Dermatology

Amin, S. D., K. B. Homan, M. Assar, M. Lee and C. D. Housewright (2019). “Hyfrecation and Interference With Implantable Cardiac Devices.” Dermatol Surg Oct 24. [Epub ahead of print].

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BACKGROUND: Mohs micrographic surgery, excisional surgery, and electrodessication and curettage (ED&C) are common dermatologic procedures that often use electrodessication through hyfrecators to achieve hemostasis. According to in vitro studies, electrodessication is considered safe in patients with implanted cardiac devices. To the authors’ knowledge, there are no in vivo data to support this claim. OBJECTIVE: In this study, the authors aim to describe the outcomes of hyfrecation during dermatologic procedures in patients with pacemakers and implantable cardiac devices. METHODS: Retrospective chart review was completed from March 2014 to April 2018 at a single center. Forty-five patients met criteria of having a cardiac device and having undergone an electrosurgery procedure using the Conmed 2000 Hyfrecator (Utica, NY). Adverse perioperative and postoperative outcomes, as well as device malfunction, were evaluated. RESULTS: No adverse perioperative effects were reported. Device reports were examined for inappropriate firing of the defibrillator, loss of capture, temporary inhibition of pacing, battery drainage, pacing at an elevated or erratic rate, failure to deliver antitachycardia, reversion to asynchronous pacing, induction of arrhythmias, or tissue damage at lead tissue, but no such issues were found. CONCLUSION: The lack of complications associated with cardiac devices with hyfrecation is reassuring. However, prospective and larger retrospective studies are warranted.

Noe, M. H., M. T. Wan, D. B. Shin, A. W. Armstrong, K. C. Duffin, Z. C. Chiesa Fuxench, R. E. Kalb, A. Menter, E. L. Simpson, J. Takeshita, S. K. Tyring, A. S. Van Voorhees, N. N. Mehta and J. M. Gelfand (2019). “Patient-Reported Outcomes of Adalimumab, Phototherapy, and Placebo in the Vascular Inflammation in Psoriasis Trial: A Randomized Controlled Study.” J Am Acad Dermatol 81(4): 923-930.

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BACKGROUND: There are limited data about the impact of narrowband ultraviolet B phototherapy on patient-reported measures of health-related quality of life. OBJECTIVE: To evaluate the impact of adalimumab and phototherapy on health-related quality of life. METHODS: We examined patient-reported outcomes from a multicenter, randomized, placebo-controlled trial (ClinicalTrials.gov no. NCT01553058). The Dermatology Life Quality Index and EQ-5D-3L were evaluated every 4 weeks. RESULTS: We enrolled 97 patients: 30.9% were female, mean age was 43.5 years (standard deviation, 14.0), and median Psoriasis Area and Severity Index score was 16.7 (interquartile range, 13.9-21.6). At week 12, patients being treated with adalimumab (odds ratio [OR], 2.88; 95% confidence interval [CI], 1.02-8.17) and phototherapy (OR, 8.83; 95% CI, 2.47-31.57) were more likely to achieve the minimal clinically important difference in the Dermatology Life Quality Index compared with those receiving placebo. There were higher odds of achieving the minimal clinically important difference for the EQ-5D-3L Index score when comparing phototherapy versus placebo (OR, 9.78; 95% CI, 2.99-31.95) and phototherapy versus adalimumab (OR, 4.07; 95% CI, 1.42-11.70). LIMITATIONS: Small sample size, secondary analysis, generalizability. CONCLUSION: Phototherapy and adalimumab both improve skin-related quality of life and overall health-related quality of life compared with placebo in patients with psoriasis; however, patients treated with phototherapy achieved more improvement in overall health-related quality of life compared with patients treated with adalimumab.

Lebwohl, M. G., C. L. Leonardi, N. N. Mehta, A. B. Gottlieb, A. M. Mendelsohn, J. Parno, S. J. Rozzo and A. Menter (2019). “Tildrakizumab Efficacy and Safety Are Not Altered by Metabolic Syndrome Status in Patients with Psoriasis: Post Hoc Analysis of 2 Phase 3 Randomized Controlled Studies (Resurface 1 and Resurface 2).” J Am Acad Dermatol Sep 26. [Epub ahead of print].

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This post hoc analysis evaluated tildrakizumab efficacy, durability of response, and safety in patients with moderate to severe chronic psoriasis with vs without metabolic syndrome (MetS) using pooled data from 2 phase 3, double-blind, randomized, placebo-controlled studies (reSURFACE 1 [NCT01722331] and 2 [NCT01729754]). Patients with vs without MetS had higher prevalence of pre-existing cardiovascular disease and diabetes and higher median baseline weight and body mass index (BMI). Six (4.1%) patients with MetS (n=5 tildrakizumab 100 mg; n=1 tildrakizumab 200 mg) and 25 (4.5%) patients without MetS (n=12 tildrakizumab 100 mg; n=13 tildrakizumab 200 mg) did not complete the study. Percentages of patients with ≥75% improvement on the Psorasis Area and Severity Index (PASI 75 responders) at weeks 12 and 52 were comparable between patients with and without MetS for both tildrakizumab doses. Percentages of PASI 90 and PASI 100 responders through week 52 were similar regardless of MetS status for both tildrakizumab doses. Tildrakizumab efficacy through week 52 was maintained comparably in patients with and without MetS. Reductions in mean PASI from baseline were similar regardless of MetS status for both tildrakizumab doses. Percentages of patients with ≥1 serious adverse event (AE) and those with ≥1 serious infection were similar in patients with and without MetS. The most common serious AEs for patients with vs without MetS were gastrointestinal and cardiac disorders following tildrakizumab 100 mg and injury / procedural complications and nervous system disorders following tildrakizumab 200 mg. Fatal AEs occurred in 2 patients with MetS (both tildrakizumab 100 mg) and 2 patients without MetS (1 per tildrakizumab dose). Infection was the most commonly reported treatment-emergent AE (TEAE). Incidence was similar in patients with and without MetS receiving tildrakizumab 100 mg and numerically higher in patients with vs without MetS receiving tildrakizumab 200 mg. Incidence of cardiovascular events did not vary by MetS status, and there were no reports of diabetes worsening after treatment. Weight increases through week 28 were limited (~1 kg on average) in patients with and without MetS across both tildrakizumab doses. Exposure-adjusted rates of tier 1 TEAEs were comparable across doses regardless of MetS status. These post hoc analyses were not powered for statistical analyses based on MetS status, and populations were not matched for smoking history and other potential co-factors. Although abdominal obesity is more highly correlated with MetS risk factors relative to BMI, the latter was used as abdominal obesity data were not collected. Sample sizes for patients with MetS were relatively small; further evaluation of the effect of weight only on treatment efficacy and safety was not feasible because only 25 patients with BMI <30 kg/m2 met ≥3 criteria for MetS. Despite limitations, these results suggest efficacy, safety, and drug survival of tildrakizumab are comparable in patients with psoriasis regardless of MetS status. (Excerpt from text of this article-in-press.)

Lebwohl, M. G., A. Blauvelt, A. Menter, K. A. Papp, S. Guenthner, R. Pillai, R. J. Israel and A. Jacobson (2019). “Efficacy, Safety, and Patient-Reported Outcomes in Patients with Moderate-to-Severe Plaque Psoriasis Treated with Brodalumab for 5 Years in a Long-Term, Open-Label, Phase Ii Study.” Am J Clin Dermatol Sep 6. [Epub ahead of print].

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BACKGROUND: Chronic inflammatory diseases such as psoriasis require treatment options that maintain efficacy and tolerability during extended treatment. OBJECTIVE: The aim of the study was to assess the long-term efficacy and safety of brodalumab, a fully human anti-interleukin-17 receptor A monoclonal antibody, in patients with moderate-to-severe plaque psoriasis. METHODS: Patients who completed a 12-week, phase II, dose-ranging clinical trial received brodalumab 210 mg every 2 weeks in an open-label extension study. Efficacy was assessed by static physician’s global assessment (sPGA) and psoriasis area and severity index (PASI). Quality of life, assessed by dermatology life quality index (DLQI), and safety were also evaluated. RESULTS: Overall, 181 patients received brodalumab for a median of 264 weeks. Brodalumab treatment resulted in rapid improvements in sPGA, PASI, and DLQI that were maintained through week 264. Achieving PASI 90 to < 100 or PASI 100 at weeks 12, 240, and 264 was associated with greater likelihood for DLQI 0 or 1 compared with achieving PASI 75 to < 90. Over 5 years, one adverse event of suicidal ideation was reported, no suicides occurred, and no new safety signals emerged. CONCLUSIONS: Brodalumab demonstrated skin clearance and improved quality of life, with an acceptable safety profile, throughout 5 years of treatment. ClinicalTrials.gov/NCT01101100.

Gupta, A. K., R. P. Love, W. Abramovits and K. D. Vincent (2019). “Duobrii (Halobetasol Propionate and Tazarotene) Lotion for Topical Use: A Newly Approved Combination Corticosteroid and Retinoid Topical Treatment of Plaque Psoriasis in Adults.” Skinmed 17(3): 181-183.

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