The Use of JAK Inhibitors in RA: Overall Efficacy
As noted earlier, tofacitinib is currently the only JAK inhibitor FDA approved for use in the United States. Although baricitinib is approved for use in Europe and Japan, its manufacturer received a complete response letter from the FDA in April 2017 asking for additional clinical data to determine the most appropriate doses of the drug. The FDA also stated that additional data are necessary to further characterize safety concerns across treatment arms in clinical trials. In August 2017, baricitinib’s manufacturer announced that it would be resubmitting the drug for FDA approval by the end of January 2018.
Tofacitinib, approved by the FDA in 2012 for the treatment of RA, primarily inhibits JAK1 and JAK3 although, like the majority of other JAK inhibitors, it also has lesser activity against other JAKs, most notably JAK2. Baricitinib is primarily a JAK1/JAK2 inhibitor.
In this section, we’ll take a closer look at these two JAK inhibitors, which have been studied thoroughly in late-stage trials, review their efficacy and safety data, and explore the guidance provided by expert committees regarding their use.
Method of Participation
Participants should read the CME/CE information, review the activity in its entirety, and complete the online post-test and evaluation. Upon completing this activity as designed and achieving a passing score on the post-test, you will be directed to a Web page that will allow you to receive your certificate of credit via e-mail or you may print it out at that time.
After completing this activity, participants should be better able to:
- Design optimal treatment strategies for patients with rheumatoid arthritis (RA) to improve remission rates and/or minimize levels of disease
- Recognize the role that Janus kinase (JAK) plays in the pathogenesis of RA and the corresponding impact of JAK inhibition in the management of RA
- Discuss treatment options for RA, including the use of JAK inhibitors, as reflected in current practice guideline
Roy Fleischmann, MD, MACR
Iain B. McInnes, FRCP, PhD, FRSE, FMedSci
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This educational activity for 1.0 contact hour is provided by Global Education Group. Nurses should claim only the credit commensurate with the extent of their participation in the activity.
Current guidelines for the management of rheumatoid arthritis (RA) address the concern that many patients fail to respond, or lose response, to first-line therapy with disease-modifying antirheumatic drugs (DMARDs). Lack of understanding about the optimal use of avail- able RA therapies—including combination therapy or switching to other drugs within a class or in a different class—means that many patients may fail to achieve remission (the ideal goal) or minimal levels of disease activity. Clinicians who are unaware of current practice guidelines may not be providing optimal management for their patients with RA. In addition, clinicians should be aware of data concerning the safety and efficacy of newly available drugs so as to ensure selection of optimal therapies for patients with RA. Knowledge of agents that have novel mechanisms of action, including Janus kinase inhibitors, can improve clinicians’ confidence when switching therapies in patients who have suboptimal response despite appropriate use of DMARD therapies.
Joint Providership Statement
This activity is jointly provided by Global Education Group and Global Academy for Medical Education.
Term of Offering
This activity was released on October 1, 2017, and is valid for 1 year. Requests for credit must be made no later than October 31, 2018.
Global Education Group Contact Information
For information about the accreditation of this activity, please contact Global Education Group at 303-395-1782 or [email protected] group.com.
Instructions for Obtaining Credit
In order to receive credit, participants must complete the online evalua- tion and post-test at the end of this activity. Participants must also score at least a 65% on the post-test. Statements of credit will be issued upon completion of the evaluation and post-test.
Fee Information and Refund/Cancellation Policy
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Disclosure of Conflicts of Interest
Global Education Group requires instructors, planners, managers, and other individuals and their spouse/life partner who are in a position to control the content of this activity to disclose any real or apparent conflict of interest they may have as related to the content of this activity. All identified conflicts of interest are thoroughly vetted by Global Education Group for fair balance, scientific objectivity of studies mentioned in the materials or used as the basis for content, and appro- priateness of patient care recommendations.
The faculty reported the following financial relationships or relation- ships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME/CE activity:
Name of Faculty or Presenter: Roy Fleischmann, MD, MACR
Reported Financial Relationship: Consultant: AbbVie, Lilly, Pfizer. Grant/Research Support: AbbVie, Lilly, Pfizer.
Name of Faculty or Presenter: Iain B. McInnes, FRCP, PhD, FRSE, FMedSci
Reported Financial Relationship: Consultant: AbbVie; Galapagos Pharma; Lilly; Pfizer. Grant/Research Support: Bristol-Myers Squibb; Janssen; Pfizer; UCB.
The planners and managers reported the following financial relation- ships or relationships to products or devices they or their spouse/life partner have with commercial interests related to the content of this CME/CE activity: Ashley Marostica, RN, MSN; Laura Gilsdorf; Ron Schaumburg; Mike LoPresti; Shirley Jones, MBA; and Scott Kober all have nothing to disclose.
Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the US Food and Drug Administration. Global Education Group and Global Academy of Medical Education do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of any organiza- tion associated with this activity. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medi- cations, or other courses of diagnosis or treatment discussed in this activity should not be used by clinicians without evaluation of patient conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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This continuing education supplement was developed from interviews with the faculty. It is the second activity in the two-part curriculum, From Science to Practice: Understanding the Role of Janus Kinase in RA Pathogenesis to Appropriately Incorporate JAK Inhibition in RA Management. The supplement content was derived from the key teaching points from the previous online activity, which may be found at: www.globalacademycme.com/specialties/rheumatology.
The faculty acknowledge the editorial assistance of Global Academy for Medical Education, LLC, and Scott Kober, medical writer, in the development of this supplement.
Neither the editors of Rheumatology News nor the Editorial Advisory Board nor the reporting staff contributed to its content. The ideas and opinions expressed are those of the faculty and do not necessarily reflect the views of the supporters, Global Academy for Medical Education, Global Education Group, or the Publisher.
Copyright © 2017 by Global Academy for Medical Education, LLC, Frontline Medical Communications Inc., and its Licensors. All rights reserved. No part of this publication may be reproduced or transmitted in any form, by any means, without prior written permission of the Publisher. Global Academy for Medical Education, LLC, Frontline Medical Communications, and Global Education Group will not assume responsibility for damages, loss, or claims of any kind arising from or related to the information contained in this publication, including any claims related to the products, drugs, or services mentioned herein.