A safety review of recent advancements in the treatment of psoriasis: analysis of clinical trial safety data.

INTRODUCTION: The management of psoriasis can include oral medications and injectable biologics. Safety data of these various treatment options are important to consider when choosing the right treatment for the patient. AREAS COVERED: This review evaluates the safety of newer treatments approved for psoriasis, including interleukin-(IL)-17 inhibitors, IL-23/p19 inhibitors, ustekinumab, certolizumab pegol and apremilast, using phases III and IV clinical trial data. EXPERT OPINION: Even as treatment of psoriasis becomes safer, it is important to recognize both common and uncommon adverse effects of treatment. Common adverse effects are similar across treatment options, including upper respiratory infection and injection-site reaction. Serious adverse effects occur less frequently and specific to the psoriasis treatment option, such as inflammatory bowel disease and candida infections with IL-17 inhibitors, tuberculosis with certolizumab pegol, and psychiatric events with apremilast. While IL-23/p19 inhibitors may have a slightly better safety profile than other biologics, long-term data are limited. The conclusions that can be drawn from clinical trial safety data are limited given that many clinical trials are not large enough to detect rare safety events. Data from registries provide important complementary information on long-term safety but there are limitations including a lack of randomized assignment between drug treatments.

Grid analysis improves reliability in follicle counts made by ultrasonography in women with polycystic ovary syndrome.

Poor reliability has been reported when counting the total number of follicles in polycystic ovaries using conventional two-dimensional (2-D) ultrasound viewing methods. In the current study, we report good reliability in follicle counts when observers imposed a programmable grid system over the viewing window. Four observers estimated total follicle counts in 45 ovarian ultrasound scans by compartmentalizing the ovary into 9 to 12 grid sections and performing focused follicle counts per section. The mean number of follicles counted per ovary was 44.6 +/- 2.3. The level of inter-observer agreement when making follicle counts was 0.82 and total follicle counts did not differ among observers. The level of intra-observer agreement was 0.93 which further corroborated the utility of this method for making dependable follicle counts. In summary, the ability to obtain reproducible follicle counts will help to establish reliable diagnostic criteria for polycystic ovarian morphology.