Background/Purpose: The assessment of achieving, maintaining, and improving clinical response to biologics in Ankylosing Spondylitis (AS) is part of treat-to-target recommendations aimed at optimizing treatment goals. Here we present patient-level secukinumab data to assess the likelihood of achieving an Assessment of Spondyloarthritis international Society (ASAS) response and maintaining or improving that response from Week (Wk) 2 (early response) to Wk 16 (primary endpoint) and from Wk 16 to Wks 52 and 104 (sustained effect) in patients with active AS from the MEASURE 2 trial.¹

Methods: This was a post-hoc analysis of AS patients originally randomized to secukinumab 150 mg (currently approved dose) who completed the 16-wk double-blind treatment period, followed by long-term uncontrolled treatment. Shift analyses on ASAS responses between Wks 2 and 16 and Wks 16 and 52/104 were performed for subgroups of secukinumab-treated patients, based on response at the earlier time point (non-responders for ASAS 20 or ASAS 40 [ASAS NR], ASAS 20 only, or ASAS 40 only) by evaluating whether these responses were decreased, maintained, or improved at the later time point using observed data.

Results: Overall, 65, 61, and 59 AS patients treated with secukinumab 150 mg had available data to determine ASAS responses for shift analyses from Wks 2 to 16, Wks 16 to 52, and Wks 16 to 104, respectively. At baseline, mean age was 41.9 ± 12.5 years, mean time since diagnosis was 7.0 ± 8.2 years, and mean Bath Ankylosing Spondylitis Disease Activity Index score was 6.6 ± 1.5. Approximately half of the ASAS NR patients at Wk 2 or 16 subsequently developed an ASAS response at the later time point of Wk 16 or 52, respectively. A majority (71% and 67%) of ASAS 20 responders at Wk 2 or 16 showed improved responses to ASAS 40 by Wk 16 or 52, respectively, whereas 21% and 16% of ASAS 20 responders maintained their response by Wk 16 or 52, respectively. A majority (64% and 84%) of ASAS 40 responders at Wk 2 or 16 maintained this response by Wk 16 or 52, respectively. Similar trends were observed in shift analyses of ASAS responses from Wks 16 to 104 (Table).

Conclusion: In this post-hoc analysis of patients with active AS, the majority of patients on secukinumab treatment maintained or improved their ASAS responses over time, consistent with the sustainability of group-level ASAS responses reported previously.¹ In particular, the vast majority of patients who achieved either an ASAS 20 or ASAS 40 response at Wk 2 or 16 maintained or improved their response by Wks 16, 52, or 104, respectively. Reference: 1. Baeten D et al. N Engl J Med. 2015;373:2534‒48.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/secukinumab-sustains-individual-clinical-responses-over-time-in-patients-with-active-ankylosing-spondylitis-2-year-results-from-a-phase-3-randomized-placebo-controlled-trial/