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.

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

Systemic hypersensitivity to fosaprepitant – A report of two cases

2016 ◽  
Vol 24 (1) ◽  
pp. 76-78 ◽  
Author(s):  
Allison Baxley ◽  
Zoe Lee ◽  
Patrick Medina
Keyword(s):  
Injection Site ◽  
Infusion Reaction ◽  
Common Type ◽  
Emetogenic Chemotherapy ◽  
Local Injection ◽  
Hypersensitivity Reactions ◽  
Review Of The Literature ◽  
Highly Emetogenic Chemotherapy ◽  
Injection Site Reactions ◽  
Systemic Hypersensitivity

Fosaprepitant is a widely administered antiemetic used mainly for moderately to highly emetogenic chemotherapy. Local injection site reactions are the most common type of infusion reaction reported from fosaprepitant. At our institution, two separate patients have experienced systemic hypersensitivity reactions to their infusions of fosaprepitant. We report a review of the literature and the details of these reactions.

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

State Recreational Marijuana Laws and Dispensaries: Chronic School Absenteeism in Washington State

2021 ◽  
Vol 8 (4) ◽  
Author(s):  
Maxim Gakh ◽  
Courtney Coughenour ◽  
Brooke Kleven ◽  
Brian Labus
Keyword(s):  
Social Factors ◽  
Statistical Significance ◽  
Secondary Analysis ◽  
Risk Groups ◽  
Washington State ◽  
School Absenteeism ◽  
Chronic Absenteeism ◽  
Significant Difference ◽  
Before And After ◽  
Recreational Marijuana

Objective: Whereas states continue to experiment with liberalized marijuana laws, how these laws impact health, education, and social factors is not yet fully understood. In this study, we examined whether chronic school absenteeism rates changed in Washington State in the presence of recreational marijuana dispensaries pursuant to implementation of the state’s recreational marijuana laws. Methods: We conducted a secondary analysis using school district chronic absenteeism rates before and after the presence of recreational dispensaries. Results: The results of the independent samples t-test showed no statistically significant difference in chronic absenteeism rates among districts with or without recreational marijuana dispensaries. Conclusions: The finding of no statistical significance for chronic absenteeism in districts with and without recreational dispensaries – a pattern that largely persisted among at-risk groups – supports that the presence of recreational marijuana dispensaries seems neither to exacerbate nor improve chronic school absenteeism rates. This finding is important for policymakers, practitioners, and researchers trying to understand the changing marijuana legal landscape.

scholarly journals Safety and convenience of once-weekly somapacitan in adult GH deficiency: a 26-week randomized, controlled trial

2018 ◽  
Vol 178 (5) ◽  
pp. 491-499 ◽  
Author(s):  
Gudmundur Johannsson ◽  
Ulla Feldt-Rasmussen ◽  
Ida Holme Håkonsson ◽  
Henrik Biering ◽  
Patrice Rodien ◽  
...  
Keyword(s):  
Injection Site ◽  
Treatment Satisfaction ◽  
Gh Deficiency ◽  
Standard Deviation Score ◽  
Fixed Dose ◽  
Once Daily ◽  
Randomized Controlled ◽  
Injection Site Reactions ◽  
Adult Gh Deficiency ◽  
Igf I

Objective Somapacitan is a reversible albumin-binding growth hormone (GH) derivative, developed for once-weekly administration. This study aimed to evaluate the safety of once-weekly somapacitan vs once-daily Norditropin®. Local tolerability and treatment satisfaction were also assessed. Design 26-week randomized, controlled phase 3 safety and tolerability trial in six countries (Nbib2382939). Methods Male or female patients aged 18–79 years with adult GH deficiency (AGHD), treated with once-daily GH for ≥6 months, were randomized to once-weekly somapacitan (n = 61) or once-daily Norditropin (n = 31) administered subcutaneously by pen. Both treatments were dose titrated for 8 weeks to achieve insulin-like growth factor I (IGF-I) standard deviation score (SDS) levels within the normal range, and then administered at a fixed dose. Outcome measures were adverse events (AEs), including injection site reactions; occurrence of anti-somapacitan/anti-GH antibodies and change in treatment satisfaction, assessed using the Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9). Results Mean IGF-I SDS remained between 0 and 2 SDS throughout the trial in both groups. AEs were mostly mild or moderate and transient in nature. The most common AEs were nasopharyngitis, headache and fatigue in both groups. More than 1500 somapacitan injections were administered and no clinically significant injection site reactions were reported. No anti-somapacitan or anti-GH antibodies were detected. The TSQM-9 score for convenience increased significantly more with somapacitan vs Norditropin (P = 0.0171). Conclusions In this 26-week trial in patients with AGHD, somapacitan was well tolerated and no safety issues were identified. Once-weekly somapacitan was reported to be more convenient than once-daily Norditropin.

scholarly journals P100 Factors associated with educational needs in patients with inflammatory arthritis

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Alice R Johnston ◽  
Mwidimi Ndosi
Keyword(s):  
Inflammatory Arthritis ◽  
Disease Duration ◽  
Statistical Significance ◽  
Secondary Analysis ◽  
Female Gender ◽  
Educational Needs ◽  
Outcome Variable ◽  
Multivariable Model ◽  
Factors Associated ◽  
Educational Priorities

Abstract Background With an overarching aim to inform person-centred patient-education, this study had two objectives: (i) to identify factors that may be associated with educational needs in patients with inflammatory arthritis (IA) (ii) to assess whether educational needs and priorities differ between subtypes of inflammatory arthritis i.e. rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS). Methods Secondary analysis of cross-sectional survey data originally used to validate the Educational Needs Assessment Tool (ENAT) was conducted. The outcome variable was educational needs, summarised as ENAT domain scores. The explanatory variables were: Age, gender, IA subtype, school leaving age and disease duration. ENAT scores were Rasch-transformed prior to analysis. Univariable analyses were conducted to explore differences between groups and multivariable analyses (multiple regression) to determine factors associated with educational needs. All explanatory factors were entered into a preliminary multivariable model. Factors that achieved statistical significance at the 10% level were entered into the final multivariable model. Those that achieved a statistical significance at the 5% level were associated with educational needs. To determine educational priorities, percentage contribution of each domain score to the total score was calculated and compared between factors with one-way analysis of variance. Results The evaluable population comprised 388 patients, 125 with RA, 133 with AS and 130 with PsA. Their mean (SD) age was 48 (13.95) years and male/female ratio 177/210. Those with early arthritis (disease duration &lt;2 years) were 36 (9.2%), RA = 15, AS = 3 and PsA=18, and 116 (29.7%) left school before the age of 16. Table 1 presents the final multi-variable models. The proportion of variance explained by the model varied across ENAT domains, the highest being movement (25%). Female gender was found to be an independent predictor of educational needs across all ENAT domains. Significant differences in educational priorities were observed between disease groups in all domains except disease process and support. Conclusion Female gender is independently associated with educational needs across all three sub-types of IA. Results of this secondary analysis are inconclusive due to limitations in the available data. Further research should include factors such as disease severity, treatments, disability and self-efficacy. Disclosures A.R. Johnston Other; Work conducted as part of Nurse and Allied Health Professional Internship Programme funded by versus Arthritis (Grant number 20867). M. Ndosi None.

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