A recent study provides the final long-term efficacy and safety results from the phase 3 ABILITY-1 trial’s open-label extension in patients with nonradiographic axial spondyloarthritis, which show that the anti–tumor necrosis factor agent adalimumab (Humira) provided sustained clinical and functional improvements through 3 years.
Anti—tumor necrosis factor (anti-TNF) agents have proven efficacy in treating patients with axial spondyloarthritis, including those patients with nonradiographic axial spondyloarthritis (nrAxSpA). A recent study provides the final long-term efficacy and safety results from the phase 3 ABILITY-1 trial’s open-label extension in patients with nrAxSpA, which show that the anti-TNF agent adalimumab (Humira) provided sustained clinical and functional improvements through 3 years.
Patients included in the extension were 18 years or older, had nrAxSpA, and had not responded adequately to (or had a contraindication for) at least 1 non-steroidal anti-inflammatory drug. The ABILITY-1 trial randomized patients to receive subcutaneous injections of either 40 mg of adalimumab or placebo every other week for 12 weeks, and in the open-label extension, patients received 40 mg of adalimumab every other week for up to 3 years. Patients in the total efficacy population (n = 185) were divided into a population of those positive for magnetic resonance imaging (MRI)—detected inflammation and for elevated C-reactive protein (CRP) levels (n = 142) and those who tested negative for both (n = 43).
Clinical and MRI remission were defined, respectively, as an Ankylosing Spondylitis Disease Activity Score (ASDAS) of less than 1.3 and a Spondyloarthritis Research Consortium of Canada (SPARCC) MRI score of less than 2 for sacroiliac joints, spine, or both. Physical function was assessed using the Bath Ankylosing Spondylitis Functional Index (BASDAI).
The researchers found the following:
During the study period, there were no incidents of malignancy, vasculitis, demyelinating disease, or reactivation of hepatitis B reported, though serious adverse events, including infections, were reported by 17.4% of patients in the overall safety population.
The authors conclude that adalimumab provided sustained clinical and functional improvements through 3 years, and also provided suppression of MRI axial inflammation in patients with nrAxSpA. These findings, say the authors, support the favorable benefit-risk profile of long-term adalimumab therapy in this patient population.
van der Heijde D, Sieper J, Maksymowych WP, et al. Clinical and MRI remission in patients with nonradiographic axial spondyloarthritis who received long-term open-label adalimumab treatment: 3-year results of the ABILITY-1 trial. Arthritis Res Ther. 2018;20(1):61. doi: 10.1186/s13075-018-1556-5.