Martin A. Menter M.D.

Matza, L. S., J. E. Brazier, K. D. Stewart, L. Pinto, R. H. Bender, L. Kircik, J. Jordan, K. J. Kim, A. Mutebi, H. N. Viswanathan and A. Menter (2019). “Developing a preference-based utility scoring algorithm for the Psoriasis Area Severity Index (PASI).” J Med Econ Jun 4:1-20. [Epub ahead of print].

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Introduction. It is challenging to identify health state utilities associated with psoriasis because generic preference-based measures may not capture the impact of dermatological symptoms. The Psoriasis Area Severity Index (PASI) is one of the most commonly used psoriasis rating scales in clinical trials. The purpose of this study was to develop a utility scoring algorithm for the PASI. Methods. Forty health states were developed based on PASI scores of 40 clinical trial patients. Health states were valued in time trade-off interviews with UK general population participants. Regression models were conducted to crosswalk from PASI scores to utilities (e.g., OLS linear, random effects, mean, robust, spline, quadratic). Results A total of 245 participants completed utility interviews (51.4% female; mean age = 45.3y). Models predicting utility based on the four PASI location scores (head, upper limbs, trunk, lower limbs) had better fit/accuracy (e.g., R(2), mean absolute error [MAE]) than models using the PASI total score. Head/upper limb scores were more strongly associated with utility than trunk/lower limb. The recommended model is the OLS linear model based on the four PASI location scores (R(2) = 0.13; MAE =0.03). An alternative is recommended for situations when it is necessary to estimate utility based on the PASI total score. Conclusions. The recommended scoring algorithm may be used to estimate utilities based on PASI scores of any treatment group with psoriasis. Because the PASI is commonly used in psoriasis clinical trials, this scoring algorithm greatly expands options for quantifying treatment outcomes in cost-effectiveness analyses of psoriasis therapies. Results indicate that psoriasis of the head/upper limbs could be more important than trunk/lower limbs, suggesting reconsideration of the standard PASI scoring approach.

Menter, A., B. E. Strober, D. H. Kaplan, D. Kivelevitch, E. F. Prater, B. Stoff, A. W. Armstrong, C. Connor, K. M. Cordoro, D. M. R. Davis, B. E. Elewski, J. M. Gelfand, K. B. Gordon, A. B. Gottlieb, A. Kavanaugh, M. Kiselica, N. J. Korman, D. Kroshinsky, M. Lebwohl, C. L. Leonardi, J. Lichten, H. W. Lim, N. N. Mehta, A. S. Paller, S. L. Parra, A. L. Pathy, R. N. Rupani, M. Siegel, E. B. Wong, J. J. Wu, V. Hariharan and C. A. Elmets (2019). “Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics.” J Am Acad Dermatol 80(4): 1029-1072.

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Psoriasis is a chronic, inflammatory multisystem disease that affects up to 3.2% of the US population. This guideline addresses important clinical questions that arise in psoriasis management and care, providing recommendations based on the available evidence. The treatment of psoriasis with biologic agents will be reviewed, emphasizing treatment recommendations and the role of the dermatologist in monitoring and educating patients regarding benefits as well as associated risks.

Elmets, C. A., C. L. Leonardi, D. M. R. Davis, J. M. Gelfand, J. Lichten, N. N. Mehta, A. W. Armstrong, C. Connor, K. M. Cordoro, B. E. Elewski, K. B. Gordon, A. B. Gottlieb, D. H. Kaplan, A. Kavanaugh, D. Kivelevitch, M. Kiselica, N. J. Korman, D. Kroshinsky, M. Lebwohl, H. W. Lim, A. S. Paller, S. L. Parra, A. L. Pathy, E. F. Prater, R. Rupani, M. Siegel, B. Stoff, B. E. Strober, E. B. Wong, J. J. Wu, V. Hariharan and A. Menter (2019). “Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with awareness and attention to comorbidities.” J Am Acad Dermatol 80(4): 1073-1113.

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Psoriasis is a chronic, inflammatory, multisystem disease that affects up to 3.2% of the US population. This guideline addresses important clinical questions that arise in psoriasis management and care, providing recommendations on the basis of available evidence.

Reich, K., P. Rich, C. Maari, R. Bissonnette, C. Leonardi, A. Menter, A. Igarashi, P. Klekotka, D. Patel, J. Li, J. Tuttle, M. Morgan-Cox, E. Edson-Heredia, S. Friedrich and K. Papp (2019). “Efficacy and Safety of Mirikizumab (LY3074828) in the Treatment of Moderate-to-Severe Plaque Psoriasis: Results from a Randomised Phase 2 Study.” Br J Dermatol Feb 7. [Epub ahead of print].

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BACKGROUND AND OBJECTIVES: Inhibiting the interleukin (IL)-23 cytokine in patients with psoriasis has demonstrated high levels of skin clearance. In this Phase 2 (AMAF, NCT02899988), multicentre, double-blind trial, we investigated the efficacy and safety of three dose groups of mirikizumab (LY3074828), a p19-directed IL-23 antibody, compared to placebo in patients with moderate-to-severe plaque psoriasis. METHODS: Adult patients were randomised 1:1:1:1 to receive placebo (N=52), mirikizumab 30 mg (N=51), 100 mg (N=51), or 300 mg (N=51) subcutaneously at Weeks 0 and 8. The primary objective was to evaluate superiority of mirikizumab to placebo in achieving a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) response at Week 16. Comparisons were done using logistic regression analysis with treatment, geographic region and previous biologic therapy in the model. Missing data were imputed as nonresponse. RESULTS: Ninety-seven percent of patients completed the first 16 weeks of Study AMAF. The primary endpoint was met for all mirikizumab dose groups versus placebo, with PASI 90 response rates at Week 16 of 0%, 29.4% (p=0.009), 58.8% (p<0.001) and 66.7% (p<0.001) for patients receiving placebo, mirikizumab 30 mg, 100 mg and 300 mg, respectively. There were 2 (1.3%) serious AEs in mirikizumab-treated patients compared to 1 (1.9%) placebo-group patient. CONCLUSIONS: At Week 16, 66.7% of patients treated with mirikizumab 300 mg at 8-week intervals achieved PASI 90. The percentage of patients reporting at least one treatment-emergent adverse event was similar among patients treated with placebo or mirikizumab.

Menter, A. and R. Warren (2019). “A Summary of 2018 and What Lies Ahead for Dermatology and Therapy in 2019.” Dermatol Ther (Heidelb) 9(1): 1-3.

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[A review of the year 2018 by the editors of the journal Dermatology and Therapy; no abstract available.]