Table 2.
Adverse laboratory events during ruxolitinib treatment
| Laboratory parameters | RESPONSE16 | COMFORT-I77 | COMFORT-II54 |
|---|---|---|---|
| Anemia | 43.6% | 96.1%/45.2% | 42% |
| Thrombocytopenia | 24.5% | 69.7%/30.5% | 68% |
| Neutropenia | 18.7% | ||
| gGT | 46.4%/7.3% | ||
| Hypercholesterolemia | 42.7% | ||
| Hypertriglyceridemia | 20.9% | ||
| High lipase | 31.8% | ||
| ALAT | 31.8% | ||
| ASAT | 28.2% | ||
| Creatinine (high) | 28.2% | ||
| Hypercalcemia | 17.3% |
Notes: RESPONSE: laboratory parameters adverse events (all grades) with a frequency at least 5% (hematological) and 10% (nonhematological) higher than in the best available therapy. COMFORT-I/II: hematological adverse events (all grades) with a frequency at least 10% higher than in the placebo and best available therapy groups, respectively. Half of grades 3–4 anemias and thrombocytopenias occurred in the first 8 weeks of treatment initiation. Thrombocytopenia was the most important cause of dose interruption/modification in Phase III trials (40%–50%). Dose reduction is advocated for any hemoglobin <100 g/L and/or platelet count <75 G/L (it should be considered already if <100 G/L). Case series of “ruxolitinib withdrawal syndrome” defined as an acute worsening of disease-related symptoms, parameters, and splenomegaly of varying severity have been described in MF patients. Bold = Grades 3–4 (according to NCI CTCAE 3.0).
Abbreviations: gGT, gamma-glutamyl transferase; ALAT, alanine aminotransferase; ASAT, aspartate aminotransferase; MF, myelofibrosis.