Bradley, Elizabeth A.

AbstractContextInhibition of the neonatal fragment crystallizable receptor (FcRn) reduces pathogenic thyrotropin receptor antibodies (TSH-R-Ab) that drive pathology in thyroid eye disease (TED).ObjectiveWe report the first clinical studies of an FcRn inhibitor, batoclimab, in TED.DesignProof-of-concept (POC) and randomized, double-blind placebo-controlled trials.SettingMulticenter.ParticipantsPatients with moderate-to-severe, active TED.InterventionIn the POC trial, patients received weekly subcutaneous injections of batoclimab 680 mg for 2 weeks, followed by 340 mg for 4 weeks. In the double-blind trial, patients were randomized 2:2:1:2 to weekly batoclimab (680 mg, 340 mg, 255 mg) or placebo for 12 weeks.Main OutcomeChange from baseline in serum anti-TSH-R-Ab and total IgG (POC); 12-week proptosis response (randomized trial).ResultsThe randomized trial was terminated because of an unanticipated increase in serum cholesterol; therefore, data from 65 of the planned 77 patients were analyzed. Both trials showed marked decreases in pathogenic anti-TSH-R-Ab and total IgG serum levels (P < .001) with batoclimab. In the randomized trial, there was no statistically significant difference with batoclimab vs placebo in proptosis response at 12 weeks, although significant differences were observed at several earlier timepoints. In addition, orbital muscle volume decreased (P < .03) at 12 weeks, whereas quality of life (appearance subscale) improved (P < .03) at 19 weeks in the 680-mg group. Batoclimab was generally well tolerated, with albumin reductions and increases in lipids that reversed upon discontinuation.ConclusionsThese results provide insight into the efficacy and safety of batoclimab and support its further investigation as a potential therapy for TED.

We present clinical and imaging predictors of ocular injuries that required medical management versus surgical intervention in cases of orbital fractures. From 2014 to 2020, a retrospective review of patients with orbital fractures who received ophthalmologic consultation and computed scan (CT) analysis at a level I trauma center was performed. Inclusion criteria were patients with confirmed orbital fracture on CT and ophthalmology consultation. Patient demographics, associated injuries, comorbidities, management, and outcomes were collected. Two hundred and one patients and 224 eyes (11.4% bilateral orbital fractures) were included. Overall, 21.9% of orbital fractures presented with a significant concomitant ocular injury. Associated facial fractures were present in 68.8% of eyes. Management included surgical treatment in 33.5% of eyes and ophthalmology-directed medical treatment in 17.4%. On multivariate analysis, clinical predictors of surgical intervention were retinal hemorrhage (OR=4.7 (1.0–21.0), P=0.0437), motor vehicle accident injury (OR=2.7 (1.4–5.1), P=0.0030) and diplopia (OR=2.8 (1.5–5.3), P=0.0011). Imaging predictors of surgical intervention were herniation of orbital contents (OR=2.1 (1.1–4.0), P=0.0281) and multiple wall fractures (OR=1.9 (1.01–3.6), P=0.0450). Predictors of medical management were corneal abrasion (OR=7.7 (1.9–31.4), P=0.0041), periorbital laceration (OR=5.7 (2.1–15.6), P=0.0006), and traumatic iritis (OR=4.7 (1.1–20.3), P=0.0444). We demonstrated a 22% incidence of concomitant ocular trauma in orbital fracture patients at our level I trauma center. Predictors of the surgical intervention included multiple wall fractures, herniation of orbital contents, retinal hemorrhage, diplopia, and motor vehicle accident injury. These findings emphasize the importance of a multidisciplinary team in managing ocular and facial trauma.

Purpose: To present 5 cases of alemtuzumab-induced thyroid eye disease (AI-TED) and review the literature to highlight the natural history, severity, and outcomes as compared with conventional thyroid eye disease (TED). Methods: A multi-institutional retrospective case series of patients with AI-TED was compiled. Chart review evaluated for clinical characteristics, imaging findings, and treatment for AI-TED. Additionally, a comprehensive review of the literature identified all previously published cases of AI-TED. Results: Five new patients with AI-TED were included in this series. The average clinical activity score on presentation was 2.8 (range 1–4) and reached an average peak of 5.0 during the active phase of the disease (4–7). Patients were treated medically with selenium (40%) or monoclonal antibodies including teprotumumab or tocilizumab (40%). Surgical treatment with orbital decompression for compressive optic neuropathy was performed on 2 (40%) patients. Combined with 11 previously reported cases, these 16 patients with AI-TED had an average clinical activity score on presentation of 3.3. The average length of the AI-TED phase was 14.0 months, and all patients were treated with medical and/or surgical interventions for their disease. Conclusions: Clinical and imaging findings in AI-TED mirror that of conventional TED, however, AI-TED may present with greater severity. AI-TED may develop many months after Graves’ disease; therefore, providers should be aware of this association and monitor patients for the development of severe TED.

Abstract The complex three-dimensional (3D) anatomy in facial allotransplantation creates a unique challenge for surgical reconstruction. Evolution of virtual surgical planning (VSP) through computer-aided design and computer-aided manufacturing has advanced reconstructive outcomes for many craniomaxillofacial indications. Surgeons use VSP, 3D models, and surgical guides to analyze and to trial surgical approaches even prior to entering the operating room. This workflow allows the surgeon to plan osteotomies and to anticipate challenges, which improves surgical precision and accuracy, optimizes outcomes, and should reduce operating room time. We present the development, evolution, and utilization of VSP and 3D-printed guides in facial allotransplantation at our institution, from guide conception to first clinical case.

Abstract Patients with receding or high hairlines have traditionally been considered unfavorable candidates for endoscopic brow lift as this can further lengthen the hairline. We analyzed outcomes in patients that underwent a novel endoscopic brow lift technique with placement of incisions and anchoring Endotine Forehead Devices (CoApt Systems Inc, Palo Alto, CA, USA) directly at the natural forehead crease lines, in an effort to minimize elevation of the hairline, whereas providing well-hidden scars. We retrospectively reviewed all patients who underwent this new Endotine and incision placement between 2016 and 2020. Preoperative and postoperative photographs of all patients were analyzed to determine the postoperative changes in brow elevation and forehead length proportion (defined as length from cranium to chin). The forehead length proportion was unchanged pre- and post-operatively, with no statistically significant differences noted (P = 0.48). The average brow position elevation ranged from 2.78 mm in the medial location to 5.05 mm in the lateral location. All patients were happy with their appearance and had improved visual fields postoperatively. The forehead scars healed well and were well hidden in forehead rhytids at long term follow-up. This novel endoscopic brow lift technique provides an option to utilize a minimally invasive approach in patients with receding hairline. With this technique, visible scars were minimized, whereas still being able to achieve reasonable brow elevation. Thus, our approach enables long term maintenance of brow elevation with inconspicuous scars in the forehead.