Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera: the “RAMP” Italian multicenter prospective study
Francesca Palandri, Giuseppe Auteri, Elisabetta Abruzzese, Giovanni Caocci, Massimiliano Bonifacio, Francesco Mendicino, Roberto Latagliata, Alessandra Iurlo, Filippo Branzanti, Bruno Garibaldi, Malgorzata Monika Trawinska, D. Cattaneo, Mauro Krampera, Olga Mulas, Enrica Antonia Martino, Michèle Cavo, Nicola Vianelli, Stefana Impera, Fabio Efficace, Florian H. Heidel, Massimo Breccia, Elena Maria Elli, Giuseppe A. Palumbo
Abstract
Ruxolitinib is beneficial in patients with myelofibrosis (MF) and polycythemia vera (PV). Information on ruxolitinib adherence is scant. The Ruxolitinib Adherence in Myelofibrosis and Polycythemia Vera (RAMP) prospective multicenter study (NCT06078319) included 189 ruxolitinib-treated patients. Patients completed the Adherence to Refills and Medications Scale (ARMS) and Distress Thermometer and Problem List (DTPL) at the earliest convenience, after registration in the study, and at later timepoints. At week-0, low adherence (ARMS > 14) and high distress (DT ≥ 4) were declared by 49.7% and 40.2% of patients, respectively. The main reason for low adherence was difficult ruxolitinib supply (49%), intentional (4.3%) and unintentional (46.7%) non-take. In multivariable regression analysis, low adherence was associated to male sex (p = 0.001), high distress (p < 0.001), and treatment duration ≥ 1 year (p = 0.03). Over time, rates of low adherence and high distress remained stable, but unintentional non-take decreased from 47.9% to 26.0% at week-48. MF patients with stable high adherence/low distress were more likely to obtain/maintain the spleen response at week-24. Low adherence to ruxolitinib represents an unmet clinical need that require a multifaceted approach, based on reason behind it (patients characteristics and treatment duration). Its recognition may help distinguishing patients who are truly refractory and those in need of therapy optimization.