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Secukinumab in US Biologic-Naive Patients With Psoriatic Arthritis: Results From the Randomized, Placebo-Controlled CHOICE Study

Nguyen, Tien; Churchill, Melvin; Levin, Robert; Valenzuela, Guillermo; Merola, Joseph F; Ogdie, Alexis; Orbai, Ana-Maria; Scher, Jose U; Kavanaugh, Arthur; Kianifard, Farid; Rollins, Chauncy; Calheiros, Renato; Chambenoit, Olivier
OBJECTIVE:To evaluate secukinumab 300 mg and 150 mg vs placebo in a US-only population of biologic-naive patients with psoriatic arthritis (PsA). METHODS:CHOICE was a randomized, double-blind, controlled trial conducted in the United States. Biologic-naive patients with PsA and psoriasis were randomized 2:2:1 to secukinumab 300 mg (n = 103), secukinumab 150 mg (n = 103), or placebo (n = 52). The primary objective was to show superiority of secukinumab 300 mg vs placebo in ACR20 response at week 16. Additional objectives included the effect of secukinumab on dactylitis, enthesitis, psoriasis, and safety. RESULTS:= .0011). Secukinumab 300 mg also led to greater ACR50/70 responses and improvements in other variables vs placebo. Responses were generally sustained over time. Patients with inadequate response to secukinumab 150 mg at weeks 16, 28, or 40 who received dose escalation to 300 mg experienced improved clinical response after uptitration. The most common adverse events were upper respiratory tract infections and diarrhea. No inflammatory bowel disease was reported or new safety signals observed. CONCLUSION/CONCLUSIONS:Secukinumab 300 mg led to rapid and significant improvements over placebo in symptoms of PsA in this heavier population of US-only biologic-naive patients. Findings were consistent with previous studies and suggest that secukinumab 300 mg is a safe and efficacious first-line biologic treatment for patients with PsA.
PMID: 35428722
ISSN: 0315-162x
CID: 5219162

Pre-operative regional block anesthesia enhances operative strategy for arteriovenous fistula creation

Reynolds, Tyler S; Kim, Karen M; Dukkipati, Ramanath; Nguyen, Tien H; Julka, Inderjeet; Kakazu, Clinton; Tokhner, Vadim; Chauvapun, Joe P
PURPOSE: we aim to assess the effect of regional block anesthesia on vein diameter, type of avf placement, and fistula size and flow volume. METHODS: 30 patients presenting for AV access procedures were followed prospectively. Vein diameters via venous ultrasound and planned location for AV access were documented. Supraclavicular brachial plexus block was followed by repeat ultrasound and alterations in operative plan were noted. Patients returned to clinic for duplex ultrasound assessment. RESULTS: Average increase from baseline vein diameter with regional block was most pronounced in the lower cephalic (34%), upper cephalic (24.2%), and basilic veins (31.3%) and less in the brachial vein (8.7%). Type of AVF was modified following regional block in 14%. The rate of native AVF placement improved from 89% to 93% with regional block. Twenty-three AVF patients were available for follow-up (mean 24 weeks). Average fistula size was 7.9 mm (CI 6.9-8.9) and all patent fistulas developed flow volume >600 mL/min. Primary patency was attained in 83%. One thrombosis occurred after a basilic artery was lacerated during dialysis access. The average fistula increased 0.33 cm from post-block diameter (SD 0.22, P<.05). CONCLUSIONS: Vein diameter increases significantly in the basilic and cephalic veins following regional block anesthesia and may improve the rate of native fistula placement. Propensity to dilate after regional block anesthesia does not predict size of the fistula.
PMID: 22116664
ISSN: 1129-7298
CID: 161632

Transmetatarsal amputation: predictors of healing

Nguyen, Tien H; Gordon, Ian L; Whalen, Delores; Wilson, Samuel E
The objective of this study is to determine the predictors of healing after transmetatarsal amputations (TMA) and factors leading to a higher level of amputation. A total of 33 TMA was performed in 31 patients during the 5 years between January 2000 and Jul 2005. All patients were men between the ages of 44 and 82 years (mean, 68 years). The mean follow-up period was 36 months (range, 1-65 months). Twelve (40%) TMA required a subsequent higher level of amputation. Seventeen (57%) TMA were successful. The average time until further proximal amputation after TMA was 3.5 months. Risk factors for subsequent higher amputation by univariate analysis included infrapopliteal arterial occlusion (P < 0.05), tobacco smoking greater than 20 years (P < 0.05), and further TMA debridement (P < 0.05). Upon multivariate analysis, only patients undergoing further TMA debridement were at risk for TMA failure (P = 0.01). The difference in ankle-to-brachial pressure ratio (ABI) between the higher amputation group (ABI = 0.51) and the successful TMA group (ABI = 0.54) was not significant. There were no perioperative deaths after TMA. Five (18%) deaths occurred at a mean of 8.2 months after the TMA. In patients who are walking preoperatively, aggressive TMA is warranted in an attempt to maintain ambulation, recognizing that requirement for further debridement, smoking history, and infrapopliteal occlusion may be predictors of nonhealing and subsequent higher amputation.
PMID: 17058748
ISSN: 0003-1348
CID: 161633

Predictors of mortality and management of patients with traumatic inferior vena cava injuries

Huerta, Sergio; Bui, Trung D; Nguyen, Tien H; Banimahd, Faried N; Porral, Diana; Dolich, Matthew O
The aim of this study was to determine factors that predict mortality in patients with traumatic inferior vena cava (IVC) injuries and to review the current management of this lethal injury. A 7-year retrospective review of all trauma patients with IVC injuries was performed. Factors associated with mortality were assessed by univariate analysis. Significant variables were included in a multivariate regression analysis model to determine independent predictors of mortality. Statistical significance was determined at P < or = 0.05. A literature review of traumatic IVC injuries was performed and compared with our institutional experience. Thirty-six IVC injuries were identified (mortality, 56%; mechanisms of injury, 28% blunt and 72% penetrating). There was no difference in mortality based on mechanism of injury. Injuries with closer proximity to the heart were associated with increased mortality (P < 0.001). Univariate analysis demonstrated that nonsurvivors had a higher injury severity scale, a lower systolic blood pressure in the emergency department, a lower Glasgow coma score (GCS), and were more likely to have thoracotomies performed in the emergency department or operating room. Multivariate analysis revealed that only GCS (P = 0.03) was an independent predictor of mortality. Typical factors predicting mortality were identified in our cohort of patients, including GCS. The mechanism of injury is not associated with survival outcome, although mortality is higher with injuries more proximal to the heart. The form of management by IVC level is reviewed in our patient population and compared with the literature.
PMID: 16676849
ISSN: 0003-1348
CID: 161634

Predictors of troponin elevation after percutaneous coronary intervention

Mandadi, Vikram R; DeVoe, Mary C; Ambrose, John A; Prakash, Anita M; Varshneya, Nikita; Gould, Randy B; Nguyen, Tien H; Geagea, Jean-Pierre M; Radojevic, Joseph A; Sehhat, Khashayar; Barua, Rajat S
The predictors of troponin release after percutaneous coronary intervention were prospectively assessed in 405 consecutive patients. Troponin release occurred frequently (27%) and was associated with complications during the procedure, including sapheneous vein graft interventions, multistent use, glycoprotein IIb/IIIa use, and a history of hypercholesterolemia.
PMID: 15019883
ISSN: 0002-9149
CID: 161635

Acute coronary lesions and troponin elevation in unstable angina pectoris or non-ST elevation acute myocardial infarction

Ambrose, John A; Gould, Randy B; Zairis, Michael N; DeVoe, Mary C; Nguyen, Tien H; Geagea, Jean-Pierre M; Arias, Jose H; Prakash, Anita M; Varshneya, Nikita; Meraj, Perwaiz; Barua, Rajat S
PMID: 12356396
ISSN: 0002-9149
CID: 161636

Calcium-dependent cleavage of striatal enriched tyrosine phosphatase (STEP)

Nguyen, T H; Paul, S; Xu, Y; Gurd, J W; Lombroso, P J
Striatal enriched phosphatase (STEP) is a family of protein tyrosine phosphatases enriched within the CNS. A member of this family, STEP61, is a membrane-associated protein located in postsynaptic densities of striatal neurons. In this study, we demonstrate that STEP61, is cleaved into smaller isoforms. To clarify the mechanism of cleavage, STEP61 was transiently expressed in NT2/D1 neuronal precursor cells. Exposure of transfected cells to the calcium ionophore, A23187, or to thapsigargin resulted in the rapid cleavage of STEP61. Pretreatment with the calpain inhibitor, calpeptin, or EGTA prevented proteolysis. One of the cleavage products has a relative molecular mass of 33 kDa (STEP33). A protein with the identical mobility is detected following calpain treatment of STEP61 fusion protein or postsynaptic densities purified from rat striatum. Exposure of primary neuronal cultures to glutamate also led to a significant increase in the concentration of a low molecular weight form of STEP. Taken together, these results suggest that in response to a rapid influx of calcium, STEP61, is proteolytically cleaved by calpain, leading to the release of a smaller isoform. This model may explain the rapid appearance of STEP33 in response to transient hypoxia-ischemia in the brain as cells attempt to counter the increase in tyrosine phosphorylation levels following neuronal insults.
PMID: 10537058
ISSN: 0022-3042
CID: 270822

Hypoxia-ischemia in perinatal rat brain induces the formation of a low molecular weight isoform of striatal enriched tyrosine phosphatase (STEP)

Gurd, J W; Bissoon, N; Nguyen, T H; Lombroso, P J; Rider, C C; Beesley, P W; Vannucci, S J
Protein tyrosine phosphatases play a critical role in controlling tyrosine phosphorylation levels of proteins. Ischemia induces changes in tyrosine phosphorylation. As part of our investigations of the mechanisms responsible for these changes, we studied the effects of cerebral hypoxia-ischemia in 7-day-old (P7) and P21 rat brains on expression of the STEP (striatal enriched phosphatase) family of protein tyrosine phosphatases. P7 and P21 rats were subjected to unilateral hypoxia-ischemia, and brains were analyzed at various intervals of recovery for the presence of STEP. Hypoxia-ischemia induced the formation of a low Mr isoform of STEP, STEP33, in the ipsilateral (damaged) hemisphere but not in the contralateral (undamaged) side. STEP33 produced as a result of ischemia was located exclusively in the cell soluble fraction. In P21 rats, the ischemia-induced elevation in STEP33 was delayed relative to P7 rats. STEP33 was produced by digestion of postsynaptic densities with calpain I and by exposure of NT2/D1 cells expressing STEP to the calcium ionophore A23187. The results suggest that ischemia-induced calcium influx results in the calcium-dependent proteolysis of membrane-associated STEP61 and the concomitant release of STEP33 into the cytoplasm.
PMID: 10537057
ISSN: 0022-3042
CID: 270832