Background Apremilast works intracellularly to regulate inflammatory mediators. Objective ESTEEM 1 evaluated efficacy/safety of apremilast at 30 mg twice a day for moderate to severe plaque ...psoriasis. Methods This phase III, multicenter, double-blind, placebo-controlled study randomized adults (2:1) to apremilast or placebo. At week 16, the placebo group switched to apremilast through week 32, followed by a randomized treatment withdrawal phase to week 52. Binary end points were analyzed using χ2 test; continuous end points used analysis of covariance. Results In all, 844 patients were randomized (n = 282, placebo; n = 562, apremilast). At week 16, significantly more patients taking apremilast achieved 75% or greater reduction from baseline Psoriasis Area and Severity Index score (PASI-75) (33.1%) versus placebo (5.3%, P < .0001; primary end point). Most (61.0%) patients rerandomized to apremilast at week 32 achieved PASI-75 at week 52 versus 11.7% rerandomized to placebo. Of patients rerandomized to apremilast at week 32, mean percentage change from baseline PASI score was −88% to −81% (weeks 32-52). During the placebo-controlled period, 55.7% and 69.3% of patients randomized to placebo and apremilast, respectively, had 1 or more adverse events. Most adverse events were mild/moderate in severity. No new significant adverse events emerged with continued apremilast exposure versus the placebo-controlled period. Limitations Data were limited to 52 weeks and may not generalize to nonplaque psoriasis. Conclusions Apremilast was effective in moderate to severe plaque psoriasis.
Background A task force of the National Psoriasis Foundation Medical Board was convened to evaluate treatment options for pustular psoriasis. Meetings were held by teleconference. Consensus on ...treatment of pustular psoriasis was achieved. Pustular psoriasis has been classified into localized and generalized forms. There are a number of treatment modalities, but there is little evidence-based information to guide the management of this type of psoriasis. Objectives The purpose of this article was to present treatment recommendations to aid in the treatment of patients with pustular psoriasis. Methods A literature review was conducted to examine treatment options for pustular psoriasis and assess the strength of the literature for each option. Results Overall the quality of the literature about the treatment of pustular psoriasis is weak. Treatment should be governed by the extent of involvement and severity of disease. Acitretin, cyclosporine, methotrexate, and infliximab are considered to be first-line therapies for those with generalized pustular psoriasis. Adalimumab, etanercept, and psoralen plus ultraviolet A are second-line modalities in this setting. Pustular psoriasis in children, in pregnant women, and in localized forms alter which agents are first-line modalities as concerns such as teratogenicity need to be factored into the decisionmaking for the individual patient. Limitations There are few high-quality studies examining treatment options for pustular psoriasis. Conclusions Treatment of patients with pustular psoriasis depends on the severity of presentation and patient’s underlying risk factors. The data are extremely limited for this type of psoriasis and we encourage further exploration.
Psoriasis is a common, chronic, inflammatory, multisystem disease with predominantly skin and joint manifestations affecting approximately 2% of the population. In the first 5 parts of the ...AmericanAcademy of Dermatology Psoriasis Guidelines of Care, we have presented evidence supporting the use of topical treatments, phototherapy, traditional systemic agents, and biological therapies for patients with psoriasis and psoriatic arthritis. In this sixth and final section of the Psoriasis Guidelines of Care, we will present cases to illustrate how to practically use these guidelines in specific clinical scenarios. We will describe the approach to treating patients with psoriasis across the entire spectrum of this fascinating disease from mild to moderate to severe, with and without psoriatic arthritis, based on the 5 prior published guidelines. Although specific therapeutic recommendations are given for each of the cases presented, it is important that treatment be tailored to meet individual patients’ needs. In addition, we will update the prior 5 guidelines and address gaps in research and care that currently exist, while making suggestions for further studies that could be performed to help address these limitations in our knowledge base.
Background An urgent need exists in the United States to establish treatment goals in psoriasis. Objective We aim to establish defined treatment targets toward which clinicians and patients with ...psoriasis can strive to inform treatment decisions, reduce disease burden, and improve outcomes in practice. Methods The National Psoriasis Foundation conducted a consensus-building study among psoriasis experts using the Delphi method. The process consisted of: (1) literature review, (2) pre-Delphi question selection and input from general dermatologists and patients, and (3) 4 Delphi rounds. Results A total of 25 psoriasis experts participated in the Delphi process. The most preferred instrument was body surface area (BSA). The most preferred time for evaluating patient response after starting new therapies was at 3 months. The acceptable response at 3 months postinitiation was either BSA 3% or less or BSA improvement 75% or more from baseline. The target response at 3 months postinitiation was BSA 1% or less. During the maintenance period, evaluation every 6 months was most preferred. The target response at every 6 months maintenance evaluation is BSA 1% or less. Limitations Although BSA is feasible in practice, it does not encompass health-related quality of life, costs, and risks of side effects. Conclusion With defined treatment targets, clinicians and patients can regularly evaluate treatment responses and perform benefit-risk assessments of therapeutic options individualized to the patient.
There have been several articles and reports in recent months about comorbidities and risks that affect psoriasis patients in addition to their underlying disease. This piece reviews the current ...literature and begins to address what should be done with this new information by updating the clinician about what health screening tests, preventative exams, and referrals should be considered in this population.
Over the past 2 decades, considerable progress has been made to further elucidate the complex pathogenesis of psoriasis, facilitating the development of a new armamentarium of more effective, ...targeted therapies. Despite these important advances, substantial deficits remain in our understanding of psoriasis and its treatment, necessitating further research in many areas. In the sixth section of the American Academy of Dermatology Psoriasis Guidelines of Care, gaps in research and care were identified. We discuss the most important gaps in research that currently exist and make suggestions for studies that should be performed to address these deficits. These encompass both basic science and clinical research studies, including large, prospective epidemiologic studies to determine the true prevalence and natural history of psoriasis; further molecular studies in patients with psoriatic and psoriatic arthritis to understand the function of psoriasis susceptibility genes and to identify novel therapeutic targets; studies to examine the role of environmental factors in the development of psoriasis; further investigation of the relationship between psoriasis and cardiometabolic disease; studies that examine the role of adjunctive therapies such as psychological interventions in appropriate patient groups; and finally, studies to identify biomarkers of disease severity and treatment response to optimize patient therapy.
Background There is a well-established lack of adherence to evidence-based clinical guidelines. The American Academy of Dermatology (AAD) developed educational sessions entitled Translating Evidence ...into Practice based on the published guidelines for psoriasis and psoriatic arthritis. Objective We sought to determine the effectiveness of Translating Evidence into Practice sessions in improving patient care. Methods Pre- and post-session surveys were administered at Translating Evidence into Practice sessions. A follow-up was administered 6 months after completion of the most recent session, which was 2.5 years after the first session. Results At both post-session and follow-up, more than 92% of participants believed the sessions had improved their knowledge. The proportion of participants that self-reported assessing disease severity, comorbidities, and quality of life increased at follow-up. Participants' self-reported counseling of patients and confidence in treating psoriasis and psoriatic arthritis also increased at post-session and follow-up. Greater than 97% of participants thought the sessions would have a positive impact on their practice whereas 50% reported making a change in practice. Limitations Lack of a control group, the self-reported nature of the data, and potential participant bias are limitations. Conclusion The AAD's Translating Evidence into Practice sessions are effective and well received for improving knowledge and practice and can be useful to determine self-reported practice gaps.
Background There are large discrepancies in reported mortality for bullous pemphigoid (BP). Objective We sought to determine the mortality of a large cohort of patients with BP and compare this with ...age-matched control subjects. Methods Data were collected on 223 patients with a new diagnosis of BP between 1998 and 2003 through our cutaneous immunofluorescence laboratory databases. The mortality of patients with BP was compared with that of age-matched control subjects in the general US population. Results The 1-, 2-, and 5-year mortality was 0.23 (95% confidence interval = 0.18, 0.29), 0.37 (95% confidence interval = 0.31, 0.44), and 0.50 (95% confidence interval = 0.42, 0.57), respectively. However, relative to age-matched control subjects, no difference in expected mortality was detected. Limitations This was a retrospective cohort analysis. Conclusions Mortality of patients with BP is more likely related to advanced age and associated medical conditions than to disease-specific factors.
An association between obesity and psoriasis has been reported. For a variety of reasons, obese persons with psoriasis are often more difficult to treat. We sought to review the literature on obesity ...and psoriasis and to discuss efficacy and safety data that could be utilized by clinicians who are making treatment decisions for obese persons with psoriasis. We performed a literature review using the terms “obesity and psoriasis” and “metabolic syndrome and psoriasis.” Evidence from relevant literature was evaluated and categorized according to the criteria of Shekelle et al (published 1999). Numerous reports cite an association between obesity and psoriasis. When compared with non-obese patients with psoriasis, obese patients with psoriasis are more likely to experience certain adverse effects to medications and are less likely to respond favorably to systemic therapies. The amount of category I evidence for objectively determining the best treatment choices for obese patients with psoriasis was scarce and thus did not allow for the development of a treatment algorithm that could be generally applied for all psoriasis patients who are obese. Efficacy and safety concerns affected by obesity are important considerations for clinicians who are making decisions on proper treatment of psoriasis.
Background Treating psoriasis in pregnant and lactating women presents a special challenge. For ethical reasons, prospective randomized control trials have not been conducted in this patient ...population although these patients do encounter new-onset psoriasis in addition to flares and may require treatment throughout their pregnancies. Objective Our aim was to arrive at consensus recommendations on treatment options for psoriasis in pregnant and lactating women. Methods The literature was reviewed regarding all psoriasis therapies in pregnant and lactating women. Results Topical therapies including emollients and low- to moderate-potency topical steroids are first-line therapy for patients with limited psoriasis who are pregnant or breast-feeding. The consensus was that second-line treatment for pregnant women is narrowband ultraviolet B phototherapy or broadband ultraviolet B, if narrowband ultraviolet B is not available. Lastly, tumor necrosis factor-α inhibitors including adalimumab, etanercept, and infliximab may be used with caution as may cyclosporine and systemic steroids (in second and third trimesters). Some specific strategies may be used to minimize risk and exposure. Limitations There are few evidence-based studies on treating psoriasis in pregnant and lactating women. Conclusions Because there will always be a question of ethical concerns placing pregnant and lactating women in prospective clinical trials, investigation of both conventional and biologic agents are unlikely to ever be performed. Some of these medications used to treat psoriasis are known abortifacients, mutagens, or teratogens and must be clearly avoided but others can be used with relative confidence in select patients with appropriate counseling of risks and benefits.
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