Early-stage rheumatoid arthritis patients now have another medication choice. The U.S. Food and Drug Administration, or FDA, has expanded the indication of the biologic drug tocilizumab, or Actemra, to include its use in patients who fail to benefit from first-line treatments such as methotrexate and other traditional disease-modifying antirheumatic drugs, or DMARDs.

Tocilizumab, an interleukin-6 receptor, or IL-6, inhibitor, was originally approved by the FDA in 2010 – but only for use in patients who had already failed to benefit from TNF inhibitors, a class of biologics that includes adalimumab, or Humira, certolizumab pegol, or Cimzia, etanercept, or Enbrel, golimumab, or Simponi, and infliximab, or Remicade. By moving up tocilizumab from a third-line treatment to a second line treatment, the FDA’s move effectively puts it on therapeutic par with the TNF inhibitors.

Tocilizumab is the first approved drug to target interleukin-6, a key cytokine, or protein, involved in the excessive inflammatory response seen in rheumatoid arthritis, or RA. Tocilizumab is given by monthly intravenous infusion.

“I think it’s a significant development,” says rheumatologist Jasvinder Singh, MD, an associate professor of medicine at the University of Alabama at Birmingham School of Medicine. “This now allows use of the medication earlier in the disease, which means patients don’t have to fail [TNF inhibitors]. So it offers more options to patients and doctors.”

Dr. Singh says one of the key benefits of the expanded indication is actually financial. While some doctors have already been using tocilizumab as second-line therapy – after a traditional DMARD fails – Dr. Singh says it can sometimes be a struggle to get insurance companies to cover an unapproved indication. “The FDA approval does not directly equate with insurance company coverage,” Dr. Singh says. “But often FDA approvals for additional indications usually make it easier, and insurance companies pay a lot of attention to what the FDA does.”