Treatment with secukinumab in patients with ankylosing spondylitis (AS) was found to provide rapid and sustained improvements in fatigue for up to 3 years, regardless of prior tumor necrosis factor (TNF) inhibitor exposure, according to results of an analysis published in Arthritis Care & Research (Hoboken).

Study authors conducted an exploratory analysis of 2 phase 3 randomized, placebo-controlled trials — MEASURE 1 and MEASURE 2 (ClinicalTrials.gov Identifiers: NCT01358175 and NCT01649375, respectively) — to explore the long-term effects of secukinumab on fatigue in patients with active AS.

In both MEASURE 1 and MEASURE 2, patients with active AS were randomly assigned to receive secukinumab or placebo. In MEASURE 1, patients received either an intravenous 75-mg loading dose followed by a subcutaneous 150-mg maintenance dose or placebo. In MEASURE 2, patients received either a subcutaneous secukinumab 150-mg maintenance dose or placebo. Participants were either naive to or had an inadequate response/intolerance to TNF inhibitors. Fatigue was evaluated using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale.


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Eligible patients were aged 18 years or more, had AS (as defined by the modified New York criteria), had an inadequate response or intolerance to nonsteroidal anti-inflammatory drugs, and had received either no prior treatment with anti-TNF therapy or experienced an inadequate response/intolerance to 1 or more anti-TNF agents.

At week 16, significant improvements in FACIT-F scores from baseline were observed with secukinumab vs placebo in both studies (P <.05). These improvements were sustained through week 156 and 104 in MEASURE 1 and MEASURE 2, respectively. Further, significantly more patients reported fatigue responses (FACIT-F increase of ≥4) with secukinumab 150 mg compared to placebo at week 16 in both MEASURE 1 (P <.05) and MEASURE 2 (P <.01).

Overall, 75.6% and 81.4% of participants achieved fatigue responses at week 156 and week 104 in the MEASURE 1 and MEASURE 2 trials, respectively. In addition, these findings were consistent in patients who were anti-TNF-naive and those who were anti-TNF-intolerant in MEASURE 1 (74.3% and 84.6%, respectively) and MEASURE 2 (81.3% and 75.0%, respectively).

Fatigue responses were moderately to strongly associated with responses in several clinical measures, including the Assessment of SpondyloArthritis International Society (ASAS)20/40, ASAS5/6 responses, AS Disease Activity Score-

C-reactive protein (ASDAS-CRP), Short-Form-36 scores, and Bath Ankylosing Spondylitis Disease Activity Index.

Study limitations included the lack of a control group after week 15, the exclusion of missing data, and potential selection bias towards patients who chose to continue to receive long-term secukinumab treatment.

Researchers concluded that the fatigue responses reported in the current analysis add to the existing evidence for secukinumab treatment in patients with AS.

Disclosure: The studies included in this analysis were supported by Novartis Pharma AG. Please see the original reference for a full list of authors’ disclosures.

Reference

Kvien TK, Conaghan PG, Gossec L, et al. Secukinumab provides sustained reduction in fatigue in patients with ankylosing spondylitis: long-term results of two phase III randomized controlled trials. Arthritis Care Res (Hoboken). Published online November 23, 2020. doi:10.1002/acr.24517