Rheum Round-up: Ixekizumab’s Extended FDA Approval, RA Biosimilars Compared, and more

Here are the top stories recently covered by DocWire News in the Rheumatology section. In this edition, read about the extended approval of ixekizumab, a comparison of reference adalimumab versus a biosimilar, sarilumab’s safety and efficacy, and the effect of the COVID-19 pandemic on spine surgeons.

Eli Lilly and Company received an additional approved indication for its drug Taltz® (ixekizumab), which is now approved to treat active non-radiographic axial spondyloarthritis (nr-axSpA) in patients with objective signs of inflammation. The approval is a milestone for Lilly, as ixekizumab is the first IL-17A antagonist to receive the FDA’s approval for nr-axSpA. Ixekizumab was first approved by the FDA in 2016 to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy (this was expanded in March of this year to include pediatric patients). In 2017, the drug was also approved to treat adults with active psoriatic arthritis. Then, in 2019, it was approved to treat adults with active axSpA.

Researchers recently compared the safety, efficacy, and pharmacodynamics of adalimumab manufactured by Hetero and marketed as Mabura, versus reference adalimumab manufactured by Abbvie and marketed as Humira. “Results of this study demonstrated no clinically meaningful difference in efficacy, pharmacodynamics, and safety between test and reference treatment groups. Hence, the test adalimumab is being equally efficacious and safe biosimilar to the reference adalimumab for treatment of active [rheumatoid arthritis] RA in patients concomitantly on [methotrexate] therapy,” they concluded.

Researchers recently assessed the safety and efficacy of sarilumab either as a monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) in patients with varying severities of RA. Overall, sarilumab was clinically superior as a monotherapy compared to adalimumab as well as in combination with csDMARDs compared to placebo plus csDMARDs across all patient demographic, disease characteristics, and prior treatments subgroups.

Orthopedic surgeons were significantly impacted by the COVID-19 pandemic, and a recent analysis forecasted that surgery volume will not return to prepandemic levels for at least a year. An estimated 83.5% of all orthopaedic surgeries were delayed due to the pandemic. Of the estimated 16.5% that were permitted to go as scheduled, these were traumas, amputations, and oncological procedures; dislocations and fractures were performed if they were considered urgent cases. However, there are less data on how the pandemic has affected subspecialties.