Great Lakes Clinical Trials

The Abbott ID NOWTM COVID-19 2.0 assay is a suitable rapid test for diagnosing COVID-19 in acute symptomatic subjects and can be used in point-of-care settings and low-resource settings. With results reported in 12 minutes or less, Abbott ID NOWTM COVID-19 2.0 facilitates timely diagnosis, enabling linkage to appropriate antiviral medication.

Background Upadacitinib (UPA), a selective JAK1 inhibitor, has demonstrated efficacy and safety in patients with rheumatoid arthritis (RA) as monotherapy and in combination with conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) such as methotrexate (MTX).1,2 However, UPA monotherapy has not been compared directly with UPA combination therapy in the Phase 3 program. Objectives To compare the efficacy of UPA monotherapy and UPA in combination with MTX using data from two Phase 3 trials of RA patients with an inadequate response (IR) to prior MTX therapy. Methods In SELECT-MONOTHERAPY, 648 MTX-IR patients were randomized to receive UPA 15 mg or 30 mg monotherapy once daily (QD), or continue with MTX monotherapy (cMTX; given as a blinded study drug), for 14 weeks. In SELECT-NEXT, 661 csDMARD-IR patients were randomized to receive UPA 15 mg or 30 mg QD or placebo (PBO) for 12 weeks on a background of csDMARDs. Only patients receiving concomitant MTX (with or without additional csDMARDs) at baseline in SELECT-NEXT were included in this analysis. The primary endpoints of both studies were the proportion of patients achieving ACR20 and DAS28(CRP) ≤3.2. Additional endpoints included ACR50/70, DAS28(CRP) Results A total of 1114 patients were included in the analysis, of whom 648 received monotherapy in SELECT-MONOTHERAPY and 466 received combination therapy in SELECT-NEXT. Of the patients receiving combination therapy, 338 (72.5%) were receiving MTX background therapy only and 128 (27.5%) were receiving MTX plus other csDMARDs. Baseline characteristics were generally similar between the study cohorts; the majority of patients in both studies were female and of white ethnicity, with a mean age of approximately 55 years and a mean MTX dose of approximately 17 mg/week. Consistent with previously reported results from SELECT-MONOTHERAPY1 and SELECT-NEXT,2 both UPA monotherapy and UPA combination therapy led to significant improvements in efficacy outcomes versus cMTX/PBO+MTX (Table). No significant differences were observed between UPA monotherapy and UPA combination therapy across a range of clinical endpoints, including ACR20/50/70 responses and measures of LDA and remission. In addition, improvements in quality of life as measured by HAQ-DI were similar with UPA monotherapy and combination therapy. Efficacy was comparable between the two UPA doses in the combination therapy group, whereas in the monotherapy group numerically higher responses were observed with UPA 30 mg versus UPA 15 mg. Conclusion In MTX-IR patients with RA, the efficacy of UPA appears comparable when administered as monotherapy or when given in combination with MTX. References 1Smolen J, et al. Ann Rheum Dis 2018;77:67?8; 2Burmester GR, et al. Lancet 2018;391:2503-12 Acknowledgement AbbVie, Inc was the study sponsor, contributed to the study design, data collection, analysis & interpretation, and to writing, reviewing, and approval of the final version. Medical writing support was provided by John Ewbank, PhD, of 2 the Nth. Disclosure of Interests Maya Buch Grant/research support from: Pfizer LTD, UCB, Consultant for: AbbVie, Eli Lilly, EMD Serono, Pfizer Ltd., Sanofi, Alvin F. Wells Consultant for: AbbVie, Andrea Rubbert-Roth Consultant for: Abbvie, Speakers bureau: AbbVie, Manish Jain Consultant for: Abbvie, Novartis, Celgene, Medac, and Takeda., Speakers bureau: Abbvie, Novartis, Celgene, Medac, and Takeda., Casey Schlacher Shareholder of: AbbVie, Employee of: AbbVie, Heidi Camp Shareholder of: AbbVie, Employee of: AbbVie, Yihan Li Shareholder of: AbbVie, Employee of: AbbVie, Yanna Song Shareholder of: AbbVie, Employee of: AbbVie, Peter Nash Grant/research support from: AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Consultant for: AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer Inc, Roche, Sanofi, UCB, Speakers bureau: AbbVie, Bristol-Myers Squibb, Eli Lilly, Janssen, Novartis, Pfizer Inc, Roche, Sanofi, UCB

ABSTRACTBackgroundFew trials have examined the effects of coconut oil consumption in comparison with polyunsaturated fatty acid–rich oils such as corn oil.ObjectiveThis trial assessed the effects of consuming foods made with corn oil compared with coconut oil on lipids, glucose homeostasis, and inflammation.MethodsThis was a preliminary randomized crossover study of men (n = 12) and women (n = 13) with a mean age of 45.2 y, mean body mass index (in kg/m2) of 27.7, fasting LDL cholesterol ≥115 mg/dL and <190 mg/dL, and triglycerides (TGs) ≤375 mg/dL. Subjects consumed muffins and rolls providing 4 tablespoons (∼54 g) per day of corn oil or coconut oil as part of their habitual diets for 4 wk, with a 3-wk washout between conditions. Fasting plasma lipids and high-sensitivity C-reactive protein (hs-CRP) and glucose metabolism were assessed via an intravenous glucose tolerance test at baseline and 15 and 29 d of treatment. Responses were compared between treatments by ANCOVA.ResultsMedian baseline concentrations of LDL cholesterol, non-HDL cholesterol, total cholesterol (total-C), HDL cholesterol, total-C:HDL cholesterol, and TGs were 123, 144, 188, 46.0, 4.21, and 92.5 mg/dL, respectively. Changes from baseline for corn oil and coconut oil conditions, respectively, were: LDL cholesterol (primary outcome; −2.7% compared with +4.6%), non-HDL cholesterol (−3.0% compared with +5.8%), total-C (−0.5% compared with +7.1%), HDL cholesterol (+5.4% compared with +6.5%), total-C:HDL cholesterol (−4.3% compared with −3.3%), and TGs (−2.1% compared with +6.0%). Non-HDL cholesterol responses were significantly different between corn and coconut oil conditions (P = 0.034); differences between conditions in total-C and LDL cholesterol approached significance (both P = 0.06). Responses for hs-CRP and carbohydrate homeostasis parameters did not differ significantly between diet conditions.ConclusionsWhen incorporated into the habitual diet, consumption of foods providing ∼54 g of corn oil/d produced a more favorable plasma lipid profile than did coconut oil in adults with elevated cholesterol. This trial was registered at clinicaltrials.gov as NCT03202654.