Evidence map›Paper›PMID 34781162›Full record

Observational studyJournal of autoimmunity2021

Impaired immunogenicity to COVID-19 vaccines in autoimmune systemic diseases. High prevalence of non-response in different patients' subgroups.

Clodoveo Ferri, Francesco Ursini, Laura Gragnani, Vincenzo Raimondo, Dilia Giuggioli, Rosario Foti, Maurizio Caminiti, Domenico Olivo, Giovanna Cuomo, Marcella Visentini and 38 more

Open access · greenAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Journal of autoimmunity, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 74 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 2 pooled it
17.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

74 citing papers in PubMed, 2 syntheses or guidelines pooled it, 121 citations in OpenAlex.

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14 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

48 authors at 17 institutions in 3 countries.

Clodoveo FerriRheumatology Unit, University of Modena and Reggio Emilia, School of Medicine, Modena, Italy; Rheumatology Clinic 'Madonna Dello Scoglio' Cotronei, Crotone, Italy. Electronic address: clferri@unimore.it.
Francesco UrsiniRheumatology Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
Laura GragnaniMASVE Interdepartmental Hepatology Center, Department of Experimental and Clinical Medicine, University of Florence Center, Center for Research and Innovation CRIA-MASVE, Firenze, Italy.
Vincenzo RaimondoRheumatology Clinic 'Madonna Dello Scoglio' Cotronei, Crotone, Italy.
Dilia GiuggioliRheumatology Unit, University of Modena and Reggio Emilia, School of Medicine, Modena, Italy.
Rosario FotiRheumatology Unit AOU Policlinico G. Rodolico - S. Marco, Catania. Italy.
Maurizio CaminitiUOD Reumatologia- Grande Ospedale Metropolitano, Reggio Calabria, Italy.
Domenico OlivoRheumatology Outpatient Clinic, San Giovanni di Dio Hospital, Crotone, Italy.
Giovanna CuomoUniversity of Campania Luigi Vanvitelli, Department of Precision Medicine, Napoli, Italy.
Marcella VisentiniDepartment of Translational and Precision Medicine, Sapienza University of Rome, Rome, Italy.
Fabio CacciapagliaUO Reumatologia - DETO, Università di Bari, Bari, Italy.
Roberta PellegriniU.O.C. Medicina Interna "M.Valentini" P.O. Annunziata, Cosenza, Italy.
Erika PigattoOspedale "Villa Salus", Mestre, Italy.
Teresa UrraroRheumatology Unit, "M. Scarlato" Hospital, Scafati, SA, Italy.
Caterina NaclerioRheumatology Unit, "M. Scarlato" Hospital, Scafati, SA, Italy.
Antonio TavoniClinical Immunology, University of Pisa, Pisa, Italy.
Lorenzo PuccettiClinical Immunology, University of Pisa, Pisa, Italy.
Giuseppe VarcasiaU.O.S. Reumatologia, Ospedale Castrovillari, Cosenza, Italy.
Ilaria CavazzanaRheumatology, Spedali Civili di Brescia, Brescia, Italy.
Massimo L'AndolinaRheumatology Outpatient Clinic, ASP- Vibo Valentia-Tropea Hospital, Italy.
Piero RuscittiRheumatology Unit, Department of Biotechnological & Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
Marta VadaccaUnità Operativa di Immunoreumatologia-Area Medicina Clinica Policlinico Universitario Campus Bio-Medico di Roma, Roma, Italy.
Pietro GigliottiU.O.T. Specialistica Ambulatoriale, ASP 201, Cosenza, Italy.
Francesca La GualanaDepartment of Translational and Precision Medicine, Sapienza University of Rome, Rome, Italy.
Franco CozziOspedale "Villa Salus", Mestre, Italy.
Amelia SpinellaRheumatology Unit, University of Modena and Reggio Emilia, School of Medicine, Modena, Italy.
Elisa VisalliRheumatology Unit AOU Policlinico G. Rodolico - S. Marco, Catania. Italy.
Ylenia Dal BoscoRheumatology Unit AOU Policlinico G. Rodolico - S. Marco, Catania. Italy.
Giorgio AmatoRheumatology Unit AOU Policlinico G. Rodolico - S. Marco, Catania. Italy.
Francesco MasiniUniversity of Campania Luigi Vanvitelli, Department of Precision Medicine, Napoli, Italy.
Giuseppa Pagano MarianoUOD Reumatologia- Grande Ospedale Metropolitano, Reggio Calabria, Italy.
Raffaele BrittelliRheumatology Clinic 'Madonna Dello Scoglio' Cotronei, Crotone, Italy.
Vincenzo AielloRheumatology Clinic 'Madonna Dello Scoglio' Cotronei, Crotone, Italy.
Rodolfo CaminitiRheumatology Clinic 'Madonna Dello Scoglio' Cotronei, Crotone, Italy.
Daniela ScorpinitiRheumatology Clinic 'Madonna Dello Scoglio' Cotronei, Crotone, Italy.
Giovanni RechichiRheumatology Clinic 'Madonna Dello Scoglio' Cotronei, Crotone, Italy.
Tommaso FerrariU.O.S. Reumatologia, Ospedale Castrovillari, Cosenza, Italy.
Monica MontiMASVE Interdepartmental Hepatology Center, Department of Experimental and Clinical Medicine, University of Florence Center, Center for Research and Innovation CRIA-MASVE, Firenze, Italy.
Giusy EliaDepartment of Surgical, Medical and Molecular Pathology and Critical Area, University of Pisa, School of Medicine, Pisa, Italy.
Franco FranceschiniRheumatology, Spedali Civili di Brescia, Brescia, Italy.
Riccardo MeliconiRheumatology Unit, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy.
Milvia CasatoDepartment of Translational and Precision Medicine, Sapienza University of Rome, Rome, Italy.
Florenzo IannoneUO Reumatologia - DETO, Università di Bari, Bari, Italy.
Roberto GiacomelliUnità Operativa di Immunoreumatologia-Area Medicina Clinica Policlinico Universitario Campus Bio-Medico di Roma, Roma, Italy.
Poupak FallahiDepartment of Translational Research & New Technologies in Medicine and Surgery, University of Pisa, School of Medicine, Pisa, Italy.
Stefano Angelo SantiniDepartment of Basic, Clinical, Intensive and Perioperative Biotechnological Sciences, Catholic University School of Medicine, Rome, Italy; Synlab Italia, Monza, MB, Italy.
Anna Linda ZignegoMASVE Interdepartmental Hepatology Center, Department of Experimental and Clinical Medicine, University of Florence Center, Center for Research and Innovation CRIA-MASVE, Firenze, Italy.
Alessandro AntonelliDepartment of Surgical, Medical and Molecular Pathology and Critical Area, University of Pisa, School of Medicine, Pisa, Italy.
University of Pisa · ITPoliclinico Universitario di Catania · ITOspedale Maggiore · ITSapienza University of Rome · ITUniversity of Florence · ITUniversity of Modena and Reggio Emilia · ITAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · ITCampus Bio Medico University Hospital · ITIstituto Ortopedico Rizzoli · ITUniversity of Bari Aldo Moro · ITUniversity of Campania "Luigi Vanvitelli" · ITAzienda Ospedaliera di Cosenza · ITHospital Base · CLI.R.C.C.S. Oasi Maria SS · ITNuovo Ospedale San Giovanni di Dio · ITUniversità Cattolica del Sacro Cuore · ITUniversity of L'Aquila · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Autoimmune systemic diseases (ASD) may show impaired immunogenicity to COVID-19 vaccines. Our prospective observational multicenter study aimed to evaluate the seroconversion after the vaccination cycle and at 6-12-month follow-up, as well the safety and efficacy of vaccines in preventing COVID-19. The study included 478 unselected ASD patients (mean age 59 ± 15 years), namely 101 rheumatoid arthritis (RA), 38 systemic lupus erythematosus (SLE), 265 systemic sclerosis (SSc), 61 cryoglobulinemic vasculitis (CV), and a miscellanea of 13 systemic vasculitis. The control group included 502 individuals from the general population (mean age 59 ± 14SD years). The immunogenicity of mRNA COVID-19 vaccines (BNT162b2 and mRNA-1273) was evaluated by measuring serum IgG-neutralizing antibody (NAb) (SARS-CoV-2 IgG II Quant antibody test kit; Abbott Laboratories, Chicago, IL) on samples obtained within 3 weeks after vaccination cycle. The short-term results of our prospective study revealed significantly lower NAb levels in ASD series compared to controls [286 (53-1203) vs 825 (451-1542) BAU/mL, p < 0.0001], as well as between single ASD subgroups and controls. More interestingly, higher percentage of non-responders to vaccine was recorded in ASD patients compared to controls [13.2% (63/478), vs 2.8% (14/502); p < 0.0001]. Increased prevalence of non-response to vaccine was also observed in different ASD subgroups, in patients with ASD-related interstitial lung disease (p = 0.009), and in those treated with glucocorticoids (p = 0.002), mycophenolate-mofetil (p < 0.0001), or rituximab (p < 0.0001). Comparable percentages of vaccine-related adverse effects were recorded among responder and non-responder ASD patients. Patients with weak/absent seroconversion, believed to be immune to SARS-CoV-2 infection, are at high risk to develop COVID-19. Early determination of serum NAb after vaccination cycle may allow to identify three main groups of ASD patients: responders, subjects with suboptimal response, non-responders. Patients with suboptimal response should be prioritized for a booster-dose of vaccine, while a different type of vaccine could be administered to non-responder individuals.

Indexed as

2019-nCoV Vaccine mRNA-1273Antibodies, NeutralizingAntibodies, ViralAutoimmune DiseasesBNT162 VaccineCOVID-19FemaleHumansItalyLupus Erythematosus, SystemicMaleMiddle AgedProspective StudiesSARS-CoV-2Scleroderma, SystemicSystemic Vasculitis2019-nCoV Vaccine mRNA-1273Antibodies, NeutralizingAntibodies, ViralBNT162 VaccineAutoimmune systemic diseasesCOVID-19 vaccineCryoglobulinemic vasculitisNeutralizing antibodiesRheumatoid arthritisSystemic lupusSystemic sclerosisSystemic vasculitis

Identifiers

PMID34781162
PMCPMC8577991
OpenAlexW3212266659

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.