Table 3.
Studies on ruxolitinib reporting on cardiovascular risk
| First author and Reference | Title | Type of study | Results |
|---|---|---|---|
| Verstovsek et al.159 | Long-term treatment with ruxolitinib for patients with myelofibrosis: 5-year update from the randomized, double-blind, placebo-controlled, phase 3 COMFORT-I trial | 5-year update of COMFORT I phase-III trial: ruxolitinib (n = 155) vs. placebo (n = 154) | Myocardial infarction 2.7% |
| Verstovsek et al.161 | Long-term survival in patients treated with ruxolitinib for myelofibrosis: COMFORT-I and -II pooled analyses | Pooled analysis | The update of results at 5 years reported 0.9% of myocardial infarction at 2 years and 2.7% at 4 years. Overall, by 48 months of therapy 6.2% of patients receiving ruxolitinib presented cardiac failure |
| Harrison et al.160 | Long-term findings from COMFORT-II, a phase 3 study of ruxolitinib vs. best available therapy for myelofibrosis | 5-year update of COMFORT II phase-III trial: ruxolitinib (n = 146) vs best available therapy (n = 118). | Cardiac failure 2% |
| Barraco et al.162 | Real-world non-interventional long-term post-authorisation safety study of ruxolitinib in myelofibrosis | Real-world experience | Occurrence of cardiac failure in only 1.6% of treated subjects |
| Samuelson et al.165 | The impact of ruxolitinib on thrombosis in patients with polycythemia vera and myelofibrosis: a meta-analysis | Meta-analysis | Rates of thrombosis were significantly lower among patients treated with ruxolitinib (risk ratio 0.45, 95% confidence interval 0.23–0.88) |
| Masciulli et al.166 | Ruxolitinib for the prevention of thrombosis in polycythemia vera: a systematic review and meta-analysis | Meta-analysis involving four randomized trials with 663 patients | Thrombosis risk ratio of 0.56 for ruxolitinib vs. best available therapy, corresponding to an incidence of 3.09% and 5.51% patients per year |
| Saliba et al.167 | Association between myelofibrosis and thromboembolism: a population-based retrospective cohort study | Population-based retrospective study; 1 469 790 adults were followed from 2007 until 2016 for the occurrence of myelofibrosis | One-third of myelofibrosis patients received ruxolitinib: no significant association was found between JAK-2 inhibitor treatment and the risk of venous or arterial thromboembolism, indirectly suggesting a favourable role of this drug from the CV |
| Colafigli et al.168 | The advantages and risks of ruxolitinib for the treatment of polycythemia vera | Expert opinion: authors searched Medline, Embase, archives from the European Hematology Association and the American Society of Hematology annual congresses from 2014 to 2020 about ruxolitinib treatment in polycythemia vera patients and safety | Thromboembolic events per 100 patient-years of 1.8 in the ruxolitinib vs. 8.2 in the best available therapy arm and 2.7 in the cross-over cohort |