gms | German Medical Science

45. Kongress der Deutschen Gesellschaft für Rheumatologie, 31. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie, 27. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie

06.09. - 09.09.2017, Stuttgart

DEKAVIL (F8IL10): A novel therapeutic approach for the treatment of rheumatoid arthritis

Meeting Abstract

  • Reinhard Voll - Department of Rheumatology and Clinical Immunology, Medical Center University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg
  • Bettina Bannert - Department of Rheumatology and Clinical Immunology, Medical Center University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg
  • Stephanie Finzel - Department of Rheumatology and Clinical Immunology, Medical Center University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg
  • Christof Specker - Universitätsklinikum Essen, St. Josef Krankenhaus, Klinik für Rheumatologie und klinische Immunologie, Essen
  • Jürgen Wollenhaupt - Schön Klinik Hamburg Eilbek, Klinik für Rheumatologie und klinische Immunologie, Hamburg
  • Mauro Galeazzi - University of Siena, Rheumatology Section, Siena, Italy
  • Enrico Selvi - University of Siena, Rheumatology Section, Siena, Italy
  • Giandomenico Sebastiani - AO San Camillo Forlanini - Reumatologia, Rome, Italien
  • Jean Dudler - HFR-Fribourg Hopital Cantonal, Service de Rhumatologie, Fribourg, Schweiz
  • Franziska Bootz - Philochem AG (Philogen Group), Clinical Department, Otelfingen, Schweiz
  • Dario Neri - ETH Zurich, Department of Chemistry and Applied Biosciences, Zürich, Schweiz
  • DEKAVIL Study Group - Philogen S.p.A., Siena, Italien

Deutsche Gesellschaft für Rheumatologie. Deutsche Gesellschaft für Orthopädische Rheumatologie. Gesellschaft für Kinder- und Jugendrheumatologie. 45. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh), 31. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh), 27. Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR). Stuttgart, 06.-09.09.2017. Düsseldorf: German Medical Science GMS Publishing House; 2017. DocRA.20

doi: 10.3205/17dgrh184, urn:nbn:de:0183-17dgrh1849

Veröffentlicht: 4. September 2017

© 2017 Voll et al.
Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung). Lizenz-Angaben siehe http://creativecommons.org/licenses/by/4.0/.


Gliederung

Text

Background: The antibody-based targeted pharmacodelivery of cytokines by means of immunocytokines has the potential to enhance therapeutic activity at the site of disease while sparing healthy tissues. Dekavil (F8IL10) is a fully human immunocytokine composed of the vascular targeting antibody F8 (specific to EDA) fused to the cytokine interleukin-10. Dekavil is currently in phase 2 clinical development for the treatment of rheumatoid arthritis (RA).

Methods: Patients with active RA despite methotrexate therapy (MTX, stable doses of 10- 25 mg/week), who failed anti-TNF treatment receive a maximum of eight weekly subcutaneous injections of Dekavil. The recently completed phase 1 dose escalation study investigated safety and tolerability of Dekavil (6 – 600µg/kg) in combination with MTX. The ongoing double-blind, placebo-controlled phase 2 study assesses the therapeutic activity of Dekavil plus MTX over MTX alone by measuring the mean change from baseline of DAS28-CRP. In total, 87 patients are randomized into two treatment groups (Dekavil 30 or 160 μg/kg plus MTX) and one placebo group (plus MTX).

Results: Phase 1: Up to 600µg/kg, an MTD was not reached. Neither SADRs nor SUSARs have been reported. One out of 35 treated patients (450 μg/kg cohort) experienced a DLT (G2 purpura) and a SAE (G2 dyspnea, not drug related). Mild injection site reactions were observed in 60% of the patients. Two cases of drug related anemia (G2-G3) were reported. All adverse reactions resolved completely. After 8 cycles of treatment, 57.7% of evaluable patients (15/26) revealed ACR and/or EULAR responses. Two patients benefited from ACR70 responses for more than 12 months.

Phase 2: As of April 2017, 22 patients have been enrolled and treated. No SUSARs, SAEs or deaths were reported.

Conclusion: The currently available data suggest that Dekavil is a safe, well tolerated and promising novel therapeutic for the treatments of RA. An interim analysis in the placebo-controlled phase 2 trial after 45 patients will allow for a more thorough understanding of the efficacy of the treatment