Talks
Presenting Author Academic/Professional Position
Priya Kale
Academic Level (Author 1)
Medical Student
Academic Level (Author 2)
Faculty
Discipline/Specialty (Author 2)
Cancer and Immunology
Discipline Track
Clinical Science
Abstract Type
Research/Clinical
Abstract
Up to 15.5% of patients taking biologic medication experience injection site reactions (ISRs) leading to morbidity, early discontinuation, and reduced treatment compliance. As biologic medications are increasingly used to treat chronic inflammatory conditions, including psoriasis and atopic dermatitis, there needs to be an improved understanding of ISRs. However, current methods of grading ISRs are nonspecific and unstandardized leading to a lack of understanding of medication-specific ISRs and ambiguity in perceptions of treatment tolerability. Here we aim to develop a standardized ISR grading scale for use in clinical trials. A scoping review was performed to evaluate current ISR grading scales and identify areas for improving the consistency and clarity of these scales. Based on these findings, a preliminary ISR grading scale was developed. Three board-certified dermatologists independently reviewed and rated a standardized set of ten public ISR images using this scale. Precision of the grading scale was assessed by measuring inter-rater variability, which was defined as the variation in grading between the dermatologists. We have developed a preliminary standardized ISR grading scale. This includes clinical variables of erythema, induration, edema, ecchymosis, papules or plaques, vesicles or bullae, hyperpigmentation, hypopigmentation, hemorrhage, and ulceration. Each variable is measured on a scale from 0 to 5 in severity with a total ISR grading score measured summatively across variables. We anticipate assessing the precision of this novel grading scale by measuring inter-rater variability. Findings will be supplemented by short-form feedback from dermatologists to highlight additional pain-related symptoms to include in the grading scale. In our next steps, we anticipate collecting patient survey data on clinical variables and their impact, to introduce weighting of variables in this grading scale. In summary, we have created a standardized ISR grading scale that takes into account multiple clinical manifestations of ISRs, with an extensive severity scale per variable, which will be instrumental in accurately and precisely grading ISRs in biologic medications.
Presentation Type
Talk
Recommended Citation
Kale, Priya and Sarin, Kavita, "Implementing a Specific and Standardized Grading Scale for Therapeutic Injection Site Reactions to Improve Adverse Event Reporting" (2025). Research Colloquium. 11.
https://scholarworks.utrgv.edu/colloquium/2025/talks/11
Implementing a Specific and Standardized Grading Scale for Therapeutic Injection Site Reactions to Improve Adverse Event Reporting
Up to 15.5% of patients taking biologic medication experience injection site reactions (ISRs) leading to morbidity, early discontinuation, and reduced treatment compliance. As biologic medications are increasingly used to treat chronic inflammatory conditions, including psoriasis and atopic dermatitis, there needs to be an improved understanding of ISRs. However, current methods of grading ISRs are nonspecific and unstandardized leading to a lack of understanding of medication-specific ISRs and ambiguity in perceptions of treatment tolerability. Here we aim to develop a standardized ISR grading scale for use in clinical trials. A scoping review was performed to evaluate current ISR grading scales and identify areas for improving the consistency and clarity of these scales. Based on these findings, a preliminary ISR grading scale was developed. Three board-certified dermatologists independently reviewed and rated a standardized set of ten public ISR images using this scale. Precision of the grading scale was assessed by measuring inter-rater variability, which was defined as the variation in grading between the dermatologists. We have developed a preliminary standardized ISR grading scale. This includes clinical variables of erythema, induration, edema, ecchymosis, papules or plaques, vesicles or bullae, hyperpigmentation, hypopigmentation, hemorrhage, and ulceration. Each variable is measured on a scale from 0 to 5 in severity with a total ISR grading score measured summatively across variables. We anticipate assessing the precision of this novel grading scale by measuring inter-rater variability. Findings will be supplemented by short-form feedback from dermatologists to highlight additional pain-related symptoms to include in the grading scale. In our next steps, we anticipate collecting patient survey data on clinical variables and their impact, to introduce weighting of variables in this grading scale. In summary, we have created a standardized ISR grading scale that takes into account multiple clinical manifestations of ISRs, with an extensive severity scale per variable, which will be instrumental in accurately and precisely grading ISRs in biologic medications.
