Preview

Modern Rheumatology Journal

Advanced search

Practice guidelines for monitoring the safety of tofacitinib (according to the proceedings of the Expert Council resolution dated 14 October 2014, Moscow)

https://doi.org/10.14412/1996-7012-2015-3-73-79

Abstract

The Meeting of the Expert Council considered in detail the key aspects associated with the possible development of adverse reactions during therapy with tofacitinib (TOFA). Active discussion gave rise to a resolution that summarized the main facts concerning the safety of TOFA and gave practical recommendations for the screening and monitoring of infections, cardiovascular diseases and other key areas requiring that exclusive control should be exercised during this therapy. TOFA is the first drug from a new group of immunomodifying and anti-inflammatory drugs, intracellular kinase inhibitors. As of now, it is the only drug that belongs to a class of the so-called small molecules, which is approved for the treatment of rheumatoid arthritis in the Russian Federation and a number of other countries. TOFA is a low molecular weight drug for oral administration; however, its unique mechanism of action brings it close to that of biological agents. A broad spectrum of biological effects of TOFA and its potential effect on a number of important physiological processes demand for special attention to the safety of its therapy.

About the Author

Article Editorial

Russian Federation


References

1. Salgado E, Maneiro JR, Carmona L, Gomez-Reino JJ. Safety profile of protein kinase inhibitors in rheumatoid arthritis: systematic review and meta-analysis. Ann Rheum Dis. 2014 May;73(5):871–82. doi: 10.1136/annrheumdis-2012-203116

2. Инструкция по медицинскому применению препарата Яквинус®, ЛП 002026-21.04.2014 [Instruction for medical application of Jakvinus, LP 002026-21.04.2014. (In Russ.)].

3. Cohen S, Radominski SC, Gomez-Reino JJ, et al. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheum. 2014 Nov;66(11):2924–37. doi: 10.1002/art.38779.

4. Avina-Zubieta JA, Thomas J, Sadatsafavi M, et al. Risk of incident cardiovascular events in patients with rheumatoid arthritis: a meta-analysis of observational studies. Ann Rheum Dis. 2012 Sep;71(9):1524–9. doi: 10.1136/annrheumdis-2011-200726

5. Van Halm VP, Peters MJ, Voskuyl AE, et al. Rheumatoid arthritis versus diabetes as a risk factor for cardiovascular disease: a crosssectional study, the CARRE Investigation. Ann Rheum Dis. 2009 Sep;68(9):1395–400. doi: 10.1136/ard.2008.094151

6. 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 Mar;70(3):482–7. doi: 10.1136/ard.2010.135871.

7. Charles-Schoeman C, Wicker Р, Sechtem U, et al. THU0136 Cardiovascular safety findings in rheumatoid arthritis patients treated with tofacitinib (CP-690,550), a novel, oral jak inhibitor. Abstract. Ann Rheum Dis 2013;71:201 doi:10.1136/annrheumdis-2012-eular.2101

8. FDA Arthritis Advisory Committee Meeting. May 9, 2012: Introductory Remarks NDA 203214: Tofacitinib for Rheumatoid Arthritis (RA).

9. 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. 2013 Mar 12.

10. Khovidhunkit W, Kim MS, Memon RA, et al. Effects of infection and inflammation on lipid and lipoprotein metabolism: mechanisms and consequences to the host. J Lipid Res. 2004 Jul;45(7):1169–96. Epub 2004 Apr 21.

11. Woods A, Brull DJ, Humphries SE, Montgomery HE. Genetics of inflammation and risk of coronary artery disease: the central role of interleukin-6. Eur Heart J. 2000 Oct;21(19):1574–83.

12. Charles-Schoeman C, Wicker P, Gonzalez-Gay MA, et al. Cardiovascular safety findings In rheumatoid arthritis patients treated with tofacitinib, a novel, oral janus kinase inhibitor. Arthritis Rheum 2013;65 Suppl 10:440. DOI: 10.1002/art.2013.65.issue-s10

13. Kume K, Amano K, Yamada S, et al. Tocilizumab monotherapy reduces arterial stiffness as effectively as etanercept or adalimumab monotherapy in rheumatoid arthritis: an open-label randomized controlled trial. J Rheumatol. 2011;38:2169–71.

14. Cohen S, Tanaka Y, Mariette X, et al. OP0154 integrated safety analysis of tofacitinib in RA clinical trials with a cumulative exposure of 12.664 patient-years. EULAR 2014: scientific abstracts. Ann Rheum Dis 2014;73:119–120 doi:10.1136/annrheumdis-2014-eular.5656

15. Lee EB, Curtis JR, Riese R, et al. EULAR 2014: Scientific Abstracts. Tofacitinib (CP-690,550), an oral Janus kinase inhibitor: analysis of gastrointestinal adverse events across the rheumatoid arthritis clinical programme. Ann Rheum Dis 2012;71 (Suppl 3):202.

16. Curtis JR, Lee EB, Kaplan IV, et al. Tofacitinib, an oral Janus kinase inhibitor: analysis of malignancies across the rheumatoid arthritis clinical development programme. Ann Rheum Dis. 2015 Apr 22. pii: annrheumdis-2014-205847. doi: 10.1136/annrheumdis-2014-205847. [Epub ahead of print].

17. Geier J, Saunder K, Reed G. EULAR 2014: Scientific Abstracts. AB1057 Contextualisation of Safety Endpoints in the Tofacitinib Rheumatoid Arthritis (RA) Development Programme: Collaboration with the Consortium of Rheumatology Researchers of North America (CORRONA) Registry. Ann Rheum Dis 2014;73:1149–1150 doi:10.1136/annrheumdis-2014-eular.2474

18. Cohen S, Zwillich SH, Chow V, et al. Co-administration of the JAK inhibitor CP-690,550 and methotrexate is well tolerated in patients with rheumatoid arthritis without need for dose adjustment. Br J Clin Pharmacol. 2010 Feb;69(2):143–51. doi: 10.1111/j.1365-2125.2009.03570.x


Review

For citations:


Practice guidelines for monitoring the safety of tofacitinib (according to the proceedings of the Expert Council resolution dated 14 October 2014, Moscow). Sovremennaya Revmatologiya=Modern Rheumatology Journal. 2015;9(3):73-79. (In Russ.) https://doi.org/10.14412/1996-7012-2015-3-73-79

Views: 1129


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 1996-7012 (Print)
ISSN 2310-158X (Online)