Asunto(s)
Anemia Ferropénica , Hierro , Humanos , Anemia Ferropénica/tratamiento farmacológico , Anemia Ferropénica/diagnóstico , Anemia Ferropénica/terapia , Anemia Ferropénica/etiología , Hierro/administración & dosificación , Hierro/uso terapéutico , Femenino , Embarazo , Masculino , Consenso , Adulto , Niño , HungríaRESUMEN
Long-term data on ustekinumab in real-life Crohn's disease patients are still missing, though randomized controlled trials demonstrated it as a favorable therapeutic option. We aimed to evaluate ustekinumab's clinical efficacy, drug sustainability, and safety in a prospective, nationwide, multicenter Crohn's disease patient cohort with a three-year follow-up. Crohn's disease patients on ustekinumab treatment were consecutively enrolled from 9 Hungarian Inflammatory Bowel Disease centers between January 2019 and May 2020. Patient and disease characteristics, treatment history, clinical disease activity (Harvey Bradshaw Index (HBI)), biomarkers, and endoscopic activity (Simple Endoscopic Score for Crohn's Disease (SES-CD)) were collected for three-years' time. A total of 148 patients were included with an overall 48.9% of complex behavior of the Crohn's disease and 97.2% of previous anti-TNF exposure. The pre-induction remission rates were 12.2% (HBI), and 5.1% (SES-CD). Clinical remission rates (HBI) were 52.2%, 55.6%, and 50.9%, whereas criteria of an endoscopic remission were fulfilled in 14.3%, 27.5%, and 35.3% of the subjects at the end of the first, second, and third year, respectively. Dose intensification was high with 84.0% of the patients on an 8-weekly and 29.9% on a 4-weekly regimen at the end of year 3. Drug sustainability was 76.9% during the follow-up period with no serious adverse events observed. Ustekinumab in the long-term is an effective, sustainable, and safe therapeutic option for Crohn's disease patients with severe disease phenotype and high previous anti-TNF biological failure, requiring frequent dose intensifications.
Asunto(s)
Enfermedad de Crohn , Ustekinumab , Humanos , Enfermedad de Crohn/tratamiento farmacológico , Ustekinumab/uso terapéutico , Ustekinumab/efectos adversos , Masculino , Femenino , Adulto , Resultado del Tratamiento , Persona de Mediana Edad , Estudios Prospectivos , Estudios de Seguimiento , Inducción de Remisión , HungríaRESUMEN
Gastric cystica profunda (GCP) is an uncommon but underestimated gastric lesion. Its precancerous potential determines its significance. In addition to previous mucosa injury due to operations, biopsy or polypectomy, chronic active and atrophic gastritis may also lead to the development of GCPs. By carefully examining the stomach and taking biopsy samples from the susceptible regions, the stage of atrophy can be determined. Chronic atrophic gastritis is a risk factor for cancer evolvement and it can also contribute to GCPs formation. GCPs frequently occur close to early gastric cancers (EGCs) or EGC can arise from the cystic glands. Endoscopic resection is an effective and minimally invasive treatment in GCP.
Asunto(s)
Mucosa Gástrica , Gastritis Atrófica , Lesiones Precancerosas , Neoplasias Gástricas , Humanos , Biopsia , Enfermedad Crónica , Quistes/cirugía , Quistes/patología , Quistes/etiología , Mucosa Gástrica/patología , Mucosa Gástrica/cirugía , Mucosa Gástrica/diagnóstico por imagen , Gastritis Atrófica/patología , Gastritis Atrófica/complicaciones , Gastritis Atrófica/cirugía , Gastroscopía , Lesiones Precancerosas/patología , Lesiones Precancerosas/cirugía , Lesiones Precancerosas/etiología , Factores de Riesgo , Gastropatías/etiología , Gastropatías/cirugía , Gastropatías/patología , Neoplasias Gástricas/patología , Neoplasias Gástricas/cirugía , Neoplasias Gástricas/etiologíaRESUMEN
Introduction: Inflammatory bowel diseases (Crohn's disease (CD) and ulcerative colitis (UC)) are chronic, immune-mediated diseases with unclear aetiology, characterized by relapsing inflammation of the gastrointestinal tract. These conditions significantly impair patients' physical and mental condition and quality of life. Aim: To investigate the impact of the current pandemic situation on inflammatory bowel disease (IBD) patients' psychological status and to determine factors that mediate the level of depression, anxiety, and health-related quality of life. Material and methods: This was a multicentre, observational, cross-sectional, questionnaire-based study. A total of 206 participants (male: 34%) were involved. The online survey consisted of 8 different psychological measures (such as depression, anxiety, coronavirus distress, health-related quality of life, etc.) and other therapy-specific and sociodemographic factors. Results: 28.2% of respondents showed depressive symptoms and 11.2% indicated moderate to severe anxiety. Also, 27.7% revealed mild, moderate, or severe distress regarding the coronavirus situation. According to regression analysis, anxiety and coronavirus distress are mostly influenced by psychological factors. In contrast, the changes in quality of life and depression can be explained by disease-specific and psychological factors as well. Conclusions: Patients need more attention during this period to help them cope with psychological factors and prevent their IBD from becoming worse.
RESUMEN
BACKGROUND: Heart transplant (HTX) recipients are prone to develop complications after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Vaccination is often ineffective due to weaker immunogenicity. In this high-volume single-center study, we aimed to determine factors influencing seroconversion after vaccination and predictors of severe SARS-CoV-2 infection. METHODS: Two hundred twenty-nine HTX recipients were enrolled. Type of the first two vaccine doses included messenger RNA (mRNA), vector, and inactivated vaccines. We carried out analyses on seroconversion after the second and third doses of vaccination and on severity of infection. Antispike protein SARS-CoV-2 immunoglobulin G (IgG) was measured after the second and third vaccines and serostatus was defined. Effect of the first two vaccine doses was studied on patients who did not suffer SARS-CoV-2 infection before antibody measurement (n = 175). The effectivity of the third vaccine was evaluated among seronegative recipients after the second vaccine (n = 53). Predictors for severe infection defined as pneumonia, hospitalization or death were assessed in all patients who contracted SARS-CoV-2 infection (n = 92). RESULTS: 62% of the recipients became seropositive after the second vaccination. Longer time between HTX and vaccination (odds ratio [OR]: 2.35) and mRNA vaccine (OR: 4.83) were predictors of seroconversion. 58% of the nonresponsive patients became seropositive after receiving the third vaccine. Male sex increased the chance of IgG production after the third dose (OR: 5.65). Clinical course of SARS-CoV-2 infection was severe in 32%. Of all parameters assessed, only seropositivity before infection was proven to have a protective effect against severe infection (OR: 0.11). CONCLUSIONS: We found that longer time since HTX, mRNA vaccine type, and male sex promoted seroconversion after SARS-CoV-2 vaccination in HTX recipients. Seropositivity-but not the number of vaccine doses-seemed to be protective against severe SARS-CoV-2 infection. Screening of HTX patients for anti-SARS-COV-2 antibodies may help to identify patients at risk for severe infection.
Asunto(s)
Vacunas contra la COVID-19 , COVID-19 , Trasplante de Corazón , Humanos , Masculino , COVID-19/epidemiología , COVID-19/prevención & control , Vacunas contra la COVID-19/uso terapéutico , Inmunoglobulina G , Vacunas de ARNm , Seroconversión , VacunaciónRESUMEN
BACKGROUND, AIMS: Patients with inflammatory bowel disease (IBD) have a more than twofold higher risk of venous thromboembolic events (VTE) than the general population. The etiology is complex, and the role of medication is not precisely defined.We aimed to assess the effect of anti-tumor necrosis factor alpha (anti-TNFα) drugs and conventional anti-inflammatory therapy, namely corticosteroids (CS), immunomodulators (IM), and 5-aminosalicylates (5-ASA) on VTE in IBD. METHODS: A systematic search was performed in five databases on the 22nd of November 2022. We included studies reporting VTE in the distinct categories of medications, determined the proportions, and calculated the odds ratios (OR) with 95% confidence intervals (CI), using the random-effects model. The risk of bias was evaluated with the Joanna Briggs Institute Critical Appraisal Checklist and the Risk of Bias in Non-randomized Studies of Interventions tool. RESULTS: The quantitative analysis included 16 observational studies, with data from 91,322 IBD patients. Patients receiving anti-TNFα medication had significantly less VTE (proportion: 0.05, CI: 0.02-0.10), than patients treated with CS (proportion: 0.16, CI: 0.07-0.32), with OR=0.42 (CI: 0.25-0.71). IMs resulted in similar proportions of VTE compared with biologics (0.05, CI: 0.03-0.10), with OR=0.94 (CI: 0.67-1.33). The proportion of patients receiving 5-ASA having VTE was 0.09 (CI: 0.04-0.20), with OR=1.00 (CI: 0.61-1.62). CONCLUSIONS: Biologics should be preferred over corticosteroids in cases of severe flare-ups and multiple VTE risk factors, as they are associated with reduced odds of these complications. Further studies are needed to validate our data.
RESUMEN
INTRODUCTION: Post-COVID syndrome may affect the gastrointestinal tract. However, risk factors of post-COVID syndrome are still unknown. OBJECTIVE: We aimed to identify the most common gastrointestinal symptoms, abnormal laboratory findings and risk factors relevant to post-COVID syndrome. METHOD: In this retrospective study, we included 79 patients admitted to Semmelweis University Department of Surgery, Transplantation and Gastroenterology between October 2020 and September 2022. We investigated clinical data, laboratory findings and determined the major risk factors. RESULTS: Most of the patients were women (46/79), their mean age was 47.6 years and patients were overweight (BMI: 26.3 kg/m2). The most common comorbidities were cardiovascular diseases (21/79), hypertension (20/79), diabetes (11/79) and malignant diseases (9/79). Typical indications for gastroscopy were dyspepsia (16/79) and epigastric pain (10/79). The most common indications for colonoscopy were diarrhea (29/79) and weight loss (28/79). Among abnormal laboratory findings, liver enzymes levels (GOT: 83.5 U/L, GPT: 85 U/L, GGT: 70 U/L) and ferritin (351.5 ng/mL) were higher in post-COVID patients. Typical conditions diagnosed by gastroscopy, colonoscopy and abdominal ultrasound were gastroesophageal reflux disease (11/26), irritable bowel syndrome (2/19) and diffuse hepatic lesions, respectively. The number of unvaccinated patients was higher compared to those receiving any COVID-19 vaccines (58% vs. 29%). Of the vaccinated patients, 12 patients received mRNA vaccines (10 Pfizer-BioNTech, 2 Moderna) and 6 patients received viral vector vaccines (2 AstraZeneca, 4 Sputnik V). CONCLUSION: We identified female gender, obesity, cardiovascular diseases, cancer, hypertension and diabetes as major risk factors of post-COVID syndrome. Vaccinated status may prevent post-COVID gastrointestinal symptoms. Orv Hetil. 2023; 164(31): 1206-1212.
Asunto(s)
COVID-19 , Enfermedades Cardiovasculares , Hipertensión , Humanos , Femenino , Persona de Mediana Edad , Masculino , Enfermedades Cardiovasculares/epidemiología , Enfermedades Cardiovasculares/etiología , Vacunas contra la COVID-19 , Estudios Retrospectivos , COVID-19/complicacionesRESUMEN
Background: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has complicated the management of inflammatory bowel diseases (IBD). Objectives: This study aimed to assess the efficacy of different anti-SARS-CoV-2 vaccines under different treatments in IBD patients and identify predictive factors associated with lower serological response, including anti-tumor necrosis factor (anti-TNF) drug levels. Design: A prospective, double-center study of IBD patients was conducted following messenger ribonucleotide acid (mRNA) and non-mRNA anti-SARS-CoV-2 vaccination. Methods: Healthy control (HC) patients were enrolled to reduce bias. Baseline and control samples were obtained 14 days after the second dose to assess the impact of conventional and biological treatments. Clinical and biochemical activity, serological response level, and anti-TNF drug levels were measured. Results: This study included 199 IBD (mean age, 40.9 ± 12.72 years) and 77 HC participants (mean age, 50.3 ± 12.36 years). Most patients (76.9%) and all HCs received mRNA vaccines. Half of the IBD patients were on biological treatment (anti-TNF 68.7%). Biological and thiopurine combined immunomodulation and biological treatment were associated with lower serological response (p < 0.001), and mRNA vaccination promoted better antibody levels (p < 0.001). Higher adalimumab levels caused lower serological response (p = 0.006). W8 persistence of anti-SARS-CoV-2 level was equal in IBD and HC groups. Vaccination did not aggravate clinical disease activity (p = 0.65). Conclusion: Anti-SARS-CoV-2 vaccination is considerably efficacious in IBD patients, with mRNA vaccines promoting better antibody levels. The negative impact of combined biological treatment, especially with high adalimumab drug levels, on serological response to vaccination should be considered. Although midterm durability of vaccination is encouraging, more data are needed to expand the existing understanding on this issue.
Adjustment of COVID-19 vaccination to adalimumab trough level is considerable due to the reduced serological response. mRNA vaccination should be preferred in case of IBD patients with an equal durability of anti-SARS-CoV-2 level of subjects and healthy control participants.
RESUMEN
Hypocalcemia is a common condition in liver cirrhosis and is associated with the severity of SARS-CoV-2 infection. However, there is a lack of data demonstrating the prognostic value of hypocalcemia in COVID-19 patients with cirrhosis. This study aimed to evaluate the prognostic value of hypocalcemia for COVID-19 severity, mortality and its associations with abnormal liver function parameters. We selected 451 COVID-19 patients in this retrospective study and compared the laboratory findings of 52 COVID-19 patients with cirrhosis to those of 399 COVID-19 patients without cirrhosis. Laboratory tests measuring albumin-corrected total serum calcium were performed on admission, and the levels were monitored during hospitalization. The total serum calcium levels were significantly lower in cirrhosis cases (2.16 mmol/L) compared to those without cirrhosis (2.32 mmol/L). Multivariate analysis showed that hypocalcemia in COVID-19 patients with cirrhosis was a significant predictor of in-hospital mortality, with an OR of 4.871 (p < 0.05; 95% CI 1.566-15.146). ROC analysis showed the AUC value of total serum calcium was 0.818 (95% CI 0.683-0.953, p < 0.05), with a sensitivity of 88.3% and a specificity of 75%. The total serum calcium levels showed a significant negative correlation with the Child-Turcette-Pugh score (r = -0.400, p < 0.05). Hypocalcemia on admission was a significant prognostic factor of disease progression in COVID-19 patients with cirrhosis.
RESUMEN
BACKGROUND: Few data are available on subjective disease control and perception of adverse events (AEs) during switching from original anti-TNF agents to biosimilars. RESEARCH DESIGN AND METHODS: Hungarian patients with inflammatory bowel disease were interviewed after a mandatory non-medical switch from an infliximab (IFX) originator to a biosimilar GP1111 or from an adalimumab (ADA) originator to a biosimilar GP2017. Drug choice was based on patient's and physician's decision. Subjective efficacy was measured using a 10-point scale, and AEs were assessed. Difference in efficacy before and after the switch was compared within and between the drugs. RESULTS: Seventy-three ADA and 106 IFX switching patients were interviewed. Subjective efficacy of IFX biosimilar was rated lower compared to IFX originator (8.72 ± 1.68 vs. 7.77 ± 2.34; p = 0.001). The ADA biosimilar was rated higher than its originator (9.02 ± 1.61 vs. 8.42 ± 1.93; p = 0.017). Patients receiving ADA biosimilar were more satisfied with the new treatment compared to IFX (p = 0.032). The incidence of new AEs was 85% in the ADA and 55% in the IFX group (1.79 vs. 0.93 AEs per patient, respectively, p < 0.001). CONCLUSION: Subjective efficacy of switching to a biosimilar was proven in case of ADA, while reduced efficacy was experienced with IFX biosimilar. Perception of AEs was high and varied between biosimilars.
Asunto(s)
Biosimilares Farmacéuticos , Enfermedades Inflamatorias del Intestino , Humanos , Infliximab/efectos adversos , Biosimilares Farmacéuticos/efectos adversos , Adalimumab/efectos adversos , Autoinforme , Inhibidores del Factor de Necrosis Tumoral/uso terapéutico , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Resultado del Tratamiento , Fármacos Gastrointestinales/efectos adversosRESUMEN
Introduction: Inflammatory bowel disease potentially elevates the risk of infections, independently from age, while the disease activity and medical treatment(s) can also increase the risks. Nevertheless, it is necessary to clarify these preconceptions as well during the COVID-19 pandemic. Methods: An observational, questionnaire based study was conducted in Hungary between February and August 2021. 2 questionnaires were completed. The first questionnaire surveyed the impact of the pandemic on patients with biologic treatments and assessed the severity and outcome of the infection, whereas the second one assessed vaccination rate and adverse events. Results: 472 patients participated in the study. 16.9 % of them acquired the infection and 6.3 % needed hospitalization. None of them required ICU care. Male sex elevated the risk of infection (p = 0.008), while glove (p = 0.02) and mask wearing (p = 0.005) was the most effective prevention strategy. Nevertheless, abstaining from community visits or workplace did not have an impact on the infection rate. Smoking, age, and disease type did not elevate the risk. UC patients had poorer condition during the infection (p = 0.003); furthermore, the disease activity could potentially worsen the course of infection (p = 0.072). The different biological treatments were equally safe; no difference was observed in the infection rate, course of COVID-19. Azathioprine and corticosteroids did not elevate the infection rate. 28 patients (35.0 %) suspended the ongoing biologic treatment, but it had no impact on the disease course. However, it resulted in changing the current treatment (p = 0.004). 9.8 % of the respondents were sceptic about being vaccinated, and 90 % got vaccinated. In one case, a serious flare-up occurred. Discussion: Most patients acquired the infection at workplace. Biologic therapies had no effect on the COVID-19 infection, whereas male sex, an active disease, and UC could be larger threat than treatments. Vaccination was proved to be safe, and patient education is important to achieve mass vaccination of the population.
RESUMEN
Liver damage in COVID-19 patients was documented as increased alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels or an elevated AST/ALT ratio, known as the De Ritis ratio. However, the prognostic value of the elevated De Ritis ratio in COVID-19 patients is still unknown. The aim of our study was to evaluate the prognostic value of the De Ritis ratio compared to other abnormal laboratory parameters and its relation to mortality. We selected 322 COVID-19 patients in this retrospective study conducted between November 2020 and March 2021. The laboratory parameters were measured on admission and followed till patient discharge or death. Of the 322 COVID-19 patients, 57 (17.7%) had gastrointestinal symptoms on admission. The multivariate analysis showed that the De Ritis ratio was an independent risk factor for mortality, with an OR of 29.967 (95% CI 5.266-170.514). In ROC analysis, the AUC value of the the De Ritis ratio was 0.85 (95% CI 0.777-0.923, p < 0.05) with sensitivity and specificity of 80.6% and 75.2%, respectively. A De Ritis ratio ≥1.218 was significantly associated with patient mortality, disease severity, higher AST and IL-6 levels, and a lower ALT level. An elevated De Ritis ratio on admission is independently associated with mortality in COVID-19 patients, indicating liver injury and cytokine release syndrome.
Asunto(s)
COVID-19 , Humanos , Alanina Transaminasa , Estudios Retrospectivos , Aspartato Aminotransferasas , PronósticoRESUMEN
Introduction: COVID19 significantly affects endoscopic labs' workflow. Endoscopic examinations are considered high-risk for virus transmission. Objectives: To determine impact of COVID19 pandemic on Hungarian endoscopic labs' workflow and on infection risk of endoscopic staff. Method: A nation-wide, cross-sectional online questionnaire was sent to heads of endoscopic labs in Hungary. The average number (with 95% confidence intervals) of upper and lower gastrointestinal endoscopies performed in 2020 was compared to that in 2019. The number of SARS-CoV-2-infected endoscopic staff members and the source of infection was also investigated. Results: Completion rate was 30% (33/111). Neither the number of upper (1.593 [7431.514] vs. 1.129 [1.0202.166], p = 0.053), nor that of lower gastrointestinal endoscopies (1.181 [8231.538] vs. 871 [5911.150], p = 0.072) decreased in 2020, but both upper and lower gastrointestinal endoscopies' number decreased by 80% during peak phases. Separate examination room was available in 12% of institutes. Appropriate quality personal protective equipment (PPE) was available during the first and second peak phase in 70% and 82%, respectively. Infection risk stratification by questionnaire and PCR testing was routinely performed in 85% and 42%, respectively. Employee number decreased by 33% and 26% for physicians, and by 19% and 21% for assistants during peak phases, mainly due to age restrictions and COVID care assignments. 32% of assistants and 41% of physicians were infected (associated with inappropriate PPE use in 16% and 18%, respectively). Conclusion: Peak phases' restrictions increase endoscopic workload afterwards. Despite PPE availability, 15% of employees' COVID infection resulted from inappropriate PPE use in pre-vaccination era.
Asunto(s)
COVID-19 , SARS-CoV-2 , Humanos , Pandemias , COVID-19/epidemiología , Estudios Transversales , Equipo de Protección PersonalRESUMEN
Endoscopic ultrasonography (EUS) is the most accurate imaging modality for the evaluation of different types of pancreatic cystic lesions. Our aim was to analyze EUS images of pancreatic cystic lesions using an image processing software. We specified the echogenicity of the lesions by measuring the gray value of pixels inside the selected areas. The images were divided into groups (serous cystic neoplasm /SCN/, intraductal papillary mucinous neoplasms and mucinous cystic neoplasms /Non-SCN/ and Pseudocyst) according to the pathology results of the lesions. Overall, 170 images were processed by the software: 81 in Non-SCN, 30 in SCN and 59 in Pseudocyst group. The mean gray value of the entire lesion in the Non-SCN group was significantly higher than in the SCN group (27.8 vs. 18.8; p < 0.0005). The area ratio in the SCN, Non-SCN and Pseudocyst groups was 57%, 39% and 61%, respectively; significantly lower in the Non-SCN group than in the SCN or Pseudocyst groups (p < 0.0005 and p < 0.0005, respectively). The lesion density was also significantly higher in the Non-SCN group compared to the SCN or Pseudocyst groups (4186.6/mm2 vs. 2833.8/mm2 vs. 2981.6/mm2; p < 0.0005 and p < 0.0005, respectively). The EUS image analysis process may have the potential to be a diagnostic tool for the evaluation and differentiation of pancreatic cystic lesions.
RESUMEN
INTRODUCTION: Clinical data on the efficacy and safety of non-medical switch between adalimumab(ADA) biosimilars are limited. AIMS: The aim of this study was to evaluate medium-term clinical efficacy, drug sustainability and safety comparing non-medical switches from the originator to biosimilar ADA, and between ADA biosimilars. METHODS: 276 consecutive patients on maintenance ADA therapy (n = 205 Crohn's disease, n = 71 ulcerative colitis) were included. Data on clinical efficacy, biomarkers and adverse events were collected at four time points: 8-12 weeks prior switch, at baseline/switch, 8-12 weeks and 20-24 weeks after switch. Drug survival was evaluated after a median 40(IQR:35-42) weeks follow-up. RESULTS: A total 174 patients underwent a non-medical switch from the originator to a biosimilar, and 102 patients had a biosimilar-to-biosimilar switch. No significant difference was found in clinical remission rates at any time point in patients switching from originator to biosimilar(87.3%/88.5%/86.5%/85.7%) or biosimilar to biosimilar(74.5%/78.4%/85.3%/79.8%). Mean C-reactive protein levels remained unchanged in both cohorts(p = 0.856 and p = 0.525). Drug survival was similar between the two cohorts with a probability of 91.6%(SE: 2.2) and 87.0%(SE:3.4) to stay on drug after 40 weeks(log-rank:0.96; p = 0.327). Five cases of injection related adverse events were reported. CONCLUSION: Clinical benefit was sustained following non-medical switch from originator to biosimilar, or between biosimilars in adalimumab treated IBD patients.
Asunto(s)
Biosimilares Farmacéuticos , Enfermedades Inflamatorias del Intestino , Humanos , Biosimilares Farmacéuticos/uso terapéutico , Adalimumab/uso terapéutico , Infliximab/uso terapéutico , Fármacos Gastrointestinales/uso terapéutico , Estudios Prospectivos , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Resultado del Tratamiento , Enfermedad CrónicaRESUMEN
It is unclear whether biological antipsoriatic therapies affect seroconversion after messenger ribonucleic acid (mRNA)-based antisevere acute respiratory syndrome coronavirus 2 (anti-SARS-CoV-2) vaccinations. To assess antibody formation and the incidence of side effects after anti-SARS-CoV-2 mRNA vaccinations in psoriatic patients receiving different biologicals compared to healthy controls. 102 moderate-to-severe psoriatic patients (56.2 [±13.5] years) and 55 age-matched healthy (56.4 ± 13.6 years) volunteers were included in our study. Ten to 21 days after the administration of the second dosage of BNT162b2 or mRNA-1273 vaccine, antibody levels specific to the SARS-CoV-2 spike (S) protein receptor binding domain were monitored. The incidence of postvaccination side effects was recorded and compared to real-life data in the literature. Of the 102 patients, 57 (55.88%) received tumor necrosis factor (TNF), 28 (27.45%) received interleukin (IL)-12/23, 16 (15.68%) received IL-17, and 1 (0.99%) received IL-23 inhibitors. No significant differences in the median serum level of anti-SARS-CoV-2S antibody were observed between the study population and the control group (median IQR range: 1681.0 U/mL (600.0-4844.0) versus 1984.0 U/mL (1000.0-3136.0; p = 0.82). The most frequent side effects of the mRNA vaccines within 7 days after the administration of both dosages were arm pain on the side of injection (23.53% and 23.53%), fatigue (9.80% and 13.72%), headache (4.9% and 5.88%), and chills or shivering (4.9% and 8.82%). Detectable antibodies against SARS-CoV-2S protein appear 10-21 days after the administration of the second dosage of BNT162b2 or mRNA-1273 vaccines in moderate-to-severe psoriatic patients receiving biologicals, similar to those of healthy controls.
Asunto(s)
Productos Biológicos , COVID-19 , Vacuna nCoV-2019 mRNA-1273 , Adulto , Anciano , Vacuna BNT162 , Productos Biológicos/efectos adversos , COVID-19/prevención & control , Vacunas contra la COVID-19/efectos adversos , Humanos , Persona de Mediana Edad , Estudios Prospectivos , ARN Mensajero , SARS-CoV-2 , Seroconversión , Vacunación/efectos adversosRESUMEN
Patients with cirrhosis are vulnerable to hepatic decompensation events and death following COVID-19 infection. Therefore, primary vaccination with COVID-19 vaccines is fundamental to reducing the risk of COVID-19 related deaths in patients with cirrhosis. However, limited data are available about the effectiveness of mRNA vaccines compared to other vaccines. The aim of our study was to investigate the efficacy of mRNA vaccines versus other vaccines in cirrhosis. In this retrospective study, we compared clinical characteristics and vaccine effectiveness of 399 COVID-19 patients without cirrhosis (GROUP A) to 52 COVID-19 patients with cirrhosis (GROUP B). 54 hospitalised cirrhosis controls without COVID-19 (GROUP C) were randomly sampled 1:1 and matched by gender and age. Of the cirrhosis cases, we found no difference (p = 0.76) in mortality rates in controls without COVID-19 (11.8%) compared to those with COVID-19 (9.6%). However, COVID-19 patients with cirrhosis were associated with higher rates of worsening hepatic encephalopathy, ascites and esophageal varices. Patients with cirrhosis receiving mRNA vaccines had significantly better survival rates compared to viral vector or inactivated vaccines. Primary vaccination with the BNT162b2 vaccine was the most effective in preventing acute hepatic decompensating events, COVID-19 infection requiring hospital admission and in-hospital mortality.
RESUMEN
Background: Treatment with antitumor necrosis factor alpha (anti-TNF-α) is safe and effective as first-line therapy; however, its efficacy is limited due to primary nonresponse (PNR) and secondary loss of response (LOR), resulting in treatment discontinuation in approximately 40%-50% of cases. Vedolizumab (VDZ) and ustekinumab (UST) therapies could be good alternatives in patient with anti-TNF failure; however, no head-to-head randomized comparison of these drugs as second- or third-line treatments has been made. Objectives: This study aimed to assess the treatment persistence and comparative effectiveness of UST and VDZ in patients with refractory Crohn's disease (CD). Design: In this nationwide retrospective study, patients with CD on UST or VDZ maintenance therapy were enrolled. Clinical data at baseline, after induction, and at week 52 were obtained. Methods: Clinical and biochemical activities as well as corticosteroid-free remission (SFR) rates were assessed, while concomitant medications, comorbidities, hospitalizations, and surgeries were recorded during the follow-up to detect any predictors. Results: A total of 161 UST- and 65 VDZ-treated patients completed the follow-up. No significant difference in clinical or biochemical remission rates was observed after induction between the two treatment groups; however, clinical remission rate at week 52 was higher in UST group. UST showed superior drug persistence than VDZ (86.5%, 57.9%, p < 0.0001). The drug type was predictive of clinical SFR at week 52 [p = 0.011, odds ratio (OR) = 2.39 with UST]. Drug failure rates were higher for VDZ than those for UST (PNR rates: 21.54% and 4.97%, respectively, p < 0.001, OR = 8.267, p = 0.001). LOR and escalations were more common during UST treatment (61.5% versus 36.9%, p < 0.001; 64.2% versus 23.1%, p < 0.001). Hospital and surgical admission rates did not differ significantly. Only one adverse event occurred with VDZ at week 20, which led to drug cessation. Conclusions: VDZ and UST were safe and effective for treating patients with CD in whom anti-TNF therapy failed. UST showed superior drug persistence than VDZ, but dose escalation was more frequent. Biologicals used in lower treatment lines resulted in better drug persistence.