SAT0288 Secukinumab demonstrates rapid and sustained efficacy in ankylosing spondylitis patients with normal or elevated baseline crp levels: pooled analysis of two phase 3 studies
Authors: J. Braun, J. Sieper, R. Landewé, X. Baraliakos, C. Miceli-Richard, E. Quebe-Fehling, B. Porter, K. Gandhi, D. van der Heijde
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> Elevated baseline (BL) CRP levels is one of the predictors of treatment response in patients (pts) with active AS.<sup>1</sup> The relationship between BL CRP levels and the treatment response to IL-17A inhibition has not been assessed in AS pts thus far. <h3>Objectives</h3> This <i>post-hoc</i> analysis assessed the response to secukinumab (SEC) treatment in AS pts with normal or elevated BL CRP from the phase 3 MEASURE 1 and MEASURE 2 studies over 3 years. <h3>Methods</h3> The study designs of MEASURE 1 and 2 have been reported.<sup>2</sup> This analysis pooled data from all pts with available BL CRP levels who received subcutaneous (s.c.) SEC 150 mg (approved dose; n=197) or placebo (PBO; n=195<b>).</b> Efficacy endpoints included ASAS20/40, BASDAI, BASDAI50, ASDAS inactive disease, and ASAS partial remission (PR) stratified by normal (&lt;5 mg/L) and elevated (≥5 mg/L) BL CRP; elevated BL CRP group was further subdivided into a range of elevated CRP levels:&gt;5–10,&gt;10–15,&gt;15 mg/L. Data are presented as non-responder imputation (NRI) at Week (Wk)16 and multiple imputation (MI) at Wk156 for binary variables and mixed-effect model repeated measure (MMRM) at Wks 16 and 156 for continuous variables. <h3>Results</h3> Overall, 36.5% (143/392) of pts with normal CRP and 63.5% (249/392) of pts with elevated BL CRP were included in the pooled analysis. BL characteristics were balanced across normal and elevated BL CRP groups.<sup>3</sup> At Wk16, efficacy endpoints were improved with SEC 150 mg vs PBO in pts with normal or elevated BL CRP.<sup>3</sup> Results were consistent across all levels of elevated BL CRP with a trend for greater improvement in pts with more elevated CRP (Table). Improvements were sustained or further improved at Wk156 in all groups (Table). <h3>Conclusions</h3> SEC 150 mg demonstrated sustained efficacy through 3 years in AS patients with both normal and elevated CRP levels, with an increased effect in elevated CRP patients. <h3>References</h3> [1] Davis JC Jr, et al. J Rheumatol. 2005;32:1751–4. [2] Baeten D, et al. N Engl J Med 2015;373:2534–48. [3] et al. Arthritis Rheumatol 2017;69 [4] Braun J, et al. Arthritis Rheumatol 2017;69(suppl 10). <h3>Acknowledgements</h3> The study was sponsored by Novartis Pharma AG <h3>Disclosure of Interest</h3> J. Braun Grant/research support from: AbbVie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, UCB, Consultant for: AbbVie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, UCB, Speakers bureau: AbbVie (Abbott), Amgen, BMS, Boehringer, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis, UCB, J. Sieper Grant/research support from: AbbVie Inc., Pfizer Inc., and Merck, Consultant for: AbbVie Inc., Pfizer Inc., Merck, UCB, and Novartis, Speakers bureau: AbbVie Inc., Pfier Inc., Merck, and UCB, R. Landewé Grant/research support from: Abbott, Amgen, Centocor, Novartis, Pfizer, Roche, Schering-Plough, UCB, Wyeth, Consultant for: Abbott/AbbVie, Ablynx, Amgen, Astra-Zeneca, Bristol-Myers Squibb, Centocor, GlaxoSmithKline, Novartis, Merck, Pfizer, Roche, Schering-Plough, UCB, Wyeth, Speakers bureau: Abbott, Amgen, Bristol-Myers Squibb, Centocor, Merck, Pfizer, Roche, Schering-Plough, UCB, Wyeth, X. Baraliakos Grant/research support from: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB, Werfen, Consultant for: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB, Werfen, Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB, Werfen, C. Miceli-Richard Grant/research support from: Abbott/AbbVie, Bristol-Myers Squibb, Novartis, Merck, Pfizer, Wyeth, Consultant for: Pfizer, Roche, UCB, Wyeth, Merck, Speakers bureau: Abbott, Bristol-Myers Squibb, Merck, Pfizer, Roche, Schering-Plough, Wyeth, E. Quebe-Fehling Employee of: Novartis, B. Porter Shareholder of: Novartis Pharmaceutical Corporation, Employee of: Novartis Pharmaceutical Corporation, K. Gandhi Shareholder of: Novartis Pharmaceutical Corporation, Employee of: Novartis Pharmaceutical Corporation, D. van der Heijde Consultant for: AbbVie, Amgen, Astellas, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Daiichi, Eli-Lilly, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB