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Background/Aims The use of Janus Kinase Inhibitors (JAKi) has been gradually increasing overtime in the management of rheumatoid arthritis (RA) and other inflammatory arthritis and these appeal to patients. being oral agents. Nevertheless, rheumatologists have become cautious about their use since recent trials have shown safety concerns about VTEs, MACE and malignancies. Methods We decided to study use of JAKi at our centre in Princess of Wales Hospital Bridgend. The aim was to assess whether appropriate patients were selected (considering cautions about MACE, VTEs and malignancies). We also wanted to see whether all patients had required pretreatment safety testing and post-treatment monitoring performed. Results These were 70 patients;59 were females and 11 were males. All of them were diagnosed as RA. Average age was 61.1 years (20-85), average duration of disease 129.9 months (16-340) and average duration of treatment was 58.1 weeks. The most common JAKi being used was baricitinib (84%) followed by tofacitinib (12%) and upadacitinib (4%). 50% patient were on concomitant csDMARDs among whom two-thirds were on methotrexate. Looking at previous biologic use, 9 patients were biologic naive, 22 had one biologic, 15 had two biologics used in the past. All patients were appropriately selected (severe RA and no significant risk factors for MACE, VTEs and malignancies). All patients had pre-treatment Hepatitis B, Hepatitis C, latent TB, FBC and LFTs checked. All patients had FBC and LFTs monitored post treatment. No patient developed VTE, MACE or cancer on treatment. 84.2% patients had lipids tested before starting JAKi. 22.8% patients had abnormal lipids before Rx initiation and 62.5% of these were on lipid lowering Rx. All patients had lipids tested post treatment, but the timing was quite variable and only 62.5% of patients had lipids tested on the recommended time. There were 2 deaths recorded in this cohort. One of those was an 80-year-old RA patient on baricitinib 2mg OD, who died due to chest infection on the background of ILD. He was not on steroids or csDMARDs. The second patient was 63 years' old (on baricitinib 4mg OD), and died due to respiratory sepsis, and was also on azathioprine. She had RA with advanced ILD. The reasons for discontinuing JAKi were inefficacy (46%), side effects (39%) and both inefficacy and side effects (15%). 41.4%of patient experienced side effects due to JAKi. These included infection 28%, deranged lipids 17%, cytopenia 14%, deranged LFTs 14%, GI side effects 10%, skin rash 7% and varicella zoster 3%. Conclusion There has been steady increase in the use of tsDMARDs for RA and other rheumatic conditions. Due to short half-life, these drugs became a popular choice during COVID-19 pandemic but on the other hand safety monitoring became extremely challenging during this time.
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Objectives: Patients with systemic lupus erythematosus (SLE) present greater severity of SARS-CoV-2 infection compared to the general population, particularly those with glomerulonephritis and who are treated with glucocorticoids. Likewise, high disease activity and some immunosuppressants have been associated with worse outcomes. The aim of this study was to describe the characteristics of SARS-CoV-2 infection in patients with SLE in Argentina from the SAR-COVID registry and to establish factors associated with a worse outcome. Method(s): Observational study. Patients diagnosed with SLE with confirmed SARS-CoV-2 infection (RT-PCR and/or positive serology) from the SAR-COVID registry were included. Data were collected from August 2020 to March 2022. The outcome of the infection was measured using the World Health Organization-ordinal scale (WHO-OS). Severe COVID-19 was defined as an WHO-OS value >=5. Descriptive analysis, Student's t , Mann Whitney U, ANOVA, Chi2 and Fisher's tests. Multivariable logistic regression. Result(s): A total of 399 patients were included, 93%female, with a mean age of 40.9 years (SD 12.2), 39.6% had at least one comorbidity. At the time of infection, 54.9% were receiving glucocorticoids, 30.8% immunosuppressants, and 3.3% biological agents. SARS-CoV-2 infection was mild in most cases, while 4.6% had a severe course and/or died. The latter had comorbidities, used glucocorticoids, and had antiphospholipid syndrome (APS) more frequently and higher disease activity at the time of infection. In the multivariate analysis, high blood pressure (OR 5.1, 95% CI 1.8-15.0), the diagnosis of APS (4.7, 95% CI 1.2-15.8), and the use of glucocorticoids (10 mg/day or more: OR 5.5, 95% CI 1.6-20.5) were associated with severe hospitalization and/or death from COVID-19 (WHO-EO >= 5). Conclusion(s): In this cohort of SLE patients with confirmed SARS-CoV-2 infection, most had a symptomatic course, 22.1% were hospitalized, and 5% required mechanical ventilation. Mortality was close to 3%. The diagnosis of APS, having high blood pressure, and the use of glucocorticoids were significantly associated with severe COVID-19.
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Objectives: As of March 5th, 2022, around 1.585 cases of MIS-C and 98 deaths (6,4%) were reported in Brazil. The state of Rio de Janeiro State (RJ) having 94 cases (5,9%) and 4 deaths (4,2%)1.Our aim was to evaluate clinical and laboratory features, and management of MIS-C in seven pediatric hospitals in RJ, Brazil. Method(s): Multicenter, observational, ambidirectional cohort study in seven tertiary hospitals in RJ(Brazil), assessing medical charts of pediatric inpatients (0-18 years) diagnosed with MIS-C according to WHO/CDC criteria, from August, 2020 to February, 2022. Descriptive statistics were used to analyze distributions of continuous variables, frequencies, and proportions. Result(s): A total of 112 cases of MIS-C were enrolled. The mean age was 4.2 years and thre was male predominance (59,8%). All cases had a SARS-CoV-2 contact (29.5% close contact;31.3%:positive PCR;serology:43.8%).Only 12.5% had comorbidities. Length of stay (LOS) was 7 days.Median duration of fever was 8 days. Most common symptoms were: rash(67%);gastrointestinal (67%);conjunctivitis (42%);neurological(39.6%);cardiovascular(37.5%);cervical lymphadenopathy (36.6%), and shock/hypotension(28.6%).Co-infection occurred in 3 patients. Forty-four patients fulfilled criteria for Kawasaki disease. Most patients were admitted to PICU(12;62,5%) for amedian of 2 days. Respiratory distress was seen in 18,7%;hypotension:28,6%, and shock in 23,2%. Main laboratory findings were: high C-reactive protein in 95%;D-dimer:77%, anemia:77%, thrombocytosis:63%;transaminitis:43.8%, lymphopenia:38%;hypoalbuminemia:34%;thrombocytopenia: 29%;hypertriglyceridemia:28%, and high pro-BNP in 27%. Echocardiogram was performed in 91/112 patients;abnormal in 70,3%;exhibiting myocardial dysfunction( 25%);pericardial effusion(21%);coronary dilation/aneurysms(11%) and, valvulitis (14.5%). IVIG+corticosteroids (CTC) were administered in 59.8%(67/ 112);18.6%(18/112) IVIG only;10.7%(12/112) CTC only;3.4%(4/112)biologics, and 15(13.3%) received no treatment. ASA low dose in 77.7% (87/112) and moderate/high dose in 34.8%. Oxygen support was needed in 27,7%;vasoactive amines:18,7%;dialysis:5,3%, and transfusion:18,7%.One patient died from a cytokine storm syndrome. Conclusion(s): Our study reports a higher number of MIS-C cases in RJ than the number reported to Brazilian authorities, highlighting underreporting. Our patients were younger, had fewer comorbidities, cardiovascular/gastrointestinal/renal involvement, shortest LOS in ICU, and a higher frequency of myopericarditis.
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Objective To investigate COVID-19 vaccination status and relevant adverse reactions in patients with psoriasis treated with biological agents, and to explore the effect of COVID-19 vaccination on psoriatic lesions. Methods Clinical data were collected from 572 psoriasis patients aged 18-60 years, who were registered in the management system of psoriasis patients treated with biological agents in the University of Hong Kong-Shenzhen Hospital from May 2019 to June 2021. The COVID-19 vaccination status was investigated by telephone interviews, and the vaccination-related information was obtained by fixed healthcare workers during a fixed time period according to a predesigned questionnaire. Measurement data were compared between two groups by using t test, and enumeration data were compared by using chi- square test or Fisher's exact test. Results The COVID-19 vaccination coverage rate was 43.13%226 casesamong the 524 patients who completed the telephone interview, and was significantly lower in the biological agent treatment group30.79%, 105/341than in the traditional drug treatment group66.12%, 121/183;chi2 = 60.60, P < 0.001. The main reason for not being vaccinated was patients' fear of vaccine safety49.66%, 148/298, followed by doctors' not recommending26.51%, 79/298. In the biological agent treatment group after vaccination, the exacerbation of psoriatic lesions was more common in patients receiving prolonged-interval treatment42.86%, 6/14compared with those receiving regular treatment 4.40%, 4/91;Fisher's exact test, P < 0.001. Skin lesions were severely aggravated in two patients after COVID-19 vaccination, who ever experienced allergic reactions and whose skin lesions did not completely subside after the treatment with biological agents. Conclusions The COVID-19 vaccination coverage rate was relatively low in the psoriasis patients treated with biological agents, and no serious adverse reaction was observed after vaccination. Prolonged-interval treatment due to COVID-19 vaccination ran the risk of exacerbation of skin lesions.Copyright © The Author(s) 2023.
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A well-planned pandemic protocol and define emerging risk preparedness checklist during pandemic help to ensure the shutdown is conducted safely and well efficiently so that manufacturing sites can be returned to normal operation as per defined timeline. As such we have implemented shutdown protocol to mitigate Occupational Health Hazards risk. The major challenge to manage the large workforce and additionally prevention of COVID 19 spread among workforces. COVID 19 risk management is a proactive preparedness which was included in revised shutdown protocol and implanted across all sites. This strategy would be great help to mitigate the risk and successfully completion of shutdown at respective manufacturing location. Methods & Guidelines: Methods: To managed shutdown risk management during a pandemic, the following methodology was considered during planning. * The first step was virtual meeting with the plant team to understand the shutdown job, list of hazardous activities, the number of the workforce, days of shutdown, etc. * The second step was to plan a Sustainable COVID 19 management program including testing and create a Bio bubble for all the employees and business partners involved in the shutdown. * The third step was to determine potential exposure to chemical, physical and biological agents, including medical OH requirements, the review of existing control measures. * The fourth step was to verification, planning, and execution of all requirements in the prescribed checklist and plant round to identify any gaps followed by a plant shutdown meeting. Result(s): Pandemic Management protocol and defined OH-IH emerging risk preparedness checklist during the pandemic had helped to ensured that Shutdown activities were well managed with proactive control program and robust system. Emerging risk details of one of the manufacturing sites are mentioned below. * Total no of workforce health screening: 25000 Nos Approx. * 24x7 ACLS ambulance with medical officer and nursing staff a defined job location * RT PCR testing before entry and periodic testing * Availability of antidotes & Safety Data Sheet * Basic first-aider training and shift wise availability * Arrangement of accommodation (Bio Bubble) till completion of shutdown Conclusion(s): Modified shutdown protocol with inclusion of COVID 19 management is great tool/approach to mitigate OH hazard including COVID 19 in shutdown and comprehensive monitoring of hazardous activities. The recommended control measures would help to ensure the next turnaround project will be completed with a well-defined checklist having all controls in place.
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Background: Inflammatory bowel disease (IBD) may be associated with a more severe course of infections and a different response to vaccination, especially in complicated IBD course and in association with immune-modifying IBD treatment. The aim of this study was to describe COVID-19 pandemic during years 2020 2022 in IBD patients with long-Term biological therapy. Method(s): A retrospective analysis of SARS-CoV-2 infection incidence in the population of 1,177 IBD (Crohn s disease or ulcerative colitis) patients with long-Term biological therapy (IBD cohort) was performed. The incidence rate, crude incidence rate and standardized incidence ratio of COVID-19 in the IBD cohort, the odds ratio of infection depending on the type of biologic therapy administered, the dynamics of COVID-19 incidence depending on the predominant SARS-CoV-2 variant in the population and the current vaccination coverage of the IBD cohort were calculated. Result(s): From January 2020 to April 2022, 548 confirmed cases of COVID-19 (46.6%) were reported in the IBD cohort, with 39% share of PCR positivity in vaccinated individuals and with 95% occurrence of infection in unvaccinated part of the IBD cohort. Standardized incidence rate ratio of COVID-19 was 27% higher in the IBD cohort compared to the general Czech population. The dynamics of the development of the number of positive cases of COVID-19 in the IBD cohort was identical to the situation in the entire country. A higher odds ratio of the chances of infection was demonstrated in patients treated with tumor necrosis factor inhibitors, but not in patients treated with anti-integrins or monoclonal antibodies against interleukins. In the IBD cohort, 85.2% of patients were properly vaccinated, which was significantly more than the vaccination rate of the entire Czech population. Discussion and conclusion: During the two pandemic years, the incidence of COVID-19 in patients with severe IBD and long-Term biological treatment was higher compared to the general Czech population, despite the favorable vaccination coverage of this high-risk patients group. A higher risk was associated with tumor necrosis factor inhibitor therapy.Copyright © 2023 Galen s.r.o.. All rights reserved.
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Background: Little is known about the course of COVID-19 in patients with severe asthma/chronic spontaneous urticaria (CSU) using biological agents. To assess the incidence and course of COVID-19 in patients with severe asthma/CSU using biological agents Method: A total of 202 patients (142 with asthma, 60 with CSU) were enrolled. The subjects were questioned via face-to- face or telephone interview whether they had been diagnosed with COVID-19 and the course of the disease. Result(s): Study group consisted of 132 women, 70 men (median age: 48 years). Thirty-one (15.3%) patients were diagnosed with COVID-19, 22 (71%) of whom were receiving omalizumab and 9 (29%) were receiving mepolizumab. Diagnosed with asthma or CSU, age, sex, smoking, weight, comorbidities, atopy and receiving biological agent were not statistically different between patients with or without COVID-19. Nine COVID -19 patients were hospitalised, three of them required intensive care. Mepolizumab usage was higher in hospitalised patients (5, 55.6%), whereas omalizumab usage was higher in home-treated patients (18, 81%). The mean duration of biologicals usage in home treated patients was significantly higher than that of the hospitalised patients (35.64 months vs.22.56 months, p = 0.024). Biological treatments were interrupted in 47 (23%) patients, self-interruption due to the infection risk was the foremost reason (34%) while having COVID-19 took the next place (28%). Conclusion(s): The incidence of COVID-19 among patients with asthma and CSU on mepolizumab and omalizumab was higher compared to studies from other countries. The disease course appeared mild in patients receiving long-term biological therapy.
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The COVID-19 outbreak may have some impact on the use of biologics in psoriatic patients because immunosuppressive effects of biologics may potentially alter the susceptibility of patients to the virus, deteriorate the condition of infected patients or even change the prognosis of infection. According to currently available recommendations from international psoriasis academic organizations and specialists, as well as specific situation in China, the authors provide some guidance on the use of biologics for psoriatic patients undergoing or planning to undergo treatment with biologics, those with low or high risk of infection, and for those with or without COVID-19 infection, so as to provide references for clinical practice.Copyright © 2020 by the Chinese Medical Association.
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Background: In first pandemic wave, SARS-CoV2 infection was hypothesized to be more frequent and severe in asthmatic patients with reduced anti-viral immune response and typical disease flares during viral respiratory infections. Despite this, the studies performed to date have not confirmed these data. The purpose of our research is to evaluate the prevalence and clinical trend in patients with bronchial asthma among hospitalized for COVID-19 in North-West Italy. Method(s): In our multicentre retrospective study, we enrolled all patients hospitalized for COVID-19 from February to July 2020 at four leading hospitals: City of Health and Science of Turin (Molinette-unit), Umberto I Hospital (Turin), Umberto Parini Hospital (Aosta) and Santa Croce and Carle Hospital (Cuneo). We inclueded all patients with SARS-CoV- 2 positive nasopharyngeal swab and/or serology and/or clinical features highly suggestive of SARS-CoV- 2 infection and a hospital stay for COVID-19 of more than 48 hours. We excluded patients with exacerbation of disease not related to SARS-CoV- 2 and fewer than 48 hours of hospital stay;for each patient were collected demographic and clinical data before and during admission. Result(s): We evalueted 1016 patients: 110 (10.8%) had obstructive airway disease [71 COPD (6.9%) and 39 bronchial asthma (6.9%)]. The majority of patients with asthma took an inhaled corticosteroids (ICS) with or without Short or Long Acting Beta-Agonists (SABA, LABA) at home (56.4%);only two cases had severe asthma, both in therapy with biologics. A comparison of clinical trend and outcomes in patients with asthma, COPD and no history of obstructive lung disease is in Table 1. Conclusion(s): The prevalence of asthma among hospitalized for COVID-19 was lower than the prevalence data reported in the general population (3.8 vs 6.6% reported by ISTAT), in Piedmont and Val d'Aosta1 (3.8 vs 5.7%) and in recent meta-analysis2 (3.8 vs 8.08%). There were no significant differences between asthmatics and non-asthmatics in gender, age, smoking habits, associated comorbidities, length of hospital stay, development of disease complications, invasive and/or non-invasive ventilation, treatment with hydroxychloroquine, antivirals or biologics or mortality.
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Background: One of the most disadvantageous group of people in Covid 19 pandemic are those with chronic diseases who have been unable to reach medical services they should have. The aim of our study was to investigate if our patients receiving either subcutaneous allergen immunotherapy (SCIT) or biologicals had been effected in terms of compliance to their treatment. Method(s): All of our patients that were being followed in our outpatient clinic receiving a regular treatment -either SCIT or a biological agent -before January 2020 were included in the study. The study group consisted of a total of 223 adult patients of whom 128 were on SCIT and 95 on a biological agent. We applied a conversation based survey to each patient by means of a phone call or during an office visit to identify any disruption in their treatment. We also screened our patient files to collect demographic data and data related to the diagnosis and duration of therapy. Patients were also asked if they had past Covid -19 infection or not. Result(s): Out of 128 patients receiving SCIT for an aeroallergen or venom,124 patients (median age 38 (min-max 18-66)) could have the survey completed. Eighty one patients (63.3%) reported that they couldn't continue their treatment while 43 (37.6%) patients could. The most common reasons of noncompliance were the reluctance of patients to go to the hospital with the fear of getting Covid 19 infection (n = 36 ;44.4%) and the difficulties in supplying the allergen immunotherapy product (n = 15;18.5%). Fourteen patients (17.3%) left the treatment as they were already close to the end of the scheduled treatment duration. Ninety one patients (median age 53 (min-max 19-75)) out of 95 who were on a biological treatment-either omalizumab or mepolizumab-had completed the survey. Only nine patients (9.9%) left the treatment while 82 patients (90.1%) did not. The most common reason for noncompliance was similarly the reluctance to go to the hospital in 4 (4.4%) of the patients . Twenty one of the SCIT patients (16.9%) and 22 patients (24.2%) receiving biologicals had documented Covid 19 infection. Conclusion(s): Covid 19 pandemic had a negative effect on our patients'compliance to their treatment. This effect was apparently higher in the patients receiving SCIT who should have their shots only in an allergy clinic under close supervision while patients on biologicals may receive their treatments in other healthcare centers.
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Background: The use of biologics during the pandemic has raised concerns throughout the scientific community. The current guidelines suggest continuing the use of biologics during the pandemic, while the initiation or continuation of treatment in case of symptomatic disease are remaining controversial unanswered questions. As a result the purpose of this study was to determine the frequency of symptomatic COVID19 infection in patients treated with biologic agents in an Allergy Unit of a University Hospital during the pandemic. Method(s): Patients of the Allergy Unit "D Kalogeromitros", who due to asthma, atopic dermatitis, Chronic Spontaneous Urticaria(CSU) or Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)were under treatment with biologic agents were included in the present study. Treatment of at least 2 months until the 31/12/2021 was necessary for a patient to be included in the present study. Result(s): A total of 77 patients [46 (59.7%) women, mean age 48.2 (range 15-82) years were included. The mean duration of treatment with biologics was 34.9 months (SD: +/-37 months). Overall, 83.1% (64/77) of patients were receiving omalizumab for asthma and CSU [13/64 (20.3%) and 51/64 (79.6%) respectively] while 9.1% (7/77) were receiving dupilumab for atopic dermatitis (4/7) and CRSwNP [4/7 (57.1%) and 3/7 (42.8%) respectively]. In addition, 5/77 (6.5%) and 1/77 (1.2%) were under treatment with mepolizumab and one with benralizumab respectively, due to severe uncontrolled asthma. A total of 6 patients with chronic spontaneous urticaria and 2/19 patients with asthma (1/5 with mepolizumab and 1/13 with omalizumab) had symptomatic COVID 19 infection as confirmed with a positive Polymerase Chain Reaction or Rapid Test. None of the patients treated with benralizumab or dupilumab had symptomatic COVID19 infection. Overall, 8/77 (10.3%) of patients had symptomatic SARS-CoV2 infection during the above period, a rate similar to the onein the same period identified in the general Greek population (11.2%). All patients had mild symptoms during the disease course with no patient admission to hospital. Conclusion(s): The frequency of symptomatic COVID19 infection identified in a population of Greek patients treated with biologic agents was no higher than than the one in the general Greek population. Furthermore, all patients had a mild course of the disease with no admissions, indicating that the use of biologics is a safe choice and can be continued during the pandemic.
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Background Taletrectinib is a potent, next-generation, CNS-active, ROS1 tyrosine kinase inhibitor (TKI) with selectivity over TRKB. In previous reports from TRUST-I, taletrectinib showed meaningful clinical efficacy and was well tolerated in pts with ROS1+ NSCLC (n = 109) regardless of crizotinib (CRZ) pretreatment status. We report updated efficacy and safety data with ~1.5 yr follow-up. Methods TRUST-I is a multicenter, open-label, single-arm study with two cohorts: ROS1 TKI-naive and CRZ-pretreated. Pts in both cohorts received taletrectinib 600 mg QD. Key study endpoints included IRC-confirmed ORR (cORR), DoR, disease control rate (DCR), PFS, and safety. A pooled analysis of ORR, PFS, and safety including pts from additional clinical trials was also conducted. Results In the 109 pts from TRUST-I (enrolled prior to Feb 2022) the median follow-up was 18.0 mo in TKI-naive (n = 67) and 16.9 mo in CRZ-pretreated pts (n = 42). cORR was 92.5% in TKI-naive and 52.6% in CRZ-pretreated pts (table). Median DoR (mDoR) and mPFS were not reached. Intracranial-ORR was 91.6%;ORR in pts with G2032R was 80.0%. In a pooled analysis with phase I studies, ORR was 89.5% and 50.0% for TKI-naive and CRZ-pretreated pts, respectively;mPFS was 33.2 mo and 9.8 mo. In 178 pts treated at 600 mg QD, treatment-emergent adverse events (TEAEs) were 92.7%;most (64.0%) were grade 1-2. The most common TEAEs were increased AST (60.7%), increased ALT (55.6%), and diarrhea (55.6%). Neurological TEAEs (dizziness, 18.5%;dysgeusia, 12.4%) and discontinuations due to TEAEs (3.4%) were low. Further updated results will be presented. [Formula presented] Conclusions With additional follow-up, taletrectinib continued to demonstrate meaningful efficacy outcomes including high response rates, prolonged PFS, robust intracranial activity, activity against G2032R, and tolerable safety with low incidence of neurological AEs. Clinical trial identification NCT04395677. Editorial acknowledgement Medical writing and editorial assistance were provided by Arpita Kulshrestha of Peloton Advantage, LLC, an OPEN Health company, and funded by AnHeart Therapeutics, Inc Legal entity responsible for the study AnHeart Therapeutics, Inc. Funding AnHeart Therapeutics, Inc. Disclosure S. He: Financial Interests, Personal, Other, Employment: AnHeart Therapeutics. T. Seto: Financial Interests, Institutional, Research Grant: AbbVie, Chugai Pharmaceutical, Daiichi Sankyo, Eli Lilly Japan, Kissei Pharmaceutical, MSD, Novartis Pharma, Pfizer Japan, Takeda Pharmaceutical;Financial Interests, Personal, Other, Employment: Precision Medicine Asia;Financial Interests, Personal, Speaker's Bureau, Honoraria for lectures: AstraZeneca, Bristol-Myers Squibb, Chugai Pharmaceutical, Covidien Japan, Daiichi Sankyo, Eli Lilly Japan, Kyowa Hakko Kirin, MSD, Mochida Pharmaceutical, Nippon Boehringer Ingelheim, Novartis Pharma, Ono Pharmaceutical, Pfizer Japan, Taiho Pharmaceutical, Takeda Pharmaceutical, Towa Pharmaceutical. C. Zhou: Financial Interests, Personal, Other, Consulting fees: Innovent Biologics Qilu, Hengrui, TopAlliance Biosciences Inc;Financial Interests, Personal, Speaker's Bureau, Payment or honoraria: Eli Lilly China, Sanofi, BI, Roche, MSD, Qilu, Hengrui, Innovent Biologics, C-Stone LUYE Pharma, TopAlliance Biosciences Inc, Amoy Diagnositics, AnHeart. All other authors have declared no conflicts of interest.Copyright © 2023 International Association for the Study of Lung Cancer. Published by Elsevier Inc.
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Case report Background: It is well known that chronic spontaneous urticaria (CSU) has an autoimmune etiology in 40% of cases. It is often comorbid with other autoimmune diseases and a wide spectrum of autoantibodies involved in the pathogenesis of CSU is discussed. Objective(s): We share a clinical case of a rare underline autoimmune disease with later onset of CSU and chronic induced urticaria (CIU). Case: A 38-year- old woman was admitted to the hospital with SARS-CoV- 2 infection. At the age of 22, she was diagnosed with Takayasu's disease involving the aorta, the common and external carotid artery, and the left subclavian artery. Surgical interventions were performed twice -angioplasty of the involved vessels, but in both cases restenosis of the affected arteries was observed. Regarding the underlying disease, the patient received 10 mg of methotrexate once a week and 20 mg of prednisone daily. Due to detailed history collection, the patient noted that for the last 4 months she has rashes, bright red in color, rising above the surface of the skin and accompanied by a strong burning and itching dominantly on the upper and lower extremities, trunk. Appearing every day spontaneously, they have a rounded shape (diameter of up to 40-50 mm). While liner scratching the rash has similar contour. Rash elements disappear within a few hours, do not leave traces. During the current hospitalization, a wheal element up to 40 mm in diameter was observed at the wrist area, stayed for a few hours. UAS-7 -42. According to examination: eosinophils 1000 cells/mcl (patient noticed that eosinophilia of the blood has happened before, an examination was conducted, helminthiasis and parasitosis were excluded), total IgE -more than 2000 IU/ml, antibodies to b2-glycoprotein were revealed. Freak test -negative, but the linear wheals were confirmed by retrospective photos. Result(s): In this clinical case, CSU occurs in combination with induced dermographic urticaria. This patient has extremely aggressive urticaria according to its frequency of occurrence despite therapy with systemic GCS and methotrexate. After recovery from coronavirus infection, further examination and consideration of the appointment of biologicals(anti-IgE) is planned.
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Different health care strategies have been implemented worldwide due to the pandemic. We explore a new approach to guarantee the follow-up of severe asthmatic (SA) children. Method(s): A retrospective/prospective cohort study. All children (GINA guidelines) from the SA clinic at Garrahan Hospital were included. Clinic attendance (virtual [V] or face-to-face [FF]), asthma control (ACT), asthma exacerbations (AE) and hospitalizations (H) were evaluated in the same group during two periods: March 2019- March 2020 (FFP) and April 2020-April 2021 (VP). During VP children performed a validated electronic ACT that was sent monthly through an electronic APP, 48 hours after they were contacted via a phone call. Student's/Wilcoxon paired tests. P <0.05 Results: All SA patients (n 74) were seen every two months during FFP;47% male;median age 13 years (IQR 10- 15) and 68 (92%) of them during VP. In FFP, 393 visits were registered (5.3 visit/pat/year);246 ACT were performed (3.3 ACT/pat/year), 22% (n 54) were uncontrolled (ACT<20). During VP, 816 ACT were sent with 642 replies (79%), 9.4 ACT/pat/year;19% (n 120) <20. There were 46 (67%) patients with AE during FFP vs 31 (46%) in VP (p 0.0004);AE in FFP 135 vs 79 in VP (p 0.0031), (2 vs 1.1 AE/pat/year) with AE decrease of 41%;91 prescribed steroid courses in FFP (1.3 courses/pat/year) vs 49 in VP (0.72 courses/pat/year) (p 0.006), with a reduction of 46%. There were no differences in H (FFP 10, VP 6;p 0.39). In FFP 19% of patients were under biologics while 12% during VP. Conclusion(s): Virtual team clinics and electronic ACT at home were introduced easily and effectively during pandemic to manage SA children. Follow-up of almost all patients could be ensured.
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Advances in technology have resulted in increasing adoption of virtual dermatology services across the National Health Service. This has accelerated dramatically during the COVID-19 pandemic. Providing remote consultation alternatives empowers many patients to manage their health away from traditional in-person services. However, there is concern that universal implementation of such services may potentially widen healthcare inequalities for some patient groups. Reliably identifying at-risk groups is challenging. Co-design of health services has been proposed as a method to ensure equality and appropriateness of provision for all patients accessing a service by including them in the design process. In this study we profile the digital health literacy of patients with chronic skin conditions with the aim of using this information to redesign virtual services to support their long-term skin health. The Multidimensional Readiness and Enablement Index for Health Technology (READHY), comprising the eHealth Literacy Questionnaire (eHLQ), Health Literacy Questionnaire (HLQ) and Health Education Impact Questionnaire (heiQ), was used to assess patient skills, confidence and experience in using technology to manage their health. Consecutive patients under long-term follow-up in two specialist clinics supporting chronic skin conditions (organ transplant surveillance and biologics monitoring) completed questionnaires either in person or over the telephone. Between July and November 2021, 99 of 128 (77.3%) of patients invited to participate took part. Overall, these patients showed high levels of self-management skills, determination not to let health problems control their life and good support from family and healthcare professionals. In the domains related to digital skills, the responses were diverse. A cluster analysis identified multiple groups of patients with varying combinations of higher or lower level of digital health literacy, social and healthcare support, as well as capabilities in handling health condition and emotional responses. These preliminary data have provided important information for optimizing a co-design process aimed at tailoring services to support patients with chronic skin diseases. In particular, it has identified patient groups with distinct differences in terms of digital health literacy. Recognition of these groups and their differing profiles in terms of barriers to accessing virtual healthcare will be a key consideration in ensuring equitable representation in the service co-design process. It provides opportunities to target support to those patients with lower digital health literacy skills so that they may benefit from virtual services or adaptation of these services to address their specific needs. Alternatively, it allows recognition of patient groups who have higher digital health literacy and may safely benefit from alternative approaches to service provision such as patient-initiated follow-up.
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Background: Intravenous (IV) infliximab (IFX) monotherapy is associated with significant loss of response. Therapeutic drug monitoring shows an association with low serum trough drug levels and development of anti-IFX antibodies. Combination therapy with immunomodulators is not always possible, and IFX dose escalation leads to higher drug costs and time pressure on infusion units. Both approaches have raised heightened patient safety concerns due to the Covid-19 pandemic. Subcutaneous (SC) IFX pharmacokinetics lead to improved drug trough levels, which could lead to better clinical outcomes. Method(s): The NHS Greater Glasgow and Clyde biologics database was used to identify selected patients currently treated with IV IFX for IBD for suitability for SC switch. Patients were contacted to allow informed choice to opt in or out of switch. Baseline clinical data was collected, and patients were reviewed at week 8 and week 24 for assessment of clinical disease activity scores, IFX trough levels/anti-drug antibody levels, and faecal calprotectin. Patient experience outcomes were assessed using a quality of life questionnaire (CUCQ-8). Result(s): 31 patients consented to switch;F:M = 17:14. The majority of patients (16) had Crohn's disease, with 13 with UC and 2 IBDU. Mean duration of disease was 9.1 years and duration of prior IV therapy was 3.3 years. 28 patients were reviewed at week 8 and 24 at week 24. At week 24, 71% of patients were in clinical remission (Harvey-Bradshaw index score <5 or partial Mayo score <2), 96% had CRP <5 mg/Land 87% had FCP <250mug/g. 21% of patients had subtherapeutic IFX trough levels at baseline, all had increased by week 8 and there were no subtherapeutic levels measured by week 24. One patient had detectable antibodies at week 24, compared with 9 patients at baseline. Three patients required oral steroid therapy during the 24-week follow up period. There were no hospital admissions, significant infections or adverse reactions within the cohort. 15 patients submitted CUCQ-8 scores, of these 7 patients' scores had worsened at week 8 but by week 24 13/15 were stable or improved compared to baseline. Conclusion(s): Switching from IV to SC infliximab is welcomed by most patients. The efficacy, tolerability, increased drug level and safety which has previously been demonstrated is reproduced in our cohort. This study is the first to explore patient experience outcomes. The finding of initial worsening of the CUCQ-8 score, but overall improvement by week 24 opens further opportunity for engaging patient involvement in switch programmes.
ABSTRACT
Introduction: COVID 19 pandemic has caused unprecedented devastation worldwide. Spectrum of Covid 19 illness is wide and variable. Risk of mortality is increased in chronic kidney disease patients, during coronavirus disease. CKD is an independent risk factor for poor outcome. AKI is also common in COVID-19 patients who are hospitalized. This study was undertaken to see the outcome of Covid-19 infection in CKD patients. Method(s): This retrospective observational study was carried out in the Kidney Foundation Hospital and Research Institute, Bangladesh from January 2021 to July 2022. One hundred CKD patients who were on regular follow up in the outpatient department and developed COVID-19 as confirmed by reverse transcription polymerase chain reaction (RT-PCR) test underwent chart review after they consented to be part of the study. Their clinical parameters, treatment regiments and laboratory investigations were noted in a data collection sheet. Data was analyzed by Statistical Analysis Software. Result(s): The mean age of the patients was 55.2 years. Of them 43% were female. Diabetes mellitus was the most common comorbidity, seen in 65% of the patients. 24% were CKD stage 4 or 5 prior to the onset of COVID-19, rest were of earlier stage. Hospitalization was required in 65.3% patients;41.1% required oxygen, steroid given in 19.8% patients,8.4% required ICU transfer. 7 patients died, all of respiratory failure. Treatment with antiviral, biologics like Tocilizumab and plasma exchange was not commonly done. AKI developed in 28% of the patients during the course of the illness. Males were more prone to develop AKI (p = 0.23). People with longer duration of symptoms had higher incidence of AKI (p < 0.0001). AKI incidence did not vary according to baseline eGFR (p = 0.16). Among those who developed AKI, 17.9% required temporary dialysis and 7.1% went on to develop end stage kidney disease. Interim outcomes such as hospitalization, oxygen requirement, ICU transfer and death did not vary according to development of AKI. Conclusion(s): People with chronic kidney disease and other comorbid conditions are at higher risk for more serious COVID-19 illness. In our study it has been shown that a significant proportion of CKD patients developed AKI after COVID 19 infection of which a number of patients develop end stage kidney disease and required renal replacement therapy. No conflict of interestCopyright © 2023
ABSTRACT
Still's disease in children (systemic juvenile idiopathic arthritis - JIA) and adult Still's disease (ASD) are considered as systemic autoinflammatory diseases of unknown etiology, which are based on similar immunopathogenetic mechanisms associated with genetically determined disorders of the mechanisms of innate immunity. ASD was first described 50 years ago by the English rheumatologist Eric George Lapthorne Bywaters. The molecular basis of ASD immunopathogenesis is the activation of innate immunity associated with NLRP3 inflammasome-dependent mechanisms of inflammation, characterized by the overproduction of "pro-inflammatory" cytokines - interleukin (IL) 1 and IL-18, inducing the synthesis of other proinflammatory inflammatory mediators. A review of new data concerning the mechanisms of immunopathology, clinical polymorphism, laboratory biomarkers and the possibilities of ASD pharmacotherapy is presented. Particular attention is paid to the prospects for the use of monoclonal antibodies to IL-1beta - canakinumab. The problems associated with the generality of clinical and laboratory disorders, pathogenetic mechanisms and pharmacotherapy of ASD and coronavirus disease 2019 (COVID-19) are considered.Copyright © 2021 Authors. All rights reserved.