Bhat, Shubha

Objective: To review the pharmacologic and clinical profile of etrasimod in the treatment of ulcerative colitis (UC). Data sources: A PubMed search was conducted from inception to November 2023 using the keywords etrasimod, ulcerative colitis, and sphingosine-1-phosphate receptor modulator. Information was also obtained from published abstracts and package insert. Study selection and data extraction: Phase 2 and 3 studies plus relevant literature on etrasimod pharmacologic and clinical profile were reviewed. Data synthesis: Per ELEVATE, 2 phase 3 studies, a higher proportion of patients with moderately to severely active UC achieved clinical remission in the induction and maintenance phase with etrasimod compared with placebo. In addition, a higher proportion of patients achieved secondary endpoints of clinical response, endoscopic improvement-histologic remission, corticosteroid-free remission, and endoscopic improvement with etrasimod vs placebo. Common adverse events include anemia and headache. Relevance to patient care and clinical practice in comparison with existing drugs: Etrasimod is now the second orally administered sphingosine-1-phosphate modulator approved for UC, providing patients with additional treatment options. Efficacy rates of this treatment are in line with other UC medication options. Similar to other sphingosine-1-phosphate receptor modulators, various assessments are required at baseline and during treatment to ensure safe and appropriate use. Conclusion: Etrasimod is another possibility in the armamentarium of UC treatment, providing patients with more oral medication options. Prior to treatment initiation, several assessments relating to safety, drug interactions, and pharmacogenomics factors are advised.

Abstract Background Given the complexity of inflammatory bowel disease (IBD) care, utilization of multidisciplinary teams is recommended to optimize outcomes. There is a growing recognition that clinical pharmacists should be an integral part of this care model. We sought to define the roles of IBD clinical pharmacists in the United States. Methods A national multidisciplinary expert panel of 12 gastroenterologists and clinical pharmacists practicing in IBD clinics was assembled. We used the RAND/University of California, Los Angeles appropriateness method, with a total of 281 statements generated based on a systematic literature review and expert opinion. Each statement was anonymously rated as appropriate, uncertain, or inappropriate in 2 rounds of voting. Results The number of publications evaluating the clinical pharmacists’ roles in IBD is limited, primarily focusing on thiopurine initiation and monitoring, medication adherence, and switching to biosimilars. Medication education; medication initiation and monitoring; therapeutic drug monitoring; biosimilar management; health maintenance review; and transitions of care were deemed by the panel to be appropriate roles for IBD clinical pharmacists. In considering real-world settings, IBD clinical pharmacists should practice clinically under a predefined scope and primarily focus on complex treatments (eg, immunomodulators, biologics, and small molecules). Clinical pharmacists should also be included in practice settings with IBD specialized physicians. Additionally, clinical pharmacists caring for patients with IBD should be residency trained and board certified. Conclusions This consensus defines IBD clinical pharmacists’ roles and provides a framework for embedded clinical pharmacists in IBD care.

Lay Summary Biosimilar medications have the potential to significantly reduce the cost of treatment in patients with inflammatory bowel disease. Observational studies have shown similar efficacy and safety of biosimilars to biologic reference products. Shared decision-making is crucial to the successful implementation of these agents.

Abstract Purpose While COVID-19 vaccine emergency use authorization (EUA) deemed the vaccines to be effective and safe for public use, the phase 3 trials leading to EUA predominantly excluded patients with immunocompromising conditions. Immunocompromised patients make up a significant proportion of the population, and in light of recent mass vaccination efforts, we aim to review current evidence and recommendations of COVID-19 vaccines in 4 patient populations with immunocompromising disorders or conditions: human immunodeficiency virus (HIV) infection, solid organ transplantation, rheumatoid arthritis, and inflammatory bowel disease. Summary Given the evolving data on the safety and efficacy of the approved COVID-19 vaccines in the immunocompromised population, it is vital that pharmacists and other immunizing providers understand the current data and recommendations and provide the public with accurate information. To date, the only immunocompromised subgroup included in phase 3 COVID-19 vaccine trials have been those with HIV infection. However, recent retrospective trials have provided reassuring data on the safety of the COVID-19 vaccine in immunocompromised patients, and the interim analysis of the Moderna phase 3 trial produced promising data on efficacy in HIV-infected patients. Presently, the US Centers for Disease Control and Prevention, British Society for Immunology, and various other governmental and professional societies and organizations endorse COVID-19 vaccination in the immunocompromised population. Conclusion While additional data is needed to determine the effects of immunocompromising medical conditions and immunosuppressing medications on the efficacy of the vaccine, the benefits of vaccination is anticipated to outweigh theoretical risks. Thus, COVID-19 vaccination is recommended for immunocompromised patients at this time, and providers should make efforts to decrease vaccine hesitancy in this population through education and reassurance.

Purpose: Current evidence regarding efficacy and safety of human papillomavirus 9-valent (9vHPV), recombinant zoster (RZV), and CpG-adjuvanted recombinant hepatitis B (HepB-CpG) vaccines in adults with human immunodeficiency virus, inflammatory bowel disease, solid organ transplant, and allogeneic hematopoietic stem cell transplant is reviewed. Summary: Patients immunocompromised due to underlying disease or treatment are at increased risk for infections; however, insufficient understanding of various vaccines’ efficacy, safety, indications, and contraindications in this population has led to suboptimal vaccination rates. The Infectious Disease Society of America (IDSA) published guidelines on vaccines in immunocompromised populations in 2013. Since then, several advances have been made including an expanded indication with 9vHPV for use in males and females 9 to 45 years old, and the introduction of new vaccines for herpes zoster (RZV) and hepatitis B (HepB-CpG). Pharmacists are instrumental to vaccination efforts and may benefit from a review of recent vaccine updates. Conclusion: The 9vHPV can be used in men and women ages 9 to 45 years old regardless of immune status. RZV safety and efficacy in several immunocompromised populations has been demonstrated; however, manufacturers and major societies have yet to update their recommendations. HepB-CpG may be used in most immunocompromised patients yet remains under-utilized.

INTRODUCTION: To characterize the clinical pharmacists' impact on caring for patients with inflammatory bowel disease during COVID-19. METHODS: A clinical pharmacist's encounters between March 17 and April 14, 2020, were audited to determine encounter frequency and indication. RESULTS: The clinical pharmacist addressed COVID-19 and inflammatory bowel disease treatment concerns with 140 patients, conducted 34 medication education and monitoring visits, reviewed 141 patients' charts and helped rescheduled 18 patients who missed their biologic infusion, transitioned 12 patients to home infusions, and assisted 5 patients with medication access. DISCUSSION: Clinical pharmacists embedded in gastroenterology practices permit for continued optimal patient care during a pandemic.