The immunosuppressive role of the underlying plasma cell clone in patients with AL amyloidosis (although tumor burden is low) is critical and these results are not significantly different from data in patients with myeloma (published from our group3 and others7)
The immunosuppressive role of the underlying plasma cell clone in patients with AL amyloidosis (although tumor burden is low) is critical and these results are not significantly different from data in patients with myeloma (published from our group3 and others7). individuals with plasma cell malignancies or additional B-cell lymphoproliferative disorders.3,4 In individuals with ATTR such a clone does not exist, but other factors could affect response to vaccination. Since it is definitely clinically relevant to evaluate the effectiveness of anti-SARS-CoV-2 vaccination in individuals with AL and ATTR amyloidosis, to optimize strategies for the immunization of this vulnerable patient populace, we measured the titers of neutralizing antibodies (NAbs) against SARS-CoV-2 after the 1st dose of the BNT162b2 and AZD1222 vaccines. This statement is definitely part of larger prospective study (“type”:”clinical-trial”,”attrs”:”text”:”NCT04743388″,”term_id”:”NCT04743388″NCT04743388) for the kinetics of anti-SARS-CoV-2 antibodies after COVID-19 vaccination. The major inclusion criteria for this analysis include: (1) a prior analysis of AL or ATTR amyloidosis; (2) eligibility for vaccination. Like a control group we used volunteers matched for age, gender (1:3) who experienced (1) no autoimmune or active malignant disease; (2) no HIV or active hepatitis B and C illness. Serum was separated within 4 CYC116 (CYC-116) hours from blood collection and stored at ?80C until the day of measurement on (1) day time 1 (D1; before the first dose of BNT162b2 or AZD1222) and (2) day time 22 (D22; before the second dose of the BNT162b2 or 3 weeks after the first dose of AZD1222). NAbs against SARS-CoV-2 were measured using FDA-approved strategy (ELISA, cPass SARS-CoV-2 NAbs Detection Kit; GenScript, Piscataway, NJ).5 The study was approved by the respective Ethical Committees in accordance with CYC116 (CYC-116) the Declaration of Helsinki and all patients and controls offered written informed consent before enrollment. Our study included 59 individuals with CYC116 (CYC-116) AL amyloidosis (34 males/25 females; median age: 62, interquartile range [IQR]: 57C72 years) and 118 settings (68 males/50 females; median age: 62, IQR: 57C72 years), who have been vaccinated during the same period, at Alexandra Hospital, Athens, Greece. The individuals adopted a centrally controlled vaccination program run from the Greek healthcare government bodies that prioritized healthcare workers, the elderly and CYC116 (CYC-116) individuals with malignancies for anti-SARS-CoV-2 vaccination (with either BNT162b2 or AZD1222). The proportion of the different vaccines was related in individual and control organizations (78% experienced BNT162b2 and 22% experienced AZD1222, respectively). At the time of vaccination, 31/59 (53%) individuals were receiving anti-clonal therapy. Table ?Table11 shows the other characteristics of the individuals. Table 1. Characteristics of the Individuals With AL Amyloidosis WHO HAVE BEEN Included in the Analysis. Male/woman34 (58%)/25 IL2R (42%)Age, median (range)62 (35C86)BNT162b246(78%)AZD122213 (22%)Renal involvement41 (69%)Heart involvement38 (64%)Liver involvement7 (12%)PNS/ANS involvement11(19%)Mayo stage 1/2/322%/51% /27%Bone marrow plasma cells at analysis10% (0C30%)eGFR (mL/min/1.73 m2)77 (9C 150)On active treatment at the time of vaccination31 (53%)Therapies (previous/current)Bortezomib or Ixazomib41 (69%)/13 (22%)Daratumumab16 (27%)/11 (19%)Lenalidomide6(10%)/3 (9%)Cyclophsophamide37 (63%)/13 (22%)Previous ASCT4 (7%)Disease in hematologic remission (CR or VGPR)44 (75%) Open in a separate window ANS = autonomic nervous system; AL = immunoglobulin light chain; ASCT = autologous stem cell transplantation; CR = total response; eGFR = estimated glomerular filtration rate; PNS = peripheral nervous system; VGPR = very good partial response. At baseline, before the 1st vaccine shot (ie, on D1), only 5 (8%) individuals and 14 (12%) settings experienced NAb titers of 30% (positivity cutoff) and there was no significant difference of the NAb titers between individuals and settings (median 11.95% versus 15.2%, = 0.831). Four individuals with AL experienced baseline NAb titers above 50%, of which only 2 reported a history of COVID-19 illness. On day time 22 after the 1st dose, there was a significant increase in the levels of NAbs in settings (combined t-test, 0.001) as well as in those with AL amyloidosis (paired t-test, = 0.0027); however, the median NAb titers CYC116 (CYC-116) for AL individuals was 22.9% (range 0.5%C97.98%) compared.