title: Validity of data collected in BIOREG, the Austrian register for biological treatment in rheumatology: current practice of bDMARD therapy in rheumatoid arthritis in Austria.
abstract: The purpose of the present study was to check the validity of data collected in BIOREG, the Austrian register for biological treatment in rheumatology, and to elucidate eventual differences with respect to disease activity (DA) in patients with rheumatoid arthritis (RA) on established biological DMARDs (bDMARDs) before inclusion into the register (EST) and beginners at the time point of inclusion (NEW) after 1 year of treatment.
  
  
  
  RA patients with a complete follow-up of 1 year in BIOREG were divided into EST and NEW and compared with respect to DA, remission rates, concomitant synthetic DMARDs (csDMARDs) and glucocorticoid therapy (GC) at baseline and after 1-year follow-up. Safety concerns are listed. Descriptive statistics are applied.
  
  
  
  For 346 RA patients (284 EST, 62 NEW) out of 970 RA patients included into BIOREG, a full data set for a 1-year follow-up was available. No differences in DA were observed after 1 year as expressed by DAS28 or RADAI-5, and small differences as expressed by remission rates according to DAS28, RADAI-5 or Boolean criteria (namely approximately 1/2, 1/3 to 1/4 and 1/4 to 1/5 of the patients respectively). Sixty-four adverse events (AEs) were noted in 56 (20 %) of EST and 20 in 19 (31 %) of NEW patients. Malignancy occurred in four patients. After 1 year, 48 % of EST patients but only 16 % of NEW patients were on bDMARD monotherapy.
  
  
  
  Regarding DA, the date collected in BIOREG appeared to be valid. After 1 year of bDMARD therapy, all patients, whether EST or NEW, achieved a similar level of DA. AEs occurred more frequently during the early phase of bDMARD treatment. Austrian rheumatologists initiate bDMARD therapy in patients with lower disease levels than in other European countries, leading to high remission rates.
authors.affiliation: Lower Austrian State Hospital Stockerau, 2nd Department for internal medicine, Lower Austrian Center for Rheumatology, Landstrasse 18, Stockerau, 2000, Austria. bernhard.rintelen@stockerau.lknoe.at.|Karl Landsteiner Institute for Clinical Rheumatology, Landstrasse 18, Stockerau, 2000, Austria. bernhard.rintelen@stockerau.lknoe.at.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Rintelen
authors.affiliation: Ludwig Boltzmann Institute of Osteology at the Hanusch Hospital of WGKK and AUVA Trauma Centre Meidling, 1st Medical Department, Hanusch Hospital Vienna, Heinrich-Collinstrasse 30, Vienna, 1140, Austria.
authors.forename: Jochen
authors.initials: J
authors.lastname: Zwerina
authors.affiliation: Medical University of Innsbruck, Anichstrasse 35, Innsbruck, 6020, Austria.
authors.forename: Manfred
authors.initials: M
authors.lastname: Herold
authors.affiliation: BIOREG, Schloßhoferstrasse 4/4/12, Vienna, 1221, Austria.
authors.forename: Franz
authors.initials: F
authors.lastname: Singer
authors.affiliation: Health Center Vienna Mariahilf, Wiener Gebietskrankenkasse, Mariahilfer Strasse 85-87, Vienna, 1060, Austria.
authors.forename: Johann
authors.initials: J
authors.lastname: Hitzelhammer
authors.affiliation: Tyrolean State Hospital Hochzirl, Hochzirl, 6170, Austria.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Halder
authors.affiliation: Office based rheumatologist, Freistätter Strasse 16, Linz, 4040, Austria.
authors.forename: Gabriela
authors.initials: G
authors.lastname: Eichbauer-Sturm
authors.affiliation: Office based rheumatologist, Freiung 19, Wels, 4070, Austria.
authors.forename: Rudolf
authors.initials: R
authors.lastname: Puchner
authors.affiliation: Department for Internal Medicine, Lower Austrian State Hospital Amstetten, Krankenhausstrasse 21, Amstetten, 3300, Austria.
authors.forename: Miriam
authors.initials: M
authors.lastname: Stetter
authors.affiliation: Lower Austrian State Hospital Stockerau, 2nd Department for internal medicine, Lower Austrian Center for Rheumatology, Landstrasse 18, Stockerau, 2000, Austria.|Karl Landsteiner Institute for Clinical Rheumatology, Landstrasse 18, Stockerau, 2000, Austria.|Medical University of Graz, Auenbruggerplatz 2, Graz, 8010, Austria.
authors.forename: Burkhard F
authors.initials: BF
authors.lastname: Leeb
mesh_terms: D000368:Aged; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D001317:Austria; D001688:Biological Products / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D005938:Glucocorticoids / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012042:Registries; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D001688:Biological Products; D005938:Glucocorticoids