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Hamburg, Germany

Reich K.,Dermatologikum Hamburg | Reich K.,University of Gottingen | Langley R.G.,Dalhousie University | Papp K.A.,Probity Medical Research | And 4 more authors.
New England Journal of Medicine | Year: 2011

BACKGROUND: Briakinumab is a monoclonal antibody against the p40 molecule shared by interleukin- 12 and interleukin-23, which is overexpressed in psoriatic skin lesions. We assessed the efficacy and safety of briakinumab as compared with methotrexate in patients with psoriasis. METHODS: In this 52-week trial, we randomly assigned 317 patients with moderate-to-severe psoriasis to briakinumab, at a dose of 200 mg at weeks 0 and 4 and 100 mg at week 8 and every 4 weeks thereafter (154 patients), or methotrexate, at a dose of 5 to 25 mg weekly (163 patients). The primary end points were the percentages of patients with at least 75% improvement in the score on the psoriasis area-and-severity index (PASI) at weeks 24 and 52 and a score on the physician's global assessment of 0 (clear; i.e., no apparent disease) or 1 (minimal disease) at weeks 24 and 52. A total of 248 patients were enrolled in an ongoing 160-week open-label continuation study. RESULTS:At week 24, a total of 81.8% of the patients in the briakinumab group versus 39.9% in the methotrexate group had at least 75% improvement in the PASI score, and 80.5% versus 34.4% had a score of 0 or 1 on the physician's global assessment. The corresponding percentages at week 52 were 66.2% versus 23.9% with at least a 75% improvement in the PASI score and 63.0% versus 20.2% with a score of 0 or 1 on the physician's global assessment (P<0.001 for all comparisons). During the 52-week study, serious adverse events occurred in 9.1% of the patients in the briakinumab group (12.9 events per 100 patient-years) and in 6.1% in the methotrexate group (10.6 events per 100 patient-years). Serious infections occurred in 2.6% of the patients in the briakinumab group (4.1 events per 100 patient-years) and in 1.8% in the methotrexate group (2.7 events per 100 patient-years); cancers occurred in 1.9% (2.0 events per 100 patient-years) versus 0%. CONCLUSIONS:Briakinumab showed higher efficacy than methotrexate in patients with moderate-to-severe psoriasis. Serious infections and cancers occurred more frequently with briakinumab, but the differences were not significant. (Funded by Abbott Laboratories; ClinicalTrials.gov number, NCT00679731.) Copyright © 2011 Massachusetts Medical Society. Source


Reich K.,Dermatologikum Hamburg | Bewley A.,University of London
Journal of the European Academy of Dermatology and Venereology | Year: 2011

This article describes a recent development in topical therapies for psoriasis and is based on a presentation given by the authors at a satellite symposium convened during the 19th Congress of the European Academy of Dermatology and Venereology, 6-10 October 2010, in Gothenburg, Sweden. Topical therapies are the mainstay of treatment for psoriasis; however, for optimal outcomes to be achieved, medications need to be used as prescribed. Patients with psoriasis often report low treatment adherence rates; the reasons for this are multifactorial, but can include specific aspects of the treatments themselves. For example, physical properties, ease of use and the vehicle in which the active ingredients are dissolved can all play a role in an individual patient's adherence to treatment. Of the available topical therapies, corticosteroids and vitamin D analogues are the treatment of choice, with combined efficacy that is superior to monotherapy with either agent. To permit simultaneous once-daily dosing, an ointment was formulated that allowed calcipotriol and betamethasone dipropionate to be delivered together; this two-compound ointment had an improved efficacy and tolerability profile vs. either compound alone. To provide an alternative for patients who may dislike ointments, but still want to benefit from the high efficacy of combination therapy, a two-compound (calcipotriol/betamethasone dipropionate) gel has recently been developed; data from phase 2 and phase 3 studies show that it is more effective than the comparators it was tested against, with fewer adverse events, and a rapid onset of action. In a series of one-to-one interviews recently conducted with 150 patients with psoriasis, gel and cream formulations were preferred for ease of use and cosmetic acceptability compared with ointment. The availability of this new gel thus increases patient choice. Ultimately, treatment should always be tailored to match individual patients' needs. © 2011 European Academy of Dermatology and Venereology. Source


Prager W.,Dermatologikum Hamburg
Clinical Pharmacology: Advances and Applications | Year: 2013

Objectives: This review examines the pharmacologic and clinical characteristics of incobotulinumtoxinA (Xeomin®/Xeomeen®/Bocouture®/XEOMIN Cosmetic™; botulinum toxin type A [150 kDa]), which is free from complexing proteins, and discusses its efficacy and safety in the treatment of glabellar frown lines. Differences between incobotulinumtoxinA and other commercially available botulinum neurotoxin type A (BoNT/A) products that have been approved by the European Medicines Agency, US Food and Drug Administration, and other regulatory agencies for this indication are also discussed. Findings: IncobotulinumtoxinA differs from other commercially available BoNT/A preparations, in that it is free from complexing proteins and contains only active neurotoxin, minimizing foreign protein load. IncobotulinumtoxinA is commonly used at a 1:1 dose ratio with onabotulinumtoxinA and displays comparable efficacy and safety; furthermore, it is associated with early onset and long duration of effect, and high levels of subject satisfaction. In terms of practical considerations, incobotulinumtoxinA does not require cold storage and demonstrates low spread, enabling precise treatment and good tolerability. Conclusion: IncobotulinumtoxinA is an efficacious and well-tolerated treatment for glabellar frown lines. It differs from other BoNT/A preparations, in that it is free from complexing proteins and contains only active neurotoxin, which is relevant clinically, as this reduces the foreign protein load and minimizes the risk of neutralizing antibody production. In practical terms, incobotulinumtoxinA has a long shelf-life, remaining stable without the need for refrigeration, and due to its limited spread is a precise localized treatment. © 2013 Prager, publisher and licensee Dove Medical Press Ltd. Source


Reich K.,Dermatologikum Hamburg
Journal of the European Academy of Dermatology and Venereology | Year: 2012

Psoriasis is a systemic, immune-mediated disorder, characterized by inflammatory skin and joint manifestations. A range of co-morbidities is associated with psoriasis, including metabolic diseases, such as diabetes, and psychological disorders. Although the systemic nature of psoriasis often remains unrecognized, the inflammatory processes involved may be associated with the development of co-morbidities, which, themselves, have a significant impact on the patient's health and quality of life. The relative risks of myocardial infarction (MI) and stroke are increased in patients with psoriasis compared with the general population. These are especially seen in younger patients with more severe disease, and are believed to contribute to the 3- to 4-year reduction in life expectancy among patients with severe psoriasis. The recent results of large studies indicate that the increased cardiovascular (CV) risk is at least partially attributable to psoriasis and independent of the presence of metabolic co-morbidities. The possible interplay between psoriasis and CV disease is complex. Metabolic diseases such as obesity and diabetes have overlapping genetic predispositions with psoriasis. Both conditions are likely to also interact at a functional level because obesity and the up-regulation of pro-inflammatory mediators in psoriasis appear to influence adipocyte homoeostasis, inducing non-professional immune functions. This may perpetuate psoriatic inflammation, displaying similarities to the immunopathogenesis of atherosclerosis. Finally, the disturbed adipokine profile and inflammation associated with psoriasis enhances insulin resistance, causing subsequent endothelial dysfunction, atherosclerosis and eventual coronary events. The differential contribution of psoriasis and uncontrolled classical CV risk factors to the increased CV risk seen in psoriasis patients is not clear. Successful treatment with methotrexate appears to lower the rates of MI in patients with psoriasis. Tumour necrosis factor-α (TNF-α) inhibitors are known to counteract insulin resistance and emerging studies demonstrate an even higher protective effect of TNF-α antagonist therapy against the development of diabetes or CV co-morbidities in patients. The recent data reviewed here indicate a role for earlier and more appropriate treatment of psoriasis with drugs such as TNF-α antagonists. Such an approach has the potential to significantly improve patient outcomes through the treatment of psoriasis itself and possibly also in protection against co-morbidities. © 2012 European Academy of Dermatology and Venereology. Source


Boer-Auer A.,Dermatologikum Hamburg
Hautarzt | Year: 2014

Adnexal tumors of the skin are epithelial skin tumors with differentiation towards the adnexal epithelial structures of the skin, namely, hair follicle, sebaceous gland, apocrine gland, and eccrine gland. Adnexal tumors include hamartomas, benign and malignant neoplasms, and hyperplasias. The specific diagnosis of adnexal tumors is important because some lesions such as sebaceous neoplasms, cylindromas, or fibrofolliculomas are herald lesions of hereditary tumor syndromes (e.g., Muir-Torre syndrome, familial cylindromatosis, Birt-Hogg-Dubé syndrome). In this article, the classification of adnexal tumors of the skin is explained on the basis of embryology and histology and the main features of tumor-associated syndromes are summarized. Moreover, some conceptual controversies and problems in differential diagnosis of cutaneous adnexal tumors are discussed. © Springer-Verlag 2014. Source

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