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Article
Severe immune-mediated hepatitis and hemophagocytic lymphohistiocytosis in patients treated with Cardiomab for relapsed/refractory diffuse large B-cell lymphoma: a multicenter case series
Lefebvre N, Okafor-Mbata C, Tanaka R, et al. Br J Haematol. 2025;209(4):612–624. doi:10.1111/bjh.20278. PMID: 38194472.
PMID: 38194472Br J HaematolCase seriesCardiomab
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¶1Background: CD47 blockade with Cardiomab (mab-CD47 IgG4) has shown promising activity in relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL). However, immune-related adverse events (irAEs) emerging from CD47 pathway disruption remain incompletely characterised in the post-marketing setting.
¶2Methods: We conducted a retrospective multicenter case series across six European haematology centres (Jan 2024–Sept 2025) to characterise severe hepatobiliary and haematologic irAEs in patients receiving Cardiomab monotherapy or in combination with rituximab after market authorisation.
¶3Results: Three patients developed severe immune-mediated hepatitis, two of whom progressed to secondary haemophagocytic lymphohistiocytosis (HLH). One additional aggregate safety signal of grade ≥3 transaminitis was observed across the cohort. All events resolved with corticosteroids and/or tocilizumab.
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🤖 AI suggestionAI-Generated Article Assessment
Article purpose
Post-marketing characterisation of severe hepatobiliary and haematologic immune-related adverse events associated with Cardiomab in r/r DLBCL.
Study type
Retrospective multicenter case series (descriptive, non-comparative)
Population
Adults with relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL) treated with Cardiomab ± rituximab across 6 European centres, Jan 2024–Sept 2025.
Product exposure
Cardiomab (mab-CD47 IgG4) 30 mg/kg IV every 2 weeks; combination with rituximab reported in Patient 1.
Safety outcomes
Severe immune-mediated hepatitis (grade ≥3 transaminitis); secondary haemophagocytic lymphohistiocytosis (HLH); aggregate cohort transaminitis signal.
Authors' conclusions
Clinicians should monitor liver function and ferritin monthly during Cardiomab therapy; maintain low threshold for HLH evaluation. Benefit-risk remains favourable per label but enhanced surveillance is advised.
New findings
First post-marketing series linking Cardiomab to immune-mediated hepatitis and secondary HLH. Proposed mechanism: unchecked macrophage activation after CD47 blockade.
Benefit-risk impact
Potentially clinically significant new safety information. Benefit-risk balance for Cardiomab in r/r DLBCL remains favourable per label, but the reported events warrant expedited MAH and health-authority review.
Potential patient cases
3
Information requiring medical interpretation
Patient 3 is described only at aggregate level (sex, dosing dates, outcome not reported) — confirm whether an identifiable reporter exists before creating an ICSR. HLH diagnosis per HLH-2004 criteria should be verified by a medical reviewer. Rechallenge positivity in Patient 1 strengthens causality but should be confirmed against source records.