Citations 12
Effective Treatment of Low Risk Acute Gvhd with Itacitinib Monotherapy
Capellini, Alexandra, Etra, Aaron , Choe, Hannah , DeFilipp, Zachariah , Ayuk, Francis, Baez, Janna , Gandhi, Isha , Kasikis, Stelios, Gleich, Sigrun, Hoepting, Matthias, Kapoor, Urvi , Kowalyk, Steven, Langston, Amelia , Morales, George , Özbek, Umut , Roesler, Wolf, Spyrou, Nikolaos , Young, Rachel , Chen, Yi‐Bin , Ferrara, James L.M. , Alousi, Amin Majid , Malki, Monzr M. Al , Hogan, William J. , Kitko, Carrie L. , Hexner, Elizabeth O. , Kwon, Deukwoo , Mielcarek, Marco B. , Qayed, Muna , Reshef, Ran , Levine, John E.
Blood | November 29, 2022 | Volume: 140 | Issue: Supplement 1 | Pages: 1867-1869
Effective treatment of low-risk acute GVHD with itacitinib monotherapy
Etra, Aaron , Capellini, Alexandra, Alousi, Amin, Malki, Monzr M. Al , Choe, Hannah , DeFilipp, Zachariah , Kitko, Carrie L. , Ayuk, Francis, Baez, Janna , Gandhi, Isha , Kasikis, Stelios, Gleich, Sigrun, Hoepting, Matthias, Kapoor, Urvi , Kowalyk, Steven, Langston, Amelia , Morales, George , Özbek, Umut , Rösler, Wolf, Spyrou, Nikolaos , Young, Rachel , Chen, Yi‐Bin , Ferrara, James L.M. , Al Malki, Monzr M , Gandhi, Isha , Hexner, Elizabeth , Langston, Amelia , Qayed, Muna , Spyrou, Nikolaos , Chen, Yi-Bin , Levine, John E , Alousi, Amin Majid , Hogan, William J. , Hexner, Elizabeth O. , Kwon, Deukwoo , Mielcarek, Marco B. , Reshef, Ran , Levine, John E.
Blood | September 12, 2022 | Volume: 141 | Issue: 5 | Pages: 481-489
Abstract The standard primary treatment for acute graft-versus-host disease (GVHD) requires prolonged, high-dose systemic corticosteroids (SCSs) that delay reconstitution of the immune system. We used validated clinical and biomarker staging criteria to identify a group of patients with low-risk (LR) GVHD that is very likely to respond to SCS. We hypothesized that itacitinib, a selective JAK1 inhibitor, would effectively treat LR GVHD without SCS. We treated 70 patients with LR GVHD in a multicenter, phase 2 trial (NCT03846479) with 28 days of itacitinib 200 mg/d (responders could receive a second 28-day cycle), and we compared their outcomes to those of 140 contemporaneous, matched control patients treated with SCSs. More patients responded to itacitinib within 7 days (81% vs 66%, P = .02), and response rates at day 28 were very high for both groups (89% vs 86%, P = .67), with few symptomatic flares (11% vs 12%, P = .88). Fewer itacitinib-treated patients developed a serious infection within 90 days (27% vs 42%, P = .04) due to fewer viral and fungal infections. Grade ≥3 cytopenias were similar between groups except for less severe leukopenia with itacitinib (16% vs 31%, P = .02). No other grade ≥3 adverse events occurred in >10% of itacitinib-treated patients. There were no significant differences between groups at 1 year for nonrelapse mortality (4% vs 11%, P = .21), relapse (18% vs 21%, P = .64), chronic GVHD (28% vs 33%, P = .33), or survival (88% vs 80%, P = .11). Itacitinib monotherapy seems to be a safe and effective alternative to SCS treatment for LR GVHD and deserves further investigation.