Rheumatology

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.

Yesterday, the FDA’s Arthritis Advisory Committee convened for a vote on whether to recommend approval of Eli Lilly’s baricitinib, a Janus kinase (JAK) inhibitor that the company hopes to sell as Olumiant for the treatment of rheumatoid arthritis (RA). The advisory committee voted in favor of recommending approval of a dose of 2 mg and against recommending approval of a higher 4-mg dose because of concerns about safety, including the risk of thrombosis.

At the American College of Rheumatology (ACR)’s State-of-the-Art (SOTA) Symposium, held last week in Chicago, Illinois, Judith James, MD, PhD, chair of arthritis and clinical immunology at Oklahoma Medical Research Foundation, presented a talk on precision medicine in rheumatology.

Rheumatologists gathered from across the country last week to discuss the latest approaches in the treatment of rheumatoid arthritis (RA) and other inflammatory diseases at the American College of Rheumatology’s (ACR) 2018 State-of-the-Art (SOTA) Clinical Symposium held in Chicago, Illinois.

Since 2017, the Italian National Agency for Drugs has approved of the off-label use of infliximab and adalimumab for juvenile idiopathic arthritis-associated uveitis, and has created a patient registry to collect anonymized data from patients in 24 pediatric rheumatology and ophthalmology centers across Italy.

Canadian patients who receive brand-name adalimumab (Humira) to treat ankylosing spondylitis (AS) are eligible for a patient support program, provided by drug maker AbbVie, that includes personalized services such as coaching phone calls before and after initiating treatment.

The researchers found that a high proportion of microbiota of the Betaproteobacteria class and Burkholderiales order prior to treatment was associated with clinical response at 3 months.

This week, the American College of Rheumatology (ACR) raised concerns that CMS’ final 2019 Payment Notice Rule, which provides states with increased flexibility to determine which plan options they can select as Essential Health Benefit- (EHB) benchmark plans and select their own sets of benefits, could seriously jeopardize care for patients with inflammatory diseases.

AbbVie reports that the trial of 15 mg of orally-administered, once-daily upadacitinib met its primary endpoints, with 71% of patients achieving 20% improvement based on American College of Rheumatology criteria (ACR20), and 29% achieving clinical remission.

Samsung Bioepis and Biogen announced today that the companies have reached a settlement with AbbVie, maker of the top-selling Humira, that will allow the partnership to launch their approved biosimilar—Imraldi—in the European Union on October 16, 2018.

A recent study provides the final long-term efficacy and safety results from the phase 3 ABILITY-1 trial’s open-label extension in patients with nonradiographic axial spondyloarthritis, which show that the anti–tumor necrosis factor agent adalimumab (Humira) provided sustained clinical and functional improvements through 3 years.

Within the juvenile idiopathic arthritis subset, “patients had an extremely favorable probability of being neoplasm-free 5 years after initiation of biologics.”

Intravenous infusion therapy has become critical for the treatment and maintenance of many pediatric rheumatic diseases, such as juvenile idiopathic arthritis, systemic lupus erythematosus, and inflammatory bowel disease-associated arthritis. Recently, researchers conducted a retrospective review of all pediatric patients given infusions at the University of Alabama at Birmingham from 2012 to 2015.

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.

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.

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.

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.