The effect of secukinumab on moderate-to-severe scalp psoriasis: Results of a 24-week, randomized, double-blind, placebo-controlled phase 3b study.

BACKGROUND: Moderate-to-severe scalp psoriasis has not been evaluated in prospective trials of patients without moderate-to-severe body psoriasis. OBJECTIVE: Evaluate the efficacy and safety of secukinumab in moderate-to-severe scalp psoriasis. METHODS: In this 24-week, double-blind, phase 3b study, 102 patients were randomized 1:1 to subcutaneous secukinumab 300 mg or placebo at baseline, weeks 1, 2, and 3, and then every 4 weeks from week 4 to 20. The primary efficacy variable was 90% improvement of Psoriasis Scalp Severity Index (PSSI 90) score from baseline to week 12. RESULTS: At week 12, PSSI 90 (secukinumab 300 mg vs placebo, 52.9% vs 2.0%) and Investigator's Global Assessment modified 2011 scalp responses of 0 or 1 (secukinumab 300 mg vs placebo, 56.9% vs 5.9%) were significantly greater with secukinumab 300 mg than placebo (P < .001 for both). In addition, significantly more patients achieved complete clearance of scalp psoriasis at week 12 with secukinumab 300 mg than placebo (35.3% vs 0%; P < .001). The median time to 50% reduction in PSSI score was 3.29 weeks with secukinumab 300 mg. The safety profile of secukinumab was consistent with previous phase 3 studies. LIMITATIONS: There was no active comparator arm. CONCLUSION: Secukinumab is efficacious and well-tolerated for patients with extensive moderate-to-severe scalp psoriasis.

Lebrikizumab in Uncontrolled Asthma: Reanalysis in a Well-Defined Type 2 Population.

BACKGROUND: LAVOLTA (L)I, LII, and ACOUSTICS were randomized, placebo-controlled, Phase 3 trials of lebrikizumab, a monoclonal antibody targeting IL-13 in patients with uncontrolled asthma. Failure to demonstrate efficacy may have been related to patient selection in those trials. OBJECTIVE: To assess the efficacy in a well-defined subpopulation of patients with elevated blood eosinophil counts and a minimum number of prior asthma exacerbations. We performed an additional analysis in a subpopulation of patients with elevated FeNO and prior exacerbations. METHODS: Adult (LI and LII) and adolescent patients (aged 12-17 years weighing ≥40 kg, ACOUSTICS) with uncontrolled asthma received lebrikizumab (125 mg, n = 832; or 37.5 mg, n = 829) or placebo (n = 833) subcutaneously every 4 weeks. Post hoc analysis of the annualized adjusted exacerbation rate (AER) was performed in a subpopulation of patients with baseline blood eosinophils of 300 cells/µL or greater and history of one or more exacerbations. In this subpopulation, there were 227 patients in the placebo group, 222 in the lebrikizumab 37.5-mg group, and 217 in the lebrikizumab 125-mg group. We summarized safety in patients who received at least one dose of lebrikizumab using adverse events. RESULTS: Lebrikizumab significantly reduced AER compared with placebo in adults (AER reduction: 125 mg [38%]; and 37.5 mg [41%]) and adolescents (AER reduction:125 mg [59%]; 37.5 mg [64%]) with baseline blood eosinophils of 300 cells/µL or greater and one or more exacerbations. Most adverse events were mild or moderate in severity and did not lead to treatment discontinuation. CONCLUSION: Lebrikizumab significantly reduced asthma exacerbations in a subpopulation of patients with elevated blood eosinophils, elevated FeNO, and a history of asthma exacerbation.

Toward a New Definition of "Healthy" Food: Issues and Challenges.

Dietary Guidelines for Americans (DGA) have become increasingly food-based guidelines. The Healthy United States-Style Eating Pattern features fruits, vegetables, whole grains, and low-fat dairy, with limits placed on added sugar, sodium, and saturated fat. Recent measures of nutrient density have followed suit, incorporating both nutrients and food groups. Most recently, the United States Food and Drug Administration (FDA) has proposed to redefine the concept of a "healthy" food for regulatory purposes. To qualify as healthy, foods will need to contain specific minimum amounts of fruits, vegetables, dairy, and whole grains, with limits placed on added sugar, sodium, and saturated fat. The present concern was that the proposed criteria, formulated by the FDA per Reference Amount Customarily Consumed, were so stringent that few foods would pass. We applied the proposed FDA criteria to foods in the USDA Food and Nutrient Database for Dietary Studies (FNDDS 2017-2018). The criteria were met by 58% of fruits, 35% of vegetables, 8% of milk and dairy products, and 4% of grain products. Many foods commonly considered to be healthy by consumers and the USDA alike did not pass the proposed FDA criteria. Federal agencies seem to define healthy in different ways. Our findings have implications for the formulation of regulatory and public health policies. We recommend that nutrition scientists be involved in the development of federal regulations and policies that affect American consumers and the food industry.

A Qualitative Study of Knowledge of Metabolic Syndrome, Attitudes about Lifestyle Modifications, and Preferences for Lifestyle Interventions among Patients with Cancer and Metabolic Syndrome.

Background: Nearly 60% of patients with cancer have metabolic syndrome, which increases the risk of mortality, but there is no clear guidance for oncology providers about its management. Here, we report on the qualitative component of a larger mixed methods study that aimed to understand cancer patients' knowledge, attitudes, and preferences regarding metabolic syndrome. Methods: Adult cancer patients with metabolic syndrome were recruited during 2022-2023 in the MD Anderson General Internal Medicine clinic and participated in semistructured interviews focused on metabolic syndrome and lifestyle interventions. Interviews were audio-recorded and transcribed verbatim. Participants' demographic information was collected. Interviews were analyzed using hybrid thematic analysis and constant comparison involving deductive and inductive coding. Researcher triangulation and debriefing were used to ensure rigor. Results: There were 19 participants, 12 female and 12 White. Eighteen had solid tumors, including gynecologic (n = 5), genitourinary (n = 4), colorectal (n = 3), and breast (n = 2). Analysis yielded 5 major themes: 1) patients' understanding of metabolic syndrome; 2) attitudes about and approaches to managing metabolic syndrome; 3) capacity and limitations regarding managing metabolic syndrome; 4) patient-led care; and 5) tailored intervention plans. Participants had limited knowledge of metabolic syndrome and its cancer-related consequences; most desired additional education. Many participants reported that their cancer or diabetes diagnosis motivated them to prioritize lifestyle Modifications. Participants expressed strong interest in personalized care plans focused on healthy lifestyle rather than simply weight loss. As part of their tailored intervention plans, participants desired clear communication with their medical team, coordination of care among team members, and collaboration with providers about treatment decisions. Conclusion: Cancer patients with metabolic syndrome want collaborative, patient-centered care. Shared decision-making based on respect for patients' distinctive needs and preferences is an essential component of the development of such collaborative care. Tailored interventions, practical implementation strategies, and personalized care plans are needed for cancer patients with metabolic syndrome. The study findings contribute to filling the gap in knowledge regarding clear guidance for oncology providers on managing metabolic syndrome and will inform the development of future lifestyle interventions for patients diagnosed with metabolic syndrome.

Preventive medicine and public health residency training: federal policy and advocacy opportunities.

BACKGROUND: Preventive medicine physicians are uniquely trained in both clinical medicine and public health to understand and reduce the risks of disease, disability, and death in individuals and populations. The nation is facing a severe shortage of preventive medicine-trained physicians, which is largely due to unstable and inadequate residency program funding. METHODS: Several policy options have been explored and evaluated to fund preventive medicine residency training programs as part of a multipronged approach to engage physicians in the policy-making process. RESULTS: The most adequate, sustainable, distributable, and politically feasible policy option was pursued, and a bill called the "Preventive Medicine and Public Health Training Act" was introduced into the House and the Senate. CONCLUSIONS: Opportunities to participate in the policy-making process and interact with key legislators and stakeholders exist in a variety of ways. Leadership at the federal level helps preventive medicine and public health physicians recognize their vital role in shaping public policy.

Alopecia areata: genetic complexity underlies clinical heterogeneity.

Alopecia areata is a complex, non-scarring hair loss disease that affects approximately 1-2% of the population. The etiology of AA is unknown, although both genetic factors and environmental agents are thought to contribute to the immune disregulation leading to the final pathways of disease. Here, we examine the complex interplay of genetic and non-genetic factors that, no doubt, underpin the wide-ranging clinical expression of AA. We further discuss emerging strategies and tools that promise to better define the genetic basis of disease and reveal novel targets for next generation therapies.

Secukinumab improves scalp pain, itching, scaling and quality of life in patients with moderate-to-severe scalp psoriasis.

INTRODUCTION: Scalp psoriasis adversely affects patients' lives and is often resistant to treatment; however, it has not been a major focus of a clinical study. This analysis assessed the effect of secukinumab on patient-reported outcomes (PRO) of scalp psoriasis. METHODS: A randomized, double-blind, placebo-controlled, multicenter study was conducted in 102 adult patients with moderate-to-severe scalp psoriasis. Patients were randomized 1:1 to secukinumab 300 mg or placebo. Patients rated their scalp-related pain, itching and scaling using a 0-10 numeric rating scale (higher scores indicate greater severity). Scalp dermatitis-related quality of life (QOL) was assessed at baseline and then every 4 weeks using the Scalpdex. Analysis of covariance models examined PRO effect up to 12 weeks. RESULTS: Baseline scalp pain, itching and scaling mean (SD) values were 3.1 (3.00), 6.7 (2.60) and 7.3 (2.02) and similar for both treatment groups. At week 12, patients treated with secukinumab reported greater reduction in scalp pain (-1.98 vs. 0.61), itching (-4.07 vs. -0.04) and scaling (-5.76 vs. -0.95) as well as greater improvements in Scalpdex total scores (-39.62 vs. -7.91) compared with placebo (all p < .001). DISCUSSION/CONCLUSIONS: Secukinumab in moderate-to-severe scalp psoriasis reduces scalp pain, itching, and scaling and improves patients' QOL.

Etanercept does not effectively treat moderate to severe alopecia areata: an open-label study.

In this prospective, open-label pilot study, we evaluated the safety and efficacy of etanercept, a TNF-alpha inhibitor, in the treatment of moderate to severe alopecia areata, alopecia totalis, or alopecia universalis. Seventeen otherwise healthy adults with moderate to severe alopecia areata were enrolled. The primary outcome measure was the extent of hair regrowth during and after the end of treatment as evaluated by the Severity of Alopecia Tool (the SALT score). After between 8 and 24 weeks of continuous treatment with etanercept 50 mg given subcutaneously twice weekly, significant regrowth of hair was not shown in any of the subjects treated. Based on these results, etanercept appears to be ineffective in treating subjects with treatment-refractory, moderate to severe alopecia areata, alopecia totalis, or alopecia universalis.

A comparison of the safety and effectiveness of dabigatran and warfarin in non-valvular atrial fibrillation patients in a large healthcare system.

Dabigatran is approved for stroke risk reduction in patients with nonvalvular atrial fibrillation (NVAF). Data from diverse clinical practice settings will help establish whether the risk:benefit ratio seen in clinical trials is comparable with routine clinical care. This study aimed to compare the safety and effectiveness of dabigatran and warfarin in clinical practice. We undertook a propensity score-matched (PSM) cohort study (N=12,793 per group; mean age 74) comparing treatment with dabigatran or warfarin in the US Department of Defense claims database, October 2009 to July 2013. Treatment-naïve patients with first prescription claim for dabigatran (either FDA-approved dose) or warfarin between October 2010 and July 2012 (index) and a diagnosis of NVAF during the 12 months before index date were included. Primary outcomes were stroke and major bleeding. Secondary outcomes included ischaemic and haemorrhagic stroke, major gastrointestinal (GI), urogenital or other bleeding, myocardial infarction (MI) and death. Time-to-event was investigated using Kaplan-Meier survival analyses. Outcomes comparisons were made utilising Cox-proportional hazards models of PSM groups. Dabigatran users experienced fewer strokes (adjusted hazard ratio [95 % confidence intervals] 0.73 [0.55-0.97]), major intracranial (0.49 [0.30-0.79]), urogenital (0.36 [0.18-0.74]) and other (0.38 [0.22-0.66]) bleeding, MI (0.65 [0.45-0.95]) and deaths (0.64 [0.55-0.74]) than the warfarin group. Major bleeding (0.87 [0.74-1.03]) and major GI bleeding (1.13 [0.94-1.37]) was similar between groups and major lower GI bleeding events were more frequent (1.30 [1.04-1.62]) with dabigatran. In conclusion, compared with warfarin, dabigatran treatment was associated with a lower risk of stroke and most outcomes measured, but increased incidence of major lower GI bleeding.

Phaeohyphomycosis caused by Coniothyrium.

A 49-year-old immunosuppressed heart transplant recipient developed a superficial and subcutaneous granulomatous infection caused by Coniothyrium. The patient responded to a combination of surgical excision and antifungal agents. We review phaeohyphomycotic infections including this second report of a Coniothyrium infection.

Association between outpatient visits following hospital discharge and readmissions among Medicare beneficiaries with atrial fibrillation and other chronic conditions.

Atrial fibrillation (AF) afflicts nearly 3 million people in the United States annually, the large majority of whom are Medicare beneficiaries with other chronic illnesses. Beneficiaries with multiple chronic conditions have high hospitalization and readmission rates but evidence on factors associated with readmissions is limited, and little is known about differences in rates between beneficiaries with and without AF. In a retrospective analysis of Medicare claims data, the relationship between outpatient visits within 14 days after hospital discharge and readmission was examined for beneficiaries with AF or other chronic conditions. About half of those beneficiaries with a hospitalization had an outpatient visit within 14 days of discharge. Readmission rates were 11% to 24% lower for beneficiaries with an outpatient visit than for those without one (P < .01). These findings suggest that follow-up care shortly after discharge may lower readmissions for patients with AF or other chronic conditions.

Readmission among hospitalized patients with nonvalvular atrial fibrillation.

PURPOSE: Hospital readmission rates for patients with nonvalvular atrial fibrillation (NVAF), as well as reasons and risk factors for rehospitalization, were investigated. METHODS: Demographic, clinical, and prescription claims data on patients hospitalized for atrial fibrillation (AF) over a five-year period were extracted from insurance claims databases; from that data set, a subset of adults with NVAF on whom continuous data were available before and after the index admission (n = 6439) was identified, and their 30-day readmission rate was examined. RESULTS: The overall 30-day readmission rate was 18.0%. The five most common readmission diagnoses (grouped per International Classification of Diseases codes) were general and other nonspecific symptoms (12.8% of readmitted patients), AF (10.2%), ischemic heart disease (7.2%), heart failure (7.1%) and cerebrovascular disease (6.0%). Controlling for demographic and clinical variables,index admission factors associated with an increased risk of readmission included a longer hospital length of stay, higher Charlson Comorbidity Index scores, and admission through the emergency room (p ≤ 0.01 for all). For the subset of patients discharged from the index admission to home self-care (n = 1161), no individual follow-up care measure evaluated (a physician or other medical office visit, International Normalized Ratio testing, filling an anticoagulant prescription) taken within 7 days of discharge correlated with reduced readmission risk during postdischarge days 8-30. CONCLUSION: The 30-day readmission rate for patients hospitalized with NVAF was comparable to rates previously documented among patients with other cardiac conditions. Symptoms, AF, ischemic heart disease, heart failure, and cerebrovascular disease were the most common reasons for readmission.

Higher persistence in newly diagnosed nonvalvular atrial fibrillation patients treated with dabigatran versus warfarin.

BACKGROUND: Oral anticoagulation therapy is the primary tool in reducing stroke risk in patients with nonvalvular atrial fibrillation but is underused. Patients nonpersistent with therapy contribute to this underuse. The objective of this study was to compare persistence rates in newly diagnosed nonvalvular atrial fibrillation patients treated with warfarin versus dabigatran as their oral anticoagulation. METHODS AND RESULTS: US Department of Defense administrative claims were used to identify patients receiving warfarin or dabigatran between October 28, 2010, and June 30, 2012. Patient records were examined for a minimum of 12 months before index date to restrict the analyses to those newly diagnosed with nonvalvular atrial fibrillation and naive-to-treatment, identifying 1775 on warfarin and 3370 on dabigatran. Propensity score matching was used to identify 1745 matched pairs. Persistence was defined as time on therapy to discontinuation. Kaplan-Meier curves were used to depict persistence over time. Cox proportional hazards model was used to determine the factors significantly associated with persistence. Using a 60-day permissible medication gap, the persistence rates were higher for dabigatran than for warfarin at both 6 months (72% versus 53%) and 1 year (63% versus 39%). Patients on dabigatran with a low-to-moderate risk of stroke (CHADS2<2) or with a higher bleed risk (HEMORR2HAGES>3) had a higher likelihood of nonpersistence (hazard ratios, 1.37; 95% confidence interval, 1.17-1.60; P<0.001; and hazard ratios, 1.24; 95% confidence interval, 1.04-1.47; P=0.016). CONCLUSIONS: Patients who initiated dabigatran treatment were more persistent than patients who began warfarin treatment. Within each cohort, patients with lower stroke risk were more likely to discontinue therapy.

Development of a conceptual model of adherence to oral anticoagulants to reduce risk of stroke in patients with atrial fibrillation.

BACKGROUND: Oral anticoagulant (OA) medication is the recommended therapy for reducing the risk of thromboembolic complications in patients with atrial fibrillation (AF), and warfarin is the medication most frequently used. However, nonadherence associated with OA medications may lead to considerable health risks. A conceptual model of OA medication adherence in patients with AF could clarify factors affecting adherence, thereby assisting in the development and structuring of adherence-promotion programs. To our knowledge, such a model, driven by information obtained directly from patients, has never been developed. OBJECTIVE: To develop a conceptual model of adherence to OA medication based on a literature review and patient feedback via qualitative research among patients with AF. METHODS: A literature search was conducted of English-language articles published between the years 2005 and 2010 that related to factors affecting OA medication adherence, excluding articles pertaining to AF associated with mechanical heart valve replacement. To expand on the literature review findings, 4 focus groups totaling 38 participants aged 60 years or older, diagnosed with nonvalvular AF, and currently taking any OA medication were conducted in 2011. Participants completed the Modified Morisky Scale (MMS), with subscales measuring motivation and knowledge, and were asked about daily processes and behaviors related to taking OA medication. The identification of focus group themes was based on the frequency of participant report and endorsement; themes were spontaneously mentioned or supported by at least 2 people in each of at least 3 focus groups. Model concepts, based on focus group themes and factors identified in the literature review, were determined by the consensus of 3 authors. RESULTS: 181 publications were identified; 30 were selected for full-text review. The focus group participants had a mean age of 69.9 years. Most participants reported a diagnosis of hypertension (86.8%, n=33), high cholesterol (50.0%, n=19), heart disease or chronic heart failure (31.6%, n=12), or diabetes (28.9%, n=11). Most (89.5%, n=34) were taking warfarin. About one-half (52.6%, n=20) had been taking an OA medication for less than 5 years. On the MMS, 78.9% of participants reported high levels of motivation, and 100% reported high levels of knowledge. Four concepts emerged from the focus groups and were supported by the literature for inclusion in the model: (a) knowledge base of the disease and continued reinforcement (i.e., health care professional reinforcement); (b) short-term and long-term motivation (e.g., avoidance of negative health consequences); (c) personalized system, habit formation, and system adaptation (e.g., developing a routine or external reminders); and (d) self-efficacy loop (i.e., the personalized system and its adaptability are reinforced as patients become more consistent, confident, and adherent). The literature review also suggested other factors that may also affect patient adherence (e.g., demographic, psychosocial, cognitive). CONCLUSION: Adherence in patients with AF is complex and involves multiple factors, some specific to each individual and others more general. This model identifies an adherence process that can guide opportunities for effective interventions, such as educational and behavioral programs targeted at these processes, to improve patient adherence to OA medication.

Anticoagulant use, the prevalence of bridging, and relation to length of stay among hospitalized patients with non-valvular atrial fibrillation.

OBJECTIVE: The objectives of this study were to describe inpatient anticoagulation and bridging in patients with non-valvular atrial fibrillation (NVAF) and to identify whether differences exist in length of stay (LOS) among bridged versus non-bridged NVAF patients. DESIGN: Administrative claims data were used to select patients ≥18 years with a primary or secondary discharge diagnosis of NVAF and inpatient warfarin use from 1 July 2004 to 30 September 2009. Patients with valvular or transient causes of NVAF or pregnancy were excluded. Inpatient bridging was defined as receipt of an anticoagulant in addition to warfarin during the hospitalization. LOS was reported for non-bridged patients (warfarin only) and compared with three bridging regimens: low molecular weight heparin/pentasaccharide (LMWH/PS); unfractionated heparin (UFH); and two-agent bridging (LMWH/PS and UFH). Multivariate analyses were performed to evaluate the association between bridging and LOS, adjusting for demographic and clinical variables. RESULTS: Of 6340 NVAF patients, 48% received inpatient warfarin (mean LOS 5.5 days); among them, 64% received bridging therapy (mean LOS 6.3 days) [LMWH/PS 45% (mean LOS 5.6 days), UFH 36% (mean LOS 6.0 days), two-agent bridging 18% (mean LOS 8.4 days)]. Following multivariate analysis, relative to patients who received inpatient warfarin only, LOS was significantly higher for patients with UFH (19.3%) and patients with two-agent bridging (45.1%). Patients with pre-period warfarin, cancer, or diabetes mellitus who received bridging agents had significantly longer LOS than patients with those conditions who were not bridged. CONCLUSION: LOS was longer for bridged than non-bridged patients. Further studies are needed to identify predictors of bridging and to explain why bridged NVAF patients had longer LOS.

Long-Term Costs of Ischemic Stroke and Major Bleeding Events among Medicare Patients with Nonvalvular Atrial Fibrillation.

Purpose. Acute healthcare utilization of stroke and bleeding has been previously examined among patients with nonvalvular atrial fibrillation (NVAF). The long-term cost of such outcomes over several years is not well understood. Methods. Using 1999-2009 Medicare medical and enrollment data, we identified incident NVAF patients without history of stroke or bleeding. Patients were followed from the first occurrence of ischemic stroke, major bleeding, or intracranial hemorrhage (ICH) resulting in hospitalization. Those with events were matched with 1-5 NVAF patients without events. Total incremental costs of events were calculated as the difference between costs for patients with events and matched controls for up to 3 years. Results. Among the 25,465 patients who experienced events, 94.5% were successfully matched. In the first year after event, average incremental costs were $32,900 for ischemic stroke, $23,414 for major bleeding, and $47,640 for ICH. At 3 years after these events, costs remained elevated by $3,156-$5,400 per annum. Conclusion. While the costs of stroke and bleeding among patients with NVAF are most dramatic in the first year, utilization remained elevated at 3 years. Cost consequences extend beyond the initial year after these events and should be accounted for when assessing the cost-effectiveness of treatment regimens for stroke prevention.

Clinical and economic outcomes associated with National Kidney Foundation guideline-concordant oral antidiabetic drug treatment among type 2 diabetes patients with chronic kidney disease.

OBJECTIVE: To assess outcomes associated with oral anti-diabetic drug (OAD) treatment concordant with guidelines from the National Kidney Foundation (NKF) among type 2 diabetes mellitus (T2DM) patients with chronic kidney disease (CKD). METHODS: Electronic health record data between 1/1/2005 and 10/31/2010 provided by an integrated health system were analyzed. T2DM patients were selected based on diagnosis from the health record. Patients with stages 3-5 CKD based on diagnosis or lab results were further identified with the date of first indicated CKD set as index date. Patients who had a medication order of OADs within three months of the index date were included. Patients were considered non-guideline-concordant if prescribed OADs that were recommended to be avoided or if they required dosage adjustment, but were unadjusted. Glycemic control, hospital admissions, and costs of encounters were assessed over a 12-month post-index period, and hypoglycemic events were evaluated until loss of follow-up. Regression analyses were performed, adjusting for patient demographic and clinical characteristics. RESULTS: Among 6058 patients (mean age: 70; 42% male), 45% were not [corrected] guideline-concordant. After adjusting for patient characteristics, guideline-concordant patients had a lower risk for hypoglycemic events (HR: 0.72; 95% CI: 0.62-0.83), were less likely to have a hospital admission (OR: 0.87; 95% CI: 0.77-0.98), and more likely to have glycemic control (OR: 1.64, 95% CI: 1.46-1.84). Non-guideline-concordant patients had annual encounter costs of 1.10 times those of guideline-concordant patients (marginal cost = $731; P = 0.04). LIMITATIONS: Unobservable confounders may still exist and bias the results; therefore, findings should be interpreted as associations instead of causations. Findings were based on a single integrated health system and may not be generalizable to larger populations. CONCLUSION: The findings of this exploratory study suggest that guideline-concordant treatment may yield better clinical and economic outcomes. Future research with a better controlled design is warranted to confirm these preliminary findings.

Alefacept for severe alopecia areata: a randomized, double-blind, placebo-controlled study.

OBJECTIVE: To assess the efficacy of alefacept for the treatment of severe alopecia areata (AA). DESIGN: Multicenter, double-blind, randomized, placebo-controlled clinical trial. SETTING: Academic departments of dermatology in the United States. PARTICIPANTS: Forty-five individuals with chronic and severe AA affecting 50% to 95% of the scalp hair and resistant to previous therapies. Intervention Alefacept, a US Food and Drug Administration-approved T-cell biologic inhibitor for the treatment of moderate to severe plaque psoriasis. Main Outcome Measure Improved Severity of Alopecia Tool (SALT) score over 24 weeks. RESULTS: Participants receiving alefacept for 12 consecutive weeks demonstrated no statistically significant improvement in AA when compared with a well-matched placebo-receiving group (P = .70). Conclusion Alefacept is ineffective for the treatment of severe AA.