Treatment Of Psoriasis In Children Research Articles

Tapinarof Cream 1% Once Daily for the Treatment of Plaque Psoriasis: Case Photography of Clinical Outcomes from Three Phase3 Trials.

Tapinarof cream 1% (VTAMA®; Dermavant Sciences, Inc.) is a non-steroidal, topical, aryl hydrocarbon receptor agonist approved by the US Food and Drug Administration (FDA) to treat plaque psoriasis in adults and under investigation for the treatment of psoriasis in children down to 2years of age, and for atopic dermatitis in adults and children down to 2years of age. The PSOARING phase3 clinical trial program evaluated tapinarof cream 1% once daily (QD) in adults with mild to severe plaque psoriasis for up to 52weeks (NCT03956355, NCT03983980, NCT04053387). Here we present case photography documenting outcomes in the PSOARING trials. Cases illustrate various outcomes across different body areas, including responses meeting the formal FDA-mandated regulatory endpoint of a Physician Global Assessment (PGA) score of 0 (clear) or 1 (almost clear) and a decrease of at least 2points from baseline at week12, meaningful clinical improvement not meeting this formal endpoint, patient-reported outcomes, and pre-specified adverse events of special interest (AESIs). Tapinarof cream 1% QD demonstrated rapid and highly statistically significant efficacy, with improvements in disease activity and quality of life. In addition, a high rate (40.9%; n = 312/763) of complete disease clearance (PGA = 0) was achieved, and improvements exceeding National Psoriasis Foundation treatment goals were demonstrated. After first achieving complete disease clearance (PGA = 0), patients treated with tapinarof experienced an approximately 4-month remittive effect off therapy. Incidence and severity of folliculitis and contact dermatitis AESIs were generally mild or moderate, localized to the site of application, and associated with low discontinuation rates. Medical images are of importance in trials of dermatologic therapies to inform clinical decision-making and enhance patient assessment. Tapinarof cream 1% QD is efficacious and well tolerated in patients with mild to severe plaque psoriasis, with clinically relevant improvements seen early in the course of treatment.Clinicaltrials.gov numbers: NCT03956355, NCT03983980, NCT04053387.

P05 Biologics combined with conventional systemic agents for the treatment of children with severe psoriasis: real-life data from the BiPe cohorts

Abstract Combined therapies, defined as treatment modalities involving combinations of two or more drugs, are used with three main aims: to increase the efficacy of each drug; to reduce the toxicity of each drug; and, in some cases, to reduce costs by reducing the required dosages of each treatment. We explored the use of combinations of conventional systemic therapies and biologics in children with psoriasis in daily practice from the 170 children in the Franco–Italian BiPe cohorts to evaluate the use, efficacy and safety of combined conventional systemic–biologic therapies. In total, 33 children (19.4%) from 13 dermatology centres received 48 combined conventional systemic–biologic therapies (cumulative duration 43.6 years), including three triple combination therapies (acitretin–methotrexate, with a TNF-α inhibitor). Fourteen different combinations were used, most frequently etanercept–acitretin (n = 10), adalimumab–acitretin (n = 7), adalimumab–methotrexate (n = 5) and ustekinumab–methotrexate (n = 5). The combined therapies were started at biologic initiation in 41 cases (85.4%), and after a period of biologic monotherapy in the remaining seven cases. Mean PGA and PASI scores decreased between baseline and M3 with all the combinations used. Four serious adverse events were reported, all with favourable outcomes. Combined therapies have been used frequently in the treatment of childhood psoriasis, in a range of clinical situations and in variable drug combinations, without significant toxicity. Although the use of these combined therapies needs to be clarified in future management guidelines, these combined therapies should be considered for the treatment of children with severe psoriasis, psoriatic arthritis and recalcitrant ­disease.

P04 Biologics combined with conventional systemic agents for the treatment of children with severe psoriasis: practice survey among French and Italian paediatric dermatologists

Abstract Combined therapies involve the use of multiple drugs to increase efficacy and reduce the toxicity of individual treatments. We performed a survey carried out among French and Italian paediatric dermatologists (SFPD, GrPso, SIDerP) to better understand the reasons for using or avoiding these combinations. The survey was completed by 61 paediatric dermatologists (France, 57.4%; Italy, 42.6%; hospital practice, 98.4%; members of societies of paediatric societies and/or psoriasis working groups, 73.8%). Thirty-nine (63.9%) had previously used or planned to use the combined therapies, most commonly TNF-α inhibitors with acitretin or methotrexate. The most common reasons for dermatologists not using combined therapies were a lack of information about the safety (27.3%) or effectiveness (22.7%) of the combinations and the absence of recommendations on how to use combined therapies (22.7%). The main reason for using these treatments was to improve the outcome of biologic therapies in cases of partial efficacy or loss of efficacy. The most frequent clinical situations in which the dermatologists indicated that they combined therapies were to control a loss of efficacy (82.1%) and to treat psoriasis flare-ups (51.3%). Combined therapies have been used by the majority of paediatric dermatologists in the treatment of childhood psoriasis. Absence of information about these combined therapies, and no guidelines about their use are major limits for their use. However, these combined therapies should be considered for the treatment of children with severe psoriasis, psoriatic arthritis and recalcitrant disease. Their use needs to be clarified in future management guidelines.

Genetically engineered biologics to treat psoriasis. Experience with ustekinumab in an adolescent with severe psoriasis

Modern pathogenetic therapy of psoriasis is the use of suppressive methods aimed to suppress immune reactions in the dermis, synovia, enthesis and eliminate the imbalance between anti-inflammatory and pro-inflammatory cytokines, chemokines. Today, genetically engineered biological drugs are one of the most promising pharmacotherapy achievements for the management of psoriasis, psoriatic arthritis in the group of immunosuppressive agents. Knowing the pathogenetic mechanisms that underlie the development of these diseases allows us today to highly selectively target the top key links of the immunopathogenetic cascade using genetically engineered biologicals, while barely affecting the protective factors of the patient’s immune system unlike the standard backbone (what is referred to as traditional) anti-inflammatory therapy. The treatment of psoriasis in children and adolescents practically involves the same drugs and methods as in adults. However, most of them are used in paediatric practice for conditions for which they are not clearly indicated, and studies on their efficacy and safety are still missing. Currently, it is possible to treat children and adolescents with genetically engineered biological drugs. Ustekinumab, etanercept, adalimumab, secukinumab, and ixekizumab are approved for use in moderate to severe psoriasis in the Russian Federation. In paediatric practice, the genetically engineered biological drug ustekinumab is one of the most effective, safe and convenient for the delivery of therapy (short induction cycle, rare infusions of the drug during maintenance therapy). The article describes the case study of the effective treatment of a 17-year-old patient with severe, continuously recurrent psoriasis. The targeted therapy, including the use of genetically engineered biological drugs, is increasingly being used to treat childhood psoriasis. Moreover, there are now more and more supporters among dermatologists who believe that genetically engineered biological drugs can be prescribed as the first-line drugs for the treatment of moderate to severe psoriasis in children and adolescents.

301 Tapinarof cream 1% once daily for the treatment of extensive atopic dermatitis in adolescents and children: 4-week maximal use trial

Abstract There is a need for efficacious non-steroidal topical therapies for atopic dermatitis (AD) without restrictions relating to duration, the extent of use and application sites. Tapinarof (VTAMA®; Dermavant Sciences, Inc., USA) is a first-in-class, non-steroidal, topical, aryl hydrocarbon receptor agonist approved by the Food and Drug Administration for the treatment of plaque psoriasis in adults and under investigation for the treatment of psoriasis in children down to 2 years of age and for AD in adults and children down to 2 years of age. Tapinarof cream 1% once daily (QD) demonstrated significant efficacy vs. vehicle at 12 weeks and was well tolerated in adults and adolescents and with moderate to severe AD in a previously reported phase 2b trial (NCT02564055). To assess the safety, tolerability, pharmacokinetics (PK) and efficacy of tapinarof cream 1% QD in adolescents and children with extensive AD. In this open-label, maximal use, phase 2 trial (NCT05186805), adolescents and children, aged 2–17 years, with a clinical diagnosis of AD, a validated Investigator Global Assessment in Atopic Dermatitis™ (vIGA-AD™) score ≥3, and percent body surface area (%BSA) involvement of ≥ 25% for adolescents (12–17 years) or ≥35% for children (2–11 years) were assigned tapinarof cream 1% QD for 27 days. Primary endpoints include adverse events, mean investigator-assessed local tolerability scores (overall and sensitive areas) and PK parameters. Secondary endpoints include a change in vIGA-AD™, Eczema Area Severity Index (EASI), %BSA affected, and Peak Pruritus-Numeric Rating Scale scores at each trial visit. Eligible patients completing this trial have the option to enrol in an open-label, long-term extension trial (NCT05142774) to receive up to an additional 48 weeks of tapinarof cream 1% QD treatment. Overall, 36 patients aged 2–17 years were enrolled at nine sites in the US and Canada. Of these patients, equal proportions (33.3% [12/36]) were young children (2–6 years), children (7–11 years) and adolescents (12–17 years); 66.7% (24/36) were male and mean age (standard deviation [SD]) was 8.9 (4.9) years. At baseline, 77.8% (28/36) had a vIGA-AD™ score of 3 (moderate) and 8/36 (22.2%) had a score of 4 (severe). At baseline, the mean (SD) %BSA affected was 52.4% (19.1%), 42.0% (10.0%) and 33.9% (8.6%) for young children, children and adolescents, respectively. The overall mean (SD) EASI score was 23.8 (9.2). This trial will assess the safety, tolerability, PK and efficacy of tapinarof cream 1% QD in 36 adolescents and children down to 2 years of age with extensive, moderate-to-severe AD.

Features of psoriasis in children

The prevalence of psoriasis reaches about 3% of the global adult population and is twice as lower in the paediatric population. In children, as well as in adults, psoriasis is associated with several different concomitant pathologies: metabolic syndrome, depression, anxiety, arthritis, etc. However, the diagnosis of psoriasis in children and subsequent treatment is quite a difficult task. The clinical presentation in a pediatric patient differs from the symptoms of the disease in an adult. Psoriatic patches are usually thinner and with less severe desquamation, which is often accompanied by itching, and children are also characterized with unusual regions of rash localization, such as the periaucular or umbilical region. Psoriatic diaper rash is often misdiagnosed as diaper dermatitis. However, diaper psoriasis is the most common manifestation, seen in about 45% of cases in children under two years of age. In children, the presence of psoriasis is associated with an increased risk of metabolic syndrome and its components, and with higher rates of hyperlipidemia, even after weight management, in addition to an observed increased risk of depression and anxiety and a possible increased risk of arthritis and Crohn’s disease. The clinical presentation of pediatric psoriasis is diverse, and the diagnosis is most often made clinically. Auspitz’s sign, Koebner’s phenomenon, and Voronov’s ring might be of some help in clinical diagnosis. The treatment of psoriasis in children is based primarily on the same principles as in adults. However, few of the existing treatment options are approved for use in children and adolescents.

Biologics combined with conventional systemic agents for the treatment of children with severe psoriasis. Real-life data from the BiPe cohorts and a practice survey among French and Italian pediatric dermatologists.

Combined therapies involve the use of multiple drugs to increase efficacy and reduce the toxicity of individual treatments. We evaluated the use of combinations of conventional systemic therapies and biologics in children with psoriasis in daily practice. This two-part study used data from the 170 children in the Franco-Italian BiPe cohorts to evaluate the use, efficacy, and safety of combined conventional systemic-biologic therapies, and from a survey carried out among French and Italian dermatologists to better understand the reasons for using or avoiding these combinations. In total, 33 children (19.4%) from 13 dermatology centers received 48 combined conventional systemic-biologic therapies (cumulative duration: 43.6 years), including three triple combination therapies (acitretin-methotrexate, with a TNF-alpha inhibitor). A total of 14 different combinations were used, most frequently etanercept-acitretin (n =10), adalimumab-acitretin (n =7), adalimumab-methotrexate (n =5), and ustekinumab-methotrexate (n =5). The combined therapies were started at biologic initiation in 41 cases (85.4%), and after a period of biologic monotherapy in the remaining 7 cases. Mean PGA and PASI scores decreased between baseline and M3 with all the combinations used. Four serious adverse events were reported, all with favorable outcomes. The survey was completed by 61 dermatologists: 39 (63.9%) had previously used or planned to use the combined therapies, most commonly TNF-alpha inhibitors with acitretin or methotrexate. The main reason for using these treatments was to improve the outcome of biologic therapies in cases of partial efficacy or loss of efficacy. Combined therapies have been used frequently in the treatment of childhood psoriasis, in a range of clinical situations and in variable drug combinations, without significant toxicity. Although the use of these combined therapies needs to be clarified in future management guidelines, these combined therapies should be considered for the treatment of children with severe psoriasis, psoriatic arthritis, and recalcitrant disease.

Nutritional factors in the pathogenesis and treatment of psoriasis in children

In the pathogenesis of the psoriatic disease, genetic and environmental factors play a significant role, and one of the most critical ecological influences is nutrition. At the same time, the influence of nutrition on the pathogenetic links of psoriasis is currently underestimated. The clinical guidelines for managing children and adults with psoriasis do not mention the need to consult a nutritionist and any dietary recommendations. The purpose of this literature review was to analyze current data on the role of various nutritional factors in the development of psoriatic disease, the pathogenesis of its complicated course, as well as the effectiveness of dietary interventions in the treatment of this category of patients. The analysis of sixty eight sources of literature has shown that dietary changes and the use of biologically active food supplements can have a specific effect on the complex therapy of the disease. The possibilities of diet therapy in patients with psoriasis and metabolic syndrome are also discussed. At the same time, it is evident that further research is needed to improve the evidence base for the effectiveness of nutritional methods in managing this category of patients, especially in paediatric-age patients.

Management of psoriasis in children (Review).

Psoriasis is a common long-lasting, inflammatory disease that mainly affects the skin. The incidence of this condition has increased significantly over time and at this point, it affects approximately 1% of children. Psoriasis can appear at any age, including childhood and adolescence, with a higher frequency in girls, an earlier onset being associated with severe psoriasis. The pathology is the result of the interaction between genetics and trigger factors such as infections, stress, diet, obesity, and chemical irritants. Paradoxically, tumor necrosis factor (TNF)-α inhibitors (infliximab, adalimumab) may induce psoriasis in children. Psoriasis is a long-term condition with periods of exacerbation; thus, the quality of life can be affected and patients should receive psychosocial support. Although most children have mild disease and topical treatment is efficient, some cases are challenging to treat. The aim of this review was to provide an overview of the current knowledge concerning the epidemiology, etiology, pathogenesis, clinical features, comorbidities, and treatment of psoriasis in children and also to emphasize the need for a multidisciplinary approach to this complex pathology.

25482 Secukinumab efficacy and safety profile in pediatric patients with severe chronic plaque psoriasis up to 1 year

Introduction: Secukinumab has proven highly efficacious in adults in the long-term treatment of multiple manifestations of psoriatic disease, with a favorable safety profile. Analyses, up to 1 year, of a study investigating secukinumab for the treatment of psoriasis in children and adolescent patients are reported here.

Effectiveness of UVB-therapy with 311 nm wave-length and tacrolimus in treatment of psoriasis in children

Relevance. Of particular relevance in recent years has become the problem of psoriasis in children, it is noted an increase in cases of severe psoriasis refractory to traditional drug therapy, which together with a high incidence raises the questions of optimization of therapeutic interventions in this category of patients in the category of social.The purpose of the study. To study the efficacy and safety of UVB-phototherapy 311 nm, tacrolimus from pediatric patients with psoriasis.Material and methods. Under supervision there were 26 patients from 5 to 16 years old. All patients received UVB 311 nm phototherapy. The effectiveness evaluated in accordance with the dynamics of the indexes PASI, BSA, Quality of Life.Results. As a result of the course of UVB-therapy with 311 nm wave-length the number of patients with PASI 100 was 69 %, PASI 90 was 23 %, PASI 75 was 8 %. Index BSA were thus reduced to 81.5 %, DIKE improved by 65.3 %. The tolerance to UVB 311 nm was evaluated as very good. Adverse reactions such as transient erythema was observed in 11.5 % of patients, xerosis in 19.2 %.Conclusion. UVB 311 nm phototherapy is a highly effective and safe method of therapy of medium-severe psoriasis in children.

S2k guidelines for the treatment of psoriasis in children and adolescents - Short version part 2.

The present guidelines are aimed at residents and board-certified physicians in the fields of dermatology, pediatrics, pediatric dermatology and pediatric rheumatology as well as policymakers and insurance funds. They were developed by dermatologists and pediatric dermatologists in collaboration with pediatric rheumatologists using a formal consensus process (S2k). The guidelines highlight topics such as disease severity, quality of life, treatment goals as well as problems associated with off-label drug therapy in children. Trigger factors and diagnostic aspects are discussed. The primary focus is on the various topical, systemic and UV-based treatment options available and includes recommendations for use and treatment algorithms. Other aspects addressed herein include vaccinations in children and adolescents with psoriasis as well as various disease subtypes such as guttate psoriasis, diaper psoriasis, pustular psoriasis and psoriatic arthritis. Finally, we also provide recommendations for imaging studies and the diagnostic workup to rule out tuberculosis prior to initiating systemic treatment. Note: This article constitutes part2 of the Sk2 guidelines for the treatment of psoriasis in children and adolescents. Part1 was published in last month's issue. It contained introductory remarks and addressed aspects of diagnosis and topical treatment.

149 Prevalence and biological treatment of psoriasis in children and adolescents in Germany

149 Prevalence and biological treatment of psoriasis in children and adolescents in Germany

S2k guidelines for the treatment of psoriasis in children and adolescents - Short version part 1.

The present guidelines are aimed at residents and board-certified physicians in the fields of dermatology, pediatrics, pediatric dermatology and pediatric rheumatology as well as policymakers and insurance funds. They were developed by dermatologists and pediatric dermatologists in collaboration with pediatric rheumatologists using a formal consensus process (S2k). The guidelines highlight topics such as disease severity, quality of life, treatment goals as well as problems associated with off-label drug therapy in children. Trigger factors and diagnostic aspects are discussed. The primary focus is on the various topical, systemic and UV-based treatment options available and includes recommendations for use and treatment algorithms. Other aspects addressed herein include vaccinations in children and adolescents with psoriasis as well as various disease subtypes such as guttate psoriasis, diaper psoriasis, pustular psoriasis and psoriatic arthritis. Finally, we also provide recommendations for imaging studies and the diagnostic workup to rule out tuberculosis prior to initiating systemic treatment. Note: This article constitutes part1 of the Sk2 guidelines for the treatment of psoriasis in children and adolescents. Part2 will be published in the next issue. It contains chapters on UV therapy, systemic treatment, tonsillectomy and antibiotics, vaccinations, guttate psoriasis, psoriatic arthritis, complementary medicine, as well as imaging studies and diagnostic workup to rule out tuberculosis prior to systemic treatment.

SYSTEM THERAPY OF PSORIASIS IN CHILDREN (PART I)

We include a review of modern methods of systemic therapy of psoriasis in children, indications for which are moderate and severe forms of psoriasis with PASI 10, skin pathological process that is uncontrollable with topical drugs, skin lesions with functional localization (lesions of genitals, palms and soles, facial skin), erythrodermic psoriasis, pustular psoriasis, psoriatic arthritis. We provide information on the techniques of narrow-band phototherapy (UVB 311 nm) that are used in the treatment of psoriasis in children. We provide data on efficacy, safety, necessary monitoring of clinical and laboratory indicators, peculiarities of vaccination during treatment of children with acitretin, methotrexate, cyclosporine.

Pediatric Psoriasis.

Psoriasis is a chronic inflammatory systemic disease associated with an important physical and physiological burden. It primarily affects the skin, but it is associated with several serious medical co-morbidities. One third of total psoriatic cases have their onset during the pediatric age, although some of them may not be diagnosed until the patient reaches adulthood. Additionally, in the pediatric age, there is an association with several medical co-morbidities; thus, an early recognition of the disease and a subsequent appropriate approach may delay or even prevent considerable co-morbidities. Because children are not just 'small adults', specific guidelines for the diagnosis, management, and treatment of psoriasis are of extreme importance. However, these guidelines are still lacking in this age group. Most of the psoriasis treatments used in adults are not officially approved for the pediatric age and require off-label prescription. Moreover, efficacy and safety studies are lacking in this population, especially with long-term follow-up and outcomes. Many biologic agents have been recently approved for the treatment of psoriasis in children, while others are currently being studied. This bibliographic review aims to summarize the most relevant aspects, as well as updated information about the epidemiology, pathogenesis, clinical features, diagnosis, co-morbidities and treatment of pediatric psoriasis.

Role of Narrowband Ultraviolet B Phototherapy in the Treatment of Childhood Psoriasis in Asian Children.

Narrowband ultraviolet B (NBUVB) phototherapy is a well-established treatment modality for psoriasis. We performed a retrospective analysis of children of East Asian descent with psoriasis treated with NBUVB phototherapy at the National Skin Centre, Singapore, over a 5-year period between 2004 and 2008 and found that NBUVB phototherapy is safe and effective for the treatment of psoriasis in children of East Asian descent.

Biologic response modifiers and pediatric psoriasis.

The efficacy and safety of biologic response modifiers such as etanercept, adalimumab, infliximab, and ustekinumab have been demonstrated in the treatment of psoriasis in adults, but none are currently approved for the treatment of psoriasis in children in the United States, and only etanercept is approved for the treatment of psoriasis in children in the European Union. Through case reports, case series, and a large clinical trial of the use of etanercept, the literature supports the use of these agents to treat psoriasis in children. Data on the use of the tumor necrosis factor-α antagonists etanercept, adalimumab, and infliximab in the treatment of other inflammatory diseases in children-namely Crohn's disease, juvenile arthritis, and uveitis--support their safety profile in children.

Management of Psoriasis in Children: a Narrative Review

Psoriasis is an inherited chronic inflammatory papulosquamous disorder with a variable clinical spectrum affecting about 0.5% to 2% of children and adolescence. In spite of all performed researches around the world for seeking better treatments with fewer adverse effects to control the disease, there is still no cure for psoriasis. Treatment of psoriasis in children is very conservative and many therapies used for adults may not be appropriate for children due to possible long-term or delayed adverse effects. A wide range of therapeutic options are existed including; topical therapy, phototherapy, chemotherapy, systemic therapies and biologic therapies. Here in, because of the lack of data in this specific field of dermatology, we decided to review the current therapies of childhood psoriasis.

Systemic Treatment of Psoriasis in Children

Childhood psoriasis has a significant impact on the child´s quality of life and those who cannot be managed with topical treatment should be considered for systemic treatment. The majority of systemic therapies used for childhood psoriasis are off-label drug therapies. Evidence-based studies on systemic treatment of childhood psoriasis are scarce, and treatment algorithms are generally based on low-level evidence. A literature search was performed and updated to October 2015 to obtain an up to date overview of relevant systemic treatment in childhood psoriasis. Methotrexate is the conventional first-line of systemic treatment, but the level of evidence for its use is low. Etanercept is FDA approved for psoriasis vulgaris in children, has a documented efficacy and a good safety profile, and is currently the drug for which most evidence for the use in children has been accumulated. Adalimumab and ustekinumab have both recently completed large double-blinded controlled trials testing in childhood psoriasis and both have recently been approved for psoriasis vulgaris in children. Thus a wider range of approved systemic treatment options is becoming available.