scholarly journals Large-Scale Postmarketing Surveillance of Biological Drugs for Immune-Mediated Inflammatory Diseases Through an Italian Distributed Multi-Database Healthcare Network: The VALORE Project

BioDrugs ◽  
2021 ◽  
Author(s):  
Gianluca Trifirò ◽  
Valentina Isgrò ◽  
Ylenia Ingrasciotta ◽  
Valentina Ientile ◽  
Luca L’Abbate ◽  
...  
Keyword(s):  
Large Scale ◽  
Inflammatory Diseases ◽  
Postmarketing Surveillance ◽  
Biological Drugs ◽  
Healthcare Network ◽  
Immune Mediated

scholarly journals THU0311 CERTOLIZUMAB THERAPY IN REFRACTORY UVEITIS DUE TO IMMUNE-MEDIATED INFLAMMATORY DISEASES (IMID). MULTICENTER STUDY OF 39 PATIENTS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 384.2-385
Author(s):  
J. L. Martín-Varillas ◽  
V. Calvo-Río ◽  
L. Sanchez-Bilbao ◽  
I. González-Mazón ◽  
I. Torre-Salaberri ◽  
...  
Keyword(s):  
Multicenter Study ◽  
Inflammatory Diseases ◽  
Certolizumab Pegol ◽  
Oral Prednisone ◽  
Retinal Vasculitis ◽  
Relapsing Polychondritis ◽  
Research Support ◽  
Biological Drugs ◽  
Immune Mediated ◽  
Adalimumab Therapy

Background:Infliximab and adalimumab therapy has significantly improved the prognosis of patients with non-infectious refractory uveitis. However, there is not enough evidence for the use of other anti-TNF drugs such as Certolizumab Pegol (CZP).Objectives:To evaluate the efficacy and safety of CZP in uveitis secondary to Immune-Mediated Inflammatory Diseases (IMID).Methods:Multicenter study of 39 patients with uveitis due to IMID refractory to glucocorticoids and conventional immunosuppressants. Efficacy of CZP was evaluated with the following ocular parameters: best corrected visual acuity (BCVA), anterior chamber cells, macular thickness and presence of retinal vasculitis. Efficacy of CZP was compared between baseline, 1st week, 1st and 6th month, and 1st and 2nd year. Statistical analysis was performed with the STATISTICA software (Statsoft Inc. Tulsa, Oklahoma, USA).Results:39 patients/56 affected eyes (18 men/21 women) with a mean age of 40.5±11.9 years were studied. IMIDs included were: spondyloarthritis (n=17), psoriatic arthritis (6), Crohn (3), JIA (2), Behçet (2), reactive arthritis (2), rheumatoid arthritis (1), relapsing polychondritis (1), pars planitis (1), Birdshot (1) and idiopathic uveitis (3). Uveitis pattern was as follows: anterior (n=30), posterior (4), panuveitis (3) and intermediate (2).Previous CZP, patients received: oral prednisone (n=18) methylprednisolone bolus (1), methotrexate (22), azathioprine (10), cyclosporine (4), leflunomide (2), mycophenolate mofetil (2) and cyclophosphamide (1). 77% of patients had received previous biological therapy, with a mean of 1.6±1.2 biological drugs per patient. Gestational desire was the reason for prescribing CZP in 8 patients. CZP was administered in monotherapy in 16 patients and in the remaining 23 patients combined with conventional immunosuppressants.After a median follow-up of 24 [6-36] months, most of the ocular variables analysed showed a rapid and significantly sustained improvement (Table). CZP was discontinued in 11 patients for the following reasons: remission (n=1), insufficient response of ocular symptoms (n=1) and limited response of extraocular manifestations (n=9). No serious adverse effects were reported.Conclusion:CZP seems to be effective and safe in patients with refractory uveitis due to IMID.TableBaseline1stweek1stMonth6thMonth1styear2ndyearBCVA (mean±SD)0.77±0.290.77±0.30*0.82±0.29*0.85±0.26*0.86±0.27*0.88±0.23*Tyndall (median [IQR])0 [0-2]0 [0-2]0 [0-1]*0 [0-0]*0 [0-0]*0 [0-0]*OCT (mean±SD)355±61.5-284.1±40.4*-224.8±121.1*-Retinal Vasculitis (eyes affected, %)2 (3.6)0 (0)0 (0)0 (0)0 (0)0 (0)*p<0.05Disclosure of Interests:José Luis Martín-Varillas Grant/research support from: AbbVie, Pfizer, Janssen and Celgene, Speakers bureau: Pfizer and Lilly, Vanesa Calvo-Río Grant/research support from: MSD and Roche, Speakers bureau: AbbVie, Lilly, Celgene, Grünenthal, UCB Pharma, Lara Sanchez-Bilbao Grant/research support from: Pfizer, Iñigo González-Mazón: None declared, Ignacio Torre-Salaberri: None declared, Álvaro García Martos: None declared, Amalia Sanchez-Andrade: None declared, Ángel García-Aparicio: None declared, JR De Dios-Jiménez Aberásturi: None declared, ANA URRUTICOECHEA-ARANA: None declared, Olga Maíz: None declared, Raul Veroz Gonzalez: None declared, Andrea García-Valle: None declared, Sergio Rodríguez Montero: None declared, Roberto Miguélez: None declared, Vega Jovani: None declared, Marisa Hernández-Garfella: None declared, Arantxa Conesa: None declared, Olga Martínez González: None declared, Paula Rubio Muñoz: None declared, Belén Atienza-Mateo: None declared, Miguel A González-Gay Grant/research support from: Pfizer, Abbvie, MSD, Speakers bureau: Pfizer, Abbvie, MSD, Ricardo Blanco Grant/research support from: AbbVie, MSD, and Roche, Speakers bureau: AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, and MSD

scholarly journals Evaluation of antibody response to BNT162b2 mRNA COVID-19 vaccine in patients affected by immune-mediated inflammatory diseases up to 5 months after vaccination

2021 ◽  
Author(s):  
Davide Firinu ◽  
Andrea Perra ◽  
Marcello Campagna ◽  
Roberto Littera ◽  
Giuseppe Fenu ◽  
...  
Keyword(s):  
Immune Response ◽  
Booster Dose ◽  
Inflammatory Diseases ◽  
Control Group ◽  
Biological Drugs ◽  
Humoral Immune ◽  
Immune Mediated ◽  
Significant Difference ◽  
Anti Cd20 ◽  
High Immunogenicity

AbstractSARS-CoV-2 vaccination with mRNA product BNT162b2 elicited high immunogenicity in healthy subjects in trials. This study aims to better understand the factors that influence the humoral immune response to vaccination against SARS-CoV-2 in patients with immune-mediated inflammatory diseases (IMIDs). We enrolled patients and healthy healthcare workers control group (HCW) that underwent mRNA BNT162b2 vaccination and measured the serum IgG anti-S-RBD response at booster dose (T1), one month after booster dose (T2) and up to 5 months (T3). Demographic, disease-specific and vaccination data were recorded. Vaccination response of 551 participants naïve to SARS-CoV-2 infection were included in HCW and 102 in the IMID group, analyzing separately those on anti-CD20. At T2 all naïve HCW developed anti-S-RBD-IgG, while 94% of IMID responded (p < 0.001). IMID patients had a significantly different level of IgG than HCW at both T1 (p = 0.031), T2 (p < 0.001), while there was no significant difference at T3. There were no statistically significant differences according to the IMID type or to ongoing treatment with immunosuppressants, corticosteroids or biological drugs other than anti-CD20. The proportion and magnitude of response was significantly lower in IMID treated with anti-CD20 drugs. There was a correlation with age at T1 and at T2 but not at T3, stronger in patients than in HCW. Immune response close after BNT162b2 vaccination is reduced in patients with IMID, but there is no significant difference at 5 months. The measured reduction is related to age and the disease itself rather than treatments, with the exception of anti-CD20 drugs.

scholarly journals Association of IL-1Ra Ser133Ser Variant with Susceptibility to Immune-Mediated and Inflammatory Diseases: A MetaAnalysis of 2622 Cases and 3854 Controls

2020 ◽  
Author(s):  
Mahdiyeh HARATI-SADEGH ◽  
Saman SARGAZI ◽  
Roghayeh SHEERVALILOU ◽  
Saeed HOSSEINI TESHNIZI ◽  
Ramin SARAVANI ◽  
...  
Keyword(s):  
Confidence Intervals ◽  
Lupus Erythematosus ◽  
Large Scale ◽  
Inflammatory Diseases ◽  
Meta Analysis ◽  
Missense Variant ◽  
Functional Variants ◽  
Immune Mediated ◽  
Increased Risk ◽  
Overall Risk

Background: The rs315952 (Ser133Ser) has been reported to influence the risk for immune-mediated as well as inflammatory diseases in many studies; however, the results remain inconsistent. The current meta-analysis was performed to give a more precise estimation for the relationship between this IL-1Ra missense variant and the risk of both types of diseases. Methods: Relevant publications were retrieved through a literature search in Web of Science, Medline, PubMed, Scopus, EMBASE, and Google scholar search engines, between 2000 and 2019. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated to assess the strength of the association.95% confidence intervals (CIs) were calculated to assess the strength of the association. Results: Twenty-two studies, including 2622 cases with and 3854 controls were identified. The IL-1Ra Ser133Ser variant does not confer an increased overall risk for immune-mediated and inflammatory diseases. This variant was statistically associated with decreased risk of systemic lupus erythematosus (under allelic, codominant heterozygous, and dominant models) or ankylosing spondylitis (in allelic and recessive models)(OR<1). Moreover, alleles, as well as genotypes of the IL-1Ra Ser133Ser variant, may confer an increased risk of immune-mediated and inflammatory diseases in Hispanics. However, this variant was not associated with susceptibility to immune-mediated and inflammatory diseases in both Asians and Arabs. Conclusion: The pooled results fail to support the hypothesis that the IL-1Ra Ser133Ser variant is associated with the overall risk of immune-mediated and inflammatory diseases. Performing large scale replication and meta-analysis of functional variants within this gene is encouraged to further investigate the influence of IL1Ra SNPs on overall disease susceptibility.

scholarly journals Evaluation of antibody response to BNT162b2 mRNA COVID-19 vaccine in patients affected by immune-mediated inflammatory diseases up to 5 months after vaccination

2021 ◽  
Author(s):  
Davide Firinu ◽  
Andrea Perra ◽  
Marcello Campagna ◽  
Roberto Littera ◽  
Giuseppe Fenu ◽  
...  
Keyword(s):  
Immune Response ◽  
Booster Dose ◽  
Inflammatory Diseases ◽  
Control Group ◽  
Biological Drugs ◽  
Humoral Immune ◽  
Immune Mediated ◽  
Significant Difference ◽  
Anti Cd20 ◽  
High Immunogenicity

Abstract SARS-CoV-2 vaccination with mRNA product BNT162b2 elicited high immunogenicity in healthy subjects in trials. This study aims to better understand the factors that influence the humoral immune response to vaccination against SARS-CoV-2 in patients with immune-mediated inflammatory diseases (IMIDs). We enrolled patients and healthy healthcare workers control group (HCW) that underwent mRNA BNT162b2 vaccination and measured the serum IgG anti-S-RBD response at booster dose (T1), one month after booster dose (T2) and up to 5 months (T3). Demographic, disease-specific and vaccination data were recorded. Vaccination response of 551 participants naïve to SARS-CoV-2 infection were included in HCW and 102 in the IMID group, analyzing separately those on anti-CD20. At T2 all naïve HCW developed anti-S-RBD-IgG, while 94% of IMID responded (p < 0.001). IMID patients had a significantly different level of IgG than HCW at both T1 (p = 0.031), T2 (p < 0.001), while there was no significant difference at T3. There were no statistically significant differences according to the IMID type or to ongoing treatment with immunosuppressants, corticosteroids or biological drugs other than anti-CD20. The proportion and magnitude of response was significantly lower in IMID treated with anti-CD20 drugs. There was a correlation with age at T1 and at T2 but not at T3, stronger in patients than in HCW. Immune response close after BNT162b2 vaccination is reduced in patients with IMID, but there is no difference at 5 months. The measured reduction is related to age and the disease itself rather than treatments, with the exception of anti-CD20 drugs

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