Background: Monoclonal antibodies acting on the CGRP pathway (CGRP-mAbs) are characterized by subcutaneous administration via autoinjectors or prefilled syringes. Unfortunately, significant local tolerability concerns about injection site pain (ISP) may degrade patient comfort, increase the fear and stress of dose administration, and negatively impact patient adherence. The aim of the present cross-sectional study was to assess the experience of patients with migraine using either CGRP-mAbs prefilled syringes or autoinjectors regarding local tolerability and perceived ease-of-usability. Methods: A self-administered electronic questionnaire was created using “Google questionnaires” to collect from migraine inpatients treated with CGR-mAbs: i) demographic and clinical parameters; ii) data related to ongoing preventive CGRP-mAb treatments and their local tolerability (in particular, evaluated by numerical rating scale); iii) data on perceived ease-of-usability; and iv) data on putative previous onabotulinumtoxinA treatment. Results: The questionnaire was sent to 405 migraine patients. After 10 days, 283 (69.87%) patients had completed the electronic form. No significant differences were found among groups regarding data on ease-of-usability and local tolerability of CGRP-mAbs regarding simplicity and modality of administration (self-administered or not), ISP, or reactions at the site of administration. However, we did identify young females (OR=0.22; p<0.001) with chronic migraine (OR=4.87; p=0.007) to be the phenotype most prone to experience ISP during CGRP-mAbs treatment. Of 96 patients who had previously received at least 3 onabotulinumtoxinA administrations, injection site pain was significantly higher with onabotulinumtoxinA compared to CGRP-mAbs (6±4 vs. 4±5; p<0.001). Conclusions: Devices used for CGRP-mAbs administration (auto-injector and prefilled syringes) are characterized by several strengths and disadvantages, one compensating for the other so that no differences in perceived ease-of-usability and local tolerability can be observed. These findings may also result in economic and ecological implications, considering the lower impact on costs and environmental pollution of prefilled syringes compared to more expensive and polluting plastic autoinjectors.
Perceived ease-of-usability and local tolerability using CGRP monoclonal antibody autoinjectors vs. syringes: an online questionnaire-based study in patients with migraine
Silvestro, Marcello;Orologio, Ilaria;Siciliano, Mattia;Trojsi, Francesca;Tessitore, Alessandro;Tedeschi, Gioacchino;Russo, Antonio
2024
Abstract
Background: Monoclonal antibodies acting on the CGRP pathway (CGRP-mAbs) are characterized by subcutaneous administration via autoinjectors or prefilled syringes. Unfortunately, significant local tolerability concerns about injection site pain (ISP) may degrade patient comfort, increase the fear and stress of dose administration, and negatively impact patient adherence. The aim of the present cross-sectional study was to assess the experience of patients with migraine using either CGRP-mAbs prefilled syringes or autoinjectors regarding local tolerability and perceived ease-of-usability. Methods: A self-administered electronic questionnaire was created using “Google questionnaires” to collect from migraine inpatients treated with CGR-mAbs: i) demographic and clinical parameters; ii) data related to ongoing preventive CGRP-mAb treatments and their local tolerability (in particular, evaluated by numerical rating scale); iii) data on perceived ease-of-usability; and iv) data on putative previous onabotulinumtoxinA treatment. Results: The questionnaire was sent to 405 migraine patients. After 10 days, 283 (69.87%) patients had completed the electronic form. No significant differences were found among groups regarding data on ease-of-usability and local tolerability of CGRP-mAbs regarding simplicity and modality of administration (self-administered or not), ISP, or reactions at the site of administration. However, we did identify young females (OR=0.22; p<0.001) with chronic migraine (OR=4.87; p=0.007) to be the phenotype most prone to experience ISP during CGRP-mAbs treatment. Of 96 patients who had previously received at least 3 onabotulinumtoxinA administrations, injection site pain was significantly higher with onabotulinumtoxinA compared to CGRP-mAbs (6±4 vs. 4±5; p<0.001). Conclusions: Devices used for CGRP-mAbs administration (auto-injector and prefilled syringes) are characterized by several strengths and disadvantages, one compensating for the other so that no differences in perceived ease-of-usability and local tolerability can be observed. These findings may also result in economic and ecological implications, considering the lower impact on costs and environmental pollution of prefilled syringes compared to more expensive and polluting plastic autoinjectors.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
