MDNN: Postive Results for Upadacitinib, HIV Testing for Older Adults, and US Disease Trends

Hi, I’m Jenna Payesko, and I’m Cecilia Pessoa-Gingerich, and this is MD Magazine News Network—it’s clinical news for connected physicians.

Jenna: This week, AbbVie announced positive top-line results from the SELECT-COMPARE clinical trial, a 12-week phase 3 examination of upadacitinib. The results showed that at week 12, 71% of patients receiving an oral once-daily 15-mg dose achieved an ACR20 response versus 36% of patients receiving placebo. Additionally, 23% more patients receiving upadacitinib achieved clinical remission versus those receiving placebo at week 12. It’s exciting news for the potential rheumatoid arthritis therapy. So, what’s the bad news?

Cecilia: Well, according to the Centers for Disease Control and Prevention, older adults are increasingly affected by HIV infections, as they constitute 17% of new diagnoses, 45% of adult persons living with HIV in the US, and 39% of HIV-related deaths in the US. And although the prevalence of HIV infection among old adults is increasing worldwide, a recent study in the US suggests that only about one-quarter of older adults have been tested for HIV. As a result of less aggressive testing in this patient population, older adults tend to be diagnosed with HIV at a later stage in the disease. The findings imply that patients older than 64 should be tested, and assumptions about sexual activity among this patient population will only put these patients at a disadvantage in the realm of HIV treatment and prevention.

Jenna: Speaking of disadvantages, a new systematic analysis has put together estimates on the trends of disease and conditions in the US, and how it has affected residents of each state. The results, from the Global Burden of Disease Study, show that the country’s health burdens have vastly changed from 1990-2016, in ways that call for similar changes to policies and medical priority. Though the overall death rate per persons in the United States has declined by more than 22% since 1990, new drivers of death—such as Alzheimer’s disease, diabetes, self-harm, opioid use disorder, and chronic liver disease—have emerged over that time and have continued to unequally affect residents at the state level.

Cecilia: Hopefully researchers can prioritize the need for a response to these rising issues. But now, for our weekly segment FDA Roundup, let’s go to Matt Hoffman. Matt, what’s the FDA been up to?

Matt: To be honest, quite a bit. This week, the FDA approved several therapies, including Exparel, the first long-acting, single-dose nerve block for patients undergoing upper extremity surgeries; The Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology, which incorporate an additive that reacts to bright light by darkening the lenses; Afinitor Disperz tablets, for adjunctive treatment of adult and pediatric patients aged 2 years and older with tuberous sclerosis complex-associated partial-onset seizures; and IDx-DR, is a software program that uses an AI algorithm to analyze images taken with the retinal camera, Topcon NW400, to detect notable eye disease diabetic retinopathy in adults with diabetes.

The administration also announced an investigational device exemption pivotal trial in order to evaluate Medtronic’s Symplicity Spyral renal denervation system in patients with hypertension, it issued an order to restrict the sale and distribution of Bayer’s Essure device to guarantee that all women contemplating the use of the permanent contraception device are provided with adequate risk information, and granted an Orphan Drug Designation to Reviva Pharmaceuticals’ clinical-stage drug candidate, RP5063, for the treatment of idiopathic pulmonary fibrosis.

From across the room, I’m Matt Hoffman with FDA Roundup. Back to you guys.

Jenna: For these stories and more, visit us at mdmag.com. I’m Jenna Payesko, and I’m Cecilia Pessoa-Gingerich. Thank you for watching MDNN.