Summary of adverse events
Parameters | ADA continued (n=106) n (%) | ADA discontinued (n=114) n (%) | p Value |
---|---|---|---|
Any AE | 51 (48.1) | 39 (34.2) | 0.040 |
SAE | 5 (4.7) | 3 (2.6) | 0.486 |
Infectious adverse event | 29 (27.4) | 17 (14.9) | 0.031 |
Serious infection | 4 (3.8)* | 1 (0.9) | 0.199 |
Gastroenteritis | 1 (0.9) | 0 | NA |
Herpes zoster | 1 (0.9) | 0 | NA |
Pneumonia | 1 (0.9) | 1 (0.9) | NA |
Acute pyelonephritis | 1 (0.9) | 0 | NA |
Sepsis | 1 (0.9) | 0 | NA |
*One patient in the ADA continuation group reported two serious infections.
Statistical significance was assessed by Fisher's exact test.
ADA, adalimumab; AE, adverse event; NA, not applicable; SAE, serious adverse event.