Meta-analysis of RCTs included in this study shows that there is a statistically significant reduction in morbidity using PA catheter-guided strategies.
Psoriasis is chronic inflammatory skin disease that can develop at any age. Approximately 20–30% of all patients report about first rashes before the age of 18. Psoriatic arthritis is one of psoriasis comorbid conditions. Its signs can range from mild to extremely severe destructive forms. Arthralgia, joint stiffness and swelling are the most common symptoms. Early psoriatic arthritis treatment onset allows to control joint damage which usually occurs during the first 2 years of the disease. The moderate and severe course of psoriasis and psoriatic arthritis may require systemic therapy, however, there is not much data on the efficacy and toxicity of systemic agents in the pediatric practice. This article provides the review of studies on etanercept efficacy and safety in children with psoriatic arthritis.
Netakimab, the original monoclonal antibody against IL-17A, is an innovative drug for the treatment of moderate-to-severe plaque psoriasis in patients who have indications for systemic therapy or phototherapy. Netakimab was approved in Russian Federation, registration certificate number ЛП-005439 from 04.04.2019. This article outlines the first 12-week results of a phase III clinical trial in patients with psoriasis.Materials and methods. The BCD-085-7 study (PLANETA) is a comparative, randomized, double-blind, placebo-controlled phase 3 clinical study of the efficacy and safety of netakimab in patients with moderate-to-severe plaque psoriasis. This review presents the results of the first 12 weeks. The study is ongoing at the moment, the total duration of treatment for each patient is 3 years (154 weeks). Patients were randomized in a ratio of 2:2:1 into one of three arms: group 1 received netakimab subcutaneously at a dose of 120 mg once a week for the first three weeks (induction) and then once every 2 weeks up to week 10, group 2 received netakimab subcutaneously at a dose of 120 mg once a week for the first three weeks (induction) and then once every 4 weeks up to week 10, group 3 received a placebo subcutaneously on day 1 at weeks 0, 1, 2, 4, 6, 8 10. In order to maintain a double-blind design, placebo was administered to patients in group 2 at weeks 4 and 8.Results. Both netakimab groups showed a significant superiority over placebo (p < 0.001) and the absence of statistically significant differences between the two regimens of therapy (p > 0.05) across all endpoints. PASI 75 at week 12 was reached by 77.65 % of patients using netakimab once every 2 weeks and 83.33 % of patients using netakimab once every 4 weeks (ITT population). The rate of clear and almost clear skin (sPGA 0–1) was reached by 81.18 and 79.76 % of patients using netakimab once every 2 weeks and once every 4 weeks, respectively. The safety assessment showed no statistically significant differences between the groups, the incidence rate of adverse events in netakimab arms was not higher than in the placebo arm. There were no cases of early withdrawal due to adverse events and cases of grade 4 toxicity according to CTCAE 4.03. During the 12 weeks of the study, one serious adverse event was registered in group 2 (pneumonia grade 3), which was recovered without any consequences. The immunogenicity assessment showed binding antibodies formation at week 12 in one patient who received BCD-085 every 2 weeks. Neutralizing antibodies were not detected. Conclusion. Netakimab showed high efficacy in the treatment of psoriasis, more than 80 % of patients achieved PASI 75 and sPGA 0–1 (clear and almost clear skin) by the week 12 of treatment. The drug showed a favorable safety profile and low immunogenicity. Based on the study results the regimen once a week during the first 3 weeks (induction), then once every 4 weeks was chosen for medical use in patients with psoriasis.
Background. Pemphigus vulgaris is an autoimmune bullous dermatosis. Its management generally involves lifelong administration of maintenance dose of systemic glucocorticosteroids, that leading to serious adverse effects especially in children. Clinical case description. Patient is the 16 years old boy with severe course of pemphigus vulgaris. The diagnosis was confirmed by the results of cell smear study from fresh erosions (> 50 acantholytic cells were revealed), histological examination of the skin biopsy from the lesion with the vesicle element (suprabasal vesicle was localized in the center, it included fibrin, neutrophil granulocytes, and acantholytic cells), skin biopsy from the area near the lesion (visually healthy skin), via direct immunofluorescence methods (IgG deposition was detected on keratinocytes’ surface throughout the epidermis), and enzyme-linked immunosorbent assay (desmoglein 1 IgG autoantibodies — 121 U/mL (reference value < 20 U/mL) and desmoglein 3 — > 200 U/mL (reference value < 20 U/mL)). Genetically engineered biologic drug, rituximab, and systemic glucocorticosteroid, methylprednisolone, were prescribed as first-line therapy with gradual dose reduction to permanent discontinuation in 8 months. Complete remission maintained after the completion of therapy course and discontinuation of systemic glucocorticosteroid. Conclusion. Combined therapy with systemic glucocorticosteroids and rituximab can be considered as first-line therapy in pediatric patients with pemphigus vulgaris due to relatively low risk of recurrence after rather rapid and complete drugs’ discontinuation.
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