Regueiro, Miguel

Abstract Background Upadacitinib (UPA) is an oral Janus kinase inhibitor approved for the treatment of moderately to severely active Crohn’s disease (CD).1 The U-ENDURE (NCT03345823) maintenance study and long-term extension (LTE) evaluate the long-term efficacy and safety of UPA maintenance therapy. Here, we report the results of the U-ENDURE LTE. Methods Patients (pts) completing the U-ENDURE 52-week (wk) maintenance study were eligible to participate in the LTE and continue their previously assigned treatment (placebo [PBO], UPA 15 mg [UPA15] once daily [QD], or UPA 30 mg [UPA30] QD; blinded until the last pt completed maintenance wk52). Clinical response, clinical remission, endoscopic response, endoscopic remission, as well as high-sensitivity C-reactive protein (hs-CRP) and faecal calprotectin (FCP) were evaluated as-observed up to wk48 of the LTE among pts (PBO [N = 89], UPA15 [N = 107], UPA30 [N = 173]); excluding pts who received open-label UPA30 rescue therapy. Safety was assessed in all pts (PBO [N = 223], UPA15 [N = 221], UPA30 [N = 229]) from wk0 of the maintenance study up to LTE wk204 (cut-off date: 01 Aug 2023). Results At LTE wk0, the SF/APS clinical remission rates were 73.0%, 78.3%, and 80.3% for PBO, UPA15, and UPA30, respectively (Figure 1A). Similar rates were reported at LTE wk0 for CDAI clinical remission (PBO 75.3%, UPA15 81.3%, UPA30 80.9%; Figure 1B) and clinical response (CR-100: PBO 79.5%, UPA15 84.9%, UPA30 84.4%). Rates of clinical remission were stable through wk48 of the LTE. Endoscopic response (PBO 32.9%, UPA15 59.6%, UPA30 66.5%) and remission rates (PBO 27.8%, UPA15 42.4%, UPA30 47.3%) at LTE wk0 were sustained through wk48 with UPA while decreased with PBO (Figure 1C-D). At LTE wk0, the mean [95% CI] change from induction BL in hs-CRP was 1.8 [–0.4, 4.1], –13.2 [–17.9, –8.6], and –12.8 [–16.8, –8.9] for PBO, UPA15, and UPA30, respectively; sustained through wk48. Similar results were observed with FCP (mean [95% CI] change from induction BL: PBO 126 [–103, 356], UPA15 –2946 [–4121, –1772], UPA30 –1871 [–2577, –1165]). Severe adverse events (AEs) and serious AEs were lower with UPA treatment compared with PBO (Table 1). The rates of most AEs of special interest were similar between UPA and PBO; however, numerically higher rates of herpes zoster, adjudicated gastrointestinal perforations, neutropenia, lymphopenia, creatine phosphokinase elevation, and hepatic disorders were reported in pts treated with UPA vs PBO (Table 1). Conclusion In pts completing wk48 of the LTE, sustained efficacy was observed in clinical and endoscopic endpoints with over 2 years of UPA treatment, while maintaining an overall positive safety profile in pts with CD. Reference: 1. Loftus EV Jr, et al. N Engl J Med. 2023;388:1966–80

LINKED CONTENTThis article is linked to Kochhar et al papers. To view these articles, visit https://doi.org/10.1111/apt.17570 and https://doi.org/10.1111/apt.17697

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.

Abstract Background Inflammatory bowel disease (IBD) treatment targets include mucosal healing based on standardized endoscopic scoring systems. The rates and ease of use of these scoring systems in practice have not been well described. We aimed to assess the rates and factors associated with the use of IBD endoscopic scoring systems in practice from IBD LIVE attendees. Methods IBD Live is an international case-based conference focusing on the management of patients with IBD. We created a web-based survey consisting of 38 questions on the frequency and ease of use of various IBD endoscopic scores. This survey was emailed to the IBD Live listserv in March 2022 with a second email sent 14 days later. We included only respondents who are currently performing endoscopy. Continuous variables were analyzed using an unpaired student’s t-test. Categorical variables were analyzed using Pearson’s chi-square test. Results There were 65 responses out of 170 (38.2% response rate) regular attendees. Eleven responses were excluded (4 with no response on the use of endoscopy scores, and 7 were not performing endoscopy). Of the respondents, 72.2% are from the United States, 70.4% are adult gastroenterologists, 53.9% in academic practice, and 40.7% in practice for ≥15 years. Of the endoscopy scores used ≥50% of the time, 74.1% were using the Mayo Endoscopic Subscore (MES), 72.3% using the Rutgeerts Score, 61.2% using the Simple Endoscopic Score for Crohn’s Disease, and 28.6% using the Pouchitis Disease Activity Index. Attending IBD LIVE ≥ monthly (P = .028), attending an IBD conference at least every 2 years (P = .020), and having the scoring system incorporated into the endoscopy documentation software (P = .002) were associated with more consistent use of the MES. Attending IBD Live at least monthly (P = .026), having an IBD volume of ≥50% (P = .011), and attending an IBD conference at least every 2 years (P = .004) was associated with more frequent use of the Rutgeerts score. There were no factors that increased the use of other endoscopic scores. Conclusions The MES and the Rutgeerts score are more commonly used with much lower rates of use of endoscopic scores for Crohn’s disease and pouchitis. The use of these endoscopy scores is more common among those who regularly attend IBD conferences, have higher volume IBD practices, and have these scoring systems incorporated into endoscopy software. Further evaluation of barriers to use and ways to improve utilization of endoscopic scoring for Crohn’s disease and pouchitis is needed.