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Disorders of Keratinization and Other Genodermatoses
Published in Ayşe Serap Karadağ, Lawrence Charles Parish, Jordan V. Wang, Roxburgh's Common Skin Diseases, 2022
Roselyn Stanger, Nanette Silverberg
Management: Neonates require care in the neonatal intensive care unit, as they are at high risk of temperature and electrolyte dysregulation, skin and respiratory infections, sepsis, and fluid loss. Several topical agents can be used to help heal the skin, including emollients, gentle exfoliants, and topical steroids; however, topical tacrolimus should be avoided due to increased absorption leading to potentially toxic systemic levels. Topical keratolytics may be too irritating. Patients with pruritus may be given antihistamines. Nutrition is essential to help mitigate the effects of failure to thrive, and patients may benefit from the help of a professional nutritionist. Patients with anaphylaxis or other atopic tendencies can be referred to an allergist and/or pulmonologist. Biologic agents that have recently been described to improve clinical features include secukinumab and dupilumab.
Dermatoses of Pregnancy
Published in Vincenzo Berghella, Maternal-Fetal Evidence Based Guidelines, 2022
Hannah J. Anderson, Dana Correale, Jason B. Lee
When IH is insufficiently controlled with CS alone, the next therapeutic option is cyclosporine A (CsA). Doses of 3–10 mg/kg/day have been reported in the treatment of IH [60–62]. Again, medication should be tapered to the lowest possible dose that results in control of the disease. The mechanism of action is inhibition of calcineurin with resultant decrease in interleukin-2 production by CD4+ T cells. CsA also inhibits interferon-γ production by T cells. CsA is pregnancy category C. The most serious adverse effects are renal dysfunction and hypertension [16]. Renal function and blood pressure should be monitored during therapy. In a study of transplant recipients treated with CsA during pregnancy there was no evidence of teratogenicity [63]. However, 44.5% of infants were born at less than 37 weeks’ gestation and 44.3% weighed less than 2500 g at birth [63]. CsA is excreted in human breast milk and breastfeeding should be avoided during therapy. Biologic therapies may be considered as an alternative to cyclosporine or next-in-line therapy. Tumor necrosis factor (TNF) α inhibitors and ustekinumab are pregnancy category B drugs. As no significant pregnancy adverse outcomes have been observed, TNFα inhibitors such as infliximab may be considered, even as the first-line therapy [64]. No human safety data during pregnancy are available for newer biologic agents such as brodalumab, ixekizumab, guselkumab, secukinumab, and tildrakizumab, but animal studies showed no adverse effects [16].
Bayesian Methods for Evaluating Drug Safety with Real-World Evidence
Published in Harry Yang, Binbing Yu, Real-World Evidence in Drug Development and Evaluation, 2021
Although there are many systemic agents approved for the treatment of psoriasis, getting patients clear of their psoriasis is still a hurdle. Secukinumab (Cosentyx), an inhibitor of IL-17, was approved for the treatment of moderate-to-severe psoriasis in 2015. Two other inhibitors of IL-17, brodalumab and ixekizumab, also are approved by the FDA for treatment of psoriasis. There has been no suicidality signal with secukinumab, nor with ixekizumab. Furthermore, antagonism of cytokine activity, and particularly of cytokines IL-6, IL-17, and IL-23, has not been associated with neurological symptoms. For example, the anti–IL-6 receptor antibody tocilizumab has shown a positive impact in rheumatoid arthritis patients' quality-of-life scoring, which includes fatigue, anxiety, depression, and a number of other factors. More to the point, the anti–IL-17 antibody secukinumab, which targets the IL-17 ligand (rather than the receptor), has not shown a link to suicide. Given the statistical analysis of real-world evidence, people may cast doubt on the claim that brodalumab increases the risk of suicide. Clearly more data are needed, and it would not be surprising if the FDA began a drug class review if the data in the brodalumab trials warranted it. They could cast quite a wide net given the complexity of this pathway, which overlaps with IL-6, IL-12, and IL-23.
Current pharmacological solutions for Behçet’s syndrome
Published in Expert Opinion on Pharmacotherapy, 2023
Yesim Ozguler, Sinem Nihal Esatoglu, Gulen Hatemi
The RCT with secukinumab in patients with uveitis did not meet its primary endpoint [68]. There were two case series on the use of secukinumab in the treatment of refractory mucocutaneous and joint involvement in BS that were reported by the same group. In their preliminary study, they treated 5 BS patients with mucocutaneous and joint involvement with 150 mg/month (n = 4) or 300 mg/month (n = 1). These patients were resistant to colchicine, conventional immunosuppressives, and at least one TNF inhibitor, and they also fulfilled the classification criteria for ankylosing spondylitis or psoriatic arthritis [69]. At month 3, only 1 patient who received secukinumab 300 mg achieved a complete response. During the follow-up, the secukinumab dose was increased to 300 mg in 3 patients due to a partial response, resulting in improvement in 2. In the second study by the same group, the long-term efficacy and safety of secukinumab were evaluated in 15 BS patients with the same inclusion criteria [70]. Although their complete or partial response rate was 86.7% at month 6, they needed to increase the dose to 300 mg/month due to inefficacy in 7 of 9 patients whose initial dose was 150 mg/month at the same time period. Exacerbations of BS manifestations were not reported.
Successful treatment of paediatric generalized pustular psoriasis with secukinumab: a case series
Published in Journal of Dermatological Treatment, 2022
Henrietta Albela, Sabeera Begum, Kin Fon Leong
Patient 3 is an 8 year old Orang Asli girl, who developed pustular lesions since 2 months of age who was initially treated as cutaneous infection at a nearby district hospital. However, due to logistics issues, the child was lost to subsequent follow up. There were intermittent mild pustular flare since the age of 4 years old but was self-treated with over-the-counter topical medications. She first presented to us with severe pustular psoriasis flare at the age of 8 years old, associated with high grade fever. She was started on intravenous antibiotics to treat for secondary bacterial skin infection. Skin biopsy performed showed findings consistent with GPP and genetic analysis found no significant mutation. Once infection was under controlled, first dose of secukinumab was given at a dose of 150 mg, followed by a second dose 1 week later. Marked improvement was seen within 48 h of the first injection, in which there were significant clearance of the lesions and reduction of 50% of GPPASI score. There was 90% clearance after 2 doses and complete clearance seen at 1-month follow up (Figure 3). She was started on oral acitretin 1 mg/kg/day concurrently with second dose, as maintenance therapy (Table 1). Due to significant logistic logistic difficulty, no further doses were given to date.
Clinical efficacy and safety of secukinumab in patients with psoriasis and comorbidities: pooled analysis of 4 phase 3 clinical trials
Published in Journal of Dermatological Treatment, 2022
Alice B. Gottlieb, Jashin J. Wu, Christopher E. M. Griffiths, Kwaku Marfo, Elisa Muscianisi, Xiangyi Meng, Jennifer Frueh, Mark Lebwohl
Baseline disease characteristics were balanced across treatment arms, as previously published, and all patients had moderate to severe psoriasis regardless of comorbidity status (Table 2) (14,29,30). As patients were not randomized by presence vs. absence of baseline comorbidities in the original studies, imbalances existed between baseline characteristics of patients with and without active baseline comorbidities. Compared with patients with no active baseline comorbidities, those with active baseline comorbidities were older, heavier (as measured by weight and BMI), more likely to be biologic experienced, and more likely to have lived with a diagnosis of psoriasis for a longer time (Table 2). Specific associations were found between individual comorbidities and imbalances in baseline characteristics. Linear regression analysis identified that both higher weight and older age were associated with the presence of specific comorbidities, including obesity, hypertension, hyperlipidemia, and diabetes (p < .05 for all comparisons) (Table 3). Additionally, patients with concomitant PsA were more likely to have previous exposure to biologics (p < .05) (Table 3). These relationships may influence clinical response to secukinumab.