For US Healthcare Professionals Only
For US Healthcare Professionals Only
Post hoc pooled analysis of COMFORT trials*
In a separate post hoc pooled analysis of OS in the COMFORT studies, each 10% reduction from baseline in spleen length at week 24 was associated with a 9% reduction in the risk of death for Jakafi-treated patients (HR, 0.91; 95% CI, 0.84-0.99; P=0.02).2
[In the] post hoc pooled analysis of these COMFORT trials, we can see the survival outcomes based on the time of Jakafi initiation. What we found was that there was a separation of the survival curves. These data inform my decision to intervene at diagnosis in my patients with MF, rather than watching and waiting.
HEAR MORE ABOUT EARLY INTERVENTION FROM DR MESA*A post hoc pooled analysis of COMFORT-I and COMFORT-II assessed the association of MF disease duration before Jakafi treatment (≤12 or >12 months from diagnosis) with disease outcomes. Data from Jakafi-treated patients in both studies were combined and data from the placebo/BAT arms were pooled. COMFORT-I was a randomized, double-blind, placebo-controlled study with 309 patients with intermediate-2-risk or high-risk MF, and COMFORT-II was a randomized, open-label study with 219 patients with intermediate-2-risk or high-risk MF. The primary endpoint in both studies was the proportion of patients achieving a ≥35% reduction in spleen volume (measured by CT or MRI)—at week 24 in COMFORT-I and at week 48 in COMFORT-II.1,3-5
BAT=best available therapy; CI=confidence interval; COMFORT=COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment; CT=computed tomography; JUMP=JAK Inhibitor RUxolitinib in Myelofibrosis Patients; MF=myelofibrosis; MRI=magnetic resonance imaging; OR=odds ratio; OS=overall survival; PBO=placebo; SVR=spleen volume reduction.
References: 1. Verstovsek S, Kiladjian J-J, Vannucchi AM, et al. Does early intervention in myelofibrosis impact outcomes? A pooled analysis of the COMFORT I and II studies. Poster presented at: American Society of Hematology (ASH); December 11-14, 2021; Atlanta, GA. Abstract 1505. 2. Vannucchi AM, Kantarjian HM, Kiladjian J-J, et al; on behalf of the COMFORT Investigators. A pooled analysis of overall survival in COMFORT-I and COMFORT-II, 2 randomized phase III trials of ruxolitinib for the treatment of myelofibrosis. Haematologica. 2015;100(9):1139-1145. 3. Jakafi [package insert]. Wilmington, DE: Incyte Corporation 4. Harrison CN, Vannucchi AM, Kiladjian J-J, et al; on behalf of the COMFORT-II Investigators. Long-term findings from COMFORT-II, a phase 3 study of ruxolitinib vs best available therapy for myelofibrosis. Leukemia. 2016;30(8):1701-1707. Supplementary appendix available at: https://www.nejm.org/doi/full/10.1056/nejmoa1110557. 5. Verstovsek S, Mesa RA, Gotlib J, et al. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med. 2012;366(9):799-807. Supplementary appendix available at: https://www.nejm.org/doi/full/10.1056/nejmoa1110557.
Indications and Usage
Jakafi® (ruxolitinib) is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea.
Jakafi is indicated for treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF and post–essential thrombocythemia MF in adults.
Jakafi is indicated for treatment of steroid-refractory acute graft-versus-host disease (aGVHD) in adult and pediatric patients 12 years and older.
Jakafi is indicated for treatment of chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
Important Safety Information
Please see Full Prescribing Information for Jakafi.
Indications and Usage
Jakafi® (ruxolitinib) is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea.
Jakafi is indicated for treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF and post–essential thrombocythemia MF in adults.
Jakafi is indicated for treatment of steroid-refractory acute graft-versus-host disease (aGVHD) in adult and pediatric patients 12 years and older.
Jakafi is indicated for treatment of chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
Important Safety Information
Please see Full Prescribing Information for Jakafi.