Among patients with axial spondyloarthritis receiving their first TNF inhibitor, 27% achieve inactive disease, defined by the Ankylosing Spondylitis Disease Activity Score, after 6 months, with approximately 80% continuing treatment after 1 year, according to data published in Annals of the Rheumatic Diseases.
“Tumor necrosis factor inhibitors improve symptoms of axial spondyloarthritis (axSpA), such as inflammatory back pain, stiffness and range of motion,” Cecilie Heegaard Brahe, MD, PhD, of the EuroSpA Coordinating Center, Copenhagen Center for Arthritis Research (COPECARE), in Denmark, and colleagues wrote. “Their effects have been demonstrated in randomized controlled trials (RCTs) and TNF [inhibitors] are now an essential part of axSpA treatment.”
“However, in contrast to the RCTs with strict inclusion and exclusion criteria, a more heterogeneous group of patients with a broad spectrum of various comorbidities, concomitant medications and atypical disease manifestations is treated in routine care,” they added. “Thus, up to 80% of patients receiving TNF [inhibitors] in routine care would not have been eligible to be enrolled in the RCTs that led to approval of the agents. This observation emphasizes the need for real-world observational studies as a valuable supplement to RCTs.”
To analyze drug retention and response rates among patients with axial SpA who receive a first TNF inhibitor, Brahe and colleagues studied data from 12 European registries. The researchers collected data prospectively from 24,195 adult patients with axial SpA.
Among patients with axial SpA receiving their first TNF inhibitor, 27% achieve inactive disease after 6 months, with approximately 80% continuing treatment after 1 year, according to data.
All patients included in the study had received at least one TNF inhibitor following diagnosis, with documented initiation and withdrawal dates. The researchers assessed drug retention rates, Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease, defined as a score of less than 1.3; Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), less than 40mm; and Assessment of SpondyloArthritis International Society responses (ASAS 20/40) for each patient at 6, 12 and 24 months.
According to the researchers, the one-year retention rate was 80% (95% CI, 79-80), ranging from 71% to 94% across all registries. ASDAS inactive disease and BASDAI40 rates at 6 months were 33% and 72% respectively. ASAS 20/40 response rates among patients were 64% and 49% respectively. Among the patients who began their first TNF inhibitor after 2009, 6,097 were registered to fulfill ASAS criteria for axial SpA, while 2,935 were registered to fulfill modified New York Criteria for Ankylosing Spondylitis. In addition, 1,178 patients who initiated treated after 2009 were registered as having nonradiographic axial SpA.
Patients with nonradiographic axial SpA, demonstrated 12-month retention rates of 73%, as well as an ASDAS Inactive disease rate of 20%, a BASDAI40 rate of 50%, and ASAS 20/40 rates of 45% and 33%. Among patients who initiated their first TNF inhibitor after 2014, 1-year retention rates — but not 6-month response rates — were numerically higher compared with those initiating treatment from 2009 to 2014.
“Data from 24,195 European patients with axSpA who received their first TNF [inhibitor] were pooled, and the retention and response rates were reported,” Brahe and colleagues wrote. “Approximately a third of patients were in ASDAS inactive disease state after 6 months, and 80% were still receiving the same TNF [inhibitor] after 1year. The EuroSpA collaboration offers unprecedented opportunities for providing real-world evidence on the effectiveness of biological drugs in European patients with axSpA.” – by Jason Laday
Disclosure: Brahe reports a professional relationship with Novartis. Please see the full study for additional authors’ disclosures.