Research Spotlight

Menter, A. and R. Warren (2019). “A Summary of 2018 and What Lies Ahead for Dermatology and Therapy in 2019.” Dermatol Ther (Heidelb) 9(1): 1-3.

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[A review of the year 2018 by the editors of the journal Dermatology and Therapy; no abstract available.]

Malec, J. F., J. M. Ketchum, F. M. Hammond, J. D. Corrigan, K. Dams-O’Connor, T. Hart, T. Novack, M. Dahdah, G. G. Whiteneck and J. Bogner (2019). “Longitudinal Effects of Medical Comorbidities on Functional Outcome and Life Satisfaction After Traumatic Brain Injury: An Individual Growth Curve Analysis of NIDILRR Traumatic Brain Injury Model System Data.” J Head Trauma Rehabil Feb 27. [Epub ahead of print].

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OBJECTIVE: To explore associations of specific physical and neuropsychiatric medical conditions to motor and cognitive functioning and life satisfaction over the first 10 years following traumatic brain injury (TBI). SETTING: Telephone follow-up through 6 TBI Model System centers. PARTICIPANTS: In total, 404 individuals or proxies with TBI enrolled in the TBI Model System longitudinal study participating in 10-year follow-up. DESIGN: Individual growth curve analysis. MAIN MEASURES: FIM Motor and Cognitive subscales, Satisfaction With Life Scales, and Medical and Mental Health Comorbidities Interview. RESULTS: Hypertension, diabetes, cancers, rheumatoid arthritis, and anxiety negatively affected the trajectory of motor functioning over time. Diabetes, cancers, chronic bronchitis, anxiety, and depression negatively impacted cognitive functioning. Numerous neuropsychiatric conditions (sleep disorder, alcoholism, drug addiction, anxiety, panic attacks, posttraumatic stress disorder, depression, and bipolar disorder), as well as hypertension, liver disease, and cancers, diminished life satisfaction. Other medical conditions had a negative effect on functioning and satisfaction at specific follow-up periods. CONCLUSION: Natural recovery after TBI may include delayed onset of functional decline or early recovery, followed by progressive deterioration, and is negatively affected by medical comorbidities. Results contribute to the growing evidence that TBI is most appropriately treated as a chronic medical condition complicated by a variety of comorbid conditions.

Menter, A., B. E. Strober, D. H. Kaplan, D. Kivelevitch, E. F. Prater, B. Stoff, A. W. Armstrong, C. Connor, K. M. Cordoro, D. M. R. Davis, B. E. Elewski, J. M. Gelfand, K. B. Gordon, A. B. Gottlieb, A. Kavanaugh, M. Kiselica, N. J. Korman, D. Kroshinsky, M. Lebwohl, C. L. Leonardi, J. Lichten, H. W. Lim, N. N. Mehta, A. S. Paller, S. L. Parra, A. L. Pathy, R. N. Rupani, M. Siegel, E. B. Wong, J. J. Wu, V. Hariharan and C. A. Elmets (2019). “Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics.” J Am Acad Dermatol Feb 13. [Epub ahead of print].

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Psoriasis is a chronic, inflammatory multisystem disease that affects up to 3.2% of the US population. This guideline addresses important clinical questions that arise in psoriasis management and care, providing recommendations based on the available evidence. The treatment of psoriasis with biologic agents will be reviewed, emphasizing treatment recommendations and the role of the dermatologist in monitoring and educating patients regarding benefits as well as associated risks.

Levy, M. Y., L. J. McGarry, H. Huang, S. Lustgarten, S. Chiroli and S. Iannazzo (2019). “Benefits and risks of ponatinib versus bosutinib following treatment failure of two prior tyrosine kinase inhibitors in patients with chronic phase chronic myeloid leukemia: a matching-adjusted indirect comparison.” Curr Med Res Opin 35(3): 479-487.

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OBJECTIVE: Comparing the benefit-risk profiles of ponatinib vs. bosutinib in third-line (3L) treatment of chronic phase chronic myeloid leukemia (CP-CML) is challenging because their pivotal trials lacked comparator arms. To characterize the overall benefit-risk profile in 3L CP-CML patients treated with bosutinib vs. ponatinib, a matching-adjusted indirect comparison (MAIC) was performed to compare efficacy outcomes and treatment duration after adjusting for trial subjects’ baseline characteristics, and tolerability was assessed with an unadjusted comparison of study-drug discontinuation. METHODS: The MAIC was performed using published data from the pivotal bosutinib trial and the most recent individual-patient-level data on file from the pivotal ponatinib trial. RESULTS: Responses were more frequent and durable with ponatinib (n = 70 MAIC-adjusted) than with bosutinib (n = 119) – complete cytogenetic response (CCyR): 61% vs. 26%; Kaplan-Meier estimate of maintaining CCyR at 4 years: 89% vs. 54%. Median treatment duration was longer with ponatinib than with bosutinib: 38.4 vs. 8.6 months. Only 9% of ponatinib patients (n = 97 unadjusted) vs. 42% of bosutinib patients discontinued due to death, disease progression or unsatisfactory response; 19% vs. 24% discontinued due to adverse events. CONCLUSIONS: Based on these surrogate measures of patient benefit-risk profiles, ponatinib appears to provide a net overall benefit vs. bosutinib in 3L CP-CML.

Hollander, P., J. Hill, J. Johnson, Z. W. Jiang, G. Golm, S. Huyck, S. G. Terra, J. P. Mancuso, S. S. Engel, B. Lauring and J. Liu (2019). “Results of VERTIS SU extension study: safety and efficacy of ertugliflozin treatment over 104 weeks compared to glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin.” Curr Med Res Opin Feb 14. [Epub ahead of print].

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OBJECTIVE: To assess the safety and efficacy of ertugliflozin over 104 weeks in patients with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin. METHODS: In this double-blind, multicenter, randomized, Phase III study (VERTIS SU; NCT01999218), adults with T2DM and glycated hemoglobin (HbA1c) 7.0-9.0% on metformin >/=1500 mg/day received ertugliflozin 5 mg, 15 mg, or glimepiride. The primary efficacy time point was Week 52; double-blinded treatment continued until Week 104. RESULTS: Baseline characteristics of randomized, treated patients (n = 1315) were similar across groups (mean age 58.2 years, HbA1c 7.8%). 76.4% completed the study; 61.6% completed on study medication. Mean glimepiride dose at 104 weeks was 3.5 mg/day. At Week 104, least squares mean change from baseline in HbA1c (95% confidence intervals) were -0.3% (-0.4, -0.2), -0.4% (-0.5, -0.3) and -0.4% (-0.5, -0.3) for ertugliflozin 5 mg, 15 mg, and glimepiride, respectively. Ertugliflozin provided sustained reductions in body weight and systolic blood pressure (SBP) over 104 weeks. The incidence of adverse events (AEs) and serious AEs was similar across groups. The incidence of symptomatic hypoglycemia was 3.8%, 6.4% and 22.1% in the ertugliflozin 5 mg, 15 mg, and glimepiride groups, respectively. Genital mycotic infections were reported in 5.3%, 2.6% and 0% of men, respectively, and 9.2%, 12.3% and 1.4% of women, respectively. The incidence of urinary tract infection and hypovolemia AEs was similar across groups. CONCLUSIONS: Ertugliflozin was well tolerated and provided clinically meaningful glycemic control and durable reductions in body weight and SBP over 104 weeks. Clinicaltrials.gov identifier NCT01999218.