FRANCISCO FELLIPE CLAUDINO FORMIGA

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Instituto de Ortopedia e Traumatologia, Hospital das Clínicas, Faculdade de Medicina
LIM/17 - Laboratório de Investigação em Reumatologia, Hospital das Clínicas, Faculdade de Medicina

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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).
  • article 8 Citação(ões) na Scopus
    2019-EULAR/ACR classification criteria domains at diagnosis: predictive factors of long-term damage in systemic lupus erythematosus
    (2022) INSFRAN, Carlos E.; AIKAWA, Nadia E.; PASOTO, Sandra G.; FILHO, Dilson M. N.; FORMIGA, Francisco F. C.; PITTA, Ana C.; BORBA, Eduardo F.; RIBEIRO, Carolina T.; SILVA, Clovis A.; BONFA, Eloisa
    The objective of this study is to assess the role of the 2019-European League Against Rheumatism/American College of Rheumatology (2019-EULAR/ACR) classification criteria at diagnosis and its domains in predicting long-term damage in systemic lupus erythematosus(SLE). We performed a retrospective analysis using an electronic chart database utilized in routine clinical care of SLE patients and established in 2000 in a tertiary hospital. Two hundred and nine consecutive SLE patients with disease onset >= 18 years old and long disease duration were included. Cumulative damage at the last visit was scored using the SLICC/ACR-Damage Index (SDI). The median age at SLE diagnosis was 28 years (18-63), disease duration was 14 years (8-25), and 88% were females. Damage (SDI >= 1) was observed in 116/209 (55%). Patients with (SDI >= 1, n=116) and without damage (SDI=0, n=93) had similar median disease duration [14 (8-25) vs. 12 (8-25) years, p=0.090[ and age at diagnosis [23 (18-55) vs. 23 (18-56) years, p=0.998[. No correlation was observed between total 2019-EULAR/ACR score at diagnosis and SDI at last visit (r=0.007, p=0.913). Presence of renal domain at diagnosis was associated with renal damage at last visit (OR=3.6, 95%CI 1.2-10.4, p=0.017) and antiphospholipid antibodies domain predicted neuropsychiatric damage (OR=3.0, 95%CI 1.2-7.6, p=0.015). A ROC analysis identified that a cut-off >24 in 2019-EULAR/ACR score could predict a trend for renal damage (p=0.077) with a lower renal survival (Kaplan-Meier curve) for patients above this limit (p=0.029). A multivariate logistic regression analysis revealed that 2019-EULAR/ACR score >24 at diagnosis (OR 4.583, 95%CI 1.052-19.962, p=0.043) was independently associated with renal damage. Specific domains in the 2019-EULAR/ACR criteria at diagnosis were associated with long-term organspecific damage, particularly renal and neuropsychiatric harm. A 2019-EULAR/ACR score >24 predicted worse renal survival.
  • article 9 Citação(ões) na Scopus
    SARS-CoV-2 infection, gut dysbiosis, and heterogeneous clinical results of hydroxychloroquine on COVID-19 therapy & mdash;Is there a link?
    (2021) BALMANT, Bianca D.; TORRINHAS, Raquel S.; ROCHA, Ilanna M.; FONSECA, Danielle C.; FORMIGA, Francisco F. C.; BONFA, Eloisa S. D. O.; BORBA, Eduardo F.; WAITZBERG, Dan L.
    Clinical manifestations of the new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection can include gastrointestinal signals and symptoms. Individuals with previous clinical conditions that usually enroll gut dysbiosis have been identified as being at high risk to develop more severe infectious phenotypes. Actually, intestinal dysbiosis has been observed in infected patients and potentially linked to systemic hyper-inflammation. These observations suggest that a previous gut dysbiosis may be aggravated by SARS-CoV-2 infection and related to progression of the coronavirus disease 2019 (COVID-19) into more severe stages. While COVID-19 & rsquo;s pathophysiology is not fully understood, it seems relevant to consider the interactions of candidate therapeutic drugs with the host, gut microbiota, and SARS-CoV-2. Here we summarize scientific evidence supporting the potential relevance of these interactions and suggest that unfavorable clinical data on hydroxychloroquine administration in COVID-19 may have been influenced by the dose provided and its impact on gut dysbiosis. The proposition is based on preliminary data on gut microbiota composition from individuals with inactive systemic lupus erythematosus under exclusive continuous hydroxychloroquine treatment, displaying a direct correlation between drug doses and markers typically associated with gut dys-biosis.
  • conferenceObject
    Influenza A(H3N2)/Singapore 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; GARCIA, Cristiana Couto; CAPAO, Artur; MARTINS, Victor Adriano de Oliveira; PROENCA, Adriana Coracini Tonacio de; FULLER, Ricardo; YUKI, Emily Figueiredo Vieira Neves; VENDRAMINI, Margarete Borges Galhardo; ROSARIO, Debora Cordeiro do; BRANDAO, Leticia Maria Kolachinski Raposo; SARTORI, Ana Marli Christovam; PASOTO, Sandra Gofinet; ANTONANGELO, Leila; BONFA, Eloisa; BORBA, Eduardo Ferreira
  • article 0 Citação(ões) na Scopus
    Robust immunogenicity to the H3N2 component of influenza A vaccine in primary Sjogren syndrome
    (2023) PASOTO, Sandra Gofinet; BORBA, Eduardo Ferreira; FORMIGA, Francisco Fellipe Claudino; PEDROSA, Tatiana do Nascimento; AIKAWA, Nadia Emi; SIQUEIRA, Marilda Agudo Mendonca Teixeira de; CAPAO, Artur Silva Vidal; PROENCA, Adriana Coracini Tonacio de; FULLER, Ricardo; YUKI, Emily Figueiredo Neves; LEON, Elaine Pires; MARTINS, Victor Adriano de Oliveira; LOPES, Marta Heloisa; DUARTE, Alberto Jose da Silva; SILVA, Clovis Artur Almeida da; BONFA, Eloisa
    Introduction Influenza A (H3N2) virus is the major cause of morbidity/mortality due to seasonal influenza over 50 years. Data about the safety/immunogenicity of influenza A/Singapore (H3N2) vaccine are scarce in primary Sjogren syndrome (pSS). Methods Twenty-one consecutive pSS patients and 42 HC (healthy control individuals) were immunized with influenza A/Singapore/INFIMH-16-0019/2016 (H3N2)-like virus. Rates of SP (seroprotection) and SC (seroconversion), GMT (geometric mean titers), FI-GMT (factor increase in GMT), ESSDAI (EULAR Sjogren's Syndrome Disease Activity Index), and adverse events were appraised before and 4 weeks post-vaccination. Results pSS and HC had similar mean age (51.2 +/- 14.2 vs. 50.6 +/- 12.1 years, p =0.886). Pre-vaccination SP rates were high in pSS and HC (90.5% vs. 71.4%, p =0.114), and GMT were higher in pSS [80.0 (52.4-160.0) vs. 40.0 (20.0-80.0), p =0.001]. The percentage of influenza vaccination in the preceding two years was elevated and similar in pSS and HC (94.1% vs. 94.6%, p = 1.000). GMT values augmented in both groups four weeks after vaccination and persisted higher in the first group [160.0 (80.0-320.0) vs. 80.0 (40.0-80.0), p< 0.001] with equivalent FI-GMT [1.4 (1.0-2.8) vs. 1.4 (1.0-2.0), p = 0.410]. Both groups had low and similar SC rates (19.0% vs. 9.5%, p = 0.423). ESSDAI values persisted steadily during the study (p = 0.313). No serious adverse events have occurred. Conclusion The novel demonstration that the influenza A/Singapore (H3N2) vaccine induces a different pattern of immunogenicity from other influenza A constituents in pSS, featured by a desirable high pre- and post-vaccination immunogenicity, is in line with reported differences in immune responses between strains in trivalent vaccines and may be related to pre-existing immunity. Clinicaltrials.gov: #NCT03540823.
  • article 19 Citação(ões) na Scopus
    Impact of Distinct Therapies on Antibody Response to SARS-CoV-2 Vaccine in Systemic Lupus Erythematosus
    (2022) YUKI, Emily F. N.; BORBA, Eduardo F.; PASOTO, Sandra G.; SEGURO, Luciana P.; LOPES, Michelle; SAAD, Carla G. S.; MEDEIROS-RIBEIRO, Ana Cristina; SILVA, Clovis A.; ANDRADE, Danieli C. O. de; KUPA, Leonard de Vinci K.; BETANCOURT, Lorena; BERTOGLIO, Isabela; VALIM, Juliana; HOFF, Camilla; FORMIGA, Francisco F. C.; PEDROSA, Tatiana; KALLAS, Esper G.; AIKAWA, Nadia E.; BONFA, Eloisa
    Objective To date, the only study that has assessed the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 mRNA) vaccine in systemic lupus erythematosus (SLE) observed a moderate response, but the sample size precluded an accurate analysis of the effect of individual drugs. Therefore, we evaluated the immunogenicity of an inactivated SARS-CoV-2 vaccine (Sinovac-CoronaVac) and the influence of different medications in SLE. Safety was also assessed. Methods We conducted a prospective controlled study of 232 SARS-CoV-2-naive SLE patients and 58 SARS-CoV-2-naive controls who were vaccinated with 2 doses of Sinovac-CoronaVac with a 28-day interval (day 0/day 28 [D0/D28]). Immunogenicity analysis at D0/D28 and D69 included anti-SARS-CoV-2 S1/S2 IgG seroconversion (SC) and neutralizing antibodies (NAb) positivity. The influence of individual drugs on immune response and safety was assessed. Results Patients and controls were well balanced for age (P = 0.771). At D69, SLE patients showed a moderate SC (70.2% versus 98.1%; P < 0.001) and moderate frequency of NAb positivity (61.5% versus 84.6%; P = 0.002), although both frequencies were lower than in controls. Factors associated with lower SC in univariate analysis at D69 were prednisone use (odds ratio [OR] 0.215 [95% confidence interval (95% CI) 0.108-0.427], P < 0.001) and mycophenolate mofetil (MMF) use (OR 0.201 [95% CI 0.107-0.378], P < 0.001), whereas hydroxychloroquine (HCQ) use led to a 2.5 increase in SC (P = 0.011). SLE patients who were receiving HCQ monotherapy had similar SC to controls at D69 (100% versus 98.1%; P = 1.000). In multivariate analysis, prednisone and MMF use were independently associated with lower SC (P < 0.001) and NAb positivity (P < 0.001). Safety analysis revealed no moderate/severe adverse events. Conclusion Sinovac-CoronaVac has a moderate immunogenicity in SARS-CoV-2-naive SLE patients with an excellent safety profile. We further demonstrate that HCQ may improve SC, whereas prednisone and MMF had a major deleterious effect in vaccine response, reinforcing the need to investigate the role of temporary MMF withdrawal or a vaccine-booster dose ( identifier: NCT04754698).