In patients with nonradiographic axial spondyloarthritis (axSpA) who achieve sustained disease remission with open-label adalimumab, continued treatment with adalimumab is associated with higher rates of remission maintenance compared with treatment withdrawal, according to the results of the multicenter, randomized, double-blind ABILITY-3 study (ClinicalTrials.gov identifier: NCT01808118) published in The Lancet.
The ABILITY-3 study examined the ability to withdraw adalimumab therapy in patients with non-radiographic axSpA who had attained sustained clinical remission following 28 weeks of open-label treatment with adalimumab. This was a 2-period study conducted at 107 sites in 20 countries. Patients ≥18 years who had been diagnosed with non-radiographic axSpA who met the Spondyloarthritis International Society classification criteria, but not the modified New York radiologic criterion for ankylosing spondylitis, were enrolled. Patients had objective evidence of active disease, active inflammation, and an inadequate response to ≥2 nonsteroidal anti-inflammatory drugs.
Patients who achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease (ASDAS <1.3) with adalimumab (40 mg subcutaneously every other week for 28 weeks) at 16, 20, 24, and 28 weeks were randomly assigned to receive double-blind adalimumab (continuation group) or placebo (withdrawal group) for 40 weeks, for a total of 68 weeks of treatment. The primary efficacy end point was the proportion of patients who did not experience a flare, defined as ASDAS ≥2.1 at 2 consecutive visits, during the double-blind phase of the study.
Of the 673 participants, 45% attained sustained remission and were randomly assigned to receive adalimumab (n=152)) or placebo (n=153). Overall, a significantly higher percentage of patients who continued adalimumab did not experience a disease flare compared with patients receiving placebo (70% vs 47%, respectively; P <.0001), occurring at up to and including 68 weeks.
With respect to adverse events, 77% of patients treated with adalimumab at any time reported an adverse event and 4% reported a serious adverse event. The most frequently reported adverse events in either group were nasopharyngitis, upper respiratory tract infection, and worsening of axSpA.
The investigators concluded that additional studies are warranted in order to predict which patients with non-radiographic axSpA are able or unable to maintain drug-free remission.
Please see original article for a complete list of disclosures.
Landewé R, Sieper J, Mease P, et al. Efficacy and safety of continuing versus withdrawing adalimumab therapy in maintaining remission in patients with non-radiographic axial spondyloarthritis (ABILITY-3): a multicentre, randomised, double-blind study [published online June 28, 2018]. Lancet. doi:10.1016/S0140-6736(18)31362-X