Safety and effectiveness of guselkumab in Japanese patients with psoriasis: 20-week interim analysis of a postmarketing surveillance study.

A 52-week postmarketing surveillance study was initiated to evaluate the safety and effectiveness of guselkumab, a human anti-interleukin 23 subunit p19 monoclonal antibody, in Japanese patients with psoriasis vulgaris, psoriatic arthritis, generalized pustular psoriasis, and erythrodermic psoriasis in real-world practice. Here, we report results of the 20-week interim analysis of the ongoing postmarketing surveillance study. Patients who received guselkumab between May 2018 (the date of commercial launch in Japan) and October 2020 were registered in this study. In total, 411 and 245 patients were included in the safety and effectiveness analysis sets, respectively. Adverse drug reactions (ADRs) occurred in 6.6% (27 of 411) and serious ADRs in 2.2% (nine of 411) of patients. The most frequent ADRs by System Organ Class were "Infections and infestations" (2.4%), with nasopharyngitis being the most frequently observed ADR (0.7%). The mean Psoriasis Area Severity Index score decreased from 11.6 at baseline to 6.5 at week 4 and 2.2 at week 20, with improvements achieving statistical significance at each time point. Clinical Global Impression, Dermatology Life Quality Index, and Nail Psoriasis Severity Index outcomesalso showed substantial improvements. Our findings demonstrate that guselkumab is well tolerated and effective in Japanese patients with psoriasis through 20 weeks of treatment in real-world clinical practice, showing significant effectiveness observed as early as 4 weeks. The study was officially registered with the University Hospital Medical Information Network Clinical Trials Registry with the identifier UMIN000032969.

Variations in the configuration of pulp chambers subjacent to protostylids.

PURPOSE: This study aimed to clarify the positional relationship between the crown contour and pulp chamber of protostylids using three-dimensional reconstructed images. METHODS: Fourteen molars with protostylids from Japanese subjects were subjected to micro-computed tomography. The external surface configurations of the teeth and pulp chambers were reconstructed. Hard tissue thicknesses in appointed buccal areas were measured on the reconstructed images. RESULTS: Well-developed protostylids exhibited pulp-prominences above or at the cervical line level. Those that were moderately developed exhibited bulges of the pulp chamber subjacent to the protostylids. Ten of the 14 teeth had prominences in the crown pulp above or at the cervical line level. In addition, 13 teeth exhibited pulp chamber bulges surrounding the lower tooth trunk. No significant differences were apparent in the buccal horizontal thickness of the hard tissue between the protostylids with pulp chamber prominences and the protostylids without pulp chamber prominences at the cervical line level. CONCLUSION: Pulp chamber configurations subjacent to protostylids vary based on the development of the traits of the protostylids. Minimum possible taper should be applied during standard vital tooth preparations, as reduced residual dentin thickness is predicted in well- and moderately developed protostylids.

Case of ketoacidosis by a sodium-glucose cotransporter 2 inhibitor in a diabetic patient with a low-carbohydrate diet.

We present a case of a 32-year-old diabetic woman with Prader-Willi syndrome who developed severe ketoacidosis caused by a sodium-glucose cotransporter 2 (SGLT2) inhibitor, a novel class of antihyperglycemic agents, during a strict low-carbohydrate diet. At admission, a serum glucose level of 191 mg/dL was relatively low, though laboratory evaluations showed severe ketoacidosis. This is the first report of ketoacidosis caused by a SGLT2 inhibitor. It is necessary to not only pay attention when using a SGLT2 inhibitor in patients following a low-carbohydrate diet, but also to start a low-carbohydrate diet in patients treated with a SGLT2 inhibitor because of a high risk for developing ketoacidosis.