Pos0199 How Does Age Affect the Safety Profile in Spondyloarthritis Patients Treated With Secukinumab in Real World? Data From the German Aquila Study

Background: Treating patients (pts) suffering from spondyloarthritis such as psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA), is challenging due to comorbidities and compromised immune system. Secukinumab (SEC) is a fully human monoclonal antibody that selectively inhibits IL-17A, a cytokine which is central in the pathogenesis of PsA and axSpA. There is little real-world data on the safety profile of SEC in an elderly population. The non-interventional study (NIS) AQUILA provides such data for pts with PsA or axSpA in Germany. Objectives: Here, we evaluate the safety profile of SEC treatment and report the incidence of adverse events (AE) in four age groups. Methods: AQUILA is an ongoing, multi-center, 52-week NIS including more than 3000 pts with active PsA or axSpA. This analysis includes data of approximately 2000 PsA and 1000 axSpA pts. Sex, body mass index (BMI), smoking status, the presence of uveitis, plaque psoriasis, heart-related diseases and the incidence of (serious) adverse events (S)AEs/AEs of special interest (AESI) were analyzed. The pts were stratified not by indication but by four age groups, <50, ≥50 to <65, ≥65 to <75, and ≥75 years (y). Results: At baseline, in the overall population, 1270 pts were <50 y, 1455 pts were ≥50 to <65 y, 278 pts were ≥65 to <75 y, and 73 pts were ≥75 y. In the youngest age group the proportion of male pts (52.3%) was higher than that of women (47.7%), with increasing age, the proportion of women rose (Table 1). Mean BMI was comparable between the age groups and ranged from 27.3 kg/m2 to 29.5 kg/m2. The proportion of non-smokers increased with age from 41.8% in the <50 age group to 72.6% in the ≥75 age group. Elderly pts (older than 65 y) had higher baseline frequencies of heart failure and coronary heart disease. Frequencies of plaque psoriasis and uveitis were comparable among the age groups. SEC mean monthly dose (MMD) of 150 mg (75 to <225 mg) was applied in more patients (53.8-66.7%) than SEC MMD 300 mg (225 to <375 mg, 33.3-45.3%) in all age groups, except ≥65 to <75 y where the dosages were evenly distributed. Lower or higher MMDs were rarely applied. The incidence of (S)AE with and without a suspected relationship to treatment with SEC was comparable between the age groups (AE: 63.0-68.3%, AE with suspected relationship to SEC: 30.1-40.3%, SAE: 22.2-27.0%, SAE with suspected relationship to SEC: 7.9-9.5%, Figure 1A). In general, the incidence of AESIs, such as inflammatory bowel disease (IBD), major adverse cardiovascular events (MACE), Crohn's disease (CD), ulcerative colitis (UC), malignant tumors, injection site reactions and Candida infection, was low among all age groups (0.0-2.2%, Figure 1B). Conclusion: Real-world data from the AQUILA study show that SEC treatment has a favorable safety profile in all age groups, including elderly pts with spondyloarthritis, despite an increased prevalence of comorbidities in this population. No new safety signals were detected and the incidence of (S)AE was comparable between age groups. REFERENCES: NIL. Acknowledgements: NIL. Disclosure of Interests: Jan Brandt-Juergens AbbVie, BMS, Gilead, Galapagos, Janssen, Lilly, Medac, MSD, Novartis, Pfizer, Roche, Sanofi-Aventis, UCB, Elke Riechers AbbVie, Chugai, Novartis, UCB, AbbVie, Chugai, Novartis, UCB, Pfizer, Karolina Gente AbbVie, BMS, Gilead/Galapagos, Janssen, Lilly, Medac, MSD, Novartis, Roche, UCB, Viatris, BMS, Gilead/Galapagos, Hexal, Lilly, Novartis, AbbVie, Novartis, Sara Bär AbbVie, Chugai, Gilead/Galapagos, GSK, Eli Lilly, Novartis, UCB, Mirjam Fliesser Novartis Pharma GmbH, Daniel Peterlik Novartis Pharma GmbH, Uta Kiltz AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Gilead, GSK, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, UCB, AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Gilead, GSK, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, UCB.