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In this European trial, ruxolitinib shrank the spleen by more than a third in 28 percent of people with myelofibrosis after 48 weeks while no patient on the best alternative treatment achieved that, and symptoms and quality of life improved.
Open-label phase 3 trial that randomised 219 patients with intermediate-2 or high-risk primary, post-polycythaemia vera or post-essential thrombocythaemia myelofibrosis two to one to oral ruxolitinib or best available therapy. The primary endpoint was a spleen volume reduction of at least 35 percent at week 48 on MRI or CT; the key secondary endpoint was the same reduction at week 24.
28 percent of the ruxolitinib group met the primary endpoint against 0 percent on best available therapy; responses were durable and role functioning and quality of life improved, with modest toxic effects. An influence on overall survival had not been shown at the primary analysis.
With COMFORT-I, the evidence for ruxolitinib as the first approved treatment for myelofibrosis and for JAK inhibition as the standard for spleen and symptom control.
Shares Ruxolitinib, Primary myelofibrosis, Myeloproliferative neoplasms (PV, ET, myelofibrosis).
Shares Ruxolitinib, Primary myelofibrosis, Myeloproliferative neoplasms (PV, ET, myelofibrosis).
Shares Ruxolitinib, Primary myelofibrosis, Myeloproliferative neoplasms (PV, ET, myelofibrosis).
Shares Ruxolitinib, Primary myelofibrosis, Myeloproliferative neoplasms (PV, ET, myelofibrosis).
Shares Ruxolitinib, Primary myelofibrosis, Myeloproliferative neoplasms (PV, ET, myelofibrosis).
Shares Ruxolitinib, Primary myelofibrosis.
Shares Ruxolitinib, Primary myelofibrosis, Myeloproliferative neoplasms (PV, ET, myelofibrosis).
Shares Primary myelofibrosis, Myeloproliferative neoplasms (PV, ET, myelofibrosis).