Table 3

Adverse events

Event, n (%)MR prednisone n=231Placebo n=119
Any AE99 (42.9)58 (48.7)
Treatment-related AE18 (7.8)10 (8.4)
AEs leading to discontinuation*5 (2.2)1 (0.8)
Severe AEs3 (1.3)5 (4.2)
Serious AEs1 (0.4)2 (1.7)
AEs reported in >1% of patients
Arthralgia24 (10.4)24 (20.2)
Aggravated RA/RA flare-up15 (6.5)11 (9.2)
Nasopharyngitis11 (4.8)4 (3.4)
Headache9 (3.9)5 (4.2)
Hypertension5 (2.2)1 (0.8)
Diarrhoea4 (1.7)1 (0.8)
Rash4 (1.7)1 (0.8)
Bronchitis3 (1.3)5 (4.2)
Back pain3 (1.3)1 (0.8)
Vomiting3 (1.3)1 (0.8)
Peripheral oedema2 (0.9)2 (1.7)
Haematuria1 (0.4)3 (2.5)
  • * AEs leading to discontinuation were headache (n=2), glaucoma (n=1), vomiting (n=1), exacerbation of RA (n=1), anxiety (n=1), and hypertension (n=1) for the MR prednisone group, and headache (n=1) for the placebo group. All AEs except exacerbation of RA were considered to be related to treatment.

  • Severe AEs were arthropod bite (n=1), joint sprain (n=1) and arthralgia (n=1) in the MR prednisone group, and arthralgia (three events), aggravated RA/RA flare-up (two events) and one event each of headache, gout and epistaxis in the placebo group.

  • The serious AE in the MR prednisone group was palpitations and chest discomfort. One patient in the placebo group was diagnosed with ischaemic heart disease and another underwent elective uterus extirpation for abnormal cervical cytology. All events were classified as serious because patients required hospitalisation but none was considered related to the study drug.

  • AE, adverse event; MR, modified release; RA, rheumatoid arthritis.