Itacitinib monotherapy is an effective and safe alternative to systemic corticosteroid treatment in patients with low-risk graft versus host disease (GVHD). This is the conclusion of American researchers Blood.
They tested the hypothesis that monotherapy with the selective JAK1 inhibitor itacitinib would be a safe and effective primary treatment for patients with low-risk GVHD. Therefore, in this multicenter phase II study (NCT03846479), 70 patients with low-risk (based on clinical and biomarker criteria) GVHD were treated for 28 days with itacitinib 200 mg/day (responders could receive a second cycle of 28 days). Their outcomes were compared to those of 140 matched control patients treated with systemic corticosteroids.
More patients responded to itacitinib within 7 days (81 vs. 66%; p = 0.02) and day 28 response rates were very high for both groups (89 vs. 86%; p = 0.67) with few symptomatic flares (11 vs. 12%; p = 0.88). In the itacitinib group, fewer patients developed a serious infection within 90 days (27 vs. 42%; p = 0.04); this was due to fewer viral and fungal infections. Grade ≥ 3 cytopenias occurred equally in both groups, although there were less severe leukopenias with itacitinib (16 vs. 31%; p = 0.02). There were no other ≥ Grade 3 adverse reactions in > 10% of itacitinib-treated patients. Also, there were no significant differences between groups at 1 year in non-relapse mortality (4 vs. 11%; p = 0.21), relapse (18 vs. 21%; p = 0.64), chronic GVHD (28 vs. 33%; p = 0.33) or survival (88 vs. 80%; p = 0.11).
Bron:
Etra AM, Capellini A, Alousi AM, et al. Effective treatment of low risk acute GVHD with itacitinib monotherapy. Blood. 2022 Sep 12. Online ahead of print.