Dose adjustment of biologic therapies for psoriasis in dermatological practice: a retrospective study.

INTRODUCTION: Despite the large routine use of biologic drugs in psoriasis treatment, the majority of studies do not take into consideration dose-adjustment practice in 'real-life' dermatological setting. In routine clinical practice, the disease management may include a large number of conditions requiring non-standard dosage regimens, including dose escalation, dose reduction and/or off-label treatment interruption. OBJECTIVE: The ONDA (Outcome of non-standard dosing regimen in Psoriasis and Psoriatic Arthritis) study aim was to retrospectively analyse dose-adjustment strategies among biologic therapies for psoriasis in dermatological practice during a 3-year period. RESULTS: This retrospective, observational, multicentre study was carried out in 350 patients (68% male, 32% female) affected by plaque-type psoriasis (Pso) with a coexistence of psoriatic arthritis in 164 patients (46.9%). At baseline mean PASI score was 14.9 (SD 7.2). Dose adjustment was demonstrated to be a common practice with 70/350 patients (20%) who needed a dose variation during the treatment time, in particular a dose increase in 20/70 patients (28.6%) and a dose reduction in 50/70 patients (71.4%). Dose increase was due to inefficacy on Pso parameters in 60% of cases and to inefficacy of PsA parameters in 40% of cases, while dose reduction (or temporary off-label treatment interruption) was due to prolonged remission in 54% of cases, other reason in 18% of cases, patient choice or request in 14% of cases, occurrence of concomitant event in 12% of cases. CONCLUSION: Dose adjustment is a common clinical practice, consisting of frequent dose reduction when a disease prolonged remission is obtained or dose increase to improve efficacy on Pso and PsA disease parameters.

Survival rate of antitumour necrosis factor-α treatments for psoriasis in routine dermatological practice: a multicentre observational study.

BACKGROUND: Adherence is an overall marker of treatment success, and it depends on multiple factors including efficacy and safety. Despite the wide use of tumour necrosis factor (TNF)-α blockers in the treatment of plaque-type psoriasis, few data regarding treatment adherence in routine clinical practice are available. OBJECTIVES: To estimate the long-term survival rate of anti-TNF-α therapy in a cohort of patients with psoriasis in routine clinical practice; to evaluate the reasons for and predictors of treatment discontinuation. METHODS: The Outcome and Survival rate Concerning Anti-TNF Routine treatment (OSCAR) study was based on a retrospective analysis to estimate the long-term survival rate of the first anti-TNF-α treatment in patients with psoriasis, from three Italian academic referral centres. Adult patients (n = 650) with plaque psoriasis treated with a first course of adalimumab, etanercept or infliximab for ≥ 3 months were included. RESULTS: Global adherence to anti-TNF-α treatments after 28·9 ± 15·4 months (867 ± 462 days) of observation was 72·6%. Etanercept showed a longer survival (mean 51·4 months, 1565 days; P < 0·001) compared with infliximab (36·8 months, 1120 days) and adalimumab (34·7 months, 1056 days). Treatment discontinuation due to primary and secondary inefficacy was observed in 5·2% and 14·5% of patients, respectively, whereas discontinuation due to adverse events was reported in 29 subjects (4·5%). Independent predictors of treatment withdrawal were female gender [hazards ratio (HR) 1·3], treatment with adalimumab or infliximab compared with etanercept (HR 2·7 and 1·7, respectively), and the concomitant use of traditional systemic treatment, as a rescue therapy, compared with monotherapy (HR 1·9). CONCLUSIONS: Overall survival of anti-TNF-α agents in psoriasis is elevated, with drug discontinuation mostly due to inefficacy. Etanercept showed a longer adherence compared with adalimumab and infliximab.

[Depressive symptoms and low self-esteem in obese children and adolescents]. / Sintomi depressivi e bassa autostima in bambini e adolescenti obesi.

AIM: The aim of th study was to assess the prevalence of depressive symptoms and low self-esteem (SE) in a clinical sample of obese children and adolescents; to examine whether Body Mass Index (BMI) or age are correlated to scores of depression and SE. METHODS: Fifty-five obese patients, aged 9-16 years, completed 2 questionnaires: the Children's Depression Inventory (CDI) and the Multidimensional Self Concept Scale (MSCS), which assesses global SE and 6 specific domains of SE (Social, Competence, Affect, Academic, Family and Physical). RESULTS: The prevalence of depressive symptoms and low global SE was not significantly different from normative data of the general pediatric population. The mean overall scores on CDI (8+/-4.69) and MSCS (96.6+/-11.54) fell within the normal range (0-19 and 85-115, respectively). The lowest scores in specific domains of MSCS were obtained in Physical SE (94.42+/-12.64). The scores on questionnaires were not significantly correlated to BMI or age. A significant negative correlation between Physical SE scores and CDI scores was found (r=-0.43; p<0.05). CONCLUSIONS: Obese children and adolescents, as a whole, did not present more depressive symptoms and lower SE than the general pediatric population. However, some obese patients may be at higher risk for psychopathology. In this study, the degree of obesity (BMI), age and sex were not risk factors for psychopathology. The relative low scores on Physical SE and their correlation to CDI scores suggest that body image dissatisfaction may be a risk factor for psychopathology in a subgroup of obese patients.

Effect of calcium supplementation as a high-calcium mineral water on bone loss in early postmenopausal women.

It is generally agreed that an adequate calcium intake is necessary for the maintenance of bone health and that calcium supplementation reduces the rate of bone loss in postmenopausal women. Mineral waters are calorie free, and some, with relatively high calcium levels, might be significant sources of calcium. We studied the effect of mineral water in 45 early postmenopausal women randomly assigned to receive a high-calcium (Ferrarelle, Italy) or a low-calcium mineral water. On the basis of the dietary regimen, women were divided in two clusters (A = 23 subjects, B = 22 subjects) significantly different only for calcium intake (CI) and for dietary consumption of calories (energy). At the end of the study period (13 +/- 1 months), bone mineral density at the distal radius showed a significant decrease (P < 0.001) only in cluster with low CI. The difference between the clusters was significant (P < 0.05). Furthermore, the cluster with high CI showed a significant (P < 0.05) reduction in osteocalcin serum levels after 3 months. This study provides further evidence to support the use of a high calcium mineral water as an effective prophylaxis against postmenopausal bone loss.

Reflex seizures as initial manifestations of systemic lupus erythematosus in childhood.

We report a 10-year-old girl with reflex seizures characterized by visual and acoustic hallucinations, induced by visual and acoustic stimulations. The EEG showed atypical spike-wave discharges on the left temporo-occipital area, markedly activated by visual and acoustic stimuli (intermittent light, pattern-reversal stimulation and monoaural right pure tone). The patient was treated with carbamazepine and seizure stopped within 7 months. After 10 months from the start of the therapy she developed signs of systemic lupus erythematosus.