Show simple item record

dc.contributor.authorKay, Jonathan
dc.contributor.authorHarigai, Masayoshi
dc.contributor.authorRancourt, Josh
dc.contributor.authorDickson, Christina
dc.contributor.authorMelby, Thomas
dc.contributor.authorIssa, Maher
dc.contributor.authorde la Torre, Inmaculada
dc.contributor.authorIsaka, Yoshitaka
dc.contributor.authorCardoso, Anabela
dc.contributor.authorSaifan, Chadi
dc.contributor.authorKeystone, Edward C.
dc.contributor.authorvan Vollenhoven, Ronald F.
dc.contributor.authorGiles, Jon T.
dc.contributor.authorHuizinga, Tom Wj.
dc.contributor.authorKremer, Joel M.
dc.date2022-08-11T08:09:57.000
dc.date.accessioned2022-08-23T16:50:22Z
dc.date.available2022-08-23T16:50:22Z
dc.date.issued2020-10-06
dc.date.submitted2020-12-28
dc.identifier.citation<p>Kay J, Harigai M, Rancourt J, Dickson C, Melby T, Issa M, de la Torre I, Isaka Y, Cardoso A, Saifan C, Keystone EC, van Vollenhoven RF, Giles JT, Huizinga TW, Kremer JM. Changes in selected haematological parameters associated with JAK1/JAK2 inhibition observed in patients with rheumatoid arthritis treated with baricitinib. RMD Open. 2020 Oct;6(3):e001370. doi: 10.1136/rmdopen-2020-001370. PMID: 33028675; PMCID: PMC7722368. <a href="https://doi.org/10.1136/rmdopen-2020-001370">Link to article on publisher's site</a></p>
dc.identifier.issn2056-5933 (Linking)
dc.identifier.doi10.1136/rmdopen-2020-001370
dc.identifier.pmid33028675
dc.identifier.urihttp://hdl.handle.net/20.500.14038/41646
dc.description.abstractOBJECTIVE: To characterise changes in selected haematological parameters following once-daily oral baricitinib dosing. METHODS: Data were pooled from eight randomised clinical trials (four phase 3, three phase 2, one phase 1b) and one long-term extension. Changes in haematological parameters were evaluated up to 128 weeks (N=2387); overall safety of baricitinib was assessed up to 6 years (N=3492). RESULTS: Mean absolute neutrophil counts decreased (-1.36x10(9)/L) within 1 month, followed by stabilisation within the normal reference range through week 128. The incidence of serious infections was not elevated in patients with neutropenia during the 24-week placebo-controlled period. Mean lymphocyte counts increased (+0.30x10(9)/L) within 1 month, then decreased to baseline (weeks 12-24). Mean platelet counts increased at week 2 (+51x10(9)/L), then decreased towards baseline. Overall, mean haemoglobin concentrations decreased (-0.12 mmol/L), then returned to baseline; however, reduced baseline haemoglobin concentrations observed in the highest baseline high-sensitivity C reactive protein quartile increased over time. Permanent drug discontinuation occurred due to laboratory abnormalities related to neutrophil count in 8 (0.2%), lymphocyte counts in 6 (0.2%), platelet counts in 8 (0.2%), and haemoglobin levels in 16 (0.5%) of all baricitinib-treated patients (N=3492 with 7993 total person-years of exposure). CONCLUSIONS: Moderate decreases in neutrophils were seen during baricitinib treatment; however, serious infection was uncommon in patients with neutropenia. Transient increases were observed in lymphocytes and platelets, which returned to baseline over time. Changes in haemoglobin concentration were generally small. Haematological abnormalities seldom led to drug discontinuation.
dc.language.isoen_US
dc.relation<p><a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=33028675&dopt=Abstract">Link to Article in PubMed</a></p>
dc.rights© Author(s) (or their employer(s)) 2020. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
dc.rights.urihttp://creativecommons.org/licenses/by-nc/4.0/
dc.subjectAnti-Inflammatory Agents
dc.subjectAntirheumatic Agents
dc.subjectArthritis
dc.subjectAutoimmune Diseases
dc.subjectInflammation
dc.subjectNon-Steroidal
dc.subjectRheumatoid
dc.subjectHematology
dc.subjectHemic and Immune Systems
dc.subjectHemic and Lymphatic Diseases
dc.subjectImmune System Diseases
dc.subjectMusculoskeletal Diseases
dc.subjectRheumatology
dc.titleChanges in selected haematological parameters associated with JAK1/JAK2 inhibition observed in patients with rheumatoid arthritis treated with baricitinib
dc.typeJournal Article
dc.source.journaltitleRMD open
dc.source.volume6
dc.source.issue3
dc.identifier.legacyfulltexthttps://escholarship.umassmed.edu/cgi/viewcontent.cgi?article=5468&amp;context=oapubs&amp;unstamped=1
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/oapubs/4438
dc.identifier.contextkey20846317
refterms.dateFOA2022-08-23T16:50:22Z
html.description.abstract<p>OBJECTIVE: To characterise changes in selected haematological parameters following once-daily oral baricitinib dosing.</p> <p>METHODS: Data were pooled from eight randomised clinical trials (four phase 3, three phase 2, one phase 1b) and one long-term extension. Changes in haematological parameters were evaluated up to 128 weeks (N=2387); overall safety of baricitinib was assessed up to 6 years (N=3492).</p> <p>RESULTS: Mean absolute neutrophil counts decreased (-1.36x10(9)/L) within 1 month, followed by stabilisation within the normal reference range through week 128. The incidence of serious infections was not elevated in patients with neutropenia during the 24-week placebo-controlled period. Mean lymphocyte counts increased (+0.30x10(9)/L) within 1 month, then decreased to baseline (weeks 12-24). Mean platelet counts increased at week 2 (+51x10(9)/L), then decreased towards baseline. Overall, mean haemoglobin concentrations decreased (-0.12 mmol/L), then returned to baseline; however, reduced baseline haemoglobin concentrations observed in the highest baseline high-sensitivity C reactive protein quartile increased over time. Permanent drug discontinuation occurred due to laboratory abnormalities related to neutrophil count in 8 (0.2%), lymphocyte counts in 6 (0.2%), platelet counts in 8 (0.2%), and haemoglobin levels in 16 (0.5%) of all baricitinib-treated patients (N=3492 with 7993 total person-years of exposure).</p> <p>CONCLUSIONS: Moderate decreases in neutrophils were seen during baricitinib treatment; however, serious infection was uncommon in patients with neutropenia. Transient increases were observed in lymphocytes and platelets, which returned to baseline over time. Changes in haemoglobin concentration were generally small. Haematological abnormalities seldom led to drug discontinuation.</p>
dc.identifier.submissionpathoapubs/4438
dc.contributor.departmentDivision of Rheumatology, Department of Medicine
dc.source.pagese001370


Files in this item

Thumbnail
Name:
e001370.full.pdf
Size:
1.054Mb
Format:
PDF

This item appears in the following Collection(s)

Show simple item record

© Author(s) (or their employer(s)) 2020. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Except where otherwise noted, this item's license is described as © Author(s) (or their employer(s)) 2020. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.