Journal of the European Academy of Dermatology and VenereologyVolume 33, Issue 7 p. e271-e272 Letter to the Editor Desensitization protocol for angio-oedema induced by encorafenib in a patient with metastatic melanoma A. Brue, Corresponding Author A. Brue alexis.brue@ap-hm.fr Department of Dermatology, Hôpital Nord, Assistance Publique – Hôpitaux de Marseille, Aix-Marseille University, 13015 Marseille, FranceCorrespondence: A. Brue. E-mail: alexis.brue@ap-hm.frSearch for more papers by this authorM. Benzaquen, M. Benzaquen Department of Dermatology, Hôpital Nord, Assistance Publique – Hôpitaux de Marseille, Aix-Marseille University, 13015 Marseille, FranceSearch for more papers by this authorN. Bonnet, N. Bonnet Department of Dermatology, Hôpital Nord, Assistance Publique – Hôpitaux de Marseille, Aix-Marseille University, 13015 Marseille, FranceSearch for more papers by this authorM.C. Koeppel, M.C. Koeppel Department of Dermatology, Hôpital Nord, Assistance Publique – Hôpitaux de Marseille, Aix-Marseille University, 13015 Marseille, FranceSearch for more papers by this authorA. Default, A. Default Department of Clinical Pharmacology, Regional Center of Pharmacovigilance Marseille – Provence – Corse, Assistance Publique -Hôpitaux de Marseille, Aix-Marseille University, 13015 Marseille, FranceSearch for more papers by this authorE. Delaporte, E. Delaporte Department of Dermatology, Hôpital Nord, Assistance Publique – Hôpitaux de Marseille, Aix-Marseille University, 13015 Marseille, FranceSearch for more papers by this authorP. Berbis, P. Berbis Department of Dermatology, Hôpital Nord, Assistance Publique – Hôpitaux de Marseille, Aix-Marseille University, 13015 Marseille, FranceSearch for more papers by this author A. Brue, Corresponding Author A. Brue alexis.brue@ap-hm.fr Department of Dermatology, Hôpital Nord, Assistance Publique – Hôpitaux de Marseille, Aix-Marseille University, 13015 Marseille, FranceCorrespondence: A. Brue. E-mail: alexis.brue@ap-hm.frSearch for more papers by this authorM. Benzaquen, M. Benzaquen Department of Dermatology, Hôpital Nord, Assistance Publique – Hôpitaux de Marseille, Aix-Marseille University, 13015 Marseille, FranceSearch for more papers by this authorN. Bonnet, N. Bonnet Department of Dermatology, Hôpital Nord, Assistance Publique – Hôpitaux de Marseille, Aix-Marseille University, 13015 Marseille, FranceSearch for more papers by this authorM.C. Koeppel, M.C. Koeppel Department of Dermatology, Hôpital Nord, Assistance Publique – Hôpitaux de Marseille, Aix-Marseille University, 13015 Marseille, FranceSearch for more papers by this authorA. Default, A. Default Department of Clinical Pharmacology, Regional Center of Pharmacovigilance Marseille – Provence – Corse, Assistance Publique -Hôpitaux de Marseille, Aix-Marseille University, 13015 Marseille, FranceSearch for more papers by this authorE. Delaporte, E. Delaporte Department of Dermatology, Hôpital Nord, Assistance Publique – Hôpitaux de Marseille, Aix-Marseille University, 13015 Marseille, FranceSearch for more papers by this authorP. Berbis, P. Berbis Department of Dermatology, Hôpital Nord, Assistance Publique – Hôpitaux de Marseille, Aix-Marseille University, 13015 Marseille, FranceSearch for more papers by this author First published: 05 March 2019 https://doi.org/10.1111/jdv.15544Citations: 2Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat No abstract is available for this article.Citing Literature Volume33, Issue7July 2019Pages e271-e272 RelatedInformation
Encorafenib is an oral BRAF kinase inhibitor used in patients with BRAFV600 mutated melanoma (1). Generalized hypersensitivity reactions (HSR) have been described with BRAF inhibitors (BRAFi) (2), but remain rare. Desensitization protocols to overcome HSR by gradual reintroduction of small amounts of the incriminating drug up to full therapeutic doses have been proposed for vemurafenib (3, 4) and dabrafenib (5), but not yet for encorafenib. We describe a successful desensitization protocol to encorafenib in a patient presenting with an encorafenib-induced angioedema. This article is protected by copyright. All rights reserved.
Angiotensin converting enzyme inhibitors (ACEI) were first introduced in 1981. They are widely used in the field of hypertension, heart failure and kidney dysfunction. In general, ACEI are effective in a high percentage of patients and are well tolerated. However, cough might sometimes appear. The cough is typically dry and is associated with a tickling or scratching sensation in the throat [ [1] Poole M.D. Postma D.S. Characterization of cough associated with angiotensin-converting enzyme inhibitors. Otolaryngol Head Neck Surg. 1991; 105: 714-716 Google Scholar ]. ACEI-induced cough is not dose-dependant [ [2] Israili Z.H. Hall W.D. Cough and angioneurotic edema associated with angiotensin-converting enzyme inhibitor therapy. A review of the literature and pathophysiology. Ann Intern Med. 1992; 117: 234-242 Crossref PubMed Scopus (888) Google Scholar ]. In a metanalysis of clinical trials, Bangalore et al. showed that ACEI cough appears in 11.48% of cases and authors suggested that ACEI-induced cough was generally underestimated [ [3] Bangalore S. Kumar S. Messerli F.H. Angiotensin-converting enzyme inhibitor associated cough: deceptive information from the physicians' desk reference. Am J Med. 2010; 123: 1016-1030 Abstract Full Text Full Text PDF PubMed Scopus (81) Google Scholar ].
Introduction. - Thrombopoietin-receptor agonists (TPO-RA) are marketed for immune thrombocytopenia (ITP). They have been associated to thrombosis occurrence in randomized controlled trials. However, the characteristics of these thromboses in the real-life practice as well as their management are poorly known. The objectives of this study were to determine the risk factors, circumstances and management of thrombosis occurring during exposure to TPO-RA in ITP. Methods. - We carried out a multicentre retrospective study in France. Moreover, all cases reported to the French pharmacovigilance system were also analyzed. Results. - Overall, 41 thrombosis (13 arterial) in 36 ITP patients (14 males and 22 females, mean age: 59 years) were recorded between January 2009 and October 2015. Twenty patients were treated with romiplostim, 15 with eltrombopag and 1 was treated by both medications. Thirty-three (92%) of the patients had another risk factor for thrombosis. Ten (28%) had an history of thrombosis and 13 (36%) received immunoglobulin in the month preceding the thrombotic event. Three had antiphospholipid antibodies; congenital low-risk thrombophilia was found in 4 cases; 18 patients (50%) were splenectomized. Median platelet count at the time of thrombosis was 172 G/I (1-1049 G/l). In 22 patients (56%), a good prognosis was associated with the thrombosis and was not linked with TPO-RA withdrawal. Bleeding events occurred in 14% of the patients treated with antiplatelet or anticoagulant drug, including 5% serious events (1 death of intracranial haemorrhage, 1 death of haemorrhagic shock). Conclusions. - The thrombotic risk may be carefully assessed before starting TPO-RA in ITP patients. The impact of antiphospholipid antibodies and of congenital thrombophilia remains to be defined. Thrombosis evolution seems independent of TPO-RA management. Bleeding manifestations seem rare. Poor prognosis was mainly due to ischemic sequelae. (C) 2016 Societe Nationale Francaise de Medecine Interne (SNFMI). Published by Elsevier Masson SAS. All rights reserved.
Little is known about the informativeness of initial patient reports before they are reviewed by a pharmacovigilance centre (PVC). We aim to describe the patterns of patient adverse drug reaction (ADR) reporting in France and estimate the contribution of a review by a PVC assessor on the informativeness of these reports.