4CPS-155 Comparative study for evaluation of the pain, ease of use and preference between two adalimumab administration devices: study adap2017
BackgroundAdalimumab is a monoclonal antibody indicated in immunomediate inflammatory diseases for subcutaneous administration by two different devices: pre-filled syringe and auto-injection pen.PurposeTo assess injection-site pain, the ease of use and patient preference between two delivery systems...
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| Veröffentlicht in: | European journal of hospital pharmacy. Science and practice 2018-03, Vol.25 (Suppl 1), p.A114-A115 |
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| creator | Muñoz, N Herrero Rosado, A Andrés Muniesa, B Hernández Lázaro, C Bravo Román, AB Fernández Alonso, A Pou Nasarre, A Ontañón Gutiérrez, MDM García López, C Mayo Gil, M García |
| description | BackgroundAdalimumab is a monoclonal antibody indicated in immunomediate inflammatory diseases for subcutaneous administration by two different devices: pre-filled syringe and auto-injection pen.PurposeTo assess injection-site pain, the ease of use and patient preference between two delivery systems of adalimumab.Material and methodsPatients were enrolled in an open-label, single-arm, sequential trial from March 2017 to September 2017.Inclusion criteriaAt least 6 months from the beginning of treatment with adalimumab pre–filled syringe and self–administration.Informed consent had to be signed (Ethics committee approval: EC1061; Protocol Number: ADAP2017).Two visits separated by an interval of 2 months were performed.Patients were informed about the change of device from pre-filled syringe to pen in Visit 1.To evaluate the ease of use, a validated questionnaire was performed. The questionnaire consisted of 15 questions about device design, inconvenients of self-administration, long injection time, handling and technique of administration (Likert-type scale: 1=very strongly disagree; 7=very strongly agree). Answers≥5 were considered acceptable (Visit 1: Syringe; Visit 2: Pen).Patients rated their pain on a visual analogue scale (VAS) (0=none, 10=the worst pain) (Visit 1: Syringe; Visit 2: Pen).Preference between devices was evaluated in Visit 2 by a single question with three possible answers (Pen/Syringe/Indifferent).Sex, birth date, diagnosis and duration of treatment were recorded. STATA® was used for statistical analysis.ResultsTwenty-seven patients were analysed:Males (67.7%).Median age: 43 years (18–73).Diagnoses: psoriasis (33.3%); spondylitis (22.2%); Crohn’s disease (40.8%); psoriatic arthritis (3.7%).Median treatment duration: 2.9 years (0.5–8.7).A reduction in injection-site pain was observed after changing the device from pre-filled syringe to pen (Mean difference: −3.04 (CI 95%–4.21 to −1.86; p |
| doi_str_mv | 10.1136/ejhpharm-2018-eahpconf.246 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_7535204</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2552768950</sourcerecordid><originalsourceid>FETCH-LOGICAL-b2096-7e07d7cfd8d90abbb56ba4848e0e4b094c636efd65a08fe30b7d6ecf9eda05393</originalsourceid><addsrcrecordid>eNp9UU1v1DAQjRBIVKX_wYIraZ34K-aAhFYUkCqBBJytcTwmXm3s4CRb9caFH9C_yC_Bq91W4sJpRjNv3ryZV1UvG3rZNExe4XaYBshj3dKmqxGGqU_RX7ZcPqnOWspVrbXkTx9zIZ9XF_McLBWMdZozfVbd882Xr3UjxJ9fvzdpnCDDEvZI5mV1d8SnTHAPu7UUUyTJk2VAMkGIrwnCjIfKWgJER6aMHjPGHonF5RYxkuU2EXCwC-M6gi3pGGKYl3xkc7gPPc5vTrsKcCqHqBfVMw-7GS9O8bz6fv3-2-ZjffP5w6fNu5vatlTLWiFVTvXedU5TsNYKaYF3vEOK3FLNe8kkeicF0M4jo1Y5ib3X6KDcr9l59fbIO612RNdjLMJ2ZsphhHxnEgTzbyeGwfxIe6MEE-WjheDViSCnnyvOi9mmNcei2bRCtEp2WtD_omhDGZNcqYISR5Qdt48SGmoOPpsHnw8DnXnw2RSf2V-vwaSi</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2010336477</pqid></control><display><type>article</type><title>4CPS-155 Comparative study for evaluation of the pain, ease of use and preference between two adalimumab administration devices: study adap2017</title><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>PubMed Central</source><creator>Muñoz, N Herrero ; Rosado, A Andrés ; Muniesa, B Hernández ; Lázaro, C Bravo ; Román, AB Fernández ; Alonso, A Pou ; Nasarre, A Ontañón ; Gutiérrez, MDM García ; López, C Mayo ; Gil, M García</creator><creatorcontrib>Muñoz, N Herrero ; Rosado, A Andrés ; Muniesa, B Hernández ; Lázaro, C Bravo ; Román, AB Fernández ; Alonso, A Pou ; Nasarre, A Ontañón ; Gutiérrez, MDM García ; López, C Mayo ; Gil, M García</creatorcontrib><description>BackgroundAdalimumab is a monoclonal antibody indicated in immunomediate inflammatory diseases for subcutaneous administration by two different devices: pre-filled syringe and auto-injection pen.PurposeTo assess injection-site pain, the ease of use and patient preference between two delivery systems of adalimumab.Material and methodsPatients were enrolled in an open-label, single-arm, sequential trial from March 2017 to September 2017.Inclusion criteriaAt least 6 months from the beginning of treatment with adalimumab pre–filled syringe and self–administration.Informed consent had to be signed (Ethics committee approval: EC1061; Protocol Number: ADAP2017).Two visits separated by an interval of 2 months were performed.Patients were informed about the change of device from pre-filled syringe to pen in Visit 1.To evaluate the ease of use, a validated questionnaire was performed. The questionnaire consisted of 15 questions about device design, inconvenients of self-administration, long injection time, handling and technique of administration (Likert-type scale: 1=very strongly disagree; 7=very strongly agree). Answers≥5 were considered acceptable (Visit 1: Syringe; Visit 2: Pen).Patients rated their pain on a visual analogue scale (VAS) (0=none, 10=the worst pain) (Visit 1: Syringe; Visit 2: Pen).Preference between devices was evaluated in Visit 2 by a single question with three possible answers (Pen/Syringe/Indifferent).Sex, birth date, diagnosis and duration of treatment were recorded. STATA® was used for statistical analysis.ResultsTwenty-seven patients were analysed:Males (67.7%).Median age: 43 years (18–73).Diagnoses: psoriasis (33.3%); spondylitis (22.2%); Crohn’s disease (40.8%); psoriatic arthritis (3.7%).Median treatment duration: 2.9 years (0.5–8.7).A reduction in injection-site pain was observed after changing the device from pre-filled syringe to pen (Mean difference: −3.04 (CI 95%–4.21 to −1.86; p<0.001).Ease of use (% acceptable answers):Device design: Syringe: 81.5%; Pen: 100%.Any inconvenience during self–administration: Syringe: 40.7%; Pen: 14.8%.Long injection time: Syringe: 29.6%; Pen: 14.8%.Ease handling: Syringe: 63.0%; Pen: 85.2%.Ease technique of administration: Syringe: 77.8%; Pen: 96.3%.Patient preferences:Pen: 81.5% (22/27).Syringe: 7.4% (2/27).Indifferent: 11.1% (3/27).ConclusionAuto-injection pen has proved superior to pre-filled syringe in injection-site pain, the ease of use and patient preference.Limitations: the pen does not contain citrate, a pain-related excipient.No conflict of interest</description><identifier>ISSN: 2047-9956</identifier><identifier>EISSN: 2047-9964</identifier><identifier>DOI: 10.1136/ejhpharm-2018-eahpconf.246</identifier><language>eng</language><publisher>London: BMJ Publishing Group LTD</publisher><subject>Immunotherapy ; Monoclonal antibodies ; Pain ; Patients ; Preferences ; Questionnaires ; Section 4: Clinical pharmacy services ; TNF inhibitors</subject><ispartof>European journal of hospital pharmacy. Science and practice, 2018-03, Vol.25 (Suppl 1), p.A114-A115</ispartof><rights>2018, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</rights><rights>Copyright: 2018 © 2018, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</rights><rights>2018 2018, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</rights><rights>2018, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions 2018</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7535204/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7535204/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,723,776,780,881,27901,27902,53766,53768</link.rule.ids></links><search><creatorcontrib>Muñoz, N Herrero</creatorcontrib><creatorcontrib>Rosado, A Andrés</creatorcontrib><creatorcontrib>Muniesa, B Hernández</creatorcontrib><creatorcontrib>Lázaro, C Bravo</creatorcontrib><creatorcontrib>Román, AB Fernández</creatorcontrib><creatorcontrib>Alonso, A Pou</creatorcontrib><creatorcontrib>Nasarre, A Ontañón</creatorcontrib><creatorcontrib>Gutiérrez, MDM García</creatorcontrib><creatorcontrib>López, C Mayo</creatorcontrib><creatorcontrib>Gil, M García</creatorcontrib><title>4CPS-155 Comparative study for evaluation of the pain, ease of use and preference between two adalimumab administration devices: study adap2017</title><title>European journal of hospital pharmacy. Science and practice</title><description>BackgroundAdalimumab is a monoclonal antibody indicated in immunomediate inflammatory diseases for subcutaneous administration by two different devices: pre-filled syringe and auto-injection pen.PurposeTo assess injection-site pain, the ease of use and patient preference between two delivery systems of adalimumab.Material and methodsPatients were enrolled in an open-label, single-arm, sequential trial from March 2017 to September 2017.Inclusion criteriaAt least 6 months from the beginning of treatment with adalimumab pre–filled syringe and self–administration.Informed consent had to be signed (Ethics committee approval: EC1061; Protocol Number: ADAP2017).Two visits separated by an interval of 2 months were performed.Patients were informed about the change of device from pre-filled syringe to pen in Visit 1.To evaluate the ease of use, a validated questionnaire was performed. The questionnaire consisted of 15 questions about device design, inconvenients of self-administration, long injection time, handling and technique of administration (Likert-type scale: 1=very strongly disagree; 7=very strongly agree). Answers≥5 were considered acceptable (Visit 1: Syringe; Visit 2: Pen).Patients rated their pain on a visual analogue scale (VAS) (0=none, 10=the worst pain) (Visit 1: Syringe; Visit 2: Pen).Preference between devices was evaluated in Visit 2 by a single question with three possible answers (Pen/Syringe/Indifferent).Sex, birth date, diagnosis and duration of treatment were recorded. STATA® was used for statistical analysis.ResultsTwenty-seven patients were analysed:Males (67.7%).Median age: 43 years (18–73).Diagnoses: psoriasis (33.3%); spondylitis (22.2%); Crohn’s disease (40.8%); psoriatic arthritis (3.7%).Median treatment duration: 2.9 years (0.5–8.7).A reduction in injection-site pain was observed after changing the device from pre-filled syringe to pen (Mean difference: −3.04 (CI 95%–4.21 to −1.86; p<0.001).Ease of use (% acceptable answers):Device design: Syringe: 81.5%; Pen: 100%.Any inconvenience during self–administration: Syringe: 40.7%; Pen: 14.8%.Long injection time: Syringe: 29.6%; Pen: 14.8%.Ease handling: Syringe: 63.0%; Pen: 85.2%.Ease technique of administration: Syringe: 77.8%; Pen: 96.3%.Patient preferences:Pen: 81.5% (22/27).Syringe: 7.4% (2/27).Indifferent: 11.1% (3/27).ConclusionAuto-injection pen has proved superior to pre-filled syringe in injection-site pain, the ease of use and patient preference.Limitations: the pen does not contain citrate, a pain-related excipient.No conflict of interest</description><subject>Immunotherapy</subject><subject>Monoclonal antibodies</subject><subject>Pain</subject><subject>Patients</subject><subject>Preferences</subject><subject>Questionnaires</subject><subject>Section 4: Clinical pharmacy services</subject><subject>TNF inhibitors</subject><issn>2047-9956</issn><issn>2047-9964</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>BENPR</sourceid><recordid>eNp9UU1v1DAQjRBIVKX_wYIraZ34K-aAhFYUkCqBBJytcTwmXm3s4CRb9caFH9C_yC_Bq91W4sJpRjNv3ryZV1UvG3rZNExe4XaYBshj3dKmqxGGqU_RX7ZcPqnOWspVrbXkTx9zIZ9XF_McLBWMdZozfVbd882Xr3UjxJ9fvzdpnCDDEvZI5mV1d8SnTHAPu7UUUyTJk2VAMkGIrwnCjIfKWgJER6aMHjPGHonF5RYxkuU2EXCwC-M6gi3pGGKYl3xkc7gPPc5vTrsKcCqHqBfVMw-7GS9O8bz6fv3-2-ZjffP5w6fNu5vatlTLWiFVTvXedU5TsNYKaYF3vEOK3FLNe8kkeicF0M4jo1Y5ib3X6KDcr9l59fbIO612RNdjLMJ2ZsphhHxnEgTzbyeGwfxIe6MEE-WjheDViSCnnyvOi9mmNcei2bRCtEp2WtD_omhDGZNcqYISR5Qdt48SGmoOPpsHnw8DnXnw2RSf2V-vwaSi</recordid><startdate>20180301</startdate><enddate>20180301</enddate><creator>Muñoz, N Herrero</creator><creator>Rosado, A Andrés</creator><creator>Muniesa, B Hernández</creator><creator>Lázaro, C Bravo</creator><creator>Román, AB Fernández</creator><creator>Alonso, A Pou</creator><creator>Nasarre, A Ontañón</creator><creator>Gutiérrez, MDM García</creator><creator>López, C Mayo</creator><creator>Gil, M García</creator><general>BMJ Publishing Group LTD</general><general>BMJ Group</general><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>5PM</scope></search><sort><creationdate>20180301</creationdate><title>4CPS-155 Comparative study for evaluation of the pain, ease of use and preference between two adalimumab administration devices: study adap2017</title><author>Muñoz, N Herrero ; Rosado, A Andrés ; Muniesa, B Hernández ; Lázaro, C Bravo ; Román, AB Fernández ; Alonso, A Pou ; Nasarre, A Ontañón ; Gutiérrez, MDM García ; López, C Mayo ; Gil, M García</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b2096-7e07d7cfd8d90abbb56ba4848e0e4b094c636efd65a08fe30b7d6ecf9eda05393</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Immunotherapy</topic><topic>Monoclonal antibodies</topic><topic>Pain</topic><topic>Patients</topic><topic>Preferences</topic><topic>Questionnaires</topic><topic>Section 4: Clinical pharmacy services</topic><topic>TNF inhibitors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Muñoz, N Herrero</creatorcontrib><creatorcontrib>Rosado, A Andrés</creatorcontrib><creatorcontrib>Muniesa, B Hernández</creatorcontrib><creatorcontrib>Lázaro, C Bravo</creatorcontrib><creatorcontrib>Román, AB Fernández</creatorcontrib><creatorcontrib>Alonso, A Pou</creatorcontrib><creatorcontrib>Nasarre, A Ontañón</creatorcontrib><creatorcontrib>Gutiérrez, MDM García</creatorcontrib><creatorcontrib>López, C Mayo</creatorcontrib><creatorcontrib>Gil, M García</creatorcontrib><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>European journal of hospital pharmacy. Science and practice</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Muñoz, N Herrero</au><au>Rosado, A Andrés</au><au>Muniesa, B Hernández</au><au>Lázaro, C Bravo</au><au>Román, AB Fernández</au><au>Alonso, A Pou</au><au>Nasarre, A Ontañón</au><au>Gutiérrez, MDM García</au><au>López, C Mayo</au><au>Gil, M García</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>4CPS-155 Comparative study for evaluation of the pain, ease of use and preference between two adalimumab administration devices: study adap2017</atitle><jtitle>European journal of hospital pharmacy. Science and practice</jtitle><date>2018-03-01</date><risdate>2018</risdate><volume>25</volume><issue>Suppl 1</issue><spage>A114</spage><epage>A115</epage><pages>A114-A115</pages><issn>2047-9956</issn><eissn>2047-9964</eissn><abstract>BackgroundAdalimumab is a monoclonal antibody indicated in immunomediate inflammatory diseases for subcutaneous administration by two different devices: pre-filled syringe and auto-injection pen.PurposeTo assess injection-site pain, the ease of use and patient preference between two delivery systems of adalimumab.Material and methodsPatients were enrolled in an open-label, single-arm, sequential trial from March 2017 to September 2017.Inclusion criteriaAt least 6 months from the beginning of treatment with adalimumab pre–filled syringe and self–administration.Informed consent had to be signed (Ethics committee approval: EC1061; Protocol Number: ADAP2017).Two visits separated by an interval of 2 months were performed.Patients were informed about the change of device from pre-filled syringe to pen in Visit 1.To evaluate the ease of use, a validated questionnaire was performed. The questionnaire consisted of 15 questions about device design, inconvenients of self-administration, long injection time, handling and technique of administration (Likert-type scale: 1=very strongly disagree; 7=very strongly agree). Answers≥5 were considered acceptable (Visit 1: Syringe; Visit 2: Pen).Patients rated their pain on a visual analogue scale (VAS) (0=none, 10=the worst pain) (Visit 1: Syringe; Visit 2: Pen).Preference between devices was evaluated in Visit 2 by a single question with three possible answers (Pen/Syringe/Indifferent).Sex, birth date, diagnosis and duration of treatment were recorded. STATA® was used for statistical analysis.ResultsTwenty-seven patients were analysed:Males (67.7%).Median age: 43 years (18–73).Diagnoses: psoriasis (33.3%); spondylitis (22.2%); Crohn’s disease (40.8%); psoriatic arthritis (3.7%).Median treatment duration: 2.9 years (0.5–8.7).A reduction in injection-site pain was observed after changing the device from pre-filled syringe to pen (Mean difference: −3.04 (CI 95%–4.21 to −1.86; p<0.001).Ease of use (% acceptable answers):Device design: Syringe: 81.5%; Pen: 100%.Any inconvenience during self–administration: Syringe: 40.7%; Pen: 14.8%.Long injection time: Syringe: 29.6%; Pen: 14.8%.Ease handling: Syringe: 63.0%; Pen: 85.2%.Ease technique of administration: Syringe: 77.8%; Pen: 96.3%.Patient preferences:Pen: 81.5% (22/27).Syringe: 7.4% (2/27).Indifferent: 11.1% (3/27).ConclusionAuto-injection pen has proved superior to pre-filled syringe in injection-site pain, the ease of use and patient preference.Limitations: the pen does not contain citrate, a pain-related excipient.No conflict of interest</abstract><cop>London</cop><pub>BMJ Publishing Group LTD</pub><doi>10.1136/ejhpharm-2018-eahpconf.246</doi><oa>free_for_read</oa></addata></record> |
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| subjects | Immunotherapy Monoclonal antibodies Pain Patients Preferences Questionnaires Section 4: Clinical pharmacy services TNF inhibitors |
| title | 4CPS-155 Comparative study for evaluation of the pain, ease of use and preference between two adalimumab administration devices: study adap2017 |
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