https://doi.org/10.4081/cc.2024.15772
Perceived ease-of-usability and local tolerability using CGRP monoclonal antibody autoinjectors vs. syringes: an online questionnaire-based study in patients with migraine
Submitted: 19 June 2024
Accepted: 21 December 2024
Published: 27 January 2025
Accepted: 21 December 2024
Abstract Views: 114
PDF: 43
SUPPLEMENTARY: 7
SUPPLEMENTARY: 7
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All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
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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.
1. Diener HC, Tassorelli C, Dodick DW, et al. Guidelines of the International Headache Society for controlled trials of preventive treatment of migraine attacks in episodic migraine in adults. Cephalalgia 2020;40:1026-44.
DOI: https://doi.org/10.1177/0333102420941839
2. Hepp Z, Dodick DW, Varon SF, et al. Adherence to oral migraine-preventive medications among patients with chronic migraine. Cephalalgia 2015;35:478-88.
DOI: https://doi.org/10.1177/0333102414547138
3. Mansfield C, Gebben DJ, Sutphin J, et al. Patient Preferences for Preventive Migraine Treatments: A Discrete-Choice Experiment. Headache 2019;59:715-26.
DOI: https://doi.org/10.1111/head.13498
4. Aurora SK, Dodick DW, Turkel CC, et al. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial. Cephalalgia 2010;30:793-803.
DOI: https://doi.org/10.1177/0333102410364676
5. Diener HC, Dodick DW, Aurora SK, et al. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial. Cephalalgia 2010;30:804-14.
DOI: https://doi.org/10.1177/0333102410364677
6. De Matteis E, Guglielmetti M, Ornello R, et al. Targeting CGRP for migraine treatment: mechanisms, antibodies, small molecules, perspectives. Expert Rev Neurother 2020;20:627-41.
DOI: https://doi.org/10.1080/14737175.2020.1772758
7. Usach I, Martinez R, Festini T, Peris JE. Subcutaneous Injection of Drugs: Literature Review of Factors Influencing Pain Sensation at the Injection Site. Adv Ther 2019;36:2986-96.
DOI: https://doi.org/10.1007/s12325-019-01101-6
8. Rho YH, Rychlewska-Hańczewska A, Śliwowska B, Kim TH. Usability of Prefilled Syringe and Autoinjector for SB4 (An Etanercept Biosimilar) in Patients with Rheumatoid Arthritis. Adv Ther 2019;36:2287-95.
DOI: https://doi.org/10.1007/s12325-019-01027-z
9. Bailey T, Thurman J, Niemeyer M, Schmeisl G. Usability and preference evaluation of a prefilled insulin pen with a novel injection mechanism by people with diabetes and healthcare professionals. Curr Med Res Opin 2011;27:2043-52.
DOI: https://doi.org/10.1185/03007995.2011.616190
10. St Clair-Jones A, Prignano F, Goncalves J, et al. Understanding and Minimising Injection-Site Pain Following Subcutaneous Administration of Biologics: A Narrative Review. Rheumatol Ther 2020;7:741-57.
DOI: https://doi.org/10.1007/s40744-020-00245-0
11. Hill RL, Wilmot JG, Belluscio BA, et al. Comparison of drug delivery with autoinjector versus manual prefilled syringe and between three different autoinjector devices administered in pig thigh. Med Devices (Auckl) 2016;9:257-66.
DOI: https://doi.org/10.2147/MDER.S83406
12. Alghonaim Y, Hijazi LO, Alraee SA, Alqubaisy Y. Injection Site Pain, Onset and Duration of Action of Botulinum Toxin Reconstituted in Normal Saline With and Without Sodium Bicarbonate: A Prospective, Single Center, Randomized, Double-Blind Interventional Study. Plastic Surgery 2022;30:227-32
DOI: https://doi.org/10.1177/22925503211011971
13. Mavridis T, Deligianni CI, Karagiorgis G, et al. Monoclonal Antibodies Targeting CGRP: From Clinical Studies to Real-World Evidence-What Do We Know So Far?. Pharmaceuticals (Basel) 2021;14:700.
DOI: https://doi.org/10.3390/ph14070700
14. Stauffer VL, Sides R, Lanteri-Minet M, et al. Comparison between prefilled syringe and autoinjector devices on patient-reported experiences and pharmacokinetics in galcanezumab studies. Patient Prefer Adherence 2018;12:1785-95.
DOI: https://doi.org/10.2147/PPA.S170636
15. Argyriou AA, Dermitzakis EV, Vlachos GS, Vikelis M. Long-term adherence, safety, and efficacy of repeated onabotulinumtoxinA over five years in chronic migraine prophylaxis. Acta Neurol Scand 2022;145:676-83.
DOI: https://doi.org/10.1111/ane.13600
16. Bangs ME, Kudrow D, Wang S, et al. Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies. BMC Neurol 2020;20:25.
DOI: https://doi.org/10.1186/s12883-020-1609-7
17. Goadsby PJ, Silberstein SD, Yeung PP, et al. Long-term safety, tolerability, and efficacy of fremanezumab in migraine: A randomized study. Neurology 2020;95:e2487-99.
DOI: https://doi.org/10.1212/WNL.0000000000010600
18. Lampl C, Kraus V, Lehner K, et al. Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials. J Headache Pain 2022;23:104.
DOI: https://doi.org/10.1186/s10194-022-01470-4
19. Bittner B, Richter W, Schmidt J. Subcutaneous Administration of Biotherapeutics: An Overview of Current Challenges and Opportunities. BioDrugs 2018;32,425–40.
DOI: https://doi.org/10.1007/s40259-018-0295-0
20. Roszkiewicz J, Swacha Z, Smolewska E. Prefilled pen versus prefilled syringe: a pilot study evaluating two different methods of methotrexate subcutaneous injection in patients with JIA. Pediatr Rheumatol Online J 2020;18:64.
DOI: https://doi.org/10.1186/s12969-020-00455-4
21. Ahmann A, Szeinbach SL, Gill J, et al. Comparing patient preferences and healthcare provider recommendations with the pen versus vial-and-syringe insulin delivery in patients with type 2 diabetes. Diabetes Technol Ther 2014;16:76-83.
DOI: https://doi.org/10.1089/dia.2013.0172
22. Rathore N, Pranay P, Eu B, et al. Variability in syringe components and its impact on functionality of delivery systems. PDA J Pharm Sci Technol 2011;65:468-80.
DOI: https://doi.org/10.5731/pdajpst.2011.00785
23. Dou Z, Eshraghi J, Guo T, et al. Performance characterization of spring actuated autoinjector devices for Emgality and Aimovig. Curr Med Res Opin 2020;36:1343-54.
DOI: https://doi.org/10.1080/03007995.2020.1783219
24. Eli Lilly and Company. Highlights of prescribing information for Emgality. 2019
25. Amgen Inc. Highlights of prescribing information for Aimovig. 2019.
26. Teva. Highlights of prescribing information for Ajovy. 2019.
27. Berteau C, Filipe-Santos O, Wang T, et al. Evaluation of the impact of viscosity, injection volume, and injection flow rate on subcutaneous injection tolerance. Med Devices (Auckl) 2015;8:473-84.
DOI: https://doi.org/10.2147/MDER.S91019
28. Mohammady M, Radmehr M, Janani L. Slow versus fast subcutaneous heparin injections for prevention of bruising and site pain intensity. Cochrane Database Syst Rev 2021;6:CD008077.
DOI: https://doi.org/10.1002/14651858.CD008077.pub6
29. Schwedt TJ, Chiang CC, Chong CD, Dodick DW. Functional MRI of migraine. Lancet Neurol 2015;14:81-91.
DOI: https://doi.org/10.1016/S1474-4422(14)70193-0
30. May A, Schulte LH. Chronic migraine: risk factors, mechanisms and treatment. Nat Rev Neurol 2016;12:455-64.
DOI: https://doi.org/10.1038/nrneurol.2016.93
31. Petrini L, Matthiesen ST, Arendt-Nielsen L. The effect of age and gender on pressure pain thresholds and suprathreshold stimuli. Perception 2015;44:587-96.
DOI: https://doi.org/10.1068/p7847
32. Russo A, Coppola G, Pierelli F, et al. Pain Perception and Migraine. Front Neurol 2018;9:576.
DOI: https://doi.org/10.3389/fneur.2018.00576
How to Cite
1.
Silvestro M, Sozio P, Orologio I, Siciliano M, Trojsi F, Tessitore A, et al. Perceived ease-of-usability and local tolerability using CGRP monoclonal antibody autoinjectors <i>vs.</i> syringes: an online questionnaire-based study in patients with migraine. Confinia Cephalal [Internet]. 2025 Jan. 27 [cited 2025 Mar. 13];34(2). Available from: https://www.confiniacephalalgica.com/site/article/view/15772
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