ACR Symposium Highlights Approaches to Using Biologics, Biosimilars in RA

At the American College of Rheumatology (ACR)'s Winter Rheumatology Symposium, held this week in Snowmass Village, Colorado, rheumatologists from across the country gathered to discuss the latest approaches to treating rheumatoid arthritis (RA).

Presenting a talk titled “Rheumatoid Arthritis: 2018 Treatment Update” was Michael E. Weinblatt, MD, of Brigham and Women’s Hospital. Weinblatt gave an overview of important recent study data, and discussed a number of studies that addressed the efficacy of different drugs and treatment options in RA.

Dose Reduction of Biologics

High-cost anti—tumor necrosis factor (anti-TNF) therapy remains a common approach to treating RA, though over the past few years, studies have been ongoing to investigate whether dose reduction of anti-TNF treatment can provide cost-savings while maintaining efficacy.

Weinblatt discussed 3 studies that found that, when a patient completely discontinues use of adalimumab, etanercept, or certolizumab, the patient is likely to have a disease flare within the first year. However, if the dose of either etanercept or certolizumab is reduced, studies have shown that clinical response very similar to that of the therapeutic dose, and can be maintained.

“In my clinical practice, I’m taking patients who have been in low disease activity or remission for 6 to 12 months and first modulating their methotrexate down a little bit…and then I start to modulate down their biologic anti-TNF therapy. I’ve got about 24% of my patients right now on anti-TNF therapy on a lower frequency of dosing and maintaining clinical response,” said Weinblatt.

Biosimilar Options

Weinblatt next discussed a Danish study in which patients with inflammatory rheumatic diseases were switched from originator infliximab, Remicade, to its biosimilar, Remsima, and the groups' flare rates were similar. There was no meaningful difference between patients who were treated with the biosimilar or the originator product.

He also addressed a Norwegian switch study, NOR-SWITCH, of biosimilar infliximab versus the originator product, in which researchers found that there was no significant difference among patients who switched.

In discussions of the usage of biosimilars within the United Kingdom, Weinblatt also reported that the preferred etanercept biosimilar costs 70% less than the originator, producing a significant cost reduction for the health system.

Biologic Agent and Infection Risk

The risk of infection, or lack thereof, in patients switched to rituximab after failing an anti-TNF versus patients switched to a second anti-TNF has also been recently investigated, said Weinblatt. Researchers found that over a 5-year period, the risk of serious infection was similar among the 2 cohorts. Weinblatt reported that these were reassuring results for rheumatologists prescribing rituximab for patients with RA.

JAK Inhibitors

Addressing Janus kinase (JAK) inhibitors, Weinblatt highlighted 1 study that compared the use of tofacitinib plus methotrexate versus adalimumab plus methotrexate, as well as tofacitinib as monotherapy. The randomized clinical trial found that the combination of tofacitinib plus methotrexate was not inferior to adalimumab plus methotrexate, while the tofacitinib monotherapy did not reach its primary endpoint of American College of Rheumatology 50% (ACR50) response at month 6.

In closing, Weinblatt stated that, although there have been great advances in the treatment of RA, there is still an unmet need; 10% of patients remain unresponsive to any available treatment option. “Access barriers for our patients [are] the greatest threat to successful treatment,” said Weinblatt.