Pegylated interferon beta-1a (Plegridy) Italian real-world experience: a Delphi analysis of injection-site reaction and flu-like symptom management

Author(s):  
Cinzia Cordioli ◽  
Graziella Callari ◽  
Roberta Fantozzi ◽  
Francesca Caruso ◽  
Giuseppe Martucci ◽  
...  
10.19082/7574 ◽  
2019 ◽  
Vol 11 (3) ◽  
pp. 7574-7579
Author(s):  
Foziah Jabbar Alshamrani ◽  
Hind Alnajashi ◽  
Fahad Alkhamis ◽  
Ibrahim Alghanimi ◽  
Abdulla Alsulaiman ◽  
...  

2008 ◽  
Vol 59 (2) ◽  
pp. S48-S49 ◽  
Author(s):  
Michael Conroy ◽  
Lindsay Sewell ◽  
O. Fred Miller ◽  
Tammie Ferringer

2017 ◽  
Vol 7 (1) ◽  
pp. 39-47 ◽  
Author(s):  
Barry Hendin ◽  
DeRen Huang ◽  
Sibyl Wray ◽  
Robert T Naismith ◽  
Sheri Rosenblatt ◽  
...  

2017 ◽  
Vol 19 (2) ◽  
pp. 85-90
Author(s):  
Theodore R. Brown ◽  
Virginia I. Simnad

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.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 2615-2615
Author(s):  
Aaron Miller ◽  
Zeynep Kosaloglu-Yalcin ◽  
Luise Westernberg ◽  
Leslie Montero ◽  
Milad Bahmanof ◽  
...  

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]


2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S515-S515 ◽  
Author(s):  
G Dragoni ◽  
A Pieraccini ◽  
S Bagnoli ◽  
S Caini ◽  
G Macrì ◽  
...  

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.


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