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Background: Approximately 1 in 4 patients with inflammatory bowel disease (IBD) will present with the disease during childhood. Pediatric IBD is linked to poor growth outcomes and pubertal delay in both Crohn's disease (CD) and ulcerative colitis (UC). In up to 46% of pediatric CD patients, a decrease in height velocity is the first symptom to present, before any gastrointestinal. This decreased growth is likely multifactorial and related to decreased caloric intake, poor nutrient absorption, corticosteroid use, and chronic inflammation. In up to 17% of pediatric IBD patients with decreased growth velocity, these early delays can lead to permanent growth deficit. This study aimed to assess the effectiveness of nutritional counseling by a registered dietician on growth velocity in the pediatric IBD population at a major medical center. Methods: This study was conducted as a retrospective chart review. Charts of pediatric IBD patients that were seen at Golisano Children's Hospital at the University of Rochester, Rochester, NY in the years 2020 and 2021 were collected using billing codes. In all, 140 total charts were reviewed, and 7 were excluded because they did not have an established IBD diagnosis. Demographic, growth velocity, and laboratory data were collected for each of the remaining 133 charts. Results: Of the pediatric IBD population sampled, 56% of patients were male, 44% were female, and the mean age of diagnosis was 11.2 years (SD 5 3.74). 80.17% of patients had Crohn's disease, 19.01% had ulcerative colitis, and 0.83% had an inconclusive IBD diagnosis. 40.60% of patients had at least one appointment or consultation with a dietician or a nutritionist, while 59.40% had not met with a dietician or a nutritionist. The mean height velocity* was 0.31 cm/month (SD 5 0.35 cm/month), the mean weight velocity* was 0.63 kg/month (SD 5 0.57 kg/month), and the mean BMI velocity* was 0.18 kg*month/m2 (SD 5 0.22 kg*month/m2). In terms of height velocity*, there was no significant difference between those who had dietary consultations and those who did not (t(125) 5 0.02, P 5 0.99). Those who received a dietary consultation had a significantly higher weight velocity* (t(125) 5 1.86, P 5 0.03). The mean weight velocity for patients who received dietary consult was 0.7 kg/month (SD 5 0.07) as compared to 0.54 kg/month (SD 5 0.07) for patients who did not receive dietary consultation. Conclusion(s):These results suggest that consultation with a dietician or nutritionist has a significant effect on the growth potential, specifically the weight gain potential, of pediatric IBD patients. We did not see a significant increase in the height velocity, which may be due to the pre/early pubertal mean age of our data. Further multivariate analyses of the laboratory data that was collected are ongoing and may help to identify if any of the laboratory tests are strong predictors of growth or delay in growth. This could then allow physicians to identify patients that are at higher risk of poor growth outcomes and design more targete...

Introduction: Guselkumab (GUS), an IL-23p19 antagonist, had greater efficacy than placebo (PBO) in achieving clinical response and clinical remission at Week (Wk) 12 in the randomized, controlled Phase 2b QUASAR Induction Study 1 (NCT04033445) in patients with moderately to severely active ulcerative colitis (UC). 1 Patients who were not in clinical response at Wk 12 received GUS treatment through Wk 24.Here, we report GUS cumulative efficacy and safety results for Induction Study 1. Methods: Eligible patients had moderately to severely active UC (modified Mayo score of 5 to 9 with a Mayo endoscopy subscore $2) at baseline. Patients were randomized 1:1:1 to IV GUS 200mg, 400mg, or PBO at Wks 0, 4, and 8. Patients who were not in clinical response to IV induction at Wk 12 received GUS treatment (PBO IV→GUS 200mg IV; GUS 200mg IV→GUS 200mg SC; GUS 400mg IV→GUS 200mg SC) at Wks 12, 16, and 20 and were evaluated at Wk 24 (Figure). Matching IV or SC PBO was administered to maintain the blind. Results: Three hundred thirteen patients were randomized and treated at baseline. Demographic and disease characteristics at baseline were similar among the treatment groups, and approximately 50% had a prior inadequate response or intolerance to advanced UC therapy. At Wk 12, clinical response was achieved by 61.4% (62/101) and 60.7% (65/107) of patients randomized to GUS 200mg and GUS 400mg IV vs 27.6 % (29/105) of patients randomized to PBO IV (both p, 0.001). Of the patients in the GUS groups who were not in clinical response at Wk 12, 54.3% (19/35) in the GUS 200mg IV→200mg SC group and 50.0% (19/38) in the GUS 400mg IV→200mg SC group achieved clinical response at Wk 24. Clinical response at Wk 12 or 24 was achieved by 80.2% of patients who were randomized to GUS 200mg IV and 78.5% of patients who were randomized to GUS 400mg IV. For patients who received PBO IV→GUS 200mg IV, clinical response at Wk 24 (65.2%) was similar to Wk 12 clinical response following GUS 200mg IV induction (61.4%). The most frequent adverse events among all GUS-treated pts (n5274) were anemia (7.7%), headache (5.1%), worsening UC (4.4%), COVID-19 (3.6%), arthralgia (2.9%) and abdominal pain (2.6%) which are consistent with Wk 12 results. Conclusion: Overall, approximately 80% of patients randomized to receive GUS achieved clinical response at Wk 12 or 24. Continued treatment with SC GUS allowed 50-54.3% of IV GUS Wk 12 clinical nonresponders to achieve clinical response at Wk 24. No new safety concerns for GUS were identified.

Background Ozanimod, an oral sphingosine 1-phosphate receptor modulator, is approved in the European Union and United States for the treatment of moderately to severely active ulcerative colitis (UC) and relapsing multiple sclerosis (RMS). A previous analysis of data from UC and multiple sclerosis (MS) open-label extension (OLE) studies showed that most patients with confirmed coronavirus infection (COVID-19) had nonserious infections, recovered, and did not require ozanimod discontinuation. Some immunomodulators and biologics may attenuate severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine response; therefore, this analysis evaluated humoral immune responses and predictors of response to SARS-CoV-2 vaccination in patients with RMS treated with ozanimod. Methods RMS participants who completed a phase 1–3 ozanimod trial could enter an OLE trial (DAYBREAK; NCT02576717) of ozanimod 0.92 mg/d. This analysis (January 2020‒October 2021) included DAYBREAK participants receiving mRNA or non-mRNA SARS-CoV-2 vaccines (1–2 doses, vaccine-dependent) with no evidence of recent infection (ie, nucleocapsid antibody negative). Receptor binding domain (RBD) antibody titers were analysed (Elecsys Anti-SARS-CoV-2 assay; Roche Diagnostics, Basel, Switzerland) prevaccination, after 1 dose, and <4, 4–8, 8–12, and >12 weeks after full vaccination. Fisher’s exact tests and regression models determined association with seroconversion and log2 antibody levels. Results Demographics were similar between the mRNA and non-mRNA vaccine recipients (Table). Seroconversion (≥0.8 U/mL spike RBD antibody) occurred in 100% (80/80) of fully vaccinated mRNA recipients and 62% (18/29) of fully vaccinated non-mRNA vaccine recipients. Higher spike RBD antibody levels were seen with mRNA (grand mean: 512.6 U/mL, range: 1.3–4572.0) vs non-mRNA (grand mean: 39.3 U/mL, range: 0.4–368.5) vaccines at all time points studied. Vaccination with a non-mRNA vaccine predicted lower antibody levels (beta: –5.90 [95% CI: –6.99 to –4.82]; P<0.0001) and less seroconversion (Fisher’s exact: P<0.0001), whereas age, sex, body mass index, and absolute lymphocyte count (ALC) did not. Conclusion Participants receiving ozanimod developed humoral immune response to SARS-CoV-2 vaccines, with 100% seroconversion after mRNA vaccination; this was independent of demographic characteristics and ALC levels at time of vaccination. However, some participants developed lower antibody concentrations and may benefit from booster doses. These findings provide important information for physicians managing ozanimod-treated patients with UC or MS.

Table 1. (continued) Outcome Vaccine (%) Unvaccinated (%) OR 95% CI Composite 2.2 13 0.15 0.08 -0.29 Hospitalization 14.4 28.2 0.42 0.31 -0.58 ICU care 2.0