First-Time Initiation of TNFi Therapy Shows Positive Disease Outcomes in Axial Spondyloarthritis

Investigators reviewed drug retention and response rates in patients with axial spondyloarthritis after their first initiation with tumor necrosis factor inhibitors.

Among patients with axial spondyloarthritis (axSpA), the first-time initiation of tumor necrosis factor inhibitor (TNFi) therapy can lead to the achievement of inactive disease status after 6 months, according to study results published in the Annals of the Rheumatic Diseases.

Researchers examined drug retention and response rates in a large European cohort of patients with axSpA who were initiating their first TNFi therapy; data were prospectively collected and pooled from 12 registries.

Primary study outcomes included the 12-month overall TNFi drug retention rate. Secondary outcomes were overall 6- and 24-month retention rates and overall percentage of patients with axSpA achieving Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease (<1.3), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) <40 mm, and Assessment of SpondyloArthritis International Society (ASAS) 20/40 response rate at 6, 12, and 24 months.

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The total study cohort included 24,195 patients with axSpA. Three subcohorts were identified: ASAS cohort (n=6097), modified New York Criteria for Ankylosing Spondylitis (NY) cohort (n=2935), and nonradiographic axSpA (nr-axSpA) cohort (n=1178). The most common treatments included adalimumab (29%), infliximab (28%), and etanercept (25%); 14% of patients were treated with golimumab, 5% were treated with certolizumab, and 31% of patients were treated with conventional synthetic disease-modifying antirheumatic drugs. Median time since diagnosis was 2 years (interquartile range [IQR], 1-9 years).

In the total cohort, the 12-month TNFi retention rate was 80%. For the ASAS, NY, and nr-axSpA subcohorts, 12-month retention rates were 81% (range, 80%-82%), 83% (range, 82%-85%), and 73% (range, 70%-76%), respectively. The overall retention rates for all patients were 88% (range, 87%-88%) at 6 months and 73% (range, 72%-73%) at 24 months. Within individual registries, the 12-month retention rate “differed significantly,” ranging from 71% to 94% (P <.001).

At 6, 12, and 24 months, ASDAS inactive disease was achieved in 33%, 35%, and 38% of patients, respectively. BASDAI <40 proportions were 72%, 75%, and 77%, with ASAS 20/40 response rates achieved in 64%/49% at 6 months, 67%/53% at 12 months, and 68%/54% at 24 months. Within the subcohorts, ASDAS inactive disease responses rates at 6 months were 30%, in the ASAS, 25% in the NY, and 26% in the nr-axSpA cohorts. Individual registry 6-month response rates ranged from 29% to 53%, and 61% to 86% for ASDAS inactive disease and BASDAI <40 measurements, respectively (P <.001).

In total, 23% (n=5673) of patients withdrew from the treatment during 24 months of follow-up. Of these, 3654 patients withdrew because of lack of efficacy, and 2019 withdrew because of adverse events. Median time to withdrawal was 7 months (IQR, 4-13 months).

Study limitations included selection bias according to data availability and a potential overestimation of drug retention rates.

“Approximately a third of patients were in ASDAS inactive disease state after 6 months, and 80% were still receiving the same TNFi after 1 year,” the researchers concluded.

Disclosure: This clinical trial was supported by Novartis Pharma AG. Please see the original reference for a full list of authors’ disclosures. 


Ørnbjerg LM, Brahe CH, Askling J, et al. Treatment response and drug retention rates in 24 195 biologic-naïve patients with axial spondyloarthritis initiating TNFi treatment: routine care data from 12 registries in the EuroSpA collaboration [published online August 20, 2019]. Ann Rheum Dis. doi:10.1136/anrheumdis-2019-215427