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

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Abstract
Background Elevated baseline (BL) CRP levels is one of the predictors of treatment response in patients (pts) with active AS.1 The relationship between BL CRP levels and the treatment response to IL-17A inhibition has not been assessed in AS pts thus far. Objectives This post-hoc 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. Methods The study designs of MEASURE 1 and 2 have been reported.2 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). Efficacy endpoints included ASAS20/40, BASDAI, BASDAI50, ASDAS inactive disease, and ASAS partial remission (PR) stratified by normal (5–10,>10–15,>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. Results 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.3 At Wk16, efficacy endpoints were improved with SEC 150 mg vs PBO in pts with normal or elevated BL CRP.3 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). Summary of Clinical Efficacy Conclusions 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. References [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). Acknowledgements The study was sponsored by Novartis Pharma AG Disclosure of Interest 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