. One recent paper, published in The Journal of Clinical Medicine, reported that, after a switch from reference infliximab to biosimilar CT-P13 (Inflectra, Remsima), patients with ankylosing spondylitis (AS) who switched to the biosimilar remained in remission at 18 months post-switch.

This week, Mylan launched its biosimilar adalimumab, Hulio, in Spain. The biosimilar, referencing Humira, was developed by Mylan’s partner, Fujifilm Kyowa Kirin Biologics, and received European authorization in September 2018.

Biosimilar developer Samsung Bioepis has gained an updated label for its biosimilar adalimumab, Imraldi, referencing Humira. The biosimilar is now approved for storage in nonrefrigerated conditions for up to 28 days. This update means that the biosimilar can now be stored for an additional 2 weeks at room temperature.

A recently published study used data from the RA-BEAM trial to assess what proportion of treated patients achieve pain relief and in what time frame, and found that an oral small-molecule Janus kinase (JAK) inhibitor may have some advantages over adalimumab (Humira) when it comes to reducing rheumatoid arthritis (RA) pain.

The multicenter, randomized, noninferiority, double-blind, controlled trial was conducted in China among 554 patients with active ankylosing spondylitis.

Given the head-to-head data from the SPIRIT trial, Humira maker AbbVie may face even further challenges in trying to maintain its sales as newer products like ixekizumab advance in such therapeutic areas as psoriatic arthritis (PsA).

Recently, researchers reported 72-week results from a phase 3 trial of biosimilar rituximab, CT-P10 (Truxima), in patients with rheumatoid arthritis (RA), in which they concluded that the product was well tolerated in long-term use and that switching from the reference did not yield differences in safety, efficacy, pharmacodynamics, or immunogenicity.

Korean drug maker Celltrion Healthcare recently presented new findings from a 2-part study at the European League Against Rheumatism European Congress of Rheumatology 2019 meeting about subcutaneous biosimilar CT-P13 (Inflectra, Remsima).