Rheumatology

Italian researchers report that 72% of their trial participants being treated for psoriatic arthritis achieved sustained remission with ETN 25 mg biweekly, which was maintained a year after treatment initiation.

A survey of German patients who used a prefilled pen for subcutaneous delivery of biosimilar etanercept SB4 has reported a very high level of patient satisfaction with the product following an interim analysis.

Catch up on the week’s top rheumatology, gastroenterology, clinical practice, regulatory, policy, and business news from the world of biosimilars.

In the short term, nonmedical switching (NMS) of stable patients with a rheumatic condition from originator biologics to biosimilars could have “considerable” short-term costs for a rheumatology medical center, according to a study presented at the annual European Congress of Rheumatology.

Research presented at the European League Against Rheumatism’s Annual European Congress of Rheumatology concluded that patients’ attitudes and level of satisfaction with switching to a biosimilar for etanercept or infliximab was associated with their level of health literacy, defined as being given sufficient and necessary information concerning their health.

New International League of Associations for Rheumatology (ILAR) recommendations are now available for the treatment of patients with psoriatic arthritis living in resource-poor regions, including Central and South America and Africa.

The study, conducted in 80 patients with rheumatic diseases who elected to switch from treatment with originator etanercept to biosimilar etanercept, found that 80% were willing to switch, and switching did not affect treatment effectiveness during 1 year of follow up.

Guidelines recommend that disease activity should be assessed every 1 to 3 months in patients with high or moderate disease activity, and every 6 to 12 months in those with low disease activity or remission, but implementation of these principles has not been well evaluated in the United States.

Rituximab has previously been shown to be effective at doses of 1000 mg in treating patients with rheumatoid arthritis (RA) who had previously received other biologic agents. Research presented at the European League Against Rheumatism's Annual European Congress of Rheumatology demonstrates that using lower doses of biosimilar rituximab—which may provide a substantial cost savings—is also effective.

At the European League Against Rheumatism Annual European Congress of Rheumatology, researchers presented findings on 3 studies in which patients switched to a biosimilar etanercept molecule from the reference Enbrel.

This week, the American College of Rheumatology (ACR) released a new position statement on the importance of pharmacovigilance and the critical need to continue monitoring new drugs after they reach the market.

During the European League Against Rheumatism’s Annual European Congress of Rheumatology, held from June 13-16 in Amsterdam, Netherlands, researchers presented findings on adalimumab biosimilars, referencing Humira.

At the European League Against Rheumatism (EULAR)'s Annual European Congress of Rheumatology, held from June 13-16 in Amsterdam, Netherlands, researchers reported on Biocad’s Russian-authorized biosimilar infliximab, BCD-055, and on switches to the widely approved infliximab biosimilar CT-P13 (Inflectra, Remsima).

During the European League Against Rheumatism’s Annual European Congress of Rheumatology, researchers published findings on the economic impacts of nonmedical switching; while 1 study found that switching to biosimilar infliximab brought down costs without sacrificing efficacy or safety, but another raised concerns about increases in overall healthcare utilization.

If European League Against Rheumatism guidelines are followed, when a patient with rheumatoid arthritis (RA) does not reach remission or a state of low disease activity after 6 months of treatment, then the patient’s treatment should be modified regardless of the drug therapy being used (biologic or small molecule).

Two biosimilar developers today announced that they have received positive opinions for products from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

Boehringer Ingelheim’s (BI) adalimumab biosimilar, Cyltezo, can be successfully self-administered—via auto-injector—by most patients with rheumatoid arthritis (RA).

While it is already known that obesity may contribute to an increased risk developing some immune-mediated inflammatory diseases, as well as more severe disease activity and a higher burden of hospitalization, a new review found that obesity is also a predictor of inferior response to anti–tumor necrosis factor (anti-TNF) agents.

The authors of a recent study report that the addition of a disease-modifying anti-rheumatic drug (DMARD) or a switch to ustekinumab showed greater efficacy than changing anti–tumor necrosis factor (anti-TNF) treatments in patients with inflammatory bowel disease (IBD) who develop paradoxical arthritis.

Novartis has announced that Sandoz, a subsidiary division of the company, has received the European Commission’s (EC) authorization for its infliximab biosimilar, to be sold as Zessly in the European Union.

Currently, beyond the evaluation of a patient’s 28-joint disease activity score (DAS28), there are no standard methods to determine whether patients will respond well to dose reduction of anti–tumor necrosis factor therapy.

Specific human leukocyte antigen (HLA) alleles are associated with the formation of anti-drug antibodies to adalimumab in patients with rheumatoid arthritis and hidradenitis suppurativa, potentially causing reduced therapeutic response.

This week, rheumatologists and rheumatology stakeholders from the American College of Rheumatology (ACR) took to Capitol Hill to advocate on pressing issues in rheumatology care, such as the rising costs of treatment and lack of access to care.

In treating ankylosing spondylitis, anti–tumor necrosis factor (anti-TNF) drugs produce a response in approximately 60% of patients. For the 40% of patients who do not respond to treatment, previous studies have suggested that patient characteristics, including sex, may play a role.

In an interview with The Center for Biosimilars®, Dennis Cryer, MD, physician co-convener of the Biologics Prescribers Collaborative (BPC), said, "We still feel that much of the effectiveness of therapy is the relationship and the trust that can be developed between the physician and the patient."

Lupin Pharmaceuticals has submitted a new drug application for its etanercept biosimilar, YLB113, in Japan, the company announced today.

Yesterday, at the British Society for Rheumatology’s Annual Conference held in Liverpool, United Kingdom, researchers presented a study that investigated the clinical outcomes of a multi-disciplinary switch to biosimilar etanercept from the reference product in patients with rheumatoid arthritis.

While adalimumab and methotrexate are understood to have a synergistic effect, the MUSICA trial sought to evaluate the ideal dose of methotrexate needed in patients who receive combination therapy for rheumatoid arthritis.

While injectable drugs, including some innovator anti–tumor necrosis factor inhibitors and their biosimilars, have revolutionized the treatment of rheumatic diseases like rheumatoid arthritis (RA), hand disability can limit the ability of patients with RA to use syringes to administer medication. Prefilled, disposable auto-injectors may help to alleviate this issue and have demonstrated acceptability studies, but questions have remained about whether patients with reduced manual dexterity may still experience needle displacement when using these devices.

The American College of Rheumatology (ACR) told CMS in a letter this week that short-term, limited-duration insurance plans could reduce or restrict access to crucial care for people living with rheumatic diseases.