“To be a biosimilar, to even get into a trial, there’s a high bar for that,” he said. “We still need clinical studies, and this is a clinical study that should reassure us.”
Unfortunately, he has heard predictions from insurance companies that the emergence of biosimilars will only help keep costs close to what they are, but won’t lower them in the long term.
Tabalumab Better Than Placebo
Another study found that tabalumab, an anti-BAFF monoclonal antibody, performed better than placebo in patients on methotrexate who were naive to biologicals. He noted, though, that the methotrexate dose—as is common in studies—was, on average, 12 mg weekly, which is well below the optimal dose.4
The three doses used all produced similar results, Dr. O’Dell said.
“There needs to be more work done on dos[age], because we don’t understand the right dose,” he said. However, there might be a “new kid on the block with a new mechanism of action.”
RACAT Trial
Dr. O’Dell then reviewed the RACAT trial, a strategy trial that he helped lead, in which patients were started on either methotrexate plus sulfasalazine and hydroxychloroquine or methotrexate plus etanercept. In a scenario that mimics actual clinical practice, patients were switched to the other group if the DAS28 score didn’t improve by more than 1.2. Patients were kept on the same therapy if the DAS28 score did improve by that much.5
Researchers found no difference between the groups. Moreover, patients were switched to the other therapy group exactly the same amount in each starting group—27% of the time.
The bottom line, according to Dr. O’Dell: “In patients with active disease despite methotrexate, add triple [therapy] first, switch to etanercept or another TNF inhibitor at six months if the patients have not significantly improved. It’s much more economical and there are no clinical or radiographic penalties for doing that.”
TEAR
Dr. O’Dell also mentioned a subanalysis of data from the TEAR trial, in which researchers tried to determine whether there was some penalty for starting on methotrexate then ramping up to combination therapy. They found that, over time, DAS28 scores ended up at the same point and there was no radiographic benefit for starting combinations up front.6
Axial Spondyloarthritis: Current Aspects
There is too long a delay in the diagnosis of axial spondyloarthritis (axial SpA), but the problem could be helped by a change in how disease is assessed, said Muhammad Asim Khan, MD, Professor Emeritus of Medicine at Case Western Reserve University.
