Background Interleukin (IL)-17A is implicated in the pathogenesis of ankylosing spondylitis (AS),1 and inhibition of this cytokine with secukinumab, a human anti–IL-17A monoclonal antibody, has previously demonstrated rapid reduction in the signs and symptoms of AS at Week (Wk) 16 in a phase 3 trial (MEASURE 2; NCT01649375).2
Objectives To evaluate the impact of subcutaneous (s.c.) secukinumab on patient-reported outcomes (PROs) at 16 and 52 wks in the randomized, double-blind, placebo-controlled, MEASURE 2 study.
Methods 219 adults with active AS, despite therapy with nonsteroidal anti-inflammatory drugs, were randomized to receive s.c. secukinumab 150 mg, 75 mg, or placebo (PBO) at baseline, Wk 1, 2, and 3, and then every 4 wks starting at Wk 4. At Wk 16, subjects randomized to PBO at baseline were re-randomized to receive secukinumab 150 mg or 75 mg every 4 wks. PROs were measured every 4 wks using the following questionnaires: Short Form-36 Health Survey (SF-36), EuroQoL (EQ-5D), AS Quality of Life (ASQoL), Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-Fatigue) and Work Productivity and Activity Impairment – General Health (WPAI-GH). SF-36 Physical Component Summary (SF-36 PCS) and ASQoL were predefined secondary endpoints, assessed at Wk 16 as part of a hierarchical statistical testing strategy with adjustment for multiplicity. Other endpoints were exploratory.
Results Demographics and disease severity were balanced across groups at baseline, with subjects experiencing moderate to severe levels of fatigue and impaired health-related quality of life (QoL). At Wk 16, secukinumab 150 mg significantly improved SF-36 PCS and ASQoL scores vs PBO; improvements in these parameters were observed from Wk 4, the first time point of measurement. Improvements vs PBO were also noted in FACIT-Fatigue at Wk 16 (Table). Mean changes from baseline with secukinumab at Wk 16 were greater than the minimum clinically important difference (MCID) for SF-36 PCS, ASQoL and FACIT-Fatigue (Table). Reductions in WPAI-GH were also observed with secukinumab vs PBO at Wk 16. Improvements in PROs from baseline were sustained or increased from Wk 16 through Wk 52 (Table).
Conclusions In subjects with active AS, secukinumab 150 mg provided rapid and sustained improvements in PROs, including fatigue, general and AS-specific QoL measures, and illness-associated reductions in work productivity.
Yeremenko N, et al. Curr Opin Rheumatol 2014;26:361–70.
Sieper J, et al. Arthritis Rheumatol 2014;66(11 Suppl):S232
Acknowledgements Medical writing support was provided by Rachel Mason at Seren Communications (Tytherington, UK), and was funded by Novartis.
Disclosure of Interest A. Deodhar Grant/research support from: AbbVie, Celgene, Janssen, Novartis, Pfizer, and UCB, Consultant for: AbbVie, Celgene, Janssen, Novartis, Pfizer, and UCB, J. Sieper Grant/research support from: AbbVie, Pfizer, and Merck, Consultant for: AbbVie, Pfizer, Merck, UCB, and Novartis, Speakers bureau: AbbVie, Pfizer, Merck, and UCB, P. Emery Consultant for: AbbVie, BMS, Merck, Novartis, Pfizer, Roche, and UCB, B. Porter Shareholder of: Novartis, Employee of: Novartis, M. Andersson Employee of: Novartis, H. Richards Employee of: Novartis
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