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https://www.jnjmedicalconnect.com/products/darzalex-faspro/medical-content/darzalex-darzalex-faspro-use-in-immune-thrombocytopenia.

thrombocytopenia (ITP). Janssen does not recommend the use of DARZALEX or DARZALEX FASPRO in a manner that is inconsistent with the approved labeling.
DART: a multicentre, clinical, open-label total dose-escalating phase 2 study with safety run-in evaluating the efficacy and safety of DARZALEX FASPRO in adult ITP patients who have not responded adequately or relapsed after corticosteroids and at least one second-line therapy including rituximab and/or thrombopoietin receptor agonist (TPO-RA).1

Tsykunova et al (2022)2 reported results of patients in the safety run-in of a phase 2, open-label, total dose-escalating, multicenter study with a safety run-in, to evaluate the efficacy and safety of DARZALEX FASPRO in patients with ITP (DART study).
All 3 patients in the safety run-in have completed treatment, with 2 patients responding at week 12, and 1 patient relapsing by week 24.
No grade >2 adverse events (AEs) or serious AEs were reported.
Tsykunova et al (2025)3 presented short-term responses from the DART study. Platelet count of >=50×109/L was attained by 2/3 patients in safety run-in, 4 (44%) in cohort 1 (95% confidence interval [CI], 13.7-78.8), and 4 (44%) in cohort 2 (95% CI, 13.7-78.8). By study week 12, out of 11 responding patients, 5 (45%) patients who were on concomitant medication treatment at the start discontinued the concomitant therapy. The most common treatment-emergent adverse events (TEAEs) were infections (38%). Grade 3 serious AEs were experienced by 2 patients, 1 patient experienced an infusion-related reaction, and 1 patient had severe acute respiratory syndrome coronavirus 2 (SARS-Cov2) infection with acute renal failure. After treatment completion, numerical improvement was observed for responders in all dimensions of the 36-item short form survey version 1 (SF-36v1).

Strüßmann et al (2024)4 reported a case series of 7 patients with refractory ITP treated with DARZALEX FASPRO. A total of 4 patients showed complete remission, 2 patients showed no sustained response, and 1 patient showed no response.
Strüßmann et al (2024)5 reported a retrospective case series of 6 consecutive patients with ITP who received DARZALEX between 2020 and 2024; 4 patients had primary ITP, and 2 patients had secondary ITP.

Four patients responded to treatment, whereas 1 patient did not respond to 4 applications and withdrew from the study. One patient is still under treatment.

Strüßmann T, Jung J, Heinz J, et al. Long-term complete remission of refractory severe idiopathic immune thrombocytopenia (ITP) treated with daratumumab. Ann Hematol. 2023;102(1):245-247.
15 Hu Y, Wang Z, Ma J, et al. The early and rapid response to daratumumab in children with chronic refractory immune thrombocytopenia from a referral single centre of China. Br J Haematol. 2024;205(1):300-305.

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