Real-Life Effectiveness and Tolerance of Baricitinib for the Treatment of Severe Alopecia Areata with 1-Year Follow-Up Data.

INTRODUCTION: The efficacy of conventional treatments for alopecia areata (AA) has been extremely variable and disappointing, with a high rate of relapse. Recent clinical trials and real-life studies have demonstrated efficacy and safety of baricitinib (an oral Janus kinase 1 and 2 inhibitor) in alopecia areata. METHODS: We retrospectively evaluated the effectiveness and tolerance of baricitinib in alopecia areata in a real-life Belgian monocentric adult cohort. The primary outcome was evaluated by the percentage of patients who achieved a Severity of Alopecia Tool (SALT) score of ≤ 20 at the end of the follow-up. All treatment-emergent adverse events were collected. RESULTS: In this 19-patient series, with a median ± interquartile range (IQR) follow-up duration of 13 ± 16.2 months, we demonstrated that: (i) hair regrowth was observed in nearly 90% of patients between 4 and 16 weeks after initiation of baricitinib; (ii) at the end of the follow-up, more than 70% and, in particular, 100% of patients with patchy AA, reached the primary outcome (SALT score ≤ 20); (iii) almost half of the patients, mostly with patchy AA, showed a complete hair regrowth (SALT score = 0), within a median ± IQR treatment time of 8.5 ± 10 months; (iv) baricitinib was discontinued in three patients with total hair regrowth, two of whom relapsed; and (v) no serious adverse events were reported. CONCLUSION: Baricitinib is effective in treating patients with alopecia areata, particularly for the patchy phenotype, but with a risk of relapse after discontinuation. Safety data are reassuring, with lipid changes being the most frequent adverse event.

Secukinumab in Pediatric Patients with Plaque Psoriasis: Pooled Safety Analysis from Two Phase 3 Randomized Clinical Trials.

BACKGROUND: Plaque psoriasis affects ~ 1% of the pediatric population, negatively impacting quality of life. The efficacy and safety of secukinumab in pediatric patients with moderate to severe or severe chronic plaque psoriasis have been established in two pivotal phase 3 trials (open-label, NCT03668613; double-blind, NCT02471144). OBJECTIVES: The aims were to report the pooled safety of secukinumab up to 52 weeks from two studies in subgroups of pediatric patients stratified by age and bodyweight, and to present, alongside the pediatric data, the pooled safety data from four pivotal adult secukinumab trials. METHODS: The safety of secukinumab was evaluated in subgroups of pediatric patients defined by age (6 to < 12 and 12 to < 18 years) and bodyweight (< 25 kg, 25 to < 50 kg, and ≥ 50 kg) in the pooled population. Patients received secukinumab low dose (LD; 75/75/150 mg), secukinumab high dose (HD; 75/150/300 mg), placebo, or etanercept (0.8 mg/kg). For safety analyses, data were pooled from the pediatric studies NCT03668613 and NCT02471144, and presented alongside the pooled data from four adult pivotal studies (NCT01365455, NCT01636687, NCT01358578, NCT01555125). RESULTS: A total of 198 pediatric patients (overall exposure: 184.6 patient-years [PY]) and 1989 adult patients (1749.5 PY) receiving secukinumab up to week 52 were included in this analysis. At week 52, the incidence of adverse events (AEs) was lower in the lower age and bodyweight subgroups. The AEs reported within these subgroups were consistent with the overall AEs reported in this analysis. Overall, exposure-adjusted incidence rates for treatment-emergent AEs were lower in the secukinumab-treated pediatric pool (198.8/100 PY) compared with the etanercept (266.3/100 PY) and adult pools (256.1/100 PY). Up to 52 weeks, the incidence rates of the AEs in the secukinumab-treated patients in the 6 to < 12 years subgroup and 12 to < 18 years subgroup were 167.7/100 PY and 214.7/100 PY, respectively. Similarly, incidence rates of the AEs in the secukinumab-treated patients in the < 25 kg, 25 kg to < 50 kg, and ≥ 50 kg subgroups were 177.3/100 PY, 192.5/100 PY, and 206.8/100 PY, respectively. Nasopharyngitis was the most frequently reported AE in secukinumab-treated pediatric patients across age (< 12 years: 11.8/100 PY; ≥ 12 years: 42.4/100 PY) and bodyweight (< 25 kg: 22.8/100 PY; 25 kg to < 50 kg: 19.0/100 PY; ≥ 50 kg: 43.0/100 PY). Of the 198 secukinumab-treated pediatric patients, one reported nail Candida, one reported skin Candida, and two reported vulvovaginal Candida. Transient and mostly mild events of neutropenia were observed with secukinumab, none leading to study treatment discontinuation. No incidence of treatment-emergent anti-drug antibodies was reported in pediatric patients treated with secukinumab. CONCLUSIONS: Secukinumab was well tolerated in pediatric patients with moderate to severe and severe plaque psoriasis across age and bodyweight subgroups. The overall safety profile of secukinumab in pediatric patients was consistent with that of adult patients. GOV IDENTIFIER: NCT03668613 (Novartis Study Code CAIN457A2311, referred to as A2311), actual study start date: August 29, 2018; actual primary completion date: September 19, 2019; estimated study completion date: September 14, 2023. NCT02471144 (Novartis Study Code CAIN457A2310, referred to as A2310), study start date: September 29, 2015; primary completion date: December 13, 2018; estimated study completion date: March 31, 2023.

Real-Life Experience of Tralokinumab for the Treatment of Adult Patients with Severe Atopic Dermatitis: A Multicentric Prospective Study.

BACKGROUND: Tralokinumab, the first fully human monoclonal antibody that binds specifically to interleukin-13, was safe and effective for treating atopic dermatitis (AD) in clinical trials, but real-life experience is still limited. OBJECTIVES: The objective of this study was to evaluate the effectiveness and safety of tralokinumab in severe AD in a real-life multicenter prospective cohort. METHODS: Adult patients with severe AD were enrolled between January 2022 and July 2022 and received tralokinumab subcutaneously for 16 weeks. Objective and subjective scores were collected at baseline, weeks 6 and 16. Adverse events were reported throughout the study. RESULTS: Twenty-one patients were included. An improvement of at least 75% on the Eczema Area and Severity Index (EASI 75) was achieved in 66.7% of patients at week 16. The median objective and subjective scores at week 16 were significantly (p < 0.001) lower than those at baseline. Combination with cyclosporine was sometimes necessary at the beginning of treatment, and addition of upadacitinib was required for some patients with very severe disease during the treatment. The most frequent adverse events were flares of eczema (23.8%) and reactions at injection site (19.0%). No cases of conjunctivitis were reported. Four patients (19.0%) discontinued treatment. CONCLUSIONS: Tralokinumab is an effective first-line biotherapy for severe AD. However, therapeutic response may be progressive. Safety data were reassuring. Atopic dermatitis flares or reactions at the injection site may lead to discontinuation of treatment. A history of conjunctivitis on dupilumab is not a contraindication to the initiation of tralokinumab.

Real-Life Effectiveness and Tolerance of Upadacitinib for Severe Atopic Dermatitis in Adolescents and Adults.

INTRODUCTION: The efficacy and safety of upadacitinib in atopic dermatitis have been defined in clinical trials, but long-term real-life experience, essential for clinical decision-making, is still limited. We aimed to assess the effectiveness and tolerance of upadacitinib in a real-life cohort of adults and adolescents with severe atopic dermatitis in whom previous systemic therapies largely failed. METHODS: Retrospective cohort study collecting data from adults and adolescents treated with upadacitinib 15 or 30 mg per day between July 2021 to August 2022. The outcomes for effectiveness were evaluated by the percentage of patients who achieved a validated Investigator's Global Assessment for atopic dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and/or an improvement of at least 75% on the Eczema Area and Severity Index (EASI 75) at the end of the follow-up. All treatment-emergent adverse events were collected. RESULTS: A total of 29 patients were included (22 adults and 7 adolescents), with a median follow-up of 54.4 weeks. At the end of the follow-up, 23 patients (79.3%) reached a vIGA-AD of 0/1, and 24 patients (82.7%) achieved EASI 75. Among patients treated with upadacitinib after initial failure of first- and/or second-line treatment with biologics or baricitinib, 5/7 patients (71.4%) reached a vIGA-AD score of 0/1. Disease control was slightly better in adults than in adolescents (81.8% vs 71.4% reached the efficacy endpoint, respectively). Response rate in patients with upadacitinib 15 mg seemed better than in clinical trials or network meta-analysis. Safety data were reassuring; lipid changes were the most frequent adverse event. CONCLUSION: This real-life study confirms the effectiveness of upadacitinib, particularly for the treatment of atopic dermatitis recalcitrant to conventional systemic agents, biologics or baricitinib. Induced lipid changes require close follow-up.

Development and validation of an automated algorithm for end point adjudication for a large U.S. national registry.

BACKGROUND: Clinical events committee (CEC) evaluation is the standard approach for end point adjudication in clinical trials. Due to resource constraints, large registries typically rely on site-reported end points without further confirmation, which may preclude use for regulatory oversight. METHODS: We developed a novel automated adjudication algorithm (AAA) for end point adjudication in the National Cardiovascular Data Registry Left Atrial Appendage Occlusion (LAAO) Registry using an iterative process using CEC adjudication as the "gold standard." A ≥80% agreement rate between automated algorithm adjudication and CEC adjudication was prespecified as clinically acceptable. Agreement rates were calculated. RESULTS: A total of 92 in-hospital and 127 post-discharge end points were evaluated between January 1, 2016 and June 30, 2019 using AAA and CEC. Agreement for neurologic events was >90%. Percent agreement for in-hospital and post-discharge events was as follows: ischemic stroke 95.7% and 94.5%, hemorrhagic stroke 97.8% and 96.1%, undetermined stroke 97.8% and 99.2%, transient ischemic attack 98.9% and 98.4% and intracranial hemorrhage 100.0% and 94.5%. Agreement was >80% for major bleeding (83.7% and 90.6%) and major vascular complication (89.1% and 97.6%). With this approach, <1% of site reported end points require CEC adjudication. Agreement remained very good during the period after algorithm derivation. CONCLUSIONS: An AAA-guided approach for end point adjudication was successfully developed and validated for the LAAO Registry. With this approach, the need for formal CEC adjudication was substantially reduced, with accuracy maintained above an 80% agreement threshold. After application specific validation, these methods could be applied to large registries and clinical trials to reduce the cost of event adjudication while preserving scientific validity.

Efficacy and safety of baricitinib in combination with topical corticosteroids in patients with moderate-to-severe atopic dermatitis with inadequate response, intolerance or contraindication to ciclosporin: results from a randomized, placebo-controlled, phase III clinical trial (BREEZE-AD4).

BACKGROUND: Baricitinib, an oral selective Janus kinase (JAK)1 and JAK 2 inhibitor, was shown to improve the signs and symptoms of moderate-to-severe atopic dermatitis (AD). OBJECTIVES: To evaluate the efficacy and safety of baricitinib with background topical corticosteroids (TCS) in patients with moderate-to-severe AD and inadequate response, intolerance or contraindication to ciclosporin A (CA). METHODS: In this double-blind, randomized, placebo-controlled, phase III study, patients were randomized 1: 1: 2: 1 to placebo (N = 93), baricitinib 1 mg (N = 93), 2 mg (N = 185) or 4 mg (N = 92) with background TCS. The primary endpoint was the proportion of patients receiving baricitinib 4 mg or 2 mg (+ TCS) vs. placebo + TCS who achieved ≥ 75% improvement from baseline in the Eczema Area and Severity Index (EASI 75) at week 16. RESULTS: Baricitinib 4 mg + TCS was superior to placebo + TCS for EASI 75 (4 mg: 32%, placebo: 17%, P = 0·031) at week 16 and for improvements in itch, skin pain and number of night-time awakenings owing to itch. Improvements were maintained through 52 weeks of treatment. Treatment-emergent adverse events (TEAEs) were more common with baricitinib than placebo (+ TCS); most were mild or moderate. The most frequent TEAEs with baricitinib 4 mg + TCS were nasopharyngitis, herpes simplex, influenza and headache. No deaths or deep vein thromboses were reported. CONCLUSIONS: Baricitinib 4 mg + TCS improved the signs and symptoms of moderate-to-severe AD through 52 weeks of treatment in patients with inadequate response, intolerance or contraindication to CA. The safety profile was consistent with previous studies of baricitinib in moderate-to-severe AD. What is already known about this topic? Ciclosporin A is indicated for the treatment of atopic dermatitis that is refractory to topical therapies. However, its use is limited by safety concerns and it may not provide adequate response for some patients. Baricitinib, an oral selective Janus kinase (JAK)1 and JAK2 inhibitor, has been shown to improve the signs and symptoms of moderate-to-severe atopic dermatitis as a monotherapy or in combination with topical corticosteroids. What does this study add? Baricitinib combined with background low- or moderate-potency topical corticosteroids provided improvements in the signs and symptoms of moderate-to-severe atopic dermatitis through 1 year of treatment in patients with a contraindication, intolerance or failure to respond to ciclosporin A. The most common treatment-emergent adverse events with baricitinib 4 mg were nasopharyngitis, herpes simplex, influenza and headache. The safety profile was consistent with previous studies in patients with moderate-to-severe atopic dermatitis.

Real-Life Effectiveness of Apremilast for the Treatment of Psoriasis in Belgium: Results From the Observational OTELO Study.

INTRODUCTION: Apremilast is approved for the treatment of psoriasis and psoriatic arthritis. However, data on the efficacy and safety of apremilast in clinical practice are limited. We assessed the real-world use and effectiveness of apremilast in patients with moderate to severe plaque psoriasis visiting dermatologist practices in Belgium, from the perspectives of the patient and the physician. METHODS: This prospective observational study enrolled adults aged 18 years or more initiating apremilast between 6 April 2017 and 30 June 2018, per Belgian reimbursement criteria. Primary outcome was the Patient Benefit Index for Skin Diseases (PBI-S). Secondary outcomes included the Patient Global Assessment (PtGA), Dermatology Life Quality Index (DLQI), Psoriasis Area and Severity Index (PASI), and body surface area (BSA). Patients were followed up for up to 18 months. RESULTS: Overall, 122 enrolled patients received at least one dose of apremilast, of which 89 received treatment for more than 150 days and were included in the reference population. Treatment goals most frequently identified (at least 70% of patients) as "very important" in the PBI-S were related to physical impairments. After 6 months of apremilast treatment, 61-78% of patients reported they had achieved these goals; only 12.5% assessed their disease as severe (PtGA, 53.6% at apremilast initiation) and over half reported a DLQI score of 5 or less, indicating improved quality of life. As assessed by the physician, 68.4% and 35.1% of patients achieved at least a 50% and 75% reduction in PASI, respectively, at month 6. Apremilast was well tolerated with no new safety signals identified. CONCLUSIONS: Our real-world data indicate that apremilast fulfils the expectations of Belgian patients with moderate to severe psoriasis, and from the perspectives of both the patient and physician, apremilast has a positive impact on their disease. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03097003.

Evaluating blood donor experiences and barriers/facilitators to blood donation in the United States using YouTube video content.

BACKGROUND: Understanding donor perception of the blood donation experience is central to maintaining an adequate blood supply. Studies that use questionnaires to assess barriers/facilitators to donation may be influenced by response bias. To address this, we conducted an innovative study integrating quantitative informatic techniques with qualitative data analysis of YouTube video content to explore donor experiences and barriers and facilitators to whole blood donation. METHODS: Sampling of YouTube videos was conducted using search parameters for identifying relevant videos, based on donors' language used to describe their whole blood donation experiences (e.g., blood donation, blood donor, donated blood, gave/give blood). We eliminated duplicate videos; filtered out non-English videos, those made outside the United States, and those with no transcripts; and restricted the time period during which videos were posted from 2015 to 2019. Search parameters were fed into a Python script, which downloaded video transcripts for all search results. The final sample was 102 noncommercial and 34 commercial transcripts. The subsequent transcriptions were uploaded into qualitative analysis software and coded two coders. A third coder randomly selected transcripts to review to ensure consistency. RESULTS: Barriers to whole blood donation include having prior negative experiences with donation and donation-related fear. Facilitators included altruism, having a personal connection to donation, donation center incentives, and positive experiences with blood center staff. CONCLUSION: Themes identified in this study were similar to those in the existing literature. This suggests that current questionnaires to address barriers/facilitators to donation are unlikely to be meaningfully impacted by response bias.

Cloud Formation From a Localized Water Release in the Upper Mesosphere: Indication of Rapid Cooling.

Polar mesospheric clouds (PMCs) occur in the summer near 82 -85km altitude due to seasonal changes of temperature and humidity. However, water vapor and associated PMCs have also been observed associated with rocket exhaust. The effects of this rocket exhaust on the temperature of the upper mesosphere are not well understood. To investigate these effects, 220 kg of pure water was explosively released at 85 km as part of the Super Soaker sounding rocket experiment on the night of January 25-26, 2018 at Poker Flat Research Range (65°N, 147°W). A cloud formed within 18 s and was measured by a ground-based Rayleigh lidar. The peak altitude of the cloud appeared to descend from 92 to 78 km over 3 min. Temperatures leading up to the release were between 197 and 232 K, about 50 K above the summertime water frost point when PMCs typically occur. The apparent motion of the cloud is interpreted in terms of the expansion of the explosive release. Analysis using a water vapor radiative cooling code coupled to a microphysical model indicates that the cloud formed due to the combined effects of rapid radiative cooling (∼25 K) by meter-scale filaments of nearly pure water vapor (∼1 ppv) and an increase in the frost point temperature (from 150 to 200 K) due to the high concentration of water vapor. These results indicate that water exhaust not only acts as a reservoir for mesospheric cloud production but also actively cools the mesosphere to induce cloud formation.

Classifying Community Organizational Health Communication Networks: Local Health Department Recognition of Public Information-Sharing Partners Across Sectors.

OBJECTIVE: Local health departments (LHDs) operate within complex, multisectoral organizational communication networks. Network composition may affect priorities, processes, and the reach of health information to key stakeholders. This study seeks to elucidate variation in local network structures to examine how different constellations may affect information sharing across audiences. DESIGN: This study analyzes data from a 2016 US survey of 491 metropolitan LHDs and 556 nonmetropolitan LHDs. Researchers first conducted social network analysis of network density, defined as the total number of potential organizations contributing to a jurisdiction's health communication activities. Researchers then conducted logistic regression to compare the relationship between network density and reported health communication activities targeting 3 specific audiences: policy makers, lay publics, and mass media. RESULTS: Three network types emerged on the basis of the number of organizations that contribute to health communication activities, with low-density Minimal networks more common in nonmetropolitan jurisdictions and higher-density Expanded and Robust networks more common in metropolitan jurisdictions. LHDs in Minimal networks were significantly less likely to communicate with policy makers, lay publics, and mass media than their counterparts in higher-density networks (P < .05). CONCLUSIONS: LHDs are embedded in organizational communication networks that vary in both the number of communication partners and the types of audiences reached. Examining their own local organizational communication networks may provide insights into LHDs that wish to improve the effectiveness of public health messaging. By adding organizational communication partners and reaching new audiences, LHDs in Minimal networks can expand the reach of messages designed to help policy makers, communities, and individuals promote health and prevent disease.

Secukinumab Use in Patients with Moderate to Severe Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis in Real-World Setting in Europe: Baseline Data from SERENA Study.

INTRODUCTION: Secukinumab, a fully human monoclonal antibody that directly inhibits interleukin-17A, has demonstrated robust efficacy in the treatment of moderate to severe psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS), with a rapid onset of action, sustained long-term clinical responses and a consistently favourable safety profile across phase 3 trials. Here, we report the clinical data at enrolment from SERENA, designed to investigate the real-world use of secukinumab across all three indications. METHODS: SERENA is an ongoing, longitudinal, observational study conducted at 438 sites across Europe in patients with moderate to severe plaque PsO, active PsA or active AS. Patients should have received at least 16 weeks of secukinumab treatment before enrolment in the study. RESULTS: Overall 2800 patients were included in the safety set; patients with PsA (N = 541) were older than patients with PsO (N = 1799) and patients with AS (N = 460); patients with PsO had a higher mean body weight than patients with PsA and patients with AS; and patients with PsO and patients with AS were predominantly male. Time since diagnosis was longer in patients with PsO compared with patients with PsA and patients with AS, and about 40% of patients were either current or former smokers. The proportion of obese patients (body mass index ≥ 30 kg/m2) was similar across indications. Patients were treated with secukinumab for a mean duration of 1 year prior to enrolment (range 0.89-1.04). The percentages of patients with prior biologics exposure were 31.5% PsO, 59.7% PsA and 55% AS. The percentages of patients prescribed secukinumab monotherapy were 75% (n = 1349) in PsO, 48.2% (n = 261) in PsA and 48.9% (n = 225) in AS groups. CONCLUSION: Baseline demographics of the study population are consistent with existing literature. This large observational study across all secukinumab indications will provide valuable information on the long-term effectiveness and safety of secukinumab in the real-world setting.

[Disclosure of an Alzheimer's disease diagnosis]. / L'annonce du diagnostic de la maladie d'Alzheimer.

The disclosure of the diagnosis of Alzheimer's disease is a necessity and a right for patients and their family. If forms part of a diagnosis procedure which gives an origin and an explanation to the impairments. The disclosure ensures patients become engaged in their care and enables them to maintain some form of hope regarding their remaining capacities.

Development of a Tool to Guide Parents Carrying a BRCA1/2 Mutation Share Genetic Results with Underage Children.

Although most parents carrying a BRCA1/2 genetic mutation share their test result with their underage children, they report needing support to decide if, when, and how to share risk information and what reactions to expect from their children. We developed a tool to guide parents carrying a BRCA1/2 mutation share their genetic result with underage children. Here, we report on the development of this tool using a qualitative methodology. A tool prototype was developed based on the International Patient Decision Aids Standards Collaboration framework. Content was assessed using feedback from focus groups, individual interviews, and a 12-item reading grid. Participants were nine BRCA1/2 mutation carriers with underage children and three cancer genetics health professionals. Thematic content analysis was conducted on interview transcripts. The tool was developed using an iterative process until saturation of data. An independent advisory committee was involved in all steps of tool development until reaching consensus. Rather than a decision aid per se (to communicate or not), the parents wanted a more comprehensive tool to help them communicate genetic test result to their children. To meet parents' needs, a communication guidance booklet was developed, setting out the pros and cons of communication, steps to prepare sharing the test result, communication tips, and parents' testimonies. This communication tool responds to a significant unmet need faced by parents carrying a genetic predisposition to cancer. Future studies are needed to assess how the information from the parent's genetic test result impacts the child's development, health behaviors, and relationship with the parent.

Efficacy and safety of adalimumab every other week versus methotrexate once weekly in children and adolescents with severe chronic plaque psoriasis: a randomised, double-blind, phase 3 trial.

BACKGROUND: Adalimumab is indicated for the treatment of moderate to severe psoriasis in adults. We assessed the efficacy and safety of adalimumab in children and adolescents with severe plaque psoriasis. METHODS: This randomised, double-blind, multiperiod, phase 3 trial was done at 38 clinics in 13 countries. Patients (aged ≥4 to <18 years) with severe plaque psoriasis who had not responded to topical therapy were randomly assigned with an interactive voice or web-response system (1:1:1) to receive adalimumab 0·8 mg/kg or 0·4 mg/kg subcutaneously at week 0, then every other week starting at week 1, or oral methotrexate once weekly (0·1-0·4 mg/kg) for 16 weeks. Randomisation was stratified by history of etanercept treatment, with a block size of three. Responders were withdrawn from treatment (for up to 36 weeks) and re-treated with adalimumab (for 16 weeks) if disease became uncontrolled. Ranked primary efficacy endpoints were the proportion of patients who achieved at least 75% improvement from baseline in Psoriasis Area and Severity Index (PASI75) score and clear or minimal physician global assessment (PGA) score at week 16, comparing adalimumab 0·8 mg/kg with methotrexate. Efficacy analysis was by intention to treat, and safety analysis included all patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, number NCT01251614, and has been completed. FINDINGS: Between Dec 14, 2010, and Feb 5, 2015, 114 patients were randomly assigned to adalimumab 0·8 mg/kg (n=38), adalimumab 0·4 mg/kg (n=39) or methotrexate (n=37). At week 16, PASI75 was achieved in 22 (58%) of 38 patients in the adalimumab 0·8 mg/kg group compared with 12 (32%) of 37 patients in the methotrexate group (p=0·027). 23 (61%) of 38 patients in the adalimumab 0·8 mg/kg group and 15 (41%) of 37 in the methotrexate group achieved clear or minimal PGA (p=0·083). In the adalimumab 0·4 mg/kg group, 17 (44%) of 39 patients achieved PASI75 and 16 (41%) achieved clear or minimal PGA. The most frequent adverse events were infections (17 [45%] of 38 in the adalimumab 0·8 mg/kg group during initial treatment; 22 [56%] of 39 in the adalimumab 0·4 mg/kg group; 21 [57%] of 37 in the methotrexate group). Three serious adverse events were reported, all in patients in the adalimumab 0·4 mg/kg group, and were not judged to be related to study drug. INTERPRETATION: Treatment with adalimumab 0·8 mg/kg in children and adolescents with severe plaque psoriasis provided significant improvements in PASI75 and a non-significant increase in the proportion of patients who achieved clear or minimal PGA compared with methotrexate. No new safety risks were identified. FUNDING: AbbVie.

Treatment patterns in moderate-to-severe plaque psoriasis: results from a Belgian cross-sectional study (DISCOVER).

PURPOSE: The present study aimed to evaluate current treatment patterns and achievement of treatment goals in Belgian patients with moderate-to-severe plaque psoriasis. MATERIALS AND METHODS: This cross-sectional observational study (DISCOVER) was conducted in 2011 - 2012 in Belgian dermatology centers. Patient data were collected during a single visit and included information on psoriasis management and severity (PASI and DLQI). Treatment success was defined according to the current European consensus treatment goal algorithm. RESULTS: Of the 556 patients included in the study, 38.1% reported no current treatment or only topicals, 34.2% were being treated with traditional systemics and/or phototherapy, and 29.5% with biologics. Methotrexate (11.7%) was the most commonly prescribed traditional systemic and adalimumab (14.2%) was the most commonly prescribed biologic agent at the time of the study. The percentage of patients achieving treatment goals was significantly higher in biologic-treated patients (73.1%) compared to those using traditional systemics (50.6%), phototherapy (41.1%), or no treatment/only topicals (20.9%; p < .001). CONCLUSIONS: Nearly 40% of Belgian patients with moderate-to-severe psoriasis in the DISCOVER study were undertreated despite the severity of their disease. Undertreatment of psoriasis remains a problem in Belgium and more effective educational strategies are needed to ensure the best treatment outcome for these patients. [Formula: see text].

An observational study of the real-life management of psoriasis patients treated with etanercept according to the new reimbursement criteria (in Belgium).

BACKGROUND: This study described the number of patients with psoriasis receiving flexible (continuous/intermittent) dosing with etanercept (ETN) and the real-world economic impact. METHODS: BeFlex was a prospective, observational study with a ≥1 year follow-up. Patients ≥18 years with moderate-to-severe psoriasis who were starting or re-starting treatment with ETN in alignment with Belgian reimbursement criteria were included. Cost of ETN was compared with cost of adalimumab, ustekinumab and infliximab using estimates from the National Institute for Sickness and Disability Insurance (INAMI/RIZIV). RESULTS: In the flexible-dosing cohort (n = 121 with dose-regimen data), 66% were treated continuously and 34% intermittently. Baseline characteristics were similar across dosing cohorts. In the per-protocol cohort (n = 138), average ETN treatment duration/year was 40 weeks; 43 weeks continuous and 33 weeks intermittent. The overall mean interruption duration was 3.9 weeks/treatment cycle; 0.2 week continuous and 11.1 weeks intermittent. Mean dose/year was 2065 mg; 2182 mg continuous and 1660 mg intermittent. Flexible ETN dosing reduced the cost by 20% versus INAMI/RIZIV estimates. The theoretical cost of the other continuously-dosed biologics was 28-44% higher than that of flexible ETN. CONCLUSION: Approximately one-third of Belgian patients received intermittent ETN treatment. Flexible ETN dosing was more cost-effective than treatment with biologic agents that require continuous dosing.