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Objectives: Interception therapy requires an individual to take a treatment today to prevent a future medical event. Patients must trade off treatment burdens incurred today against future benefits. We examined the preferences of high-risk lung cancer (LC) individuals for potential interception therapies that reduce the risk of developing lung cancer. Method(s): An online discrete-choice experiment (DCE) was developed for hypothetical LC interception treatments with four attributes: reduction in risk of LC over 3 years, injection site reaction severity, nonfatal serious infection risk, and death from serious infection risk. Respondents chose between two alternative treatments or a no-treatment option. The DCE was analyzed using random-parameters logit, and maximum acceptable risk for an LC risk reduction was calculated. Logit analysis explored characteristics of respondents who always selected no treatment. Result(s): The sample included 803 adults aged 50-80 years with at least a 20 pack-year smoking history. Respondents had an average willingness to accept interception therapy (alternative-specific constant=1.30, 95% CI: 0.91-1.69). Respondents viewed larger reductions in the risk of LC as most important. Respondents were willing to accept increases in risk of nonfatal serious infection up to 15% for a 15% improvement in relative LC risk reduction and increases in risk of death from serious infection up to 1.5% for a 23% improvement in relative LC risk reduction. However, 16% of respondents selected 'no treatment' for all DCE questions. Older respondents, current smokers who have never tried to quit, and those who did not get regular skin exams for cancer and/or COVID-19 vaccine were more likely to opt out of interception therapy. Conclusion(s): Generally, individuals at high risk of LC are willing to consider interception therapy. Study results can support benefit-risk assessments for future systemic LC interception treatments, and the results may have implications for other therapeutic areas.Copyright © 2023
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Aim. An online survey among social network users was conducted to assess the frequency of COVID-19 cases, the spectrum of medications used for treatment, and the subjective assessment of clinical manifestations of the disease. Material and methods. An anonymous online survey was conducted among users of various social networks using a questionnaire created on the SurveyMonkey survey and research platform. During the first month of December 2021, the survey included 23 questions regarding the clinical and demographic characteristics of respondents, the number of COVID-19 cases, clinical manifestations, and severity, as well as the need for medical help and medication. Results. 752 respondents took part in the online survey, more than 70% of them are under 50 years old. Among the respondents 59.73% had a new coronavirus infection (COVID-19). More than 40% of the participants had COVID-19 in the period from September 2020 to April 2021 (2nd wave in Russia). In 79.2% of people, the presence of a new coronavirus infection was confirmed by one of the diagnostic methods: polymerase chain reaction (PCR test), radiography, the presence of antibodies to Ig G/M, and took into account the presence of contact with infected SARS-CoV-2. 411 participants observed any clinical manifestations of the disease. Most often respondents who had COVID-19 indicated weakness, cough, dyspnea, disappearance or decrease in the acuity of smell and taste. The volume of lung tissue damage in 36.5% of cases was less than 25%. The disappearance of any clinical manifestations of the disease immediately after recovery was noted by 32.0% of respondents. Most of the patients (59.2%) sought medical help at the polyclinic, 38.9% had to self-medicate. 71.9% respondents indicated they had been vaccinated against COVID-19, but without specifying the timing and completeness of the course. Side effects after immunization (fever, weakness, soreness, and redness at the injection site) were subjectively assessed by 41.9% of respondents. Conclusion. Among the surveyed respondents, 62.7% of the disease symptoms were mild. The highest number of cases occurred in the 2nd and 4th waves of COVID-19 morbidity in Russia. Most often respondents indicated symptoms of acute respiratory infection. The complete disappearance of clinical manifestations of the disease immediately after recovery was noted by 32.0 % of respondents, and the persistence of symptoms for up to a year - 7.5. More than 70% of the participants in the online survey reported vaccination against COVID-19, but the questionnaire did not include questions about the timing of vaccinations (before or after COVID-19) and the completeness of the course.Copyright © Eco-Vector, 2023. All rights reserved.
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Background: Given the paucity of data on safety and effectiveness of mRNA COVID-19 booster vaccinations in lower income settings with high HIV prevalence, we evaluated a heterologous mRNA-1273 (Moderna) boost after priming with 1 or 2 doses of Ad26.COV2.S (Janssen, Johnson & Johnson) vaccine among health care workers (HCWs) in South Africa. Method(s): SHERPA is an open-label, phase 3 mRNA-1273 booster study, nested in the Sisonke Phase 3b implementation trial, that vaccinated ~500000 HCWs with 1 or 2 doses of Ad26.COV2.S from Feb and Dec 2021. Sisonke participants were offered mRNA-1273 boosters between 23 May and 12 Nov 2022 (median 17 and 8 months after 1 and 2 Ad26.COV2.S, respectively), with data cut-off on 12 Dec 2022. Reactogenicity and adverse events (AEs) were self-reported via an online data entry link shared by SMS with participants 1, 7 and 28 days after boosting. Using national databases analyses are underway to compare effectiveness against COVID-19 infections and severe disease with Sisonke participants who did not receive the booster. Result(s): 12188 HCWs (79.5% female, 28.6% with self-reported previous COVID-19 diagnosis) received a mRNA-1273 booster, of whom 44.6% and 55.4% had received 1 and 2 prior Ad26.COV2.S vaccines in Sisonke, respectively. 3056 (25.2%) reported being HIV positive, more among those receiving only 1 previous Ad26.COV2.S (26.8% vs 23.9%), and 1.4% reported not being on antiretroviral therapy. 17.0% of participants reported hypertension and 6.4% diabetes mellitus. 262 participants (2.1% of women, 2.5% of men) reported 234 reactogenicity events and 95 AEs post-vaccination, with more reported by those with prior COVID-19 infection (3.5% vs 1.6%), HIV negative status (2.5% vs 1.2%) and those who received 2 prior doses of Ad26.COV2.S (2.4% vs 1.8%) (Table). Among 159 (1.3%) reporting injection site reactions the commonest were pain (59.7%), swelling (42.1%) and induration (20.1%). Of 177 (1.5%) systemic reactogenicity events (all grade 1 or 2 severity), the commonest were myalgia (69.5%), headache (67.8%) and fever (37.9%). 14 participants had AEs of special interest or serious AEs, of which 4 (all AESIs of ageusia or anosmia) were deemed related to the booster. 13 COVID-19 infections occurred a median of 125 days post booster vaccination (IQR 90-154) after 3477 person-years of follow up. Conclusion(s): A mRNA-1273 booster administered after 1 or 2 doses of Ad26. COV2.S was well tolerated regardless of HIV status, other chronic conditions or prior COVID-19 infection.
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Background: To date, over 10 million doses of mRNA vaccines (BNT162b2 mRNA and mRNA-1273) have been administered in Singapore. Initial studies have shown that 0.8% of individuals who received Moderna mRNA vaccine developed delayed injection-site reactions. Reactions to the Moderna mRNA vaccine are thought to be benign and not a contraindication to further doses. Injection-site reactions associated with the Pfizer-BioNTech mRNA vaccine are less clearly defined. We report the characteristics of mRNA COVID-19 injection-site reactions, comparing the clinical features between Moderna (mRNA-1273) and Pfizer-BioNTech (BNT162b2) reactions in the Singaporean adult population. Method(s): We retrospectively reviewed patients referred to the Dermatology Service / Allergy Centre of a tertiary hospital in Singapore for reactions post COVID-19 vaccination between 10 Jan 2021 and 26 Aug 2021. Inclusion criteria were adult patients who developed a localised injection-site reaction after either Moderna or Pfizer-BioNTech mRNA COVID-19 vaccination. Result(s): 322 patients were referred for post-COVID- 19 vaccine reactions, of which 21 developed injection-site reactions. 11 (52%) had received the Moderna mRNA vaccine while 10 (48%) received the Pfizer-BioNTech mRNA vaccine. Patients receiving the Moderna mRNA vaccine had a longer mean latency period (p = 0.047) and were more likely to have a latency duration of > 5 days (p = 0.007). Secondary dissemination of the injection-site reaction was seen in 2 patients. 11 (52%) of these reactions resolved without treatment;while the remaining 10 (48%) required symptomatic treatment with topical corticosteroids, antihistamines, or a combination of both. All 21 patients subsequently received the second vaccine dose, of which 2 (9.5%) developed recurrence of the reaction;both of which were mild and did not require treatment. Conclusion(s): Localised injection-site reactions post Moderna or Pfizer-BioNTech mRNA COVID-19 vaccination are uncommon and appear to be phenotypically different. Such reactions are benign and self-limited. While recurrence of the reaction can arise during repeat vaccine doses, these are mild and self-limited.
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Background: SARS-CoV- 2 infection remains a significant global concern. Since vaccination is one of the most effective methods of severe disease prevention, the question of its side effects is substantial. Therefore, collaboration between clinicians and the Pharmacovigilance department of the national competent authority is important and can provide essential information on this matter. Method(s): Spontaneous reports of adverse drug reactions received by the State Agency of Medicines of Latvia between 2021-01- 01 and 2022-01- 05 were reviewed to identify cases of hypersensitivity reactions. MedDRA Queries were used for data selection. In data analysis, descriptive statistics were used. Result(s): A total 90 possible hypersensitivity reactions were selected for analysis, of which 34 cases (37.8%) were reported by healthcare professionals and 56 cases (62.2%) by patients. 12 cases (13.3%) were anaphylaxis, 10 (11.1%) were immediate type reactions and 68 (75.6%) were potential delayed type reactions, among them 66 cases were possible type IV and 2 cases possible type III reactions. 70 patients (78.7%) were women and 19 (21.3%) were men. The mean age of patients was 43.13 +/- 15.9 (17-80) years old. 21 patients (23.3%) received Vaxzevria, 16 (17.8%) Janssen, 39 (43.3%) Comirnaty and 14 (15.6%) Spikevax. The most commonly reported symptoms in the anaphylaxis group was: impaired consciousness (33.3%), angioedema (33.3%), skin erythema (25%), urticaria (25%), hypotension (25%), tachycardia (25%), nausea and vomiting (25%), in the immediate type reaction group: dyspnoe (40%), skin erythema (30%), angioedema (30%), skin pruritus (20%), unspecified skin rash (20%), dizziness (20%), and in the delayed type reaction group: skin rash (92.6%), pruritus (25%), injection site reaction (23.5%). There were only eight patients with prior history of allergies. Conclusion(s): More than a half of the spontaneously reported cases of hypersensitivity reactions selected for the analysis were submitted by patients. Vast majority of all selected cases concerned women. Individuals who were affected by hypersensitivity reactions after COVID-19 vaccination were more likely to experience delayed-type than immediate-type reactions. Although, it should be considered that underreporting might be in place.
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Background: Chronic urticaria (CU) is a common chronic inflammatory disease. Vaccination against viral infections including COVID-19 can induce increased CU disease activity. As of now, it is unclear how often CU exacerbations occur after COVID-19 vaccination. Method(s): COVAC-CU is an international, multicenter, observational, cross-sectional study of the global network of urticaria centers of reference and excellence (UCAREs). COVAC-CU evaluates the effects of COVID-19 vaccination in patients with CU including rates and risk factors of CU exacerbation. Here, we analyzed 1857 patients with CU who had received at least one COVID-19 vaccination. Data were collected via a questionnaire and retrieved from patient charts. Result(s): Of 1857 patients with CU (median age: 42 years;range: 18-91 years), 72.1% were female and 71.2%, 14.4% and 14.4% had chronic spontaneous urticaria, chronic inducible urticaria, or both, respectively. Most patients had received two doses of COVID-19 vaccine (79.1%), compared to one (9.7%), three (11%), or four (0.3%). Vaccine type included: BTN162b2 (58.4%;BioNTech/Pfizer), ChAdOx1 nCOV-19 (13.8%;AstraZeneca), BBIBP-CorV (8.2%;Sinopharm), Gam-COVID- Vac (8%;Sputnik), mRNA-1273 (5.3%;Moderna), and Ad26.COV 2.5 (4.7%;Janssen/J&J). Less than 10% of patients used premedication, and less than half of patients (44.4%) reported one or more adverse reactions after vaccination. The most common adverse reactions were local injection site reactions (29.6%), fatigue (19.7%), fever (19%), muscle pain (17.9%), headache (14%), and exacerbation of CU (15%). Severe allergic reactions/anaphylaxis were reported by 0.4% of CU patients. In almost all patients who experienced exacerbation of their CU, this occurred within one week after receiving the vaccine, i.e. after 1 to 12 hours (25.8 %), after 12 hours to 48 hours (31.1%) or after 2-7 days (37.9%). Conclusion(s): Most CU patients tolerate COVID-19 vaccination well;severe allergic reaction (anaphylaxis) rates were similar or lower than the self-reported rates reported in the general population. Exacerbation of urticaria was reported in one in five patients, mostly in a week after receiving the vaccine.
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Introduction (contexte de la recherche): In Parts A and B of the 3-part phase 3 LIBERTY EoE TREET study (NCT03633617), dupilumab 300 mg weekly (DPL qw) vs. placebo (PBO) demonstrated significant efficacy and acceptable safety up to 24 weeks (wks) in adults and adolescents with eosinophilic esophagitis (EoE). For patients (pts) who completed Parts A or B, Part C was an extended active treatment period for 28 wks. Objectif: To assess the safety and efficacy of DPL in pts who completed Part B and continued to Part C, up to 52 wks. Methodes: Of 80 DPL qw pts in Part B, 74 continued DPL qw in Part C (DPL/DPL). Of 79 PBO pts in Part B, 37 pts received DPL qw in Part C (PBO/DPL). Part B co-primary endpoints were proportion of pts achieving peak esophageal intraepithelial eosinophil (eos) count <= 6 eos/high power field (hpf) and absolute change from Part B baseline (BL) in Dysphagia Symptom Score (DSQ) score at Wk 24. Secondary endpoints included peak eos count, EREFS, and HSS grade and stage scores. In Part C, all co-primary and secondary endpoints were assessed at Wk 52 as secondary endpoints. Safety was also assessed. Resultats: Part B BL characteristics were similar across groups. At Wk 52 of Part C, 84.6% of DPL/DPL and 67.6% of PBO/DPL groups achieved peak eos count of <= 6 eos/hpf and mean (SD) absolute change from Part B BL in DSQ score was -30.26 (15.39) for DPL/DPL and -27.25 (11.46) for PBO/DPL pts. At Wk 52, peak eos count, EREFS, HSS grade and stage scores were reduced, compared with Part B BL, and EDP and T2 NESs were suppressed in DPL/DPL and PBO/DPL groups. Dupilumab demonstrated an acceptable safety profile in Part C;the most common (occurring >= 10%) treatment-emergent adverse events in DPL/DPL and PBO/DPL groups were injection-site reactions (13.5% and 10.8%), COVID-19 (9.5% and 10.8%) and nasopharyngitis (4.1% and 10.8%). Conclusion(s): As observed in Part A/C, dupilumab qw demonstrated persistent improvements in clinical, symptomatic, histologic, endoscopic and molecular features of EoE up to 52 wks and had an acceptable safety profile. PBO pts from Part B who received dupilumab in Part C showed similar efficacy to dupilumab qw pts of Part B.Copyright © 2023
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Background: The coronavirus disease 2019 (COVID-19) has been sabotaging the world over the last two years and vaccine is one of the key solutions. However, the concerns over its side effects can cause vaccine refusal, subsequently affecting many countries' education system recovery plans. Objective(s): To actively evaluate adverse effects and their severity following COVID-19 immunization among schoolchildren aged 12 to 17 years, to support parents' decision-making. Material(s) and Method(s): The present study was an observational study whereby a Google-form survey on Pfizer COVID-19 vaccine adverse effects (CVAE) was responded between January and April 2022 by 537 participants. Descriptive statistics were used to analyze basic characteristics. Chi-square tests were performed for comparative analyses between junior (aged 12 to 15 years) versus senior (aged 16 to 17 years) high school students, and McNemar's test for the first dose versus second dose groups analysis with a significance level set at p-value less than 0.05. Result(s): At least one CVAE was reported in 93.85% of the included participants, albeit mostly mild. The most common symptom as a local event was tenderness at the puncture site (82.50%), whereas systemic events were predominated by myalgia (74.67%). The second dose was associated with increased frequency and severity of adverse effects compared to the first dose (p<0.001). The older age group had significantly more side effects compared to the younger group (p<0.05). Conclusion(s): The high incidence of CVAEs in schoolchildren was predominated by mild symptoms, with the second dose and older group associated with increased frequency of symptoms. The predominance of mild symptoms found in the present study may help reduce the concerns of parents over CVAEs, ultimately accelerating vaccine coverage in the children group, which is still a gap in vaccine administration.Copyright © 2023 JOURNAL OF THE MEDICAL ASSOCIATION OF THAILAND.
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Studies for vaccine development have been completed in an unprecedented time to prevent further outbreak of the dangerous and potentially fatal coronavirus disease-2019 (COVID-19) caused by severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2). Some of these vaccines have been approved by various authorities and made available worldwide. While vaccine applications continue globally, the number of dermatological side effects reported after vaccination is increasing daily. Many cutaneous reactions have been reported in the literature, such as injection site reactions, pernio lesions, pityriasis rosacea, herpes zoster, and exacerbations of chronic inflammatory dermatoses such as atopic dermatitis and psoriasis. Most COVID-19 vaccines require two doses and a booster dose, and considering the new variants of the coronavirus, vaccination is estimated to continue for a while. In this context, dermatologists are more likely to encounter vaccine-related dermatological side effects in their daily practice. Dermatologists play an essential role in many issues such as diagnosis and treatment of cutaneous reactions after COVID-19 vaccination, informing patients and providing necessary counseling. This perspective will also provide helpful information for the future in terms of vaccination strategies to be developed for repeated doses. In this study, most of the cutaneous reactions reported after COVID-19 vaccination in the current literature are reviewed.Copyright © Telif Hakki 2022 Deri ve Zuhrevi Hastaliklar Dernegi.
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Studies for vaccine development have been completed in an unprecedented time to prevent further outbreak of the dangerous and potentially fatal coronavirus disease-2019 (COVID-19) caused by severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2). Some of these vaccines have been approved by various authorities and made available worldwide. While vaccine applications continue globally, the number of dermatological side effects reported after vaccination is increasing daily. Many cutaneous reactions have been reported in the literature, such as injection site reactions, pernio lesions, pityriasis rosacea, herpes zoster, and exacerbations of chronic inflammatory dermatoses such as atopic dermatitis and psoriasis. Most COVID-19 vaccines require two doses and a booster dose, and considering the new variants of the coronavirus, vaccination is estimated to continue for a while. In this context, dermatologists are more likely to encounter vaccine-related dermatological side effects in their daily practice. Dermatologists play an essential role in many issues such as diagnosis and treatment of cutaneous reactions after COVID-19 vaccination, informing patients and providing necessary counseling. This perspective will also provide helpful information for the future in terms of vaccination strategies to be developed for repeated doses. In this study, most of the cutaneous reactions reported after COVID-19 vaccination in the current literature are reviewed.Copyright © Telif Hakki 2022 Deri ve Zuhrevi Hastaliklar Dernegi.
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Psoriasis is a chronic inflammatory skin condition characterized by scaly erythematous patches or plaques affecting the extensor surfaces that are prominent but spreading to all areas of the body, including the flexor surfaces. Psoriasis occurs when the body's immune system attacks the skin;the interleukin (IL)-12 and IL-17/23 axes play a major role in its pathogenesis. Biologic therapies targeting IL-17 or IL-23 have emerged as an important treatment option for psoriasis and have led to substantial improvements in patients' quality of life. This systematic review aimed to evaluate the comparative efficacy and safety of secukinumab, ustekinumab and guselkumab for the treatment of moderate to severe plaque psoriasis. Based on the final analysis, there were 10 articles, namely 5 RCTs and 5 observational. We found that patients who were given secukinumab showed a rapid response, whereas guselkumab was superior in terms of long-term response (approximately 1 year) and complete remission compared to other biologics. Among all the biologics assessed, ustekinumab showed relatively low efficacy.
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Objective: Vaccination is the most effective way to control the COVID-19 pandemic all over the world. We aimed to evaluate the relationship between antibody titers and vaccine side effects after the BNT162b2 vaccine was administered as a reminder dose in healthcare workers (HCW) who received two doses of inactivated SARS-CoV-2 vaccine name CoronaVac (Sinovac Life Sciences, Beijing, China). Method(s): A total of 428 HCWs participated in the study. Participants who received the mRNA vaccine as a reminder dose were evaluated with a questionnaire regarding antibody values and vaccine side effects. Three weeks after the first BNT162b2 vaccine, the same questionnaire was applied face-to-face to HCW, and the same questionnaire was applied to those who received a second reminder dose via telephone. Result(s): Out of 428, 373 (87.1%) HCWs preferred one and 55 (12.9%) two doses of the BNT162b2 vaccine as reminder doses after being vaccinated with an inactivated vaccine. It was observed that side effects were more frequent in women aged 18-40 after a single dose of the BNT162b2 vaccine (p<0.001). The most common side effects are redness, swelling, and pain at the injection site, with a rate of 59.6%. Fatigue-weakness was the most common systemic reaction, with a rate of 58.6%. Axillary lymphadenopathy was observed seen in 3 (1.1%) HCWs. The median value of IgG titers in the third week after the reminder dose was found to be higher in HCW with side effects than those without side effects (p<0.001). When the cumulative incidence rate of vaccinated people was evaluated over 389 people, no cases were observed on the 14th and 30th days after the first reminder dose of BNT162b2. However, the first case was observed on the 60th day, and after the second reminder dose, cases were seen on the 14th, 30th, and 60th days. Conclusion(s): Since the side effects detected after the BNT162b2 reminder dose were mild to moderate and progressed with local symptoms, it was concluded that highly protective mRNA vaccines could be safely preferred for protection from COVID-19. Copyright © 2022, DOC Design and Informatics Co. Ltd.. All rights reserved.
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This study aimed to compare adverse reactions following BNT162b2 and influenza vaccinations in healthcare workers. This study included healthcare workers who received the BNT162b2 vaccine and/or inactivated influenza vaccine, quadrivalent (IIV4), on 18-29 October 2021 at a tertiary hospital in Korea. IIV4 was administered and BNT162b2 was subsequently administered one week later. The participants responded to a mobile questionnaire regarding adverse events. The overall adverse reaction rates were 90.6% in the BNT162b2 + IIV4 group, 90.4% in the BNT162b2 alone group, and 44.1% in the IIV4 alone group (p < 0.001). Fever occurred in 19.5%, 26.9%, and 3.3% of participants in the BNT162b2 + IIV4, BNT162b2 alone, and IIV4 alone groups, respectively (p < 0.001). The most common local and systemic adverse reactions were injection site pain (65.0%) and fatigue (58.6%), respectively. Injection-site pain was experienced by 88.7%, 88.5%, and 37.5% of the BNT162b2 + IIV4, BNT162b2 alone, and IIV4 alone groups, respectively (p < 0.001). Fatigue was experienced by 74.8%, 78.8%, and 38.6% of the BNT162b2 + IIV4, BNT162b2 alone, and IIV4 alone groups, respectively (p < 0.001). Adverse reactions occurred at a significantly higher frequency after BNT162b2 than after IIV4. The frequency of adverse reactions one week after vaccination with IIV4 and BNT162b2 was not different from that after vaccination with BNT162b2 alone. Therefore, coadministration of influenza vaccine with BNT162b2 can be expected to be safe.
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Background. There is a continued need for therapeutics for the treatment of COVID-19, including intramuscular (IM) agents, which will enable broader use across a variety of healthcare delivery settings. Methods. COMET-PEAK (NCT04779879) is a 3-part study evaluating the safety, tolerability, pharmacokinetics (Part A), and viral pharmacodynamics (PD) of sotrovimab as treatment in adults >= 18 years with early mild/moderate COVID-19. In Parts B and C, the safety, tolerability and viral PD of sotrovimab administered as a 500 mg intravenous (IV) infusion or as a 500 mg or 250 mg IM injection, respectively, was evaluated. The primary objective for Parts B and C was to compare the virologic response of sotrovimab IM to IV, with an endpoint of mean area under the curve (AUC) of SARS-CoV-2 viral load as measured by qRT-PCR from Day 1 to Day 8 (AUCD1-8) in nasopharyngeal swabs and predefined 90% confidence interval (CI) limits of 0.5-2.0 indicating equivalence. Results. A total of 167 and 157 participants were enrolled in Part B and C, respectively, from February-July 2021. The median age of participants was 47 and 42 years in Part B and C, respectively, and ~50% had >= 1 risk factor for progression to severe disease. The viral load at baseline and through Day 29 of follow-up for each arm is shown in Table 1 and Figure 1. The primary objective was met for both study parts: the ratio of the least square geometric mean viral load AUC(D1-8) of sotrovimab IM vs IV was 1.04 (90% CI, 0.98, 1.09) and 1.02 (90% CI, 0.94, 1.11), for Part B and C, respectively. Through Day 29 of follow-up, the most common adverse event was injection site reactions (ISRs) in the IM arms. A total of 10 (12%) participants in the 500 mg IM group and 4 (5%) participants in the 250 mg IM group experienced an ISR, all Grade 1. Serious adverse events were uncommon, and related to COVID-19 progression, including one death in the 250 mg IM arm (Table 2). ISRs aside, there were few treatment-related AEs (2/84 IV, 1/82 IM) in Part B, none serious. Conclusion. IM administration of sotrovimab 500 mg and 250 mg each demonstrated equivalence to 500 mg sotrovimab IV in viral load assessments. Overall, there were no treatment-related serious AEs and sotrovimab was well tolerated. An 500 mg IM formulation will allow for expanded treatment potential with sotrovimab.
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Background: CoronaVac, the first coronavirus disease 2019 vaccine administered in our country, was found safe in clinical trials. Objective: We aimed to reveal the rate and features of CoronaVac vaccine-associated allergic reactions among vaccinated healthcare workers (HCWs) in real-life. Methods: This study was planned as a questionnaire-based study. Participants who reported a postvaccination allergic reaction were interviewed on phone and their medical records were also checked for confirmation. Results: A total of 2,488 HCWs took part in the study and 4,054 postvaccination complete questionnaire-responses were obtained. Twenty-one HCWs (female: male, 17:4) with a mean age of 40.95 ± 10.09 stated that they had an allergic reaction after a total of 23 vaccine injections. Accordingly, the reaction rate was 0.56% among all vaccine doses. The most common reactions were systemic skin reactions (2.7%) consisting of generalized pruritus, diffuse pruritic erythema, urticaria, and maculopapular rash. That was followed by local injection site reaction (0.12%). Anaphylaxis was reported in 4 cases (0.09%) with a mean onset time of 12 ± 6 minutes. One of them had a history of anaphylaxis with 2 drugs, another had venom and food allergy. Three of the subjects had level 2 diagnostic certainty according to the Brighton Collaboration criteria and one had level 3. All anaphylaxis cases were discharged within 24 hours and none of them required intensive care. Conclusion: Our study demonstrated that allergic reactions to CoronaVac were rare and mostly mild. Although anaphylaxis was also rare, the importance of early intervention with close follow-up was once again emphasized.
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Introduction: Vaccination plays an important role in all strategic actions against the COVID-19 pandemic. Despite the high safety and efficacy of vaccination, side effects of the vaccines may also occur. The purpose of this study was to evaluate the clinical and sonographic findings and short-term results of cervical and axillary lymphadenopathy after the BNT-162b2 mRNA vaccine. Materials and Methods: The patients who received at least one dose of BNT-162b2 mRNA vaccine between July-September 2021 and were detected to have ipsilateral axillary and cervical lymphadenopathy related closely to the vaccination period, were included in the study. Clinical characteristics, sonographic findings of lymphadenopathies, and short-term results were analyzed retrospectively. Results: A total of 13 patients [six females (46.2%), seven males (53.8%)] were evaluated in the present study. Mean age of the patients was 41.9 years (min-max= 20-56). Median time-lapse between vaccination and presentation to hospital was six days, and seven (53.8%) patients presented with symptoms and findings after the first dose, and six patients (46.2%) after the second dose. Three (23.1%) axillary lymphadenopathies, and 10 (76.9%) cervical lymphadenopathies were detected. Sonographic examination revealed lymphadenopathies predominantly oval morphology (69.2%), asymmetric cortical thickening (61.5%), and hilar-type vascularization (69.2%). Mean time of regression was found 19.2 days (min-max= 10-35). Conclusion: Ipsilateral cervical and axillary lymphadenopathies may occur because of vaccines against COVID-19. The sonographic findings of these lymphadenopathies may not be distinguished clearly from malignant lymph nodes;and for this reason, close clinical and radiological follow-up would be appropriate to elucidate the process.
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Introduction: Prognosis of cats with feline infectious peritonitis (FIP), hitherto an invariably fatal disease, has purportedly improved with the introduction of the unlicensed nucleoside analog GS-441524 (GS). Method(s): A prospective observational study. Inclusion criteria comprised a complete medical record, characteristic clinical signs and laboratory changes, and a confirmatory RT-PCR test for the presence of feline coronavirus and FIP pathogenic strains in pleural/peritoneal/cerebrospinal fluid samples. Clinical signs, laboratory parameters, and adverse effects were recorded at diagnosis, during treatment, and at the end of a 12-week observation period. Remission was defined as completion of 12 weeks or more of treatment and resolution of clinical signs. Result(s): Overall, 175 medical files were reviewed but only 38 cases met the inclusion criteria. Samples of used vials were analyzed by high-performance liquid chromatography and identified GS-441524 as the active component. Twenty-one cats (55%) were considered in full remission, 7 (18 %) cats are currently treated, and 4 cats are in the 12-week observation period. Two cats experienced a relapse, 1 and 6 weeks after completion of treatment. Six (15%) cats died. Anemia (65%), jaundice (50%), thrombocytopenia (50%), and an albumin globulin ratio under 0.6 (81%) were common findings. Clinical manifestation included effusive (n = 30), noneffusive (n = 3), and neurological (n = 6) forms. Adverse effects included injection site reactions (52% of cats) and pain (95% of cats), and temporary creatinine increase (64%). Conclusion(s): Short-term efficacy against FIP disease, using an unlicensed nucleotide analog, was observed herein. The unknown purity or biological activity of these unlicensed compounds is a major limitation of this treatment.
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The FDA has approved tirzepatide (Mounjaro - Lilly), a peptide hormone with activity at both glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, to improve glycemic control in adults with type 2 diabetes. Tirzepatide, which is injected subcutaneously once weekly, is the fi rst dual GIP/GLP-1 receptor agonist to become available in the US. Selective GIP receptor agonists are not available in the US;GLP-1 receptor agonists have been available for years. Copyright © 2022, Medical Letter Inc.. All rights reserved.
ABSTRACT
Background: The efficacy of ravulizumab (intravenous [IV] formulation;administered every 8 weeks) for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) has been demonstrated in several randomized trials (NCT02946463, NCT03056040, NCT03406507). In study 303 (NCT03748823), subcutaneous (SC) ravulizumab, administered weekly via an on-body delivery system, showed pharmacokinetic non-inferiority to IV ravulizumab in adult patients with PNH who were clinically stable on prior IV eculizumab treatment. Here, we report results from the first 1 year of SC treatment, starting at day 15 for patients who continued SC ravulizumab during the extension period (SC/SC) and day 71 for patients who switched from IV ravulizumab to SC ravulizumab (IV/SC). Aims: To evaluate the efficacy, treatment administration satisfaction and safety of SC ravulizumab through the first 1 year (day 351) of treatment in adult patients with PNH previously treated with eculizumab. Methods: Patients (≥ 18 years) with clinically stable PNH (lactate dehydrogenase [LDH] levels ≤ 1.5 × upper limit of normal [246 U/L]) and ≥ 3 months prior eculizumab treatment were enrolled in the study, which consisted of a screening period (day-1 to day-30), a 10-week randomized treatment period and an extension period of up to 172 weeks. During the randomized treatment period, patients were assigned (2:1 ratio) to receive either SC ravulizumab or IV ravulizumab;all patients received SC ravulizumab during the extension period. Efficacy endpoints included: change in LDH from baseline;incidence of breakthrough hemolysis;transfusion avoidance;and stabilized hemoglobin (avoidance of a ≥ 2 g/dL decrease in hemoglobin in the absence of transfusion). Treatment administration satisfaction was assessed via the Treatment Administration Satisfaction Questionnaire (TASQ), which has been validated in a PNH population. Safety, including adverse events (AEs), serious AEs (SAEs) and adverse device effects (ADEs), were also assessed up to the 1-year data cut-off. Results: In total, 128 patients received SC ravulizumab (SC/SC: n = 84;IV/SC: n = 44;mean [range] duration of SC treatment: 486.4 [37-709] days). Efficacy endpoints (SC/SC and IV/SC) remained stable over time through 1 year of SC ravulizumab treatment. Mean (standard deviation [SD]) percentage change in LDH from baseline to SC day 351 was 0.9% (20.5%). Breakthrough hemolysis events were infrequent: 5/128 patients (3.9%);no event was considered free C5-related. Transfusion avoidance was maintained in 83.6% of patients during SC treatment, and 79.7% achieved stabilized hemoglobin. Improvement in total TASQ score with SC ravulizumab (compared with baseline IV eculizumab) was apparent at the first post-SC treatment assessment (SC day 29) and maintained until data cut-off (Figure). The most common AEs (reported by ≥ 10% of patients, excluding ADEs related to device product issues) during SC treatment were headache (14.1%, all grade ≤ 2), COVID-19 (14.1%, one death) and pyrexia (10.9%);injection site reaction (4.7%) was the most common non-device related ADE. Treatment-emergent SAEs were experienced by 21.1% of patients through to data cut-off. Although many patients had ≥ 1 device issue ADE, full SC dose administration was achieved in 99.9% of attempts. ADE incidence decreased over time. Image: Summary/Conclusion: The SC method of administration provides an additional treatment option for patients with PNH receiving ravulizumab therapy. Patients may be switched from IV eculizumab or IV ravulizumab to SC ravulizumab without loss of efficacy.