Immune-related generalised oedema – A new category of adverse events with immune checkpoint inhibitors

Velev, Maud; Baroudjian, Barouyr; Pruvost, Roxane; Martin, Eléonora De; Laparra, Ariane; Babai, Samy; Teysseire, S.; Danlos, François‐Xavier; Albigès, Laurence; Bernigaud, C.; Benderra, Marc-Antoine; Pradère, Pauline; Zaidan, Mohamad; Decroisette, C.; Fallah, Fatma; Matergia, Gaelle; Lavaud, Pernelle; Jantzem, Hélène; Atzenhoffer, Marina; Buyse, Véronique; Robert, Caroline; Champiat, Stéphane; Messayke, Sabine; Marabelle, Aurélien; Guettier, Catherine; Lebbe, Célèste; Lambotte, Olivier; Michot, Jean‐Marie

doi:10.1016/j.ejca.2022.11.001

Cited by 4 publications

(12 citation statements)

References 37 publications

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“…In all cases, the main causes of hypoalbuminemia and edematous syndrome were to be ruled out. Because hemoconcentration is less consistent in secondary CLS such as drug-associated CLS [4,6,11], we decided not to include this criterion so that we could include some borderline presentations for which diagnostic criteria are less consensual than in the idiopathic form [12].…”

Section: Systematic Reviewmentioning

confidence: 99%

“…Two patients developed CLS with chylothorax due to lymphatic hyperpermeability [19,20]. Hemoconcentration was reported in 77% (10/13) of patients [9,10,12,[19][20][21][22]. The Landis test was performed in three patients, all of whom had extravascular leakage of radiotracer [4,19,20].…”

Section: Systematic Reviewmentioning

confidence: 99%

“…Three CLS occurred after ICI discontinuation (between 1 and 3 months after the last injection) [10,19,20]. A total of 8 patients (57%) had an irAE (hypothyroidism n = 4, hepatitis n = 3, diabetes n = 2, psoriasis flare-up n = 1, pneumonitis n = 1, and thrombocytopenia n = 1) that preceded or was contemporaneous with CLS [4,9,10,12,20,21]. No recurrence or tumor progression was reported in six cases [9,10,12,19], clinical response to ICI was observed in three patients [12,20,22] and disease progression in one [12].…”

Section: Systematic Reviewmentioning

confidence: 99%

“…A total of 8 patients (57%) had an irAE (hypothyroidism n = 4, hepatitis n = 3, diabetes n = 2, psoriasis flare-up n = 1, pneumonitis n = 1, and thrombocytopenia n = 1) that preceded or was contemporaneous with CLS [4,9,10,12,20,21]. No recurrence or tumor progression was reported in six cases [9,10,12,19], clinical response to ICI was observed in three patients [12,20,22] and disease progression in one [12]. In all but three patients, glucocorticosteroids were the first-line treatment, and five patients were subsequently treated with IVIg (Table 1).…”

Section: Systematic Reviewmentioning

confidence: 99%

“…In all but three patients, glucocorticosteroids were the first-line treatment, and five patients were subsequently treated with IVIg (Table 1). A fatal outcome was reported in 29% (4/14) of patient due to generalized edema [12], worsening anasarca associated with bacteremia [23], multiple thromboses with mesenteric ischemia [12], and of unspecified cause in the last case [9]. The remaining patients showed complete or partial recovery with variable Note: Methodological quality score assessed using the tool proposed by Murad et al [13] (Table S1).…”

Section: Systematic Reviewmentioning

confidence: 99%

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Immune checkpoint inhibitor–associated capillary leak syndrome: A systematic review and a worldwide pharmacovigilance study

Bouibede

Jonville‐Béra

et al. 2023

J Intern Med

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Background. Although a few case reports have shown that immune checkpoint inhibitors (ICIs) are potential inducers of capillary leak syndrome (CLS), an incidental finding cannot be ruled out. The aim of this study was to describe the clinical characteristics of ICI-induced CLS through a systematic review and to assess a potential safety signal.Methods. Medline/PubMed, Embase, and Reactions Weekly were screened, and a global disproportionality study was performed using the World Health Organization pharmacovigilance database through January 15, 2023. A signal of disproportionate reporting was defined as a Bayesian information component (IC) with a 95% credibility interval (CrI) lower boundary that exceeds 0. Results.A total of 47 cases of ICI-associated CLS were included, 14 from the systematic review (of 61 screened articles) and 33 from VigiBase (of 34,058,481 reports of adverse drug reactions). The median time to CLS onset from the start of ICI was 12 weeks (interquartile range 8-49, n = 24). A total of 57% (8/14) of patients experienced an immunerelated adverse event (irAE) before CLS. A fatal outcome was reported in 23% (7/31) of patients. A significant overreporting of CLS was found with ICIs compared with all other drugs (IC 2.4, 95% CrI from 1.8 to 2.8). Conclusion.This study showed a significant signal of disproportionality reporting for ICI-induced CLS, characterized by a long time to onset, and compared with the idiopathic form of the disease with a less abrupt onset and a less consistent hemoconcentration pattern.

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Section: Systematic Reviewmentioning

confidence: 99%

Section: Systematic Reviewmentioning

confidence: 99%

Section: Systematic Reviewmentioning

confidence: 99%

Section: Systematic Reviewmentioning

confidence: 99%

Section: Systematic Reviewmentioning

confidence: 99%

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Immune checkpoint inhibitor–associated capillary leak syndrome: A systematic review and a worldwide pharmacovigilance study

Bouibede

Jonville‐Béra

et al. 2023

J Intern Med

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Multiple drugs

2023

Reactions Weekly

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Rare Immune-Related Adverse Events (irAEs): Approach to Diagnosis and Management

Javaid,

Bennett,

Rao

et al. 2024

Pharm Med

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Immune checkpoint inhibitors (ICIs) have revolutionised the treatment landscape across many solid organ malignancies and form part of routine clinical practice in many tumours. As indications for monotherapy, doublet therapy and combination approaches with chemotherapy and targeted agents expand, clinicians must be aware of the wide range of possible immune-related adverse events (irAEs). Common toxicities, including rash, colitis, hepatitis and pneumonitis are well described in the literature, and have established diagnostic and management algorithms. Rarer toxicities, often with an incidence of less than 1%, are less defined. These syndromes can be poorly recognised, may take on a fulminant course and do not have established or evidence-based diagnostic and management strategies. As such, patients may experience increased morbidity, mortality and poorer outcomes, related both to these irAEs as well as how the treatment of these may affect the management of their underlying malignancy. In this review, we aim to explore the incidence, potential biomarkers, pathogenesis, diagnostic work-up and clinical sequelae of a selection of uncommon irAEs, with a focus on myocarditis, neurological and haematologic syndromes. Further prospective research is required to accurately define the incidence and pathogenesis of these conditions, with the aim of increasing clinician awareness of rare irAEs and to assist with a more personalised and mechanism-based approach to these syndromes.

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Immune-related generalised oedema – A new category of adverse events with immune checkpoint inhibitors

Cited by 4 publications

References 37 publications

Immune checkpoint inhibitor–associated capillary leak syndrome: A systematic review and a worldwide pharmacovigilance study

Immune checkpoint inhibitor–associated capillary leak syndrome: A systematic review and a worldwide pharmacovigilance study

Multiple drugs

Rare Immune-Related Adverse Events (irAEs): Approach to Diagnosis and Management

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