Table 4.
Colchicine safety: adverse event dose relationship in 27 PFAPA patients.
| Colchicine dose | Patients, N (%) | Adverse event | Severity |
|---|---|---|---|
| First follow-up (adverse events in a total of 8 patients) | |||
| 0.5 mg/day | 5/27 (19) | Abdominal pain, diarrhea | Mild |
| 1/27 (4) | LDH elevated | Mild (ULR + 40 U/L) | |
| 1 mg/day | 1/27 (4) | ALAT elevated | Mild (ULR + 20 U/L) |
| 1/27 (4) | Abdominal pain | Mild | |
| Last follow-up (adverse events in a total of 11 patients) | |||
| 0.5 mg/day | 1/27 (4) | Leucopenia | Mild (Leuc. 4,430/μl) |
| 1 mg | 1/27 (4) | Abdominal pain | Mild |
| 1/27 (4) | Abdominal pain, leucopenia | Mild (Leuc. 3,870/μl) | |
| 1/27 (4) | Abdominal pain | Moderate | |
| 1/27 (4) | Abdominal pain, diarrhea | Moderate | |
| 1.5 mg | 1/27 (4) | LDH elevated | Mild (ULR + 20 U/L) |
| 1/27 (4) | Abdominal pain | Mild | |
| 1/27 (4) | Abdominal pain, diarrhea | Mild to moderate | |
| 1/27 (4) | Abdominal pain, diarrhea | Moderate | |
| 2 mg | 2/27 (7) | Abdominal pain, diarrhea | Mild |
Severity grading: abdominal pain and diarrhea: mild = 1–2 times/week, moderate = 3–6 times/week; Liver enzyme elevation [modified according to (41)]: mild = ALAT/ASAT/LDH ≤ 3 ULR, BL/y-GT ≤ 1.5 ULR; Leukopenia: mild ≥3,000 and <4,500/μL.
PFAPA, periodic fever, aphthous stomatitis, pharyngitis and adenitis; mg, milligram; LDH, Lactate-Dehydrogenase; ALAT, Alanine-Aminotransferase; U, Units; L, Liter; ULR, upper limit of reference; BL, bilirubin.