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Baricitinib: The Second FDA-Approved JAK Inhibitor for the Treatment of Rheumatoid Arthritis.
Ann Pharmacother. 2019 09; 53(9):947-953.AP

Abstract

Objective:

To review the pharmacology, pharmacokinetics, safety, and efficacy of baricitinib, a recently approved selective Janus Kinase (JAK) inhibitor for the treatment of rheumatoid arthritis (RA), and explore its potential role in therapy. Data Sources: Articles were identified using a PubMed search from inception through January 2019 using the terms rheumatoid arthritis, Olumiant, baricitinib, and LY3009104, its molecular name. Study Selection and Data Extraction: Articles relating to randomized clinical trials, pharmacology, pharmacokinetics, efficacy, and safety of baricitinib were evaluated. Data Synthesis: Baricitinib exerts its effects by inhibiting JAK1 and JAK2 enzymes, targeting cytokine and growth factor receptor stimulation, thus reducing downstream immune cell function. Four trials have demonstrated the efficacy of baricitinib with or without methotrexate in patients naïve to disease-modifying antirheumatic drugs (DMARDs) and those who had an inadequate response to or intolerance to both conventional and biological DMARDs. Furthermore, baricitinib was associated with delayed radiographic progression. Despite baricitinib 4 mg often demonstrating greater efficacy compared with the 2 mg dose, only the 2 mg dose is Food and Drug Administration approved because of safety concerns with the 4 mg dose, primarily thromboembolism. Relevance to Patient Care and Clinical Practice: Baricitinib provides an oral treatment option for patients failing tumor necrosis factor inhibitors (TNFis). Safety, cost, and comparative effectiveness to tofacitinib should be considered prior to prescribing baricitinib.

Conclusion:

Baricitinib is the second medication in its class and has been proven efficacious for the treatment of RA. Given concerns for adverse effects associated with baricitinib, it should be reserved for patients who have failed one or more TNFis.

Authors+Show Affiliations

1 Binghamton University School of Pharmacy and Pharmaceutical Sciences, Binghamton, NY, USA.2 Rhode Island Hospital, Providence, RI, USA.2 Rhode Island Hospital, Providence, RI, USA.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

30907116

Citation

Mogul, Amanda, et al. "Baricitinib: the Second FDA-Approved JAK Inhibitor for the Treatment of Rheumatoid Arthritis." The Annals of Pharmacotherapy, vol. 53, no. 9, 2019, pp. 947-953.
Mogul A, Corsi K, McAuliffe L. Baricitinib: The Second FDA-Approved JAK Inhibitor for the Treatment of Rheumatoid Arthritis. Ann Pharmacother. 2019;53(9):947-953.
Mogul, A., Corsi, K., & McAuliffe, L. (2019). Baricitinib: The Second FDA-Approved JAK Inhibitor for the Treatment of Rheumatoid Arthritis. The Annals of Pharmacotherapy, 53(9), 947-953. https://doi.org/10.1177/1060028019839650
Mogul A, Corsi K, McAuliffe L. Baricitinib: the Second FDA-Approved JAK Inhibitor for the Treatment of Rheumatoid Arthritis. Ann Pharmacother. 2019;53(9):947-953. PubMed PMID: 30907116.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Baricitinib: The Second FDA-Approved JAK Inhibitor for the Treatment of Rheumatoid Arthritis. AU - Mogul,Amanda, AU - Corsi,Katherine, AU - McAuliffe,Laura, Y1 - 2019/03/24/ PY - 2019/3/26/pubmed PY - 2020/4/15/medline PY - 2019/3/26/entrez KW - bone/joint disorders KW - drug development and approval KW - literature evaluation KW - rheumatoid arthritis KW - rheumatology SP - 947 EP - 953 JF - The Annals of pharmacotherapy JO - Ann Pharmacother VL - 53 IS - 9 N2 - Objective: To review the pharmacology, pharmacokinetics, safety, and efficacy of baricitinib, a recently approved selective Janus Kinase (JAK) inhibitor for the treatment of rheumatoid arthritis (RA), and explore its potential role in therapy. Data Sources: Articles were identified using a PubMed search from inception through January 2019 using the terms rheumatoid arthritis, Olumiant, baricitinib, and LY3009104, its molecular name. Study Selection and Data Extraction: Articles relating to randomized clinical trials, pharmacology, pharmacokinetics, efficacy, and safety of baricitinib were evaluated. Data Synthesis: Baricitinib exerts its effects by inhibiting JAK1 and JAK2 enzymes, targeting cytokine and growth factor receptor stimulation, thus reducing downstream immune cell function. Four trials have demonstrated the efficacy of baricitinib with or without methotrexate in patients naïve to disease-modifying antirheumatic drugs (DMARDs) and those who had an inadequate response to or intolerance to both conventional and biological DMARDs. Furthermore, baricitinib was associated with delayed radiographic progression. Despite baricitinib 4 mg often demonstrating greater efficacy compared with the 2 mg dose, only the 2 mg dose is Food and Drug Administration approved because of safety concerns with the 4 mg dose, primarily thromboembolism. Relevance to Patient Care and Clinical Practice: Baricitinib provides an oral treatment option for patients failing tumor necrosis factor inhibitors (TNFis). Safety, cost, and comparative effectiveness to tofacitinib should be considered prior to prescribing baricitinib. Conclusion: Baricitinib is the second medication in its class and has been proven efficacious for the treatment of RA. Given concerns for adverse effects associated with baricitinib, it should be reserved for patients who have failed one or more TNFis. SN - 1542-6270 UR - https://www.unboundmedicine.com/medline/citation/30907116/Baricitinib:_The_Second_FDA_Approved_JAK_Inhibitor_for_the_Treatment_of_Rheumatoid_Arthritis_ L2 - https://journals.sagepub.com/doi/10.1177/1060028019839650?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -