SAN DIEGO, CA—Changing directly from adalimumab to tofacitinib sustained clinical response and improved ACR response rates in patients with rheumatoid arthritis, an open-label extension study presented at the 2013 ACR/ARHP Annual Meeting has found.
Mark C. Genovese, MD, of Stanford University, Palo Alto, CA, and colleagues conducted a Phase 3 randomized controlled trial—ORAL Standard—evaluating tofacitinib for the treatment of RA. Patients on background methotrexate received tofacitinib 5mg twice daily (BID), tofacitinib 10mg BID, adalimumab 40mg injected subcutaneously every other week, placebo advanced to tofacitinib 5mg BID, or placebo advanced to tofacitinib 10mg BID (4:4:4:1:1).
Eligible patients from the trial were permitted to enroll in the ongoing open-label extension study, ORAL Sequel. They received tofacitinib 10mg BID without washout (last adalimumab dose to first open-label extension tofacitinib dose ≤1 week). Researchers conducted a post-hoc analysis and described results for adalimumab patients 4.5 months before and at the end of the randomized controlled trial and 4.5 months after transition to tofacitinib in the open-label extension; data for tofacitinib 10mg BID were calculated at the same time points.
A total of 145 of 204 patients randomized to adalimumab were enrolled in the open-label extension; of these, 125 started tofacitinib without washout. Eight patients (6.4%) discontinued treatment during the initial 4.5 months of open-label extension (3 drug-related adverse events [AE], 1 unrelated AE, 1 pregnancy, 1 death, 2 other reasons).
Among patients randomized to tofacitinib 10mg BID in the randomized controlled trial, 148 of 201 enrolled in open-label extension; of these, 124 received the first dose of tofacitinib in the open-label extension ≤1 week after their last dose of tofacitinib.
American College of Rheumatology (ACR)20 response rate in adalimumab to tofacitinib patients (n=124) was 74.2% at 4.5 months before end of randomized controlled trial, 76.6% at end of randomized controlled trial, and 90.5% at 4.5 months after transition to tofacitinib. ACR50 response rates (44.4%, 50.8%, 65.5%) and ACR70 response rates (16.1%, 21.0%, 36.2%) showed a similar pattern at the same time points.
A health assessment questionnaire-disability index (HAQ-DI) showed mean change in baseline of -0.55, -0.60, and -0.70 at these time points. Tofacitinib results were also similar at the same time points and showed a similar pattern of increases from randomized controlled trial to open-label extension.