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Abatacept retention and clinical outcomes in Austrian patients with rheumatoid arthritis: real-world data from the 2-year ACTION study

Abatacepttherapietreue und klinische Ergebnisse bei Patienten mit rheumatoider Arthritis in Österreich: 2-Jahres-Daten der ACTION-Studie aus dem Praxisalltag

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Summary

Background

AbataCepT In rOutiNe clinical practice (ACTION; NCT02109666) was a 2-year international observational study of patients with moderate to severe rheumatoid arthritis.

Methods

Baseline characteristics, abatacept retention rates, and clinical outcomes were compared by treatment line in the Austrian cohort of ACTION.

Results

Of 100 patients enrolled in Austria, 98 (98.0%) were evaluable: 33/98 (33.7%) biologic naïve and 65/98 (66.3%) with ≥1 prior biologic failure. At baseline, biologic-naïve patients had shorter disease duration and lower concomitant corticosteroid use than biologic-failure patients. Overall crude abatacept retention rate was 60.5% and retention rate was higher in biologic-naïve (65.1%) versus biologic-failure (58.0%) patients. Good/moderate EULAR (European League Against Rheumatism) response rates were 85.7% in biologic-naïve and 100% in biologic-failure patients.

Conclusions

In the Austrian cohort of ACTION, overall abatacept retention at 2 years was high, with higher retention rates in patients receiving abatacept as an earlier treatment line. Good/moderate EULAR response rate was higher in biologic-failure than in biologic-naïve patients.

Zusammenfassung

Grundlagen

„AbataCepT In rOutiNe clinical practice“ (ACTION; NCT02109666) war eine internationale 2‑Jahres-Beobachtungsstudie an Patienten mit mittel- bis schwergradiger rheumatoider Arthritis.

Methodik

Ausgangsdaten, Raten der Abatacepttherapietreue und klinische Ergebnisse wurden in Hinsicht auf die Therapielinie in der österreichischen Kohorte der ACTION-Studie verglichen.

Ergebnisse

Von 100 Patienten, die in Österreich in die Studie aufgenommen wurden, waren die Daten von 98 (98,0%) auswertbar: Biologikanaiv waren 33/98 (33,7%) und bei 65/98 (66,3%) lag mindestens ein vorheriges Biologikatherapieversagen vor. Zu Studienbeginn wiesen die biologikanaiven Patienten eine kürzere Krankheitsdauer und einen geringeren Einsatz von Kortikosteroiden als Begleitmedikation auf als die Patienten mit Biologikatherapieversagen. Die rohe Gesamttherapietreuerate zu Abatacept betrug 60,5%, und die Therapietreuerate war bei biologikanaiven Patienten (65,1%) höher als bei Patienten mit Biologikatherapieversagen (58,0%). Gute/mittelmäßige Therapieansprechraten gemäß EULAR-Kriterien (European League Against Rheumatism) gab es bei 85,7% der biologikanaiven Patienten und bei 100% derer mit Biologikatherapieversagen.

Schlussfolgerungen

In der österreichischen Kohorte der ACTION-Studie war die Gesamttherapietreue zu Abatacept nach 2 Jahren hoch, dabei bestanden höhere Therapietreueraten bei Patienten, die Abatacept eher als Therapie erhielten. Eine gute/mittelmäßige Ansprechrate gab es in höherem Maße bei Patienten mit Biologikatherapieversagen als bei biologikanaiven Patienten.

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Acknowledgements

The authors would like to thank all patients and the physicians in private practice in Linz, Klagenfurt, and Villach, and at the following sites: EKH Wien, Wien; LKH Vöcklabruck, Vöcklabruck; St-Johanns-Spital, Salzburg; KH der Barmherzigen Brüder Eggenberg, Graz; LKH Bludenz, Bludenz; Universitätsklinik für Innere Medizin, Innsbruck; and Rheumapraxis and Gammaswingzentrum, Hall in Tirol, who participated in the ACTION study.

Funding

The study was sponsored by Bristol-Myers Squibb (Study number: NCT02109666). Syneos Health was the contract research organization for this study and StatProcess performed the statistical analysis. Professional medical writing and editorial assistance was provided by Fiona Boswell, PhD, at Caudex and was funded by Bristol-Myers Squibb.

Author information

Authors and Affiliations

  1. Evangelisches Krankenhaus Wien, Hans-Sachs-Gasse 10–12, 1180, Vienna, Austria

    Peter Peichl

  2. Schlosspark-Klinik University Medicine, Berlin, Germany

    Rieke Alten

  3. University of Siena, Siena, Italy

    Mauro Galeazzi

  4. University Hospital, Heidelberg, Germany

    Hanns-Martin Lorenz

  5. University of Erlangen-Nuremberg, Nuremberg, Germany

    Hubert Nüßlein

  6. University Hospital Virgen Macarena, Seville, Spain

    Federico Navarro

  7. Excelya, Boulogne-Billancourt, France

    Yedid Elbez

  8. Bristol-Myers Squibb, Rueil-Malmaison, France

    Melanie Chartier

  9. Bristol-Myers Squibb, Vienna, Austria

    Roland Hackl

  10. Bristol-Myers Squibb, Munich, Germany

    Christiane Rauch

  11. Bristol-Myers Squibb, Princeton, NJ, USA

    Sean E Connolly

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  1. Peter Peichl
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Corresponding author

Correspondence to Peter Peichl.

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Conflict of interest

M. Galeazzi declares that he has no competing interests. P. Peichl: consulting fees: Astropharma, Bristol-Myers Squibb, Eli Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Sandoz; research grants: Bristol-Myers Squibb, Merck Sharp & Dohme, Novartis. R. Alten: research grants: Bristol-Myers Squibb. H.-M. Lorenz: consulting fees: AbbVie, Actelion, AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Janssen-Cilag, Medac, Merck Sharp & Dohme, Novartis, Pfizer, Roche-Chugai, Sobi, UCB. H. Nüßlein: consulting fees: AbbVie, Bristol-Myers Squibb, Celgene, Janssen, Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Roche, UCB. F. Navarro: consulting fees: AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Merck Sharp & Dohme, Pfizer, Roche, UCB; research grants: AbbVie, Bristol-Myers Squibb, Merck Sharp & Dohme, Pfizer, Roche; speakers’ bureau: AbbVie, Bristol-Myers Squibb, Merck Sharp & Dohme, Pfizer, Roche, UCB. Y. Elbez: consulting fees: Bristol-Myers Squibb. M. Chartier, R. Hackl: employment: Bristol-Myers Squibb. C. Rauch, S.E. Connolly: employment and shareholding: Bristol-Myers Squibb.

Ethical standards

ACTION was conducted in accordance with the Declaration of Helsinki, the International Conference on Harmonization Good Clinical Practice guidelines, and the Good Epidemiological Practice guidelines. The study protocol and patient enrollment materials were approved by local ethics committees and review boards. All enrolled patients provided written informed consent in accordance with local laws.

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Peichl, P., Alten, R., Galeazzi, M. et al. Abatacept retention and clinical outcomes in Austrian patients with rheumatoid arthritis: real-world data from the 2-year ACTION study. Wien Med Wochenschr 170, 132–140 (2020). https://doi.org/10.1007/s10354-019-00710-8

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