Jordan Valley Dermatology

To evaluate the equivalence of immunogenicity, safety and efficacy of Gan & Lee (GL) Glargine (Basalin®; Gan & Lee Pharmaceutical) with that of the reference product (Lantus®) in adult participants with type 2 diabetes mellitus. This was a phase 3, multicenter, open-label, equivalence trial conducted across 57 sites. In total, 567 participants with type 2 diabetes mellitus were randomized in a 1:1 ratio to undergo treatment with either GL Glargine or Lantus® for 26 weeks. The primary endpoint was the proportion of participants in each treatment arm who manifested treatment-induced anti-insulin antibodies (AIA). Secondary endpoints included efficacy and safety metrics, changes in glycated haemoglobin levels, and a comparative assessment of adverse events. Results were analysed using an equivalence test comparing the limits of the 90% confidence interval (CI) for treatment-induced AIA development to the prespecified margins. The percentages of participants positive for treatment-induced glycated haemoglobin by week 26 were similar between the GL Glargine (19.2%) and Lantus® (21.3%) treatment groups, with a treatment difference of -2.1 percentage points and a 90% CI (-7.6%, 3.5%) (predefined similarity margins: -10.7%, 10.7%). The difference in glycated haemoglobin was -0.08% (90% CI, -0.23, 0.06). The overall percentage of participants with any treatment-emergent adverse events was similar between the GL Glargine (80.1%) and Lantus® (81.6%) treatment groups. GL Glargine was similar to Lantus® in terms of immunogenicity, efficacy,and safety, based on the current study.

Center for Orthopedic and Rehabilitation Excellence, West Jordan, UT. (No relevant relationships reported)

Background: Atopic dermatitis (AD) is a chronic inflammatory skin disease that affects children and adults. Hallmarks of AD include pruritus and pruritus-induced scratching, which can lead to exacerbation of symptoms and worsening of disease. Objective: To assess the pooled efficacy, safety, and early relief of pruritus from two Phase 3 studies evaluating crisaborole ointment, an anti-inflammatory phosphodiesterase 4 inhibitor, in patients with mild to moderate AD. Methods: …

Extraorbital idiopathic pseudotumors of the skull base are very uncommon. We report the case of a 50-year-old woman who presented with left ophthalmoplegia and vision loss. Imaging studies revealed an enhancing lesion involving the left petrous apex and cavernous sinus. A transnasal endoscopic approach was used to obtain a biopsy of the left petrous apex. Pathology identified the lesion as an idiopathic pseudotumor. The patient was treated with high-dose steroids and steroid-sparing immunomodulators, and she experienced a significant improvement. To the best of our knowledge, this is the first reported case of a transnasal endoscopic approach to a biopsy of a pseudotumor involving the petrous apex. We discuss the features of this case, and we review the literature on this condition.