Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies

Annals of the Rheumatic Diseases

Volumn 77, Issue 7, 2018, Pages 988-995

  Taylor, Peter C ^a   Kremer, Joel M ^b   Emery, Paul ^c   Zuckerman, Steven H ^d   Ruotolo, Giacomo ^d   Zhong, Jinglin ^e   Chen, Lei ^d   Witt, Sarah ^d   Saifan, Chadi ^d   Kurzawa, Monika ^d   Otvos, James ^f   Connelly, Margery A ^f   Macias, William L ^d   Schlichting, Douglas E ^d   Rooney, Terence ^d   De Bono, Stephanie ^d   McInnes, Iain B ^g  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b ALBANY MEDICAL COLLEGE   (United States)

^c UNIVERSITY OF LEEDS   (United Kingdom)

^d ELI LILLY AND COMPANY   (United States)

^e IQVIA   (United States)

^f LABORATORY CORPORATION OF AMERICA   (United States)

^g UNIVERSITY OF GLASGOW   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

APOLIPOPROTEIN A1; APOLIPOPROTEIN B; BARICITINIB; CHOLESTEROL; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; HYDROXYMETHYLGLUTARYL COENZYME A REDUCTASE INHIBITOR; LIPID; LIPOPROTEIN; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PLACEBO; TRIACYLGLYCEROL; ANTIRHEUMATIC AGENT; AZETIDINE DERIVATIVE; SULFONAMIDE;

ADULT; AGED; ARTICLE; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; CHOLESTEROL BLOOD LEVEL; COHORT ANALYSIS; CONTROLLED STUDY; DRUG EFFECT; FEMALE; HUMAN; LIPID BLOOD LEVEL; LIPOPROTEIN BLOOD LEVEL; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; PARTICLE SIZE; PRIORITY JOURNAL; RHEUMATOID ARTHRITIS; SIDE EFFECT; TREATMENT DURATION; TRIACYLGLYCEROL BLOOD LEVEL; BLOOD; DOSE RESPONSE; DRUG ADMINISTRATION; LIPID METABOLISM; ORAL DRUG ADMINISTRATION; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); REFERENCE VALUE; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; ADULT; AGED; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; AZETIDINES; CHOLESTEROL, HDL; CHOLESTEROL, LDL; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS; LIPID METABOLISM; MALE; MIDDLE AGED; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REFERENCE VALUES; SEVERITY OF ILLNESS INDEX; SULFONAMIDES; TREATMENT OUTCOME;

EID: 85047873374     PISSN: 00034967     EISSN: 14682060     Source Type: Journal    
DOI: 10.1136/annrheumdis-2017-212461     Document Type: Article

References (38)

1. Fridman JS, Scherle pA, Collins r, et al. Selective inhibition of JAK1 and JAK2 is efficacious in rodent models of arthritis: preclinical characterization of InCB028050. J Immunol 2010;184:5298–307.
2. Fleischmann r, Schiff M, van der Heijde d, et al. Baricitinib, Methotrexate, or Combination in patients With rheumatoid Arthritis and no or Limited prior disease-Modifying Antirheumatic drug treatment. Arthritis Rheumatol 2017;69:506–17.
3. taylor pC, Keystone EC, van der Heijde d, et al. Baricitinib versus placebo or adalimumab in rheumatoid arthritis. N Engl J Med 2017;376:652–62.
4. dougados M, van der Heijde d, Chen YC, et al. Baricitinib in patients with inadequate response or intolerance to conventional synthetic dMArds: results from the rA-BUILd study. Ann Rheum Dis 2017;76:88–95.
5. Genovese MC, Kremer J, Zamani o, et al. Baricitinib in patients with refractory rheumatoid Arthritis. N Engl J Med 2016;374:1243–52.
6. robertson J, peters MJ, McInnes IB, et al. Changes in lipid levels with inflammation and therapy in rA: a maturing paradigm. Nat Rev Rheumatol 2013;9:513–23.
7. o’neill F, Charakida M, topham E, et al. Anti-inflammatory treatment improves high-density lipoprotein function in rheumatoid arthritis. Heart 2017;103:766–73.
8. tam LS, tomlinson B, Chu tt, et al. Impact of tnF inhibition on insulin resistance and lipids levels in patients with rheumatoid arthritis. Clin Rheumatol 2007;26:1495–8.
9. navarro-Millán I, Charles-Schoeman C, Yang S, et al. Changes in lipoproteins associated with methotrexate or combination therapy in early rheumatoid arthritis: results from the treatment of early rheumatoid arthritis trial. Arthritis Rheum 2013;65:1430–8.
10. Genovese MC, McKay Jd, nasonov EL, et al. Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modifying antirheumatic drug therapy study. Arthritis Rheum 2008;58:2968–80.
11. Charles-Schoeman C, Fleischmann r, davignon J, et al. potential mechanisms leading to the abnormal lipid profile in patients with rheumatoid arthritis versus healthy volunteers and reversal by tofacitinib. Arthritis Rheumatol 2015;67:616–25.
12. Kremer JM, Genovese MC, Keystone E, et al. Effects of Baricitinib on Lipid, Apolipoprotein, and Lipoprotein particle profiles in a phase IIb Study of patients With Active rheumatoid Arthritis. Arthritis Rheumatol 2017;69:943–52.
13. rizzo M, Berneis K. Low-density lipoprotein size and cardiovascular risk assessment. QJM 2006;99:1–14.
14. otvos Jd, Shalaurova I, Wolak-dinsmore J, et al. GlycA: a composite nuclear magnetic resonance biomarker of systemic inflammation. Clin Chem 2015;61:714–23.
15. ormseth MJ, Chung Cp, oeser AM, et al. Utility of a novel inflammatory marker, GlycA, for assessment of rheumatoid arthritis disease activity and coronary atherosclerosis. Arthritis Res Ther 2015;17:117.
16. Bartlett dB, Connelly MA, AbouAssi H, et al. A novel inflammatory biomarker, GlycA, associates with disease activity in rheumatoid arthritis and cardio-metabolic risk in BMI-matched controls. Arthritis Res Ther 2016;18:86.
17. Connelly MA, Gruppen EG, otvos Jd, et al. Inflammatory glycoproteins in cardiometabolic disorders, autoimmune diseases and cancer. Clin Chim Acta 2016;459:177–86.
18. AbouAssi H, Connelly MA, Bateman LA, et al. does a lack of physical activity explain the rheumatoid arthritis lipid profile? Lipids Health Dis 2017;16:39.
19. Joshi AA, Lerman JB, Aberra tM, et al. GlycA is a novel biomarker of inflammation and subclinical cardiovascular disease in psoriasis. Circ Res 2016;119:1242–53.
20. Greenwald MW, Fidelus-Gort r, Levy r, et al. A randomized dose-ranging, placebo-controlled study of InCB028050, a selective JAK1 and JAK2 inhibitor in subjects with active rheumatoid arthritis. Arthritis Rheum 2010;62(Suppl 10):2172.
21. Keystone EC, taylor pC, drescher E, et al. Safety and efficacy of baricitinib at 24 weeks in patients with rheumatoid arthritis who have had an inadequate response to methotrexate. Ann Rheum Dis 2015;74:333–40.
22. tanaka Y, Emoto K, Cai Z, et al. Efficacy and Safety of Baricitinib in Japanese patients with Active rheumatoid Arthritis receiving Background Methotrexate therapy: A 12-week, double-blind, randomized placebo-controlled Study. J Rheumatol 2016;43:504–11.
23. Smolen J, Genovese M, takeuchi t, et al. tHU0166 Safety profile of Baricitinib in patients with Active rA: An Integrated Analysis: table 1. Ann Rheum Dis 2016;75(Suppl 2):243.2–4.
24. Jacobson tA, Ito MK, Maki KC, et al. national Lipid Association recommendations for patient-centered management of dyslipidemia: part 1 - executive summary. J Clin Lipidol 2014;8:473–88.
25. Jeyarajah EJ, Cromwell WC, otvos Jd. Lipoprotein particle analysis by nuclear magnetic resonance spectroscopy. Clin Lab Med 2006;26:847–70.
26. Wilson pW, d’Agostino rB, Levy d, et al. prediction of coronary heart disease using risk factor categories. Circulation 1998;97:1837–47.
27. ridker pM, Buring JE, rifai n, et al. development and validation of improved algorithms for the assessment of global cardiovascular risk in women: the reynolds risk Score. JAMA 2007;297:611–9.
28. ridker pM, paynter np, rifai n, et al. C-reactive protein and parental history improve global cardiovascular risk prediction: the reynolds risk Score for men. Circulation 2008;118:2243–51.
29. Marks JL, Edwards CJ. protective effect of methotrexate in patients with rheumatoid arthritis and cardiovascular comorbidity. Ther Adv Musculoskelet Dis 2012;4:149–57.
30. Greenberg Jd, Kremer JM, Curtis Jr, et al. CorronA Investigators. tumour necrosis factor antagonist use and associated risk reduction of cardiovascular events among patients with rheumatoid arthritis. Ann Rheum Dis 2011;70:576–82.
31. Myasoedova E, Crowson CS, Kremers HM, et al. Lipid paradox in rheumatoid arthritis: the impact of serum lipid measures and systemic inflammation on the risk of cardiovascular disease. Ann Rheum Dis 2011;70:482–7.
32. Choy E, Ganeshalingam K, Semb AG, et al. Cardiovascular risk in rheumatoid arthritis: recent advances in the understanding of the pivotal role of inflammation, risk predictors and the impact of treatment. Rheumatology 2014;53:2143–54.
33. Giles Jt, Sattar n, Gabriel SE, et al. Cardiovascular risk in rheumatoid arthritis: recent advances in the understanding of the pivotal role of inflammation, risk predictors and the impact of treatment. Arthritis Rheumatol 2016;68(Suppl 10):4357–9.
34. McInnes IB, Kim HY, Lee SH, et al. open-label tofacitinib and double-blind atorvastatin in rheumatoid arthritis patients: a randomised study. Ann Rheum Dis 2014;73:124–31.
35. Kitas Gd, Gabriel SE. Cardiovascular disease in rheumatoid arthritis: state of the art and future perspectives. Ann Rheum Dis 2011;70:8–14.
36. Annema W, tietge UJ. role of hepatic lipase and endothelial lipase in high-density lipoprotein-mediated reverse cholesterol transport. Curr Atheroscler Rep 2011;13:257–65.
37. McInnes IB, thompson L, Giles Jt, et al. Effect of interleukin-6 receptor blockade on surrogates of vascular risk in rheumatoid arthritis: MEASUrE, a randomised, placebo-controlled study. Ann Rheum Dis 2015;74:694–702.
38. Yue x, Wu M, Jiang H, et al. Endothelial lipase is upregulated by interleukin-6 partly via the p38 MApK and p65 nF-κB signaling pathways. Mol Med Rep 2016;14:1979–85.