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Translating ORAL Surveillance: Navigating Safety Data to Shape the Future of HS Care
While JAK inhibitor (JAKi) therapies continue to transform the dermatologic landscape, fully realizing their clinical potential requires a nuanced understanding of the long-term safety data initially established by the ORAL Surveillance trial. For patients with hidradenitis suppurativa (HS), the emerging JAKi pipeline offer a powerful opportunity to overcome long-standing treatment limitations and elevate patient expectations. By providing unique mechanism-driven targeting of multiple inflammatory cytokine pathways, rapid efficacy, a more favorable administration route, and versatility for both mild and severe disease, these small-molecule therapies allow clinicians to target the disease more effectively. To fully unlock this therapeutic potential, health care professionals (HCPs) must be equipped to confidently navigate the unique baseline risk profile of the HS population in conjunction with risks identified by ORAL Surveillance and responsibly contextualize class-wide safety data. This educational initiative is designed to aid HCPs in translating emerging evidence into clinical competence and ultimately facilitate strategic integration of innovative therapies to optimize patient outcomes.
Target Audience
This activity is designed for an audience of physicians, nurses, and other advanced practice providers (nurse practitioners/physician assistants) in medical practices that specialize in dermatology.
Learning Objectives
Upon completion of the educational activity, participants should be better able to:
- Identify the specific patient risk factors and safety signals highlighted in the ORAL Surveillance trial that inform the strategic management of inflammatory dermatoses, including hidradenitis suppurativa, with JAKi therapies.
- Apply longitudinal safety and efficacy data alongside real-world evidence to develop tailored treatment plans for patients with hidradenitis suppurativa being considered for emerging JAKi therapies.
Course summary
- 0.50 AAPA Category I CME
- 0.50 AMA PRA Category 1 Credit™
- 0.50 ANCC
- 0.50 Participation
Translating Oral Surveillance Data into Dermatology Practice
Mechanistic rationale for multi-cytokine suppression with JAKi therapy
Key takeaways from ORAL Surveillance and boxed warnings
Extrapolating safety data and selectivity profiles
Baseline AE risks in patients with HS
Assessing the Clinical Evidence and Emerging Pipeline
Navigating the emerging JAKi pipeline in HS: clinical trial efficacy and safety data
Povorcitinib
Upadacitinib
Brepocitinib
 |  |
Jennifer L. Hsiao, MD | Christopher Bunick, MD, PhD Associate Professor of Dermatology Yale University New Haven, CT |
Credit provided by AKH Inc., Advancing Knowledge in Healthcare
In support of improving patient care, this activity has been planned and implemented by AKH Inc., Advancing Knowledge in Healthcare and Tarsus Cardio dba LiVDerm. AKH Inc., Advancing Knowledge in Healthcare is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
This activity was planned by and for the healthcare team, and learners will receive 0.5 Interprofessional Continuing Education (IPCE) credit for learning and change.
Physician
AKH Inc., Advancing Knowledge in Healthcare designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Nurses
0.5 ANCC contact hours.
Physician Assistant
AKH Inc., Advancing Knowledge in Healthcare has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 0.5 AAPA Category 1 CME credits. Approval is valid until April 1, 2027. PAs should only claim credit commensurate with the extent of their participation.
Commercial Support
This activity is supported by an educational grant from Incyte Corporation.
Disclosure
It is the policy of AKH Inc. to ensure independence, balance, objectivity, scientific rigor, and integrity in all of its continuing education activities. The author must disclose to the participants any significant relationships with ineligible companies whose products or devices may be mentioned in the activity or with the commercial supporter of this continuing education activity. Identified conflicts of interest are mitigated by AKH prior to accreditation of the activity. AKH planners and reviewers have no relevant financial relationships to disclose.
DISCLOSURES | ||
Name | Relationship | Commercial Interest |
Christopher G. Bunick, MD, PhD | Advisor | AbbVie, Almirall, Alumis, Amgen, Apogee, Arcutis, Botanix, Castle Biosciences, Connect BioPharma, Daiichi Sankyo, Dermavant, Disc Medicine, Eli Lilly, Galderma, Incyte, LEO Pharma, Novartis, Ortho Dermatologics, Palvella, Pfizer, Regeneron, Sanofi, South Beach Symposium, Sun Pharma, Takeda, Timber, Teladoc, Triveni, UCB, and Veradermics |
Consultant | AbbVie, Almirall, Alumis, Amgen, Apogee, Arcutis, Botanix, Castle Biosciences, Connect BioPharma, Daiichi Sankyo, Dermavant, Disc Medicine, Eli Lilly, Galderma, Incyte, LEO Pharma, Novartis, Ortho Dermatologics, Palvella, Pfizer, Regeneron, Sanofi, South Beach Symposium, Sun Pharma, Takeda, Timber, Teladoc, Triveni, UCB, and Veradermics | |
Researcher | AbbVie, Almirall, Sun Pharma | |
Jennifer L. Hsiao, MD
| Consultant/Advisory board | AbbVie, Aclaris, Boehringer Ingelheim, Galderma, Incyte, Insmed, Moonlake, Leo Pharma, Navigator Medicines, Novartis, Oruka Therapeutics, Pfizer, Sanofi, Regeneron, UCB |
Investigator | Amgen, AstraZeneca, Incyte, Novartis | |
Speaker | AbbVie, Galderma, Novartis, Sanofi, Regeneron, UCB | |
Dorothy Caputo, MA, BSN, RN, President, AKH Planner | N/A | Nothing to disclose |
Rebecca Lakofsky, BSN, RN, AKH Reviewer | N/A | Nothing to disclose |
AKH Inc Staff and Planners | N/A | Nothing to disclose |
MCI OPCO, LLC dba LiVDerm Staff and Planners | N/A | Nothing to disclose |
All of the relevant financial relationships listed for these individuals have been mitigated. | ||
Disclosure of Unlabeled Use and Investigational Product
This educational activity may include discussion of uses of agents that are investigational and/or unapproved by the FDA. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Disclaimer
This course is designed solely to provide the healthcare professional with information to assist in his/her practice and professional development and is not to be considered a diagnostic tool to replace professional advice or treatment. The course serves as a general guide to the healthcare professional, and therefore, cannot be considered as giving legal, nursing, medical, or other professional advice in specific cases. AKH Inc. specifically disclaims responsibility for any adverse consequences resulting directly or indirectly from information in the course, for undetected error, or through participant's misunderstanding of the content.
If you would like to opt out from future communications from AKH please send an email to [email protected] with your information with "Opt Out" in the subject line.
AKH Privacy Policy (link: https://akhcme.com/akhcme/pages/privacy )
Available Credit
- 0.50 AAPA Category I CME
- 0.50 AMA PRA Category 1 Credit™
- 0.50 ANCC
- 0.50 Participation
Required Hardware/software
A computer with an internet connection
Other additional software may be required such as PowerPoint or Adobe Acrobat Reader
PC Microsoft Internet Explorer 11 or later, Windows Edge browser, Mozilla Firefox, and Google Chrome For HTML Client – Google Chrome (v70.0 & above), Mozilla Firefox (v65.0 & above), and Edge (v42.0 & above)
| MAC Mozilla Firefox, Apple Safari, Google Chrome For HTML Client – Google Chrome (v70.0 & above), Apple Safari (v12.0 & above), and Mozilla Firefox (v65.0 & above)
|
Criteria for Success
In order to receive CME/CE credits, participants must complete the pre-assessment questions, post-assessment, and program evaluation. Participants must also score at least 70% on the post-assessment. Certificates will be distributed online at the conclusion of the activity. Your online certificate will be saved within your Dashboard or Transcript, which you can access at any time.