medwireNews: Results of the ABILITY-3 trial suggest that patients with nonradiographic axial spondyloarthritis (axSpA) who achieve sustained remission with adalimumab are likely to benefit from continued treatment with the tumor necrosis factor (TNF) inhibitor.
“While we know that TNF inhibitors should not be stopped in patients with ankylosing spondylitis, or radiographic axSpA, we do not know if we can or should stop TNF inhibitors in patients with nonradiographic axSpA who have achieved remission,” Robert Landewé (University of Amsterdam, the Netherlands) told delegates at the 2017 ACR/ARHP Annual Meeting in San Diego, California, USA.
In ABILITY-3, 673 patients with active nonradiographic axSpA at baseline were given open-label treatment with adalimumab for 28 weeks, after which time the 305 patients who achieved inactive disease according to an Ankylosing Spondylitis Disease Activity Score (ASDAS) below 1.3 points were randomly assigned to continue with adalimumab treatment or switch to placebo for an additional 40 weeks.
In all, 70% of patients who received continuous adalimumab treatment were free from flares at the 68-week follow-up, compared with 47% of those who switched to placebo, a significant difference.
The relative risk for flare with treatment withdrawal was therefore 1.77, explained Landewé.
Moreover, secondary endpoints “were all in favor of continuation of adalimumab,” he said. For example, a significantly greater proportion of participants who continued treatment achieved inactive disease (57 vs 33%) or a major improvement in disease activity (59 vs 32%) at week 68, and these patients were significantly more likely to achieve at least a 20% or 40% improvement in Assessment of SpondyloArthritis international Society (ASAS) scores than those who stopped treatment.
The researchers found a comparable incidence of adverse events (AEs) among patients in the adalimumab and placebo groups at week 68, with corresponding rates of 65% and 69%. A total of 1% of patients in the continuation group and 7% of those who switched to placebo experienced serious AEs.
This increased incidence of serious AEs among patients in the withdrawal group may be attributed to patients experiencing flares that led to hospital admission, said Landewé.
“Safety findings were consistent with the established safety profile of adalimumab,” he summarized.
And Landewé concluded that “these results, in our opinion, support the continuation of adalimumab therapy after achievement of sustained remission.”
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