scholarly journals Embolia Cutis Medicamentosa after Subcutaneous Injection with Glatiramer Acetate

2021 ◽  
pp. 114-120
Author(s):  
Lyubomira Vlahova ◽  
Lutz Kretschmer ◽  
Michael P. Schön ◽  
Rotraut Mössner
Keyword(s):  
Multiple Sclerosis ◽  
Injection Site ◽  
Glatiramer Acetate ◽  
Subcutaneous Injection ◽  
Rare Case ◽  
Injection Site Reaction ◽  
Disease Course ◽  
Site Reaction ◽  
Photo Documentation ◽  
Embolia Cutis Medicamentosa

Embolia cutis medicamentosa (ECM) is a rare and unpredictable injection site reaction, occurring after intramuscular, subcutaneous, and even after intraarticular injection of various drugs. We report a very rare case of necrotizing ECM after injection of glatiramer acetate for multiple sclerosis, include a photo documentation over the entire disease course, and discuss hypotheses as to etiology and treatment.

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 A Topical Adhesive Containing Anesthetic and Heating Components to Reduce Injection Pain with Subcutaneous Multiple Sclerosis Medications

2017 ◽  
Vol 19 (2) ◽  
pp. 85-90
Author(s):  
Theodore R. Brown ◽  
Virginia I. Simnad
Keyword(s):  
Multiple Sclerosis ◽  
Injection Site ◽  
Interferon Beta ◽  
Injection Site Reaction ◽  
Local Injection ◽  
Injection Pain ◽  
Site Reaction ◽  
Drug Injection ◽  
Randomized Controlled Studies ◽  
Scale Scores

Background: Injection pain and fear of pain are common with subcutaneous medications for treating multiple sclerosis (MS). Synera is a peel-and-stick topical adhesive (S-TA) with a novel heating component to enhance the delivery of an anesthetic mixture of lidocaine and tetracaine. We studied the effect of S-TA on pain and other aspects of comfort after subcutaneous MS drug injection. Methods: Thirty participants with MS having injection reactions to subcutaneous interferon beta (IFNβ) or glatiramer acetate (GA) were enrolled in an open-label prospective study. We captured six to seven injections at baseline and with 60- and 30-minute S-TA application times. The primary outcome was immediate pain on injection. Secondary outcomes included 12- and 24-hour pain ratings, 24-hour local injection-site reaction scale scores, 24-hour tenderness, and fear of injection (FOI). Results: Twenty-nine participants completed the study (interferon beta = 4, GA = 25, mean age = 51 years, females = 86%). There were significant reductions in injection pain, pain at 12 and 24 hours, tenderness at 24 hours, local injection-site reaction scale scores, and FOI for the 30- and 60-minute applications of S-TA (all P < .01). Results were similar in the GA subgroup. Adverse events included muscle spasm and lightheadedness (n = 1) and mild dermatitis (n = 1). Conclusions: These results suggest that S-TA applied 30 or 60 minutes before MS drug injection may reduce pain, tenderness, and FOI. Randomized controlled studies are needed to confirm the efficacy of ST-A.

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 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 Predictors of Subcutaneous Injection Site Reactions to Sustained-Release Buprenorphine in Rhesus Macaques (Macaca mulatta)

2021 ◽  
Author(s):  
Andrew J Haertel ◽  
Matthew A Schultz ◽  
Lois M Colgin ◽  
Amanda L Johnson
Keyword(s):  
Sustained Release ◽  
Injection Site ◽  
Macaca Mulatta ◽  
Subcutaneous Injection ◽  
Rhesus Macaques ◽  
Single Case ◽  
Subcutaneous Tissue ◽  
Injection Site Reaction ◽  
Reaction Rates ◽  
Injection Site Reactions

Subcutaneous injection site reactions to sustained-release buprenorphine hydrochloride (Buprenorphine SR) in macaqueshave been reported in only a single case report. In the current study, we evaluated the incidence rate and predictors ofbuprenorphine SR reactions in the subcutaneous tissue of rhesus macaques (Macaca mulatta) based on retrospective reviewof macaque buprenorphine SR injection records. Potentially predictive variables were identified with logistic regressionmodeling and were evaluated using model selection based on Akaike information criterion. Record review revealed subcutaneoustissue reactions occurred in 52 (3%) of 1559 injections and were noted between 4 and 311 d after injection. Modelselection showed that body weight and MHC allele Mamu-B*29 were the best predictors of subcutaneous reactions. Basedon these results, we recommend consideration of potential risk factors prior to the administration of buprenorphine SR toa rhesus macaque. In addition, the authors advise that using the highest concentration of buprenorphine SR available mayreduce injection site reaction rates due to the injection of less copolymer.

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