Pos1013 how Does Body Mass Index Affect Secukinumab Treatment Outcomes and Safety in Patients With Psoriatic Arthritis? – Real World Data From the German Aquila Study

Abstract

BackgroundThere is a higher prevalence of obesity in patients (pts) with psoriatic disease1. The German non-interventional study AQUILA provides real-world data on the influence of body mass index (BMI) of pts with psoriatic arthritis (PsA) on therapeutic effectiveness and safety under treatment with secukinumab, a fully human monoclonal antibody that selectively inhibits IL-17A.ObjectivesThe aims of this interim analysis are to describe selected baseline (BL) demographics and to evaluate secukinumab treatment outcomes on disease activity and impact of disease on health and to report safety profile depending on the BMI of PsA pts.MethodsAQUILA is an ongoing, multi-center study including up to 3000 pts with active PsA or ankylosing spondylitis. Pts were observed from BL up to week (w) 52. Real-world data were assessed prospectively and analyzed as observed. Data were collected on Psoriatic Arthritis Impact of Disease-12 items (PsAID-12 score) and Patient’s Global Assessment (PGA). For calculation of proportion of pts that experienced (serious) adverse events ((S)AEs), all PsA pts were included that received at least one dose of secukinumab. This interim analysis focuses on BMI subgroups ≤25 kg/m2 (normal weight), >25 to ≤30 kg/m2 (overweight) and >30 kg/m2 (obese) in PsA pts.ResultsAt BL, BMI data were available for 1228 PsA pts: 26.5% (n=325) normal weight, 35.0% (n=430) overweight and 38.5% (n=473) obese PsA pts. Proportion of men was lower in normal weight and obese PsA pts. As BMI increased, so did age and comorbidities/extraarticular manifestations (EAMs; Table 1); e.g. percentage of PsA pts with heart-related disease increased from 5.2% in normal weight to 9.3% in obese PsA pts.Table 1.Overview of baseline characteristics in PsA pts depending on BMIDemographicsBMI ≤25 kg/m2(N=325)BMI >25 to ≤30 kg/m2(N=430)BMI >30 kg/m2(N=473)Male*105 (32.3)219 (50.9)188 (39.7)Age, years**49.5 (±12.7)53.2 (±11.0)54.1 (±10.6)PsAID**4.7 (2.4)4.9 (2.2)5.4 (2.0)PGA**4.8 (2.6)5.4 (2.4)5.5 (2.4)Comorbidities/EAMs* Heart-related disease17 (5.2)29 (6.7)44 (9.3) Coronary heart disease10 (3.1)25 (5.8)35 (7.4) Stroke1 (0.3)9 (2.1)11 (2.3) Heart insufficiency9 (2.8)15 (3.5)15 (3.2) Uveitis5 (1.5)6 (1.4)10 (2.1) Depression137 (53.5)190 (55.2)231 (58.5)*variables are given as n (%); **variables given as mean (SD)Mean PsAID at BL was similar for all BMI subgroups (≤25: 4.7; >25-≤30: 4.9; >30: 5.4; Figure 1A). Mean improvement from BL to w52 was 1.9 (40.4%) for normal weight, 1.8 (36.7%) for overweight, and 1.7 (31.5%) for obese PsA pts.Figure 1.Impact of disease and PGA in PsA pts stratified by BMI.Note: p-values are of exploratory nature. Wilcoxon tests were used to show significant subroup differences.Mean PGA developed in a similar way over time with lowest scores for normal weight and highest scores for obese PsA pts (Figure 1B). Mean improvement from BL to w52 was 2.0 (41.6%) for normal weight, 2.2 (40.7%) for overweight, and 1.8 (32.7%) for obese PsA pts.The occurrence of AEs/SAEs with or without suspected relationship to secukinumab was most frequent in overweight and obese PsA pts. For example, the percentage of SAEs in normal weight PsA pts was 21.6%, in overweight 26.3% and in obese 25.9%. There were no unexpected safety signals in either subgroup. One male obese PsA patient died. Cause of death was not reported, however, treating physician did not suspect a causal relationship to secukinumab.ConclusionIn a real-world setting, secukinumab improved impact of disease and patient´s global assessment of disease activity in all BMI subgroups of PsA pts. However, normal weight PsA pts had numerically better PsAID and PGA scores than obese PsA pts. Altogether, real-world data of this interim analysis show that secukinumab is an effective treatment with a favorable safety profile up to 52 weeks in PsA pts in all BMI subgroups.References[1]Queiro, R., Lorenzo, A., Tejón, P., Coto, P. & Pardo, E. Medicine (Baltimore) 98, e16400 (2019).Disclosure of InterestsUta Kiltz Consultant of: AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Gilead, GSK, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, UCB, Grant/research support from: AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Gilead, GSK, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, UCB, Jan Brandt-Juergens Consultant of: Abbvie, Affibody, BMS, Gilead, Janssen, Lilly, Medac, MSD, Novartis, Pfizer, Roche, Sanofi-Aventis, UCB, Peter Kästner Consultant of: Chugai, Novartis, Elke Riechers Consultant of: AbbVie, Chugai, Novartis, UCB, Grant/research support from: AbbVie, Chugai, Novartis, UCB, Pfizer, Daniel Peterlik Employee of: Novartis, Christina Budden Employee of: Novartis, Hans-Peter Tony Consultant of: AbbVie, Astra-Zeneca, BMS, Chugai, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi

Effectiveness and safety of secukinumab in ankylosing spondylitis and psoriatic arthritis: a 52-week real-life study in an Italian cohort

“…However, we lack body mass index data for many of our patients, so we cannot draw definitive conclusions. Indeed, the effects of increased body mass index on secukinumab response have been controversial in previous studies, ranging from no influence [31], to some numerical but not statistical difference [46], to an even favorable role [47].…”

Interleukin-17–targeted treatment in patients with spondyloarthritis and associated cardiometabolic risk profile

“…BASDAI) and in global functioning and health (Assessment of Spondyloarthritis international Society Health Index [ASAS–HI]) up to 1 year in all patients, irrespective of their BMI ( 109 ). Moreover, secukinumab treatment had a favorable safety profile, with no new safety concerns identified in these patients ( 108 , 109 ).…”

“…The ongoing non-interventional AQUILA study is investigating the real-world effectiveness and safety of secukinumab treatment in 3000 patients with active PsA ( 108 ) or AS ( 109 ) according to their BMI. In patients with PsA, preliminary reports described improvements in disease activity (e.g.…”

“…In patients with PsA, preliminary reports described improvements in disease activity (e.g. Psoriatic Arthritis Impact of Disease-12 [PsAID-12] score and Patient’s Global Assessment [PGA]) up to 1 year in all BMI subgroups ( 108 ). Similarly, in patients with AS, preliminary reports described improvements in disease activity (e.g.…”