scholarly journals Liraglutide-induced injection site reaction

2019 ◽  
Vol 23 (2) ◽  
pp. 97 ◽  
Author(s):  
NadaFouda Neel ◽  
Yasser Ghobara ◽  
Mohammed Turkmani
Keyword(s):  
Injection Site ◽  
Injection Site Reaction ◽  
Site Reaction

A phase 1b study of personalized neoantigen vaccine plus pembrolizumab in adults with advanced cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 2615-2615
Author(s):  
Aaron Miller ◽  
Zeynep Kosaloglu-Yalcin ◽  
Luise Westernberg ◽  
Leslie Montero ◽  
Milad Bahmanof ◽  
...  
Keyword(s):  
T Cell ◽  
Injection Site ◽  
Cell Function ◽  
Injection Site Reaction ◽  
Therapeutic Vaccine ◽  
T Cell Responses ◽  
Patient Specific ◽  
Clinical Activity ◽  
Site Reaction ◽  
Cell Responses

2615 Background: Neoantigens (NeoAg) are key targets for personalized immunotherapy but efficient methods for their systematic identification and therapeutic targeting remain elusive. We developed a methodology to reliably identify and verify somatic alteration-derived neoantigens based on natural T cell responses against them which formed the basis of an individualized therapeutic vaccine strategy. Methods: This is a phase Ib study to assess the immunogenicity, safety and early clinical activity of personalized synthetic long peptides (PSLP) cancer vaccines in combination with pembrolizumab for patients with treatment refractory metastatic solid tumors or PSLP vaccine alone as an adjuvant treatment with patients with no evidence of disease (NED) that incorporates patient-specific NeoAg identified by an HLA-agnostic, functional T-cell assay (see table). Results: At the time of data cutoff, a total of 5 patients had been treated on ARM-A, 5 patients on ARM-C and 2 patients on ARM-D. AES possibly attributed to personalized vaccine (PSLP), or pembrolizumab, or both include: Grade 1: Arthralgia (1); Diarrhea (1); Fever (4); Fatigue (7); Generalized muscle weakness (1); Headache (2); Nausea (1); Confusion (1); Injection site reaction (5); Rash maculo-papular (3); Flu like symptoms (5); Myalgia (1); and Grade 2: Diarrhea (1); Fatigue (1); Hyperhidrosis (1); Hypothyroidism (1); Injection site reaction (1); Proteinuria (1); Renal and Urinary – other (1); and Grade 3: Colitis (1). For the 9 patients with at least 1 radiographic assessment at the time of analysis 6 had a best response of stable disease (SD) and 3 had progressive disease (PD). Immune monitoring of peripheral blood specimens consistently demonstrated that NeoAg-specific T cell responses were enhanced following administration of PSLP vaccine. On-treatment biopsies demonstrated immune-editing with the variant allele frequency of targeted mutations decreasing following administration of the PSLP vaccine. Conclusions: Taken together, these data meet the trial primary endpoint by demonstrating PSLP vaccines targeting NeoAg identified using the HLA-agnostic pipeline augment effector T cell function against these targets. Clinical trial information: NCT02287428. [Table: see text]

scholarly journals A prospective study comparing injectable interferon beta-1a (Rebif 22-44), (Avonex 30) and 1b (Betaseron 250) injection site reaction in multiple sclerosis patients

10.19082/7574 ◽  
2019 ◽  
Vol 11 (3) ◽  
pp. 7574-7579
Author(s):  
Foziah Jabbar Alshamrani ◽  
Hind Alnajashi ◽  
Fahad Alkhamis ◽  
Ibrahim Alghanimi ◽  
Abdulla Alsulaiman ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Prospective Study ◽  
Injection Site ◽  
Interferon Beta ◽  
Injection Site Reaction ◽  
Site Reaction ◽  
Multiple Sclerosis Patients ◽  
A Prospective Study

scholarly journals P620 Maintenance of clinical remission with SB5 biosimilar after switch from adalimumab originator: Real-life experience of a tertiary referral centre

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S515-S515 ◽  
Author(s):  
G Dragoni ◽  
A Pieraccini ◽  
S Bagnoli ◽  
S Caini ◽  
G Macrì ◽  
...  
Keyword(s):  
Injection Site ◽  
Clinical Remission ◽  
Life Experience ◽  
Cox Regression ◽  
Injection Site Reaction ◽  
Real Life ◽  
Site Reaction ◽  
Tertiary Referral Centre ◽  
Historical Cohort ◽  
Over Time

Abstract Background Adalimumab (ADM) biosimilars have been demonstrated as safe and effective as the ‘originator’ in trials for other autoimmune disorders, but real-life evidence in inflammatory bowel diseases (IBD) is lacking. The aim of the study was to demonstrate maintenance of clinical remission (CR) after switch from ADM ‘originator’ to biosimilar SB5. Methods Data were retrospectively collected from November 2018 to September 2019. All IBD patients in CR after at least 6 months of ‘originator’ and switched to SB5 were included. The primary outcomes were maintenance of CR at 6 months after switch (defined as Partial Mayo Score 0–1 for ulcerative colitis and Harvey–Bradshaw Index ≤4 for Crohn’s disease) and overall comparable safety. A historical cohort of patients treated only with the ‘originator’ was included for comparison, using a Cox regression model with a time-varying covariate. Results In total, 96 patients were included. Baseline characteristics of the cohort are reported in Table 1. Maintenance of CR after 6 months of switch was reported in 89/96 (92.7%) patients. Levels of C-reactive protein (CRP) significantly increased over time from baseline to 6 months (from 2.67 ± 2.61 to 4.98 ± 5.81 mg/dl, p = 0.03), but no difference between the two time points was found when considering a relevant flare only for CRP above the lab cut-off (5 mg/dl). A comparison of CR persistence over time between ‘originator’ cohort and SB5 ‘switching’ cohort did not show any statistical difference (Hazard Ratio 1.07, 95% CI 0.57 – 2.01). With regard to adverse events, SB5 showed an overall safety profile, with only 2/96 (2.1%) patients interrupting the treatment due to anti-TNF-induced psoriasis. In 42/96 (43.8%) of patients, at least one injection site reaction was reported; only in one case a re-switch to ‘originator’ was needed for local intolerance. Conclusion SB5 is safe and effective in maintaining CR after switching from the ‘originator’. Injection site reaction is a frequent but usually manageable side effect. Larger multi-centre cohort and endoscopic assessment are needed to confirm the initial findings.

scholarly journals PMS36 INJECTION SITE REACTION QUESTIONNAIRE: AN ADEQUATE TOOL FOR MEASURING INJECTION SITE REACTIONS?

2010 ◽  
Vol 13 (3) ◽  
pp. A129
Author(s):  
EH Lee ◽  
E Jutkowitz ◽  
S Parasuraman ◽  
C Derk ◽  
LT Pizzi
Keyword(s):  
Injection Site ◽  
Injection Site Reaction ◽  
Site Reaction ◽  
Injection Site Reactions

scholarly journals Injection-site reaction to ixekizumab histologically mimicking lupus tumidus: Report of two cases

2018 ◽  
Vol 84 (5) ◽  
pp. 610 ◽  
Author(s):  
Marta Prieto-Barrios ◽  
Jose Luis Rodriguez-Peralto ◽  
Cristina Vico-Alonso ◽  
Virginia Velasco-Tamariz ◽  
Alba Calleja-Algarra ◽  
...  
Keyword(s):  
Injection Site ◽  
Injection Site Reaction ◽  
Site Reaction ◽  
Lupus Tumidus

Indirect comparison of the efficacy and safety of alirocumab and evolocumab: a systematic review and network meta-analysis

2020 ◽  
Author(s):  
Paul Guedeney ◽  
Sabato Sorrentino ◽  
Gennaro Giustino ◽  
Celine Chapelle ◽  
Silvy Laporte ◽  
...  
Keyword(s):  
Systematic Review ◽  
Injection Site ◽  
Meta Analysis ◽  
Injection Site Reaction ◽  
Indirect Comparison ◽  
Lipid Lowering ◽  
Lipid Lowering Therapy ◽  
Efficacy And Safety ◽  
Site Reaction ◽  
Increased Risk

Abstract Aims Although alirocumab and evolocumab have both been associated with improved outcomes in patients with dyslipidaemia or established atherosclerotic cardiovascular disease, data on their respective performances are scarce. This study aimed at providing an indirect comparison of the efficacy and safety of alirocumab vs. evolocumab. Methods and results We conducted a systematic review and network meta-analysis of randomized trials comparing alirocumab or evolocumab to placebo with consistent background lipid-lowering therapy up to November 2018. We estimated the relative risk (RR) and the 95% confidence intervals (CIs) using fixed-effect model in a frequentist pairwise and network meta-analytic approach. A total of 30 trials, enrolling 59 026 patients were included. Eligibility criteria varied significantly across trials evaluating alirocumab and evolocumab. Compared with evolocumab, alirocumab was associated with a significant reduction in all-cause death (RR 0.80, 95% CI 0.66–0.97) but not in cardiovascular death (RR 0.83, 95% CI 0.65–1.05). This study did not find any significant differences in myocardial infarction (RR 1.15, 95% CI 0.99–1.34), stroke (RR 0.96, 95% CI 0.71–1.28), or coronary revascularization (RR 1.13, 95% CI 0.99–1.29) between the two agents. Alirocumab was associated with a 27% increased risk of injection site reaction compared to evolocumab; however, no significant differences were found in terms of treatment discontinuations, systemic allergic reaction, neurocognitive events, ophthalmologic events, or new-onset of or worsening of pre-existing diabetes. Conclusion Alirocumab and evolocumab share a similar safety profile except for injection site reaction. No significant differences were observed across the efficacy endpoints, except for all-cause death, which may be related to the heterogeneity of the studied populations treated with the two drugs.

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