ExtaviJect® 30G device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective European study
Gabriel Boeru,1 Ivan Milanov,2 Francesca De Robertis,3 Wojciech Kozubski,4 Michael Lang,5 Sònia Rojas-Farreras,6 Mark Tomlinson7 1Military Hospital, Bucharest, Romania; 2University Hospital Saint Naum, Sofia, Bulgaria; 3Department of Neurology, Vito Fazzi Hospital of Lecce, Lecce, Italy;...
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Dove Medical Press
2013
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oai:doaj.org-article:999807382c6d45288a4c359c5b7c0c332021-12-02T00:48:57ZExtaviJect® 30G device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective European study1179-1470https://doaj.org/article/999807382c6d45288a4c359c5b7c0c332013-11-01T00:00:00Zhttp://www.dovepress.com/extavijectreg-30g-device-for-subcutaneous-self-injection-of-interferon-a14999https://doaj.org/toc/1179-1470Gabriel Boeru,1 Ivan Milanov,2 Francesca De Robertis,3 Wojciech Kozubski,4 Michael Lang,5 Sònia Rojas-Farreras,6 Mark Tomlinson7 1Military Hospital, Bucharest, Romania; 2University Hospital Saint Naum, Sofia, Bulgaria; 3Department of Neurology, Vito Fazzi Hospital of Lecce, Lecce, Italy; 4Department of Neurology, Poznan University of Medical Sciences, Poznan, Poland; 5NeuroPoint Patient Academy and Neurological Practice, Ulm, Germany; 6IMS Health, Barcelona, Spain; 7Novartis Pharma AG, Basel, Switzerland Background: The ExtaviJect® 30G autoinjector was developed to facilitate parenteral self-administration of interferon beta-1b (Extavia®), a first-line disease-modifying therapy in patients with multiple sclerosis. Our aim was to assess patient compliance with treatment when using the autoinjector, patients' and nurses' experiences of using the device, its tolerability, and patient satisfaction. Methods: This was a 12-week, real-world, prospective, observational, noninterventional study conducted in nine European countries. Questionnaires were used to measure patient compliance and to assess patients' and nurses' experiences. All adverse events were recorded by severity, including injection site reactions or pain. Patient satisfaction and health-related quality of life were assessed using the Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) and EuroQol-5 Dimension (EQ-5D) instruments, respectively. Results: Of 582 patients enrolled, 568 (98%) received at least one injection and attended the first follow-up visit at 6 weeks, and 542 (93%) attended the second follow-up visit at 12 weeks. For the whole study, 548 of 568 (97%) patients were compliant with treatment. Among the various questions assessing whether the device was easy and quick to use accurately, without fear of the needle, 56%–98% of patients and 59%–98% of nurses were in agreement. There were nine serious adverse events (four disease-related) reported among the 227 (39%) patients reporting adverse events. Scores increased in the TSQM-9 convenience domain between weeks 6 and 12 (P=0.0009), and in the EQ-5D visual analog scale between baseline and week 12 (P<0.0001), indicating improvement in health-related quality of life. Conclusion: ExtaviJect 30G was convenient to use and was associated with high levels of compliance. Keywords: autoinjector, injections, subcutaneous, interferon beta, multiple sclerosis, relapsing-remitting, patient preference, self-administrationBoeru GMilanov IDe Robertis FKozubski WLang MRojas-Farreras STomlinson MDove Medical PressarticleMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol 2013, Iss default, Pp 175-184 (2013) |
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Medical technology R855-855.5 |
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Medical technology R855-855.5 Boeru G Milanov I De Robertis F Kozubski W Lang M Rojas-Farreras S Tomlinson M ExtaviJect® 30G device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective European study |
| description |
Gabriel Boeru,1 Ivan Milanov,2 Francesca De Robertis,3 Wojciech Kozubski,4 Michael Lang,5 Sònia Rojas-Farreras,6 Mark Tomlinson7 1Military Hospital, Bucharest, Romania; 2University Hospital Saint Naum, Sofia, Bulgaria; 3Department of Neurology, Vito Fazzi Hospital of Lecce, Lecce, Italy; 4Department of Neurology, Poznan University of Medical Sciences, Poznan, Poland; 5NeuroPoint Patient Academy and Neurological Practice, Ulm, Germany; 6IMS Health, Barcelona, Spain; 7Novartis Pharma AG, Basel, Switzerland Background: The ExtaviJect® 30G autoinjector was developed to facilitate parenteral self-administration of interferon beta-1b (Extavia®), a first-line disease-modifying therapy in patients with multiple sclerosis. Our aim was to assess patient compliance with treatment when using the autoinjector, patients' and nurses' experiences of using the device, its tolerability, and patient satisfaction. Methods: This was a 12-week, real-world, prospective, observational, noninterventional study conducted in nine European countries. Questionnaires were used to measure patient compliance and to assess patients' and nurses' experiences. All adverse events were recorded by severity, including injection site reactions or pain. Patient satisfaction and health-related quality of life were assessed using the Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) and EuroQol-5 Dimension (EQ-5D) instruments, respectively. Results: Of 582 patients enrolled, 568 (98%) received at least one injection and attended the first follow-up visit at 6 weeks, and 542 (93%) attended the second follow-up visit at 12 weeks. For the whole study, 548 of 568 (97%) patients were compliant with treatment. Among the various questions assessing whether the device was easy and quick to use accurately, without fear of the needle, 56%–98% of patients and 59%–98% of nurses were in agreement. There were nine serious adverse events (four disease-related) reported among the 227 (39%) patients reporting adverse events. Scores increased in the TSQM-9 convenience domain between weeks 6 and 12 (P=0.0009), and in the EQ-5D visual analog scale between baseline and week 12 (P<0.0001), indicating improvement in health-related quality of life. Conclusion: ExtaviJect 30G was convenient to use and was associated with high levels of compliance. Keywords: autoinjector, injections, subcutaneous, interferon beta, multiple sclerosis, relapsing-remitting, patient preference, self-administration |
| format |
article |
| author |
Boeru G Milanov I De Robertis F Kozubski W Lang M Rojas-Farreras S Tomlinson M |
| author_facet |
Boeru G Milanov I De Robertis F Kozubski W Lang M Rojas-Farreras S Tomlinson M |
| author_sort |
Boeru G |
| title |
ExtaviJect® 30G device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective European study |
| title_short |
ExtaviJect® 30G device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective European study |
| title_full |
ExtaviJect® 30G device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective European study |
| title_fullStr |
ExtaviJect® 30G device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective European study |
| title_full_unstemmed |
ExtaviJect® 30G device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective European study |
| title_sort |
extaviject® 30g device for subcutaneous self-injection of interferon beta-1b for multiple sclerosis: a prospective european study |
| publisher |
Dove Medical Press |
| publishDate |
2013 |
| url |
https://doaj.org/article/999807382c6d45288a4c359c5b7c0c33 |
| work_keys_str_mv |
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