Introduction
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Until relatively recently, onychomycosis generally was not recognized as an infection that warranted serious clinical consideration. This was due, in part, to the fact that prior to the introduction of oral terbinafine, effective therapy was not available. With the approval by the US Food and Drug Administration (FDA) of terbinafine in 1996 and the subsequent approval of the topical agent ciclopirox in 1999, interest in diagnosing and treating onychomycosis increased. However, although these new medications were effective in many cases, the achievement of a mycologic cure and cosmetic clearance of the infection were elusive goals for many other patients. Moreover, even after the introduction of these medications, patients typically sought attention for onychomycosis only when pain or other symptoms had progressed to the point at which the infection could no longer be ignored. Early cases of this fungal infection were not commonly identified by either patients or clinicians, and the importance of early treatment was not appreciated. Finally, recurrence was the rule rather than the exception.
Within the past decade, research regarding the pathogenesis of onychomycosis has led to a better understanding of the underlying infectious organisms, the introduction in 2014 of two new topical agents, and, as a result, a resurgence of interest in the diagnosis and treatment of both onychomycosis and a commonly related cutaneous infection, tinea pedis. In this supplement, the faculty provides an overview of the state of the art in onychomycosis diagnosis and treatment, with a particular focus on the efficacy and safety data from clinical studies of the newer and emerging medications and devices. Also, a discussion of the mechanisms of action of these modalities is presented, to help clinicians tailor therapy according to individual patient profiles. In addition, management strategies for challenging patient populations are offered, as well as some practical approaches for improving treatment results and reducing the risk for recurrence of infection.
The goal of this educational activity is to provide clinicians with up-to-date information on the diagnosis and treatment of onychomycosis that will support their efforts to work with patients to manage or, when possible, eradicate this infection.
Managing Onychomycosis: New and Emerging Treatments and Recurrence Prevention Strategies
This educational activity is designed for dermatologists, family practitioners, internists, nurse practitioners, physician assistants, and other clinicians who treat patients with onychomycosis.
Supported by educational grants from:
Valeant Pharmaceuticals North America LLC
Activity Information
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Original Release Date: June 2015
Latest Review Date: June 2015
Expiration Date: June 30, 2017
Estimated Time to Complete Activity: 2.5 hours
Method of Participation
Participants should read the activity 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 email or you may print it out at that time.The online post-test and evaluation can be accessed at http://tinyurl.com/onycho15.Inquiries may be directed to Global Academy for Medical Education [email protected] or (973) 290-8225.
Target Audience
This educational activity is designed for dermatologists, family practitioners, internists, nurse practitioners, physician assistants, and other clinicians who treat patients with onychomycosis.
Program Overview
With the introduction of more effective treatments—particularly the recently approved topical agents—clinicians in dermatology as well as other specialties and general primary care have a renewed interest in diagnosing and treating onychomycosis, an infection that is now recognized as clinically important but was once considered largely a cosmetic problem with minimal or no medical implications.
However, although efficacy with some treatments is good, the medications must be used consistently and correctly for several months before clinical evidence of improvement appears, and before patients perceive that treatment is working.
Treatment options currently approved in the United States for onychomycosis include topical and oral agents, as well as laser therapy. Oral agents must be chosen for their activity against the involved pathogens (dermatophytes, nondermatophytes, or yeast species, or combination infections). The currently approved systemic agents generally are safe for most patients, but concerns remain with respect to systemic side effects (for example, hepatotoxicity), particularly in pediatric patients, the elderly, and others with underlying medical conditions such as diabetes. The three agents currently approved for topical therapy are ciclopirox gel 0.77%, approved in 1999, and efinaconazole 10% topical solution and tavaborole topical solution, 5%, both approved in 2014. Other classes of topical antifungals are being evaluated both here and abroad. Clinicians must be able to effectively and safely use the currently approved agents, and must be prepared to evaluate the emerging data on medications now being investigated. Several laser devices are approved, and other types of lasers as well as other modalities (including photodynamic therapy) are being tested in clinical trials.
This supplement focuses on the efficacy and safety of onychomycosis treatments, particularly those recently approved, and provides an overview of emerging therapies. Mechanisms of action of drugs and devices also are presented to help clinicians tailor therapy according to individual patient clinical profiles. Management strategies for challenging patient populations are offered, and practical approaches to preventing recurrence are addressed— in particular, strategies for enhancing patient adherence to medication use and avoidance of sources of reinfection.
Learning Objectives
As a result of participating in this activity, participants should be better able to:
- Explain the benefits of early diagnosis and treatment of onychomycosis and the potential sequelae if this infection is untreated or is inadequately treated.
- Establish or improve practice protocols for identifying patients with onychomycosis, particularly in special populations (for example, the elderly, pediatric patients, immunocompromised patients, patients with psoriasis, and those with diabetes mellitus).
- Identify the mechanism of action for the currently available therapeutic options, including differences in formulation and associated efficacy, and use this knowledge to more effectively tailor treatment choices to individual patients.
- Incorporate or enhance monitoring for onychomycosis in patients in special, at-risk, or difficult-to-manage populations (for example, the elderly, pediatric patients, immunocompromised patients, patients with psoriasis, and those with diabetes mellitus).
- More effectively use currently available oral and topical medications to treat various patient populations.
- Discuss techniques, including obtaining good culture specimens, that permit more accurate diagnosis of the infecting organisms and the most appropriate choice of therapy.
- Review and, if necessary, improve patient education materials and teaching plans regarding the patient’s role in the treatment of onychomycosis and the prevention of recurrence to increase the chances of effective long-term management of this disease.
- Evaluate the results of clinical studies on new and emerging and available treatments for onychomycosis.
Accreditation Statements
Physicians
This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of The University of Louisville and Global Academy for Medical Education LLC.
The University of Louisville is accredited by the ACCME to provide continuing medical education for physicians. The University of Louisville Office of Continuing Medical Education & Professional Development designates this enduring material for a maximum of 2.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Nurses
This program has been approved by the Kentucky Board of Nursing for 3.0 contact hours through the University of Louisville Hospital, provider number 4-0068-7-16-820. The Kentucky Board of Nursing approval of an individual nursing education provider does not constitute endorsement of program content. Participants must complete the entire activity, provide license, and complete the evaluation to receive contact hours.
Disclosure Declarations
As a provider accredited by the ACCME, the Office of CME & PD, School of Medicine, University of Louisville must ensure balance, independence, objectivity, and scientific rigor in all its sponsored educational activities. All planners, faculty, reviewers, and other persons that affected the content of this CME activity were required to submit a financial disclosure form from which relevant conflicts of interest were determined.
Faculty Disclosures
David M. Pariser, MD, Consultant: Anacor Pharmaceuticals, Inc., DUSA Pharmaceuticals, Inc., LEO Pharma Inc., and Valeant Pharmaceuticals North America LLC.
Nathaniel J. Jellinek, MD, Advisory Board: Valeant Pharmaceuticals.
Phoebe Rich, MD, Grant/Research: Anacor, Meiji Seika Pharma Co., Ltd., Topica Pharmaceuticals, Inc., and Valeant Pharmaceuticals.
Melodie S. Young, MSN, RN, A/GNP-c, has no relevant financial relationships to disclose.
CME Reviewer: Cindy England Owen, MD, Assistant Professor, Division of Dermatology, University of Louisville School of Medicine, has no relevant financial relationships to disclose.
The CME & PD Staff and Advisory Board have nothing to disclose with the exception of Dr. Douglas Coldwell, Speaker: Sirtex, Inc. and Consultant: DFine, Inc.
Global Academy for Medical Education Staff: Sylvia H. Reitman, MBA, DipEd; Shirley V. Jones, MBA; and Joanne Still, BA have no relevant financial relationships to disclose
Off Label/Investigational-Use Disclosure
This CME/CE activity discusses the off-label use of fluconazole for the treatment of onychomycosis and unapproved dosing schedules for itraconazole and terbinafine. Also discussed is the use in pediatric patients of medications approved for the treatment of onychomycosis in adults; currently, no medication is approved for the treatment of onychomycosis in pediatric patients
This continuing education supplement was developed from interviews with the faculty. The Guest Editors acknowledge the editorial assistance of Global Academy for Medical Education and Joanne Still, medical writer, in the development of this supplement. The manuscript was reviewed and approved by the Guest Editors as well as the Editors of Seminars in Cutaneous Medicine and Surgery. The ideas and opinions expressed in this supplement are those of the Guest Editors and do not necessarily reflect the views of the supporters, Global Academy for Medical Education, the University of Louisville, or the Publisher.
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Copyright
Copyright © 2015 by Frontline Medical Communications Inc. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without written permission from the Publisher. Printed in the United States of America.
Disclosures
As a provider accredited by the ACCME, the Office of CME & PD, School of Medicine, University of Louisville must ensure balance, independence, objectivity, and scientific rigor in all its sponsored educational activities. All planners, faculty, reviewers, and other persons that affected the content of this CME activity were required to submit a financial disclosure form from which relevant conflicts of interest were determined.
David M. Pariser, MD, Consultant: Anacor Pharmaceuticals, Inc., DUSA Pharmaceuticals, Inc., LEO Pharma Inc., and Valeant Pharmaceuticals North America LLC.
Nathaniel J. Jellinek, MD, Advisory Board: Valeant Pharmaceuticals.
Phoebe Rich, MD, Grant/Research: Anacor, Meiji Seika Pharma Co., Ltd., Topica Pharmaceuticals, Inc., and Valeant Pharmaceuticals.
Melodie S. Young, MSN, RN, A/GNP-c, has no relevant financial relationships to disclose.
CME Reviewer: Cindy England Owen, MD, Assistant Professor, Division of Dermatology, University of Louisville School of Medicine, has no relevant financial relationships to disclose.
The CME & PD Staff and Advisory Board have nothing to disclose with the exception of Dr. Douglas Coldwell, Speaker: Sirtex, Inc. and Consultant: DFine, Inc.
Global Academy for Medical Education Staff: Sylvia H. Reitman, MBA, DipEd; Shirley V. Jones, MBA; and Joanne Still, BA have no relevant financial relationships to disclose.