Prescriptions hors AMM (autorisation de mise sur le marché) dans le psoriasis de l'enfant

International audienceIntroduction: Psoriasis affects 0.5% of children in Europe, with moderate to severe clinical forms in 15–35% of cases warranting the use of systemic treatments. Few treatments are licensed for childhood psoriasis. In this study, we analyzed the frequency of such prescriptions. Materials and methods: Our study was based on 3 retrospective cohort trials conducted in France between 2012 and 2018: χ-Psocar (313 children with psoriasis seen in hospitals), PsoLib (207 children seen in a private practice), and BiPe (134 children on biotherapies). Our evaluation was centered on off-label use. To avoid duplicates between cohorts, analysis focused on each cohort independently. Results: In the χ-Psocar study, in 34.8% of cases, use of at least one off-label treatment, mainly topical vitamin D (36.0%), and systemic treatments (methotrexate and cyclosporine) was noted, on account of either the clinical type of psoriasis (13.7%) or patient age (24.6%). In the PsoLib study, in 41.5% of cases, at least one off-label treatment was noted, mainly combined calcipotriol-betamethasone (24.2%), ciclopirox shampoo (7.2%) and systemic treatments (n = 20). The main reason was patient age (41.5%). In the BiPe study, in 97.0% of cases, at least one off-label treatment was noted. These prescriptions mainly concerned a combination of calcipotriol-betamethasone (68.7%) and tacrolimus (11.2%) along with systemic treatment comprising methotrexate, cyclosporin, methoxsalen or apremilast (n = 125), but also biotherapies (n = 85). The biotherapies were used off-label since at that time they had not yet been granted marketing authorisation. Discussion: This study focused on 3 cohorts of children with psoriasis seen either in private practice or in a hospital setting, and it involved all types of treatment. Off-label prescriptions ranged from one-third to almost 100% of the children, depending on the individual cohorts. The prescribed drugs were topical treatments, conventional systemic drugs and biotherapies. Off-label prescription is not strictly prohibited in France provided it is within a well-defined regulatory framework. Where there is a rich bibliography, confident recommendations may be made. Unfortunately, in childhood psoriasis, the literature and recommendations are very limited, leaving prescribers with considerable individual responsibilities. Review of the license concerning children with psoriasis, a push to conduct therapeutic studies and the drafting of recommendations all appear necessary

Characteristics of patients with plaque psoriasis who have discordance between Psoriasis Area Severity Index and dermatology life quality index scores

International audienc

How are eczema 'flares' defined? A systematic review and recommendation for future studies.

Eczema is an important public health problem due to high prevalence and associated morbidity. As a chronic, relapsing disease, the ability to capture disease flares is important when evaluating treatment success, yet it is unclear how flares should be defined. This study systematically reviews and critically appraises the literature defining flares in eczema, and explores methodological and practical aspects of including eczema flares as outcome measures in trials to inform developing an international consensus definition adding details of our own recent experience. A systematic review was undertaken of flare definitions in prospective intervention studies of eczema published up until 14 February 2013. Data were double-extracted. We pre-specified that important characteristics of a good flare definition should include (i) being feasible to collect and (ii) being recorded at the time flare symptoms were experienced. Three hundred and fourteen papers were identified of which 26 included some description of eczema flares. Overall, 22 different flare definitions were used. Flares were included as the primary outcome in 17 studies (65%). Only four studies (15%) used a patient-reported flare definition. No studies fulfilled all of our pre-specified essential characteristics. No validation studies were identified. The wide variation and lack of validation of flare definitions hampers comparison of findings between studies for this chronic, relapsing disease. None of the currently used definitions seem fit for purpose. Further research should establish which aspects of worsening of disease are most important to patients, and how best to capture these data in a way that is valid, reliable and feasible in all clinical and research settings

Real-World Effectiveness and Safety of Apremilast in Older Patients with Psoriasis

Introduction: Apremilast is a drug recently developed for psoriasis. Few data are available on its use in the elderly. We evaluated the tolerance and effectiveness of apremilast used in daily practice for psoriasis treatment in older patients. Methods: We performed a multicenter, retrospective study involving patients aged ≥ 65 years who had received apremilast as a psoriasis treatment. Demographic data and details regarding psoriasis and adverse events (AEs) were collected from patient medical records. Results: 135 patients were included (mean age: 73.5 years). Treatment was stopped in 74 patients (54.8%) for AEs (n = 43, 56.6%), primary failures (n = 18, 23.4%), and relapses (n = 7, 9.2%). When patients were stratified by age at treatment initiation, the main cause of discontinuation in patients ≥ 75 years was AEs, whereas in patients aged 65–74 years it was primary failures (28.3%). Sixty-one patients reported AEs, mainly digestive (n = 49). Regarding effectiveness, 45.2% of patients reached PGA 0/1 between 3 and 6 months after treatment initiation. One-year apremilast continuation rates were better in the 65–74 and 75–84 years subgroups than in the > 85 years subgroup (p = 0.01). Conclusion: Apremilast seems to be an effective and safe therapeutic option for psoriasis in the elderly. The main AEs reported by patients did not seem to differ from those reported previously in younger populations. However, AEs were more frequent in patients > 75 years old leading to more frequent discontinuation of apremilast compared with younger patients, suggesting a higher level of vigilance is needed in the elderly

Effectiveness and safety of anti-interleukin-17 therapies in elderly patients with psoriasis

Anti-interleukin-17 agents have recently been develo-ped for the treatment of psoriasis. This study evaluated the tolerance and effectiveness of anti-interleukin-17 agents for psoriasis in elderly patients in daily practi-ce. A multicentre, retrospective study was performed, involving psoriatic patients aged ≥65 years who had received an anti-interleukin-17 agent, including se-cukinumab, ixekizumab or brodalumab. A total of 114 patients were included: 72 received secukinumab, 35 ixekizumab, and 7 brodalumab. Treatment was stop-ped in 32 patients (28.9%), because of relapses in 14 patients (41.2%), primary failures in 11 patients (32.4%), or adverse events in 7 patients (20.6%). The 3 most frequently reported adverse events were injec-tion site reactions (n = 4), oral candidiasis (n = 3), and influenza-like illness (n = 3). Regarding effectiveness, 80 patients (70%) reached a Physician Global Assessment score of 0/1, 6 months after treatment initiation. In conclusion, anti-interleukin-17 therapy appears to be an effective and safe therapeutic option for psoriasis treatment in patients aged ≥ 65 years