Sustained response of recombinant human C1 esterase inhibitor for acute treatment of hereditary angioedema attacks
Abstract Background Symptoms of hereditary angioedema (HAE) attacks can recur soon after initial treatment; the durability of response for recombinant human C1 esterase inhibitor (rhC1INH) treatment is unknown. Objective To examine the efficacy and durability of rhC1INH for acute HAE attacks. Method...
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| Veröffentlicht in: | Annals of allergy, asthma, & immunology asthma, & immunology, 2017-04, Vol.118 (4), p.452-455 |
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| container_title | Annals of allergy, asthma, & immunology |
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| creator | Bernstein, Jonathan A., MD Relan, Anurag, MD Harper, Joseph R., PharmD Riedl, Marc, MD |
| description | Abstract Background Symptoms of hereditary angioedema (HAE) attacks can recur soon after initial treatment; the durability of response for recombinant human C1 esterase inhibitor (rhC1INH) treatment is unknown. Objective To examine the efficacy and durability of rhC1INH for acute HAE attacks. Methods In this pooled post hoc analysis of 2 trials, patients with type I or II HAE (functional C1INH levels |
| doi_str_mv | 10.1016/j.anai.2017.01.029 |
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Objective To examine the efficacy and durability of rhC1INH for acute HAE attacks. Methods In this pooled post hoc analysis of 2 trials, patients with type I or II HAE (functional C1INH levels <50% of normal) and a baseline visual analog scale score of at least 50 mm were included if they had received at least 1 intravenous dose of 50 U/kg of rhC1INH. Response was defined as symptom relief within 4 hours after treatment with persistence (≥20-mm decrease in visual analog scale scores [0 mm {“no symptoms at all”} to 100 mm {“extremely disabling”}] at 2 consecutive time points) during the 4 hours. Durability was the response without an increase of at least 20 mm in the minimum post-treatment visual analog scale score up to 24 hours. Recurrence and new attack symptoms were determined for patients with 72-hour post-treatment data. Results Data were analyzed for 127 patients treated with 50 U/kg of rhC1INH in 2 studies. Most attacks (90.7%) responded within 4 hours, with differences in response rates among attack locations (61.5%–94.4%). The median time to the beginning of symptom relief was 75.0 minutes (95% confidence interval 65.0–80.0). No relapse occurred during 24 hours for attacks that initially responded. Only 7.1% of attacks were associated with symptom recurrence within 72 hours of initial rhC1INH treatment. Conclusion This integrated analysis supports the efficacy of rhC1INH for treatment of acute HAE across multiple attacks, with a sustained response for at least 3 days. Trial Registration ClinicalTrials.gov Identifiers: NCT00225147 and NCT00262301.</description><identifier>ISSN: 1081-1206</identifier><identifier>EISSN: 1534-4436</identifier><identifier>DOI: 10.1016/j.anai.2017.01.029</identifier><identifier>PMID: 28284978</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Adolescent ; Adult ; Aged ; Allergy and Immunology ; Complement C1 Inhibitor Protein - administration & dosage ; Complement C1 Inhibitor Protein - therapeutic use ; Disease Progression ; Female ; Hereditary Angioedema Types I and II - drug therapy ; Humans ; Male ; Middle Aged ; Recombinant Proteins - administration & dosage ; Recombinant Proteins - therapeutic use ; Recurrence ; Time-to-Treatment ; Treatment Outcome ; Young Adult</subject><ispartof>Annals of allergy, asthma, & immunology, 2017-04, Vol.118 (4), p.452-455</ispartof><rights>The Authors</rights><rights>2017 The Authors</rights><rights>Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c455t-d23060e2ed4f189e6c45522c165e06b7fb04568ad2e1a167cd0bb82f80fde5db3</citedby><cites>FETCH-LOGICAL-c455t-d23060e2ed4f189e6c45522c165e06b7fb04568ad2e1a167cd0bb82f80fde5db3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.anai.2017.01.029$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28284978$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bernstein, Jonathan A., MD</creatorcontrib><creatorcontrib>Relan, Anurag, MD</creatorcontrib><creatorcontrib>Harper, Joseph R., PharmD</creatorcontrib><creatorcontrib>Riedl, Marc, MD</creatorcontrib><title>Sustained response of recombinant human C1 esterase inhibitor for acute treatment of hereditary angioedema attacks</title><title>Annals of allergy, asthma, & immunology</title><addtitle>Ann Allergy Asthma Immunol</addtitle><description>Abstract Background Symptoms of hereditary angioedema (HAE) attacks can recur soon after initial treatment; the durability of response for recombinant human C1 esterase inhibitor (rhC1INH) treatment is unknown. Objective To examine the efficacy and durability of rhC1INH for acute HAE attacks. Methods In this pooled post hoc analysis of 2 trials, patients with type I or II HAE (functional C1INH levels <50% of normal) and a baseline visual analog scale score of at least 50 mm were included if they had received at least 1 intravenous dose of 50 U/kg of rhC1INH. Response was defined as symptom relief within 4 hours after treatment with persistence (≥20-mm decrease in visual analog scale scores [0 mm {“no symptoms at all”} to 100 mm {“extremely disabling”}] at 2 consecutive time points) during the 4 hours. Durability was the response without an increase of at least 20 mm in the minimum post-treatment visual analog scale score up to 24 hours. Recurrence and new attack symptoms were determined for patients with 72-hour post-treatment data. Results Data were analyzed for 127 patients treated with 50 U/kg of rhC1INH in 2 studies. Most attacks (90.7%) responded within 4 hours, with differences in response rates among attack locations (61.5%–94.4%). The median time to the beginning of symptom relief was 75.0 minutes (95% confidence interval 65.0–80.0). No relapse occurred during 24 hours for attacks that initially responded. Only 7.1% of attacks were associated with symptom recurrence within 72 hours of initial rhC1INH treatment. Conclusion This integrated analysis supports the efficacy of rhC1INH for treatment of acute HAE across multiple attacks, with a sustained response for at least 3 days. Trial Registration ClinicalTrials.gov Identifiers: NCT00225147 and NCT00262301.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Allergy and Immunology</subject><subject>Complement C1 Inhibitor Protein - administration & dosage</subject><subject>Complement C1 Inhibitor Protein - therapeutic use</subject><subject>Disease Progression</subject><subject>Female</subject><subject>Hereditary Angioedema Types I and II - drug therapy</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Recombinant Proteins - administration & dosage</subject><subject>Recombinant Proteins - therapeutic use</subject><subject>Recurrence</subject><subject>Time-to-Treatment</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>1081-1206</issn><issn>1534-4436</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kc-L1TAQx4Mo7rr6D3iQHr20zqRtmgciyMNfsOBhFbyFNJn68rZNnkm6sP-9KW_14MFDyBA-32HyGcZeIjQIKN4cG-21azjg0AA2wHeP2CX2bVd3XSselxok1shBXLBnKR0BAKVon7ILLrnsdoO8ZPFmTVk7T7aKlE7BJ6rCVGoTltF57XN1WBftqz1WlDJFXQDnD250OcRqKkebNVOVI-m8UOFL_ECRrMs63lfa_3SBLC260jlrc5uesyeTnhO9eLiv2PePH77tP9fXXz992b-_rk3X97m2vAUBxMl2E8odie2Zc4OiJxDjMI3Q9UJqywk1isFYGEfJJwmTpd6O7RV7fe57iuHXWoZXi0uG5ll7CmtSKAchsRPAC8rPqIkhpUiTOkW3lPEVgtpcq6PaXKvNtQJUxXUJvXrov44L2b-RP3IL8PYMUPnlnaOoknHkTVFT_GZlg_t__3f_xM3svDN6vqV7SsewRl_8KVSJK1A327a3ZePQAgL8aH8D14em5Q</recordid><startdate>20170401</startdate><enddate>20170401</enddate><creator>Bernstein, Jonathan A., MD</creator><creator>Relan, Anurag, MD</creator><creator>Harper, Joseph R., PharmD</creator><creator>Riedl, Marc, MD</creator><general>Elsevier Inc</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20170401</creationdate><title>Sustained response of recombinant human C1 esterase inhibitor for acute treatment of hereditary angioedema attacks</title><author>Bernstein, Jonathan A., MD ; Relan, Anurag, MD ; Harper, Joseph R., PharmD ; Riedl, Marc, MD</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c455t-d23060e2ed4f189e6c45522c165e06b7fb04568ad2e1a167cd0bb82f80fde5db3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Allergy and Immunology</topic><topic>Complement C1 Inhibitor Protein - administration & dosage</topic><topic>Complement C1 Inhibitor Protein - therapeutic use</topic><topic>Disease Progression</topic><topic>Female</topic><topic>Hereditary Angioedema Types I and II - drug therapy</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Recombinant Proteins - administration & dosage</topic><topic>Recombinant Proteins - therapeutic use</topic><topic>Recurrence</topic><topic>Time-to-Treatment</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bernstein, Jonathan A., MD</creatorcontrib><creatorcontrib>Relan, Anurag, MD</creatorcontrib><creatorcontrib>Harper, Joseph R., PharmD</creatorcontrib><creatorcontrib>Riedl, Marc, MD</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Annals of allergy, asthma, & immunology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bernstein, Jonathan A., MD</au><au>Relan, Anurag, MD</au><au>Harper, Joseph R., PharmD</au><au>Riedl, Marc, MD</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Sustained response of recombinant human C1 esterase inhibitor for acute treatment of hereditary angioedema attacks</atitle><jtitle>Annals of allergy, asthma, & immunology</jtitle><addtitle>Ann Allergy Asthma Immunol</addtitle><date>2017-04-01</date><risdate>2017</risdate><volume>118</volume><issue>4</issue><spage>452</spage><epage>455</epage><pages>452-455</pages><issn>1081-1206</issn><eissn>1534-4436</eissn><abstract>Abstract Background Symptoms of hereditary angioedema (HAE) attacks can recur soon after initial treatment; the durability of response for recombinant human C1 esterase inhibitor (rhC1INH) treatment is unknown. Objective To examine the efficacy and durability of rhC1INH for acute HAE attacks. Methods In this pooled post hoc analysis of 2 trials, patients with type I or II HAE (functional C1INH levels <50% of normal) and a baseline visual analog scale score of at least 50 mm were included if they had received at least 1 intravenous dose of 50 U/kg of rhC1INH. Response was defined as symptom relief within 4 hours after treatment with persistence (≥20-mm decrease in visual analog scale scores [0 mm {“no symptoms at all”} to 100 mm {“extremely disabling”}] at 2 consecutive time points) during the 4 hours. Durability was the response without an increase of at least 20 mm in the minimum post-treatment visual analog scale score up to 24 hours. Recurrence and new attack symptoms were determined for patients with 72-hour post-treatment data. Results Data were analyzed for 127 patients treated with 50 U/kg of rhC1INH in 2 studies. Most attacks (90.7%) responded within 4 hours, with differences in response rates among attack locations (61.5%–94.4%). The median time to the beginning of symptom relief was 75.0 minutes (95% confidence interval 65.0–80.0). No relapse occurred during 24 hours for attacks that initially responded. Only 7.1% of attacks were associated with symptom recurrence within 72 hours of initial rhC1INH treatment. Conclusion This integrated analysis supports the efficacy of rhC1INH for treatment of acute HAE across multiple attacks, with a sustained response for at least 3 days. Trial Registration ClinicalTrials.gov Identifiers: NCT00225147 and NCT00262301.</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>28284978</pmid><doi>10.1016/j.anai.2017.01.029</doi><tpages>4</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adolescent Adult Aged Allergy and Immunology Complement C1 Inhibitor Protein - administration & dosage Complement C1 Inhibitor Protein - therapeutic use Disease Progression Female Hereditary Angioedema Types I and II - drug therapy Humans Male Middle Aged Recombinant Proteins - administration & dosage Recombinant Proteins - therapeutic use Recurrence Time-to-Treatment Treatment Outcome Young Adult |
| title | Sustained response of recombinant human C1 esterase inhibitor for acute treatment of hereditary angioedema attacks |
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