Double-Blinded, Vehicle-Controlled Proof of Concept Study to Investigate the Recurrence of Inflammatory and Noninflammatory Acne Lesions Using Tretinoin Gel (Microsphere) 0.04% in Male Patients after Oral Isotretinoin Use

Background. Although isotretinoin orally is commonly used for moderate to severe or scarring acne, it is not a cure. Unfortunately recurrence is unpredictable and varies within the acne population. Objectives. Using a proof of concept study, determine the recurrence of acne after isotretinoin use in male patients. Methods. Twenty males aged 18–45 years old were enrolled. Subjects successfully completed a treatment of acne vulgaris with oral isotretinoin (120–150 mg/kg/course). Subjects were randomized 1 to 1. The study duration was 24 weeks. The primary endpoint measured was the absolute change in lesion counts from baseline to weeks 16 and 24. Local tolerability assessments were measured. Results. There were favorable changes in all outcomes measured. Overall, there was a 38.7% lower lesion count with tretinoin 0.04% microsphere gel use versus vehicle. The active product was well tolerated with great patient satisfaction. There were no significant safety issues. The limitations included the low number of patients enrolled, average age, and percentage of patients lost to follow-up. Conclusion. In summary, the results favored tretinoin 0.04% microsphere gel in the prevention of recurrent acne after isotretinoin use in male patients over 18 years old over a six-month period

Systemic Role for Vitamin D in the Treatment of Psoriasis and Metabolic Syndrome

The novel discovery of the systemic role of vitamin D in the modulation of the immune system especially the Type 1 helper T cell (Th1) pathway reveals its potential for treating Th1 inflammatory diseases. Psoriasis has been recently established to be a systemic disease centered on inflammation and involvement of cytokines of the Th1 pathway. There is an increased prevalence of metabolic syndrome in patients with psoriasis. Metabolic syndrome also involves a proinflammatory state. This paper proposes the idea of the potential use of oral vitamin D to treat psoriasis and metabolic syndrome concurrently. We propose there is merit in more clinical trials investigating the use of vitamin D to treat both psoriasis and metabolic syndrome through its anti-inflammatory effects. On application to psoriasis management and prognosis, the goal is to decrease the risk for cardiovascular disease and decrease disease morbidity and mortality

Biosimilars for the treatment of patients with psoriasis : A consensus statement from the Biosimilar Working Group of the International Psoriasis Council

As biosimilars have become available in various parts of the world, the International Psoriasis Council has reviewed aspects of their use. To provide consensus statements from the Biosimilar Working Group about the use of biosimilars in patients with psoriasis. A semiqualitative structured process was employed to approve the consensus statements on biosimilars using the nominal group technique. The final statements were validated by a survey of the paricipants. The approval of the consensus statements was predefined as >80% positive opinions. A consensus was reached in 36/38 statements regarding regulatory considerations, extrapolation of indication, interchangeability, substitution at the pharmacy level, pharmacovigilance, traceability, naming, biosimilar policy, education, and cost of biosimilars. Example statements include "Switching a stable patient from a reference product to a biosimilar product is appropriate if the patient and physician agree to do so" and "Patients and patients' organisations should be involved in all decision making and policy development about the use of biosimilars." The International Psoriasis Council Biosimilar Working Group provides consensus statements for the use of biosimilars in the treatment of patients with psoriasis. We suggest that these statements provide global guidance to clinicians, healthcare organizations, pharmaceutical companies, regulators, and patients regarding the development and use of biosimilars in patients with psoriasis

Viewpoint about biologic agents for psoriasis: are they immunosuppressants or immunomodulators?

Over the past two decades, promising advancements have emerged in the field of psoriasis management. Most notably, highly effective targeted biologic therapies that offered significant breakthroughs in the management of psoriasis have been developed. One of the most challenging components of marketing and prescribing these biologic therapies has been in classifying them as immunomodulators or immunosuppressants. The purpose of this narrative review was to discuss the features that distinguish immunomodulators from immunosuppressants to successfully categorize the biologic therapies used for psoriasis management and subsequently enhance patient and physician understanding of the risks associated with the use of these drugs

Speed and Cumulative Responses According to Body Regions in Patients with Moderate-to-Severe Plaque Psoriasis Treated with Ixekizumab (Interleukin-17A Antagonist) versus Guselkumab (Interleukin-23p19 Inhibitor)

Abstract Introduction When assessing the effect of a therapy for psoriasis (PsO), it is important to consider speed of response and cumulative response. However, responses among biologics may differ by body regions. This post hoc analysis compares speed of response and cumulative response for ixekizumab (IXE), an interleukin-17A antagonist, and guselkumab (GUS), an interleukin-23p19 inhibitor, in different body regions of patients with moderate-to-severe plaque PsO participating in the IXORA-R study, up to week 24. Methods The IXORA-R design has been previously described. Patients received the respective on-label dosing of IXE or GUS. The median time to first Psoriasis Area and Severity Index (PASI) 50, 75, 90, and 100 response (50%, 75%, 90%, and 100% improvement from baseline, respectively) and the cumulative days with clear skin for PASI 50, 75, 90, and 100 responses were assessed in four body regions: head, trunk, upper extremities, and lower extremities. Results A total of 1027 patients were enrolled and received IXE (N = 520) or GUS (N = 507). Median time to first PASI 50, 75, 90, and 100 response was shortest in the head region, followed by the remaining body regions in both IXE and GUS cohorts. In each body region, IXE was significantly faster than GUS (p < 0.001) in achieving PASI 50, 75, 90, and 100. Through 24 weeks, the number of days with clear skin for PASI 90 and 100 was greater in the head region, followed by trunk, upper extremities, and lastly lower extremities in both IXE and GUS cohorts. In each body region, through 24 weeks, patients on IXE experienced a significantly higher number of days with clear skin for PASI 50, 75, 90, and 100 than patients on GUS (p < 0.01). Conclusions As compared to GUS, IXE provided a faster skin clearance and more days with clear skin in all body regions of patients with moderate-to-severe plaque PsO through 24 weeks. Trial Registration Number https://www.clinicaltrials.gov/ : NCT03573323 (IXORA-R)

Supplemental Material, PROPEL_Manuscript_Supplementary_File_3 – Canadian Patients’ Preferences in Topical Psoriasis Care: Insights From the PROPEL Surveys

<p>Supplemental Material, PROPEL_Manuscript_Supplementary_File_3 for Canadian Patients’ Preferences in Topical Psoriasis Care: Insights From the PROPEL Surveys by Ronald Vender, Melinda J. Gooderham, Lyn C. Guenther, Dimitrios Kyritsis, Jaggi Rao, Alice Kowalczyk and John Ashkenas in Journal of Cutaneous Medicine and Surgery</p