Secukinumab Provides Sustained Reduction in Fatigue in Patients with Ankylosing Spondylitis: Long‐term Results of Two Phase III Randomized Controlled Trials

Objective

To investigate the longer‐term effects of secukinumab 150 mg on fatigue in patients with ankylosing spondylitis (AS) in MEASURE 1 (up to 3 years) and MEASURE 2 (up to 2 years).

Methods

Patients with active AS were randomized to secukinumab or placebo in MEASURE 1 (10 mg/kg intravenous [IV] followed by 150 mg subcutaneous [SC]) and MEASURE 2 (150 mg SC). Patients were naive to or had an inadequate response/intolerance to tumor necrosis factor inhibitors (anti‐TNF‐naive/ anti‐TNF‐IR). Fatigue was measured using the Functional Assessment of Chronic Illness Therapy‐Fatigue (FACIT‐F) scale. Relationships between fatigue response and baseline characteristics and clinical/laboratory variables were explored.

Results

Significant improvements in FACIT‐F scores from baseline were observed with secukinumab across both studies versus placebo at week 16 (P < 0.05). Improvements were sustained through week 156 (MEASURE 1)/week 104 (MEASURE 2). Significantly more patients reported fatigue responses (FACIT‐F increase ≥4; observed data) with secukinumab 150 mg than placebo at week 16 in both MEASURE 1 (P < 0.05) and MEASURE 2 (P < 0.01). Fatigue responses were achieved by 75.6% of patients receiving secukinumab at week 156 (MEASURE 1) and 81.4% at week 104 (MEASURE 2); these results were consistent in both anti‐TNF‐naive (74.3% and 84.6%) and anti‐TNF‐IR (81.3% and 75.0%) patients. Baseline characteristics did not predict improvement in fatigue consistently. Fatigue responses were moderately to strongly correlated with responses in several clinical measures, including Assessment of SpondyloArthritis international Society (ASAS)20/40, ASAS5/6 responses, Ankylosing Spondylitis Disease Activity Score‐C reactive protein (ASDAS‐CRP), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and Short‐form (SF)‐36 scores.

Conclusion

Secukinumab provided rapid and sustained improvements in fatigue for up to 3 years, regardless of prior anti‐TNF exposure.