Adherence to Treatment in Myelofibrosis Patients: Preliminary Results from Italian Romei Observational Study

Background: Non-adherence to medications is recognized as one of the most important and costly worldwide healthcare problems in the 21st century; according to an EU report, non-adherence to therapies is responsible for 194,500 deaths and costs €125 billion annually. Taking into account those data, the use of adherence measurements in clinical trials could be extremely useful, in order to better understand patients (pts) behaviours and outcomes. The 8-item Morisky Medication Adherence Scale (MMAS-8, Morisky DE et al, J Clin Hypertens,2008 - Krousel-Wood MA et al, Am J Manag Care 2009- Morisky DE et al, J Clin Epidemiol. 2011) is a widely used questionnaire to asses indirectly pts adherence to medications. The first seven items are yes/no questions, and the last item is a five point Likert-scale. Ruxolitinib (RUX) is an oral JAK1/2 inhibitor approved for the treatment of symptoms and/or splenomegaly in myelofibrosis (MF) pts. ROMEI (CINC424AIT04-Ruxolitinib Observational study in Myelofibrosis treated patients in Italy) is a prospective observational study focused on real life management of MF pts with RUX; the trial enrolled 215 pts and included a prospective evaluation of MMAS-8 as a secondary endpoint. To date, no data regarding MMAS-8 and RUX are available and here we show a descriptive analysis of MMAS-8 after 24 weeks (wks) of RUX treatment. Methods: After informed consent signature, pts started RUX according to Summary of Product Characteristics; MMAS-8 questionnaire was administered at wks 4, 8, 12 and 24 after RUX initiation. MMAS-8 were analysed only if pts provided all responses to the questionnaire; a score ˂ 6 indicates low adherence, a score between 6 and 8 indicates medium adherence, and a score = 8 suggests high adherence. As per protocol, only adherence classes (low-medium-high) assessment was scheduled and in case of low or medium adherence (ie suboptimal adherence), no action in term of target education or psychological interventions was planned. Results: Out of 215 enrolled pts, 188 were evaluable for MMAS-8. The MMAS-8 was completed by 163 pts (87%) at week (wk) 4, 156 pts (83%) at wk 8, 146 pts (78%) at wk 12 and 134 pts (71%) at wk 24. A total of 101 out of 188 eligible pts (54%) completed all 4 scheduled questionnaires. MMAS-8 total score seems to remain stable over the time. Mean MMAS-8 total score was 7.54±0.77 (min; max: 4.75; 8.00) at wk 4 and 7.67±0.70 (min; max: 4.25; 8.00) at wk 24, resulting in a mean change from wk 4 of 0.14±