{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,22]],"date-time":"2026-08-22T08:24:05Z","timestamp":1787387045329,"version":"build-2736575974"},"reference-count":23,"publisher":"Springer Science and Business Media LLC","issue":"9","license":[{"start":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T00:00:00Z","timestamp":1782777600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T00:00:00Z","timestamp":1782777600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"funder":[{"name":"Alexion, AstraZeneca Rare Disease"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Adv Ther"],"published-print":{"date-parts":[[2026,9]]},"DOI":"10.1007\/s12325-026-03663-8","type":"journal-article","created":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T23:37:55Z","timestamp":1782862675000},"page":"4249-4265","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Usability and Acceptance of Autoinjector and Prefilled Syringe Devices by Patients with Generalized Myasthenia Gravis in a Human Factors Study"],"prefix":"10.1007","volume":"43","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7589-8826","authenticated-orcid":false,"given":"Kelly G.","family":"Gwathmey","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Panru","family":"Jing","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott","family":"Laorr","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joe","family":"Koo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sanjay","family":"Rakhade","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7058-7490","authenticated-orcid":false,"given":"Emmett Alton","family":"Sartor","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J. T.","family":"Tibung","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jason","family":"Murray","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina","family":"Laskar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,6,30]]},"reference":[{"issue":"11","key":"3663_CR1","doi-asserted-by":"publisher","first-page":"2843","DOI":"10.1172\/jci29894","volume":"116","author":"BM Conti-Fine","year":"2006","unstructured":"Conti-Fine BM, Milani M, Kaminski HJ. Myasthenia gravis: past, present, and future. J Clin Invest. 2006;116(11):2843\u201354. https:\/\/doi.org\/10.1172\/jci29894.","journal-title":"J Clin Invest"},{"issue":"2","key":"3663_CR2","doi-asserted-by":"publisher","first-page":"141","DOI":"10.1002\/mus.20950","volume":"37","author":"D Grob","year":"2008","unstructured":"Grob D, Brunner N, Namba T, Pagala M. Lifetime course of myasthenia gravis. Muscle Nerve. 2008;37(2):141\u20139. https:\/\/doi.org\/10.1002\/mus.20950.","journal-title":"Muscle Nerve"},{"issue":"2","key":"3663_CR3","doi-asserted-by":"publisher","first-page":"253","DOI":"10.1016\/j.ncl.2018.01.002","volume":"36","author":"MK Hehir","year":"2018","unstructured":"Hehir MK, Silvestri NJ. Generalized myasthenia gravis: classification, clinical presentation, natural history, and epidemiology. Neurol Clin. 2018;36(2):253\u201360. https:\/\/doi.org\/10.1016\/j.ncl.2018.01.002.","journal-title":"Neurol Clin"},{"issue":"11","key":"3663_CR4","doi-asserted-by":"publisher","first-page":"2235","DOI":"10.3390\/jcm10112235","volume":"10","author":"L Dresser","year":"2021","unstructured":"Dresser L, Wlodarski R, Rezania K, Soliven B. Myasthenia gravis: epidemiology, pathophysiology and clinical manifestations. J Clin Med. 2021;10(11):2235. https:\/\/doi.org\/10.3390\/jcm10112235.","journal-title":"J Clin Med"},{"issue":"1","key":"3663_CR5","doi-asserted-by":"publisher","first-page":"169","DOI":"10.1186\/s13023-023-02727-0","volume":"18","author":"M Mahic","year":"2023","unstructured":"Mahic M, Bozorg A, DeCourcy J, et al. Physician- and patient-reported perspectives on myasthenia gravis in Europe: a real-world survey. Orphanet J Rare Dis. 2023;18(1):169. https:\/\/doi.org\/10.1186\/s13023-023-02727-0.","journal-title":"Orphanet J Rare Dis"},{"issue":"1","key":"3663_CR6","doi-asserted-by":"publisher","first-page":"516","DOI":"10.1186\/s12967-021-03185-7","volume":"19","author":"N Salari","year":"2021","unstructured":"Salari N, Fatahi B, Bartina Y, et al. Global prevalence of myasthenia gravis and the effectiveness of common drugs in its treatment: a systematic review and meta-analysis. J Transl Med. 2021;19(1):516. https:\/\/doi.org\/10.1186\/s12967-021-03185-7.","journal-title":"J Transl Med"},{"issue":"1","key":"3663_CR7","doi-asserted-by":"publisher","first-page":"16","DOI":"10.1177\/1941875210382918","volume":"1","author":"LC Wendell","year":"2011","unstructured":"Wendell LC, Levine JM. Myasthenic crisis. Neurohospitalist. 2011;1(1):16\u201322. https:\/\/doi.org\/10.1177\/1941875210382918.","journal-title":"Neurohospitalist"},{"key":"3663_CR8","doi-asserted-by":"publisher","first-page":"115","DOI":"10.1186\/s12955-015-0298-1","volume":"13","author":"MI Boldingh","year":"2015","unstructured":"Boldingh MI, Dekker L, Maniaol AH, et al. An up-date on health-related quality of life in myasthenia gravis -results from population based cohorts. Health Qual Life Outcomes. 2015;13:115. https:\/\/doi.org\/10.1186\/s12955-015-0298-1.","journal-title":"Health Qual Life Outcomes"},{"issue":"5","key":"3663_CR9","doi-asserted-by":"publisher","first-page":"e068104","DOI":"10.1136\/bmjopen-2022-068104","volume":"13","author":"S Berrih-Aknin","year":"2023","unstructured":"Berrih-Aknin S, Palace J, Meisel A, et al. Patient-reported impact of myasthenia gravis in the real world: findings from a digital observational survey-based study (MyRealWorld MG). BMJ Open. 2023;13(5):e068104. https:\/\/doi.org\/10.1136\/bmjopen-2022-068104.","journal-title":"BMJ Open"},{"issue":"10","key":"3663_CR10","doi-asserted-by":"publisher","first-page":"4377","DOI":"10.1007\/s12325-023-02604-z","volume":"40","author":"S Dewilde","year":"2023","unstructured":"Dewilde S, Phillips G, Paci S, et al. People diagnosed with myasthenia gravis have lower health-related quality of life and need more medical and caregiver help in comparison to the general population: analysis of two observational studies. Adv Ther. 2023;40(10):4377\u201394. https:\/\/doi.org\/10.1007\/s12325-023-02604-z.","journal-title":"Adv Ther"},{"key":"3663_CR11","doi-asserted-by":"publisher","first-page":"283","DOI":"10.1016\/b978-0-12-823912-4.00026-8","volume":"200","author":"MR Tannemaat","year":"2024","unstructured":"Tannemaat MR, Huijbers MG, Verschuuren J. Myasthenia gravis\u2014pathophysiology, diagnosis, and treatment. Handb Clin Neurol. 2024;200:283\u2013305. https:\/\/doi.org\/10.1016\/b978-0-12-823912-4.00026-8.","journal-title":"Handb Clin Neurol"},{"issue":"1","key":"3663_CR12","doi-asserted-by":"publisher","first-page":"14","DOI":"10.1002\/mus.26447","volume":"60","author":"S Muppidi","year":"2019","unstructured":"Muppidi S, Utsugisawa K, Benatar M, et al. Long-term safety and efficacy of eculizumab in generalized myasthenia gravis. Muscle Nerve. 2019;60(1):14\u201324. https:\/\/doi.org\/10.1002\/mus.26447.","journal-title":"Muscle Nerve"},{"issue":"5","key":"3663_CR13","doi-asserted-by":"publisher","first-page":"EVIDoa2100066","DOI":"10.1056\/EVIDoa2100066","volume":"1","author":"T Vu","year":"2022","unstructured":"Vu T, Meisel A, Mantegazza R, et al. Terminal complement inhibitor ravulizumab in generalized myasthenia gravis. NEJM Evid. 2022;1(5):EVIDoa2100066. https:\/\/doi.org\/10.1056\/EVIDoa2100066.","journal-title":"NEJM Evid"},{"key":"3663_CR14","doi-asserted-by":"publisher","first-page":"29","DOI":"10.1016\/j.molimm.2023.12.004","volume":"165","author":"S Jindal","year":"2024","unstructured":"Jindal S, Pedersen DV, Gera N, et al. Characterization of the bispecific VHH antibody gefurulimab (ALXN1720) targeting complement component 5, and designed for low volume subcutaneous administration. Mol Immunol. 2024;165:29\u201341. https:\/\/doi.org\/10.1016\/j.molimm.2023.12.004.","journal-title":"Mol Immunol"},{"key":"3663_CR15","unstructured":"Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis NCT05556096. ClinicalTrials.gov, 2025. Available at: https:\/\/www.clinicaltrials.gov\/study\/NCT05556096?term=nct05556096&rank=1. Accessed May 21, 2026."},{"key":"3663_CR16","unstructured":"Gwathmey KG, Koo J, Laorr S, et al. Human factors validation study of gefurulimab prefilled syringe and autoinjector devices [poster]. Presented at: Myasthenia Gravis Foundation of America (MGFA) International Conference; May 13-15, 2025; the Hague, the Netherlands."},{"key":"3663_CR17","unstructured":"Applying Human Factors and Usability Engineering to Medical Devices. Guidance for Industry and Food and Drug Administration Staff. U.S. Food and Drug Administration, 2016. Available at: https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/applying-human-factors-and-usability-engineering-medical-devices. Accessed May 21, 2026."},{"key":"3663_CR18","unstructured":"Application of Human Factors Engineering Principles for Combination Products: Questions and Answers. Guidance for Industry and FDA Staff. U.S. Food and Drug Administration, 2023. Available at: https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/application-human-factors-engineering-principles-combination-products-questions-and-answers. Accessed May 21, 2026."},{"key":"3663_CR19","volume-title":"Human factors engineering\u2014design of medical devices","author":"American National Standards Institute\/Association for the Advancement of Medical Instrumentation","year":"2018","unstructured":"American National Standards Institute\/Association for the Advancement of Medical Instrumentation. Human factors engineering\u2014design of medical devices. Washington, DC: American National Standards Institute; 2018."},{"key":"3663_CR20","volume-title":"Medical devices\u2014Part 1: application of usability engineering to medical devices. IEC 62366-1:2015","author":"International Organization for Standardization","year":"2015","unstructured":"International Organization for Standardization. Medical devices\u2014Part 1: application of usability engineering to medical devices. IEC 62366-1:2015. International Organization for Standardization; 2015."},{"issue":"4","key":"3663_CR21","doi-asserted-by":"publisher","first-page":"414","DOI":"10.1016\/j.eprac.2022.01.010","volume":"28","author":"A Andre","year":"2022","unstructured":"Andre A, Squittieri N, Patil S. Evaluating use of the octreotide acetate pen injector in a summative human factors validation study. Endocr Pract. 2022;28(4):414\u20139. https:\/\/doi.org\/10.1016\/j.eprac.2022.01.010.","journal-title":"Endocr Pract"},{"issue":"8","key":"3663_CR22","doi-asserted-by":"publisher","first-page":"1263","DOI":"10.1080\/17425247.2024.2390553","volume":"21","author":"A Linnane","year":"2024","unstructured":"Linnane A, Lau M, Miranda P, Elliott S. Formative and validation human factors studies of a new disposable prefilled injection device for subcutaneous delivery of Acthar gel (repository corticotropin injection). Expert Opin Drug Deliv. 2024;21(8):1263\u201378. https:\/\/doi.org\/10.1080\/17425247.2024.2390553.","journal-title":"Expert Opin Drug Deliv"},{"issue":"10","key":"3663_CR23","doi-asserted-by":"publisher","first-page":"977","DOI":"10.1080\/17434440.2024.2403700","volume":"21","author":"B Domanska","year":"2024","unstructured":"Domanska B, Franchini A, Boroojerdi B, et al. Usability of the zilucoplan prefilled syringe for the treatment of generalized myasthenia gravis: Insights from a human factors validation study. Expert Rev Med Devices. 2024;21(10):977\u201382. https:\/\/doi.org\/10.1080\/17434440.2024.2403700.","journal-title":"Expert Rev Med Devices"}],"container-title":["Advances in Therapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12325-026-03663-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s12325-026-03663-8","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12325-026-03663-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,22]],"date-time":"2026-08-22T08:04:36Z","timestamp":1787385876000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s12325-026-03663-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,6,30]]},"references-count":23,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2026,9]]}},"alternative-id":["3663"],"URL":"https:\/\/doi.org\/10.1007\/s12325-026-03663-8","relation":{},"ISSN":["0741-238X","1865-8652"],"issn-type":[{"value":"0741-238X","type":"print"},{"value":"1865-8652","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,6,30]]},"assertion":[{"value":"27 March 2026","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"29 May 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"30 June 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Kelly G. Gwathmey has received honoraria from AcademicCME, Alexion, AstraZeneca Rare Disease, Amgen, argenx, Novartis, and UCB. Panru Jing and Scott Laorr are employees of Insight by Nemera and were compensated for conduct of the study by Alexion, AstraZeneca Rare Disease. Joe Koo, Sanjay Rakhade, Emmett Alton Sartor, JT Tibung, and Jason Murray are employees of Alexion, AstraZeneca Rare Disease, and may hold stock or stock options in AstraZeneca. Christina Laskar was an employee of Alexion, AstraZeneca Rare Disease, at the time of this study and may hold stock or stock options in AstraZeneca.","order":1,"name":"Ethics","label":"Conflict of interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The protocol, informed consent form, and recruitment materials were approved by an institutional review board (protocol number: ALEXIO141-01; Castle IRB, Chesterfield, MO) prior to study initiation. The study was conducted in accordance with the ethical principles of the Declaration of Helsinki, Good Clinical Practice, and all applicable legal and regulatory requirements. All participants provided written informed consent.","order":2,"name":"Ethics","label":"Ethical Approval","group":{"name":"EthicsHeading","label":"Declarations"}}]}}