First-in-human phase I/Ib study of NIZ985, a recombinant heterodimer of IL-15 and IL-15Rα, as a single agent and in combination with spartalizumab in patients with advanced and metastatic solid tumors.

Background: Preclinically, interleukin-15 (IL-15) monotherapy promotes antitumor immune responses, which are enhanced when IL-15 is used in combination with immune checkpoint inhibitors (ICIs). This first-in-human study investigated NIZ985, a recombinant heterodimer comprising physiologically active IL-15 and IL-15 receptor α, as monotherapy and in combination with spartalizumab, an anti-programmed cell death protein-1 (anti-PD-1) monoclonal antibody, in patients with advanced solid tumors.

Methods: This phase I/Ib study had two dose-escalation arms: single-agent NIZ985 administered subcutaneously thrice weekly (TIW, 2 weeks on/2 weeks off) or once weekly (QW, 3 weeks on/1 week off), and NIZ985 TIW or QW administered subcutaneously plus spartalizumab (400 mg intravenously every 4 weeks (Q4W)).

A first-in-human phase 1/2 study of FGF401 and combination of FGF401 with spartalizumab in patients with hepatocellular carcinoma or biomarker-selected solid tumors.

Background: Deregulation of FGF19-FGFR4 signaling is found in several cancers, including hepatocellular carcinoma (HCC), nominating it for therapeutic targeting. FGF401 is a potent, selective FGFR4 inhibitor with antitumor activity in preclinical models. This study was designed to determine the recommended phase 2 dose (RP2D), characterize PK/PD, and evaluate the safety and efficacy of FGF401 alone and combined with the anti-PD-1 antibody, spartalizumab.

Study design with staggered sampling times for evaluating sustained unresponsiveness to peanut sublingual immunotherapy.

In this work, we delineate an altered study design of a pre-existing clinical trial that is currently being implemented in the Department of Pediatrics at the University of North Carolina at Chapel Hill. The purpose of the ongoing investigation of the desensitized pediatric cohort is to address the effectiveness of sublingual immunotherapy in achieving sustained unresponsiveness (SU) as assessed by repeated double-blind placebo-controlled food challenges (DBPCFC). With scarce published literature characterizing SU, the length of time off-therapy that would represent clinically meaningful benefit remains undefined.

Side effects from use of one or more psychiatric medications in a population-based sample of children and adolescents.

Objective: The purpose of this study was to investigate the side effect risks from using one or more psychiatric medications (including antipsychotics, antidepressants, α-2 agonists, benzodiazepines, mood stabilizers, and stimulants) among a national cohort of children and adolescents.

Methods: A questionnaire survey was administered to parents who filled a prescription for a psychiatric medication for their child at a large national retail pharmacy chain. Primary outcome variables were the total count of side effects from a list of 12 problem areas, as well as parent-reported side effect intensity (mild/moderate/severe).

Evaluating components of dental care utilization among adults with diabetes and matched controls via hurdle models.

Background: About one-third of adults with diabetes have severe oral complications. However, limited previous research has investigated dental care utilization associated with diabetes. This project had two purposes: to develop a methodology to estimate dental care utilization using claims data and to use this methodology to compare utilization of dental care between adults with and without diabetes.

A population-based study of periodontal care among those with and without diabetes.

Background: Our objectives were to describe the prevalence of periodontal care (a marker of periodontitis) among persons with and without diabetes and to examine the association between periodontal care and diabetes.

Methods: We conducted a cross-sectional analysis, using 5 years of electronic data from a population-based cohort (N = 46,132), aged 40 to 70 years, with dental and medical insurance, and ≥ 1 dental and ≥ 1 medical visit. Periodontal care (yes/no) was defined by dental claims codes for procedures used to manage periodontitis.

Cross-sectional study of periodontal care and Glycosylated Hemoglobin in an insured population.

Objective: Compare GHb among people with diabetes who have and have not received periodontal care.

Research Design And Methods: This cross-sectional study linked 5 years of electronic medical record and dental insurance data for dually insured patients with diabetes, ages 40-70 years (n = 5,103). We assessed the association between annual mean GHb (%) and periodontal care (a proxy for periodontitis) defined using claim codes.

Case study of linking dental and medical healthcare records.

Objective: To link the administrative data of a large dental carrier and an integrated health plan in Washington State to conduct an observational study of diabetes and periodontal disease.

Study Design: Evaluation of variable suitability, testing of linkage variables, and performing an n - 1 deterministic linkage strategy.

Methods: We examined a variety of administrative data variables for their consistency over time and their information richness to use as matching variables.