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  • article 3 Citação(ões) na Scopus
    Influenza A/Singapore (H3N2) component vaccine in systemic lupus erythematosus: A distinct pattern of immunogenicity
    (2021) FORMIGA, Francisco Fellipe Claudino; SILVA, Clovis Artur; PEDROSA, Tatiana do Nascimento; AIKAWA, Nadia Emi; PASOTO, Sandra Gofinet; GARCIA, Cristiana Couto; CAPAO, Artur Silva Vidal; MARTINS, Victor Adriano de Oliveira; PROENCA, Adriana Coracini Tonacio de; FULLER, Ricardo; YUKI, Emily Figueiredo Neves; VENDRAMINI, Margarete Borges Galhardo; ROSARIO, Debora Cordeiro do; BRANDAO, Leticia Maria Kolachinski Raposo; SARTORI, Ana Marli Christovam; ANTONANGELO, Leila; BONFA, Eloisa; BORBA, Eduardo Ferreira
    Introduction Influenza A (H3N2) virus is the most important cause of seasonal influenza morbidity and mortality in the last 50 years, surpassing the impact of H1N1. Data assessing immunogenicity and safety of this virus component are lacking in systemic lupus erythematosus (SLE) and restricted to small reports with other H3N2 strains. Objective This study aims to evaluate short-term immunogenicity and safety of influenza A/Singapore (H3N2) vaccine in SLE. Methods 81 consecutive SLE patients and 81 age- and sex-matched healthy controls (HC) were vaccinated with the influenza A/Singapore/INFIMH-16-0019/2016(H3N2)-like virus. Seroprotection (SP) and seroconversion (SC) rates, geometric mean titers(GMT), and factor increase in GMT(FI-GMT) and adverse events were assessed before and 4 weeks post-vaccination. Disease activity and therapies were also evaluated. Results Before immunization, SLE and HC groups had high SP rates (89% vs 77%, p = 0.061) and elevated GMT titer with higher levels in SLE (129.1(104.1-154.1) vs 54.8(45.0-64.6), p < 0.001). Frequency of two previous years' influenza vaccination was high and comparable in SLE and HC (89% vs 90%, p = 1.000). Four weeks post-vaccination, median GMT increased for both groups and remained higher in SLE compared to HC (239.9(189.5-290.4) vs 94.5(72.6-116.4), p < 0.0001) with a comparable FI-GMT (2.3(1.8-2.9) vs 1.9(1.5-2.3), p = 0.051). SC rates were low and comparable for both groups (16% vs 11%, respectively, p = 0.974). Disease activity scores remained stable throughout the study (p = 1.000) and severe adverse events were not identified. Conclusion Influenza A/Singapore (H3N2) vaccine has an adequate safety profile. The distinct immunogenicity pattern from other influenza A components characterized by a remarkably high pre- and post-vaccination SP rate and high GMT levels may be associated with previous influenza A vaccination. (, NCT03540823).
  • conferenceObject
    Immunogenicity and Safety of an Inactivated Virus Vaccine Against SARS-CoV-2 in Patients with Autoimmune Rheumatic Diseases
    (2021) MEDEIROS-RIBEIRO, Ana; AIKAWA, Nadia; SAAD, Carla Goncalves Schahin; YUKI, Emily Figueiredo Vieira Neves; PEDROSA, Tatiana do Nascimento; FUSCO, Solange; ROJO, Priscila; PEREIRA, Rosa; SHINJO, Samuel; ANDRADE, Danieli; SAMPAIO-BARROS, Percival; RIBEIRO, Carolina; DEVEZA, Giordano; MARTINS, Victor Adriano de Oliveira; SILVA, Clovis Artur; LOPES, Marta; DUARTE, Alberto; ANTONANGELO, Leila; SABINO, Ester; KALLAS, Esper; PASOTO, Sandra Gofinet; BONFA, Eloisa
  • article 6 Citação(ões) na Scopus
    Hydroxychloroquine blood levels in stable lupus nephritis under low dose (2-3 mg/kg/day): 12-month prospective randomized controlled trial
    (2021) ZANETTI, Caio B.; PEDROSA, Tatiana; KUPA, Leonard de V. K.; AIKAWA, Nadia E.; BORBA, Eduardo F.; VENDRAMINI, Margarete B. G.; SILVA, Clovis A.; PASOTO, Sandra G.; BONFA, Eloisa
    Introduction The American Academy of Ophthalmology (2016-AAO) recommended hydroxychloroquine (HCQ) dose not to exceed 5 mg/kg/day (real body weight). Recently, it was reported that prescribed 2016-AAO dose provided adequate HCQ levels for most lupus nephritis (LN) patients, with low flare risk. However, the minimum HCQ dose required to keep adequate levels is unknown. Objectives To evaluate if a further reduction in 2016-AAO dose (2-3 mg/kg/day) would sustain 12-month HCQ levels in LN patients with stable inactive disease. Methods Seventy-three stable LN patients under prescribed full HCQ 2016-AAO dose for >= 6 months and adequate baseline HCQ levels (>= 613.5 ng/mL) were divided in two groups: reduced 2016-AAO dose (2-3 mg/kg/day), n = 32, and full 2016-AAO dose (5 mg/kg/day), n = 41. All patients were assessed at baseline, 3, 6, and 12 months. HCQ levels were measured by liquid chromatography-tandem mass spectrometry. Flare was defined as augment >= 3 in SLE Disease Activity Index-2000 and/or change in treatment. Rigorous clinical/laboratorial surveillance was performed. Results Prospective evaluation revealed for reduced 2016-AAO dose group a decrease of HCQ levels from baseline to 3 months (1,404.9 +/- 492.0 vs. 731.6 +/- 385.0 ng/mL, p < 0.01), and sustained levels at 6 months (p = 0.273) and 12 months (p = 0.091) compared to 3 months. For the full 2016-AAO dose group, a decrease occurred only from baseline to 12 months (1343.5 +/- 521.5 vs. 991.6 +/- 576.3 ng/mL, p < 0.001). Frequencies of patients with inadequate levels at 6 months was higher in reduced 2016-AAO group than full 2016-AAO dose (59% vs. 24%, p = 0.005), as well as at 12 months (66% vs. 32%, p = 0.002). Six-month and 12-month flare frequencies were comparable for both groups (p > 0.05). Conclusions Prescribed HCQ low-dose regimen (2-3 mg/kg/day) does not sustain, for most patients, 6- and 12-month adequate HCQ levels. Full 2016-AAO dose maintained HCQ levels way above this limit. Trail registration: NCT03122431, registered on April 20, 2017
  • article 1 Citação(ões) na Scopus
    Short-term Accrual 2019 European League Against Rheumatism/American College of Rheumatology Domains and Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage in Lupus Patients With and Without Nephritis at Disease Onset
    (2023) MUNHOZ, Gabriela A.; AIKAWA, Nadia E.; SILVA, Clovis A.; PASOTO, Sandra G.; PEDROSA, Tatiana N.; SEGURO, Luciana P. C.; BONFA, Eloisa; BORBA, Eduardo F.
    ObjectiveTo determine in a historical inception cohort the impact of lupus nephritis at disease onset in short-term accrual 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) domains. The possible association with treatment and damage was also investigated.MethodsOne hundred thirty-three consecutive adult systemic lupus erythematosus patients according to the 2019 EULAR/ACR criteria were divided according to the presence (RENAL-lupus) or absence of renal involvement (NONRENAL-lupus) at disease onset. The 2019 EULAR/ACR score and Systemic Lupus International Collaborating Clinics/ACR (SDI) were longitudinally evaluated over 3 years.ResultsRENAL-lupus (n = 49 [36.8%]) and NONRENAL-lupus (n = 84 [63.2%]) were similar regarding age (p = 0.704), female sex (p = 0.313), and black race (p = 0.506). At study entry, RENAL-lupus had higher 2019 EULAR/ACR total domains (30 [12-42] vs. 22 [10-36], p < 0.001) and used more often glucocorticoid (p < 0.001), mycophenolate mofetil (p = 0.007), and cyclophosphamide (p = 0.001). After 3 years, a stable number of domain scores was observed for the RENAL-lupus (30 [12-42] vs. 30 [12-42], p = 0.125), whereas an increase was observed for the NONRENAL-lupus (22 [10-36] vs. 23 [10-40], p < 0.001) compared with baseline. Accordingly, RENAL-lupus patients had a lower frequency of additional domains (3/49 [6.1%] vs. 37/84 [44.0%], p < 0.0001). New kidney involvement occurred in 15 (44.1%) of 34 patients of the NONRENAL-lupus. Both groups evolved with a comparable increase in frequency of patients with damage (SDI >= 1) at the end of the study (23/49 [46.9%] vs. 34/89 [40.54%], p = 0.585) with a similar median of SDI (1 [0-4] vs. 0 [0-2], p = 0.132).ConclusionsThe distinct pattern of accrual 2019 EULAR/ACR domains in patients with and without nephritis at disease onset suggests that close surveillance for additional organ involvement, including kidney, is mandatory in NONRENAL lupus in the first 3 years of disease. The unexpected comparable early damage in both groups despite milder disease and less intense immunosuppression in NONRENAL lupus reinforces the need for new and tailored therapies for these patients.
  • conferenceObject
    Hydroxychloroquine Blood Levels Predicts 6-Months Disease Activity in Juvenile Lupus Nephritis
    (2020) BALBI, Verena; SILVA, Clovis; PEDROSA, Tatiana; PEREIRA, Rosa; CAMPOS, Lucia; LEON, Elaine; DUARTE, Nilo; CARVALHO, Valdemir; PASOTO, Sandra; ROSARIO, Debora; BRANDAO, Leticia; BONFA, Eloisa; AIKAWA, Nadia
  • conferenceObject
    SARS-COV-2 VACCINE IN SPONDYLOARTHRITIS PATIENTS: OVERALL MODERATE/HIGH IMMUNOGENICITY IMPAIRED BY IMMUNOSUPPRESSANTS AND BIOLOGICAL THERAPY
    (2022) SAAD, C.; SILVA, M. Rodrigues; SAMPAIO-BARROS, P. Degrava; MORAES, J.; GOLDENSTEIN-SCHAINBERG, C.; AIKAWA, N.; NEVES, E.; PASOTO, S.; PEDROSA, T.; AOYAMA, R. Kenji; ARAUJO, C. Scognamiglio Renner; SILVA, C.; RIBEIRO, A. C. Medeiros; BONFA, E.
  • article 22 Citação(ões) na Scopus
    Immunogenicity and safety of two doses of the CoronaVac SARS-CoV-2 vaccine in SARS-CoV-2 seropositive and seronegative patients with autoimmune rheumatic diseases in Brazil: a subgroup analysis of a phase 4 prospective study
    (2022) AIKAWA, Nadia E.; KUPA, Leonard V. K.; PASOTO, Sandra G.; MEDEIROS-RIBEIRO, Ana C.; YUKI, Emily F. N.; SAAD, Carla G. S.; PEDROSA, Tatiana; FULLER, Ricardo; SHINJO, Samuel K.; SAMPAIO-BARROS, Percival D.; ANDRADE, Danieli C. O.; PEREIRA, Rosa M. R.; SEGURO, Luciana P. C.; VALIM, Juliana M. L.; WARIDEL, Filipe; SARTORI, Ana Marli C.; DUARTE, Alberto J. S.; ANTONANGELO, Leila; SABINO, Ester C.; MENEZES, Paulo Rossi; KALLAS, Esper G.; SILVA, Clovis A.; BONFA, Eloisa
    Background We aimed to examine the immunogenicity pattern induced by the inactivated SARS-CoV-2 vaccine CoronaVac (Sinovac Life Sciences, Beijing, China) in SARS-CoV-2 seropositive patients with autoimmune rheumatic diseases compared with seropositive controls, seronegative patients with autoimmune rheumatic diseases, and seronegative controls. Methods CoronavRheum is an ongoing, prospective, controlled, phase 4 study, in which patients aged 18 years or older with autoimmune rheumatic diseases, and healthy controls were recruited from a single site (Rheumatology Division of Hospital das Clinicas, Faculdade de Medicina da Universidade de Sao Paulo) in Sao Paulo, Brazil Participants were vaccinated with two doses of CoronaVac (intramuscular injection, 3 mu g in 0middot5 mL of beta-propiolactone inactivated SARSCoV-2) on day 0 and on day 28. Blood samples were taken pre-vaccination on day 0, day 28, and also on day 69. For this subgroup analysis, participants were defined as being SARS-CoV-2 seropositive or seronegative prevaccination via anti-SARS-CoV-2 spike (S)1 or S2 IgG (cutoff of 15middot0 arbitrary units [AU] per mL) or neutralising antibody titres (cutoff of >= 30%) and were matched for age and sex, via convenience sampling, in a 1:3:1:1 ratio (seropositive patients to seronegative patients to seropositive controls to seronegative controls). The primary outcomes were rates of anti-SARSCoV-2 S1 and S2 IgG seropositivity and SARS-CoV-2 neutralising antibody positivity at day 28 and day 69 and immunogenicity dynamics assessed by geometric mean titres (GMTs) of IgG and median neutralising activity in seropositive patients with autoimmune rheumatic diseases compared with seronegative patients and seropositive and seronegative controls. We assessed safety in all participants randomly selected for this subgroup analysis. This study is registered with ClinicalTrials.gov, NCT04754698, and is ongoing for long-term immunogenicity evaluation. Findings Between Feb 4 and Feb 8, 2021, 1418 patients and 542 controls were recruited, of whom 1685 received two vaccinations (1193 patients and 492 controls). After random sampling, our immunogenicity analysis population comprised 942 participants, of whom 157 were SARS-CoV-2 seropositive patients with autoimmune rheumatic diseases, 157 were seropositive controls, 471 were seronegative patients, and 157 were seronegative controls; the median age was 48 years (IQR 38-56) and 594 (63%) were female and 348 (37%) were male. For seropositive patients and controls, an increase in anti-SARS-CoV-2 S1 and S2 IgG titres (seropositive patients GMT 52middot3 [95% CI 42middot9-63middot9] at day 0 vs 128middot9 [105middot6-157middot4] at day 28; seropositive controls 53middot3 [45middot4-62middot5] at day 0 vs 202middot0 [174middot8-233middot4] at day 28) and neutralising antibody activity (seropositive patients 59% [IQR 39-83] at day 0 vs 82% [54-96] at day 28; seropositive controls 58% [41-79] at day 0 vs 92% [79-96] at day 28), was observed from day 0 to day 28, without further increases from day 28 to day 69 (at day 69 seropositive patients' GMT was 137middot1 [116middot2-161middot9] and neutralising antibody activity was 79% [57-94]); and seropositive controls' GMT was 188middot6 [167middot4-212middot6] and neutralising antibody activity was 92% [75-96]). By contrast, for seronegative patients and controls, the second dose was required for maximum response at day 69, which was lower in seronegative patients than in seronegative controls. GMTs in seronegative patients were 2middot3 (95% CI 2middot2-2middot3) at day 0, 5middot7 (5middot1-6middot4) at day 28, and 29middot6 (26middot4-33middot3) at day 69, and in seronegative controls were 2middot3 (2middot1-2middot5) at day 0, 10middot6 (8middot7-13middot1) at day 28, and 71middot7 (63middot5-81middot0) at day 69; neutralising antibody activity in seronegative patients was 15% (IQR 15-15) on day 0, 15% (15-15) at day 28, and 39% (15-65) at day 69, and in seronegative controls was 15% (15-15) at day 0, 24% (15-37) at day 28, and 61% (37-79) at day 69. Neither seronegative patients nor seronegative controls reached the GMT or antibody activity levels of seropositive patients at day 69. Interpretation By contrast with seronegative patients with autoimmune rheumatic diseases, seropositive patients have a robust response after a single dose of CoronaVac. Our findings raise the possibility that the reduced immunogenicity observed in seronegative patients might not be the optimum response potential to SARS-CoV-2 vaccination, and therefore emphasise the importance of at least a single booster vaccination in these patients.
  • 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 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 9 Citação(ões) na Scopus
    SARS-CoV-2 vaccine in patients with systemic sclerosis: impact of disease subtype and therapy
    (2022) SAMPAIO-BARROS, Percival Degrava; MEDEIROS-RIBEIRO, Ana Cristina; LUPPINO-ASSAD, Ana Paula; MIOSSI, Renata; SILVA, Henrique Carrico da; YUKI, Emily F. V. N.; PASOTO, Sandra G.; SAAD, Carla G. S.; SILVA, Clovis A.; KUPA, Leonard V. K.; DEVEZA, Giordano B. H.; PEDROSA, Tatiana N.; AIKAWA, Nadia E.; BONFA, Eloisa
    Objective. To analyse the safety, immunogenicity and factors affecting antibody response to Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) vaccination in patients with SSc. Methods. This is a phase 4 prospective study within a larger trial of two doses of inactivated SARS-CoV-2 vaccine (CoronaVac) in 51 SSc patients compared with 153 controls. Anti-SARS-CoV-2-IgG and neutralizing antibodies (NAb) were assessed at each vaccine shot (D0/D28) and 6 weeks after the second dose(D69), only in individuals with negative baseline IgG/NAb and those who did not have coronavirus-19(COVID19) during follow-up. Vaccine safety was also assessed in all participants. Results. Patients and controls had comparable median ages [48(38.5-57) vs 48(38-57) years, P =0.945]. Patients had mostly diffuse SSc (68.6%) and the majority (74.5%) had interstitial lung disease. Most patients were under immunosuppressive therapy (72.5%), mainly MMF (52.9%). After full vaccination (D69), anti-SARS-CoV-2-IgG frequency (64.1% vs 94.2%, P < 0.001) and NAb positivity (53.8% vs 76.9%; P =0.006) were moderate, although lower than controls. The first dose response (D28) was low and comparable for both seroconvertion rates (SC) (P =0.958) and NAb positivity (P =0.537). SSc patients under MMF monotherapy vs other (no therapy/other DMARDs) had lower immunogenicity (SC: 31.3% vs 90%, P < 0.001) and NAb(18.8% vs 85%, P < 0.001). Multiple regression analysis confirmed that MMF use, but not disease subtype, is associated with insufficient seroconversion [odds ratio (OR)=0.056(95% CI: 0.009, 0.034), P =0.002] and NAb positivity [OR =0.047(95% CI: 0.007, 0.036), P =0.002]. No moderate/severe side-effects were observed. Conclusion. CoronaVac has an excellent safety profile and moderate response to anti-SARS-CoV-2 vaccine in SSc. Vaccine antibody response is not influenced by disease subtype and is greatly affected by MMF, reinforcing the need for additional strategies to up-modulate vaccine response in this subgroup of patients.