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Table 3 Patients with adverse events (AEs) and serious adverse events (SAEs)

From: Induction of sustained remission in early inflammatory arthritis with the combination of infliximab plus methotrexate: the DINORA trial

  Total
n = 90
IFX + MTX
n = 38
MTX
n = 36
PL
n = 16
Adverse events, n (%)     
 Infectious/parasitic disease 31 (35%) 19 (50%) 9 (25%) 3 (19%)
 Malignancy 1 (1%) 0 1 (3%) 0
 Disease of blood, blood-forming organs, and immune mechanisms (except arthritis) 1 (1%) 1 (3%) 0 0
 Endocrine, nutritional, and metabolic diseases 9 (10%) 2 (5%) 5 (14%) 2 (12%)
 Disease of the nervous system 17 (19%) 6 (16%) 9 (25%) 2 (13%)
 Diseases of the eye 3 (3%) 1 (3%) 2 (6%) 0
 Diseases of circulatory system 16 (18%) 6 (16%) 7 (19%) 3 (19%)
 Diseases of respiratory system 43 (48%) 23 (61%) 16 (44%) 4 (25%)
 Diseases of the digestive system 37 (41%) 15 (39%) 17 (47%) 5 (31%)
 Diseases of the skin and subcutaneous tissue 25 (28%) 12 (32%) 8 (22%) 5 (31%)
 Diseases of musculoskeletal system and connective tissue 30 (33%) 15 (39%) 9 (25%) 6 (38%)
 Diseases of urogenital system (pregnancy, childbirth, and puerperium) 4 (4%) 2 (5%) 2 (6%) 0
 Symptoms, signs, and abnormal clinical and laboratory findings not elsewhere classified 27 (30%) 11 (29%) 11 (31%) 5 (31%)
 Injury, poisoning and certain other consequences of external causes 9 (10%) 6 (16%) 3 (8%) 0
 External causes of morbidity 1 (1%) 1 (3%) 0 0
 Total   120 99 35
SAEs (n = 12)
 Hospitalisation due to different reasonsa 4 1 3
 Fainted during blood collection prior to administration of study drug 1 0 0
 Significantly raised transaminase levels 1 0 0
 Hematuria, followed by a diagnosis of bladder cancer 0 1 0
 Hypertensive episode 1 h after the last infusion with study drug 0 1 0
  1. Only 4 (0.9%) of all reported AEs and no SAEs were considered definitely related to the study drug. 155 AEs (37%) and no SAEs were regarded as possibly/probably related to one of the study drugs. No participant died during the 2-year study period. Two SAEs were related to infections (1 gastrointestinal, 1 genitourinary); however, in both cases patients were on PL only. One of these SAEs was related to a malignancy (bladder cancer on MTX monotherapy) and none to tuberculosis
  2. IFX infliximab, MTX methotrexate, PL placebo
  3. aHyperglycemia (PL), diarrhoea (PL), urinary tract infection (IFX + MTX), urinary tract infection with fever (PL), MTX pneumonitis (opportunistic) infection (IFX + MTX), significant flare of disease activity (IFX + MTX), myocardial infarction more than half a year after last study drug (MTX), and biliary pancreatitis in a time after the study medication (IFX + MTX)