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Evaluation of the Efficacy and Safety of Tavaborole Topical Solution, 5%, In Journal of Dermatological Treatment ISSN: 0954-6634 (Print) 1471-1753 (Online) Journal homepage: http://www.tandfonline.com/loi/ijdt20 Evaluation of the efficacy and safety of tavaborole topical solution, 5%, in the treatment of onychomycosis of the toenail in adults: a pooled analysis of an 8-week, post-study follow-up from two randomized phase 3 studies Aditya K. Gupta, Steve Hall, Lee T. Zane, Shari R. Lipner & Phoebe Rich To cite this article: Aditya K. Gupta, Steve Hall, Lee T. Zane, Shari R. Lipner & Phoebe Rich (2017): Evaluation of the efficacy and safety of tavaborole topical solution, 5%, in the treatment of onychomycosis of the toenail in adults: a pooled analysis of an 8-week, post-study follow-up from two randomized phase 3 studies, Journal of Dermatological Treatment, DOI: 10.1080/09546634.2017.1329510 To link to this article: http://dx.doi.org/10.1080/09546634.2017.1329510 Accepted author version posted online: 18 May 2017. Published online: 30 May 2017. Submit your article to this journal Article views: 41 View related articles View Crossmark data Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=ijdt20 Download by: [Oregon Health & Science University Library] Date: 27 September 2017, At: 13:42 JOURNAL OF DERMATOLOGICAL TREATMENT, 2017 https://doi.org/10.1080/09546634.2017.1329510 ORIGINAL ARTICLE Evaluation of the efficacy and safety of tavaborole topical solution, 5%, in the treatment of onychomycosis of the toenail in adults: a pooled analysis of an 8-week, post-study follow-up from two randomized phase 3 studies Aditya K. Guptaa,b, Steve Hallc, Lee T. Zaned, Shari R. Lipnere and Phoebe Richf aDepartment of Medicine, University of Toronto, Toronto, Canada; bMediprobe Research Inc., London, Canada; cMedical Affairs, Sandoz Pharmaceuticals Inc., Princeton, NJ, USA; dAnacor Pharmaceuticals Inc., Palo Alto, CA, USA; eDepartment of Dermatology, Weill Cornell Medicine, New York, NY, USA; fOregon Dermatology and Research, Portland, OR, USA ABSTRACT ARTICLE HISTORY Purpose: The role of topical antifungal agents in the long-term management of toenail onychomycosis is Received 13 March 2017 not well established. The current study evaluated durability of clinical benefit of tavaborole topical solu- Accepted 17 March 2017 tion, 5%, for the treatment of toenail onychomycosis. Methods: We conducted a pooled analysis of 8-week, post-study follow-up (PSFU) data from two phase 3, KEYWORDS randomized controlled trials in a subset of patients who experienced complete or almost clear nail (CN) at Antifungal agents; AN-2690; the end of treatment (week 52); 48 weeks of treatment with once-daily tavaborole compared with placebo long-term follow-up; in adults with distal subungual onychomycosis was evaluated at week 60. Complete cure (completely CN tavaborole; tinea unguium plus negative mycology) of the target great toenail and treatment success (<10% nail involvement plus negative mycology) were evaluated at week 52 versus week 60. Results: Of the 62 patients who completed the PSFU, complete cure was higher in the tavaborole-treated group versus the vehicle control group (28.6% vs. 7.7%). Additionally, treatment success was 53.1% for the tavaborole group versus 23.1% in the vehicle group. Small sample size entering the PSFU limited robust statistical analysis. Conclusion: Tavaborole topical solution, 5%, appears to provide durable clinical benefit, making it an attractive long-term treatment option for dermatophyte-associated onychomycosis of the toenail. Introduction epidermal necrolysis, Stevens–Johnson syndrome) that warrant monitoring, particularly in children, the elderly, patients with liver The overall incidence of onychomycosis in North America is disease and immunocompromised individuals (6,13,14). In 2014, approximately 14% (1), increasing in prevalence with advancing the US Food and Drug Administration (FDA) approved two topical age; it affects 28–40% of individuals aged >60 years (2). antifungal solutions, efinaconazole and tavaborole, for the treat- Onychomycosis is primarily caused by dermatophytes in temper- ate climates, with Trichophyton rubrum and Trichophyton menta- ment of toenail onychomycosis caused by T. rubrum and T. menta- grophytes being the predominant causative pathogens (3,4). grophytes (16,17). However, their role in the long-term Although onychomycosis may be asymptomatic, progressive management of toenail onychomycosis has not been well destruction and deformity of the toenails and fingernails may established. occur if the condition is left untreated (5). This can result in dis- Tavaborole topical solution, 5% (developed by Anacor comfort and/or pain (6), impairment or loss of tactile function (7), Pharmaceuticals Inc., Palo Alto, CA; marketed by PharmaDerm a impaired foot mobility (8) and reduced quality of life (7–10). Division of Fougera Pharmaceuticals Inc., Princeton, NJ), is a novel, Downloaded by [Oregon Health & Science University Library] at 13:42 27 September 2017 Furthermore, treatment failure and recurrences are common boron-based medication that inhibits fungal protein synthesis (17). (11,12). Risk factors such as age, gender, lifestyle and comorbid- Two phase 3 clinical trials evaluated the efficacy and safety of ities (e.g. diabetes, psoriasis, immunodeficiency) increase the likeli- tavaborole for the treatment of distal subungual onychomycosis hood of disease recurrence. The burden of onychomycosis (18). Tavaborole demonstrated a favorable benefit-risk profile after highlights the importance of effective long-term management 52 weeks, with significantly higher complete cure rates (6–9%) and strategies to prevent and treat infection or recurrence of infection. higher rates of completely clear nail (CN) or almost CN (<10% nail Current treatment options for onychomycosis include oral and involvement) plus negative mycology (15–18%) compared with topical antifungals, adjunctive treatments (i.e. nail filing, trimming, vehicle control (18). Both studies were amended to include add- curettage or debridement), mechanical interventions (e.g. chemical itional 8-week, post-study follow-up (PSFU) assessments in a sub- or surgical nail avulsion), and laser and light therapies (6). Oral set of patients. The objective of this week-60 extension phase was antifungal therapies, such as terbinafine and itraconazole, provide to assess the durability of clinical benefit after 48 weeks of treat- higher complete cure rates (38–14%) than topical treatments ment with tavaborole in patients with distal subungual toenail (5–18%) (13–17), but are associated with several safety concerns onychomycosis. The durability of clinical benefit was summarized (e.g. hepatotoxicity, clinically significant drug interactions, toxic for the subset of patients who participated in the PSFU, and was CONTACT Aditya K. Gupta [email protected] Mediprobe Research Inc., 645 Windermere Road, London, ON, N5X 2P1, Canada ß 2017 Informa UK Limited, trading as Taylor & Francis Group 2 A. K. GUPTA ET AL. defined as the complete cure rate at week 52 versus week 60, and Efficacy outcomes the treatment success outcome at week 52 versus week 60. The efficacy outcomes at 52 weeks of both studies have been described in detail (18). Patients eligible for PSFU were assessed at Methods week 60 for durability of clinical benefit, which included evalu- ation of the primary endpoint: complete cure of the TGT at week Patients and study treatments 52 versus week 60. Treatment success at week 52 versus week 60 Patient eligibility criteria have been described in detail (18). was also evaluated. Negative mycology (defined as negative KOH Briefly, adult patients (aged 18 years) with distal subungual toe- wet mount and negative fungal culture) was also evaluated at nail onychomycosis involving 20–60% of one or more target great week 60. The clinical characteristics of the nail from the end of toenails (TGTs) were eligible for inclusion if they had a positive treatment (week 48) through week 60 were also assessed. potassium hydroxide (KOH) wet mount and positive fungal culture Complete cure was defined as completely CN and negative for dermatophytes. Major exclusion criteria included conditions mycology of the TGT. Treatment success was defined as com- affecting the TGT (e.g. proximal subungual onychomycosis, super- pletely or almost (<10%) CN and negative mycology of the TGT. ficially white onychomycosis, infection/coinfection with a nonder- matophyte fungus), anatomic abnormalities of the toe(s) or toenail(s) to be treated, chronic moccasin-type tinea pedis, active Safety interdigital tinea pedis or exclusively plantar tinea pedis, and the Safety assessments were conducted at each visit, as was a physical concurrent use of topical/systemic antifungals, anti-inflammatory, examination evaluating the frequency and severity of application- corticosteroid, or immunomodulatory agents applied to the toes, site reactions (ASRs): burning/stinging, induration/edema, oozing/ toenails or feet. crusting, pruritus, erythema and scaling. Adverse events (AEs), Study treatments included tavaborole topical solution, 5%, or treatment-emergent AEs, serious AEs and vital signs were moni- vehicle control, which was self-administered by patients once daily tored throughout the study, including the PSFU period. Disease- for 48 weeks. Patients were instructed to apply the study treat- focused physical examination and assessment of ASRs were con- ment on, under and around infected TGTs and infected
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