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Peter Cornelisse - One of the best experts on this subject based on the ideXlab platform.
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patient rated suitability of a novel electronic device for self injection of subcutaneous interferon beta 1a in relapsing multiple sclerosis an international single arm multicentre phase iiib study
BMC Neurology, 2010Co-Authors: Virginia Devonshire, Barry Singer, Michael Lang, Txomin Arbizu, Bjorn Borre, Alessandra Lugaresi, Elisabetta Verdun Di Cantogno, Peter CornelisseAbstract:Background: Multiple sclerosis (MS) currently requires long-term treatment with disease-modifying drugs, administered parenterally up to once daily. The need for regular self-injection can be a barrier to treatment for many patients. Autoinjectors can help patients overcome problems or concerns with self-injection and could, therefore, improve treatment adherence. This study was performed to assess the suitability of a new electronic device for the subcutaneous (sc) administration of interferon (IFN) beta-1a, 44 mcg three times weekly, for relapsing MS. Methods: In this Phase IIIb, multicentre, single-arm study, patients with relapsing MS who had been consistently selfinjecting sc IFN beta-1a using an Autoinjector for at least 6 weeks were taught to use the new device and selfadministered treatment for 12 weeks thereafter. Patient-rated suitability of the device was assessed at the end of Week 12 using the Patient User Trial Questionnaire. Patient satisfaction with, and evaluation of, the injection process was assessed using the MS Treatment Concern Questionnaire. Trainers evaluated the device using the Trainer User Trial Questionnaire. Results: At Week 12, 71.6% (73/102) of patients considered the device 'very suitable' or 'suitable' for self-injection; 92.2% (94/102) reported some degree of suitability and only 7.8% (8/102) found the device 'not at all suitable'. At Weeks 4, 8 and 12, most patients reported that injection preparation and clean-up, performing injections and ease of device use in the previous 4 weeks compared favourably with, or was equivalent to, their previous experience of selfinjection. Injection-related pain, injection reactions and 'flu-like' symptoms remained stable over the 12 weeks. Each device feature was rated 'very useful' or 'useful' by at least 80% of patients. All trainers and 95.2% (99/104) of patients found device functions 'very easy' or 'easy' to use. Overall convenience was considered the most important benefit of the device. Conclusions: Most patients considered the new electronic injection device suitable for the sc injection of IFN beta-1a. They found the device easy to use with useful features, and reported benefits such as overall convenience. The device may, therefore, increase treatment adherence in patients with MS, particularly those with injection-related issues. Trial registration: NCT00735007
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patient rated suitability of a novel electronic device for self injection of subcutaneous interferon beta 1a in relapsing multiple sclerosis an international single arm multicentre phase iiib study
BMC Neurology, 2010Co-Authors: Virginia Devonshire, Barry A Singer, Michael Lang, Txomin Arbizu, Bjorn Borre, Alessandra Lugaresi, Elisabetta Verdun Di Cantogno, Peter CornelisseAbstract:Multiple sclerosis (MS) currently requires long-term treatment with disease-modifying drugs, administered parenterally up to once daily. The need for regular self-injection can be a barrier to treatment for many patients. Autoinjectors can help patients overcome problems or concerns with self-injection and could, therefore, improve treatment adherence. This study was performed to assess the suitability of a new electronic device for the subcutaneous (sc) administration of interferon (IFN) beta-1a, 44 mcg three times weekly, for relapsing MS. In this Phase IIIb, multicentre, single-arm study, patients with relapsing MS who had been consistently self-injecting sc IFN beta-1a using an Autoinjector for at least 6 weeks were taught to use the new device and self-administered treatment for 12 weeks thereafter. Patient-rated suitability of the device was assessed at the end of Week 12 using the Patient User Trial Questionnaire. Patient satisfaction with, and evaluation of, the injection process was assessed using the MS Treatment Concern Questionnaire. Trainers evaluated the device using the Trainer User Trial Questionnaire. At Week 12, 71.6% (73/102) of patients considered the device 'very suitable' or 'suitable' for self-injection; 92.2% (94/102) reported some degree of suitability and only 7.8% (8/102) found the device 'not at all suitable'. At Weeks 4, 8 and 12, most patients reported that injection preparation and clean-up, performing injections and ease of device use in the previous 4 weeks compared favourably with, or was equivalent to, their previous experience of self-injection. Injection-related pain, injection reactions and 'flu-like' symptoms remained stable over the 12 weeks. Each device feature was rated 'very useful' or 'useful' by at least 80% of patients. All trainers and 95.2% (99/104) of patients found device functions 'very easy' or 'easy' to use. Overall convenience was considered the most important benefit of the device. Most patients considered the new electronic injection device suitable for the sc injection of IFN beta-1a. They found the device easy to use with useful features, and reported benefits such as overall convenience. The device may, therefore, increase treatment adherence in patients with MS, particularly those with injection-related issues. NCT00735007
Peter Nash - One of the best experts on this subject based on the ideXlab platform.
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efficacy and safety of secukinumab administration by Autoinjector in patients with psoriatic arthritis results from a randomized placebo controlled trial future 3
Arthritis Research & Therapy, 2018Co-Authors: Peter Nash, Iain B Mcinnes, Philip J Mease, Eva Dokoupilova, Mats Andersson, Proton Rahman, Ricardo Blanco, Christopher T Ritchlin, Radhika Kajekar, Shephard MpofuAbstract:The study aimed to assess 52-week efficacy and safety of secukinumab self-administration by Autoinjector in patients with active psoriatic arthritis (PsA) in the FUTURE 3 study ( ClinicalTrials.gov NCT01989468). Patients (≥ 18 years of age; N = 414) with active PsA were randomized 1:1:1 to subcutaneous (s.c.) secukinumab 300 mg, 150 mg, or placebo at baseline, weeks 1, 2, 3, and 4, and every 4 weeks thereafter. Per clinical response, placebo-treated patients were re-randomized to s.c. secukinumab 300 or 150 mg at week 16 (nonresponders) or week 24 (responders) and stratified at randomization by prior anti-tumor necrosis factor (TNF) therapy (anti-TNF-naive, 68.1%; intolerant/inadequate response (anti-TNF-IR), 31.9%). The primary endpoint was the proportion of patients achieving at least 20% improvement in American College of Rheumatology response criteria (ACR20) at week 24. Autoinjector usability was evaluated by Self-Injection Assessment Questionnaire (SIAQ). Overall, 92.1% (300 mg), 91.3% (150 mg), and 93.4% (placebo) of patients completed 24 weeks, and 84.9% (300 mg) and 79.7% (150 mg) completed 52 weeks. In the overall population (combined anti-TNF-naive and anti-TNF-IR), ACR20 response rate at week 24 was significantly higher in secukinumab groups (300 mg, 48.2% (p < 0.0001); 150 mg, 42% (p < 0.0001); placebo, 16.1%) and was sustained through 52 weeks. SIAQ results showed that more than 93% of patients were satisfied/very satisfied with Autoinjector usage. Secukinumab was well tolerated with no new or unexpected safety signals reported. Secukinumab provided sustained improvements in signs and symptoms in active PsA patients through 52 weeks. High acceptability of Autoinjector was observed. The safety profile was consistent with that reported previously. ClinicalTrials.gov NCT01989468 . Registered 21 November 2013. EudraCT 2013–004002-25 . Registered 17 December 2013.
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Additional file 1: of Efficacy and safety of secukinumab administration by Autoinjector in patients with psoriatic arthritis: results from a randomized, placebo-controlled trial (FUTURE 3)
2018Co-Authors: Peter Nash, Eva Dokoupilova, Mats Andersson, Proton Rahman, Ricardo Blanco, Christopher T Ritchlin, Radhika Kajekar, Philip Mease, Iain Mcinnes, Shephard MpofuAbstract:Figure S1. Showing study design, Table S1. Presenting independent ethics committees (IECs) or institutional review boards (IRB) by study center, Table S2. Presenting a summary of observed efficacy data at week 52 among patients randomized to secukinumab at baseline, Table S3. Presenting patient-reported acceptability of the Autoinjector, and Table S4. Presenting SAEs by SOC reported across the entire study period. (DOCX 438 kb
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patient and healthcare professionals preference for brenzys vs enbrel Autoinjector for rheumatoid arthritis a randomized crossover simulated use study
Advances in Therapy, 2017Co-Authors: Marc Egeth, Peter Nash, Jennifer Soosaar, D Choquette, Ricardo Infante, Dena R Ramey, Sevag Sahakian, Angela Lai, Jin Ju KimAbstract:Introduction: Brenzys was developed as an etanercept biosimilar of Enbrel. The aim of this study was to assess preference and perceived ease of use for the new Brenzys Autoinjector compared to the currently available marketed Enbrel MYCLIC Autoinjector (Australia) and Enbrel SureClick Autoinjector (Canada) for the treatment of rheumatoid arthritis (RA). Because RA affects manual dexterity, ease of use of an Autoinjector is a particularly important consideration in developing effective self-delivery of long-term courses of therapy. Methods: Patients (N = 191) reporting a diagnosis of RA and nurses and rheumatologists (N = 90) with experience managing RA were shown how to use Brenzys and Enbrel Autoinjectors (in counterbalanced order between participants), then they used each Autoinjector by injecting into a pad simulating skin, and completed a questionnaire. Study sessions took place in Australia and Canada. Results: A binomial test showed that significantly more patients indicated that the Brenzys Autoinjector was easier to use than the Enbrel Autoinjector (79% reporting Brenzys easier to use; p < 0.001, two-sided, 95% CI [73%, 85%]). In addition, significantly more nurses and rheumatologists with experience managing RA also indicated that the Brenzys Autoinjector was easier to use (86%; p < 0.001, two-sided, 95% CI [77%, 92%) and that they would recommend the buttonless Brenzys Autoinjector over the Enbrel Autoinjector to patients (83%; p < 0.001, two-sided, 95% CI [74%, 90%]). Almost all patients who reported past experience using an Enbrel Autoinjector (N = 17) reported on the basis of using the two devices in the study that they would prefer to switch their device to the Brenzys Autoinjector rather than continue their course of therapy using the Enbrel Autoinjector (16/17, 94%, 95% CI [71%, 100%]). Conclusion: On the basis of the study results, the Brenzys Autoinjector was rated statistically significantly easier to use, and was overall preferred by patients and healthcare professionals with experience managing RA patients. Funding: Merck & Co., Inc.
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patient and healthcare professionals preference for brenzys vs enbrel Autoinjector for rheumatoid arthritis a randomized crossover simulated use study
Advances in Therapy, 2017Co-Authors: Marc Egeth, Peter Nash, Jennifer Soosaar, D Choquette, Ricardo Infante, Dena R Ramey, Sevag Sahakian, Angela Lai, Jin Ju KimAbstract:Introduction Brenzys was developed as an etanercept biosimilar of Enbrel. The aim of this study was to assess preference and perceived ease of use for the new Brenzys Autoinjector compared to the currently available marketed Enbrel MYCLIC Autoinjector (Australia) and Enbrel SureClick Autoinjector (Canada) for the treatment of rheumatoid arthritis (RA). Because RA affects manual dexterity, ease of use of an Autoinjector is a particularly important consideration in developing effective self-delivery of long-term courses of therapy.
Virginia Devonshire - One of the best experts on this subject based on the ideXlab platform.
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patient rated suitability of a novel electronic device for self injection of subcutaneous interferon beta 1a in relapsing multiple sclerosis an international single arm multicentre phase iiib study
BMC Neurology, 2010Co-Authors: Virginia Devonshire, Barry Singer, Michael Lang, Txomin Arbizu, Bjorn Borre, Alessandra Lugaresi, Elisabetta Verdun Di Cantogno, Peter CornelisseAbstract:Background: Multiple sclerosis (MS) currently requires long-term treatment with disease-modifying drugs, administered parenterally up to once daily. The need for regular self-injection can be a barrier to treatment for many patients. Autoinjectors can help patients overcome problems or concerns with self-injection and could, therefore, improve treatment adherence. This study was performed to assess the suitability of a new electronic device for the subcutaneous (sc) administration of interferon (IFN) beta-1a, 44 mcg three times weekly, for relapsing MS. Methods: In this Phase IIIb, multicentre, single-arm study, patients with relapsing MS who had been consistently selfinjecting sc IFN beta-1a using an Autoinjector for at least 6 weeks were taught to use the new device and selfadministered treatment for 12 weeks thereafter. Patient-rated suitability of the device was assessed at the end of Week 12 using the Patient User Trial Questionnaire. Patient satisfaction with, and evaluation of, the injection process was assessed using the MS Treatment Concern Questionnaire. Trainers evaluated the device using the Trainer User Trial Questionnaire. Results: At Week 12, 71.6% (73/102) of patients considered the device 'very suitable' or 'suitable' for self-injection; 92.2% (94/102) reported some degree of suitability and only 7.8% (8/102) found the device 'not at all suitable'. At Weeks 4, 8 and 12, most patients reported that injection preparation and clean-up, performing injections and ease of device use in the previous 4 weeks compared favourably with, or was equivalent to, their previous experience of selfinjection. Injection-related pain, injection reactions and 'flu-like' symptoms remained stable over the 12 weeks. Each device feature was rated 'very useful' or 'useful' by at least 80% of patients. All trainers and 95.2% (99/104) of patients found device functions 'very easy' or 'easy' to use. Overall convenience was considered the most important benefit of the device. Conclusions: Most patients considered the new electronic injection device suitable for the sc injection of IFN beta-1a. They found the device easy to use with useful features, and reported benefits such as overall convenience. The device may, therefore, increase treatment adherence in patients with MS, particularly those with injection-related issues. Trial registration: NCT00735007
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patient rated suitability of a novel electronic device for self injection of subcutaneous interferon beta 1a in relapsing multiple sclerosis an international single arm multicentre phase iiib study
BMC Neurology, 2010Co-Authors: Virginia Devonshire, Barry A Singer, Michael Lang, Txomin Arbizu, Bjorn Borre, Alessandra Lugaresi, Elisabetta Verdun Di Cantogno, Peter CornelisseAbstract:Multiple sclerosis (MS) currently requires long-term treatment with disease-modifying drugs, administered parenterally up to once daily. The need for regular self-injection can be a barrier to treatment for many patients. Autoinjectors can help patients overcome problems or concerns with self-injection and could, therefore, improve treatment adherence. This study was performed to assess the suitability of a new electronic device for the subcutaneous (sc) administration of interferon (IFN) beta-1a, 44 mcg three times weekly, for relapsing MS. In this Phase IIIb, multicentre, single-arm study, patients with relapsing MS who had been consistently self-injecting sc IFN beta-1a using an Autoinjector for at least 6 weeks were taught to use the new device and self-administered treatment for 12 weeks thereafter. Patient-rated suitability of the device was assessed at the end of Week 12 using the Patient User Trial Questionnaire. Patient satisfaction with, and evaluation of, the injection process was assessed using the MS Treatment Concern Questionnaire. Trainers evaluated the device using the Trainer User Trial Questionnaire. At Week 12, 71.6% (73/102) of patients considered the device 'very suitable' or 'suitable' for self-injection; 92.2% (94/102) reported some degree of suitability and only 7.8% (8/102) found the device 'not at all suitable'. At Weeks 4, 8 and 12, most patients reported that injection preparation and clean-up, performing injections and ease of device use in the previous 4 weeks compared favourably with, or was equivalent to, their previous experience of self-injection. Injection-related pain, injection reactions and 'flu-like' symptoms remained stable over the 12 weeks. Each device feature was rated 'very useful' or 'useful' by at least 80% of patients. All trainers and 95.2% (99/104) of patients found device functions 'very easy' or 'easy' to use. Overall convenience was considered the most important benefit of the device. Most patients considered the new electronic injection device suitable for the sc injection of IFN beta-1a. They found the device easy to use with useful features, and reported benefits such as overall convenience. The device may, therefore, increase treatment adherence in patients with MS, particularly those with injection-related issues. NCT00735007
Michael Lang - One of the best experts on this subject based on the ideXlab platform.
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adherence satisfaction and functional health status among patients with multiple sclerosis using the betaconnect Autoinjector a prospective observational cohort study
BMC Neurology, 2017Co-Authors: Ingo Kleiter, Michael Lang, Judith Jeske, Christiane Norenberg, Barbara Stollfus, Markus SchürksAbstract:Maintaining patient adherence to disease modifying drugs in multiple sclerosis is a challenge, which can be improved by Autoinjectors. The BETACONNECT® is a fully electronic Autoinjector for the injection of interferon beta-1b (IFN beta-1b) automatically recording injections. The BETAEVAL study was a prospective, observational, cohort study over 24 weeks among patients with relapsing remitting multiple sclerosis or clinically isolated syndrome treated with IFN beta-1b in Germany using the BETACONNECT®. The primary aim was to investigate treatment adherence, secondary aims included assessing satisfaction and functional health status. Adherence was evaluated from injection data recorded by the device. Patient-related data were obtained from clinical examinations and patient questionnaires. Of the 151 patients enrolled, 143 were available for analysis. Thirty-four patients discontinued the study prematurely. 107/143 (74.8%) patients still used the BETACONNECT® at the end of the study. Injection data from the device at any visit was available for 107 patients. Among those, the percentage of adherent patients injecting ≥80% of doses and still participating in the study was 57.9% at week 24. 29% of patients prematurely stopped the study, 13.1% injected <80%. Among patients with BETACONNECT® data at the respective visit, the proportion of adherent patients was high over the entire study period (week 4: 81.1% [N = 95], week 12: 86.7% [N = 83], week 24: 80.5% [N = 77]). Participants (N = 143) indicated high satisfaction with the BETACONNECT®. At week 24, 98.0% of patients who completed the corresponding questionnaire (strongly) agreed that it was user-friendly, 81.2% felt confident in using it compared to their previous way and 85.5% preferred it to their previous way of injection. Injection-related pain was rated as mild to moderate at all follow-up visits. Whereas 17.2% of patients with corresponding questionnaire indicated using analgesics prior to injection at week 4, only 9.1% did at week 24. Outcomes from questionnaires assessing functional health status, depression, fatigue and cognitive function were very similar throughout the study course. The majority of patients continued using the BETACONNECT® for IFN beta-1b treatment during the 24-week study period. Adherence was high among participants still using the BETACONNECT® and patients were highly satisfied with the device. Ongoing studies will evaluate long-term adherence and treatment outcomes in patients using the BETACONNECT®. clinicaltrails.gov NCT02121444 (registered April 22, 2014).
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Adherence, satisfaction and functional health status among patients with multiple sclerosis using the BETACONNECT® Autoinjector: a prospective observational cohort study
'Springer Science and Business Media LLC', 2017Co-Authors: Ingo Kleiter, Michael Lang, Judith Jeske, Christiane Norenberg, Barbara Stollfuß, Markus SchürksAbstract:Abstract Background Maintaining patient adherence to disease modifying drugs in multiple sclerosis is a challenge, which can be improved by Autoinjectors. The BETACONNECT® is a fully electronic Autoinjector for the injection of interferon beta-1b (IFN beta-1b) automatically recording injections. Methods The BETAEVAL study was a prospective, observational, cohort study over 24 weeks among patients with relapsing remitting multiple sclerosis or clinically isolated syndrome treated with IFN beta-1b in Germany using the BETACONNECT®. The primary aim was to investigate treatment adherence, secondary aims included assessing satisfaction and functional health status. Adherence was evaluated from injection data recorded by the device. Patient-related data were obtained from clinical examinations and patient questionnaires. Results Of the 151 patients enrolled, 143 were available for analysis. Thirty-four patients discontinued the study prematurely. 107/143 (74.8%) patients still used the BETACONNECT® at the end of the study. Injection data from the device at any visit was available for 107 patients. Among those, the percentage of adherent patients injecting ≥80% of doses and still participating in the study was 57.9% at week 24. 29% of patients prematurely stopped the study, 13.1% injected
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Additional file 2: of Adherence, satisfaction and functional health status among patients with multiple sclerosis using the BETACONNECT® Autoinjector: a prospective observational cohort study
2017Co-Authors: Ingo Kleiter, Michael Lang, Judith Jeske, Christiane Norenberg, Barbara Stollfuß, Markus SchürksAbstract:Adherence, satisfaction and functional health status among patients with multiple sclerosis using the BETACONNECT® Autoinjector: a prospective observational cohort study. Description of data: description of the rating scales used for documentation of other patient-reported outcomes. (DOCX 17 kb
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patient rated suitability of a novel electronic device for self injection of subcutaneous interferon beta 1a in relapsing multiple sclerosis an international single arm multicentre phase iiib study
BMC Neurology, 2010Co-Authors: Virginia Devonshire, Barry Singer, Michael Lang, Txomin Arbizu, Bjorn Borre, Alessandra Lugaresi, Elisabetta Verdun Di Cantogno, Peter CornelisseAbstract:Background: Multiple sclerosis (MS) currently requires long-term treatment with disease-modifying drugs, administered parenterally up to once daily. The need for regular self-injection can be a barrier to treatment for many patients. Autoinjectors can help patients overcome problems or concerns with self-injection and could, therefore, improve treatment adherence. This study was performed to assess the suitability of a new electronic device for the subcutaneous (sc) administration of interferon (IFN) beta-1a, 44 mcg three times weekly, for relapsing MS. Methods: In this Phase IIIb, multicentre, single-arm study, patients with relapsing MS who had been consistently selfinjecting sc IFN beta-1a using an Autoinjector for at least 6 weeks were taught to use the new device and selfadministered treatment for 12 weeks thereafter. Patient-rated suitability of the device was assessed at the end of Week 12 using the Patient User Trial Questionnaire. Patient satisfaction with, and evaluation of, the injection process was assessed using the MS Treatment Concern Questionnaire. Trainers evaluated the device using the Trainer User Trial Questionnaire. Results: At Week 12, 71.6% (73/102) of patients considered the device 'very suitable' or 'suitable' for self-injection; 92.2% (94/102) reported some degree of suitability and only 7.8% (8/102) found the device 'not at all suitable'. At Weeks 4, 8 and 12, most patients reported that injection preparation and clean-up, performing injections and ease of device use in the previous 4 weeks compared favourably with, or was equivalent to, their previous experience of selfinjection. Injection-related pain, injection reactions and 'flu-like' symptoms remained stable over the 12 weeks. Each device feature was rated 'very useful' or 'useful' by at least 80% of patients. All trainers and 95.2% (99/104) of patients found device functions 'very easy' or 'easy' to use. Overall convenience was considered the most important benefit of the device. Conclusions: Most patients considered the new electronic injection device suitable for the sc injection of IFN beta-1a. They found the device easy to use with useful features, and reported benefits such as overall convenience. The device may, therefore, increase treatment adherence in patients with MS, particularly those with injection-related issues. Trial registration: NCT00735007
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patient rated suitability of a novel electronic device for self injection of subcutaneous interferon beta 1a in relapsing multiple sclerosis an international single arm multicentre phase iiib study
BMC Neurology, 2010Co-Authors: Virginia Devonshire, Barry A Singer, Michael Lang, Txomin Arbizu, Bjorn Borre, Alessandra Lugaresi, Elisabetta Verdun Di Cantogno, Peter CornelisseAbstract:Multiple sclerosis (MS) currently requires long-term treatment with disease-modifying drugs, administered parenterally up to once daily. The need for regular self-injection can be a barrier to treatment for many patients. Autoinjectors can help patients overcome problems or concerns with self-injection and could, therefore, improve treatment adherence. This study was performed to assess the suitability of a new electronic device for the subcutaneous (sc) administration of interferon (IFN) beta-1a, 44 mcg three times weekly, for relapsing MS. In this Phase IIIb, multicentre, single-arm study, patients with relapsing MS who had been consistently self-injecting sc IFN beta-1a using an Autoinjector for at least 6 weeks were taught to use the new device and self-administered treatment for 12 weeks thereafter. Patient-rated suitability of the device was assessed at the end of Week 12 using the Patient User Trial Questionnaire. Patient satisfaction with, and evaluation of, the injection process was assessed using the MS Treatment Concern Questionnaire. Trainers evaluated the device using the Trainer User Trial Questionnaire. At Week 12, 71.6% (73/102) of patients considered the device 'very suitable' or 'suitable' for self-injection; 92.2% (94/102) reported some degree of suitability and only 7.8% (8/102) found the device 'not at all suitable'. At Weeks 4, 8 and 12, most patients reported that injection preparation and clean-up, performing injections and ease of device use in the previous 4 weeks compared favourably with, or was equivalent to, their previous experience of self-injection. Injection-related pain, injection reactions and 'flu-like' symptoms remained stable over the 12 weeks. Each device feature was rated 'very useful' or 'useful' by at least 80% of patients. All trainers and 95.2% (99/104) of patients found device functions 'very easy' or 'easy' to use. Overall convenience was considered the most important benefit of the device. Most patients considered the new electronic injection device suitable for the sc injection of IFN beta-1a. They found the device easy to use with useful features, and reported benefits such as overall convenience. The device may, therefore, increase treatment adherence in patients with MS, particularly those with injection-related issues. NCT00735007
David Gordon - One of the best experts on this subject based on the ideXlab platform.
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ab0416 reliability and safety of a novel Autoinjector for self administration of subcutaneous belimumab in patients with systemic lupus erythematosus sle
Annals of the Rheumatic Diseases, 2016Co-Authors: Saira Z Sheikh, Herbert Struemper, David M. Roth, J Groark, N L Fox, Anne E Hammer, David GordonAbstract:Background The ability to self-administer subcutaneous (SC) belimumab would enhance treatment options for patients with SLE. Objectives The reliability and safety of a novel Autoinjector for self-administration of belimumab SC was examined in patients with SLE. Methods Study 200339 (NCT02124798) enrolled adults with SLE who had received at least three prior intravenous (IV) doses of belimumab 10 mg/kg plus standard care, or who had completed the open-label continuation phase of a randomised, controlled trial of belimumab SC (prefilled syringe). Open-label belimumab 200 mg SC (1 mL) was self-administered weekly (thigh or abdomen) using an Autoinjector, under clinic observation at Weeks 1, 2, 4, 8 and at home at Weeks 3, 5, 6, 7. Patients assessed and recorded injections using a diary. Investigators assessed clinic injections. The primary endpoint was the proportion of patients who successfully administered the first two injections. Secondary endpoints included success at Weeks 4 and 8 within the clinic and success at Weeks 3, 5, 6, and 7 at home. Results 95 patients enrolled: 91 completed the study (3 withdrew due to AEs, 1 patient was lost to follow-up). 88 (93%) patients were female; mean (SD) age was 44.8 (12.5) years. Overall, 94% (89/95) of patients successfully administered belimumab at Weeks 1 and 2 using the Autoinjector. Five patients completed their 1st injection with assistance from clinic personnel. Of 736 attempted injections 720 (98%) were considered to be successful. Of the 16 injections reported to be incomplete, 14 (4 from 1 patient) were associated with use errors, 13 of which were concluded to be related to not holding the Autoinjector in place until the injection was completed. Use errors were repeated by only 1 patient. Reported pain levels were low and diminished over time. A total of 39 (41%) patients reported at least one adverse event (AE) and 15 (16%) patients reported an AE considered to be drug related. Four (4%) patients reported 7 serious AEs: anaemia/neutropenia/pneumonia/pyrexia, postoperative abscess, pulmonary embolism and deep vein thrombosis. Four (4%) patients reported injection site reactions: erythema (2), pruritus, rash, injection-related reaction and site reaction. No serious systemic reactions or deaths were reported. Conclusions Patients with SLE successfully administered belimumab SC using a novel Autoinjector. Acknowledgement Study funded by GSK. Louisa Pettinger, PhD, Fishawack Indicia Ltd, provided submission assistance, funded by GSK. Disclosure of Interest S. Sheikh: None declared, N. L. Fox Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline, A. Hammer Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline, H. Struemper Shareholder of: GlaxoSmithKline, Employee of: PAREXEL, J. Groark Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline, D. Roth Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline, D. Gordon Shareholder of: GlaxoSmithKline, Employee of: GlaxoSmithKline
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relative bioavailability of a single dose of belimumab administered subcutaneously by prefilled syringe or Autoinjector in healthy subjects
Clinical pharmacology in drug development, 2016Co-Authors: Herbert Struemper, David M. Roth, J Groark, N L Fox, Thomas Murtaugh, Jane Gilbert, Matthew E Barton, Joseph John Fire, David GordonAbstract:Intravenous belimumab is approved for the treatment of systemic lupus erythematosus; subcutaneous self-administration would enable greater patient access. This study assessed relative bioavailability, tolerability, and safety of 1 subcutaneous dose of self-administered belimumab by healthy subjects using a single-use Autoinjector or prefilled syringe. Subjects (randomized 1:1:1:1) self-administered belimumab 200 mg subcutaneously (abdomen or thigh) by prefilled syringe or Autoinjector. Pharmacokinetics, adverse events (AEs), injection-site pain, and administration errors were recorded. Of 81 subjects, 5 experienced administration errors and were excluded from pharmacokinetic analyses. Mean serum belimumab concentration profiles were similar for both devices, with a weak trend toward higher concentrations for thigh injection compared with abdominal injections. Maximum observed serum concentration was slightly higher with the Autoinjector (27.0 vs 25.3 µg/mL) and area under the concentration–time curve slightly lower (701 vs 735 day · μg/mL), compared with the prefilled syringe. Incidence of AEs was 51% (41 of 81 subjects; headache was most common), with no serious or severe AEs. Median injection-site pain scores were low (0 after 1 hour). Device handling was reported as acceptable by ≥95% of Autoinjector users and ≥90% of prefilled syringe users for each characteristic assessed. These results support the use of either device for belimumab subcutaneous administration.
