SANDRA GOFINET PASOTO

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Instituto Central, Hospital das Clínicas, Faculdade de Medicina - Médico
LIM/17 - Laboratório de Investigação em Reumatologia, Hospital das Clínicas, Faculdade de Medicina
LIM/03 - Laboratório de Medicina Laboratorial, Hospital das Clínicas, Faculdade de Medicina

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Assunto: COVID-19 ×

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  • article 13 Citação(ões) na Scopus
    Strong response after fourth dose of mRNA COVID-19 vaccine in autoimmune rheumatic diseases patients with poor response to inactivated vaccine
    (2022) AIKAWA, Nadia E.; KUPA, Leonard V. K.; SILVA, Clovis A.; SAAD, Carla G. S.; PASOTO, Sandra G.; YUKI, Emily F. N.; FUSCO, Solange R. G.; SHINJO, Samuel K.; ANDRADE, Danieli C. O.; SAMPAIO-BARROS, Percival D.; PEREIRA, Rosa M. R.; CHASIN, Anna C. S.; SHIMABUCO, Andrea Y.; LUPPINO-ASSAD, Ana P.; LEON, Elaine P.; LOPES, Marta H.; ANTONANGELO, Leila; MEDEIROS-RIBEIRO, Ana C.; BONFA, Eloisa
    Objectives. To assess immunogenicity of a heterologous fourth dose of an mRNA (BNT162b2) severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine in autoimmune rheumatic diseases (ARD) patients with poor/non-response to inactivated vaccine (Sinovac-CoronaVac). Methods. A total of 164 ARD patients who were coronavirus disease 2019 (COVID-19) poor/non-responders (negative anti-SARS-CoV-2 S1/S2 IgG and/or neutralizing antibodies-NAb) to the third dose of Sinovac-CoronaVac received an additional heterologous dose of mRNA (BNT162b2) 3 months after last dose. IgG and NAb were evaluated before and after the fourth dose. Results. Significant increases were observed after the fourth dose in IgG (66.4 vs 95.1%, P < 0.001), NAb positivity (5.5 vs 83.5%, P < 0.001) and geometric mean titre (29.5 vs 215.8 AU/ml, P < 0.001), and 28 (17.1%) remained poor/non-responders. Patients with negative IgG after a fourth dose were more frequently under rituximab (P = 0 .001) . Negative NAb was associated with older age (P = 0.015), RA (P = 0 .002) , SSc (P = 0 .026) , LEF (P = 0 .01 6) and rituximab use (P = 0.007) . In multiple logistic regression analysis, prednisone dose >= 7.5 mg/day (OR =0.34; P = 0.047) , LEF (OR =0.32, P = 0.036) and rituximab use (OR =0.19, P = 0.022) were independently associated with negative NAb after the fourth vaccine dose. Conclusions. This is the largest study to provide evidence of a remarkable humoral response after the fourth dose of heterologous mRNA SARS-CoV-2 vaccination in ARD patients with poor/non-response to the third dose of an inactivated vaccine. We further identified that treatment, particularly rituximab and prednisone, impaired antibody response to this additional dose.
  • article 4 Citação(ões) na Scopus
    Physical activity and antibody persistence 6 months after the second dose of CoronaVac in immunocompromised patients
    (2022) GUALANO, Bruno; LEMES, Italo Ribeiro; SILVA, Rafael Pires da; PINTO, Ana Jessica; MAZZOLANI, Bruna Caruso; SMAIRA, Fabiana Infante; SIECZKOWSKA, Sofia Mendes; AIKAWA, Nadia Emi; PASOTO, Sandra; MEDEIROS-RIBEIRO, Ana Cristina; SAAD, Carla; YUK, Emily; SILVA, Clovis; SWINTON, Paul; HALLAL, Pedro Curi; ROSCHEL, Hamilton; BONFA, Eloisa
    This prospective cohort study within an open-label, single-arm, phase 4 vaccination trial ( #NCT04754698) aimed to investigate the association between physical activity and persistent anti-SARS-CoV-2 antibodies 6 months after two-dose schedule of CoronaVac in autoimmune rheumatic diseases (ARD) patients (n = 748). Persistent immunogenicity 6 months after the full-course vaccination was assessed using seroconversion rates of total anti-SARS-CoV-2 S1/S2 IgG, geometric mean titers of anti-S1/S2 IgG (GMT), and frequency of positive neutralizing antibodies (NAb). Physical activity was assessed trough questionnaire. Adjusted point estimates from logistic regression models indicated that physically active patients had greater odds of seroconversion rates (OR: 1.5 [95%CI: 1.1 to 2.1]) and NAb positivity (OR: 1.5 [95%CI: 1.0 to 2.1]), and approximately 43% greater GMT (42.8% [95%CI: 11.9 to 82.2]) than inactive ones. In conclusion, among immunocompromised patients, being physically active was associated with an increment in antibody persistence through 6 months after a full-course of an inactivated SARS-CoV-2 vaccine.
  • article 0 Citação(ões) na Scopus
    No Associations Between Physical Activity and Immunogenicity in SARS-CoV-2 Seropositive Patients With Autoimmune Rheumatic Diseases Prior to and After Vaccination
    (2023) SMAIRA, Fabiana Infante; MAZZOLANI, Bruna Caruso; LEMES, italo Ribeiro; SILVA, Rafael Pires da; PINTO, Ana J.; SIECZKOWSKA, Sofia M.; AIKAWA, Nadia E.; PASOTO, Sandra G.; MEDEIROS-RIBEIRO, Ana C.; SAAD, Carla G. S.; YUK, Emily F. N.; SILVA, Clovis A.; SWINTON, Paul; KUPA, Leonard de Vinci Kanda; HALLAL, Pedro C.; ROSCHEL, Hamilton; GUALANO, Bruno; BONFA, Eloisa
    Aim: To investigate the association between physical activity and immunogenicity among SARS-CoV-2 seropositive patients with autoimmune rheumatic diseases prior to and following a 2-dose schedule of CoronaVac (Sinovac inactivated vaccine). Methods: This was a prospective cohort study within an open-label, single-arm, phase 4 vaccination trial conducted in Sao Paulo, Brazil. In this substudy, only SARS-CoV-2 seropositive patients were included. Immunogenicity was assessed by seroconversion rates of total anti-SARS-CoV-2 S1/S2 immunoglobulin G (IgG), geometric mean titers of anti-S1/S2 IgG, frequency of positive neutralizing antibodies, and neutralizing activity before and after vaccination. Physical activity was assessed through a questionnaire. Model-based analyses were performed controlling for age (<60 or>_60 y), sex, body mass index (<25, 25-30, and >30 kg/m2), and use of prednisone, immunosuppressants, and biologics. Results: A total of 180 seropositive autoimmune rheumatic disease patients were included. There was no association between physical activity and immunogenicity before and after vaccination. Conclusions: This study suggests that the positive association between physical activity and greater antibody responses seen in immunocompromised individuals following vaccination is overridden by previous SARS-CoV-2 infection, and does not extend to natural immunity.
  • article 12 Citação(ões) na Scopus
    Systemic autoimmune myopathies: a prospective phase 4 controlled trial of an inactivated virus vaccine against SARS-CoV-2
    (2022) SHINJO, Samuel K.; SOUZA, Fernando H. C. de; BORGES, Isabela B. P.; SANTOS, Alexandre M. Dos; MIOSSI, Renata; MISSE, Rafael G.; MEDEIROS-RIBEIRO, Ana C.; SAAD, Carla G. S.; YUKI, Emily F. N.; PASOTO, Sandra G.; KUPA, Leonard V. K.; CENEVIVA, Carina; SERAPHIM, Julia C.; PEDROSA, Tatiana N.; VENDRAMINI, Margarete B. G.; SILVA, Clovis A.; AIKAWA, Nadia E.; BONFA, Eloisa
    Objectives. To evaluate immunogenicity and safety of an inactivated SARS-CoV-2 vaccine in systemic autoimmune myopathies (SAMs) and the possible influence of baseline disease parameters, comorbidities and therapy on immune response. Methods. This prospective controlled study included 53 patients with SAMs and 106 non-immunocompromised control group (CTRL). All participants received two doses of the Sinovac-CoronaVac vaccine (28-day interval). Immunogenicity was assessed by anti-SARS-CoV-2 S1/S2 IgG seroconversion (SC), anti-S1/S2 IgG geometric mean titre (GMT), factor increase GMT (FI-GMT), neutralizing antibodies (NAb) positivity, and median neutralizing activity after each vaccine dose (D0 and D28) and six weeks after the second dose (D69). Participants with pre-vaccination positive IgG serology and/or NAb and those with RT-PCR confirmed COVID-19 during the protocol were excluded from immunogenicity analysis. Results. Patients and CTRL had comparable sex (P>0.99) and age (P=0.90). Immunogenicity of 37 patients and 79 CTRL-naive participants revealed at D69, a moderate but significantly lower SC (64.9% vs 91.1%, P<0.001), GMT [7.9 (95%CI 4.7-13.2) vs 24.7 (95%CI 30.0-30.5) UA/ml, P<0.001] and frequency of NAb (51.4% vs 77.2%, P<0.001) in SAMs compared with CTRL. Median neutralizing activity was comparable in both groups [57.2% (interquartile range (IQR) 43.4-83.4) vs 63.0% (IQR 40.3-80.7), P=0.808]. Immunosuppressives were less frequently used among NAb+ patients vs NAb- patients (73.7% vs 100%, P=0.046). Type of SAMs, disease status, other drugs or comorbidities did not influence immunogenicity. Vaccine-related adverse events were mild with similar frequencies in patients and CTRL (P>0.05). Conclusion. Sinovac-CoronaVac is safe and has a moderate short-term immunogenicity in SAMs, but reduced compared with CTRL. We further identified that immunosuppression is associated with diminished NAb positivity.
  • article 31 Citação(ões) na Scopus
    Increment of immunogenicity after third dose of a homologous inactivated SARS-CoV-2 vaccine in a large population of patients with autoimmune rheumatic diseases
    (2022) AIKAWA, Nadia Emi; KUPA, Leonard de Vinci Kanda; MEDEIROS-RIBEIRO, Ana Cristina; SAAD, Carla Goncalves Schahin; YUKI, Emily Figueiredo Neves; PASOTO, Sandra Gofinet; ROJO, Priscila Tagliaferro; PEREIRA, Rosa Maria Rodrigues; SHINJO, Samuel Katsuyuki; SAMPAIO-BARROS, Percival Degrava; ANDRADE, Danieli Castro Oliveira; HALPERN, Ari Stiel Radu; FULLER, Ricardo; SOUZA, Fernando Henrique Carlos; GUEDES, Lissiane Karine Noronha; ASSAD, Ana Paula Luppino; MORAES, Julio Cesar Bertacini de; LOPES, Michelle Remiao Ugolini; MARTINS, Victor Adriano de Oliveira; BETANCOURT, Lorena; RIBEIRO, Carolina Torres; SALES, Lucas Peixoto; BERTOGLIO, Isabela Maria; BONOLDI, Virginia Lucia Nazario; MELLO, Renata Lys Pinheiro; BALBI, Gustavo Guimaraes Moreira; SARTORI, Ana Marli Christovam; ANTONANGELO, Leila; SILVA, Clovis Artur; BONFA, Eloisa
    Objective To determine the immunogenicity of the third dose of CoronaVac vaccine in a large population of patients with autoimmune rheumatic diseases (ARD) and the factors associated with impaired response. Methods Adult patients with ARD and age-balanced/sex-balanced controls (control group, CG) previously vaccinated with two doses of CoronaVac received the third dose at D210 (6 months after the second dose). The presence of anti-SARS-CoV-2 S1/S2 IgG and neutralising antibodies (NAb) was evaluated previously to vaccination (D210) and 30 days later (D240). Patients with controlled disease suspended mycophenolate mofetil (MMF) for 7 days or methotrexate (MTX) for 2 weekly doses after vaccination. Results ARD (n=597) and CG (n=199) had comparable age (p=0.943). Anti-S1/S2 IgG seropositivity rates significantly increased from D210 (60%) to D240 (93%) (p<0.0001) in patients with ARD. NAb positivity also increased: 38% (D210) vs 81.4% (D240) (p<0.0001). The same pattern was observed for CG, with significantly higher frequencies for both parameters at D240 (p<0.05). Multivariate logistic regression analyses in the ARD group revealed that older age (OR=0.98, 95% CI 0.96 to 1.0, p=0.024), vasculitis diagnosis (OR=0.24, 95% CI 0.11 to 0.53, p<0.001), prednisone >= 5 mg/day (OR=0.46, 95% CI 0.27 to 0.77, p=0.003), MMF (OR=0.30, 95% CI 0.15 to 0.61, p<0.001) and biologics (OR=0.27, 95% CI 0.16 to 0.46, p<0.001) were associated with reduced anti-S1/S2 IgG positivity. Similar analyses demonstrated that prednisone >= 5 mg/day (OR=0.63, 95% CI 0.44 to 0.90, p=0.011), abatacept (OR=0.39, 95% CI 0.20 to 0.74, p=0.004), belimumab (OR=0.29, 95% CI 0.13 to 0.67, p=0.004) and rituximab (OR=0.11, 95% CI 0.04 to 0.30, p<0.001) were negatively associated with NAb positivity. Further evaluation of COVID-19 seronegative ARD at D210 demonstrated prominent increases in positivity rates at D240 for anti-S1/S2 IgG (80.5%) and NAb (59.1%) (p<0.0001). Conclusions We provide novel data on a robust response to the third dose of CoronaVac in patients with ARD, even in those with prevaccination COVID-19 seronegative status. Drugs implicated in reducing immunogenicity after the regular two-dose regimen were associated with non-responsiveness after the third dose, except for MTX.
  • article 12 Citação(ões) na Scopus
    Immunogenicity, safety, and antiphospholipid antibodies after SARS-CoV-2 vaccine in patients with primary antiphospholipid syndrome
    (2022) SIGNORELLI, Flavio; BALBI, Gustavo Guimaraes Moreira; AIKAWA, Nadia E.; SILVA, Clovis A.; KUPA, Leonard de Vinci Kanda; MEDEIROS-RIBEIRO, Ana C.; YUKI, Emily F. N.; PASOTO, Sandra G.; SAAD, Carla G. S.; BORBA, Eduardo F.; SEGURO, Luciana Parente Costa; PEDROSA, Tatiana; OLIVEIRA, Vitor Antonio de Angeli; COSTA, Ana Luisa Cerqueira de Sant'Ana; RIBEIRO, Carolina T.; SANTOS, Roseli Eliana Beseggio; ANDRADE, Danieli Castro Oliveira; BONFA, Eloisa
    Objective Coronavirus disease 19 (COVID-19) has an increased risk of coagulopathy with high frequency of antiphospholipid antibodies (aPL). Recent reports of thrombosis associated with adenovirus-based vaccines raised concern that SARS-CoV-2 immunization in primary antiphospholipid syndrome (PAPS) patients may trigger clotting complications. Our objectives were to assess immunogenicity, safety, and aPL production in PAPS patients, after vaccinating with Sinovac-CoronaVac, an inactivated virus vaccine against COVID-19. Methods This prospective controlled phase-4 study of PAPS patients and a control group (CG) consisted of a two-dose Sinovac-CoronaVac (D0/D28) and blood collection before vaccination (D0), at D28 and 6 weeks after second dose (D69) for immunogenicity/aPL levels. Outcomes were seroconversion (SC) rates of anti-SARS-CoV-2 S1/S2 IgG and/or neutralizing antibodies (NAb) at D28/D69 in naive participants. Safety and aPL production were also assessed. Results We included 44 PAPS patients (31 naive) and 132 CG (108 naive) with comparable age (p=0.982) and sex (p>0.999). At D69, both groups had high and comparable SC (83.9% vs. 93.5%, p=0.092), as well as NAb positivity (77.4% vs. 78.7%, p=0.440), and NAb-activity (64.3% vs. 60.9%, p=0.689). Thrombotic events up to 6 months or other moderate/severe side effects were not observed. PAPS patients remained with stable aPL levels throughout the study at D0 vs. D28 vs. D69: anticardiolipin (aCL) IgG (p=0.058) and IgM (p=0.091); anti-beta-2 glycoprotein I (a beta 2GPI) IgG (p=0.513) and IgM (p=0.468). Conclusion We provided novel evidence that Sinovac-CoronaVac has high immunogenicity and safety profile in PAPS. Furthermore, Sinovac-CoronaVac did not trigger thrombosis nor induced changes in aPL production.
  • article 2 Citação(ões) na Scopus
    Effect of an exercise bout before the booster dose of an inactivated SARS-CoV-2 vaccine on immunogenicity in immunocompromised patients
    (2022) GUALANO, Bruno; SAAD, Carla G. S.; SIECZKOWSKA, Sofia M.; LEMES, Italo Ribeiro; SILVA, Rafael Pires da; PINTO, Ana J.; MAZZOLANI, Bruna C.; I, Fabiana Smaira; GIL, Saulo; OLIVEIRA-JUNIOR, Gersiel; AIKAWA, Nadia E.; MEDEIROS-RIBEIRO, Ana C.; SILVA, Clovis A.; YUKI, Emily F. N.; PASOTO, Sandra G.; PEREIRA, Rosa Maria R.; SHINJO, Samuel K.; ANDRADE, Danieli C. O.; SAMPAIO-BARROS, Percival D.; ROSCHEL, Hamilton; BONFA, Eloisa
    This randomized controlled study aimed to investigate whether a single bout of exercise before the homologous booster dose of a SARS-CoV-2 inactivated vaccine could enhance immunogenicity in patients with spondyloarthritis. We selected 60 consecutive patients with spondyloarthritis (SpA). Patients assigned to the intervention group performed an exercise bout comprising three exercises. Then, they remained at rest for 1 h before vaccination. The control group remained at rest before vaccination. Immunogenicity was assessed before (Pre) and 1 mo after (Post) the booster using seropositivity rates of total anti-SARS-CoV-2 S1/S2 IgG, geometric mean titers of anti-S1/S2 IgG (GMT), frequency of neutralizing antibodies (NAb) positivity, and NAb activity. At Pre, 16 patients from the exercise group and 16 patients from the control group exhibited seropositivity for IgG (59% vs. 57.1%), and 1 mo after the booster dose, seropositivity occurred in 96% versus 100% of the cases. Only 10 patients from the exercise group and 12 patients from the control group showed positive NAb serology at Pre (37% vs. 42.8%). One month following the booster, NAb positivity was 96% versus 93%. GMT was comparable between groups at Pre. At Post, GMT increased similarly in both groups. Likewise, NAb activity was similar between groups at Pre and increased similarly in both of them as a result of the booster (47.5% vs. 39.9%). In conclusion, a single bout of exercise did not enhance immunogenicity to a homologous booster dose of an inactivated SARS-CoV-2 vaccine among patients with spondyloarthritis. NEW & NOTEWORTHY We tested the role of exercise as an adjuvant to a booster of a COVID-19 vaccine. Immunocompromised patients were immunized after an acute bout of exercise or not. Patients exhibited an excellent immunogenicity in response to
  • article 16 Citação(ões) na Scopus
    SARS-CoV-2 infection in patients with primary Sjogren syndrome: characterization and outcomes of 51 patients
    (2021) BRITO-ZERON, Pilar; MELCHOR, Sheila; SEROR, Raphaele; PRIORI, Roberta; SOLANS, Roser; KOSTOV, Belchin; BALDINI, Chiara; CARUBBI, Francesco; CALLEJAS, Jose Luis; GUISADO-VASCO, Pablo; HERNANDEZ-MOLINA, Gabriela; PASOTO, Sandra G.; VALIM, Valeria; SISO-ALMIRALL, Antoni; MARIETTE, Xavier; CARREIRA, Patricia; RAMOS-CASALS, Manuel
    Objective. To analyse the prognosis and outcomes of SARS-CoV-2 infection in patients with primary SS. Methods. We searched for patients with primary SS presenting with SARS-CoV-2 infection (defined following and according to the European Centre for Disease Prevention and Control guidelines) among those included in the Big Data Sjogren Registry, an international, multicentre registry of patients diagnosed according to the 2002/2016 classification criteria. Results. A total of 51 patients were included in the study (46 women, mean age at diagnosis of infection of 60 years). According to the number of patients with primary SS evaluated in the Registry (n = 8211) , the estimated frequency of SARS-CoV-2 infection was 0.62% (95% CI 0.44, 0.80). All but two presented with symptoms suggestive of COVID-19, including fever (82%), cough (57%), dyspnoea (39%), fatigue/myalgias (27%) and diarrhoea (24%), and the most frequent abnormalities included raised lactate dehydrogenase (LDH) (88%), CRP (81%) and D-dimer (82%) values, and lymphopenia (70%). Infection was managed at home in 26 (51%) cases and 25 (49%) required hospitalization (five required admission to ICU, four died). Compared with patients managed at home, those requiring hospitalization had higher odds of having lymphopenia as laboratory abnormality (adjusted OR 21.22, 95% CI 2.39, 524.09). Patients with comorbidities had an older age (adjusted OR 1.05, 95% CI 1.00, 1.11) and showed a risk for hospital admission six times higher than those without (adjusted OR 6.01, 95% CI 1.72, 23.51) in the multivariate analysis. Conclusion. Baseline comorbidities were a key risk factor for a more complicated COVID-19 in patients with primary SS, with higher rates of hospitalization and poor outcomes in comparison with patients without comorbidities.
  • article 9 Citação(ões) na Scopus
    Inactivated SARS-CoV-2 vaccine in primary Sjogren's syndrome: humoral response, safety, and effects on disease activity
    (2022) PASOTO, Sandra Gofinet; HALPERN, Ari Stiel Radu; GUEDES, Lissiane Karine Noronha; RIBEIRO, Ana Cristina Medeiros; YUKI, Emily Neves Figueiredo; SAAD, Carla Goncalves Schahin; SILVA, Clovis Artur Almeida da; KUPA, Leonard de Vinci Kanda; VILLAMARIN, Lorena Elizabeth Betancourt; MARTINS, Victor Adriano de Oliveira; MARTINS, Carolina Campagnoli Machado Freire; DEVEZA, Giordano Bruno Henriques; LEON, Elaine Pires; BUENO, Cleonice; PEDROSA, Tatiana Nascimento; SANTOS, Roseli Eliana Beseggio; SOARES, Renata; AIKAWA, Nadia Emi; BONFA, Eloisa
    Introduction There is no study specifically focused on SARS-CoV-2 vaccine in primary Sjogren's syndrome (pSS). Objectives To assess the immunogenicity, safety, possible effects on disease activity, and autoantibody profile of the Sinovac-CoronaVac vaccine in pSS. Methods Fifty-one pSS patients and 102 sex- and age-balanced controls without autoimmune diseases were included in a prospective phase 4 trial of the Sinovac-CoronaVac vaccine (two doses 28 days apart, D0/D28). Participants were assessed in three face-to-face visits (D0/D28 and six weeks after the 2nd dose (D69)) regarding adverse effects; clinical EULAR Sjogren's Syndrome Disease Activity Index (clinESSDAI); anti-SARS-CoV-2 S1/S2 IgG (seroconversion (SC) and geometric mean titers (GMT)); neutralizing antibodies (NAb); and pSS autoantibody profile. Results Patients and controls had comparable female sex frequency (98.0% vs. 98.0%, p= 1.000) and mean age (53.5 +11.7 vs. 53.4 +11.4 years, p= 0.924), respectively. On D69, pSS patients presented moderate SC (67.5% vs. 93.0%, p< 0.001) and GMT (22.5 (95% CI 14.6-34.5) vs. 59.6 (95% CI 51.1-69.4) AU/mL, p< 0.001) of anti-SARS-CoV-2 S1/S2 IgG but lower than controls, and also, moderate NAb frequency (52.5% vs. 73.3%, p= 0.021) but lower than controls. Median neutralizing activity on D69 was comparable in pSS (58.6% (IQR 43.7-63.6)) and controls (64% (IQR 46.4-81.1)) (p= 0.219). Adverse events were mild. clinESSDAI and anti-Ro(SS-A)/anti-La(SS-B) levels were stable throughout the study (p> 0.05). Conclusion Sinovac-CoronaVac vaccine is safe in pSS, without a deleterious impact on disease activity, and has a moderate short-term humoral response, though lower than controls. Thus, a booster dose needs to be studied in these patients.
  • article 8 Citação(ões) na Scopus
    Interaction of TNFi and conventional synthetic DMARD in SARS-CoV-2 vaccine response in axial spondyloarthritis and psoriatic arthritis
    (2023) SAAD, Carla G. S.; SILVA, Matheus S. R.; SAMPAIO-BARROS, Percival D.; MORAES, Julio C. B.; SCHAINBERG, Claudia G.; GONCALVES, Celio R.; SHIMABUCO, Andrea Y.; AIKAWA, Nadia E.; YUKI, Emily F. N.; PASOTO, Sandra G.; KUPA, Leonard V. K.; AOYAMA, Renato K.; ARAUJO, Carlo S. R.; SILVA, Clovis A.; MEDEIROS-RIBEIRO, Ana C.; BONFA, Eloisa
    Objectives: To evaluate humoral responses to three doses of the inactivated SARS-CoV-2 vaccine (CoronaVac) in patients with spondyloarthritis (SpA) and the effect of therapy, compared with a control group (CG).Methods: Prospective cohort of axial SpA/psoriatic arthritis patients and age/sex-balanced CG from the CoronavRheum phase 4 trial (NCT04754698). CoronaVac was given in two doses (28-days interval) with a booster at day 210. Blood samples were collected in the days 0/28 (D28)/69 (D69) and 240 (D240) to evaluate anti-SARS-CoV-2 IgG seropositivity (SP) and neutralising antibodies (NAb).Results: One hundred and ninety-four SpA patients were enrolled and 183 patients were age/sex-balanced with 183 CG. At D69, SpA patients showed a high SP (80.2% vs. 95.7%, P < 0.001) and moderate NAb positivity (61.6% vs. 82.7%, P < 0.001), but lower than CG. In patients, older age prednisone (P < 0.001), methotrexate (MTX) (P < 0.001) and TNF inhibitors (TNFi) (P < 0.001) were independently associated with lower SP, while Caucasian ethnicity (P < 0.05) and prednisone (P < 0.01) were associated with diminished NAb. In contrast, sulfasalazine (SSZ) use was associated with NAb presence (P < 0.05). In monotherapy, only TNFi was also associated with absence of SP (P < 0.05). Further comparison with CG revealed that TNFi and/or MTX negatively impacted SP/NAb (P < 0.05). In contrast, patients under SSZ monotherapy achieved 100% SP (P > 0.999) and 83.3% NAb positivity (P > 0.999). SSZ + TNFi combination resulted in a similar response than CG [SP (P = 0.153) and NAb (P = 0.715)]. After third dose (D69-D240), a major increment occurred for SP (81.3% to 93.1%, P < 0.001) and NAb (63.2% to 86.1%, P < 0.001), but still lower than CG (P < 0.05), and only TNFi impaired both SP (P = 0.016)/NAb (P = 0.002).Conclusions: We provided novel data demonstrating that TNFi attenuates immunogenicity in SpA patients while SSZ has a positive impact on vaccine antibody production. We also confirmed that MTX in combination with TNFi had a major negative impact in vaccine humoral response (CoronavRheum clinicaltrials.gov #NCT04754698).(c) 2022 Socie acute accent te acute accent franc , aise de rhumatologie.