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Table 4 Adverse events during first year of observation (+/- 3 months). Adverse events reported fewer than three times are not listed, except that there were at least three reported adverse events in one group of patients. (Number of reported cases (in N of patients), % of all reported adverse events). The last two columns describe adverse events recorded in all patients included in BIOREG RA-group with completed 1-year observation (n = 511)

From: Validity of data collected in BIOREG, the Austrian register for biological treatment in rheumatology: current practice of bDMARD therapy in rheumatoid arthritis in Austria

  EST (in 19.7 % of pts) NEW (in 30.7 % of pts) All RA pts in BIOREG with one year of observation (in 26.8 % of pts)
All 64 (56) 100 % 20 (19) 100 % 153 (137) 100 %
SAE 31 (23) 48.4 % 4 (4) 20.0 % 72 (58) 47.1 %
Infections 25 (23) 39.1 % 8 (8) 40.0 % 60 (56) 39.2 %
Ulcerative skin lesions 4 (4) 6.3 % 1 (1) 5.0 % 6 (6) 3.9 %
Malignant diseases 3 (3) a 4.7 % 1 (1) b 5.0 % 6 (6) c 3.9 %
Ophthalmic diseases 3 (3) 4.7 % 0   7 (7) 4.6 %
Thrombotic diseases 3 (3) 4.7 % 1 (1) 5.0 % 4 (4) 2.6 %
Intolerance of biologic drug 1 (1) 1.6 % 3 (3) 15.0 % 9 (9) 5.9 %
Vertigo 3 (2) 4.7 % 0   3 (2) 2.0 %
Others 22(17) 34.4 % 6 (6) 30.0 % 58 (55) 37.9 %
  1. Abbreviations: EST pts with established bDMARD treatment before inclusion in BIOREG of whom a full data set as described is viable, NEW pts included in BIOREG with start of biologic treatment ± 30 days of whom a full data set as described is viable, PTS patients, RA rheumatoid arthritis, SAE serious adverse event
  2. a relapse of breast cancer, B-cell lymphoma, thyroid cancer
  3. b prostate cancer
  4. c as listed plus colorectal cancer and lung cancer