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1.
Blood ; 138:4732, 2021.
Article in English | EMBASE | ID: covidwho-1736295

ABSTRACT

mRNA vaccines BNT162b2 and mRNA1273 are highly effective in preventing SARS-CoV-2 infection and mortality in healthy adults. However, their immunogenicity in immunocompromised Multiple Myeloma (MM) patients is less clear. We performed an observational prospective study of 96 MM patients (pts) treated at our centre, aimed at assessing the humoral and cell-mediated immune (CMI) response following the full immunization schedule. To this aim, we measured serum levels of neutralizing IgG anti Spike-protein (IgG anti S-RBD) at 1, 3, 6, 9 and 12 months after the 2 nd dose of vaccination, using the electrochemiluminescence (ECLIA) platform (Elecsys® Anti-sars-Cov-2 ECLIA assay) and evaluated CMI response in terms of pts with a SARS-CoV-2 specific IFNγ T cell response by IGRA (Interferon-Gamma Release Assays) test at 3 and 12 months after 2 nd dose. A concentration level of IgG anti S-RBD ≥0.80 U/ml was considered a seropositive result. Herein, we report preliminary data on the development of humoral response in 96 MM pts who reached the first study timepoint (1 month after 2 nd dose), compared to 54 health-care workers as controls. At vaccination, the median age of the 96 patients (51 males/45 females) was 66.5 (range 47-83) years. The median number of previous lines of therapy was 1 (range 1-11) and only 7 (7.3%) pts were not receiving active treatment. 44.8% (n=43) pts had relapse/refractory MM. Among 72 (75%) transplant-eligible pts, 63 patients had previously received autologous stem-cell transplantation (ASCT) with a median time between ASCT and vaccine of 31 (range 3-274) months. 70 (72.9%) pts had received immunomodulatory drugs (IMIDs) containing regimens, 30 (31.3%) proteasome inhibitors (PIs), 11 (11.5%) IMIDs + PIs, 32 (33.3%) anti-CD38 monoclonal antibodies (anti-CD38 moAbs). 33 (34.4%) pts were in lenalidomide (R) maintenance therapy. At vaccination, 67 (68.8%) pts were in VGPR or higher, 18 (18.7%) in PR and 11 (11.3%) in SD or PD. Immunoparesis (≥1 uninvolved Ig below lower level limit) was observed in 78 (88.6%) pts, of whom 59 (67.1%) showed a reduction of two Ig classes. All pts had completed the 2 planned doses of BNT162b2 (40.6%) or mRNA1273 (59.4%) vaccine 3 or 4 weeks apart, respectively. Control cohort (n=54;median age of 51 [range 40-66] years) received mRNA vaccine during the same period. People with previous SARS-CoV-2 infection (positive IgG anti S-RBD or anti-nucleocapsid N antibody titer before vaccines) were excluded from the analysis. At 1 month post 2 nd dose, (median 30 days, IQR 28-32) seropositive response rate to vaccination was 91.7% (n=88) for MM pts vs 100% for controls, p=0.05;the median IgG anti S-RBD titer was 435 (range 0.4-2500) vs 1040.5 U/ml (range 160-2500), respectively;p=0.008. No difference in the rate of seropositive response between those who received the 2 type of vaccines was found (p=0.09). Pts with response level ≥ CR had a median antibody (Ab) titer (1242 U/ml, range 0.4-2500) significantly higher than those with ≤CR (221.5 U/ml, range 0.4- 2500), p<0.001. Pts receiving PI (median Ab titer 156;range 0.4- 2500) and anti-CD38 MoAbs (median titer 265 U/ml;0.4- 2500) containing regimens had a lower Ab titer than all the other pts (p=0.003 and p<0.001, respectively). Median Ab titer was higher in pts who received ASCT vs others (1042, range 0.4- 2500 vs 160 U/ml, range 228-2500, p<0.001) and in pts receiving R maintenance (1681.2, range 0.4-2500 vs 529.5 U/ml, range 0.4-2500, p<0.001). In pts with 2-Ig immunoparesis, the median Ab titer was 272 (range 0.4-2500) vs 2500 U/ml (range 228-2500) for no immunoparesis (p= 0.0037). A distribution analysis of the Ab titer revealed a significant correlation between better humoral response and hematological response ≥ CR (p<0.001), being in first-line treatment (p=0.039), having received ASCT (p=0.001) and receiving R maintenance (p=0.001). Multivariate analysis confirmed ≥ CR [OR 2.54, 95% CI 93-756], being in first line treatment [OR 2.10, CI 22-722] and R maintenance therapy [OR 4.53, CI 484-1233] as independen predictors of better humoral response at 1 month after 2 nd vaccine dose. In conclusion, mRNA vaccines provided a high seropositivity rate in pts in active MM treatment, with a better humoral response in pts achieving CR, those who received ASCT and receiving R maintenance. Immunoparesis was confirmed to be an unfavourable factor for the development of humoral response, as well as treatment with anti-CD-38 moAbs. Disclosures: Mancuso: Celgene: Honoraria;Takeda: Honoraria;Sanofi: Honoraria;Amgen: Honoraria;Janssen: Honoraria. Zamagni: Takeda: Honoraria;Amgen: Honoraria;Bristol-Myers-Squibb: Honoraria;Janssen: Honoraria. Pantani: Amgen: Honoraria;Janssen: Honoraria. Rocchi: Amgen: Honoraria;GalxoSmithKline: Honoraria;Janssen: Honoraria. Rizzello: Amgen: Honoraria;GlaxoSmithKline: Honoraria;Sanofi: Honoraria. Tacchetti: Amgen: Honoraria;BMS/Celgene: Honoraria;Janssen: Honoraria;Takeda: Honoraria;AbbVie: Honoraria;Sanofi: Honoraria;GlaxoSmithKline: Honoraria;Oncopeptides: Honoraria. Zinzani: JANSSEN-CILAG: Other: Advisory board, Speakers Bureau;MSD: Consultancy, Other: Advisory board, Speakers Bureau;SANDOZ: Other: Advisory board;TG Therapeutics: Other: Advisory board, Speakers Bureau;GILEAD: Other: Advisory board, Speakers Bureau;SERVIER: Other: Advisory board, Speakers Bureau;BMS: Other: Advisory board, Speakers Bureau;CELLTRION: Other: Advisory board, Speakers Bureau;TAKEDA: Other: Advisory board, Speakers Bureau;ROCHE: Other, Speakers Bureau;EUSAPHARMA: Consultancy, Other, Speakers Bureau;KYOWA KIRIN: Other, Speakers Bureau;Incyte: Other, Speakers Bureau;NOVARTIS: Consultancy, Other, Speakers Bureau;ADC Therap.: Other;Beigene: Other, Speakers Bureau;VERASTEM: Consultancy, Other: Advisory board, Speakers Bureau. Cavo: Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau;Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel Accommodations, Speakers Bureau;AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees;Adaptive Biotechnologies: Consultancy, Honoraria;Novartis: Honoraria;Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: TRAVEL, ACCOMMODATIONS, EXPENSES, Speakers Bureau;Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau;GlaxoSmithKline: Consultancy, Honoraria;Sanofi: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau;Bristol-Myers Squib: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau.

2.
Allergy: European Journal of Allergy and Clinical Immunology ; 76(SUPPL 110):468-469, 2021.
Article in English | EMBASE | ID: covidwho-1570395

ABSTRACT

In 2012 a 25-year-old man presented to our outpatient clinic for severe atopic dermatitis (AD) and severe allergic eosinophilic asthma in polisensitivity (house dust mite, cat, gramineous plants, birch, milk protein and, in particular, Alternaria). His clinical history was also characterized by gastro-esophageal reflux disease and chronic rhinitis without polyposis, with septal deviation and turbinate hypertrophy, worthy of surgical intervention. History taking revealed egg and cow milk protein allergy and severe asthma since the first months of life, with frequent hospital admissions due to exacerbations. AD was severe and diffuse, involving especially face, neck, back and superior limbs, often complicated by impetigo. The esthetic, social and psychological impact led him to quit his job as a barman. At presentation, the Eczema Area and Severity Index (EASI) score was 72/72. Laboratory tests showed eosinophilic count ranging between 1.060 and 2.140/mm3, and high serum levels of total Immunoglobulin E (5.939 kUI/L). Tryptase levels were normal and autoantibody analysis was negative. Parasite stool examination was negative. Nasal swab tested positive for Staphylococcus aureus, which was treated with Sulfamethoxazole-Trimethoprim. Asthma Control Test was 15/25, pulmonary function tests (PFTs) showed mild obstruction (FEV1 4.43 L, 103%, FEV1/FVC 69%), with positive bronchodilator testing (FEV1 5.12 L, + 670 mL, + 16%). Firstly, he was treated with topical steroids and sometimes with oral corticosteroids, with poor response. Then, in July 2019, he initiated therapy with cyclosporine 3-5 mg/kg. Soon, the drug had to be discontinued due to adverse effects (gastrointestinal symptoms and infections). In November 2019, at the age of 32 years, he started therapy with monoclonal antibody anti-IL-5 receptor alpha (benralizumab 30 mg 1 subcutaneous vial every 4 weeks for the first three administrations and then every 8 weeks), with a terrific clinical improvement of AD since the first administrations and with benefit on asthma control (ACT after the first administration increased up to 25/25;PFTs could not be performed, due to SARS-CoV-2 pandemic). This therapy has always been well tolerated. The eosinophilic count decreased to 0/mm3 after the first administration. At the moment, after one year of therapy, AD is almost fully disappeared (EASI SCORE 4/72), despite being in free diet, and the quality of life of the patient has definitely improved.

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