FRI0406 AQUILA STUDY IN GERMANY – REAL WORLD DATA ON SECUKINUMAB’S EFFECTIVENESS IN ANKYLOSING SPONDYLITIS PATIENTS – RESULTS FROM AN INTERIM ANALYSIS

Background:There is growing body of evidence that smoking is associated with more active and severe disease in patients (pts) with ankylosing spondylitis (AS).1,2The German non-interventional study AQUILA provides real-world data on the influence of smoking on therapeutic effectiveness and safety under secukinumab (SEC), a fully human monoclonal antibody that selectively inhibits interleukin-17A.Objectives:The aim of this interim analysis is to describe selected baseline (BL) demographics, to evaluate SEC effectiveness on disease activity and global functioning and health, and to report safety profile depending on smoking status of AS pts.Methods:AQUILA is an ongoing, multi-center, non-interventional study including up to 2700 pts with active AS or psoriatic arthritis. Pts were observed from BL up to week (w) 52. Real-world data was assessed prospectively and analyzed as observed. Assessment of CRP and 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) and depressive mood (Beck´s Depression Inventory version II, BDI-II). For calculation of proportion of pts who experienced (serious) adverse events ((S)AEs), all AS pts were included who received at least one dose of SEC irrespective of further documentation of any study visit. This analysis focuses on the subgroups non-smoker (NS) and smoker (S).Results:At BL, 311 AS pts were included: 42.1% (n=131) NS and 32.8% (n=102) S. Remaining subgroups were 15.1% (n=47) ex-smoker and 10.0% (n=31) of unknown smoking status. About half of AS pts in NS were male, while in S (69.6%) portion of men was more than twice as high as of women. S were slightly younger than NS (mean age: 43.9/49.0 years). During the study, CRP value decreased irrespective of smoking status with numerically higher fluctuations in S (Fig. 1A). BASDAI (NS: 5.2 at BL to 3.7 at w52, S: 5.6 at BL to 4.1 at w52) and ASAS-HI (Fig. 1B) scores numerically improved best in NS, whereas more variations were seen in S; the same was observed for BDI-II score values (NS: 11.8 at BL to 9.2 at w52, S: 13.0 at BL to 12.1 at w52). Although no major significant differences in mean values existed between NS and S, S displayed – except in w4 – overall higher mean values in the parameters mentioned above. Regarding the occurrence of AEs/SAEs with or without suspected relationship to SEC, there was no significant difference between NS and S (Table 1).Table 1.Overview of AEs (and SAEs) under SEC treatment depending on smoking status in AS ptsNumber of pts withNS (N=140), n (%)S (N=110),n (%)P valueAE95 (67.9)78 (70.9)0.80AE with suspected relationship to SEC66 (47.1)41 (37.3)0.29SAE39 (27.9)30 (27.3)0.95SAE with suspected relationship to SEC15 (10.7)10 (9.1)0.87Conclusion:In a real-world setting, SEC improved disease activity and global functioning and health in AS pts with slight (mostly non-significant) differences between NS and S. Overall, this interim analysis shows that SEC is an effective treatment with a favorable safety profile up to 52 weeks, irrespective of the pts’ smoking status. Further progress of the AQUILA study will reveal whether this trend will continue.Figure 1.CRP and global functioning and health in AS pts treated with SEC depending on smoking status**CRP data/ASAS-HI scores were documented not for all AS pts at BL and subsequent visits.References:[1]Averns HL et al, Scand J Rheumatol 1996;25:138-42; 2. Chung HY et al, Ann Rheum Dis 2012;71:809-16Disclosure of Interests:Elke Riechers Grant/research support from: AbbVie, Chugai, Lilly, Janssen, Novartis, Pfizer, Roche, UCB, Consultant of: AbbVie, Chugai, Novartis, UCB, Uta Kiltz Grant/research support from: AbbVie, Amgen, Biogen, Novartis, Pfizer, Consultant of: AbbVie, Biocad, Eli Lilly and Company, Grünenthal, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Novartis, Pfizer, Roche, UCB, Jan Brandt-Juergens: None declared, Peter Kästner Consultant of: Chugai, Novartis, Daniel Peterlik Employee of: Novartis Pharma GmbH, Hans-Peter Tony Consultant of: AbbVie, Astra-Zeneca, BMS, Chugai, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi

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FRI0200 Insight into the quality of life of patients with ankylosing spondylitis: real-world data from a us-based life impact survey

10.1136/annrheumdis-2018-eular.2650 ◽

2018 ◽

Author(s):

J.T. Rosenbaum ◽

L. Pisenti ◽

Y. Park ◽

R. Howard

Keyword(s):

Quality Of Life ◽

Ankylosing Spondylitis ◽

Real World ◽

Real World Data ◽

World Data ◽

Life Impact ◽

Insight Into

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AB0817 DOES SMOKING AFFECT SECUKINUMAB TREATMENT OUTCOMES AND SAFETY IN PATIENTS WITH PSORIATIC ARTHRITIS? - REAL WORLD DATA FROM THE GERMAN AQUILA STUDY

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.365 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 1711.1-1711

Author(s):

E. Riechers ◽

U. Kiltz ◽

J. Brandt-Juergens ◽

P. Kästner ◽

D. Peterlik ◽

...

Keyword(s):

Psoriatic Arthritis ◽

Disease Activity ◽

Real World ◽

Interim Analysis ◽

Smoking Status ◽

Depressive Mood ◽

Research Support ◽

Real World Data ◽

World Data ◽

Number Of Patients

Background:Several studies have shown a negative association between smoking status and psoriatic arthritis (PsA) clinical outcomes.1,2The German non-interventional study AQUILA provides real-world data on the influence of smoking on therapeutic effectiveness and safety issues under secukinumab (SEC), a fully human monoclonal antibody that selectively inhibits interleukin-17A.Objectives:The aim of this interim analysis is to describe selected baseline (BL) demographics, to evaluate SEC effectiveness on disease activity and depressive mood and to report the safety profile depending on smoking status of PsA patients.Methods:AQUILA is an ongoing, multi-center study including up to 2700 patients with active PsA or ankylosing spondylitis. Patients were observed from BL up to week (w) 52. Real-world data was assessed prospectively and analyzed as observed. In addition to the assessment of C-reactive protein (CRP), data was collected on patient´s disease activity (tender/swollen joint counts, TJC/SJC), skin disease activity (Psoriasis Area and Severity Index, PASI) and depressive mood (Beck´s Depression Inventory version II, BDI-II). For calculation of the proportion of patients who experienced (serious) adverse events ((S)AEs), all PsA patients were included who received at least one dose of SEC irrespective of further documentation of any study visit. This interim analysis focuses on subgroups non-smoker (NS) and smoker (S).Results:At BL, 641 PsA patients were included: 49.8% (n=319) non-smokers (NS) and 24.3% (n=156) smokers (S). 17.5% (n=112) were ex-smoker and 8.4% (n=54) of unknown smoking status. In both, NS and S, the proportion of women was higher (58.0% in NS and 67.3% in S). NS were slightly older than S (mean age: 53.8/49.7 years). There were no significant differences between NS and S in mean CRP within the 52 weeks (Fig. 1A). Both TJC and SJC improved over time and were similar between NS and S (Fig. 1B). Although mean absolute PASI value was worse in S at BL, a similar temporal improvement was seen in both groups (NS: 7.0 at BL to 1.0 at w52; S: 9.2 at BL to 1.0 at w52). BDI-II scores decreased in both groups with overall higher values in S (NS: 10.9 at BL to 9.1 at w52; S: 12.8 at BL and 10.8 at w52). Regarding the occurrence of AEs and SAEs with or without suspected relationship to SEC, NS had percentagewise less events than S (Table 1). In addition, percentage of PsA patients who discontinued SEC treatment due to an AE was lower for NS compared to S.Table 1.Overview of AEs (and SAEs) under SEC treatment depending on smoking status in PsA patientsNumber of patients withNS (N=333), n (%)S (N=161),n (%)P valueAE233 (70.0)118 (73.3)0.11AE with suspected relationship to SEC129 (38.7)72 (44.7)0.10SAE74 (22.2)45 (28.0)0.06SAE with suspected relationship to SEC29 (8.7)18 (11.2)0.37Figure 1.Disease activity in PsA patients treated with SEC depending on the smoking status**CRP data/ACR joint counts were documented not for all PsA patients at BL and subsequent visits.Conclusion:In a real-world setting, SEC improved disease activity and depressive mood of PsA patients with no obvious differences between NS and S. Overall, this interim analysis shows that SEC is an effective and reliable treatment, irrespective of the PsA patients’ smoking status. Further progress of the AQUILA study as well as long-term data from other real-world observational studies with SEC, such as SERENA, will reveal whether this trend will continue.References:[1]Hojgaard P et al, Ann Rheum Dis 2015; 74:2130-6; 2. Eder L et al, Arthritis Care Res 2011 Aug; 63:1091-7Disclosure of Interests:Elke Riechers Grant/research support from: AbbVie, Chugai, Lilly, Janssen, Novartis, Pfizer, Roche, UCB, Consultant of: AbbVie, Chugai, Novartis, UCB, Uta Kiltz Grant/research support from: AbbVie, Amgen, Biogen, Novartis, Pfizer, Consultant of: AbbVie, Biocad, Eli Lilly and Company, Grünenthal, Janssen, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Novartis, Pfizer, Roche, UCB, Jan Brandt-Juergens: None declared, Peter Kästner Consultant of: Chugai, Novartis, Daniel Peterlik Employee of: Novartis Pharma GmbH, Hans-Peter Tony Consultant of: AbbVie, Astra-Zeneca, BMS, Chugai, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, Sanofi

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P198 Efficacy and safety of secukinumab in ankylosing spondylitis: real-world data from Midlands Ankylosing Spondylitis Collaboration (MASC)

Rheumatology ◽

10.1093/rheumatology/keab247.193 ◽

2021 ◽

Vol 60 (Supplement_1) ◽

Author(s):

Nibha Jain ◽

Ramasharan Laxminarayan ◽

Arumugam Moorthy ◽

Roshan Amarasena ◽

Natasha Cleaton ◽

...

Keyword(s):

Clinical Trials ◽

Ankylosing Spondylitis ◽

Clinical Improvement ◽

Real World ◽

Patient Choice ◽

Efficacy And Safety ◽

Real World Data ◽

Data Set ◽

World Data ◽

Leicester Royal Infirmary

Abstract Background/Aims Secukinumab is an interleukin-17 inhibitor has been found to be effective in the treatment of ankylosing spondylitis (AS) in studies, including phase 3 clinical trials, however these are conducted in highly selected patients and it is important to confirm the efficacy and safety in a real world data. Response to secukinumab should be assessed after 16-weeks and continued if there has been sufficient response to treatment according to the BASDAI and spinal VAS scores. Methods This was a multicentre cross-sectional observational study in collaboration with Midland Ankylosing Spondylitis Collaboration. Consecutive baseline and 16th week data of all AS patients on Secukinumab from 2017 to 2019 were collected and analysed to assess treatment response. All data were compiled in excel sheets and analysed using Medcalc calculator. Data were collected from collaborative efforts of the Royal Wolverhampton NHS trust, Queen’s Hospital (Burton on Trent), Leicester Royal Infirmary and Robert Jones and Agnes Hunt hospital. Results Total 92 patients with radiographic AS on standard dose of secukinumab were included at baseline and 88 were followed up till week 16. Mean age was 45.9(SD ± 15) (Median=44years) and 67% were male. Baseline Mean BASDAI was 7 (SD ± 1.7); Mean CRP was 16.6 (SD ± 11.2), Mean VAS was 7.6(SD ± 1.6). There was statistical significant change in BASDAI, VAS and CRP levels at week 16th. ΔBASDAI=2.2 (SD ± 2) (p = 0.002), ΔVAS=3.2 (SD ± 2.1) (p = 0.001), ΔCRP=6.9 (SD ± 17) (p = 0.03). At 16th week, 68% had clinical improvement while 4 patients discontinued therapy (2-colitis, 1-uveitis and 1-patient choice). 10% overall had some adverse effects with most common being upper respiratory tract infection. We also compared patients with previous anti-TNF exposure (TE) to Anti-TNF naïve (TN). 63% were in TE group vs 37% in TN. 69% of TE and 76% of TN showed clinical improvement at week 16.Mean ΔBASDAI was more in TN group vs TE (p = 0.01), however there was no difference in ΔVAS and ΔCRP levels. (p = 0.0 & p = 0.2 respectively). Conclusion This multi-centre retrospective analysis found secukinumab to be clinically effective in 68% of patients with AS. There was significant improvement in BASDAI, VAS and CRP levels at week16. Compared to anti-TNF resistant patients, TNF-Naïve responded better to secukinumab, although both showed good clinical improvement. These findings support the use of secukinumab in the treatment of AS, as a first line therapy or for those who have failed anti-TNF therapy. Safety signals observed in the real-word data set were consistent with those seen in the clinical trials and the Summary of Product Characteristics. Disclosure N. Jain: None. R. Laxminarayan: Honoraria; Honorarium from Novartis, Lilly, Pfizer and Abvie. A. Moorthy: Honoraria; Speaker and conference fee MSD, Novartis, Abbvie. R. Amarasena: None. N. Cleaton: None. G. Kakade: None. A. Gunawardane: None. T. Khan: None. H. Sapkota: None. N. Barkham: Grants/research support; research funding from Novartis, Eli Lilly, UCB.

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