THU0198 Patient Evaluations of Autoinjectors for Delivery of Subcutaneous Golimumab for Treatment of Rheumatoid Arthritis

Background Self-injection of subcutaneous (SC) golimumab (GLM) using an autoinjector device may be useful for patients with rheumatoid arthritis (RA), especially if they have functional impairment in the joints of the hand and fingers. An autoinjector designed to account for RA patient disability ma...

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Veröffentlicht in:Annals of the rheumatic diseases 2013-06, Vol.72 (Suppl 3), p.A230-A231
Hauptverfasser: Schulze-Koops, H., Giacomelli, R., Samborski, W., Rednic, S., Herold, M., Yao, R., Govoni, M., Vastesaeger, N., Weng, H. H.
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container_end_page A231
container_issue Suppl 3
container_start_page A230
container_title Annals of the rheumatic diseases
container_volume 72
creator Schulze-Koops, H.
Giacomelli, R.
Samborski, W.
Rednic, S.
Herold, M.
Yao, R.
Govoni, M.
Vastesaeger, N.
Weng, H. H.
description Background Self-injection of subcutaneous (SC) golimumab (GLM) using an autoinjector device may be useful for patients with rheumatoid arthritis (RA), especially if they have functional impairment in the joints of the hand and fingers. An autoinjector designed to account for RA patient disability may improve patient satisfaction. Objectives To measure the acceptability, ease of use, and preferences for use of a SmartJect autoinjector for SC GLM administration; effects of patient age and functional impairment were evaluated. Methods GO-MORE was an open-label, multinational, prospective study in biologic-naïve patients with active RA (DAS28-ESR ≥3.2). Patients self-injected 50-mg SC GLM once monthly for 6 months. At months 4 and 6, patients reported their use preferences and opinions of the autoinjector device on a questionnaire. Responses were analyzed descriptively. Effects of patient age and functional impairment on responses were evaluated. Results Overall, the vast majority of patients found the autoinjector to be easy to use, to cause mild or no discomfort, and to cause mild or no pain (table). At month 6, most of the efficacy-evaluable patients reported they preferred to self-inject in the thigh (75.2%; 1563/2077), followed by the abdomen (17.5%; 363/2077) and the upper arm (7.3%; 151/2077). More than 85% of patients indicated that they used their right hand for self-injection. More than 95% of patients were sure or very sure that when they used the autoinjector, the treatment had been fully injected; and 92.1% were satisfied or very satisfied with the monthly autoinjection frequency. Responses did not differ by patient age group. Patients with minimal or no functional impairment (HAQ-DI ≤0.5) at baseline tended to have more favorable responses, including greater ease of injection and less pain with injection, than those with functional impairment. At month 6, the overall self-injection experience was considered extremely favorable by 53.7% and favorable by 39.5% of patients without impairment and extremely favorable by 42.5% and favorable by 49.1% of patients with impairment. Conclusions Most patients had very favorable evaluations of the SmartJect autoinjector device for GLM, reporting it to be easy to use, with minimal pain or discomfort upon injection and satisfactory administration frequency. Disclosure of Interest H. Schulze-Koops Consultant for: Abbott, Actelion, Biotest, BMS, Chugai, Essex, GSK, MSD, Medac, Merck, Mundai Pharma, Novartis, Nyco
doi_str_mv 10.1136/annrheumdis-2013-eular.726
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H.</creator><creatorcontrib>Schulze-Koops, H. ; Giacomelli, R. ; Samborski, W. ; Rednic, S. ; Herold, M. ; Yao, R. ; Govoni, M. ; Vastesaeger, N. ; Weng, H. H.</creatorcontrib><description>Background Self-injection of subcutaneous (SC) golimumab (GLM) using an autoinjector device may be useful for patients with rheumatoid arthritis (RA), especially if they have functional impairment in the joints of the hand and fingers. An autoinjector designed to account for RA patient disability may improve patient satisfaction. Objectives To measure the acceptability, ease of use, and preferences for use of a SmartJect autoinjector for SC GLM administration; effects of patient age and functional impairment were evaluated. Methods GO-MORE was an open-label, multinational, prospective study in biologic-naïve patients with active RA (DAS28-ESR ≥3.2). Patients self-injected 50-mg SC GLM once monthly for 6 months. At months 4 and 6, patients reported their use preferences and opinions of the autoinjector device on a questionnaire. Responses were analyzed descriptively. Effects of patient age and functional impairment on responses were evaluated. Results Overall, the vast majority of patients found the autoinjector to be easy to use, to cause mild or no discomfort, and to cause mild or no pain (table). At month 6, most of the efficacy-evaluable patients reported they preferred to self-inject in the thigh (75.2%; 1563/2077), followed by the abdomen (17.5%; 363/2077) and the upper arm (7.3%; 151/2077). More than 85% of patients indicated that they used their right hand for self-injection. More than 95% of patients were sure or very sure that when they used the autoinjector, the treatment had been fully injected; and 92.1% were satisfied or very satisfied with the monthly autoinjection frequency. Responses did not differ by patient age group. Patients with minimal or no functional impairment (HAQ-DI ≤0.5) at baseline tended to have more favorable responses, including greater ease of injection and less pain with injection, than those with functional impairment. At month 6, the overall self-injection experience was considered extremely favorable by 53.7% and favorable by 39.5% of patients without impairment and extremely favorable by 42.5% and favorable by 49.1% of patients with impairment. Conclusions Most patients had very favorable evaluations of the SmartJect autoinjector device for GLM, reporting it to be easy to use, with minimal pain or discomfort upon injection and satisfactory administration frequency. Disclosure of Interest H. Schulze-Koops Consultant for: Abbott, Actelion, Biotest, BMS, Chugai, Essex, GSK, MSD, Medac, Merck, Mundai Pharma, Novartis, Nycomed, Pfizer, Roche, UCB., R. Giacomelli: None Declared, W. Samborski: None Declared, S. Rednic: None Declared, M. Herold: None Declared, R. 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For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b2207-ad9ecc6910d6791ad154846ad5c40f55a87d86509504127f14bc78e5b2dde1543</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttp://ard.bmj.com/content/72/Suppl_3/A230.3.full.pdf$$EPDF$$P50$$Gbmj$$H</linktopdf><linktohtml>$$Uhttp://ard.bmj.com/content/72/Suppl_3/A230.3.full$$EHTML$$P50$$Gbmj$$H</linktohtml><link.rule.ids>114,115,314,780,784,3196,23571,27924,27925,77600,77631</link.rule.ids></links><search><creatorcontrib>Schulze-Koops, H.</creatorcontrib><creatorcontrib>Giacomelli, R.</creatorcontrib><creatorcontrib>Samborski, W.</creatorcontrib><creatorcontrib>Rednic, S.</creatorcontrib><creatorcontrib>Herold, M.</creatorcontrib><creatorcontrib>Yao, R.</creatorcontrib><creatorcontrib>Govoni, M.</creatorcontrib><creatorcontrib>Vastesaeger, N.</creatorcontrib><creatorcontrib>Weng, H. H.</creatorcontrib><title>THU0198 Patient Evaluations of Autoinjectors for Delivery of Subcutaneous Golimumab for Treatment of Rheumatoid Arthritis</title><title>Annals of the rheumatic diseases</title><addtitle>Ann Rheum Dis</addtitle><description>Background Self-injection of subcutaneous (SC) golimumab (GLM) using an autoinjector device may be useful for patients with rheumatoid arthritis (RA), especially if they have functional impairment in the joints of the hand and fingers. An autoinjector designed to account for RA patient disability may improve patient satisfaction. Objectives To measure the acceptability, ease of use, and preferences for use of a SmartJect autoinjector for SC GLM administration; effects of patient age and functional impairment were evaluated. Methods GO-MORE was an open-label, multinational, prospective study in biologic-naïve patients with active RA (DAS28-ESR ≥3.2). Patients self-injected 50-mg SC GLM once monthly for 6 months. At months 4 and 6, patients reported their use preferences and opinions of the autoinjector device on a questionnaire. Responses were analyzed descriptively. Effects of patient age and functional impairment on responses were evaluated. Results Overall, the vast majority of patients found the autoinjector to be easy to use, to cause mild or no discomfort, and to cause mild or no pain (table). At month 6, most of the efficacy-evaluable patients reported they preferred to self-inject in the thigh (75.2%; 1563/2077), followed by the abdomen (17.5%; 363/2077) and the upper arm (7.3%; 151/2077). More than 85% of patients indicated that they used their right hand for self-injection. More than 95% of patients were sure or very sure that when they used the autoinjector, the treatment had been fully injected; and 92.1% were satisfied or very satisfied with the monthly autoinjection frequency. Responses did not differ by patient age group. Patients with minimal or no functional impairment (HAQ-DI ≤0.5) at baseline tended to have more favorable responses, including greater ease of injection and less pain with injection, than those with functional impairment. At month 6, the overall self-injection experience was considered extremely favorable by 53.7% and favorable by 39.5% of patients without impairment and extremely favorable by 42.5% and favorable by 49.1% of patients with impairment. Conclusions Most patients had very favorable evaluations of the SmartJect autoinjector device for GLM, reporting it to be easy to use, with minimal pain or discomfort upon injection and satisfactory administration frequency. Disclosure of Interest H. Schulze-Koops Consultant for: Abbott, Actelion, Biotest, BMS, Chugai, Essex, GSK, MSD, Medac, Merck, Mundai Pharma, Novartis, Nycomed, Pfizer, Roche, UCB., R. Giacomelli: None Declared, W. Samborski: None Declared, S. Rednic: None Declared, M. Herold: None Declared, R. Yao Employee of: Merck, M. Govoni Employee of: Merck, N. Vastesaeger Employee of: Merck, H. 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H.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>THU0198 Patient Evaluations of Autoinjectors for Delivery of Subcutaneous Golimumab for Treatment of Rheumatoid Arthritis</atitle><jtitle>Annals of the rheumatic diseases</jtitle><addtitle>Ann Rheum Dis</addtitle><date>2013-06</date><risdate>2013</risdate><volume>72</volume><issue>Suppl 3</issue><spage>A230</spage><epage>A231</epage><pages>A230-A231</pages><issn>0003-4967</issn><eissn>1468-2060</eissn><coden>ARDIAO</coden><abstract>Background Self-injection of subcutaneous (SC) golimumab (GLM) using an autoinjector device may be useful for patients with rheumatoid arthritis (RA), especially if they have functional impairment in the joints of the hand and fingers. An autoinjector designed to account for RA patient disability may improve patient satisfaction. Objectives To measure the acceptability, ease of use, and preferences for use of a SmartJect autoinjector for SC GLM administration; effects of patient age and functional impairment were evaluated. Methods GO-MORE was an open-label, multinational, prospective study in biologic-naïve patients with active RA (DAS28-ESR ≥3.2). Patients self-injected 50-mg SC GLM once monthly for 6 months. At months 4 and 6, patients reported their use preferences and opinions of the autoinjector device on a questionnaire. Responses were analyzed descriptively. Effects of patient age and functional impairment on responses were evaluated. Results Overall, the vast majority of patients found the autoinjector to be easy to use, to cause mild or no discomfort, and to cause mild or no pain (table). At month 6, most of the efficacy-evaluable patients reported they preferred to self-inject in the thigh (75.2%; 1563/2077), followed by the abdomen (17.5%; 363/2077) and the upper arm (7.3%; 151/2077). More than 85% of patients indicated that they used their right hand for self-injection. More than 95% of patients were sure or very sure that when they used the autoinjector, the treatment had been fully injected; and 92.1% were satisfied or very satisfied with the monthly autoinjection frequency. Responses did not differ by patient age group. Patients with minimal or no functional impairment (HAQ-DI ≤0.5) at baseline tended to have more favorable responses, including greater ease of injection and less pain with injection, than those with functional impairment. At month 6, the overall self-injection experience was considered extremely favorable by 53.7% and favorable by 39.5% of patients without impairment and extremely favorable by 42.5% and favorable by 49.1% of patients with impairment. Conclusions Most patients had very favorable evaluations of the SmartJect autoinjector device for GLM, reporting it to be easy to use, with minimal pain or discomfort upon injection and satisfactory administration frequency. Disclosure of Interest H. Schulze-Koops Consultant for: Abbott, Actelion, Biotest, BMS, Chugai, Essex, GSK, MSD, Medac, Merck, Mundai Pharma, Novartis, Nycomed, Pfizer, Roche, UCB., R. Giacomelli: None Declared, W. Samborski: None Declared, S. Rednic: None Declared, M. Herold: None Declared, R. Yao Employee of: Merck, M. Govoni Employee of: Merck, N. Vastesaeger Employee of: Merck, H. Weng Employee of: Merck</abstract><cop>London</cop><pub>BMJ Publishing Group Ltd and European League Against Rheumatism</pub><doi>10.1136/annrheumdis-2013-eular.726</doi></addata></record>
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title THU0198 Patient Evaluations of Autoinjectors for Delivery of Subcutaneous Golimumab for Treatment of Rheumatoid Arthritis
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