Phase II Open Label Study of Anakinra in Intravenous Immunoglobulin–Resistant Kawasaki Disease
Objective Anakinra has been shown to be successful in preventing and treating cardiovascular lesions both in experimental murine models of Kawasaki disease (KD) and in several studies on intravenous immunoglobulin (IVIG)– and steroid‐resistant patients with KD. This study was undertaken to determine...
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| Veröffentlicht in: | Arthritis & rheumatology (Hoboken, N.J.) N.J.), 2021-01, Vol.73 (1), p.151-161 |
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| creator | Koné‐Paut, Isabelle Tellier, Stéphanie Belot, Alexandre Brochard, Karine Guitton, Corinne Marie, Isabelle Meinzer, Ulrich Cherqaoui, Bilade Galeotti, Caroline Boukhedouni, Nadja Agostini, Helene Arditi, Moshe Lambert, Virginie Piedvache, Céline |
| description | Objective
Anakinra has been shown to be successful in preventing and treating cardiovascular lesions both in experimental murine models of Kawasaki disease (KD) and in several studies on intravenous immunoglobulin (IVIG)– and steroid‐resistant patients with KD. This study was undertaken to determine the safety of blocking interleukin‐1 in patients with IVIG‐resistant KD.
Methods
Sixteen patients were included in the present study. Patients with KD who were not responsive to 1 or more courses of 2 mg/kg of IVIG received anakinra by subcutaneous daily injections. Starting doses were 2 mg/kg of IVIG (4 mg/kg in patients who were age 38°C, indicative of a fever. Treatment duration was 14 days. The last visit was on day 45. Primary outcome was abatement of fever. Secondary measures included disease activity, coronary artery Z score, and C‐reactive protein (CRP) levels.
Results
Seventy‐five percent of patients in the intention‐to‐treat group and 87.5% in the per‐protocol group became afebrile within 48 hours of the last escalation dose of anakinra. Reduction of disease activity by 50% was indicated on 93.3% (95% confidence interval [95% CI] 68.1–99.8%) of physician evaluations and on 100% (95% CI 73.5–100%) of parent evaluations. CRP values normalized by day 30. At the initial screening, 12 of 16 patients had a maximum coronary artery Z score of >2, and 10 of 16 patients had a maximum Z score of >2.5. At day 45, 5 of 10 patients (50% [95% CI 18.7–81.3%]) and 6 of 12 patients (50% [95% CI 21.1–78.9%]) had achieved coronary artery Z scores of |
| doi_str_mv | 10.1002/art.41481 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_hal_p</sourceid><recordid>TN_cdi_hal_primary_oai_HAL_hal_03631549v1</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2472941262</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4531-7b3d33f38469463c2e29409b5949b3c5e2d7e431900a2487f29a93988c113aff3</originalsourceid><addsrcrecordid>eNp1kUtO5DAQhi3ECBDDggsgS2xg0WC7nIeXLYYZIloC8VibStoBQ-L02Emj3s0d5oacBEPzkJDwxlbp81dV-gnZ5uyAMyYO0fcHksucr5ANASIdJYIlq-9vrvg62QrhnsWjMpayZI2sg8gylaewQW7O7zAYWhT0bGYcnWBpGnrZD9MF7Wo6dvhgnUdqHS1c73FuXDcEWrTt4LrbpiuHxrqnf_8vTLChR9fTU3zEEH_RXzaYqP5JftTYBLP1dm-S69_HV0cno8nZn-JoPBlVMgE-ykqYAtSQy1TJFCphhJJMlYmSqoQqMWKaGQlcMYZC5lktFCpQeV5xDljXsEn2l947bPTM2xb9Qndo9cl4ol9qDFLgiVRzHtm9JTvz3d_BhF63NlSmadCZuJ4WEkSepBmoiO5-Qe-7wbu4SaSyOCMXqfhsXvkuBG_qjwk40y8p6ZiSfk0psjtvxqFszfSDfM8kAodL4NE2ZvG9SY8vrpbKZ2rkmUQ</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2472941262</pqid></control><display><type>article</type><title>Phase II Open Label Study of Anakinra in Intravenous Immunoglobulin–Resistant Kawasaki Disease</title><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><source>Alma/SFX Local Collection</source><creator>Koné‐Paut, Isabelle ; Tellier, Stéphanie ; Belot, Alexandre ; Brochard, Karine ; Guitton, Corinne ; Marie, Isabelle ; Meinzer, Ulrich ; Cherqaoui, Bilade ; Galeotti, Caroline ; Boukhedouni, Nadja ; Agostini, Helene ; Arditi, Moshe ; Lambert, Virginie ; Piedvache, Céline</creator><creatorcontrib>Koné‐Paut, Isabelle ; Tellier, Stéphanie ; Belot, Alexandre ; Brochard, Karine ; Guitton, Corinne ; Marie, Isabelle ; Meinzer, Ulrich ; Cherqaoui, Bilade ; Galeotti, Caroline ; Boukhedouni, Nadja ; Agostini, Helene ; Arditi, Moshe ; Lambert, Virginie ; Piedvache, Céline</creatorcontrib><description>Objective
Anakinra has been shown to be successful in preventing and treating cardiovascular lesions both in experimental murine models of Kawasaki disease (KD) and in several studies on intravenous immunoglobulin (IVIG)– and steroid‐resistant patients with KD. This study was undertaken to determine the safety of blocking interleukin‐1 in patients with IVIG‐resistant KD.
Methods
Sixteen patients were included in the present study. Patients with KD who were not responsive to 1 or more courses of 2 mg/kg of IVIG received anakinra by subcutaneous daily injections. Starting doses were 2 mg/kg of IVIG (4 mg/kg in patients who were age <8 months and who weighed ≥5 kilograms), and the dose was increased up to 6 mg/kg every 24 hours if the patient’s body temperature remained >38°C, indicative of a fever. Treatment duration was 14 days. The last visit was on day 45. Primary outcome was abatement of fever. Secondary measures included disease activity, coronary artery Z score, and C‐reactive protein (CRP) levels.
Results
Seventy‐five percent of patients in the intention‐to‐treat group and 87.5% in the per‐protocol group became afebrile within 48 hours of the last escalation dose of anakinra. Reduction of disease activity by 50% was indicated on 93.3% (95% confidence interval [95% CI] 68.1–99.8%) of physician evaluations and on 100% (95% CI 73.5–100%) of parent evaluations. CRP values normalized by day 30. At the initial screening, 12 of 16 patients had a maximum coronary artery Z score of >2, and 10 of 16 patients had a maximum Z score of >2.5. At day 45, 5 of 10 patients (50% [95% CI 18.7–81.3%]) and 6 of 12 patients (50% [95% CI 21.1–78.9%]) had achieved coronary artery Z scores of <2.5 and <2, respectively. Five serious adverse events were observed in 3 patients, but no serious infections or deaths occurred.
Conclusion
Anakinra was well tolerated in the study patients and may have some efficacy in reducing fever, markers of systemic inflammation, and coronary artery dilatation in individuals with IVIG‐refractory KD.</description><identifier>ISSN: 2326-5191</identifier><identifier>ISSN: 2326-5205</identifier><identifier>EISSN: 2326-5205</identifier><identifier>EISSN: 2326-5191</identifier><identifier>DOI: 10.1002/art.41481</identifier><identifier>PMID: 32779863</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>Animal models ; Antirheumatic Agents - therapeutic use ; Body temperature ; C-Reactive Protein - immunology ; Child ; Child, Preschool ; Confidence intervals ; Coronary Aneurysm - diagnostic imaging ; Coronary artery ; Coronary vessels ; Echocardiography ; Evaluation ; Female ; Fever ; Humans ; Immunoglobulins ; Immunoglobulins, Intravenous - therapeutic use ; Immunologic Factors - therapeutic use ; Infant ; Interleukin 1 receptor antagonist ; Interleukin 1 Receptor Antagonist Protein - therapeutic use ; Interleukins ; Intravenous administration ; Kawasaki disease ; Life Sciences ; Male ; Mucocutaneous lymph node syndrome ; Mucocutaneous Lymph Node Syndrome - diagnostic imaging ; Mucocutaneous Lymph Node Syndrome - drug therapy ; Mucocutaneous Lymph Node Syndrome - immunology ; Mucocutaneous Lymph Node Syndrome - physiopathology ; Proof of Concept Study ; Steroids ; Treatment Failure ; Treatment Outcome ; Veins & arteries</subject><ispartof>Arthritis & rheumatology (Hoboken, N.J.), 2021-01, Vol.73 (1), p.151-161</ispartof><rights>2020, American College of Rheumatology</rights><rights>2020, American College of Rheumatology.</rights><rights>2021 American College of Rheumatology</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4531-7b3d33f38469463c2e29409b5949b3c5e2d7e431900a2487f29a93988c113aff3</citedby><cites>FETCH-LOGICAL-c4531-7b3d33f38469463c2e29409b5949b3c5e2d7e431900a2487f29a93988c113aff3</cites><orcidid>0000-0001-8939-5763 ; 0000-0001-8539-6507 ; 0000-0003-4902-5332</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fart.41481$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fart.41481$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,776,780,881,1411,27903,27904,45553,45554</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32779863$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://uvsq.hal.science/hal-03631549$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Koné‐Paut, Isabelle</creatorcontrib><creatorcontrib>Tellier, Stéphanie</creatorcontrib><creatorcontrib>Belot, Alexandre</creatorcontrib><creatorcontrib>Brochard, Karine</creatorcontrib><creatorcontrib>Guitton, Corinne</creatorcontrib><creatorcontrib>Marie, Isabelle</creatorcontrib><creatorcontrib>Meinzer, Ulrich</creatorcontrib><creatorcontrib>Cherqaoui, Bilade</creatorcontrib><creatorcontrib>Galeotti, Caroline</creatorcontrib><creatorcontrib>Boukhedouni, Nadja</creatorcontrib><creatorcontrib>Agostini, Helene</creatorcontrib><creatorcontrib>Arditi, Moshe</creatorcontrib><creatorcontrib>Lambert, Virginie</creatorcontrib><creatorcontrib>Piedvache, Céline</creatorcontrib><title>Phase II Open Label Study of Anakinra in Intravenous Immunoglobulin–Resistant Kawasaki Disease</title><title>Arthritis & rheumatology (Hoboken, N.J.)</title><addtitle>Arthritis Rheumatol</addtitle><description>Objective
Anakinra has been shown to be successful in preventing and treating cardiovascular lesions both in experimental murine models of Kawasaki disease (KD) and in several studies on intravenous immunoglobulin (IVIG)– and steroid‐resistant patients with KD. This study was undertaken to determine the safety of blocking interleukin‐1 in patients with IVIG‐resistant KD.
Methods
Sixteen patients were included in the present study. Patients with KD who were not responsive to 1 or more courses of 2 mg/kg of IVIG received anakinra by subcutaneous daily injections. Starting doses were 2 mg/kg of IVIG (4 mg/kg in patients who were age <8 months and who weighed ≥5 kilograms), and the dose was increased up to 6 mg/kg every 24 hours if the patient’s body temperature remained >38°C, indicative of a fever. Treatment duration was 14 days. The last visit was on day 45. Primary outcome was abatement of fever. Secondary measures included disease activity, coronary artery Z score, and C‐reactive protein (CRP) levels.
Results
Seventy‐five percent of patients in the intention‐to‐treat group and 87.5% in the per‐protocol group became afebrile within 48 hours of the last escalation dose of anakinra. Reduction of disease activity by 50% was indicated on 93.3% (95% confidence interval [95% CI] 68.1–99.8%) of physician evaluations and on 100% (95% CI 73.5–100%) of parent evaluations. CRP values normalized by day 30. At the initial screening, 12 of 16 patients had a maximum coronary artery Z score of >2, and 10 of 16 patients had a maximum Z score of >2.5. At day 45, 5 of 10 patients (50% [95% CI 18.7–81.3%]) and 6 of 12 patients (50% [95% CI 21.1–78.9%]) had achieved coronary artery Z scores of <2.5 and <2, respectively. Five serious adverse events were observed in 3 patients, but no serious infections or deaths occurred.
Conclusion
Anakinra was well tolerated in the study patients and may have some efficacy in reducing fever, markers of systemic inflammation, and coronary artery dilatation in individuals with IVIG‐refractory KD.</description><subject>Animal models</subject><subject>Antirheumatic Agents - therapeutic use</subject><subject>Body temperature</subject><subject>C-Reactive Protein - immunology</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Confidence intervals</subject><subject>Coronary Aneurysm - diagnostic imaging</subject><subject>Coronary artery</subject><subject>Coronary vessels</subject><subject>Echocardiography</subject><subject>Evaluation</subject><subject>Female</subject><subject>Fever</subject><subject>Humans</subject><subject>Immunoglobulins</subject><subject>Immunoglobulins, Intravenous - therapeutic use</subject><subject>Immunologic Factors - therapeutic use</subject><subject>Infant</subject><subject>Interleukin 1 receptor antagonist</subject><subject>Interleukin 1 Receptor Antagonist Protein - therapeutic use</subject><subject>Interleukins</subject><subject>Intravenous administration</subject><subject>Kawasaki disease</subject><subject>Life Sciences</subject><subject>Male</subject><subject>Mucocutaneous lymph node syndrome</subject><subject>Mucocutaneous Lymph Node Syndrome - diagnostic imaging</subject><subject>Mucocutaneous Lymph Node Syndrome - drug therapy</subject><subject>Mucocutaneous Lymph Node Syndrome - immunology</subject><subject>Mucocutaneous Lymph Node Syndrome - physiopathology</subject><subject>Proof of Concept Study</subject><subject>Steroids</subject><subject>Treatment Failure</subject><subject>Treatment Outcome</subject><subject>Veins & arteries</subject><issn>2326-5191</issn><issn>2326-5205</issn><issn>2326-5205</issn><issn>2326-5191</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kUtO5DAQhi3ECBDDggsgS2xg0WC7nIeXLYYZIloC8VibStoBQ-L02Emj3s0d5oacBEPzkJDwxlbp81dV-gnZ5uyAMyYO0fcHksucr5ANASIdJYIlq-9vrvg62QrhnsWjMpayZI2sg8gylaewQW7O7zAYWhT0bGYcnWBpGnrZD9MF7Wo6dvhgnUdqHS1c73FuXDcEWrTt4LrbpiuHxrqnf_8vTLChR9fTU3zEEH_RXzaYqP5JftTYBLP1dm-S69_HV0cno8nZn-JoPBlVMgE-ykqYAtSQy1TJFCphhJJMlYmSqoQqMWKaGQlcMYZC5lktFCpQeV5xDljXsEn2l947bPTM2xb9Qndo9cl4ol9qDFLgiVRzHtm9JTvz3d_BhF63NlSmadCZuJ4WEkSepBmoiO5-Qe-7wbu4SaSyOCMXqfhsXvkuBG_qjwk40y8p6ZiSfk0psjtvxqFszfSDfM8kAodL4NE2ZvG9SY8vrpbKZ2rkmUQ</recordid><startdate>202101</startdate><enddate>202101</enddate><creator>Koné‐Paut, Isabelle</creator><creator>Tellier, Stéphanie</creator><creator>Belot, Alexandre</creator><creator>Brochard, Karine</creator><creator>Guitton, Corinne</creator><creator>Marie, Isabelle</creator><creator>Meinzer, Ulrich</creator><creator>Cherqaoui, Bilade</creator><creator>Galeotti, Caroline</creator><creator>Boukhedouni, Nadja</creator><creator>Agostini, Helene</creator><creator>Arditi, Moshe</creator><creator>Lambert, Virginie</creator><creator>Piedvache, Céline</creator><general>Wiley Subscription Services, Inc</general><general>Wiley</general><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>7QL</scope><scope>7QP</scope><scope>7T5</scope><scope>7TM</scope><scope>7U7</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><scope>1XC</scope><orcidid>https://orcid.org/0000-0001-8939-5763</orcidid><orcidid>https://orcid.org/0000-0001-8539-6507</orcidid><orcidid>https://orcid.org/0000-0003-4902-5332</orcidid></search><sort><creationdate>202101</creationdate><title>Phase II Open Label Study of Anakinra in Intravenous Immunoglobulin–Resistant Kawasaki Disease</title><author>Koné‐Paut, Isabelle ; Tellier, Stéphanie ; Belot, Alexandre ; Brochard, Karine ; Guitton, Corinne ; Marie, Isabelle ; Meinzer, Ulrich ; Cherqaoui, Bilade ; Galeotti, Caroline ; Boukhedouni, Nadja ; Agostini, Helene ; Arditi, Moshe ; Lambert, Virginie ; Piedvache, Céline</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4531-7b3d33f38469463c2e29409b5949b3c5e2d7e431900a2487f29a93988c113aff3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Animal models</topic><topic>Antirheumatic Agents - therapeutic use</topic><topic>Body temperature</topic><topic>C-Reactive Protein - immunology</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Confidence intervals</topic><topic>Coronary Aneurysm - diagnostic imaging</topic><topic>Coronary artery</topic><topic>Coronary vessels</topic><topic>Echocardiography</topic><topic>Evaluation</topic><topic>Female</topic><topic>Fever</topic><topic>Humans</topic><topic>Immunoglobulins</topic><topic>Immunoglobulins, Intravenous - therapeutic use</topic><topic>Immunologic Factors - therapeutic use</topic><topic>Infant</topic><topic>Interleukin 1 receptor antagonist</topic><topic>Interleukin 1 Receptor Antagonist Protein - therapeutic use</topic><topic>Interleukins</topic><topic>Intravenous administration</topic><topic>Kawasaki disease</topic><topic>Life Sciences</topic><topic>Male</topic><topic>Mucocutaneous lymph node syndrome</topic><topic>Mucocutaneous Lymph Node Syndrome - diagnostic imaging</topic><topic>Mucocutaneous Lymph Node Syndrome - drug therapy</topic><topic>Mucocutaneous Lymph Node Syndrome - immunology</topic><topic>Mucocutaneous Lymph Node Syndrome - physiopathology</topic><topic>Proof of Concept Study</topic><topic>Steroids</topic><topic>Treatment Failure</topic><topic>Treatment Outcome</topic><topic>Veins & arteries</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Koné‐Paut, Isabelle</creatorcontrib><creatorcontrib>Tellier, Stéphanie</creatorcontrib><creatorcontrib>Belot, Alexandre</creatorcontrib><creatorcontrib>Brochard, Karine</creatorcontrib><creatorcontrib>Guitton, Corinne</creatorcontrib><creatorcontrib>Marie, Isabelle</creatorcontrib><creatorcontrib>Meinzer, Ulrich</creatorcontrib><creatorcontrib>Cherqaoui, Bilade</creatorcontrib><creatorcontrib>Galeotti, Caroline</creatorcontrib><creatorcontrib>Boukhedouni, Nadja</creatorcontrib><creatorcontrib>Agostini, Helene</creatorcontrib><creatorcontrib>Arditi, Moshe</creatorcontrib><creatorcontrib>Lambert, Virginie</creatorcontrib><creatorcontrib>Piedvache, Céline</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Immunology Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><jtitle>Arthritis & rheumatology (Hoboken, N.J.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Koné‐Paut, Isabelle</au><au>Tellier, Stéphanie</au><au>Belot, Alexandre</au><au>Brochard, Karine</au><au>Guitton, Corinne</au><au>Marie, Isabelle</au><au>Meinzer, Ulrich</au><au>Cherqaoui, Bilade</au><au>Galeotti, Caroline</au><au>Boukhedouni, Nadja</au><au>Agostini, Helene</au><au>Arditi, Moshe</au><au>Lambert, Virginie</au><au>Piedvache, Céline</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase II Open Label Study of Anakinra in Intravenous Immunoglobulin–Resistant Kawasaki Disease</atitle><jtitle>Arthritis & rheumatology (Hoboken, N.J.)</jtitle><addtitle>Arthritis Rheumatol</addtitle><date>2021-01</date><risdate>2021</risdate><volume>73</volume><issue>1</issue><spage>151</spage><epage>161</epage><pages>151-161</pages><issn>2326-5191</issn><issn>2326-5205</issn><eissn>2326-5205</eissn><eissn>2326-5191</eissn><abstract>Objective
Anakinra has been shown to be successful in preventing and treating cardiovascular lesions both in experimental murine models of Kawasaki disease (KD) and in several studies on intravenous immunoglobulin (IVIG)– and steroid‐resistant patients with KD. This study was undertaken to determine the safety of blocking interleukin‐1 in patients with IVIG‐resistant KD.
Methods
Sixteen patients were included in the present study. Patients with KD who were not responsive to 1 or more courses of 2 mg/kg of IVIG received anakinra by subcutaneous daily injections. Starting doses were 2 mg/kg of IVIG (4 mg/kg in patients who were age <8 months and who weighed ≥5 kilograms), and the dose was increased up to 6 mg/kg every 24 hours if the patient’s body temperature remained >38°C, indicative of a fever. Treatment duration was 14 days. The last visit was on day 45. Primary outcome was abatement of fever. Secondary measures included disease activity, coronary artery Z score, and C‐reactive protein (CRP) levels.
Results
Seventy‐five percent of patients in the intention‐to‐treat group and 87.5% in the per‐protocol group became afebrile within 48 hours of the last escalation dose of anakinra. Reduction of disease activity by 50% was indicated on 93.3% (95% confidence interval [95% CI] 68.1–99.8%) of physician evaluations and on 100% (95% CI 73.5–100%) of parent evaluations. CRP values normalized by day 30. At the initial screening, 12 of 16 patients had a maximum coronary artery Z score of >2, and 10 of 16 patients had a maximum Z score of >2.5. At day 45, 5 of 10 patients (50% [95% CI 18.7–81.3%]) and 6 of 12 patients (50% [95% CI 21.1–78.9%]) had achieved coronary artery Z scores of <2.5 and <2, respectively. Five serious adverse events were observed in 3 patients, but no serious infections or deaths occurred.
Conclusion
Anakinra was well tolerated in the study patients and may have some efficacy in reducing fever, markers of systemic inflammation, and coronary artery dilatation in individuals with IVIG‐refractory KD.</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>32779863</pmid><doi>10.1002/art.41481</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0001-8939-5763</orcidid><orcidid>https://orcid.org/0000-0001-8539-6507</orcidid><orcidid>https://orcid.org/0000-0003-4902-5332</orcidid></addata></record> |
| fulltext | fulltext |
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| ispartof | Arthritis & rheumatology (Hoboken, N.J.), 2021-01, Vol.73 (1), p.151-161 |
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| source | MEDLINE; Wiley Online Library Journals Frontfile Complete; Alma/SFX Local Collection |
| subjects | Animal models Antirheumatic Agents - therapeutic use Body temperature C-Reactive Protein - immunology Child Child, Preschool Confidence intervals Coronary Aneurysm - diagnostic imaging Coronary artery Coronary vessels Echocardiography Evaluation Female Fever Humans Immunoglobulins Immunoglobulins, Intravenous - therapeutic use Immunologic Factors - therapeutic use Infant Interleukin 1 receptor antagonist Interleukin 1 Receptor Antagonist Protein - therapeutic use Interleukins Intravenous administration Kawasaki disease Life Sciences Male Mucocutaneous lymph node syndrome Mucocutaneous Lymph Node Syndrome - diagnostic imaging Mucocutaneous Lymph Node Syndrome - drug therapy Mucocutaneous Lymph Node Syndrome - immunology Mucocutaneous Lymph Node Syndrome - physiopathology Proof of Concept Study Steroids Treatment Failure Treatment Outcome Veins & arteries |
| title | Phase II Open Label Study of Anakinra in Intravenous Immunoglobulin–Resistant Kawasaki Disease |
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