Author Interviews, Dermatology, NEJM / 28.04.2021 Interview with: Prof. Kristian Reich, MD, PhD Professor for Translational Research in Inflammatory Skin Diseases Institute for Health Services Research in Dermatology and Nursing University Medical Center Hamburg-Eppendorf What is the background for this study? What are the main findings? Response: Complete skin clearance is an important treatment goal for patients with psoriasis and is closely associated with treatment satisfaction and improved quality of life. However, it remains an unmet need for many patients. The interleukin (IL)-17 isoforms IL-17A and IL-17F play central roles in psoriasis pathophysiology and are overexpressed in psoriatic tissues. Existing biologic therapies, such as secukinumab, inhibit IL-17A only. However, increasing evidence indicates that IL-17F contributes independently to the pathobiology of plaque psoriasis, and that blocking both IL-17A and IL-17F may lead to more complete suppression of inflammation and superior clinical outcomes, compared with blocking IL‑17A alone. Bimekizumab is a humanized monoclonal IgG1 antibody that has been designed to selectively inhibit IL-17F in addition to IL-17A. (more…)
Author Interviews, Cost of Health Care, Emergency Care, Neurology / 10.01.2020 Interview with: Simon Borghs MSc RWE Strategy Lead of Neurology UCB:  Union Chimique Belge What is the background for this study? Response: Epilepsy is an episodic disease and so is associated with a more or less unpredictable occurrence of health care encounters. These encounters are costly and so reducing them, or their unpredictability, could be cost saving. The objective was to assess one half of this equation, that is the actual cost of those encounters to insurers. This could prompt insurers to consider addressing possible interventions in epilepsy to reduce the number of encounters (more…)
Author Interviews, Epilepsy / 19.12.2019 Interview with: Steve S. Chung MD Epilepsy Neurology Banner University Medical Center University of Arizona, Phoenix, AZ What is the background for this study? Response: Prior studies have shown that midazolam nasal spray (MDZ-NS) is superior to placebo in providing rapid, sustained seizure control and a favorable safety profile when administered to patients experiencing seizure clusters, a type of seizure emergency impacting an estimated 150,000 patients in the U.S. with uncontrolled epilepsy. To explore the influence of concomitant antiepileptic drugs (AEDs) on treatment outcomes, we conducted a post hoc analysis of a Phase III trial to evaluate the tolerability and efficacy of midazolam nasal spray in patients 12 years of age and older with seizure clusters, according to concomitant enzyme-inducing AED (EIAED)/non-enzyme-inducing AED (NEIAED) status and by the number of concomitant AEDs. (more…)
Author Interviews, Epilepsy / 19.12.2019 Interview with: Eun Jung Choi, MD, PhD; Senior Director, New Product Launch, Neurology UCB What is the background for this study? Response: Patients experiencing seizure clusters, a type of seizure emergency impacting an estimated 150,000 patients in the U.S. with uncontrolled epilepsy, are at risk for potentially serious consequences including hospitalization, mortality, physical injury, neurological damage, and status epilepticus. Although unmet needs of seizure clusters are intuitively well accepted, the burden of seizure clusters has not been well characterized and evaluated in a systemic matter. As a result, the seizure cluster patients are overlooked, and burden of seizure clusters is under-recognized. So we systematically assessed the clinical, humanistic, and economic burden associated with seizure clusters to provide the comprehensive body of evidence about burden of seizure clusters. (more…)
Author Interviews, Hematology / 19.12.2019 Interview with: Tadeusz Robak MD, Ph.D. Professor of Hematology Medical University of Lodz, Poland What is the background for this study? What are the main findings?
  • Rozanolixizumab is an advanced SC anti-neonatal FcRn therapy currently in clinical development which has the potential to provide a targeted, convenient option to optimize individualized patient care.
  • The rozanolixizumab Phase II (TP0001) study was specifically designed to explore multiple dose regimens in order to inform the dosing strategy for further development in primary immune thrombocytopenia (ITP). Patients received either a single dose (1 x 15 mg/kg or 1 x 20 mg/kg) or multiple doses (5 x 4 mg/kg, 3 x 7 mg/kg, 2 x 10 mg/kg) of subcutaneous (SC) rozanolixizumab. The total dose was similar in all treatment groups, ranging from 15 to 21 mg/kg.
  • Rozanolixizumab was well tolerated by patients with primary ITP across all dose groups, consistent with previous rozanolixizumab studies. Additionally, improved platelet counts and reduced immunoglobin G (IgG) levels were seen at all doses and regimens of rozanolixizumab treatment, with higher response rate, higher percentage of responders and shorter time to response achieved by the 1 x 15 mg/kg, 1 x 20 mg/kg and the 3 x 7 mg/kg rozanolixizumab dose groups. These safety, tolerability and efficacy data support the Phase III development in patients with primary ITP.