Landewé R, et al. - Authors assessed the ability to withdraw adalimumab treatment in patients with non-radiographic axial spondyloarthritis who achieved sustained clinical remission after open-label treatment with adalimumab. Findings suggested an association of continued therapy with significantly fewer patients flaring in patients with active non-radiographic axial spondyloarthritis who achieved sustained remission with adalimumab than was treatment withdrawal.

Methods

• Experts conducted ABILITY-3; a multicentre, two-period study done in 107 sites in 20 countries.
• They enrolled adult patients (≥18 years) diagnosed with non-radiographic axial spondyloarthritis, fulfilling Assessment of SpondyloArthritis international Society classification criteria but not the modified New York radiologic criterion, who had objective evidence of active inflammation, active disease, and inadequate response to at least 2 non-steroidal anti-inflammatory drugs.
• They randomly assigned (1:1) the patients who achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease (<1·3) with open-label adalimumab (40 mg subcutaneously every other week for 28 weeks) at weeks 16, 20, 24, and 28 using an interactive voice or web response system to 40-week, double-blind treatment with adalimumab (continuation) or placebo (withdrawal).
• The proportion of patients who did not experience a flare (defined as ASDAS ≥2·1 at two consecutive visits) during the double-blind period was the primary efficacy endpoint.
• Researchers rescued the patients who flared with open-label adalimumab.

Results

• As per data, 673 patients were enrolled to the study between June 27, 2013, and October 22, 2017.
• Findings suggested that the trial completed on April 14, 2017.
• Results demonstrated that 305 (45%) out of 673 enrolled patients, achieved sustained remission and were randomly assigned to double-blind treatment (152 patients to adalimumab and 153 to placebo).
• A flare was not experienced in a greater proportion of patients continuing adalimumab than those receiving placebo (107 [70%] of 152 patients vs 72 [47%] of 153 patients; p < 0·0001) up to and including week 68.
• They noted that 516 (77%) patients among 673 patients receiving adalimumab at any time, reported an adverse event and 28 (4%) experienced a serious adverse event.
• In both the adalimumab and placebo groups, the most common adverse events were nasopharyngitis (25 [16%] vs 20 [13%]), upper respiratory tract infection (20 [13%] vs 12 [8%]), and worsening of axial spondyloarthritis (ten [7%] vs 21 [14%]).