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
BackgroundObesity is a risk factor for worse overall health in people with ankylosing spondylitis (AS)1. The German non-interventional study AQUILA provides real-world data in AS on the influence of body mass index (BMI) 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 global functioning and health and to report safety profile depending on the BMI of AS patients (pts).MethodsAQUILA is an ongoing, multi-center, non-interventional study including up to 3000 pts with active AS or psoriatic arthritis. Pts were observed from BL up to week (w) 52 according to clinical routine. Real-world data were assessed prospectively and analyzed as observed. Validated questionnaires were used to collect data on disease activity (Bath Ankylosing Spondylitis Disease Activity Index, BASDAI) and global functioning and health (Assessment of SpondyloArthritis-Health Index, ASAS-HI). For calculation of proportion of pts that experienced (serious) adverse events ((S)AEs), all AS 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 AS pts.ResultsAt BL, BMI data were available for 667 AS pts: 33.6% (n=224) normal weight, 39.9% (n=266) overweight and 26.5% (n=177) obese AS pts (Table 1). In all BMI subgroups the proportion of men was higher, even doubled among overweight AS pts. As BMI increased, so did age and comorbidities/extraarticular manifestations (EAMs, Table 1).Table 1.Overview of baseline characteristics in AS pts depending on BMIDemographicsBMI ≤25 kg/m2 (N=224)BMI >25 to ≤30 kg/m2 (N=266)BMI >30 kg/m2 (N=177)Male*123 (54.9)178 (66.9)94 (53.1)Age, years**43.3 (12.1)47.5 (12.3)49.2 (11.0)BASDAI**4.8 (2.0)5.5 (1.8)5.5 (2.0)ASAS-HI**7.4 (3.7)7.7 (3.3)8.1 (3.6)Comorbidities/EAMs*Heart-related disease4 (1.8)12 (4.5)12 (6.8)Coronary heart disease4 (1.8)10 (3.8)8 (4.5)Stroke1 (0.4)0 (0.0)2 (1.1)Heart insufficiency1 (0.4)4 (1.5)8 (4.5)Uveitis11 (4.9)17 (6.4)13 (7.3)Depression88 (55.3)121 (58.2)73 (54.9)*variables are given as n (%); **variables given as mean (SD)Mean BASDAI developed similarly over time with lowest scores for normal weight and highest scores for obese AS pts (Figure 1A). Mean improvement from BL to w52 was 1.3 (27.1%) for normal weight, 1.5 (27.2%) for overweight, and 1.2 (21.8%) for obese AS pts.Figure 1.Disease activity and global functioning under secukinumab treatment in AS pts stratified by BMIMean ASAS-HI at BL was similar for all BMI subgroups (≤25: 7.4; >25-≤30: 7.7; >30: 8.1); the best improvement was observed in normal weight, the least in obese AS pts (Figure 1B). Mean improvement from BL to w52 was 2.1 (28.4%) for normal weight, 1.3 (16.9%) for overweight, and 0.6 (7.4%) for obese AS pts.The occurrence of AEs/SAEs with or without suspected relationship to secukinumab increased with increasing BMI. For example, the percentage of SAEs in normal weight was 21%, in overweight 26.7% and in obese AS pts 30.9% (data not shown). There were no events with fatal outcome or unexpected safety signals in either subgroup.ConclusionIn a real-world setting, secukinumab improved disease activity and global functioning and health in all BMI subgroups of AS pts; normal weight AS pts had numerically better ASAS-HI and BASDAI scores than obese AS 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 AS pts in all BMI subgroups.References[1]Chen, C.-H., et al. International Journal of Rheumatic Diseases23, 1165-1174 (2020).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
BackgroundIn both, ankylosing spondylitis (AS) and psoriatic arthritis (PsA), women typically have a longer delay in diagnosis.1,2 There is scientific evidence that prognosis for AS and PsA improves when diagnosed early. The German non-interventional study AQUILA provides real-world data on the influence of time to diagnosis and gender on treatment outcomes under secukinumab, a fully human monoclonal antibody that selectively inhibits interleukin-17A.ObjectivesThe aims of this interim analysis are to describe selected baseline (BL) demographics of AS and PsA patients (pts) and to evaluate the impact of time to diagnosis and gender on secukinumab treatment outcomes, such as disease activity and global functioning and health.MethodsAQUILA is an ongoing, multi-center, non-interventional study including up to 3000 pts with AS or PsA. Pts were observed from BL up to week (w) 52 according to clinical routine. Real-world data were assessed prospectively and analyzed as observed. Validated questionnaires were used to collect data on disease activity (Bath Ankylosing Spondylitis Disease Activity Index, BASDAI), global functioning and health (Assessment of SpondyloArthritis-Health Index, ASAS-HI) in AS, and skin and joint-related disease activity (Psoriasis Area and Severity Index, PASI; tender/swollen joint counts, TJC/SJC) and impact of disease (Psoriatic Arthritis Impact of Disease - 12 items, PsAID-12 score) in PsA pts. This interim analysis focused on the subgroups of male and female AS and PsA pts stratified by time to diagnosis after disease onset (˂1 year [y] and ≥1y for early and late diagnosis, respectively).ResultsAt BL, 609 AS and 1145 PsA pts were included with information on time to diagnosis (Table 1); only 18.7% of AS and 25.8% of PsA pts were diagnosed within one year. Of interest, both female AS and PsA pts as well as male PsA pts with increased BMI tended to be diagnosed later (Table 1). Regarding BASDAI scores, male AS pts diagnosed late had increased disease activity at BL and throughout the study (Figure 1A); female AS pts diagnosed late showed reduced total treatment effect with increasing time to diagnosis (Figure 1B). Similarly, both male and female AS pts diagnosed late had slightly increased ASAS-HI at BL and throughout the study (Table 1). For PsA pts, there was no difference in skin- (PASI, Figure 1C/D) and joint-related (Figure 1E/F) disease activity with respect to time to diagnosis. Furthermore, there was no difference in PsAID scores (data not shown) between early- and late-diagnosed PsA pts.Table 1.Overview of selected BL characteristics in AS and PsA pts stratified by time to diagnosisAS (N=609)Time to diagnosis ˂1 year (n=114)Time to diagnosis ≥1 year (n=495)Male (n=63)Female (n=51)Male (n=301)Female (n=194)Age, years43.146.345.947.7BMI27.725.927.327.8BASDAI4.75.05.35.2ASAS-HI6.78.07.48.2PsA (N=1145)Time to diagnosis ˂1 year (n=295)Time to diagnosis ≥1 year (n=850)Male (n=126)Female (n=169)Male (n=363)Female (n=487)Age, years50.151.852.353.1BMI28.729.429.328.8PASI6.56.27.07.2PsAID4.65.24.85.3TJC/SJC5.9/3.37.3/3.27.0/3.77.3/3.8All variables given as meanFigure 1.Disease activity in early- and late-diagnosed AS and PsA ptsConclusionIn a real-world setting, secukinumab improved disease activity and global functioning in both AS and PsA pts. Both, male and female AS pts had a higher treatment response when diagnosed early. Interestingly, delay in diagnosis appeared to be BMI-dependent in female AS pts and PsA pts of both genders. However, in contrast to AS, treatment response of early- and late-diagnosed PsA pts did not differ in the further course.References[1]Rusman, T., van Bentum, R.E. & van der Horst-Bruinsma, I.E. Rheumatology59, iv38-iv46 (2020). 2. Passia, E., et al. OP0057. Annals of the Rheumatic Diseases79, 38-39 (2020).Disclosure of InterestsKarolina Benesova Speakers bureau: Abbvie, BMS, Gilead/Galapagos, Janssen, Lilly, Medac, MSD, Novartis, Roche, Viatris, Consultant of: Gilead/Galapagos, Novartis, Grant/research support from: Abbvie, Novartis, Oliver Hansen Grant/research support from: Novartis, Uta 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, Annika Boas Employee of: Novartis, Stefanie Welle Employee of: Novartis, Hans-Peter Tony Consultant of: AbbVie, Astra-Zeneca, BMS, Chugai, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi
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