Author: Metafuni, Elisabetta ; Sica, Simona ; Giannotta, Juri A. ; Iori, Anna P. ; Aydin, Semra ; Quattrocchi, Luisa ; Carbone, Cecilia ; Fattizzo, Bruno ; Di Bona, Eros ; Beggiato, Eloise ; Barone, Federica ; Pomponi, Fabrizio ; Notaro, Rosario ; Lanza, Francesco ; Barcellini, Wilma

The COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has raised several concerns regarding patients with haematol. and immunemediated diseases.This also includes paroxysmal nocturnal haemoglobinuria (PNH), due to its known association with bone marrow failures and to therapy with complement inhibitors in the classic haemolytic form.We conducted a survey on 156 patients with PNH (median age 50 years, range 19-86; 88 females and 68 males) among eight Italian reference centers to evaluate the occurrence and clin. characteristics of SARS-CoV-2 infection from the outbreak (24 Feb. 2020) until the time of writing (15 Dec. 2020).Most patients suffered from classic haemolytic PNH (n=111, 71%), a minority had a concomitant aplastic anemia (AA) or myelodysplastic syndrome (n = 31, 20%), and the remainder subclin. disease.Regarding therapy, 105 subjects (673%) were on stable treatment with complement inhibitors at the time of COVID-19 outbreak (n=80 eculizumab, n=21 ravulizumab, n=3 crovalimab and n=1 iptacopan).During the observation period, 101 patients underwent at least one surveillance nasal-pharyngeal swab (35/101 were regularly swabbed every 2-4 wk).Four patients were found to be pos., two asymptomatic and two with symptoms (cumulative incidence 25%), mostly.Concomitant to the second wave of infections.Three out of four patients were on treatment with complement inhibitors, and one experienced breakthrough haemolysis (BTH).Particularly, patient #1 had an estimated high thrombotic risk due to a history of breast cancer and active haemolytic PNH (lactate dehydrogenase levels fivefold the upper limit of normal) without complement inhibition therapy because of patient's choice.As regards the remaining 152 patients without a demonstrated SARS-CoV-2 infection, eight experienced a febrile episode, two haemolytic crises in untreated patients (n = 50), and two a BTH event (101 patients on C5 inhibitor); four patients required transfusion support.This is the first survey on a large cohort of PNH patients, suggesting that PNH subjects, either on complement inhibition or not, are not at significantly higher risk of SARS-CoV-2 infection compared with the general population.These measures also guaranteed a safe continuity of care of PNH patients.Notably, a young male patient on eculizumab, working as medical doctor in a COVID-19 ward, did not contract the infection.In conclusion, our results suggest that complement inhibition did not increase SARSCoV-2 infectious risk in PNH, and may also contribute to smother the clin. severity of COVID-19.

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Indication	Highest Phase	Country/Location	Organization	Date
Geographic Atrophy	Preclinical	United States	EyePoint Pharmaceuticals, Inc.	26 Jul 2024

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