gms | German Medical Science

47. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 33. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh), 29. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR)

04.09. - 07.09.2019, Dresden

Safety profile of Secukinumab in ankylosing spondylitis and psoriatic arthritis patients in real world – Interim data from the German AQUILA Study

Meeting Abstract

  • Uta Kiltz - Rheumazentrum Ruhrgebiet und Ruhr-Universität Bochum, Herne
  • Jan Brandt-Jürgens - Rheumatologische Schwerpunktpraxis, Berlin
  • Peter Kästner - MVZ Ambulantes Rheumazentrum Erfurt, Erfurt
  • Regina Max - Universitätsklinikum Heidelberg, Medizinische Klinik V, Sektion Rheumatologie, Heidelberg
  • Daniel Peterlik - Novartis Pharma GmbH, Nürnberg
  • Veronika Winkelmann - Novartis Pharma GmbH, Nürnberg
  • Hans-Peter Tony - Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik II, Schwerpunkt Rheumatologie und klinische Immunologie, Würzburg

Deutsche Gesellschaft für Rheumatologie. Deutsche Gesellschaft für Orthopädische Rheumatologie. Gesellschaft für Kinder- und Jugendrheumatologie. 47. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 33. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh), 29. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR). Dresden, 04.-07.09.2019. Düsseldorf: German Medical Science GMS Publishing House; 2019. DocSpA.35

doi: 10.3205/19dgrh246, urn:nbn:de:0183-19dgrh2468

Published: October 8, 2019

© 2019 Kiltz et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.


Outline

Text

Background: Secukinumab is a fully human monoclonal antibody that selectively neutralizes interleukin (IL)-17A and has shown significant efficacy in the treatment of ankylosing spondylitis (AS) and psoriatic arthritis (PsA) with a favorable safety profile in several phase III studies [1], [2]. There is limited information on secukinumab’s safety under real world conditions [3]. Here, we report real world safety data on secukinumab treatment from an interim analysis of the first 1000 AS and PsA patients enrolled in the German AQUILA study.

Methods: AQUILA is an ongoing, 52 week non-interventional study enrolling 2000 patients with active AS or PsA in Germany. AS and PsA patients treated with secukinumab according to local label were documented from baseline up to week 52 according to clinical routine practice. Treatment decision was made independently of participating in this study. For this interim analysis, exposure adjusted incidence rate (EAIR) is presented as number of incidences per 100 exposed patient years. Real world safety data was assessed prospectively, analyzed as observed and combined for AS and PsA patients.

Results: Safety data was collected in patients who received at least one dose of secukinumab: 330 AS and 667 PsA patients. In total, the mean number of administrations was 14.3 per patient, resulting in a total patient exposure time of 954.5 years. Overall, 71.4% of patients (712/997) experienced an adverse event (AE) (EAIR 135.6) with 42.1% of AEs suspected to be related to secukinumab (EAIR 55.2). One (sudden) death occurred during the observation period and was judged by the investigator not to be related to secukinumab. Serious adverse events (SAEs) occurred in 258 (25.9%, EAIR 30.9) patients; most frequent SAEs by System Organ Class (SOC) were “musculoskeletal and connective tissue disorders” (10.2%, n=102), “infections and infestations” (7.8%, n=78) and “gastrointestinal disorders” (2.7%, n=27). 100 SAEs (10%, EAIR 10.9) were suspected to have a relationship to secukinumab. The most common AE (preferred term) was “nasopharyngitis” (n=112, 11.2%); further common AEs were “headache” (n=45, 4.5%) and “bronchitis” (n=39, 3.9%). Overall, there were no relevant differences between AS and PsA patients.

Conclusion: The German AQUILA provides the largest prospective real-world analysis on secukinumab treatment in AS and PsA patients to date. This interim analysis provides promising data on secukinumab’s safety in a real world setting. Overall, it’s safety profile is consistent with previous trials, with no unexpected findings [1], [2], [3], [4], [5].


References

1.
Pavelka K, et al. Efficacy, safety, and tolerability of secukinumab in patients with active ankylosing spondylitis: a randomized, double-blind phase 3 study, MEASURE 3. Arthritis Research & Therapy. 2017;19:285.
2.
Mease PJ, et al. Secukinumab Inhibition of Interleukin-17A in Patients with Psoriatic Arthritis. N Engl J Med. 2015;373:1329-39.
3.
Thaçi D, et al. In: 27th EADV Congress; 2018 Sep 12-16; Paris. 2018. P1994.
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Deodhar A, et al. In: 46. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); September 2018; Mannheim. 2018. SpA.12
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Mease PJ, et al. In: 46. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); September 2018; Mannheim; 2018. SpA.09.