Faculty Bibliography

Contact dermatitis (CD) is the 5th most common skin disease1 and affects 15-20% of the general population over their lifetimes.2 Currently, the T.R.U.E. TEST® is the only FDA-approved diagnostic product to aid in the diagnosis of Allergic Contact Dermatitis. To address that diagnostic gap, the US Food and Drug Administration held a public workshop in October 2025. These proceedings summarize the workshop presentations and discussions.

Background Stroke remains a leading cause of death and long-term disability. Although stem cell-based approaches are being investigated as possible regenerative strategies for stroke, public perceptions of their potential benefits, risks, mechanisms, and clinical use are not well-characterized. This exploratory survey described responses to an investigator-developed questionnaire about stem cell therapy for stroke. Methods A 10-item cross-sectional questionnaire was distributed electronically through Google Forms (Google, Inc., Mountain View, CA) to 36 individuals in a convenience sample; 26 completed questionnaires were received (response rate: 72.2%). The questionnaire was investigator-developed and was not validated as a measure of factual knowledge, clinical efficacy, or safety. Responses were categorized as "yes," "no," or "maybe"; one item used time-based response categories. Counts and percentages were calculated using the total number of completed questionnaires as the denominator. The survey was independently conducted as a student-led summer academic project and did not undergo review by an institutional review board, school ethics committee, or independent ethics authority. Results Twenty-six responses were analyzed. For the item asking whether embryonic stem cells are effective in stroke treatment, eight respondents (30.77%) selected "yes," 16 (61.54%) selected "maybe," and two (7.69%) selected "no." For the item asking whether stem cell treatment has advantages for stroke, 21 respondents (80.77%) selected "yes," four (15.38%) selected "maybe," and one (3.85%) selected "no." "Maybe" was the majority or joint-most-frequent response for six of 10 items, including items about animal testing, adverse effects, alternative regenerative treatments, and use during pregnancy. Conclusions In this small convenience sample, responses to an investigator-developed questionnaire suggested favorable perceptions of possible benefits of stem cell therapy for stroke, alongside frequent uncertainty about safety, mechanisms, the timing of improvement, and use in special populations. Because the questionnaire was not validated as a factual-knowledge instrument, findings should be interpreted strictly as descriptive perceptions rather than as evidence of respondents' medical knowledge, treatment confidence, or the clinical efficacy or safety of stem cell therapy. Larger studies using validated instruments and representative sampling are needed.

BACKGROUND:Bispecific T-cell-engaging antibodies against BCMA and GPRC5D demonstrate high efficacy in relapsed/refractory multiple myeloma (RRMM) but are associated with cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), traditionally prompting inpatient monitoring when commencing therapy. Contemporary step-up dosing and prophylactic strategies may enable safe outpatient administration. PATIENTS AND METHODS/METHODS:We conducted a single-center retrospective study evaluating outpatient step-up dosing (SUD) of teclistamab or talquetamab in adults with RRMM. Patients met institutional outpatient eligibility criteria and received standard pre-medications; prophylactic tocilizumab was administered at physician discretion. The primary endpoint was incidence and severity of CRS/ICANS. Secondary endpoints included SUD completion, healthcare utilization, and need for hospitalization. RESULTS:Thirty-eight patients underwent 43 outpatient SUD initiations (teclistamab n = 30; talquetamab n = 13). Median age was 72 years, and disease burden was high. SUD completion occurred in 93%. CRS occurred in 26% of initiations and was exclusively grade 1-2; no grade ≥ 3 CRS occurred. One possible grade III ICANS event (2%) occurred after completion of SUD. CRS incidence was similar with and without prophylactic tocilizumab (29% vs 32%). Most events occurred during the first two step-up doses. Hospitalization occurred in 5 (12%) SUD initiations for CRS/ICANS events and overall healthcare utilization was modest. CONCLUSION/CONCLUSIONS:Outpatient administration of teclistamab and talquetamab SUD in RRMM is feasible and safe with low rates of low-grade CRS. Toxicities occur early and are manageable with structured monitoring, supporting outpatient delivery in appropriately selected patients.

BACKGROUND:The purpose of this study was to compare outcomes of distal radius fractures with a volar ulnar corner (VUC) component treated with standard volar plating or by specific VUC fixation. This study investigated outcomes, radiographic measures, and specialty-based preference associated with surgical treatment of VUC injuries using VUC-specific fixation versus nonspecific VUC fixation. METHODS:We retrospectively analyzed outcomes for 39 patients with a distal radius fracture with VUC component at a level-1 trauma center over 10 years, 2011-2021. Patients underwent either VUC-specific fixation with implants such as a volar rim plate, or with a standard volar plate. The primary outcome of this study was fixation failure and need for revision. Secondary outcomes included complication rate, radiographic alignment, and differences in fixation based on fellowship training. RESULTS:Sixteen of the 39 patients studied had undergone VUC-specific fixation, with a significantly higher rate of use of VUC-specific fixation in fellowship trained hand surgeons compared with fellowship-trained trauma surgeons. There was no significant difference in loss of reduction, revision surgery, or complications. Radiographic measures were statistically similar between both groups postoperatively. Trauma trained surgeons had a significantly increased postoperative radial inclination versus hand-trained surgeons. CONCLUSIONS:This study suggests that not all VUC injuries require specific VUC fixation, and we may be overtreating distal radius fractures that have a VUC component. Fellowship-trained hand surgeons are more likely to employ VUC-specific fixation methods. Additional studies are warranted to determine whether other considerations such as dynamic testing intraoperatively are worthwhile.

BACKGROUND:Sinus of Valsalva aneurysms (SVAs) are rare cardiac anomalies that often remain silent until rupture occurs. Prompt recognition and repair is essential, as untreated ruptured SVAs can lead to progressive right heart failure and early mortality. CASE SUMMARY:A 26-year-old woman with a ruptured SVA and aorto-right atrial fistula underwent definitive surgical repair after failed transcatheter closure, with excellent postoperative recovery. DISCUSSION:Ruptured SVAs are rare and can present with subtle symptoms that can mimic other pathologies. Astute clinical examination, multimodal imaging, and timely surgical management all assist in ensuring excellent long-term outcomes. TAKE-HOME MESSAGE:Early recognition and meticulous perioperative management of ruptured SVAs are the keys to ensuring excellent long-term outcomes.

BACKGROUND:The potential impact of treatment sequencing in chemoimmunotherapy combinations remains underexplored. We evaluated 2 alternative dosing schedules of chemotherapy (cisplatin and gemcitabine [GC]) and an immune checkpoint inhibitor (CPI; atezolizumab [A]) for metastatic urothelial carcinoma (mUC). METHODS:This multicenter phase II study randomized cisplatin-eligible patients with previously untreated mUC in a 1:1 ratio. The chemo-first schedule included 2 cycles of GC, followed by 4 cycles of GC + A and A maintenance. The CPI-first schedule originally included a two-cycle A lead-in, later amended to a one-cycle lead-in, followed by 6 cycles of GC + A and A maintenance. The primary endpoint was objective response rate after the protocol amendment. Secondary endpoints included progression-free survival, overall survival, and safety. RESULTS:Overall, 31 patients were randomized between 9/2017 and 2/2021 (chemo-first, n = 15; CPI-first, n = 16), with early discontinuation due to the evolving mUC management paradigm. Among the per-protocol evaluable patients (n = 19), ORR was 44% (95% CI, 14%-79%) in the chemo-first schedule and 40% (95% CI, 12%-74%) in the CPI-first amended schedule, with neither arm meeting the predefined efficacy threshold. Median follow-up was 60 months (95% CI 48-not reached [NR]). Median progression-free survival and overall survival (95% CI) were: chemo-first, 6.1 (4.4-NR) and 15 (10-NR) months; CPI-first original, 1.3 (1.1-NR) and 12 (8.4-NR) months; and CPI-first amended, 7.6 (2.0-NR) and 26 (3.6-NR) months. No new safety signals or treatment-related deaths occurred. CONCLUSIONS:This study evaluating the impact of chemotherapy and CPI dosing sequence in patients with mUC was limited by a small sample size and early discontinuation, with neither arm meeting the primary endpoint. Exploratory observations highlight CPI lead-in duration as a potential consideration for future trial design.

The phase III CEPHEUS trial (ClinicalTrials.gov identifier: NCT03652064) of patients with transplant-ineligible (TIE) or transplant-deferred newly diagnosed multiple myeloma (NDMM; N = 395) demonstrated improved overall minimal residual disease (MRD) negativity rates among patients achieving ≥complete response and progression-free survival (PFS) with daratumumab plus bortezomib, lenalidomide, and dexamethasone (DVRd) versus VRd. We present efficacy and safety outcomes in the CEPHEUS TIE subgroup (N = 289; DVRd, n = 144; VRd, n = 145). Patients were either age 18-70 years with ≥1 comorbidity likely to negatively affect tolerability of high-dose chemotherapy with autologous stem cell transplantation or age ≥70 years. At a median follow-up of 58.7 months, the MRD negativity rate (10^-5) was 60.4% (DVRd) versus 39.3% (VRd; P = .0004). Rates of sustained MRD negativity (10^-5) for ≥12 months (47.2% v 28.3%; P = .0010) and ≥24 months (40.3% v 22.8%; P = .0015) were significantly higher with DVRd. Risk of disease progression or death was 49% lower for DVRd versus VRd (hazard ratio [HR], 0.51 [95% CI, 0.35 to 0.74]; P = .0003). Although immature, overall survival favored DVRd (HR, 0.66 [95% CI, 0.42 to 1.03]). Adverse events were consistent with known safety profiles. This analysis demonstrates that the deep responses achieved with DVRd translate into improved PFS in patients with TIE NDMM, reinforcing DVRd as a standard of care.

BACKGROUND:Right ventricular ejection fraction (RVEF) is a known predictor of adverse outcomes; however, its prognostic value diminishes in tricuspid regurgitation (TR). OBJECTIVES/OBJECTIVE:This study aims to assess whether effective right ventricular ejection fraction (eRVEF) offers a more physiologic assessment of RV function and improves risk stratification in patients with TR. METHODS:The derivation cohort comprised 453 consecutive patients with at least moderate functional TR (regurgitant fraction ≥30% or volume ≥30 mL) on cardiac magnetic resonance (CMR). eRVEF was calculated as the ratio of forward volume to RV end-diastolic volume. The eRVEF threshold (≤25%) was derived based on all-cause mortality data. Clinical data were collected from standardized questionnaires at the time of CMR and supplemented with electronic health records; the primary outcome was all-cause mortality. External validation was performed in 2 independent cohorts, totaling 316 patients using identical inclusion criteria. RESULTS:In the derivation cohort, impaired eRVEF was associated with more advanced biventricular remodeling, worse biventricular function, and greater burden of late gadolinium enhancement (P < 0.05 for all), which was paralleled by higher TR volume and fraction (both P < 0.05). Over a median follow-up period of 2.7 years (Q1-Q3: 0.6-6.6 years), 20% of the patients died; mortality was higher in patients with impaired versus preserved eRVEF (28% vs 12%; HR: 1.72 [95% CI: 1.16-2.54]; P = 0.007). After adjusting for known TR risk markers including age, RV size, TR severity, conventional RVEF, and clinical markers of right-sided congestion, eRVEF remained independently predictive of mortality (HR: 0.49 [95% CI: 0.24-0.97]; P = 0.042). Adding eRVEF to a model inclusive of RVEF improved mortality prediction (chi-square from 30.6 to 37.0; P = 0.011) whereas adding RVEF to eRVEF did not (chi-square from 35.4 to 37.0; P = 0.199). External validation confirmed the prognostic significance of eRVEF ≤25% in both cohorts (HR: 2.66-2.86; both P < 0.05). CONCLUSIONS:eRVEF independently predicts mortality in TR and provides incremental prognostic value over conventional prognostic markers.