Research Spotlight

Whitlock, S. M., C. W. Enos, A. W. Armstrong, A. Gottlieb, R. G. Langley, M. Lebwohl, J. F. Merola, C. Ryan, M. P. Siegel, J. M. Weinberg, J. J. Wu and A. S. Van Voorhees (2018). “Management of psoriasis in patients with inflammatory bowel disease: From the Medical Board of the National Psoriasis Foundation.” J Am Acad Dermatol 78(2): 383-394.

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BACKGROUND: There is a significant association between psoriasis and inflammatory bowel disease (IBD). Many treatments for psoriasis and psoriatic arthritis are also used for IBD. OBJECTIVE: To assess therapeutic options for patients with psoriasis and concurrent IBD. METHODS: A systematic literature search was performed for clinical studies of biologic and systemic psoriasis medications in psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease, for the period from January 1, 1947, to February 14, 2017. Randomized, controlled, double-blinded studies were selected if available. If not, the next highest level of available evidence was selected. RESULTS: Of the 2282 articles identified, 132 were selected. Infliximab and adalimumab have demonstrated efficacy in psoriasis, psoriatic arthritis, ulcerative; colitis, and Crohn’s disease. Ustekinumab has demonstrated efficacy in psoriasis, psoriatic arthritis, and Crohn’s disease. Certolizumab has demonstrated efficacy in psoriatic arthritis and Crohn’s disease. Etanercept, secukinumab, brodalumab, and ixekizumab have demonstrated efficacy in psoriasis and psoriatic arthritis but may exacerbate or induce IBD. Guselkumab has demonstrated efficacy in psoriasis. LIMITATIONS: There are no known clinical trials of treatment specifically for concurrent psoriasis and IBD. CONCLUSIONS: Infliximab and adalimumab have demonstrated efficacy in psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease; other agents have demonstrated efficacy for some, but not all, of these indications.

Wesson, D. E. and H. E. Kitzman (2018). “How Academic Health Systems Can Achieve Population Health in Vulnerable Populations Through Value-Based Care: The Critical Importance of Establishing Trusted Agency.” Acad Med. Jan 16. [Epub ahead of print].

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Improving population health may require health systems to proactively engage patient populations as partners in the implementation of healthy behaviors as a shared value using strategies that incentivize healthy outcomes for the population as a whole. The current reactive health care model, which focuses on restoring the health of individuals after it has been lost, will not achieve the goal of improved population health. To achieve this goal, health systems must proactively engage in partnerships with the populations they serve. Health systems will need the help of community entities and individuals who have the trust of the population being served to act on behalf of the health system if they are to achieve this effective working partnership. The need for these trusted agents is particularly pertinent for vulnerable and historically underserved segments of the population. In this Invited Commentary, the authors discuss ways by which health systems might identify, engage, and leverage trusted agents to improve the health of the population through value-based care.E

Warren, A. M., G. Testa, T. Anthony, G. J. McKenna, G. B. Klintmalm, K. Wallis, E. C. Koon, R. T. Gunby, Jr. and L. Johannesson (2018). “Live nondirected uterus donors: Psychological characteristics and motivation for donation.” Am J Transplant. Jan 24. [Epub ahead of print].

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Emerging research suggests that uterus transplantation is a viable option for women without a uterus who want to become pregnant and carry a child to term. Currently, no knowledge exists regarding nondirected uterus donors. This study (NCT 02656550) explored the baseline psychological characteristics of nondirected uterus donors at a single study site. Of the 62 potential donors who underwent initial screening, six nondirected donors were chosen and participated in uterus donation. Participants received a comprehensive evaluation, which included clinical history and psychological assessments. The mean age of the donors was 42 years; most (83%) were white/not Hispanic, and all had a college degree. Current depression was reported by two participants, past depression was reported in two participants, and past anxiety was reported in three participants. Based on several different psychological measures, donors had a higher general well-being than the normative sample, and none of the participants’ scores indicated psychological distress. All six women indicated that giving another woman an opportunity to carry her own child was a motivation for pursuing uterus donation. Further research on potential psychological motives and gains for the donor as well as long-term effects on donors is crucial for ethical practice.

Trombello, J. M., M. O. Killian, A. Liao, K. Sanchez, T. L. Greer, R. Walker, B. Grannemann, C. D. Rethorst, T. Carmody and M. H. Trivedi (2018). “Psychometrics of the Self-Report Concise Associated Symptoms Tracking Scale (CAST-SR): Results From the STRIDE (CTN-0037) Study.” J Clin Psychiatry 79(1). Jan 9. [Epub ahead of print].

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OBJECTIVE: The self-report Concise Associated Symptoms Tracking Scale (CAST-SR) was developed to track mania, irritability, anxiety, panic, and insomnia symptoms among depressed outpatients receiving antidepressant medication. Given the overlap between these domains, depression, and stimulant use disorders, we reexamined CAST-SR psychometrics in a novel sample: individuals with stimulant use disorder receiving aerobic exercise or health education interventions. METHODS: Using the subsample of stimulant-dependent (following DSM-IV criteria) individuals prescribed antidepressants (N = 124) from the multisite Stimulant Reduction Intervention Using Dosed Exercise (CTN-0037) trial (total sample N = 302), conducted July 2010 to February 2013, we analyzed CAST-SR data collected at the first assessment after participant’s discharge from residential treatment. We also evaluated the convergent/discriminant validity of the CAST-SR with several self-report questionnaires. RESULTS: Confirmatory factor analysis revealed a 12-item measure composed of 4 factors: irritability, anxiety, panic, and insomnia. This factor structure loaded only in participants prescribed antidepressant medication, not in those who were not prescribed antidepressants. These results replicate the original CAST-SR factor structure, except for the mania factor, which failed to load. Internal consistency was high (alpha = 0.92 for total scale and alpha = 0.78-0.89 for the 4 factors), and convergent validity was established, especially for the insomnia and irritability factors, alongside the total score with depressive symptoms, insomnia, quality of life, suicide risk, and physical health measures. CONCLUSIONS: These results demonstrate the factor structure, reliability, and validity of the CAST-SR in a novel population of only individuals with stimulant use disorders receiving both exercise/health education interventions and antidepressant medication. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01141608.

Traina, T. A., K. Miller, D. A. Yardley, J. Eakle, L. S. Schwartzberg, J. O’Shaughnessy, W. Gradishar, P. Schmid, E. Winer, C. Kelly, R. Nanda, A. Gucalp, A. Awada, L. Garcia-Estevez, M. E. Trudeau, J. Steinberg, H. Uppal, I. C. Tudor, A. Peterson and J. Cortes (2018). “Enzalutamide for the Treatment of Androgen Receptor-Expressing Triple-Negative Breast Cancer.” J Clin Oncol: Jan 26: JCO2016713495. [Epub ahead of print].

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Purpose Studies suggest that a subset of patients with triple-negative breast cancer (TNBC) have tumors that express the androgen receptor (AR) and may benefit from an AR inhibitor. This phase II study evaluated the antitumor activity and safety of enzalutamide in patients with locally advanced or metastatic AR-positive TNBC. Patients and Methods Tumors were tested for AR with an immunohistochemistry assay optimized for breast cancer; nuclear AR staining > 0% was considered positive. Patients received enzalutamide 160 mg once per day until disease progression. The primary end point was clinical benefit rate (CBR) at 16 weeks. Secondary end points included CBR at 24 weeks, progression-free survival, and safety. End points were analyzed in all enrolled patients (the intent-to-treat [ITT] population) and in patients with one or more postbaseline assessment whose tumor expressed >/= 10% nuclear AR (the evaluable subgroup). Results Of 118 patients enrolled, 78 were evaluable. CBR at 16 weeks was 25% (95% CI, 17% to 33%) in the ITT population and 33% (95% CI, 23% to 45%) in the evaluable subgroup. Median progression-free survival was 2.9 months (95% CI, 1.9 to 3.7 months) in the ITT population and 3.3 months (95% CI, 1.9 to 4.1 months) in the evaluable subgroup. Median overall survival was 12.7 months (95% CI, 8.5 months to not yet reached) in the ITT population and 17.6 months (95% CI, 11.6 months to not yet reached) in the evaluable subgroup. Fatigue was the only treatment-related grade 3 or higher adverse event with an incidence of > 2%. Conclusion Enzalutamide demonstrated clinical activity and was well tolerated in patients with advanced AR-positive TNBC. Adverse events related to enzalutamide were consistent with its known safety profile. This study supports additional development of enzalutamide in advanced TNBC.