EFFICACY AND SAFETY OF COVID-19-SPECIFIC TREATMENTS IN SLE: A MULTICENTRE CASE-CONTROL STUDY

BackgroundCOVID-19 is associated with higher morbidity and mortality burdens in immunocompromised individuals, including patients with systemic lupus erythematosus (SLE;1). These patients might benefit from treatment with anti-SARS-CoV-2-specific antiviral agents and monoclonal antibodies, but clinical evidence is to date limited.Objectivesto comparatively assess the course of COVID-19 in patients with SLE treated or untreated with COVID-19-specific agents.MethodsPatients with SLE and COVID-19 treated with antivirals and/or monoclonal antibodies from February 2020 to December 2022 were identified within a three-centre cohort of tertiary referral centres and age-, sex- SLE extension- and SLE duration-matched 1:2 with patients with a history of untreated COVID-19. Data on COVID-19 presentation, course (including time to viral clearance) and sequelae, along with SLE treatment at COVID-19 onset and SLE course after COVID-19 were collected. COVID-19 severity at presentation was quantitated through a 0-4 analogue scale [2]. Data are expressed as median (interquartile range, IQR) unless otherwise specified.ResultsOver three years, 39% of patients with SLE had at least one COVID-19 event. Eighteen subjects (16 women) were treated with antivirals (n=12) or monoclonal antibodies (n=6) and were matched with 36 controls. There was no difference in the frequency of organ involvement between the two groups. Treated patients were receiving significantly higher prednisone daily doses at COVID-19 onset (6.25 (0-10) vs 0 (0-2.5) mg;p=0.005) and had a higher prevalence of previous high-dose steroid treatments (83% vs 47%;p=0.019) compared to controls. SLE disease activity index (3 (0-5) vs 1 (0-4)) and SLE International Collaborating Clinics Damage Index scores (1 (0-3) vs 0 (0-1)) were also numerically higher in treated patients at COVID-19 onset. Patients in the treated group had more severe COVID-19 at presentation but showed no significant differences with control subjects in terms of COVID-19 resolution, prevalence of sequelae and viral clearance (Table 1). There was also no difference in flare occurrence between the two groups (Log-rank=0.02, p=0.889). Two patients reported mild adverse events with monoclonal antibodies (muscle cramps and chest pain, both self-resolving).ConclusionThese data support the safe use of COVID-19 specific treatments in patients with SLE. Patients treated with antivirals and monoclonal antibodies had a favourable COVID-19 course, despite a more severe presentation and a higher risk of deterioration due to SLE and corticosteroid treatment burden, suggesting the potential efficacy of COVID-specific treatments in preventing severe COVID-19 in patients with SLE.References[1]Strangfeld A et al, Ann Rheum Dis, 2021[2]World Health Organization. Clinical management of COVID-19;Interim guidance 27 May 2020.Table 1.COVID-19 presentation and courseTreated (n=18)Untreated (n=36)Number of vaccine doses3 (2-3)3 (2-3)Time from last vaccine administration (days)118 (53-184)134 (30-210)COVID-19 featuresWHO class at presentation1 (1-1)**0 (0-1)Symptoms at presentation: n(%)Dyspnoea3 (17)3 (8)Fever10 (56)22 (61)Upper Respiratory Symptoms16 (89)29 (81)GI symptoms1 (6)2 (6)Pneumonia3 (17)3 (8)COVID-19 courseTime to symptom resolution (days)5 (4-8)7 (3-8)Time to viral clearance (days)10 (7-14)9 (7-14)Any complication: n(%)1 (6)6 (17)Hospitalisations: n(%)1 (6)0 (0)Long COVID: n(%)3 (17)6 (17)Deaths: n(%)0 (0)1 (3)AcknowledgementsWe thank Dr. Giordano Vitali and his staff for assisting and treating patients with SLE and COVID-19 from IRCCS San Raffaele Hospital in the local mild COVID-19 clinic.Disclosure of InterestsGiuseppe Alvise Ramirez Consultant of: Astrazeneca, Maria Gerosa: None declared, Daniel Arroyo-Sánchez: None declared, Chiara Asperti: None declared, Lorenza Maria Argolini: None declared, Gabriele Gallina: None declared, Chiara Bellocchi: None declared, Martina Cornalba: None declared, Isabella Scotti: None declared, Ilaria Suardi: None declared, Lorenzo Beretta: None declared, Luca Moroni Consultant of: strazeneca, Enrica Bozzolo: None declared, Roberto Caporali Speakers bureau: AbbVie, Amgen, BMS, Celltrion, Fresenius, Galapagos, Janssen, Lilly, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Fresenius, Galapagos, Lilly, Novartis, Pfizer, and UCB, Lorenzo Dagna Consultant of: Abbvie, Amgen, Astra-Zeneca, Biogen, Boehringer-Ingelheim, Bristol-Myers Squibb, Celltrion, Eli Lilly and Company, Galapagos, GlaxoSmithKline, Janssen, Kiniksa Pharmaceuticals, Novartis, Pfizer, Roche, Sanofi-Genzyme, Swedish Orphan Biovitrium (SOBI), and Takeda, Grant/research support from: Abbvie, Bristol-Myers Squibb, Celgene, GlaxoSmithKline, Janssen, Kiniksa, Merk Sharp & Dohme, Mundipharma Pharmaceuticals, Novartis, Pfizer, Roche, Sanofi-Genzyme, and SOBI.

The role of skin tests with polyethylene glycol and polysorbate 80 in the vaccination campaign for COVID-19: results from an Italian multicenter survey.

Summary: Background. International guidelines suggested skin tests with Polyethylene-glycol (PEG) and polysorbate 80 (PS-80), to investigate a possible hypersensitivity to these excipients either to identify subjects at risk of developing allergic reactions to Covid-19 vaccines, or in patients with suspected IgE mediated hypersensitivity reactions (HR) to the Covid-19 vaccine. The main purpose of this study was to investigate the prevalence of PEG and PS sensitization in patients with a clinical history of HR to drugs containing PEG/PS and in patients with a suspected Covid-19 vaccine immediate HR. Methods. This was a multicenter retrospective study conducted by allergists belonging to 20 Italian medical centers. Skin testing was performed in 531 patients with either a clinical history of suspected hypersensitivity reaction (HR) to drugs containing PEG and/or PS-80 (group 1:362 patient) or a suspected HR to Covid-19 vaccines (group 2: 169 patient), as suggested by the AAIITO/SIAAIC guidelines for the "management of patients at risk of allergic reactions to Covid-19 vaccines" [1]. Results. 10/362 (0.02%) had positive skin test to one or both excipients in group 1, 12/169 (7.1%) in group 2 (p less than 0.01). In group 2 HRs to Covid-19 vaccines were immediate in 10/12 of cases and anaphylaxis occurred in 4/12 of patients. Conclusions. The positivity of skin test with PEG and or PS before vaccination is extremely rare and mostly replaceable by an accurate clinical history. Sensitization to PEG and PS has to be investigated in patients with a previous immediate HR to a Covid-19 vaccine, in particular in patients with anaphylaxis.