Etra, Aaron and Capellini, Alexandra and Alousi, Amin and Al Malki, Monzr M. and Choe, Hannah and DeFilipp, Zachariah and Hogan, William J. and Kitko, Carrie L. and Ayuk, Francis and Baez, Janna and Gandhi, Isha and Kasikis, Stelios and Gleich, Sigrun and Hexner, Elizabeth and Hoepting, Matthias and Kapoor, Urvi and Kowalyk, Steven and Kwon, Deukwoo and Langston, Amelia and Mielcarek, Marco and Morales, George and Ozbek, Umut and Qayed, Muna and Reshef, Ran and Roesler, Wolf and Spyrou, Nikolaos and Young, Rachel and Chen, Yi-Bin and Ferrara, James L. M. and Levine, John E. (2023) Effective treatment of low-risk acute GVHD with itacitinib monotherapy. BLOOD, 141 (5). pp. 481-489. ISSN 0006-4971, 1528-0020
Full text not available from this repository. (Request a copy)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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | VERSUS-HOST-DISEASE; THERAPY; INFECTION; SAFETY; BLOOD; SCORE; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin III (Hämatologie und Internistische Onkologie) |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 18 Apr 2024 13:18 |
| Last Modified: | 18 Apr 2024 13:18 |
| URI: | https://pred.uni-regensburg.de/id/eprint/60855 |
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