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OBJECTIVES: We aimed to explore current practice and interregional differences in the treatment of idiopathic inflammatory myopathies (IIMs). We triangulated these observations considering countries' Gross National Income (GNI), disease subtypes, and symptoms using patient-reported information. METHODS: A cross-sectional ancillary analysis of the "COVID-19 vaccination in auto-immune disease" (COVAD) e-survey containing demographic characteristics, IIM subtypes (dermatomyositis (DM), polymyositis (PM), inclusion-body myositis (IBM), anti-synthetase syndrome (ASSD), immune-mediated necrotizing myopathy (IMNM), overlap myopathies (OM)), current symptoms (surrogate for organ involvement), and treatments (corticosteroids (CS), immunomodulators (IM), i.e., antimalarials, immunosuppressants (IS), intravenous immunoglobulins (IVIG), biological treatments, and targeted-synthetic small molecules). Treatments were presented descriptively according to continents, GNI, IIM, and organ involvement, and associated factors were analyzed using multivariable binary logistic regressions. RESULTS: Of 18,851 respondents from 94 countries, 1,418 with IIM were analyzed (age 61 years, 62.5% females). DM (32.4%), IBM (24.5%), and OM (15.8%) were the most common subtypes. Treatment categories included IS (49.4%), CS (38.5%), IM (13.8%), and IVIG (9.4%). Notably, treatments varied across regions, GNI categories (IS mostly used in higher-middle income, IM in lower-middle income, IVIG and biologics largely limited to high-income countries), IIM subtypes (IS and CS associated with ASSD, IM with OM and DM, IVIG with IMNM, and biological treatments with OM and ASSD) and disease manifestations (IS and CS with dyspnea). Most inter-regional treatment disparities persisted after multivariable analysis. CONCLUSION: We identified marked regional treatment disparities in a global cohort of IIM. These observations highlight the need for international consensus-driven management guidelines considering patient-centered care and available resources.
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Background/Aims Post COVID-19 syndrome (PCS) is an emerging cause of morbidity and poor quality of life in COVID-19 survivors. We aimed to assess the prevalence, risk factors, outcomes, and association with disease flares of PCS in patients with autoimmune rheumatic diseases (AIRDs) and non-rheumatic autoimmune diseases (nrAIDs), both vulnerable groups understudied in the current literature using data from the 2nd COVID-19 Vaccination in Autoimmune Diseases (COVAD) global multicentre patient self-reported e-survey. Methods The survey was circulated from February to July 2022 by the international COVAD Study Group (157 collaborators from 106 countries), and demographics, comorbidities, AIRD/nrAID status, COVID-19 history, vaccination details, and PROMIS physical and mental function were recorded. PCS was defined as symptom resolution time >90 days following acute COVID-19. Predictors of PCS were analysed using regression models for the different groups. Results 7666 total respondents completed the survey. Of these, 2650 respondents with complete responses had positive COVID-19 infection, and 1677 (45.0% AIRDs, 12.5% nrAIDs, 42.5% HCs) completed the survey >90 days post acute COVID-19. Of these, 136 (8.1%) had PCS. Prevalence of PCS was higher in AIRDs (10.8%) than healthy controls HCs (5.3%) (OR: 2.1;95%CI: 1.4-3.1, p=0.002). Across the entire cohort, a higher risk of PCS was seen in women (OR: 2.9;95%CI: 1.1-7.7, p=0.037), patients with long duration of AIRDs/ nrAIDs (OR 1.01;95%CI: 1.0-1.02, p=0.016), those with comorbidities (OR: 2.8;95%CI: 1.4-5.7, p=0.005), and patients requiring oxygen supplementation for severe acute COVID-19 (OR: 3.8;95%CI: 1.1- 13.6, p=0.039). Among patients with AIRDs, comorbidities (OR 2.0;95%CI: 1.08-3.6, p=0.026), and advanced treatment (OR: 1.9;95%CI: 1.08-3.3, p=0.024), or intensive care (OR: 3.8;95%CI: 1.01-14.4, p=0.047) for severe COVID-19 were risk factors for PCS. Notably, patients who developed PCS had poorer PROMIS global physical [15 (12-17) vs 12 (9-15)] and mental health [14 (11-16) vs 11 (8-14)] scores than those without PCS. Conclusion Individuals with AIRDs have a greater risk of PCS than HCs. Associated comorbid conditions, and advanced treatment or intensive care unit admission for severe COVID-19 confer a higher risk of PCS. It is imperative to identify risk factors for PCS for immediate multidisciplinary management in anticipation of poor physical and mental health.
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Background/Aims Flares following COVID-19 vaccination are an emerging concern among patients with rare rheumatic disease like idiopathic inflammatory myositis (IIMs), whereas data and understanding of this is rather limited. We aimed to study the prevalence, characteristics and determinants of IIM flares following COVID-19 vaccination. Methods CoVAD (COVID-19 Vaccination In Autoimmune Diseases) surveys are global patient self-reported e-surveys from 109 countries conducted in 2021 and 2022. Flares of IIM were defined by 4 definitions;a. patient self-reported, b. physician and immunosuppression (IS) denoted, c. sign directed (new erythematous rash, or worsening myositis or arthritis), d. MCID worsening of PROMISPF10a score between the patients who had taken both surveys. Descriptive statistics and multivariate regression were used to describe the predictors of flare. Cox-regression analysis was used to differentiate flares by IIM subtypes. Results Among the 1,278 IIM patients, aged 63 (50-71) years, 276 (21.5%) were dermatomyositis, 237 (18.5%) IBM, 899 (70.3%) were female and most were Caucasian (80.8%). Flares of IIM were seen in 123/1278 (9.6%), 163/1278 (12.7%), 112/1278 (8.7%), and 16/96 (19.6%) by definitions a-d respectively with median time to flare being 71.5 (10.7- 235) days. Muscle weakness (69.1%), and fatigue (56.9%) were the most common symptoms of flare. The predictors of self-reported flare were: inactive/disease in remission prior to first dose of vaccine (OR=4.3, 95%CI=2.4-7.6), and anxiety disorder (OR=2.2, 95%CI=1.1-4.7). Rituximab use (OR=0.3, 95%CI=0.1-0.7) and IBM (OR=0.3, 95%CI=0.1-0.7) were protective. Physician defined flares were seen more often in females, mixed ethnicity, and those with asthma, ILD, and anxiety disorder (OR ranging 1.6-7.0, all p<0.05). Notably, overlap myositis (OM) had higher HR for flare compared to polymyositis (HR=2.3, 95%CI=1.2-4.4, p=0.010). Conclusion Nearly one in ten individuals with IIM develop flares after vaccination, more so among women, those with overlap myositis, and inactive disease prior to vaccination. Formal definition of flares in IIM is needed.
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BACKGROUND: Recent disruption of medical oxygen during second wave of COVID-19 has caused nationwide panic. This study attempts to objectively analyze the medical oxygen supply chain in India along the principles of value stream mapping (VSM), identify bottlenecks and recommend systemic improvements. METHODOLOGY: Process mapping of the medical oxygen supply chain in India was done. Different licenses & approvals, their conditions, compliances, renewals among others were factored-in. All relevant circulars (Government Notices), official orders, amendments and gazette notifications pertaining to medical oxygen from April 2020-April 2021 were studied and corroborated with information from Petroleum & Explosives Safety Organization (PESO) official website. FINDINGS: Steps of medical oxygen supply chain right from oxygen manufacture to filling, storage and transport up to the end users; have regulatory bottlenecks. Consequently flow of materials is sluggish and very poor information flow has aggravated the inherent inefficiencies of the system. Government of India has been loosening regulatory norms at every stage to alleviate the crisis. CONCLUSION: Regulatory bottlenecks have indirectly fueled the informal sector over the years, which is not under Government's control with difficulty in controlling black-marketing and hoarding. Technology enabled, data-driven regulatory processes with minimum discretionary human interface can make the system more resilient.
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OBJECTIVE: COVID-19 vaccines have a favorable safety profile in patients with autoimmune rheumatic diseases (AIRDs) such as idiopathic inflammatory myopathies (IIMs), however hesitancy continues to persist among these patients.Therefore, we studied the prevalence, predictors, and reasons for hesitancy in patients with IIMs, other AIRDs, non-rheumatic autoimmune diseases (nrAIDs) and healthy controls (HCs), using data from the two international COVID-19 Vaccination in Autoimmune Diseases (COVAD) e-surveys. METHODS: The 1st and 2nd COVAD patient self-reported e-surveys were circulated from March to December 2021, and February to June 2022 (ongoing). We collected data on demographics, comorbidities, COVID-19 infection and vaccination history, reasons for hesitancy, and patient reported outcomes. Predictors of hesitancy were analyzed using regression models in different groups. RESULTS: We analyzed data from 18,882 (COVAD-1) and 7666 (COVAD-2) respondents. Reassuringly, hesitancy decreased from 2021 (16.5%) to 2022 (5.1%) [OR 0.26; 95%CI: 0.24-0.30, p < 0.001]. However, concerns/fear over long-term safety had increased [OR 3.6;95% CI:2.9-4.6, p < 0.01].We noted with concern greater skepticism over vaccine science among patients with IIMs than AIRDs [OR:1.8; 95%CI: 1.08-3.2, p = 0.023] and HCs [OR: 4; 95%CI: 1.9-8.1, p < 0.001], as well as more long-term safety concerns/fear [IIMs vs AIRDs; OR: 1.9; 95%CI: 1.2-2.9, p = 0.001; IIMs vs HCs; OR: 5.4 95%CI: 3-9.6), p < 0.001].Caucasians [OR 4.2 (1.7-10.3)] were likely to be more hesitant, while those with better PROMIS physical health score were less hesitant [OR 0.9 (0.8-0.97)]. CONCLUSION: Vaccine hesitancy has decreased from 2021 to 2022, long-term safety concerns remain among patients with IIMs, particularly in Caucasians and those with poor physical function.
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Background. Significant gaps are present in the evidence of the spectrum and severity of COVID-19 infection in idiopathic inflammatory myopathies (IIMs). Patients with IIMs typically require immunosuppressive therapy, may have multiple disease sequelae, and frequent comorbidities, and thus may be more susceptible to severe COVID-19 infection and complications. The possibility of attenuated immunogenicity and reduced efficacy of COVID-19 vaccines due to concomitant immunosuppressive medication is a major concern in these patients, and there is little data available on COVID-19 vaccine breakthrough infections (BI) in IIMs Methods. We developed an extensive patient self-reporting electronic-survey (COVAD survey) featuring 36 questions to collect respondent demographics, SAID details, COVID-19 infection history, COVID-19 vaccination details, 7-day post vaccination adverse events and patient reported outcome measures using the PROMIS tool. After pilot testing, validation, translation into 18 languages on the online platform surveymonkey.com, and vetting by international experts, the COVAD survey was circulated in early 2021 by a multicenter study group of >110 collaborators in 94 countries. BI was defined as COVID-19 infection occurring more than 2 weeks after receiving 1st dose of a COVID-19 vaccine. We analysed data from the baseline survey for descriptive and intergroup comparative statistics based on data distribution and variable type. Results. Data from 10,900 respondents [42 (30-55) years, 74% females, 45% Caucasians] were analysed. Most were HCs (47%), followed by SAIDs (42%) and IIMs (11%). All respondents included in the final analysis had received a single dose of the vaccine and 69% had received 2 primary doses. Pfizer (39.8%) was the most common vaccine received, followed by Oxford/AstraZeneca (13.4%), and Covishield (10.9%). IIM patients were older, had a higher Caucasian representation and higher Pfizer uptake than other SAIDs, and HC. A higher proportion of IIM patients received immunosuppressants than other SAIDs. After adjustment for covariates, COVID-19 severity and BIs were comparable among patients with IIMs, SAIDs, and HCs, except for all-cause hospitalisation prior to vaccination (IIMs vs. HCs, OR=2.5, 95%CI 1.1-5.8) and COVID-19 cases prior to vaccination (IIMs vs. SAIDs, OR=0.6, 95%CI 0.4-0.8, and IIMs vs HCs, OR=0.4, 95%CI 0.3-0.5). BIs in IIMs were uncommon, with only 17 (1.4%) patients reporting BIs, of whom 13 were on immunosuppressants, and 3 required hospitalisation. Unvaccinated individuals with IIMs were at 4.6 (95%CI 2.7-8.0) times higher odds for developing COVID-19, and the 2nd vaccine dose had a protective effect on BI occurrence (Figure 1). Conclusion. IIMs patients reported fewer COVID-19 prior to vaccination than SAIDs and HCs, but had higher odds of all-cause hospitalisation than HCs. Vaccination protected patients with IIMs against COVID-19. COVID-19 breakthrough infections were uncommon in IIMs, with a similar symptom profile, disease duration, and severity in comparison to patients with SAIDs and HCs.
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OBJECTIVES: Disease flares in the post COVID-19 vaccination period represent a prominent concern, though risk factors are poorly understood. We studied these flares among patients with idiopathic inflammatory myopathies (IIMs) and other autoimmune rheumatic diseases (AIRDs). METHODS: The COVAD-1 and -2 global surveys were circulated in early 2021 and 2022 respectively, and we captured demographics, comorbidities, AIRDs details, COVID-19 infection history, and vaccination details.Flares of IIMs were defined as a. patient self-reported, b. immunosuppression (IS) denoted, c. clinical sign directed, and d. with >7.9-point MCID worsening of PROMISPF10a score. Risk factors of flares were analyzed using regression models. RESULTS: Of 15165 total respondents, 1278 IIMs (age 63 years, 70.3% female, 80.8% Caucasians), and 3453 AIRDs were included. Flares of IIM were seen in 9.6%, 12.7%, 8.7%, and 19.6% patients by definitions a-d respectively with a median time to flare of 71.5 (10.7-235) days, similar to AIRDs. Patients with active IIMs pre-vaccination (OR:1.2; 95%CI:1.03-1.6, p = 0.025) were prone to flares, while those receiving Rituximab (OR:0.3; 95%CI:0.1-0.7, p = 0.010) and Azathioprine (OR:0.3, 95%CI:0.1-0.8, p = 0.016) were at lower risk. Female gender and comorbidities predisposed to flares requiring changes in immunosuppression. Asthma (OR: 1.62; 95%CI: 1.05-2.50, p = 0.028) and higher pain VAS (OR: 1.19; 95%CI: 1.11-1.27, p < 0.001) were associated with disparity between self-reported and IS-denoted flares. CONCLUSION: A diagnosis of IIMs confers an equal risk of flares in the post COVID-19 vaccination period to AIRDs, with active disease, female gender, and comorbidities conferring a higher risk. Disparity between patient and physician reported outcomes represents a future avenue for exploration.
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COVID-19 has posed formidable challenges including overwhelming bio-medical waste. Guidelines have been rapidly changing along with mounting pressure of waste generation. These challenges were managed by smart re-engineering of structure and processes for desired outcomes. Dedicated staff in PPE with appropriate training were deployed to collect waste using dedicated trolleys. A dedicated route plan was drawn with a dedicated lift meant for COVID-19. A new temporary holding area was created. Dedicated trucks with requisite labels were deployed to transport COVID-19 waste to CBWTF. Communication challenge was addressed through timely circulars, which were further reinforced and reiterated during various on-going training programs.Before the onset of COVID-19 pandemic Bio-Medical Waste generated was 1.93kg/Bed/Day and currently the quantum of COVID-19 biomedical waste generated is 7.76Kg/COVID Bed/Day. Daily COVID-19 waste generation data is maintained and uploaded in an android Application. Till date none of the worker handling COVID-19 waste has acquired Healthcare associated COVID-19 infection which reflects on the soundness of the new system and the infection control practices in the Institute. A responsive leadership harmonizing with a robust communication and training system has augmented timely re-engineering of structure and processes for better outcomes in the war on waste.
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OBJECTIVES: To compare pain intensity among individuals with idiopathic inflammatory myopathies (IIMs), other systemic autoimmune rheumatic diseases (AIRDs), and without rheumatic disease (wAIDs). METHODS: Data were collected from the COVID-19 Vaccination in Autoimmune Diseases (COVAD) study, an international cross-sectional online survey, from December 2020 to August 2021. Pain experienced in the preceding week was assessed using numeral rating scale (NRS). We performed a negative binomial regression analysis to assess pain in IIMs subtypes and whether demographics, disease activity, general health status, and physical function had an impact on pain scores. RESULTS: Of 6988 participants included, 15.1% had IIMs, 27.9% had other AIRDs, and 57.0% were wAIDs. The median pain NRS in patients with IIMs, other AIRDs, and wAIDs were 2.0 (interquartile range [IQR] = 1.0-5.0), 3.0 (IQR = 1.0-6.0), and 1.0 (IQR = 0-2.0), respectively (P < 0.001). Regression analysis adjusted for gender, age, and ethnicity revealed that overlap myositis and antisynthetase syndrome had the highest pain (NRS = 4.0, 95% CI = 3.5-4.5, and NRS = 3.6, 95% CI = 3.1-4.1, respectively). An additional association between pain and poor functional status was observed in all groups. Female gender was associated with higher pain scores in almost all scenarios. Increasing age was associated with higher pain NRS scores in some scenarios of disease activity, and Asian and Hispanic ethnicities had reduced pain scores in some functional status scenarios. CONCLUSION: Patients with IIMs reported higher pain levels than wAIDs, but less than patients with other AIRDs. Pain is a disabling manifestation of IIMs and is associated with a poor functional status.
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Autoimmune Diseases , COVID-19 , Myositis , Rheumatic Diseases , Humans , Female , Cross-Sectional Studies , COVID-19 Vaccines , Autoantibodies , COVID-19/complications , Myositis/diagnosis , Myositis/epidemiology , Myositis/complications , Autoimmune Diseases/diagnosis , Autoimmune Diseases/epidemiology , Autoimmune Diseases/complications , Rheumatic Diseases/diagnosis , Rheumatic Diseases/epidemiology , Rheumatic Diseases/complicationsABSTRACT
The safety profile of COVID-19 vaccines is understudied in patients with systemic sclerosis (SSc). We compared short-term adverse events (AEs) 7 days following vaccination in patients with SSc vs other rheumatic (AIRDs), non-rheumatic autoimmune diseases (nrAIDs), and healthy controls (HCs). The COVID-19 Vaccination in autoimmune diseases (COVAD) self-reporting e-survey was circulated by a group of > 110 collaborators in 94 countries from March to December 2021. AEs were analyzed between different groups using regression models. Of 10,679 complete respondents [73.8% females, mean age 43 years, 53% Caucasians], 478 had SSc. 83% had completed two vaccine doses, Pfizer-BioNTech (BNT162b2) (51%) was the most common. Minor and major AEs were reported by 81.2% and 3.3% SSc patients, respectively, and did not differ significantly with disease activity or different vaccine types, though with minor symptom differences. Frequencies of AEs were not affected by background immunosuppression, though SSc patients receiving hydroxychloroquine experienced fatigue less commonly (OR 0.4; 95% CI 0.2-0.8). Frequency of AEs and hospitalisations were similar to other AIRDs, nrAIDs, and HC except a higher risk of chills (OR 1.3; 95% CI 1.0-1.7) and fatigue (OR 1.3; 95% CI 1.0-1.6) compared to other AIRDs. COVID-19 vaccines were largely safe and well tolerated in SSc patients in the short term. Background immunosuppression and disease activity did not influence the vaccination-related short-term AEs.
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Autoimmune Diseases , COVID-19 , Rheumatic Diseases , Scleroderma, Systemic , Female , Humans , Adult , Male , COVID-19 Vaccines/adverse effects , BNT162 Vaccine , COVID-19/prevention & control , Autoimmune Diseases/epidemiology , Vaccination/adverse effects , Self Report , Fatigue , Rheumatic Diseases/drug therapyABSTRACT
OBJECTIVES: The assessment of physical function is fundamental in the management of patients with idiopathic inflammatory myopathies (IIMs). We aimed to investigate the physical function of patients with IIMs compared with those with non-IIM autoimmune rheumatic diseases (AIRDs) utilizing Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) data obtained in the COVAD study, an international self-reported e-survey assessing the safety of COVID-19 vaccines in AIRDs. METHODS: Demographics, AIRD diagnosis, disease activity, and PROMIS PF short form-10a data were extracted from the COVAD database. PROMIS PF-10a scores were compared between disease categories and stratified by disease activity. Factors affecting PROMIS PF-10a scores other than disease activity were identified by multivariable regression analysis in patients with inactive disease. RESULTS: 1057 IIM patients, 3635 non-IIM AIRD patients, and 3981 healthy controls (HCs) responded to the COVAD e-survey from April to August 2021. Using a binomial regression model, the predicted mean of PROMIS PF-10a scores was significantly lower in IIM patients compared with non-IIM AIRD patients or HCs (36.3 [95% confidence interval (CI) 35.5-37.1] vs 41.3 [95%CI 40.2-42.5] vs 46.2 [95%CI 45.8-46.6], P < 0.001), irrespective of disease activity. The independent factors for lower PROMIS PF-10a scores in patients with inactive disease were older age, female, longer disease duration, and a diagnosis of inclusion body myositis or polymyositis. CONCLUSION: Physical function is significantly impaired in IIMs compared with non-IIM AIRDs or HCs, even in patients with inactive disease. Our study highlights a critical need for better strategies to minimize functional disability in patients with IIMs.
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Background/Aim: Long COVID-19 is one of the post-infection challenging issues. We aimed to assess the prevalence and characteristics of this syndrome in patients with autoimmune and rheumatic diseases (AIRDs) through a multicentre international e-surveys (The COVID-19 Vaccination in Autoimmune Diseases) COVAD study. Method(s): The COVAD group comprised of collaborators from 109 countries. An online survey platform was conducted in Jan-July 2022 to capture self-reported COVID-19 infection and vaccination data in patients with AIRDs and healthy controls (HCs). Long COVID-19 was defined as per WHO definitions as persistence of symptoms beyond 3 months of COVID-19 infection. Descriptive statistics and multivariable regression adjusted for age, gender, ethnicity, and disease modifying anti-rheumatic drugs (DMARDs) were employed. Result(s): Among the 7666 complete survey respondents, 1677 who had taken the survey >90 days of last COVID-19 infection were analyzed. Among them, a total of 8.1% (n = 136) had long COVID-19 syndrome and the median age was 46 (34-55) years, with Male: Female ratio of 1:6.3. The prevalence of long COVID-19 was significantly higher in patients with AIRDs compared to HCs (OR 2 [1.3-2.9], P < 0.001). Respondents with long COVID-19 had worse PROMIS 10a quality of life global physical and mental health score, as well as fatigue and pain VAS compared to those without post-COVID- 19 (all P < 0.001). Among patients with AIRDs, those with long COVID-19 reported to have higher flares of AIRDs following COVID-19 infection (OR 4.3, P < 0.01). On multivariable regression analysis, the characteristics of patients with long COVID-19 were female gender, Caucasian ethnicity and presence of comorbid insomnia. Presence of fatigue, muscle aches, dyspnoea and loss of taste during previous COVID-19 infection were the significant predictors of long COVID-19. Among patients with AIRDs, comorbidities (OR 2.0;95% CI: 1.08-3.6, P = 0.026), and advanced treatment (OR: 1.9;95% CI: 1.08-3.3, P = 0.024), or intensive care (OR: 3.8;95% CI: 1.01-14.4, P = 0.047) for severe COVID-19 were risk factors for long COVID-19. The use of rituximab, iv immunoglobulins (IVIG), mycophenolate mofetil and anti-TNF agents use also predicted long COVID-19. Conclusion(s): Patients with AIRDs are at higher risk of long-COVID- 19 syndrome. Associated comorbid conditions and advanced treatment or intensive care for severe COVID-19 confer a higher risk.
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Background: COVID-19 vaccinations have been proven to be generally safe in healthy populations. However, the data on the vaccine safety in patients with Type 1 Diabetes Mellitus (T1DM) is inadequate. The study aimed to evaluate the frequency and severity of the adverse vaccination effects (ADEs) and their risk factors among T1DM patients. Methods: This study analyzed data from the COVID-19 vaccination in Autoimmune Diseases (COVAD) survey database (May-Dec 2021;110 collaborators, 94 countries), comparing COVID-19 vaccine adverse drug events among T1DM patients and healthy controls (HCs). The study was designed to assess post-COVID-19 vaccination ADE in patients with autoimmune diseases. Descriptive and comparative analysis was performed based on data distribution and variable types. Results: We included 5480 completed responses in this study. Of all responses, 5408 were HCs, and 72 were T1DM patients (43 females, 48.0% Caucasians). The majority of the respondents had received Pfizer vaccines (p < 0.001). 4052/5480 (73.9%) respondents had received 2 vaccine doses, rest had received 1 vaccine dose. The most common ADE reported was injection site pain (50.0%), with T1DM patients reporting significantly lower frequency of injection site pain than HCs [OR 0.6 (0.3-0.9), p = 0.045]. Multivariate analysis showed that T1DM respondents had higher frequency of severe skin rashes [OR = 8.0 (1.7-36.0), p = 0.007] than HCs. However, overall ADEs, major ADEs, minor ADE and hospitalization frequency remained similar between T1DM and HCs. Conclusions: COVID-19 vaccination was largely safe and well tolerated in patients with T1DM with similar ADE profile compared to HCs, except for increased frequency of skin rashes in them.
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SARS-CoV-2 was a devastating global pandemic that swept the globe in late 2019, claiming the lives of an estimated 4 million people. Amidst challenging times, we are remembering Martin Luther King Jr.'s remark, "Mankind must put an end to war or war will put an end to mankind." In that sense, scientists are repurposing drugs meticulously to curb the nCOVID-19. New antiviral drugs on the other hand are being developed at unparallel rates. Among those Pfizer's inventive Nirmatrelvir/Ritonavir (PaxlovidTM), which inhibits the main protease (Mpro) of SARS-CoV-2, 3CL protease, will be another arrow in the quiver to mount resistance towards SARS-CoV-2. In patients treated with nirmatrelvir/ritonavir within five days of symptom onset, COVID-19-related hospitalizations and mortality were dramatically reduced. Paxlovid's high oral availability, allows it to be used in both hospitalized and outpatient patients. In this brief review, we presented pharmacokinetic, preclinical, and clinical evidence on Paxlovids for the treatment of moderate nCOVID-19.
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BACKGROUND: BBV152 is a whole-virion inactivated SARS-CoV-2 vaccine that has been deployed in India. The results of the phase 3 trial have shown clinical efficacy of BBV152. We aimed to evaluate the effectiveness of BBV152 against symptomatic RT-PCR-confirmed SARS-CoV-2 infection. METHODS: We conducted a test-negative, case-control study among employees of the All India Institute of Medical Sciences (a tertiary care hospital in New Delhi, India), who had symptoms suggestive of COVID-19 and had an RT-PCR test for SARS-CoV-2 during the peak of the second wave of the COVID-19 pandemic in India between April 15 and May 15, 2021. Cases (test-positives) and controls (test-negatives) were matched (1:1) on the basis of age and gender. The odds of vaccination with BBV152 were compared between cases and controls and adjusted for level of occupational exposure (to COVID-19), previous SARS-CoV-2 infection, and calendar time, using conditional logistic regression. The primary outcome was effectiveness of two doses of BBV152 (with the second dose received at least 14 days before testing) in reducing the odds of symptomatic RT-PCR-confirmed SARS-CoV-2 infection, expressed as (1 - odds ratio) × 100%. FINDINGS: Between April 15 and May 15, 2021, 3732 individuals had an RT-PCR test. Of these, 2714 symptomatic employees had data on vaccination status, and 1068 matched case-control pairs were available for analysis. The adjusted effectiveness of BBV152 against symptomatic COVID-19 after two doses administered at least 14 days before testing was 50% (95% CI 33-62; p<0·0001). The adjusted effectiveness of two doses administered at least 28 days before testing was 46% (95% CI 22-62) and administered at least 42 days before testing was 57% (21-76). After excluding participants with previous SARS-CoV-2 infections, the adjusted effectiveness of two doses administered at least 14 days before testing was 47% (95% CI 29-61). INTERPRETATION: This study shows the effectiveness of two doses of BBV152 against symptomatic COVID-19 in the context of a huge surge in cases, presumably dominated by the potentially immune-evasive delta (B.1.617.2) variant of SARS-CoV-2. Our findings support the ongoing roll-out of this vaccine to help control the spread of SARS-CoV-2, while continuing the emphasis on adherence to non-pharmacological measures. FUNDING: None. TRANSLATION: For the Hindi translation of the abstract see Supplementary Materials section.
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COVID-19 Vaccines , COVID-19/prevention & control , SARS-CoV-2 , Vaccination , Vaccines, Inactivated , Adult , COVID-19 Nucleic Acid Testing , Case-Control Studies , Humans , India , Middle Aged , Virion/immunologyABSTRACT
BACKGROUND: One of the challenges has been coping with an increasing need for COVID-19 testing. A COVID-19 screening and testing facility was created. There was a need for increasing throughput of the facility within the existing space and limited resources. Discrete event simulation was used to address this challenge. METHODOLOGY: A cross-sectional interventional study was done from September 2020 to October 2020. Detailed process mapping with all micro-processes was done. Patient arrival patterns and time taken at each step were measured by two independent observers at random intervals over two weeks. The existing system was simulated and a bottleneck was identified. Two possible alternatives to the problem were simulated and evaluated. RESULTS: Scenario 1 showed a maximum throughput of 316. The average milestone times of all the processes after the step of "Preparation of sampling kits" jumped 62%; from 82 to 133â min. Staff state times also showed that staff at this step was stretched and medical lab technicians were underutilized. Scenario 2 simulated the alternative with lesser time spent on sampling kit preparation with a 22.4% increase in throughput, but could have led to impaired quality check. Scenario 3 simulated with increased manpower at the stage of bottleneck with 26.5% increase in throughput and was implemented on-ground. CONCLUSION: Discrete event simulation helped to identify the bottleneck, simulate possible alternative solutions without disturbing the ongoing work, and finally choose the most suitable intervention to increase throughput, without the need for additional space allocation. It therefore helped to optimally utilize resources and get "more from less."
ABSTRACT
Background/Objectives: The use of hydroxychloroquine (HCQ) for COVID-19 has raised concerns for adverse effects. We aimed to understand the practice, perceptions, and experience of adverse drug reactions (ADRs) with HCQ use for COVID-19 and other indications. Methods: A validated e-survey with 30 questions was circulated among rheumatologists and other specialists using SurveyMonkey. Responses from rheumatologists were compared with other doctors (odds ratio [OR], median, interquartile range), and ADRs encountered based on their indications. Results: Among 410 respondents (71.2% rheumatologists, 27% academicians) with a lifetime experience of 17886 (4884-52074) patients over 12 (7-20) years, and 148 (48-349) prescription of HCQ per month, one-third (135) were managing COVID-19 with 10 (0-60) prescriptions per physician. Electrocardiograms were seldom ordered preprescription (5%), but visual scans were requested by one-thirds, especially by rheumatologists (OR-1.9). Agreement on the safety of HCQ for non-COVID indications was nearly unanimous (99%), but only two-third (64%) perceived it to be safe for COVID-19, with most (72%) being uncomfortable using HCQ with macrolides. ADRs were most often encountered after middle-age with skin pigmentation (554 [123-2063]) being the most frequent, followed by gastrointestinal intolerance (222 [42-980] per million prescriptions). Cardiac toxicity was rarely reported. ADRs other than cutaneous and visual were noted more frequently by nonrheumatologists. Rheumatologists were less likely to consider HCQ unsafe (OR-0.04) and reportedly faced a greater challenge in drug procurance (OR-2.6) during the pandemic. Conclusions: Most ADRs are rare with HCQ use in our respondent population with a large user experience. HCQ use was considered unsafe by one-thirds in the setting of COVID-19 but not outside it, lesser so by rheumatologists. © 2021 Wolters Kluwer Medknow Publications. All rights reserved.