Table 4.

Adverse events

Adverse Event from Biopsy Date to the End of Follow-UpAdverse Event from 6 mo to the End of Follow-Up
0 mg Prednisone 6 Mo (n=69)Prednisone >6 Moa (n=78)P Valueb0 mg Prednisone 6 Mo (n=69)Prednisone >6 Moa (n=78)P Valueb
At least 1 infection38 (55)49 (63)0.4022 (32)31 (40)0.39
Absolute no. of infections/patient1.25±1.621.56±2.420.460.82±1.381.15±2.290.47
Incidence of infection (per person-year) (95% CI)0.39 (0.35–0.43)0.64 (0.56–0.73)<0.00010.23 (0.21–0.25)0.42 (0.39–0.46)<0.0001
New-onset DM13 (19)25 (32)0.092 (3)3 (4)1.00
Osteoporosis5 (7)6 (8)1.002 (3)2 (3)1.00
Cancer7 (10)6 (8)0.775 (7)4 (5)0.73
Neuropsychiatric event8 (12)8 (10)0.8000N/A
Cataracts2 (3)5 (6)0.451 (1)4 (5)0.37
Myopathy6 (9)11 (14)0.443 (4)1 (1)0.34
GI bleedingc5 (7)6 (8)1.001 (1)1 (1)1.00
Acne5 (7)8 (10)0.5702 (3)0.50
  • Data are expressed as n (%) or median (interquartile range). CI, confidence interval; DM, diabetes mellitus; GI, gastrointestinal.

  • a Includes patients taking ≥5 mg prednisone.

  • b P values were calculated by Fisher exact test.

  • c Gastrointestinal bleeding deemed not to be vasculitic in origin.