Dermatology

Garg, A., E. Neuren, D. Cha, . . . S. Y. Paek, B. Resnik, Q. Ju, L. Wang and A. Strunk (2019). “Evaluating Patients’ Unmet Needs in Hidradenitis Suppurativa: results from the Global VOICE project.” J Am Acad Dermatol Jul 3. [Epub ahead of print].

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BACKGROUND: A needs assessment for patients with hidradenitis suppurativa (HS) will support advancements in multidisciplinary care, treatment, research, advocacy, and philanthropy. OBJECTIVE: To evaluate unmet needs from the perspective of HS patients. METHODS: Prospective multinational survey of patients between October, 2017 and July, 2018. RESULTS: Majority (63.7%, n=827) visited a physician >/=5 times prior to receiving formal HS diagnosis. Mean delay in diagnosis was 10.2 years (+/- 8.9 years). Patients experienced flare daily, weekly, or monthly in 23.0%, 29.8%, and 31.1%, respectively. Most (61.4%, n=798) rated recent HS-related pain as moderate or higher, while 4.5% described recent pain to be worst possible. Access to dermatology was rated as difficult by 37.0% (n=481). Patients reported visiting the emergency department and hospital >/=5 times for symptoms in 18.3% and 12.5%, respectively. An extreme impact on life was reported by 43.3% (n=563), and 14.5% were disabled due to disease. Patients reported high frequency of comorbidities, most commonly mood disorders. Patients were dissatisfied with medical or procedural treatments in 45.9% and 34.5%, respectively. LIMITATIONS: Data was self-reported. Patients with more severe disease may have been selected. CONCLUSIONS: HS patients have identified several critical unmet needs that will require stakeholder collaboration to meaningfully address.

Fawaz, B., B. H. Chamseddin and J. R. Griffin (2019). “Defining the role of mirtazapine in the treatment of refractory pruritus.” J Dermatolog Treat Jun 27: 1-5. [Epub ahead of print]: 1-5.

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Background/Objective: Mirtazapine has traditionally been used for the treatment of major depressive disorder, with an added benefit in patients who have comorbid insomnia or anxiety. Recent studies describe its usefulness in treating refractory pruritus of various causes as well. Our goal is to better define the use of mirtazapine in the treatment of refractory pruritus. Method: Through a thorough literature review of PubMed, we identified all reports of the use of mirtazapine for pruritus. Results: Upon examination of 8 supporting articles, we found mirtazapine has quality evidence for the treatment of intra-thecal morphine-induced pruritus. Mirtazapine may also be effective in treating pruritus related to various other conditions, including psoriasis, atopic dermatitis, cutaneous malignancies (primary or metastatic), hematologic malignancies (lymphomas and leukemias), liver failure, renal failure, cholestasis, as well as pruritus of unknown origin. Conclusions: Mirtazapine plays a role in treatment for intra-thecel morphine-induced pruritis yet high-quality trials are needed to confirm its efficacy in other dermatologic conditions.

Elewski, B., A. Menter, J. Crowley, S. Tyring, Y. Zhao, S. Lowry, S. Rozzo, A. M. Mendelsohn, J. Parno and K. Gordon (2019). “Sustained and Continuously Improved Efficacy of Tildrakizumab in Patients with Moderate-to-Severe Plaque Psoriasis.” J Dermatolog Treat Jul 3: 1-19. [Epub ahead of print].

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Background: Tildrakizumab is a high-affinity, humanized, IgG1 kappa, anti-interleukin-23 monoclonal antibody approved for moderate-to-severe plaque psoriasis. Objectives: This analysis examined whether tildrakizumab’s week-28 efficacy can be sustained or improved to week 52. Methods: Psoriasis patients on the same-dose tildrakizumab (100 or 200 mg) in the first 52 weeks achieving week-28 PASI >/=50 were pooled from two phase-3 randomized controlled trials, and grouped into four mutually exclusive week-28 PASI response groups. Patients’ week-52 PASI responses were compared to their week-28 PASI responses. Results: Of 352 patients receiving 100-mg tildrakizumab, 10.5%, 25.3%, 38.4%, and 25.9% achieved PASI 50-74, 75-89, 90-99, and 100 at week 28, respectively. Among patients achieving PASI >/=90, >/=75, or >/=50 at week 28, 89.4%, 91.1%, or 97.4% maintained their week-28 PASI responses at week 52, respectively. Among patients achieving PASI 50-74, 75-89, or 90-99 at week 28, 64.8%, 33.7%, or 25.2% improved their week-28 PASI responses at week 52, respectively. Limitations: This post-hoc analysis may be less robust than an a priori analysis. Conclusions: Most tildrakizumab-treated patients with week-28 PASI >/=75 maintained their week-28 PASI improvement at week 52. More than half of week-28 partial responders (PASI 50-74) improved their PASI responses to PASI >/=75 at week 52. Clinicaltrials.gov Identifiers: NCT01722331, NCT01729754.

Callewaert, C., T. Nakatsuji, R. Knight, T. Kosciolek, A. Vrbanac, P. Kotol, M. Ardeleanu, T. Hultsch, E. Guttman-Yassky, R. Bissonnette, J. I. Silverberg, J. Krueger, A. Menter, N. M. H. Graham, G. Pirozzi, J. D. Hamilton and R. L. Gallo (2019). “IL-4Ralpha Blockade by Dupilumab Decreases Staphylococcus aureus Colonization and Increases Microbial Diversity in Atopic Dermatitis.” J Invest Dermatol Jun 25. [Epub ahead of print].

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Dupilumab is a fully human antibody to interleukin-4 receptor alpha that improves the signs and symptoms of moderate-to-severe atopic dermatitis. To determine the effects of dupilumab on Staphylococcus aureus colonization and microbial diversity on the skin, bacterial DNA was analyzed from swabs collected from lesional and nonlesional skin in a double-blind, placebo-controlled study of 54 patients with moderate-to-severe atopic dermatitis randomized (1:1) and treated with either dupilumab (200 mg weekly) or placebo for 16 weeks. Microbial diversity and relative abundance of Staphylococcus were assessed by DNA sequencing of 16S rRNA, and absolute S. aureus abundance was measured by quantitative PCR. Before treatment, lesional skin had lower microbial diversity and higher overall abundance of S. aureus than nonlesional skin. During dupilumab treatment, microbial diversity increased and the abundance of S. aureus decreased. Pronounced changes were seen in nonlesional and lesional skin. Decreased S. aureus abundance during dupilumab treatment correlated with clinical improvement of atopic dermatitis and biomarkers of type 2 immunity. We conclude that clinical improvement of atopic dermatitis that is mediated by interleukin-4 receptor alpha inhibition and the subsequent suppression of type 2 inflammation is correlated with increased microbial diversity and reduced abundance of S. aureus. ClinicalTrials.gov identifier: NCT01979016.

Raoof, T. J., D. Hooper, A. Moore, M. Zaiac, T. Sullivan, L. Kircik, E. Lain, J. Jankicevic and I. Stuart (2019). “Efficacy and Safety of a Novel Topical Minocycline Foam for the Treatment of Moderate-to-Severe Acne Vulgaris: A Phase 3 Study.” J Am Acad Dermatol Jun 1. [Epub ahead of print].

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BACKGROUND: FMX101 4% topical minocycline foam, has been demonstrated as an effective and safe treatment for acne vulgaris. OBJECTIVE: Further evaluate the efficacy and safety of FMX101 4% in treating moderate-to-severe AV. METHODS: A 12-week, multicenter, randomized (1:1), double-blind, vehicle-controlled study was conducted. Co-primary end points were the absolute change in inflammatory lesion count from baseline and the rate of treatment success (IGA score: 0 or 1 with a greater-than-or-equal-to 2-grade improvement). RESULTS: 1488 subjects were in the intent-to-treat population. FMX101 4% group had significantly greater reductions in the number of inflammatory lesions from baseline (P<.0001) and a greater rate of IGA treatment success (P<.0001) vs foam vehicle group at week 12. FMX101 4% was generally safe and well-tolerated. LIMITATIONS: Efficacy and safety of FMX101 4% was not characterized in subjects with mild AV. CONCLUSION: FMX101 4% topical minocycline foam was effective and safe for the treatment of moderate-to-severe AV.