PMID- 28536934
OWN - NLM
STAT- MEDLINE
DCOM- 20190909
LR  - 20190909
IS  - 1435-1250 (Electronic)
IS  - 0340-1855 (Linking)
VI  - 77
IP  - 1
DP  - 2018 Feb
TI  - [Off-label biological therapies in patients with large vessel vasculitis and/or 
      polymyalgia rheumatica : Safety and efficacy analysis of a nationwide German 
      registry (GRAID2)].
PG  - 12-20
LID - 10.1007/s00393-017-0325-1 [doi]
AB  - OBJECTIVE: To evaluate the safety and clinical outcome of biological therapies in 
      patients with large vessel vasculitis (LVV) or polymyalgia rheumatica (PMR) 
      refractory to standard of care therapy in a real-life setting in Germany. 
      METHODS: GRAID 2 (German Registry in Autoimmune Diseases 2) is a retrospective, 
      noninterventional, multicenter registry collecting data from all patients with 
      inflammatory rheumatic diseases refractory to conventional therapy treated with 
      an initial off-label biological between August 2006 and December 2013. The 
      retrospective documentation comprised case history, diagnosis, course of disease 
      including safety and overall efficacy. RESULTS: Data from 14 patients were 
      collected, 11 with LVV (78.6%) and 3 with isolated PMR (21.4%). Ten patients were 
      treated with tocilizumab (71.4%), while 3 patients received infliximab infusions 
      (21.4%) and 1 patient was treated with rituximab (7.1%). All clinical as well as 
      laboratory efficacy parameters improved substantially. After the first 
      application, tolerability of biologicals was assessed as "very good"/"good" by 
      the physicians in 92.3% of the 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 
      serious AE, requiring ICU treatment representing a rate of serious AEs of 7.9 per 
      100 patient-years. No deaths occurred during the observation period. CONCLUSION: 
      With known limitations of a retrospective database, the results of this survey 
      confirm data of smaller case series and proof-of-concept studies and suggest 
      a substantial response to biological therapies in patients with otherwise 
      refractory LVV or PMR with no new safety signals.
FAU - Henes, J C
AU  - Henes JC
AD  - Abteilung fur Onkologie, Hamatologie, klinische Immunologie, Rheumatologie, 
      Pulmologie, Medizinische Klinik II, Universitat Tubingen, Tubingen, Deutschland.
FAU - Schulze-Koops, H
AU  - Schulze-Koops H
AD  - Sektion Rheumatologie und Klinische Immunologie, Medizinische Klinik und 
      Poliklinik IV, Klinikum, Universitat Munchen, Munchen, Deutschland.
FAU - Witt, M
AU  - Witt M
AD  - Sektion Rheumatologie und Klinische Immunologie, Medizinische Klinik und 
      Poliklinik IV, Klinikum, Universitat Munchen, Munchen, Deutschland.
FAU - Tony, H P
AU  - Tony HP
AD  - Abteilung fur Rheumatologie und klinische Immunologie, Zentrum fur Innere 
      Medizin, Universitatsklinikum Wurzburg, Wurzburg, Deutschland.
FAU - Mueller, F
AU  - Mueller F
AD  - Sektion Rheumatologie und Klinische Immunologie, Medizinische Klinik und 
      Poliklinik IV, Klinikum, Universitat Munchen, Munchen, Deutschland.
FAU - Grunke, M
AU  - Grunke M
AD  - Sektion Rheumatologie und Klinische Immunologie, Medizinische Klinik und 
      Poliklinik IV, Klinikum, Universitat Munchen, Munchen, Deutschland.
FAU - Czihal, M
AU  - Czihal M
AD  - Sektion Angiologie, Gefasszentrum, Klinikum der Universitat Munchen, Medizinische 
      Klinik und Poliklinik IV, Universitat Munchen, Munchen, Deutschland.
FAU - Dorner, T
AU  - Dorner T
AD  - Abteilung fur Rheumatologie, Medizinische Klinik m.S. Rheumatologie und klinische 
      Immunologie, Charite Universitatsmedizin Berlin, Berlin, Deutschland.
FAU - Proft, F
AU  - Proft F
AD  - Sektion Rheumatologie und Klinische Immunologie, Medizinische Klinik und 
      Poliklinik IV, Klinikum, Universitat Munchen, Munchen, Deutschland. 
      Fabian.Proft@charite.de.
AD  - Abteilung fur Rheumatologie, Campus Benjamin Franklin, Medizinische Klinik fur 
      Gastroenterologie, Infektiologie und Rheumatologie, Charite Universitatsmedizin 
      Berlin, Hindenburgdamm 30, 12203, Berlin, Deutschland. Fabian.Proft@charite.de.
LA  - ger
PT  - Journal Article
TT  - Off-label-Biologikatherapie bei Patienten mit Grossgefassvaskulitiden und/oder 
      Polymyalgia rheumatica : Wirksamkeits- und Sicherheitsanalyse eines nationalen 
      Registers (GRAID2).
PL  - Germany
TA  - Z Rheumatol
JT  - Zeitschrift fur Rheumatologie
JID - 0414162
SB  - IM
MH  - Biological Therapy
MH  - Germany
MH  - Humans
MH  - *Off-Label Use
MH  - *Polymyalgia Rheumatica/drug therapy
MH  - Registries
MH  - Retrospective Studies
OTO - NOTNLM
OT  - Biologicals
OT  - GRAID
OT  - Large vessel vasculitis
OT  - Off-label use
OT  - Polymyalgia rheumatica
EDAT- 2017/05/26 06:00
MHDA- 2019/09/10 06:00
CRDT- 2017/05/25 06:00
PHST- 2017/05/26 06:00 [pubmed]
PHST- 2019/09/10 06:00 [medline]
PHST- 2017/05/25 06:00 [entrez]
AID - 10.1007/s00393-017-0325-1 [pii]
AID - 10.1007/s00393-017-0325-1 [doi]
PST - ppublish
SO  - Z Rheumatol. 2018 Feb;77(1):12-20. doi: 10.1007/s00393-017-0325-1.