BACKGROUND:Ozanimod is a once-daily oral selective sphingosine 1-phosphate receptor modulator approved for the treatment of moderately to severely active ulcerative colitis (UC) or relapsing multiple sclerosis (RMS). Previous analyses in both indications demonstrated favorable long-term safety profiles of ozanimod. Here we report an integrated analysis of the long-term safety of ozanimod in patients with UC or RMS. METHODS:Data were pooled in patients with UC who received ozanimod in phase 2, phase 3, and open-label extension (OLE) trials and in patients with RMS who received ozanimod in an OLE trial after completing any phase 1-3 parent trial. Safety assessments included treatment-emergent adverse events (TEAEs) and laboratory abnormalities. RESULTS:Overall, 3652 patients with UC or RMS had 16 144 patient-years (PY) of ozanimod exposure over 10 years of follow-up. The most common TEAEs were nasopharyngitis, headache, and coronavirus disease 2019. Rates of TEAEs leading to treatment discontinuation (1.4/100 PY) and TEAEs of special interest, including serious infections (1.0/100 PY), herpes zoster (0.5/100 PY), malignancies (0.4/100 PY), bradycardia (0.1/100 PY), sinus bradycardia (0.04/100 PY), complete atrioventricular block (0.01/100 PY), and macular edema (0.1/100 PY), were low. No serious hepatic events or Hy's law cases occurred. Absolute lymphocyte count of < 200 cells/µL was not temporally associated with serious or opportunistic infections. CONCLUSIONS:Long-term exposure to ozanimod is well tolerated in patients with moderate to severe UC or RMS, confirming the previously established safety profile of ozanimod. CLINICAL TRIAL REGISTRY:NCT01647516; NCT02435992; NCT02576717.
BACKGROUND:Given their emphasis on holistic, patient-centered care, nurse practitioners (NPs) and physician assistants (PAs) play an increasingly critical role in the care of patients with gastrointestinal conditions, including irritable bowel syndrome (IBS). OBJECTIVES:To review key clinical considerations for the diagnosis and management of IBS, focusing on IBS with diarrhea (IBS-D), alongside 2 case presentations. DATA SOURCES:PubMed and Google Scholar searches of English-language articles published between January 1, 2009, and April 2, 2025, were conducted to identify publications on the burden, diagnosis, and treatment of IBS-D. RESULTS:Data indicate that IBS-D impairs quality of life, daily activities, and work productivity and imposes a substantial socioeconomic burden. A positive diagnostic approach involving a detailed medical history and physical examination, with limited laboratory testing in the absence of alarm features, is recommended to facilitate timely and accurate diagnosis. Effective ongoing management relies on a patient-provider relationship that uses shared decision making, patient education and empowerment, and a personalized treatment strategy targeting the IBS subtype and most bothersome symptoms. Treatments considered for IBS-D include dietary management, over-the-counter agents, United States Food and Drug Administration-approved medications, neuromodulators, and gut-brain behavioral therapies. CONCLUSIONS:Positive diagnosis of IBS-D and an evidence-based, symptom-targeted therapeutic approach are recommended to minimize disease burden. IMPLICATIONS FOR PRACTICE:Both NPs and PAs are well positioned to provide individualized, compassionate, and competent care to patients with IBS-D. Communicating a confident, positive diagnosis and collaborating on a treatment plan that considers symptom presentation and most bothersome symptoms can improve patient outcomes.
BACKGROUND:Crohn's Disease patients are often subject to repeat computed tomography (CT) upon presentation to the emergency departments (ED). Due to early age of diagnosis and increase in ED visits, they can be exposed to substantial radiation posing long term increased risk of malignancy. In this retrospective study, we assess frequency of CT scans in the ED, urgent findings on CT, and patient characteristics correlating with multiple scans. We hope to identify predictive factors for urgent findings and for negative CT scans. METHODS:Six-hundred-and-sixty previously diagnosed Crohn's patients from four gastroenterology practices presented to three hospitals between April 15, 2015 and December 31, 2018 for 2473 total encounters. Patients were identified and cross-referenced with a radiology database search generating 1778 CT scans performed. Data was analyzed for presence of findings and demographics. RESULTS:CT scans were performed in 72% of encounters. There was a skewed distribution of CT scans (skew = 3.30), with 41% receiving only 1 scan, 43% receiving 2-4, and 16% receiving >5; the maximum was 24 scans for 1 patient. Positive findings including obstruction, perforation, or abscess were found in 28.5% of scans. Patients with barriers to healthcare had an increased rate of ED visits and imaging findings. CONCLUSIONS:Radiation exposure in Crohn's patients is higher than that of the general population, owing to multiple CT scans often performed acutely in the ED. Factors we assessed could not reliably predict urgent findings on CT and a significant percentage of patients had urgent findings. However, we identified a group with multiple CTs associated with barriers to healthcare.
