SAN FRANCISCO – Rheumatoid arthritis patients who did not respond to the first tumor necrosis factor inhibitor they tried had a higher rate of good or moderate response when they switched to a non–TNF inhibitor biologic, rather than another anti-TNF agent, after 48 weeks in the first randomized trial to compare the two strategies.
The results of this French open-label study, called Rotation or Change, provides evidence to guide the choice of a second biologic in patients who fail first biologic treatment with an anti-TNF agent. The trial also confirms findings reported in observational registry studies, principal investigator Dr. Jacques-Eric Gottenberg said in an interview at the annual meeting of the American College of Rheumatology.
But in contrast to the main study results, a post hoc analysis suggested that a second TNF inhibitor may be just as effective as a non–TNF inhibitor biologic in patients who develop antidrug antibodies to the first TNF inhibitor, said Dr. Gottenberg of the department of rheumatology at Strasbourg (France) University Hospital.
He and his colleagues aimed to mimic what happens in daily practice by allowing participating rheumatologists at French academic medical centers to choose which drug each patient received after randomization. During 2009-2012, 292 patients were randomized to any of four TNF inhibitors (adalimumab, certolizumab pegol, etanercept, or infliximab) or any of three non–TNF inhibitor biologics (abatacept, rituximab, or tocilizumab). (Golimumab was not available in France when the trial began in 2009.)
At 12 weeks, 48% of participants who switched to another TNF inhibitor had good or moderate responses based on European League Against Rheumatism criteria, and this rose to 52% at 24 weeks and then dropped to 43% at 48 weeks. At those time points, good or moderate response occurred in an additional 16%-18% of participants who switched to a non–TNF inhibitor biologic: 64% at 12 weeks, 70% at 24 weeks, and 60% at 48 weeks.
In the post hoc analysis of 278 patients who were tested for antidrug antibodies, 20 patients with ADAs who had been randomized to a non–TNF targeted biologic had a response at 24 weeks that was similar to 12 patients with ADAs who had been randomized to a second TNF inhibitor.