Inoculation Age of Bacillus Calmette-Guérin Tokyo-172 Strain and Vaccine-related Adverse Reactions in Taiwan Birth Cohort of 2012–2017

2020 ◽  
Author(s):  
Wei Huang ◽  
Nan-Chang Chiu ◽  
Hsin Chi ◽  
Fu-Yuan Huang ◽  
Ching-Ying Huang
Keyword(s):  
Soft Tissue ◽  
Injection Site ◽  
Birth Cohort ◽  
Adverse Reactions ◽  
Statistical Significance ◽  
Bacillus Calmette Guerin ◽  
Observational Period ◽  
Injection Site Reactions ◽  
Clinical Presentations ◽  
Compensation Program

Abstract Background In 2016 in Taiwan, inoculation with the Bacillus Calmette-Guérin (BCG) Tokyo-172 vaccine was postponed from 24 hours after birth to 5–8 months of age. We reviewed BCG-induced adverse reactions reported to the Vaccine Injury Compensation Program (VICP) to identify differences between early and delayed BCG inoculation. Methods Clinical presentations of BCG-related adverse reactions reported to VICP for the 2012–2017 birth cohort were reviewed until the end of 2019. The correlations between inoculation age and complications were evaluated. Results We analyzed 233 BCG adverse reactions, including regional lymphadenitis (33.9%), injection site reactions (35.2%), osteitis/osteomyelitis (27.9%), and distant soft tissue infections (3.0%). The incidence of osteitis/osteomyelitis was lower when vaccination was done after 5 months of age (relative risk [RR], 0.32; 95% confidence interval [CI], .16–.64). Injection site reactions (RR, 8.82; 95% CI, 5.04–15.44) and lymphadenitis (RR, 2.24; 95% CI, 1.44–3.45) were significantly more common in vaccinees older than 5 months. Shorter onset durations of mild adverse reactions (lymphadenitis and injection site reactions) were reported in vaccinees older than 5 months, while no statistical significance was found regarding osteitis/osteomyelitis. Conclusions Osteomyelitis and distant soft tissue infection may occur less frequently when BCG inoculation occurs after 5 months of age, although mild adverse reactions can be more frequent, symptom onset times can be shortened. As few severe reactions might occur more than 2 years after BCG inoculation and the policy of delayed BCG inoculation was implemented in 2016, a longer observational period is needed to clarify the exact severe complications decrement.

scholarly journals POS0598 COMPARISON OF INJECTION SITE REACTIONS AND INJECTION SITE ERYTHEMA BETWEEN YLB113 AND ETANERCEPT REFERENCE PRODUCT FROM PHASE 3 ACTIVE COMPARATOR STUDY (STUDY NO. YLB113-002)

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 533.1-533
Author(s):  
D. Stefanidis ◽  
U. G ◽  
J. Sánchez-Bursón ◽  
C. Shah ◽  
D. Bakhle
Keyword(s):  
Rheumatoid Arthritis ◽  
Comparative Study ◽  
Injection Site ◽  
Reference Product ◽  
Statistical Significance ◽  
Risk Difference ◽  
P Value ◽  
Chi Square ◽  
Injection Site Reactions ◽  
Significant Difference

Background:YLB113 is an etanercept biosimilar approved in all indications of its etanercept Reference Product (RP). Therapeutic equivalence in terms of clinical efficacy, safety and immunogenicity was previously demonstrated in a pivotal multicenter, double-blind, randomized, parallel-group, active-control, comparative study (YLB113-002) in rheumatoid arthritis (RA) subjects.1,2 Similar incidence of treatment emergent adverse events (TEAEs) was seen in both treatment arms except for injection site reactions (ISRs) and injection site erythema (ISE), both of which were less frequent in subjects treated with YLB113.Objectives:This post-hoc analysis was performed to further evaluate the differences in the incidence of ISRs and ISE during the 24 week treatment when the subjects with RA were treated with 50 mg of YLB113 or RP given once a week as a SC injection along with methotrexate.Methods:Safety analysis set (263 in YLB113 arm and 254 in RP arm) was considered for this analysis.Local reactions at the site of injection were assessed at each of eight study visits.The number of subjects who experienced ISRs and ISE were statistically compared for YLB113 and RP. The risk difference and 95% confidence interval (CI) were computed between arms to understand the magnitude of difference in the incidence of events. The statistical significance of between group difference was tested using chi-square test.Results:The result of this analysis showed a statistically significant difference in the incidences of ISRs and ISE between subjects who received YLB113 and RP. The risk difference between YLB113 and RP arms for ISR was -9.98% (95% CI, WALD -14.81%, -5.15%) and, for ISE it was -7.94% (95% CI, WALD -11.96%, - 3.92%; Table 1). This could be possibly explained by the absence of latex in the syringe needle cap of YLB113.3Table 1.Differences in ISRs and ISEs between YLB113 and Reference Product (RP)EventYLB113N=263RPN=254YLB113 vs RPNo of subjects with events [n(%)]No of subjects with events[n(%)])Risk Diff (95%CI, WALD)P-value (Chi-Square)Injection-site reactions10 (3.8%)35 (13.8%)-9.98% (-14.81%, -5.15%)<0.0001Injection-site erythema5 (1.9%)25 (9.8%)-7.94% (-11.96%, -3.92%)0.0001Conclusion:YLB113 has shown statistically significant lower incidences of ISRs (P-value <0.0001) and ISEs (P value 0.0001) compared to RP. This property may translate to a better acceptability by patients.References:[1]EULAR Abstract AB0416 (2019). Ann Rheum Dis, volume 78, supplement 2, year 2019, page A1670.[2]Yamanaka H, Kamatani N, Tanaka Y, et al. A Comparative Study to Assess the Efficacy, Safety, and Immunogenicity of YLB113 and the Etanercept Reference Product for the Treatment of Patients with Rheumatoid Arthritis. Rheumatol Ther. 2020;7(1):149-163.[3]Viatris Etanercept Summary of Product Characteritics May 2020.Disclosure of Interests:Dimitris Stefanidis Employee of: Viatris GmbHSr. Director, Global Medical Affairs Lead, Immunology Biosimilars, Unmesh G Employee of: Viatris, Juan Sánchez-Bursón: None declared, Chirag Shah Shareholder of: As an employee, Shareholder of Lupin LTD, Employee of: Employee of Lupin LTD, Dhananjay Bakhle Shareholder of: As part of Employee Stock Options Plan from Lupin LTD, Employee of: Employee of Lupin LTD

Evaluation of subcutaneous daratumumab injections in the ambulatory care setting

2021 ◽  
pp. 107815522110469
Author(s):  
Andrew H. Tam ◽  
Yoonie Jung ◽  
Rebecca Young ◽  
Chiung-Yu Huang ◽  
Jeffrey Wolf ◽  
...  
Keyword(s):  
Injection Site ◽  
Median Time ◽  
Statistical Significance ◽  
Secondary Analysis ◽  
Systemic Reaction ◽  
Medical Intervention ◽  
Hypersensitivity Reactions ◽  
Ambulatory Care Setting ◽  
Dose Monitoring ◽  
Injection Site Reactions

Introduction Subcutaneous daratumumab is non-inferior to intravenous daratumumab for the treatment of multiple myeloma and significantly reduced incidence of systemic reactions. However, manufacturer for subcutaneous daratumumab has not provided guidance regarding optimal methods for monitoring for hypersensitivity reactions following subcutaneous daratumumab administration. Methods A retrospective analysis was performed in two cohorts of patients who received at least two doses of subcutaneous daratumumab for the treatment of plasma cell disorders: patients with previous exposure to intravenous daratumumab (dara-exposed) and patients without history of intravenous daratumumab (dara-naïve). The primary outcome was incidence of systemic and injection-site reactions following first dose of subcutaneous daratumumab. Secondary analysis included time to systemic and injection-site reactions, grading of adverse reaction, and incidence of second systemic reaction. Results Thirty-one patients were dara-naïve and 49 patients were dara-exposed. Differences in incidence of systemic (dara-naïve: 9.7% vs dara-exposed: 6.1%, p = 0.67) and injection-site reactions (dara-naïve: 12.9% vs dara-exposed: 14.3%, p = 0.99) did not reach statistical significance. Difference in median time to systemic reaction (dara-naïve: 3 h vs dara-exposed: 12 h, p = 0.18) was clinically important but did not reach statistical significance. Median time to injection-site reactions (dara-naïve: 6 h vs dara-exposed: 24 h, p = 0.03) was shorter in the dara-naïve cohort. No clinically meaningful difference was observed for incidence of second systemic reaction. Conclusion Most reactions were mild and did not require medical intervention. Following first subcutaneous daratumumab dose, monitoring for 3 h for dara-naïve patients and no monitoring time for dara-exposed patients for hypersensitivity reactions may be a safe and reasonable practice.

scholarly journals Safety and Immunogenicity of Tetanus-Diphtheria-Acellular Pertussis Vaccine Administered to Children 10 or 11 Years of Age

2014 ◽  
Vol 21 (11) ◽  
pp. 1560-1564 ◽  
Author(s):  
Gary S. Marshall ◽  
Vitali Pool ◽  
David P. Greenberg ◽  
David R. Johnson ◽  
Xiaohua Sheng ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Injection Site ◽  
Adverse Reactions ◽  
Geometric Mean ◽  
Serious Adverse Events ◽  
Intramuscular Dose ◽  
Injection Site Reactions ◽  
Systemic Reactions ◽  
Pertussis Antigens

ABSTRACTBoosting immunity to tetanus, diphtheria, and pertussis through the use of Tdap vaccines is routinely recommended at 11 to 12 years of age; some states, however, require Tdap for entry into middle school, which may begin at 10 years of age. This study was conducted to determine whether Tdap5 (Adacel), which is licensed for use in children beginning at 11 years of age, is as safe and immunogenic in 10-year-olds as it is in 11-year-olds. Children who had received 5 previous doses of any diphtheria-tetanus-acellular pertussis (DTaP) vaccine were enrolled in a phase IV clinical trial; 646 10-year-olds and 645 11-year-olds completed the study, which involved a single intramuscular dose of Tdap5 along with pre- and postvaccination serologies. Postvaccination geometric mean concentrations (GMCs) of antibody to pertussis antigens (pertussis toxoid, filamentous hemagglutinin, pertactin, and fimbria types 2 and 3) of 10-year-olds were noninferior to those of 11-year-olds, as were booster response rates for all pertussis antibodies, except for those to fimbrial antigens (94% and 97%, respectively). Seroprotection rates among 10-year-olds for tetanus and diphtheria were noninferior to those in 11-year-olds. Rates of injection site reactions, solicited systemic reactions, and unsolicited adverse events, adverse reactions, and serious adverse events were similar in the two groups. These data support the conclusion that Tdap5 is safe and immunogenic in 10-year-olds. (This study has been registered at ClinicalTrials.gov under registration no. NCT01311557.)

scholarly journals Granulomatous Hepatitis Following Intra-Vesical Instillation of Bacillus Calmette–Guérin for Treatment of Bladder Cancer

2021 ◽  
Vol 13 (3) ◽  
pp. 611-618
Author(s):  
Elsa Alves Branco ◽  
Raquel Duro ◽  
Teresa Brito ◽  
António Sarmento
Keyword(s):  
Bladder Cancer ◽  
Hepatitis A ◽  
Adverse Reactions ◽  
Superficial Bladder Cancer ◽  
Rare Complication ◽  
Immunocompetent Patient ◽  
Clinical Suspicion ◽  
Bacillus Calmette Guerin ◽  
Granulomatous Hepatitis ◽  
Appropriate Treatment

Intra-vesical instillation of bacillus Calmette–Guérin (BCG) is an important treatment modality of superficial bladder cancer. It is usually well tolerated, although some adverse reactions can occur. One possible yet rare complication is granulomatous hepatitis, that is thought to be caused either by BCG infection or a hypersensitivity reaction to the bacillus. We present a case of a 79-year-old apparently immunocompetent patient who developed granulomatous hepatitis a few months after BCG administration for bladder cancer immunotherapy. It is important to notice that acid-fast smears and cultures are often negative, and these should not exclude diagnosis nor delay treatment. Our case highlights the importance of clinical suspicion and prompt initiation of appropriate treatment.

scholarly journals AB0978 EFFICACY OF ANAKINRA TREATMENT IN PEDIATRIC RHEUMATIC DISEASES; A SINGLE-CENTER EXPERIENCE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1783.1-1784
Author(s):  
F. Demir ◽  
E. Gürler ◽  
B. Çolak ◽  
B. Sözeri
Keyword(s):  
Familial Mediterranean Fever ◽  
Injection Site ◽  
Rheumatic Diseases ◽  
Systemic Juvenile Idiopathic Arthritis ◽  
Inactive Disease ◽  
Daily Injection ◽  
Recurrent Pericarditis ◽  
Injection Site Reactions ◽  
Mediterranean Fever ◽  
Anakinra Treatment

Background:Anakinra, a recombinant IL-1 receptorantagonist, is a treatment option that acts byblocking the biological activity of IL-1 in autoinflammatory conditions. The diseases that the IL-1 was over expressed are the potential conditions for this treatment. Such as familial Mediterranean fever (FMF), cryopyrin-associated periodic syndrome (CAPS), and hyperimmunglobulin D syndrome (HIDS) with monogenic inheritance, and systemic juvenile idiopathic arthritis (SoJIA) or idiopathic recurrent pericarditis as non-Mendelian polygenic diseases, can be listed as examples of these diseases.Objectives:The aim of this study was to review the efficacy of anakinra treatment in children with rheumatic disease followed in our center.Methods:The study group consisted of children with pediatric rheumatic diseases followed up in the Pediatric Rheumatology Department of University of Health Sciences and treated with anakinra (anti-IL 1) for at least one month, between 1 July 2016 and 1 January 2020. The data of these patients were collected retrospectively. The disease activity of the patients at 3rd month and 12th month after the treatment were assessed. We aim to report our experiences of pediatric rheumatic diseases treated with anakinra.Results:There were 28 patients treated with anakinra for the different pediatric rheumatic diseases. The diagnoses of these patients were as follows; eight were macrophage activation syndrome (MAS) complicating SoJIA, six were HIDS, four were CAPS, four were FMF, four were idiopathic recurrent pericarditis, one was deficiency of interleukin-36 receptor antagonist (DITRA), and one was undefined systemic autoinflammatory disease. 46.4% of the patients were male and 53.6% were female. The median age of diagnosis of the patients was 6.5 ((interquartile range (IQR): 4-12.7) years. The median follow-up duration of the patients was 14 (IQR: 3.7-28) months. The patients median anakinra treatment duration was 3 (IQR: 1-4) months. Fever reduced and C-reactive protein normalized within median 2 (IQR: 1-3) and 5 (IQR: 5-7) days, respectively. In the 3rd month after treatment; It was observed that 53.6% of patients achieved a complete remission (no attack was seen or MAS was improved). The frequency of attacks were decreased more than 50% in 35.7% of patients and less than 50% in 7.1%. 3.6% of patients were unresponsive to treatment. In the 12th month assessment after the initiation of treatment, it was observed that 28.6% of patients were still under anakinra treatment and in remission, 10.7% of them were in remission without anakinra treatment. In 60.7% of patients, anakinra was switch to other biological treatments for different reasons (35.7% partial response or unresponsiveness, 17.8% injection site reactions and 7.1% daily-injection difficulty). Biologic drug switch to canakinumab and tocilizumab was observed in 88.2% and 11.8% of patients, respectively. One patient developed recurrent MAS episodes when the anakinra dose was tapered, and one another patient was unresponsive to the anakinra and dead due to secondary to MAS.Conclusion:Anakinra seems to be a successful treatment to achieve inactive disease in a significant portion of patients in the early period. The recurrence of disease attacks while drug tapering and injection site reactions were appears the main causes of treatment switch or discontinuation.References:[1]Ben-Zvi I, Kukuy O, Giat E, Pras E, Feld O, Kivity Set al. Anakinra for Colchicine-Resistant Familial Mediterranean Fever: A Randomized, Double-Blind, Placebo-Controlled Trial. Arthritis Rheumatol. 2017;69:854-862.Acknowledgments:We thank our patients and their familiesDisclosure of Interests:None declared

Large Injection Site Reactions After a Second Dose of Varicella Vaccine

2008 ◽  
Vol 27 (8) ◽  
pp. 757-759 ◽  
Author(s):  
Emmanuel B. Walter ◽  
Martha A. Snyder ◽  
Dennis A. Clements ◽  
Samuel L. Katz
Keyword(s):  
Injection Site ◽  
Varicella Vaccine ◽  
Injection Site Reactions ◽  
Large Injection

scholarly journals Rheumatological Adverse Events Following Immunotherapy for Cancer

Medicina ◽  
2022 ◽  
Vol 58 (1) ◽  
pp. 94
Author(s):  
Ioana Cretu ◽  
Bogdan Cretu ◽  
Catalin Cirstoiu ◽  
Adrian Cursaru ◽  
Mihaela Milicescu ◽  
...  
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
Adverse Reactions ◽  
Cancer Treatments ◽  
Treatment Conditions ◽  
Clinical Presentations ◽  
Rheumatic Manifestations ◽  
Grade 3 ◽  
Dose Dependent ◽  
Rheumatological Manifestations

Background and Objectives: The occurrence of rheumatological side effects in a patient after receiving immunotherapy for cancer is becoming increasingly common. Oncologists often fail to diagnose and refer affected patients to rheumatologists. This paper presents the various rheumatological adverse events that occur after immunotherapy in patients as well as their treatment and evolution. Materials and Methods: A total of 36 patients were monitored between November 2018 and March 2020. The oncologist monitoring the immunotherapy-treated patients identified the occurrence of musculoskeletal side effects. The grading of toxicities was performed by both the oncologist and the rheumatologist using common terminology criteria for adverse events (CTCAE). Rheumatological treatment was administered, and for some patients, immunotherapy was discontinued. Results: The clinical presentations of the patients varied. Mild side effects (grade 1–2) were reported in a higher proportion than severe side effects (grade 3–5). Therefore, thirty-one patients had mild-to-moderate side effects, and five patients had severe side effects. Adverse reactions occurred, on average, 10 weeks after the initiation of immunotherapy; this indicated that the severity of the toxicity was dose dependent. Patients were treated with NSAIDs or prednisone, depending on the severity of the side effects, and for patients with severe manifestations, immunotherapy was discontinued. The remission of rheumatic manifestations varied depending on the grade of the manifestations. Conclusions: The clinical, biological, and ultrasound presentations of the patients with adverse events followed by cancer treatments differed from classic rheumatological manifestations. Thorough examinations of these patients by both oncologists and rheumatologists are needed in order to correctly diagnose and treat rheumatological adverse events. Multiple studies that include a larger number of participants are needed in order to better understand the pathogenesis and clinical evolution of these patients under different treatment conditions.

Recurrent Abscess Formation Following DTP Immunizations: Association with Hypersensitivity to Tetanus Toxoid

PEDIATRICS ◽  
1985 ◽  
Vol 75 (5) ◽  
pp. 899-900
Author(s):  
JOSEPH A. CHURCH ◽  
WARREN RICHARDS
Keyword(s):  
Injection Site ◽  
Tetanus Toxoid ◽  
Adverse Reactions ◽  
Antibody Responses ◽  
Abscess Formation ◽  
Intramuscular Injections ◽  
Pertussis Antigen ◽  
Dtp Vaccine ◽  
Local Reactions

Adverse local reactions to vaccines containing diphtheria and tetanus toxoids and pertussis antigen (DTP) are common, but generally benign. Most often, these reactions are manifested by erythema, induration, and tenderness occurring at the injection site 12 to 24 hours following immunization.1-3 Less frequently, abscess formation may complicate intramuscular injections and these may be staphylococcal, clostridial, or sterile in etiology.4 Tetanus toxoid has been associated with a reaction incidence of 3% to 13%,5,6 and adverse reactions appear to be related to the number of prior immunizations and the height of preexisting antibody responses.3,6 However, recurrent abscess formation associated with hypersensitivity to one or more of the components of the DTP vaccine has not been reported previously.

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