gms | German Medical Science

43. Kongress der Deutschen Gesellschaft für Rheumatologie, 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie, 25. Wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie

02.-05. September 2015, Bremen

Safety and efficacy of biological therapies in large vessel vasculitis and polymyalgia rheumatica – results from a nationwide german registry (GRAID2)

Meeting Abstract

  • Fabian Proft - Klinikum der Universität München, Medizinische Klinik und Poliklinik IV, Rheumaeinheit, München
  • Hendrik Schulze-Koops - Klinikum der Universität München, Medizinische Klinik und Poliklinik IV, Rheumaeinheit, München
  • Hans-Peter Tony - Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik II, Schwerpunkt Rheumatologie und klinische Immunologie, Würzburg
  • Martin Aringer - Universitätsklinikum "Carl Gustav Carus" an der Technischen Universität Dresden, Medizinische Klinik III, Rheumatologie, Dresden
  • Jörg Henes - Universitätsklinikum Tübingen, Innere Medizin II - Onkologie, Hämatologie, klinische Immunologie, Rheumatologie und Pulmologie, Tübingen
  • Annett M. Jacobi - Universitätsklinikum Münster, Westfälische Wilhelms-Universität, Innere Medizin D, Rheumatologie und Klinische Immunologie, Münster
  • Reinhold E. Schmidt - Medizinische Hochschule Hannover, Klinik für Immunologie und Rheumatologie, Hannover
  • Leonore Unger - Städtisches Klinikum Dresden-Friedrichstadt, I. Medizinische Klinik, Dresden
  • Michael Czihal - Klinikum der Universität München, Medizinische Klinik und Poliklinik IV, Angiologie, München
  • Felix Müller - Klinikum der Universität München, Medizinische Klinik und Poliklinik IV, Rheumaeinheit, München
  • Mathias Grünke - Rheumapraxis Bad Aibling, Rheumatologische Schwerpunktpraxis, Bad Aibling
  • Thomas Dörner - Charité - Universitätsmedizin Berlin, Medizinische Klinik mit Schwerpunkt Rheumatologie und klinische Immunologie, Berlin
  • Matthias Witt - Klinikum der Universität München, Medizinische Klinik und Poliklinik IV, Rheumaeinheit, München

Deutsche Gesellschaft für Rheumatologie. Deutsche Gesellschaft für Orthopädische Rheumatologie. Gesellschaft für Kinder- und Jugendrheumatologie. 43. Kongress der Deutschen Gesellschaft für Rheumatologie (DGRh); 29. Jahrestagung der Deutschen Gesellschaft für Orthopädische Rheumatologie (DGORh); 25. wissenschaftliche Jahrestagung der Gesellschaft für Kinder- und Jugendrheumatologie (GKJR). Bremen, 02.-05.09.2015. Düsseldorf: German Medical Science GMS Publishing House; 2015. DocVK.17

doi: 10.3205/15dgrh243, urn:nbn:de:0183-15dgrh2438

Published: September 1, 2015

© 2015 Proft 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

Introduction: To evaluate the safety and clinical outcome of biological therapies in patients with large-vessel vasculitides (LVV) or polymyalgia rheumatica (PMR) refractory to standard of care therapy in a real life setting in Germany.

Methods: GRAID 2 (German Register in Autoimmune Diseases 2) is a retrospective, non-interventional multicentre online registry collecting data from all patients with inflammatory rheumatic diseases treated with an initial biological off-label therapy between August 2006 and December 2013. The retrospective documentation comprised case history, diagnosis, course of disease including safety and global efficacy. In LVV and PMR patients, clinical parameters included bilateral proximal myalgia, headache, jaw-claudicatio, scalp-tenderness, visual-deterioration, tender and swollen joint counts, morning stiffness, fatigue, depression, B symptoms and general wellbeing. The laboratory parameters included ESR, CRP, leukocytes and thrombocytes. Additionally, the investigators rated their patients as non- (NR), partial (PR) or complete responders (CR) based on clinical judgements.

Results: Data from 14 patients were collected, 11 (78.6%) with LVV and 3 (21.4%) with isolated PMR, with 10 (71.4%) female and 4 (28.6%) male patients and a mean age of 55.54 +/- 18.40 years. The mean follow-up period was 10.8 +/- 8.52 months resulting in 12.7 patient years of follow-up. 10 patients (71.4%) were treated with tocilizumab (TOC), while 3 patients (21.4%) had infliximab(IFX)-infusions and 1 patient (7%) was treated with rituximab (RTX). On average, all clinical as well as laboratory efficacy parameters improved substantially. After the first application, tolerability of biologicals was assessed as "very good"/"good" by physicians in 92.3% of patients. Altogether, 8 adverse events (AEs) occurred in 4 patients including 3 infections (1 urogenital infection, 2 diverticulitis) representing a rate of 23.6 infections per 100 patient years. One of these infections (diverticulitis under infliximab-treatment) was rated as SAE, requiring ICU-treatment representing a rate of SAEs of 7.9 per 100 patient years.

Conclusion: With known limitations of a retrospective data base, the results of this survey confirm data of smaller case series, suggest a substantial response to biological therapies in patients with treatment refractory LVV or PMR with an overall favorable safety profile.