The Nova classification(1) categorises foods according to the degree of food processing. Ultra-processed food have undergone a high level of industrial processing and typically contain cosmetic additives(1). Increased consumption of ultra-processed food has been associated with adverse health outcomes, including obesity and chronic diseases(2). Evaluating household food acquisition according to the Nova classification allows the assessment of dietary quality within populations, a strategy of nutrition surveillance that can support the development of effective public health actions to improve dietary quality. In Aotearoa New Zealand (NZ), there is limited up-to-date information on population dietary habits and a lack of data on ultra-processed food consumption. This study aimed to: i) develop a methodology to classify food items purchased by NZ households according to the Nova food groups: unprocessed/minimally processed foods (Group 1 [G1]), processed culinary ingredients (Group 2 [G2]), processed foods (Group 3 [G3]), and ultra-processed foods (Group 4 [G4]) and; ii) to describe the proportions of unique food items purchased according to Nova. We obtained data on food items purchased by NZ households from the 2019 NielsenIQ Homescan® panel, a national dataset of approximately 2,000 households who recorded their grocery purchases over 1-year. In total, 28,824 unique items were purchased. Using barcodes, we merged the products with the 2019 Nutritrack dataset, an inventory of NZ supermarkets foods(2), to obtain the products’ ingredient lists. We followed best practices for classification according to Nova(3). Where available, the ingredient lists were used to classify products. Of the total unique products, 13,263 (46%) were matched to Nutritrack and classified based on their ingredient lists. For the remaining 15,561 products (54%), we identified whole Nielsen product categories (PC) that were exclusively associated with a single Nova group. Items classified by PC level included rice, fresh fruits, eggs and coffee beans in G1; baking powder, liquid cooking oils and salt in G2; beer and wine in G3; and margarine, carbonated soft drinks and bubble gum in G4. An additional 6,398 products were identified at this stage, representing 41.1% of the total 15,561 products without ingredient lists. We classified the remaining 9,163 items (58.9% of those 15,561 without ingredient list) based on the distribution of Nova groups for the 60% most purchased items within their PC. If the ingredient list was absent for any item under the 60% most purchased group, it was obtained from a search of online supermarkets. The final unweighted distribution of unique products purchased in NZ according to the Nova classification were 5583 (21.7%) in G1, 671 (2.6%) in G2, 3043 (11.8%) in G3, and 16466 (63.9%) in G4. Further stages of the research will estimate the energy from Nova groups derived from household food purchases in NZ, examining socioeconomic distribution and temporal trends.

In childhood, diets high in sodium and low in potassium contribute to raised blood pressure and cardiovascular disease later in life(1). For New Zealand (NZ) children, bread is a major source of dietary sodium, and fruit, vegetables, and milk are major dietary sources of potassium(2,3). However, it is mandatory to use iodised salt in NZ bread meaning reducing the salt and thus sodium content could put children at risk of iodine deficiency(4). Our objective was to measure the sodium, potassium, and iodine intake, and blood pressure of NZ school children 8-13 years old. A cross-sectional survey was conducted in five primary schools in Auckland and Dunedin. Primary schools were recruited between July 2022 and February 2023 using purposive sampling. Seventy-five children (n= 37 boys, 29 girls, and nine children who did not state their gender) took part. The most common ethnicity was NZ European and Other (n=54 or 72%) followed by Māori (indigenous inhabitants; n=9 or 12%) and Pasifika (n=5 or 7%). The main outcomes were 24-hour sodium and potassium intake, sodium to potassium molar ratio, 24-hour iodine intake, and BP. Sodium, potassium, and iodine intake were assessed using 24-hour urine samples and BP was assessed using standard methods. Differences by gender were tested using two-sample t-tests and nonparametric Wilcoxon two-sample tests. The mean (SD) 24-hour sodium excretion, potassium excretion, and sodium to potassium molar ratio for children with complete samples (n=59) were 2,420 (1,025) mg, 1,567 (733) mg, and 3.0 (1.6), respectively. The median (25th, 75th percentile) urinary iodine excretion was 88 (61, 122) µg per 24 hours and the mean (SD) systolic and diastolic blood pressure (n=74) were 105 (10) mmHg and 67 (9) mmHg, respectively. There was a significant difference between boys and girls for iodine (77 (43, 96) vs. 98 (72, 127) µg per 24 hours; p=0.02) but no other outcomes. In conclusion, children consumed more sodium and less potassium and iodine than World Health Organization recommendations(5). However, future research should confirm these findings in a nationally representative sample. Evidence-based, equitable interventions and policies with adequate monitoring should be considered to reduce potentially suboptimal sodium, potassium, and iodine intakes in New Zealand.

New Zealand and Australian governments rely heavily on voluntary industry initiatives to improve population nutrition, such as voluntary front-of-pack nutrition labelling (Health Star Rating [HSR]), industry-led food advertising standards, and optional food reformulation programmes. Research in both countries has shown that food companies vary considerably in their policies and practices on nutrition(1). We aimed to determine if a tailored nutrition support programme for food companies improved their nutrition policies and practices compared with control companies who were not offered the programme. REFORM was a 24-month, two-country, cluster-randomised controlled trial. 132 major packaged food/drink manufacturers (n=96) and fast-food companies (n=36) were randomly assigned (2:1 ratio) to receive a 12-month tailored support programme or to the control group (no intervention). The intervention group was offered a programme designed and delivered by public health academics comprising regular meetings, tailored company reports, and recommendations and resources to improve product composition (e.g., reducing nutrients of concern through reformulation), nutrition labelling (e.g., adoption of HSR labels), marketing to children (reducing the exposure of children to unhealthy products and brands) and improved nutrition policy and corporate sustainability reporting. The primary outcome was the nutrient profile (measured using HSR) of company food and drink products at 24 months. Secondary outcomes were the nutrient content (energy, sodium, total sugar, and saturated fat) of company products, display of HSR labels on packaged products, company nutrition-related policies and commitments, and engagement with the intervention. Eighty-eight eligible intervention companies (9,235 products at baseline) were invited to participate, of whom 21 accepted and were enrolled in the REFORM programme (delivered between September 2021 and December 2022). Forty-four companies (3,551 products at baseline) were randomised to the control arm. At 24 months, the model-adjusted mean HSR of intervention company products was 2.58 compared to 2.68 for control companies, with no significant difference between groups (mean difference -0.10, 95% CI -0.40 to 0.21, p-value 0.53). A per protocol analysis of intervention companies who enrolled in the programme compared to control companies with no major protocol violation also found no significant difference (2.93 vs 2.64, mean difference 0.29, 95% CI -0.13 to 0.72, p-value 0.18). We found no significant differences between the intervention and control groups in any secondary outcome, except in total sugar (g/100g) where the sugar content of intervention company products was higher than that of control companies (12.32 vs 6.98, mean difference 5.34, 95% CI 1.73 to 8.96, p-value 0.004). The per-protocol analysis for sugar did not show a significant difference (10.47 vs 7.44, mean difference 3.03, 95% CI -0.48 to 6.53, p-value 0.09).In conclusion, a 12-month tailored nutrition support for food companies did not improve the nutrient profile of company products.

Background: While efgartigimod usage is expected to reduce immunoglobulin (IG) utilization, evidence in clinical practice is limited. Methods: In this retrospective cohort study, patients with gMG treated with efgartigimod for ≥1-year were identified from US medical/pharmacy claims data (April 2016-January 2024) and data from the My VYVGART Path patient support program (PSP). The number of IG courses during 1-year before and after efgartigimod initiation (index date) were evaluated. Patients with ≥6 annual IG courses were considered chronic IG users. Myasthenia Gravis Activities of Daily Living (MG-ADL) scores before and after index were obtained from the PSP where available. Descriptive statistics were used without adjustment for covariates. Results: 167 patients with ≥1 IG claim before index were included. Prior to efgartigimod initiation, the majority of patients (62%) received IG chronically. During the 1-year after index, the number of IG courses fell by 95% (pre: 1531, post: 75). 89% (n=149/167) of patients fully discontinued IG usage. Mean (SD) best-follow up MG-ADL scores were significantly reduced after index (8.0 [4.1] to 2.8 [2.1], P<0.05, n=73/167, 44%). Conclusions: Based on US claims, IG utilization was substantially reduced among patients who continued efgartigimod for ≥1-year, with patients demonstrating a favorable MG-ADL response.

Background: TERT promoter mutation (TPM) is an established biomarker in meningiomas associated with aberrant TERT expression and reduced progression-free survival (PFS). TERT expression, however, has also been observed even in tumours with wildtype TERT promoters (TP-WT). This study aimed to examine TERT expression and clinical outcomes in meningiomas. Methods: TERT expression, TPM status, and TERT promoter methylation of a multi-institutional cohort of meningiomas (n=1241) was assessed through nulk RNA sequencing (n=604), Sanger sequencing of the promoter (n=1095), and methylation profiling (n=1218). 380 Toronto meningiomas were used for discovery, and 861 external institution samples were compiled as a validation cohort. Results: Both TPMs and TERTpromoter methylation were associated with increased TERT expression and may represent independent mechanisms of TERT reactivation. TERT expression was detected in 30.4% of meningiomas that lacked TPMs, was associated with higher WHO grades, and corresponded to shorter PFS, independent of grade and even among TP-WT tumours. TERT expression was associated with a shorter PFS equivalent to those of TERT-negative meningiomas of one higher grade. Conclusions: Our findings highlight the prognostic significance of TERT expression in meningiomas, even in the absence of TPMs. Its presence may identify patients who may progress earlier and should be considered in risk stratification models.

Background: Deep brain stimulation (DBS) in Parkinson’s disease (PD) requires extensive trial-and-error programming, often taking over a year to optimize. An objective, rapid biomarker of stimulation success is needed. Our team developed a functional magnetic resonance imaging (fMRI)-based algorithm to identify optimal DBS settings. This study prospectively compared fMRI-guided programming with standard-of-care (SoC) clinical programming in a double-blind, crossover, non-inferiority trial. Methods: Twenty-two PD-DBS patients were prospectively enrolled for fMRI using a 30-sec DBS-ON/OFF cycling paradigm. Optimal settings were identified using our published classification algorithm. Subjects then underwent >1 year of SoC programming. Clinical improvement was assessed under SoC and fMRI-determined stimulation conditions. Results: fMRI optimization significantly reduced the time required to determine optimal settings (1.6 vs. 5.6 months, p<0.001). Unified Parkinson’s Disease Rating Scale (UPDRSIII) improved comparably with both approaches (23.8 vs. 23.6, p=0.9). Non-inferiority was demonstrated within a predefined margin of 5 points (p=0.0018). SoC led to greater tremor improvement (p=0.019), while fMRI showed greater bradykinesia improvement (p=0.040). Conclusions: This is the first prospective evaluation of an algorithm able to suggest stimulation parameters solely from the fMRI response to stimulation. It suggests that fMRI-based programming may achieve equivalent outcomes in less time than SoC, reducing patient burden while potentially enhancing bradykinesia response.

Background: Ischemic stroke is a major cause of morbidity and mortality in Canada. Since 2015, mechanical thrombectomy has been the standard of care for eligible large vessel occlusions (LVOs), though anesthetic strategies remain variable. Methods: We conducted a single-center retrospective review of patients undergoing mechanical thrombectomy for anterior circulation LVOs between 2021 and 2023. Patients were categorized by anesthetic strategy (general anesthesia vs. conscious sedation), and outcomes, including time to recanalization, angiographic results (mTICI), and 90-day functional status (mRS), were compared. Statistical analyses included Student’s t-test, Mann-Whitney U-test, and Fisher’s exact test. Results: Among 226 patients, 177 (78%) received general anesthesia and 49 (22%) underwent conscious sedation. Baseline characteristics including sex, age, NIHSS, ASPECTS, collaterals, and laterality were similar between groups. Conscious sedation was associated with a statistically significant shorter time from arrival to the angiography suite to groin puncture (p=0.007), but no differences in time to recanalization (p=0.893), angiographic outcomes (p=0.987), or 90-day functional status (p=0.795) were observed. Conclusions: Conscious sedation led to faster procedural initiation, though no difference in clinical or radiographic outcome was observed. Anesthetic choice should be individualized based on patient and physician factors in acute mechanical thrombectomy.

Background: Identifying white matter abnormalities after acute concussion is challenging due to variable microstructural changes and individual imaging limitations. Combining diffusion tensor imaging (DTI) and neurite orientation dispersion and density imaging (NODDI) improves sensitivity to alterations. This study integrates neuroimaging and behavioural assessments to improve detection and characterization of abnormalities for clinical management. Methods: We recruited 12 recently concussed athletes (21 ± 2.1 years, 7 ± 4.6 days post-injury; 9 completed behavioural testing) and 24 controls. All participants underwent DTI and NODDI to assess white matter integrity. Kinematic performance was evaluated using the Kinarm exoskeleton robot’s Reverse Visually Guided Reaching (RVGR) task. Group differences in imaging and kinematic metrics were analyzed using permutation-based and parametric tests, controlling for age and sex. Results: Concussed athletes had elevated fractional anisotropy, reduced mean and radial diffusivity, and lower isotropic volume fraction in affected tracts. However, no group differences emerged in RVGR parameters, indicating intact sensorimotor function despite imaging abnormalities. Conclusions: Our findings reveal that acute concussion leads to measurable microstructural changes without corresponding functional deficits on a cognitive inhibition task. These findings highlight the clinical utility of neuroimaging for early and precise diagnosis, emphasizing its sensitivity over behavioural measures to detect subtle impairment for acute concussion management.

Background: The WHO grade of meningioma was updated in 2021 to include homozygous deletions of CDKN2A/B and TERT promotor mutations. Previous work including the recent cIMPACT-NOW statement have discussed the potential value of including chromosomal copy number alterations to help refine the current grading system. Methods: Chromosomal copy number profiles were inferred from from 1964 meningiomas using DNA methylation. Regularized Cox regresssion was used to identify CNAs independenly associated with post-surgical and post-RT PFS. Outcomes were stratified by WHO grade and novel CNAs to assess their potential value in WHO critiera. Results: Patients with WHO grade 1 tumours and chromosome 1p loss had similar outcomes to those with WHO grade 2 tumours (median PFS 5.83 [95% CI 4.36-Inf] vs 4.48 [4.09-5.18] years). Those with chromosome 1p loss and 1q gain had similar outcomes to those with WHO grade 3 cases regardless of initial grade (median PFS 2.23 [1.28-Inf] years WHO grade 1, 1.90 [1.23-2.25] years WHO grade 2, compared to 2.27 [1.68-3.05] years in WHO grade 3 cases overall). Conclusions: We advocate for chromosome 1p loss being added as a criterion for a CNS WHO grade of 2 meningioma and addition of 1q gain as a criterion for a CNS WHO grade of 3.

Background: Meningiomas exhibit considerable heterogeneity. We previously identified four distinct molecular groups (immunogenic, NF2-wildtype, hypermetabolic, proliferative) which address much of this heterogeneity. Despite their utility, the stochasticity of clustering methods and the requirement of multi-omics data limits the potential for classifying cases in the clinical setting. Methods: Using an international cohort of 1698 meningiomas, we constructed and validated a machine learning-based molecular classifier using DNA methylation alone. Original and newly-predicted molecular groups were compared using DNA methylation, RNA sequencing, whole exome sequencing, and clinical outcomes. Results: Group-specific outcomes in the validation cohort were nearly identical to those originally described, with median PFS of 7.4 (4.9-Inf) years in hypermetabolic tumors and 2.5 (2.3-5.3) years in proliferative tumors (not reached in the other groups). Predicted NF2-wildtype cases had no NF2 mutations, and 51.4% had others mutations previously described in this group. RNA pathway analysis revealed upregulation of immune-related pathways in the immunogenic group, metabolic pathways in the hypermetabolic group and cell-cycle programs in the proliferative group. Bulk deconvolution similarly revealed enrichment of macrophages in immunogenic tumours and neoplastic cells in hypermetabolic/proliferative tumours. Conclusions: Our DNA methylation-based classifier faithfully recapitulates the biology and outcomes of the original molecular groups allowing for their widespread clinical implementation.

Background: Studies have found similar rates of functional independence for men and women after endovascular thrombectomy (EVT). Less is known regarding EVT-related procedural complications and symptomatic intracerebral hemorrhage (sICH) between sexes. Methods: Using the OPTIMISE registry including data from 20 comprehensive stroke centers across Canada between 1/1/2018 and 12/31/2022, we performed a retrospective descriptive analysis of patients divided between men and women. Hemorrhagic transformation on follow-up imaging with associated clinical deterioration was required to define sICH. Results: 3631 patients were included (1778 men and 1853 women) for analysis. Female patients were older (71.8±14.6 vs 68.0±13.1 years, p<0.001). There were no differences in sICH rates (2.5% men vs. 2% women, p= 0.388}. Procedural complication rates were not different between men and women (5.8 vs 5.6% p=0.76): dissection {26 (1.5%) vs. 30 (1.6%), p=0.804}, perforation {11 (0.6%) vs. 7 (0.4%), p=0.426}, embolization {25 (1.4%) vs. 25 (1.3%), p=0.996} and arterial access complications {45 (2.5%) vs. 43 (2.3%), p=0.761}. Conclusions: In this large multicentre registry of stroke patients undergoing EVT, men and women had similarly low and reassuring rates of sICH and procedural complications. This complements previous data showing similar functional outcomes for men and women after EVT.

Background: Telemedicine evaluation for treatment of acute stroke patients with IV thrombolysis has been shown to be beneficial. Its usefulness for the evaluation of patients transferred from a primary stroke centre (PSC) to a comprehensive stroke centre (CSC) for endovascular thrombectomy (EVT) is less well defined. Methods: We retrospectively analyzed the Canadian OPTIMISE registry which included data from 20 comprehensive stroke centers across Canada between January 1, 2018, and December 31, 2022 to compare treatment metrics and early outcomes between two groups: patients evaluated by telemedicine (TM) and patients evaluated in person (non-TM) at the PSC prior to CSC transfer. Results: We included 3317 patients who were transferred from a PSC to a CSC for: 888 TM and 2429 non-TM. There were no major differences in baseline characteristics, including intravenous thrombolysis administration, though the TM group included more men. TM patients had longer onset-to-puncture times (441 vs 403 minutes, p<0.001) and higher symptomatic intracerebral hemorrhage (sICH) rates (7.4% vs 3.7%, p<0.001), but CSC door-to-puncture times and successful recanalization rates did not differ. Conclusions: Patients transferred to a CSC for EVT first evaluated by TM had similar characteristics to those evaluated in person at the PSC, but longer onset-to-puncture times and higher sICH rates.

Background: Inuit children have been observed to have high rates of macrocephaly, which leads to burdensome travel for medical evaluation, often with no pathology identified. Given reports that WHO growth charts may not reflect all populations, we compared head circumference (HC) measurements in a cohort of Inuit children with the WHO charts. Methods: We extracted HC data from a retrospective cohort study where, with Inuit partnership, we reviewed medical records of Inuit children, born between 2010-2013, and residing in Nunavut. We excluded children with preterm birth, documented neurologic/genetic disease, and most congenital anomalies. We compared HC values with the 2007 WHO charts. Results: We analyzed records of 1960 Inuit children (8866 data points). Most data were from ages 0-36 months. At all age points, the cohort had statistically significantly larger HC than WHO medians. At age 12 months, median HC were 1.3 cm and 1.5 cm larger for male and female Inuit children. Using WHO growth curves, macrocephaly was overdiagnosed and microcephaly underdiagnosed. Conclusions: Our results support the observation that Inuit children from Nunavut have larger HCs, and use of the WHO charts may lead to overdiagnosis of macrocephaly and underdiagnosis of microcephaly. Population specific growth curves for Inuit children should be considered.

Background: Generalized myasthenia gravis (gMG) is a potentially life threatening chronic autoimmune disease that can impair patients’ ability to work effectively and increase reliance on public support benefits. A public economic framework was used to explore how treatment influences patients’ and caregivers’ economic activity, including tax revenues and public support in Canada. Methods: Natural history of gMG was simulated using a multi-state Markov cohort model. Health states were based on MG Activities of Daily Living (MG-ADL) total score in patients with AChR-Ab+ refractory gMG. Treatment, costs, and economic outcomes of patients taking efgartigimod were compared with alternative therapeutic options. Canadian public support benefits were based on official government sources. Results: Improved MG-ADL states predict higher workforce participation, lower rates of disability and less caregiving needs, resulting in higher tax revenues and less public support costs. Compared to alternative therapeutic options, efgartigimod is estimated to yield lifetime fiscal gains of $458,755 that exceed the incremental cost of $291,073, suggesting the Canadian government receives $1.6 for every $1.0 spent on efgartigimod for the treatment of gMG. Conclusions: Compared with alternative options, efgartigimod generated a positive fiscal return for the Canadian governments with additional savings from disease management, public benefits, and averted tax revenue losses.

Background: Anterior (ACS) and posterior circulation (PCS) stroke patients have different clinical presentations and prognoses, though both benefit from endovascular thrombectomy (EVT). We sought to determine whether ACS and PCS patients treated with EVT differed with regards to treatment metrics and functional outcomes. Methods: We retrospectively analysed theCanadian OPTIMISE registry which included data from 20 comprehensive stroke centers across Canada between January 1, 2018, and December 31, 2022. We performed a descriptive analysis of patients divided in two groups (ACS= carotid artery and its branches, PCS= vertebrobasilar system). Results: Of the 6391 patients included (5929 ACS and 462 PCS), PSC patients were younger (67 vs. 71.3, p<0.001), more often male (61.9% vs. 48.6%, p<0.001), had longer (in minutes) onset-to-door (362 vs. 256, p<0.001), door-to-needle (172 vs. 144, p=0.0016), and onset-to-puncture (459 vs. 329, p<0.001) times. They were less often thrombolyzed (39.8% vs. 50.4%, p<0.001), and more frequently underwent general anesthesia (47.6% vs. 10.6%, p<0.001). Successful reperfusion and functional independence at 90 days were similar between the two groups. Conclusions: Patients with PCS had worst treatment metrics than ACS. Strategies to improve PCS management times are critical to decrease these disparities, including faster pre-hospital recognition and in-hospital workflows.

Background: Efgartigimod, a human immunoglobulin (Ig)G1 antibody Fc fragment, blocks the neonatal Fc receptor, reducing IgGs involved in chronic inflammatory demyelinating polyneuropathy (CIDP). The multi-stage, double-blinded, placebo-controlled ADHERE (NCT04281472) and open-label extension ADHERE+ (NCT04280718) trials (interim analysis cutoff: February 16, 2024) assessed efgartigimod PH20 SC in participants with CIDP. Methods: Participants with active CIDP received open-label, weekly efgartigimod PH20 SC 1000 mg during ≤12-week run-in (stage-A). Responders were randomized (1:1) to efgartigimod or placebo for ≤48 weeks (stage-B). Participants with clinical deterioration in stage-B or who completed ADHERE entered ADHERE+. Week 36 changes from run-in baseline (CFB) in adjusted Inflammatory Neuropathy Cause and Treatment (aINCAT), Inflammatory Rasch-built Overall Disability Scale (I-RODS), and grip strength scores were evaluated. Results: Of 322 stage-A participants, 221 were randomized and treated in stage-B, and 99% entered ADHERE+. Mean CFB (SE) in aINCAT, I-RODS, and grip strength scores were -1.2 (0.15) and 8.8 (1.46) and 17.5 (2.02), respectively, at ADHERE+ Week 36 (N=150). Half the participants with clinical deterioration during ADHERE stage-B restabilized on efgartigimod from ADHERE+ Week 4. Conclusions: Interim results from ADHERE+ indicate long-term effectiveness of efgartigimod PH20 SC in clinical outcomes in participants with CIDP.

Background: Efgartigimod, a human immunoglobulin (Ig)G1 antibody Fc fragment, blocks the neonatal Fc receptor, reducing IgGs involved in chronic inflammatory demyelinating polyneuropathy (CIDP), a rare, progressive, immune-mediated disease that can lead to irreversible disability. The multi-stage, double-blinded, placebo-controlled ADHERE (NCT04281472) trial assessed efgartigimod PH20 SC in participants with CIDP. Methods: Participants with active CIDP received open-label, weekly efgartigimod PH20 SC 1000 mg during ≤12-week run-in (stage-A). Responders were randomized (1:1) to weekly efgartigimod or placebo for ≤48 weeks (stage-B). This posthoc analysis evaluated changes from run-in baseline (study enrollment) to stage-B last assessment and items of the Inflammatory Rasch-built Overall Disability Scale (I-RODS). Results: Of 322 participants who entered stage-A, 221 were randomized and treated in stage-B, and 191/221 had data for run-in baseline and post–stage-B timepoints. Mean (SE) I-RODS change at stage-B last assessment vs run-in baseline was 5.7 (1.88) and -4.9 (1.82) in participants randomized to efgartigimod and placebo, respectively. 37/97 (38.1%) and 24/92 (26.1%) participants randomized to efgartigimod and placebo, respectively, experienced ≥4-point improvements in I-RODS score. Efgartigimod-treated participants improved ≥1 point in I-RODS items of clinical interest. Conclusions: Participants who received efgartigimod in stage-B experienced improvements in I-RODS score from study enrollment to stage-B last assessment.

Background: Nipocalimab is a human IgG1 monoclonal antibody targeting FcRn that selectively reduces IgG levels without impacting antigen presentation, T- and B-cell functions. This study describes the effect of nipocalimab on vaccine response. Methods: Open-label, parallel, interventional study randomized participants 1:1 to receive intravenous 30mg/kg nipocalimab at Week0 and 15mg/kg at Week2 and Week4 (active) or no drug (control). On Day 3, participants received Tdap and PPSV®23 vaccinations and were followed through Wk16. Results: Twenty-nine participants completed the study and are included (active, n=15; control, n=14). Participants with a positive anti-tetanus IgG response was comparable between groups at Wk2 and Wk16, but lower at Wk4 (nipocalimab 3/15 [20%] vs control 7/14 [50%]; P=0.089). All maintained anti-tetanus IgG above the protective threshold (0.16IU/mL) through Wk16. While anti-pneumococcal-capsular-polysaccharide (PCP) IgG levels were lower during nipocalimab treatment, the percent increase from baseline at Wk2 and Wk16 was comparable between groups. Post-vaccination, anti-PCP IgG remained above 50mg/L and showed a 2-fold increase from baseline throughout the study in both groups. Nipocalimab co-administration with vaccines was safe and well-tolerated. Conclusions: These findings suggest that nipocalimab does not impact the development of an adequate IgG response to T-cell–dependent/independent vaccines and that nipocalimab-treated patients can follow recommended vaccination schedules.