LAUSR

Background Pooled safety data from secukinumab (SEC) studies in psoriasis and psoriatic arthritis (PsA) have been reported previously.1 Objectives To report updated longer-term safety data with up to 5 years of SEC treatment from psoriasis and PsA studies. Methods The moderate to severe plaque psoriasis and active PsA data pool consisted of 15 and 3 Phase III studies, respectively. Different SEC doses in the studies included intravenous (up to 10 mg/kg) or subcutaneous (s.c.; 75–300 mg) loading, followed by s.c. maintenance dosing (300, 150 or 75 mg). Placebo patients were re-randomised to SEC at 12–24 weeks depending on study design. Adverse events (AEs) were reported as exposure adjusted incident rates (EAIR) per 100 patient-years and analyses included all patients who received ≥1 dose of SEC. Results A total of 5181 and 1380 patients from psoriasis and PsA studies representing an exposure of 10416.9 and 3866.9 patient years, respectively, were included in this study. The most frequently reported AE was viral upper respiratory tract infection (table 1). EAIRs for serious infections, Candida infections, inflammatory bowel disease (IBD) and major adverse cardiac events (MACE) were low and similar in both psoriasis and PsA indications (table 1). No cases of tuberculosis were reported.Abstract THU0325 – Table 1 Summary of Secukinumab Safety across Psoriasis and PsA studies: Entire Safety Period Psoriasis PsA Any secukinumabn=5181 Any secukinumabn=1380 Total exposure, patient-years 10416.9 3866.9 Min–max exposure (days) 1–1825 8–1827 Exposure (days), mean (SD) 734.4 (562.9) 1023.5 (472.3) Death, n (%) 9 (0.2) 11 (0.8) EAIR per 100 Patient-years (95% Cl) Any AE 204.4 (198.4, 210.5) 147.0 (138.9,155.5) Any serious AE 6.9 (6.3, 7.4) 7.9 (7.0–8.9) Most Common AEs1 Viral upper respiratory tract infection 21.0 (19.9–22.0) 12.1 (10.9–13.4) Headache 6.2 (5.8, 6.8) 3.8 (3.2, 4.5) Upper respiratory tract infection 5.4 (4.9, 5.9) 9.1 (8.1, 10.2) AEs of Selected Interest Serious infections2 1.4 (1.2, 1.6) 1.9 (1.5, 2.4) Candida infections3 2.2 (1.9, 2.5) 1.5 (1.1, 2.0) IBD4Crohn’s disease4Ulcerative colitis4 0.01 (0.0–0.05)0.05 (0.02–0.11)0.13 (0.07–0.23) 0.05 (0.01–0.19)0.08 (0.02–0.23)0.08 (0.02–0.23) MACE5 0.3 (0.2, 0.5) 0.4 (0.3–0.7) 1AEs in the SEC group that occurred with an EAIR of ≥5 during the entire safety period in either of the pooled groups; 2Rates are for system organ class; 3Rates are for high level term; 4Rates are for PT (IBD PT data are reported for unspecified IBD); 5Rates are for Novartis MedDRA Query term; EAIR, exposure adjusted incidence rate per 100 patient-years; N, number of patients in the analysis; SD, standard deviation Conclusions SEC demonstrated a favourable safety profile during long-term treatment (up to 5 years) in patients with moderate to severe plaque psoriasis or PsA, hence, supporting long-term use. The safety profile was consistent with previous reports and comparable across psoriasis and PsA patients. Reference [1] Mease, et al. Arthritis Rheumatol2017; 69(suppl 10):A606. Disclosure of Interest P. Mease Grant/research support from: AbbVie, Amgen, BMS, Janssen, Lilly, Novartis, Pfizer, and UCB, Consultant for: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Merck, Novartis, Pfizer, SUN Pharma, UCB,, Speakers bureau: AbbVie, Amgen, BMS, Janssen, Lilly, Pfizer, and UCB, I. McInnes Grant/research support from: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, and UCB, Consultant for: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, and UCB, Speakers bureau: AbbVie, Amgen, BMS, Celgene, Janssen, Lilly, Novartis, Pfizer, and UCB, K. Reich Consultant for: Abbvie, Affibody, Amgen, Biogen, Boehringer Ingelheim Pharma, Celgene, Centocor, Covagen, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, Leo, Lilly, Medac, Merck Sharp and Dohme Corp., Novartis, Ocean Pharma, Pfizer, Regeneron, Sanofi, Takeda, UCB Pharma, Xenoport, Speakers bureau: Abbvie, Affibody, Amgen, Biogen, Boehringer Ingelheim Pharma, Celgene, Centocor, Covagen, Forward Pharma, GlaxoSmithKline, Janssen-Cilag, Leo, Lilly, Medac, Merck Sharp and Dohme Corp., Novartis, Ocean Pharma, Pfizer, Regeneron, Sanofi, Takeda, UCB Pharma, Xenoport., P. Nash Grant/research support from: AbbVie, Amgen, BMS, Celgene, Eli Lilly, Hospira, MSD, Pfizer, Janssen, UCB, Novartis, Roche, Consultant for: AbbVie, Amgen, BMS, Celgene, Eli Lilly, Hospira, MSD, Pfizer, Janssen, UCB, Novartis, Roche, Speakers bureau: AbbVie, Amgen, BMS, Celgene, Eli Lilly, Hospira, MSD, Pfizer, Janssen, UCB, Novartis, Roche, A. Widmer Shareholder of: Novartis Stock, Employee of: Novartis, K. Abrams Shareholder of: Novartis Stock, Employee of: Novartis, L. Pricop Shareholder of: Novartis Stock, Employee of: Novartis, T. Fox Shareholder of: Novartis Stock, Employee of: Novartis