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.
Reference
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.
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