Research Spotlight

Posted February 19th 2016

Culturally adaptive storytelling method to improve hypertension control in Vietnam – “We talk about our hypertension”: study protocol for a feasibility cluster-randomized controlled trial.

Hoa L. Nguyen M.D.

Hoa L. Nguyen, M.D.

Allison, J. J., H. L. Nguyen, D. A. Ha, G. Chiriboga, H. N. Ly, H. T. Tran, N. T. Phan, N. C. Vu, M. Kim and R. J. Goldberg (2016). “Culturally adaptive storytelling method to improve hypertension control in Vietnam – “We talk about our hypertension”: study protocol for a feasibility cluster-randomized controlled trial. Trials 17(1): 26.

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BACKGROUND: Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. At present, the major risk factors for cardiovascular disease (CVD) are either on the rise or at alarming levels in Vietnam; inasmuch, the burden of CVD will continue to increase in this country unless effective prevention and control measures are put in place. A national survey in 2008 found that the prevalence of hypertension (HTN) was approximately 25 % among Vietnamese adults and it increased with advancing age. Therefore, novel, large-scale, and sustainable interventions for public health education to promote engagement in the process of detecting and treating HTN in Vietnam are urgently needed. METHODS: A feasibility randomized trial will be conducted in Hung Yen province, Vietnam to evaluate the feasibility and acceptability of a novel community-based intervention using the “storytelling” method to enhance the control of HTN in adults residing in four rural communities. The intervention will center on stories about living with HTN, with patients speaking in their own words. The stories will be obtained from particularly eloquent patients, or “video stars,” identified during Story Development Groups. The study will involve two phases: (i) developing a HTN intervention using the storytelling method, which is designed to empower patients to facilitate changes in their lifestyle practices, and (ii) conducting a feasibility cluster-randomized trial to investigate the feasibility, acceptability, and potential efficacy of the intervention compared with usual care in HTN control among rural residents. The trial will be conducted at four communes, and within each commune, 25 individuals 50 years or older with HTN will be enrolled in the trial resulting in a total sample size of 100 patients. DISCUSSION: This feasibility trial will provide the necessary groundwork for a subsequent large-scale, fully powered, cluster-randomized controlled trial to test the efficacy of our novel community-based intervention. Results from the full-scale trial will provide health policy makers with practical evidence on how to combat a key risk factor for CVD using a feasible, sustainable, and cost-effective intervention that could be used as a national program for controlling HTN in Vietnam and other developing countries. TRIAL REGISTRATION: ClinicalTrials.gov. REGISTRATION NUMBER: https://clinicaltrials.gov/ct2/show/NCT02483780 (registration date June 22, 2015).


Posted February 19th 2016

Translating psoriasis guidelines into practice: Important gaps revealed.

Alan M. Menter M.D.

Alan M. Menter, M.D.

Bhushan, R., M. G. Lebwohl, A. B. Gottlieb, K. Boyer, E. Hamarstrom, N. J. Korman, R. S. Kirsner, A. J. Sober and A. Menter (2016). “Translating psoriasis guidelines into practice: Important gaps revealed.” J Am Acad Dermatol. 74(3): 544-551.

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BACKGROUND: There is a well-established lack of adherence to evidence-based clinical guidelines. The American Academy of Dermatology (AAD) developed educational sessions entitled Translating Evidence into Practice based on the published guidelines for psoriasis and psoriatic arthritis. OBJECTIVE: We sought to determine the effectiveness of Translating Evidence into Practice sessions in improving patient care. METHODS: Pre- and post-session surveys were administered at Translating Evidence into Practice sessions. A follow-up was administered 6 months after completion of the most recent session, which was 2.5 years after the first session. RESULTS: At both post-session and follow-up, more than 92% of participants believed the sessions had improved their knowledge. The proportion of participants that self-reported assessing disease severity, comorbidities, and quality of life increased at follow-up. Participants’ self-reported counseling of patients and confidence in treating psoriasis and psoriatic arthritis also increased at post-session and follow-up. Greater than 97% of participants thought the sessions would have a positive impact on their practice whereas 50% reported making a change in practice. LIMITATIONS: Lack of a control group, the self-reported nature of the data, and potential participant bias are limitations. CONCLUSION: The AAD’s Translating Evidence into Practice sessions are effective and well received for improving knowledge and practice and can be useful to determine self-reported practice gaps.


Posted February 19th 2016

A Randomized Phase 2b Trial of Baricitinib, an Oral JAK1/JAK2 Inhibitor, in Patients with Moderate-to-Severe Psoriasis.

Alan M. Menter M.D.

Alan M. Menter, M.D.

Papp, K., M. A. Menter, M. Raman, D. Disch, D. E. Schlichting, C. Gaich, W. Macias, X. Zhang and J. M. Janes (2016). “A Randomized Phase 2b Trial of Baricitinib, an Oral JAK1/JAK2 Inhibitor, in Patients with Moderate-to-Severe Psoriasis.” Br J Dermatol. Jan 22. doi: 10.1111/bjd.14403. [Epub ahead of print]

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BACKGROUND: The safety and efficacy of baricitinib, an oral JAK1/JAK2 inhibitor, in patients with moderate-to-severe psoriasis was evaluated in a randomized, double-blind, placebo-controlled, dose-ranging phase 2b study. METHODS: Patients were randomized (n=271) to receive placebo or oral baricitinib at 2, 4, 8, or 10 mg once daily for 12 weeks (Part A). Dose adjustment for 12 additional weeks was based on percentage improvement in Psoriasis Area and Severity Index (PASI) score. OBJECTIVES: Primary endpoint was PASI-75 at 12 weeks for North American patients (n=238); secondary were safety and efficacy measures in the entire population. RESULTS: At week 12, more North American patients in 8-mg (43%) and 10-mg (54%) baricitinib groups than in placebo group (17%; p<0.05) achieved PASI-75. All baricitinib-treated groups had greater mean changes from baseline in PASI score (p<0.05) at 12 weeks and (except 2 mg) had higher rates of PASI-50 than placebo group; statistically significant PASI-90 responses were achieved in the 8-mg and 10-mg groups at 8 and 12 weeks. More than 81% of PASI-75 responders maintained their scores through 24 weeks. During Part A, study discontinuations due to adverse events (AEs) were 0%, 0%, 2.8%, 6.3%, and 5.8% and treatment-emergent AE rates were 44%, 50%, 47%, 58%, and 64% for placebo and 2-, 4-, 8-, and 10-mg baricitinib groups, respectively. No opportunistic infections were observed in any treatment group. Dose-dependent changes in laboratory values were observed. CONCLUSION: Patients with moderate-to-severe psoriasis treated with baricitinib for 12 weeks achieved significant improvements in PASI-75.


Posted February 19th 2016

A randomized, double-blind, placebo-controlled, dose-escalation study of the safety and efficacy of INCB039110, an oral janus kinase 1 inhibitor, in patients with stable, chronic plaque psoriasis.

Alan M. Menter M.D.

Alan M. Menter, M.D.

Bissonnette, R., M. Luchi, R. Fidelus-Gort, S. Jackson, H. Zhang, R. Flores, R. Newton, P. Scherle, S. Yeleswaram, X. Chen and A. Menter (2016). “A randomized, double-blind, placebo-controlled, dose-escalation study of the safety and efficacy of INCB039110, an oral janus kinase 1 inhibitor, in patients with stable, chronic plaque psoriasis.” J Dermatolog Treat: 1-7.

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BACKGROUND: Chronic plaque psoriasis is partially mediated by elevation of proinflammatory cytokines, including several within the Janus kinase/signal transducer and activator of transcription (JAK/STAT) pathway. OBJECTIVE: To evaluate the safety and efficacy of the oral selective JAK1 inhibitor INCB039110 in stable, chronic plaque psoriasis. METHODS: This was a phase 2, randomized, double-blind, placebo-controlled, dose-escalation study of INCB039110 (100 mg once daily, 200 mg once daily, 200 mg twice daily and 600 mg once daily) for 28 days. The primary endpoint was mean percent change from baseline in the static Physician Global Assessment (sPGA) at day 28. The protocol was institutional review board approved. RESULTS: Of 50 patients, 48 completed the study. At day 28, mean percent reduction from baseline in sPGA was 22.2% for INCB039110 100 mg once daily (p = 0.270 vs. placebo), 29.4% for 200 mg once daily (p = 0.118), 35.2% for 200 mg twice daily (p = 0.053), 42.4% for 600 mg once daily (p = 0.003) and 12.5% for placebo. Across groups, 11.1% to 45.5% achieved an sPGA score of 1 versus 0% for placebo. INCB039110 was generally well tolerated; the most common treatment-emergent adverse event was nasopharyngitis (18.4%). CONCLUSION: INCB039110 produced significant improvements in sPGA, demonstrating proof of concept in chronic plaque psoriasis.


Posted February 19th 2016

Results of the Nellix system investigational device exemption pivotal trial for endovascular aneurysm sealing.

Clifford J. Buckley M.D.

Clifford J. Buckley, M.D.

Carpenter, J. P., R. Cuff, C. Buckley, C. Healey, S. Hussain, M. M. Reijnen, J. Trani and D. Bockler (2016). “Results of the Nellix system investigational device exemption pivotal trial for endovascular aneurysm sealing.” J Vasc Surg 63(1): 23-31.e21.

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OBJECTIVE: The Nellix EndoVascular Aneurysm Sealing system (Endologix, Inc, Irvine, Calif) is a novel approach to abdominal aortic aneurysm (AAA) endovascular repair whereby biocompatible polymer is employed to exclude and to seal the AAA sac. We report 30-day results of the U.S. pivotal trial. METHODS: Consecutive, eligible, consenting patients were enrolled at 29 sites in the United States and Europe.  Inclusion criteria required an asymptomatic infrarenal AAA, with aortic neck length >/=10 mm and angle to the sac </=60 degrees, aortic neck diameter of 18 to 32 mm, aneurysm blood lumen diameter </=6 cm, common iliac artery lumen diameter of 9 to 35 mm, access artery diameter >/=6 mm, and serum creatinine level </=2 mg/dL. Follow-up at 30 days included clinical assessment and computed tomography angiography evaluation of endoleaks and device integrity as assessed by a core laboratory. The primary safety end point is the incidence of independently adjudicated 30-day major adverse events (MAEs), with success defined as superiority with reference to the Society for Vascular Surgery open repair control group (56%). RESULTS: Between January and November 2014, 150 trial patients having a mean AAA diameter of 5.8 cm were enrolled and treated with the Nellix system with 100% procedural success. One early death (0.7%) occurred secondary to multisystem organ failure. All 149 surviving patients completed 30-day follow-up. There were no aneurysm ruptures, conversions, limb thromboses, stent fractures, or stent kinking. Five early MAEs occurred in four patients (2.7%) and included one death, bowel ischemia (1), renal failure (2), and respiratory failure (1). One (0.7%) secondary intervention to treat inadvertent coverage of a renal artery was performed. The core laboratory identified nine (6%) endoleaks (one type I, eight type II) on 30-day computed tomography angiography. Freedom from MAE was 97.3% (95% confidence interval, 93.3%-99.0%). CONCLUSIONS: In selected patients, perioperative outcomes with the Nellix system for endovascular aneurysm sealing are encouraging, with very low 30-day morbidity and mortality and high procedural success. The primary safety end point has been achieved. Longer term follow-up is in progress.