ABSTRACT
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.
ABSTRACT
Background: Systemic lupus erythematosus (SLE) is an autoimmune disease with a multiple organs-involvement. SLE pathogenesis is sustained by innate and adaptive immune system disregulation, complement activation, immune complexes, and tissue inflammation. The pattern of clinical manifestations is heterogenous and changes over time. Hydroxychloroquine (HCQ)is a primary drug in the treatment of SLE. It modulates the immune response by inhibiting B cell receptor and TLR signaling and activation. Clinical Case: This is a case report of a 61-years-old female affected by SLE with recurrent oral aftosis, Lupus anti-coagulant antibodies and previous pleuritis in remission. The patient had a long course treatment with low-dose oral corticosteroids (5 mg prednisone) and HCQ for three weeks. After 20 days of treatment with HCQ she developed an abrupt cutaneous manifestation consisting in painful and infiltrating papules which appeared over the upper trunk and limbs, redness, scales lesions on palms and soles, lip swelling, painful conjunctivitis and mild disphagia. Slowly, progressive improvement of cutaneous and mucosal signs was observed after drug discontinuation, two days after appearance of clinical manifestations, and introducing medium-high dose of oral corticosteroids therapy. Results: Clinical exams, performed in the acute phase highlighted a marked lymphocyto penia and raise of Reactive C Protein (RCP). Nicolsky sign was slightly positive. After discontinuation of HCQ the patient did not show cutaneous or infective sequelae due to prompt identification of Steven-Johnson Syndrome (SJS). The patient replaced HCQ with the increase of the mainteinance dose of oral corticosteroids. Skin tests were not perfomed for the risk of SJS exacerbation and concomitant corticosteroids therapy. Conclusions: Like all medications, HCQ has side effects which may occur in autoimmune disease patients. The main undesirable effects observed are digestive disorders and skin manifestations. Although skin diseases are common side effects of HCQ severe drug hypersensitivity reaction is a rare condition described in few case reports of DRESS and SJS. Despite the rare occurrence of these reactions, we observed other cases of drug reactions during the pandemic breakthrough in Italy when HCQ was widely used for the treatment of COVID-19.