FRI0272 SECUKINUMAB DEMONSTRATES A CONSISTENT SAFETY PROFILE IN PATIENTS WITH PSORIASIS, PSORIATIC ARTHRITIS AND ANKYLOSING SPONDYLITIS OVER LONG TERM: UPDATED POOLED SAFETY ANALYSES
Authors: A. Deodhar, I. Mcinnes, X. Baraliakos, K. Reich, A. B. Gottlieb, M. Lebwohl, S. Schreiber, W. Bao, K. Marfo, H. Richards, L. Pricop, A. Shete, J. Safi, P. J. Mease
Journal: Annals of the Rheumatic Diseases (2020)

Background: Pooled safety data has been reported with secukinumab (SEC) in patients (pts) with Psoriatic arthritis (PsA), Ankylosing Spondylitis (AS) and Psoriasis (PsO). 1 Objectives: To report longer-term safety data of SEC treatment in PsA, AS, PsO pts up to 5 years. Methods: The integrated clinical trial safety dataset included data pooled from 28 randomised controlled clinical trials of SEC 300 or 150 or 75 mg in PsO (11 Phase 3 and 8 Phase 4 trials), PsA (5 Phase 3 trials), and AS (4 Phase 3 trials), along with post-marketing safety surveillance data with a cut-off date of 25 December 2018. Adverse events (AEs) were reported as exposure-adjusted incident rates (EAIRs) per 100 pt-years. Analyses included all pts who received ≥1 dose of SEC. Results: A total of 12637 pts (8819, 2678 and 1140 pts with PsO, PsA and AS, with an exposure of 15063.1, 5984.6 and 3527.2 pt-years, respectively) were included. The most frequent AE was upper respiratory tract infection and EAIR per 100 pt-years for IBD, malignancies and MACE remained low. The EAIR per 100 pt-years for adverse events (AEs) of special interest are reported in Table 1. The cumulative post-marketing exposure to SEC was estimated to be ~285,811 pt-years across the approved indications. Safety data from post-marketing surveillance are reported in Table 2. Table 1. Selected AEs of interest with SEC across pooled clinical trials Variable PsO PsA AS SEC N=8819 SEC N=2678 SEC N=1140 Exposure (Days), Mean (SD) 623.9 (567.7) 816.2 (580.7) 1130.1 (583.0) Death, n (%) 15 (0.2) 13 (0.5) 10 (0.9) Selected AE’s of interest, EAIR (95% CI) Serious infections 1 1.4 (1.2, 1.6) 1.8 (1.5, 2.2) 1.2 (0.9, 1.6) Candida infections 2 2.9 (2.7, 3.2) 1.5 (1.2, 1.9) 0.7 (0.5, 1.1) IBD 3 Crohn’s disease 3 Ulcerative colitis 3 0.01 (0.0, 0.05) 0.1 (0.05, 0.2) 0.1 (0.08, 0.2) 0.03 (0.0, 0.1) 0.1 (0.04, 0.2) 0.1 (0.04, 0.2) 0.03 (0.0, 0.2) 0.4 (0.24, 0.7) 0.2 (0.1, 0.5) MACE 4 0.4 (0.31, 0.5) 0.4 (0.3, 0.6) 0.7 (0.4, 1.0) Uveitis 3 0.01 (0.0, 0.05) 0.1 (0.04, 0.2) 1.2 (0.9, 1.7) Malignancy 5 0.9 (0.7, 1.0) 1.0 (0.77, 1.3) 0.5 (0.3, 0.8) 1 Rates for system organ class; 2 Rates for high level term; 3 Rates for preferred term (PT; IBD for unspecified IBD); 4 Rates for Novartis MedDRA Query term; 5 Rates for standardized MedDRA query term – ‘malignancies and unspecified tumour’; EAIR, exposure adjusted incidence rate per 100 pt-years; N, number of pts in the analysis Table 2. Summary of SEC post-marketing safety Exposure (PTY) PSUR1 26Dec14 -25Jun15 PSUR2 26 Jun - 25Dec15 PSUR3 26Dec15 -25Jun16 PSUR4 26Jun -25Dec16 PSUR5 26Dec16 -25Dec17 PSUR6 26Dec17 -25Dec18 Cumulative 1838 7450 16871 28549 93744 137325 285811 n (Reporting rate PTY) Serious infections 89 (4.8) 149 (2.0) 232 (1.4) 475 (1.7) 649 (0.7) 1841 (1.3) 3980 (1.4) Malignancy 2 (0.1) 15 (0.2) 21 (0.1) 50 (0.2) 225 (0.2) 422 (0.3) 788 (0.3) Total IBD 4 (0.2) 12 (0.2) 37(0.2) 46 (0.2) 185 (0.2) 340 (0.3) 693 (0.2) MACE 6 (0.3) 15 (0.2) 16 (0.1) 39 (0.1) 151 (0.2) 238 (0.2) 504 (0.2) PSUR, periodic safety update report; PTY, pt-treatment years Conclusion: In this long-term analysis across clinical trials and post-marketing surveillance, of pts with PsO, PsA and AS, SEC was well tolerated, with a safety profile consistent with previous reports. 1 Reference: [1]Deodhar et al. Arthritis Research &amp; Therapy (2019) 21:111. Disclosure of Interests: Atul Deodhar Grant/research support from: AbbVie, Eli Lilly, GSK, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myer Squibb (BMS), Eli Lilly, GSK, Janssen, Novartis, Pfizer, UCB, Iain McInnes Grant/research support from: Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Janssen, and UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly and Company, Gilead, Janssen, Novartis, Pfizer, and UCB, Xenofon Baraliakos Grant/research support from: Grant/research support from: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Consultant of: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Speakers bureau: AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB and Werfen, Kristian Reich Grant/research support from: Affibody; Almirall; Amgen; Biogen; Boehringer Ingelheim; Celgene; Centocor; Covagen; Eli Lilly; Forward Pharma; Fresenius Medical Care; GlaxoSmithKline; Janssen; Kyowa Kirin; LEO Pharma; Medac; Merck; Novartis; Miltenyi Biotec; Ocean Pharma; Pfizer; Regeneron; Samsung Bioepis; Sanofi Genzyme; Takeda; UCB; Valeant and Xenoport., Consultant of: Affibody; Almirall; Amgen; Biogen; Boehringer Ingelheim; Celgene; Centocor; Covagen; Eli Lilly; Forward Pharma; Fresenius Medical Care; GlaxoSmithKline; Janssen; Kyowa Kirin; LEO Pharma; Medac; Merck; Novartis; Miltenyi Biotec; Ocean Pharma; Pfizer; Regeneron; Samsung Bioepis; Sanofi Genzyme; Takeda; UCB; Valeant and Xenoport., Speakers bureau: Affibody; Almirall; Amgen; Biogen; Boehringer Ingelheim; Celgene; Centocor; Covagen; Eli Lilly; Forward Pharma; Fresenius Medical Care; GlaxoSmithKline; Janssen; Kyowa Kirin; LEO Pharma; Medac; Merck; Novartis; Miltenyi Biotec; Ocean Pharma; Pfizer; Regeneron; Samsung Bioepis; Sanofi Genzyme; Takeda; UCB; Valeant and Xenoport., Alice B Gottlieb Grant/research support from:: Research grants, consultation fees, or speaker honoraria for lectures from: Pfizer, AbbVie, BMS, Lilly, MSD, Novartis, Roche, Sanofi, Sandoz, Nordic, Celltrion and UCB., Consultant of:: Research grants, consultation fees, or speaker honoraria for lectures from: Pfizer, AbbVie, BMS, Lilly, MSD, Novartis, Roche, Sanofi, Sandoz, Nordic, Celltrion and UCB., Speakers bureau:: Research grants, consultation fees, or speaker honoraria for lectures from: Pfizer, AbbVie, BMS, Lilly, MSD, Novartis, Roche, Sanofi, Sandoz, Nordic, Celltrion and UCB., Mark Lebwohl Grant/research support from: AbbVie, Amgen, Arcutis, AstraZeneca, Boehringer Ingelheim, Celgene, Clinuvel, Eli Lilly, Incyte, Janssen Research &amp; Development, LLC, Kadmon Corp., LLC, Leo Pharmaceutucals, Medimmune, Novartis, Ortho Dermatologics, Pfizer, Sciderm, UCB, Inc., and ViDac, Consultant of: Allergan, Almirall, Arcutis, Inc., Avotres Therapeutics, BirchBioMed Inc., Boehringer-Ingelheim, Bristol-Myers Squibb, Cara Therapeutics, Castle Biosciences, Corrona, Dermavant Sciences, Evelo, Foundation for Research and Education in Dermatology, Inozyme Pharma, LEO Pharma, Meiji Seika Pharma, Menlo, Mitsubishi, Neuroderm, Pfizer, Promius/Dr. Reddy’s Laboratories, Theravance, and Verrica, Stefan Schreiber Consultant of: AbbVie, Arena, BMS, Biogen, Celltrion, Celgene, IMAB, Gilead, MSD, Mylan, Pfizer, Fresenius, Janssen, Takeda, Theravance, provention Bio, Protagonist and Falk, Weibin Bao Shareholder of: Novartis, Employee of: Novartis, Kwaku Marfo Shareholder of: Novartis, Employee of: Novartis, Hanno Richards Shareholder of: Novartis, Employee of: Novartis, Luminita Pricop Shareholder of: Novartis, Employee of: Novartis, Abhijit Shete Shareholder of: Novartis, Employee of: Novartis, Jorge Safi Shareholder of: Novartis, Employee of: Novartis, Philip J Mease Grant/research support from: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – grant/research support, Consultant of: Abbott, Amgen, Biogen Idec, BMS, Celgene Corporation, Eli Lilly, Novartis, Pfizer, Sun Pharmaceutical, UCB – consultant, Speakers bureau: Abbott, Amgen, Biogen Idec, BMS, Eli Lilly, Genentech, Janssen, Pfizer, UCB – speakers bureau