Primary analysis of JUMP, a phase 3b, expanded‐access study evaluating the safety and efficacy of ruxolitinib in patients with myelofibrosis, including those with low platelet counts
Summary Ruxolitinib is a potent Janus kinase (JAK) 1/JAK2 inhibitor approved for the treatment of myelofibrosis (MF). Ruxolitinib was assessed in JUMP, a large (N = 2233), phase 3b, expanded‐access study in MF in countries without access to ruxolitinib outside a clinical trial, which included patien...
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| Veröffentlicht in: | British journal of haematology 2020-06, Vol.189 (5), p.888-903 |
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| creator | Al‐Ali, Haifa Kathrin Griesshammer, Martin Foltz, Lynda Palumbo, Giuseppe A. Martino, Bruno Palandri, Francesca Liberati, Anna Marina Coutre, Philipp García‐Hernández, Carmen Zaritskey, Andrey Tavares, Renato Gupta, Vikas Raanani, Pia Giraldo, Pilar Hänel, Mathias Damiani, Daniela Sacha, Tomasz Bouard, Catherine Paley, Carole Tiwari, Ranjan Mannelli, Francesco Vannucchi, Alessandro M. |
| description | Summary
Ruxolitinib is a potent Janus kinase (JAK) 1/JAK2 inhibitor approved for the treatment of myelofibrosis (MF). Ruxolitinib was assessed in JUMP, a large (N = 2233), phase 3b, expanded‐access study in MF in countries without access to ruxolitinib outside a clinical trial, which included patients with low platelet counts ( |
| doi_str_mv | 10.1111/bjh.16462 |
| format | Article |
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Ruxolitinib is a potent Janus kinase (JAK) 1/JAK2 inhibitor approved for the treatment of myelofibrosis (MF). Ruxolitinib was assessed in JUMP, a large (N = 2233), phase 3b, expanded‐access study in MF in countries without access to ruxolitinib outside a clinical trial, which included patients with low platelet counts (<100 × 109/l) and patients without splenomegaly – populations that have not been extensively studied. The most common adverse events (AEs) were anaemia and thrombocytopenia, but they rarely led to discontinuation (overall, 5·4%; low‐platelet cohort, 12·3%). As expected, rates of worsening thrombocytopenia were higher in the low‐platelet cohort (all grades, 73·2% vs. 53·5% overall); rates of anaemia were similar (all grades, 52·9% vs. 59·5%). Non‐haematologic AEs, including infections, were mainly grade 1/2. Overall, ruxolitinib led to meaningful reductions in spleen length and symptoms, including in patients with low platelet counts, and symptom improvements in patients without splenomegaly. In this trial, the largest study of ruxolitinib in patients with MF to date, the safety profile was consistent with previous reports, with no new safety concerns identified. This study confirms findings from the COMFORT studies and supports the use of ruxolitinib in patients with platelet counts of 50–100 × 109/l. (ClinicalTrials.gov identifier NCT01493414).</description><identifier>ISSN: 0007-1048</identifier><identifier>EISSN: 1365-2141</identifier><identifier>DOI: 10.1111/bjh.16462</identifier><identifier>PMID: 32017044</identifier><language>eng</language><publisher>England: Blackwell Publishing Ltd</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Anemia ; Anemia - chemically induced ; Enzyme inhibitors ; Female ; Hematology ; Humans ; Janus kinase ; Janus Kinase 1 - antagonists & inhibitors ; Janus kinase 2 ; Janus Kinase 2 - antagonists & inhibitors ; Kaplan-Meier Estimate ; Leukemia, Myeloid, Acute - etiology ; Male ; Middle Aged ; Myelofibrosis ; Neoplasms - etiology ; Patients ; Platelet Count ; Platelets ; Primary Myelofibrosis - blood ; Primary Myelofibrosis - complications ; Primary Myelofibrosis - drug therapy ; Progression-Free Survival ; Proportional Hazards Models ; Protein Kinase Inhibitors - adverse effects ; Protein Kinase Inhibitors - therapeutic use ; Pyrazoles - adverse effects ; Pyrazoles - therapeutic use ; ruxolitinib ; Safety ; Spleen ; Spleen - pathology ; Splenomegaly ; Splenomegaly - etiology ; symptoms ; Thrombocytopenia ; Thrombocytopenia - chemically induced ; Young Adult</subject><ispartof>British journal of haematology, 2020-06, Vol.189 (5), p.888-903</ispartof><rights>2020 British Society for Haematology and John Wiley & Sons Ltd</rights><rights>2020 British Society for Haematology and John Wiley & Sons Ltd.</rights><rights>2020. This article is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3882-943394469c34f1b8182bba2a82a4f98a1c66f6f65fdeae7f2001d4df677bd29e3</citedby><cites>FETCH-LOGICAL-c3882-943394469c34f1b8182bba2a82a4f98a1c66f6f65fdeae7f2001d4df677bd29e3</cites><orcidid>0000-0002-7207-6595 ; 0000-0001-8718-7004 ; 0000-0002-1663-4468 ; 0000-0001-5009-2239</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fbjh.16462$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fbjh.16462$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,1433,27924,27925,45574,45575,46409,46833</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32017044$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Al‐Ali, Haifa Kathrin</creatorcontrib><creatorcontrib>Griesshammer, Martin</creatorcontrib><creatorcontrib>Foltz, Lynda</creatorcontrib><creatorcontrib>Palumbo, Giuseppe A.</creatorcontrib><creatorcontrib>Martino, Bruno</creatorcontrib><creatorcontrib>Palandri, Francesca</creatorcontrib><creatorcontrib>Liberati, Anna Marina</creatorcontrib><creatorcontrib>Coutre, Philipp</creatorcontrib><creatorcontrib>García‐Hernández, Carmen</creatorcontrib><creatorcontrib>Zaritskey, Andrey</creatorcontrib><creatorcontrib>Tavares, Renato</creatorcontrib><creatorcontrib>Gupta, Vikas</creatorcontrib><creatorcontrib>Raanani, Pia</creatorcontrib><creatorcontrib>Giraldo, Pilar</creatorcontrib><creatorcontrib>Hänel, Mathias</creatorcontrib><creatorcontrib>Damiani, Daniela</creatorcontrib><creatorcontrib>Sacha, Tomasz</creatorcontrib><creatorcontrib>Bouard, Catherine</creatorcontrib><creatorcontrib>Paley, Carole</creatorcontrib><creatorcontrib>Tiwari, Ranjan</creatorcontrib><creatorcontrib>Mannelli, Francesco</creatorcontrib><creatorcontrib>Vannucchi, Alessandro M.</creatorcontrib><title>Primary analysis of JUMP, a phase 3b, expanded‐access study evaluating the safety and efficacy of ruxolitinib in patients with myelofibrosis, including those with low platelet counts</title><title>British journal of haematology</title><addtitle>Br J Haematol</addtitle><description>Summary
Ruxolitinib is a potent Janus kinase (JAK) 1/JAK2 inhibitor approved for the treatment of myelofibrosis (MF). Ruxolitinib was assessed in JUMP, a large (N = 2233), phase 3b, expanded‐access study in MF in countries without access to ruxolitinib outside a clinical trial, which included patients with low platelet counts (<100 × 109/l) and patients without splenomegaly – populations that have not been extensively studied. The most common adverse events (AEs) were anaemia and thrombocytopenia, but they rarely led to discontinuation (overall, 5·4%; low‐platelet cohort, 12·3%). As expected, rates of worsening thrombocytopenia were higher in the low‐platelet cohort (all grades, 73·2% vs. 53·5% overall); rates of anaemia were similar (all grades, 52·9% vs. 59·5%). Non‐haematologic AEs, including infections, were mainly grade 1/2. Overall, ruxolitinib led to meaningful reductions in spleen length and symptoms, including in patients with low platelet counts, and symptom improvements in patients without splenomegaly. In this trial, the largest study of ruxolitinib in patients with MF to date, the safety profile was consistent with previous reports, with no new safety concerns identified. This study confirms findings from the COMFORT studies and supports the use of ruxolitinib in patients with platelet counts of 50–100 × 109/l. (ClinicalTrials.gov identifier NCT01493414).</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Anemia</subject><subject>Anemia - chemically induced</subject><subject>Enzyme inhibitors</subject><subject>Female</subject><subject>Hematology</subject><subject>Humans</subject><subject>Janus kinase</subject><subject>Janus Kinase 1 - antagonists & inhibitors</subject><subject>Janus kinase 2</subject><subject>Janus Kinase 2 - antagonists & inhibitors</subject><subject>Kaplan-Meier Estimate</subject><subject>Leukemia, Myeloid, Acute - etiology</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Myelofibrosis</subject><subject>Neoplasms - etiology</subject><subject>Patients</subject><subject>Platelet Count</subject><subject>Platelets</subject><subject>Primary Myelofibrosis - blood</subject><subject>Primary Myelofibrosis - complications</subject><subject>Primary Myelofibrosis - drug therapy</subject><subject>Progression-Free Survival</subject><subject>Proportional Hazards Models</subject><subject>Protein Kinase Inhibitors - adverse effects</subject><subject>Protein Kinase Inhibitors - therapeutic use</subject><subject>Pyrazoles - adverse effects</subject><subject>Pyrazoles - therapeutic use</subject><subject>ruxolitinib</subject><subject>Safety</subject><subject>Spleen</subject><subject>Spleen - pathology</subject><subject>Splenomegaly</subject><subject>Splenomegaly - etiology</subject><subject>symptoms</subject><subject>Thrombocytopenia</subject><subject>Thrombocytopenia - chemically induced</subject><subject>Young Adult</subject><issn>0007-1048</issn><issn>1365-2141</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kUtuFDEQhi0EIpPAggsgS6yQphO_ph9LEiWEKBFZkHXLjzLjkafdtN1MepcjcBzOw0nwpAO72Asv_NVXqvoRekfJMc3nRG3Wx7QUJXuBFpSXq4JRQV-iBSGkKigR9QE6jHFDCOVkRV-jA84IrYgQC_T7dnBbOUxYdtJP0UUcLL66u7ldYon7tYyAuVpiuO9lZ8D8efgltYYYcUyjmTD8lH6UyXXfcVoDjtJC2rsMBmudlnra-4bxPniXKaew63CfC6BLEe9cWuPtBD5Yp4aQuy_zv_ajmYUhd39kfNjh3ssEHhLWYczFb9ArK32Et0_vEbq7OP92dllcf_385ezTdaF5XbOiEZw3QpSN5sJSVdOaKSWZrJkUtqkl1WVp811ZAxIqy_KSjDC2rCplWAP8CH2Yvf0QfowQU7sJ45CXFVsmSFOyKusz9XGmdB4jDmDbft5rS0m7z6jNGbWPGWX2_ZNxVFsw_8l_oWTgZAZ2zsP0vKk9vbqclX8BfhGfcg</recordid><startdate>202006</startdate><enddate>202006</enddate><creator>Al‐Ali, Haifa Kathrin</creator><creator>Griesshammer, Martin</creator><creator>Foltz, Lynda</creator><creator>Palumbo, Giuseppe A.</creator><creator>Martino, Bruno</creator><creator>Palandri, Francesca</creator><creator>Liberati, Anna Marina</creator><creator>Coutre, Philipp</creator><creator>García‐Hernández, Carmen</creator><creator>Zaritskey, Andrey</creator><creator>Tavares, Renato</creator><creator>Gupta, Vikas</creator><creator>Raanani, Pia</creator><creator>Giraldo, Pilar</creator><creator>Hänel, Mathias</creator><creator>Damiani, Daniela</creator><creator>Sacha, Tomasz</creator><creator>Bouard, Catherine</creator><creator>Paley, Carole</creator><creator>Tiwari, Ranjan</creator><creator>Mannelli, Francesco</creator><creator>Vannucchi, Alessandro M.</creator><general>Blackwell Publishing Ltd</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>7T5</scope><scope>H94</scope><orcidid>https://orcid.org/0000-0002-7207-6595</orcidid><orcidid>https://orcid.org/0000-0001-8718-7004</orcidid><orcidid>https://orcid.org/0000-0002-1663-4468</orcidid><orcidid>https://orcid.org/0000-0001-5009-2239</orcidid></search><sort><creationdate>202006</creationdate><title>Primary analysis of JUMP, a phase 3b, expanded‐access study evaluating the safety and efficacy of ruxolitinib in patients with myelofibrosis, including those with low platelet counts</title><author>Al‐Ali, Haifa Kathrin ; Griesshammer, Martin ; Foltz, Lynda ; Palumbo, Giuseppe A. ; Martino, Bruno ; Palandri, Francesca ; Liberati, Anna Marina ; Coutre, Philipp ; García‐Hernández, Carmen ; Zaritskey, Andrey ; Tavares, Renato ; Gupta, Vikas ; Raanani, Pia ; Giraldo, Pilar ; Hänel, Mathias ; Damiani, Daniela ; Sacha, Tomasz ; Bouard, Catherine ; Paley, Carole ; Tiwari, Ranjan ; Mannelli, Francesco ; Vannucchi, Alessandro M.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3882-943394469c34f1b8182bba2a82a4f98a1c66f6f65fdeae7f2001d4df677bd29e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Anemia</topic><topic>Anemia - chemically induced</topic><topic>Enzyme inhibitors</topic><topic>Female</topic><topic>Hematology</topic><topic>Humans</topic><topic>Janus kinase</topic><topic>Janus Kinase 1 - antagonists & inhibitors</topic><topic>Janus kinase 2</topic><topic>Janus Kinase 2 - antagonists & inhibitors</topic><topic>Kaplan-Meier Estimate</topic><topic>Leukemia, Myeloid, Acute - etiology</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Myelofibrosis</topic><topic>Neoplasms - etiology</topic><topic>Patients</topic><topic>Platelet Count</topic><topic>Platelets</topic><topic>Primary Myelofibrosis - blood</topic><topic>Primary Myelofibrosis - complications</topic><topic>Primary Myelofibrosis - drug therapy</topic><topic>Progression-Free Survival</topic><topic>Proportional Hazards Models</topic><topic>Protein Kinase Inhibitors - adverse effects</topic><topic>Protein Kinase Inhibitors - therapeutic use</topic><topic>Pyrazoles - adverse effects</topic><topic>Pyrazoles - therapeutic use</topic><topic>ruxolitinib</topic><topic>Safety</topic><topic>Spleen</topic><topic>Spleen - pathology</topic><topic>Splenomegaly</topic><topic>Splenomegaly - etiology</topic><topic>symptoms</topic><topic>Thrombocytopenia</topic><topic>Thrombocytopenia - chemically induced</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Al‐Ali, Haifa Kathrin</creatorcontrib><creatorcontrib>Griesshammer, Martin</creatorcontrib><creatorcontrib>Foltz, Lynda</creatorcontrib><creatorcontrib>Palumbo, Giuseppe A.</creatorcontrib><creatorcontrib>Martino, Bruno</creatorcontrib><creatorcontrib>Palandri, Francesca</creatorcontrib><creatorcontrib>Liberati, Anna Marina</creatorcontrib><creatorcontrib>Coutre, Philipp</creatorcontrib><creatorcontrib>García‐Hernández, Carmen</creatorcontrib><creatorcontrib>Zaritskey, Andrey</creatorcontrib><creatorcontrib>Tavares, Renato</creatorcontrib><creatorcontrib>Gupta, Vikas</creatorcontrib><creatorcontrib>Raanani, Pia</creatorcontrib><creatorcontrib>Giraldo, Pilar</creatorcontrib><creatorcontrib>Hänel, Mathias</creatorcontrib><creatorcontrib>Damiani, Daniela</creatorcontrib><creatorcontrib>Sacha, Tomasz</creatorcontrib><creatorcontrib>Bouard, Catherine</creatorcontrib><creatorcontrib>Paley, Carole</creatorcontrib><creatorcontrib>Tiwari, Ranjan</creatorcontrib><creatorcontrib>Mannelli, Francesco</creatorcontrib><creatorcontrib>Vannucchi, Alessandro M.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>British journal of haematology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Al‐Ali, Haifa Kathrin</au><au>Griesshammer, Martin</au><au>Foltz, Lynda</au><au>Palumbo, Giuseppe A.</au><au>Martino, Bruno</au><au>Palandri, Francesca</au><au>Liberati, Anna Marina</au><au>Coutre, Philipp</au><au>García‐Hernández, Carmen</au><au>Zaritskey, Andrey</au><au>Tavares, Renato</au><au>Gupta, Vikas</au><au>Raanani, Pia</au><au>Giraldo, Pilar</au><au>Hänel, Mathias</au><au>Damiani, Daniela</au><au>Sacha, Tomasz</au><au>Bouard, Catherine</au><au>Paley, Carole</au><au>Tiwari, Ranjan</au><au>Mannelli, Francesco</au><au>Vannucchi, Alessandro M.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Primary analysis of JUMP, a phase 3b, expanded‐access study evaluating the safety and efficacy of ruxolitinib in patients with myelofibrosis, including those with low platelet counts</atitle><jtitle>British journal of haematology</jtitle><addtitle>Br J Haematol</addtitle><date>2020-06</date><risdate>2020</risdate><volume>189</volume><issue>5</issue><spage>888</spage><epage>903</epage><pages>888-903</pages><issn>0007-1048</issn><eissn>1365-2141</eissn><abstract>Summary
Ruxolitinib is a potent Janus kinase (JAK) 1/JAK2 inhibitor approved for the treatment of myelofibrosis (MF). Ruxolitinib was assessed in JUMP, a large (N = 2233), phase 3b, expanded‐access study in MF in countries without access to ruxolitinib outside a clinical trial, which included patients with low platelet counts (<100 × 109/l) and patients without splenomegaly – populations that have not been extensively studied. The most common adverse events (AEs) were anaemia and thrombocytopenia, but they rarely led to discontinuation (overall, 5·4%; low‐platelet cohort, 12·3%). As expected, rates of worsening thrombocytopenia were higher in the low‐platelet cohort (all grades, 73·2% vs. 53·5% overall); rates of anaemia were similar (all grades, 52·9% vs. 59·5%). Non‐haematologic AEs, including infections, were mainly grade 1/2. Overall, ruxolitinib led to meaningful reductions in spleen length and symptoms, including in patients with low platelet counts, and symptom improvements in patients without splenomegaly. In this trial, the largest study of ruxolitinib in patients with MF to date, the safety profile was consistent with previous reports, with no new safety concerns identified. This study confirms findings from the COMFORT studies and supports the use of ruxolitinib in patients with platelet counts of 50–100 × 109/l. (ClinicalTrials.gov identifier NCT01493414).</abstract><cop>England</cop><pub>Blackwell Publishing Ltd</pub><pmid>32017044</pmid><doi>10.1111/bjh.16462</doi><tpages>16</tpages><orcidid>https://orcid.org/0000-0002-7207-6595</orcidid><orcidid>https://orcid.org/0000-0001-8718-7004</orcidid><orcidid>https://orcid.org/0000-0002-1663-4468</orcidid><orcidid>https://orcid.org/0000-0001-5009-2239</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | British journal of haematology, 2020-06, Vol.189 (5), p.888-903 |
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| subjects | Adolescent Adult Aged Aged, 80 and over Anemia Anemia - chemically induced Enzyme inhibitors Female Hematology Humans Janus kinase Janus Kinase 1 - antagonists & inhibitors Janus kinase 2 Janus Kinase 2 - antagonists & inhibitors Kaplan-Meier Estimate Leukemia, Myeloid, Acute - etiology Male Middle Aged Myelofibrosis Neoplasms - etiology Patients Platelet Count Platelets Primary Myelofibrosis - blood Primary Myelofibrosis - complications Primary Myelofibrosis - drug therapy Progression-Free Survival Proportional Hazards Models Protein Kinase Inhibitors - adverse effects Protein Kinase Inhibitors - therapeutic use Pyrazoles - adverse effects Pyrazoles - therapeutic use ruxolitinib Safety Spleen Spleen - pathology Splenomegaly Splenomegaly - etiology symptoms Thrombocytopenia Thrombocytopenia - chemically induced Young Adult |
| title | Primary analysis of JUMP, a phase 3b, expanded‐access study evaluating the safety and efficacy of ruxolitinib in patients with myelofibrosis, including those with low platelet counts |
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