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BACKGROUND & AIMS: Management of inflammatory bowel diseases (IBD) is complex and variation in care has been well-documented. However, the drivers of practice variation remain unexplored. We examined variation based on the treating gastroenterologist's IBD focus (proportion of outpatient visits for IBD). METHODS: We conducted a retrospective cohort of newly diagnosed patients with IBD using data from Optum's deidentified Clinformatics Data Mart Database (2000-2020). The exposure variable was whether the treating gastroenterologist had an IBD focus (>90th percentile of IBD visits/total outpatient visits). We used adjusted regression models to evaluate associations between provider IBD focus and process measures (use of mesalamine, corticosteroid, biologic, and narcotic medications and endoscopic or radiographic imaging) and clinical outcomes (time to IBD-related hospitalization and bowel resection surgery). We tested for change in treatment patterns over time by including an interaction term for study era (2004-2012 vs 2013-2020). RESULTS: The study included 772 children treated by 493 providers and 2864 adults treated by 2076 providers. In children, none of the associations between provider focus and process or outcome measures were significant. In adults, care from an IBD-focused provider was associated with more use of biologics, combination therapy, and imaging and endoscopy, and less mesalamine use for Crohn's disease (P < .05 for all comparisons) but not with other process measures. Biologics were prescribed more frequently and narcotics less frequently during the later era (P < .05 for both). Hospitalization and surgery rates were not associated with IBD focus or era. CONCLUSIONS: IBD care for adults varies by provider specialization. Given the evolving complexity, novel methods may be needed to standardize care.
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Adolescents with inflammatory bowel disease (IBD) are at an increased risk of anxiety and depression compared to peers, but availability of mental health services in IBD clinics does not meet patients' needs, and use of primary care services for mental health screening and care is low. This study provides qualitative data regarding adolescent and caregiver perspectives on addressing mental health in IBD. Interviews were conducted with adolescents with IBD and caregivers of adolescents with IBD. Interview transcripts were coded and analyzed for prominent themes. Thirteen adolescents and fourteen caregivers were interviewed. Three primary themes emerged: mental health stigma makes discussing it more difficult, physician-adolescent trust makes conversations about mental health easier, and asking about mental health directly can help adolescents feel comfortable. Adolescents and caregivers highlighted the importance of considering each patient and their family individually when choosing how to discuss mental health. Fostering trust with adolescents with IBD is vital to addressing mental health. While encouraging standardized screening is important, the most patient-centered approach to mental health involves considering families individually to identify and address mental health challenges. Given the increased risk of anxiety and depression in pediatric patients with IBD, all providers encountering these patients should be equipped to discuss mental health non-judgmentally.
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INTRODUCTION: Obesity is common among patients with pediatric Crohn's disease (PCD). Some adult studies suggest obese patients respond less well to anti-tumor necrosis factor (TNF) treatment. This study sought compares anti-TNF response and anti-TNF levels between pediatric patients with normal and high body mass index (BMI). METHODS: The COMBINE trial compared anti-TNF monotherapy with combination therapy with methotrexate in patients with PCD. In this secondary analysis, a comparison of time-to-treatment failure among patients with normal BMI vs BMI Z -score >1, adjusting for prescribed anti-TNF (infliximab [IFX] or adalimumab [ADA]), trial treatment assignment (combination vs monotherapy), and relevant covariates. Median anti-TNF levels across BMI category was also examined. RESULTS: Of 224 participants (162 IFX initiators and 62 ADA initiators), 111 (81%) had a normal BMI and 43 (19%) had a high BMI. High BMI was associated with treatment failure among ADA initiators (7/10 [70%] vs 12/52 [23%], hazard ratio 0.29, P = 0.007) but not IFX initiators. In addition, ADA-treated patients with a high BMI had lower ADA levels compared with those with normal BMI (median 5.8 vs 12.8 µg/mL, P = 0.02). IFX trough levels did not differ between BMI groups. DISCUSSION: Overweight and obese patients with PCD are more likely to experience ADA treatment failure than those with normal BMI. Higher BMI was associated with lower drug trough levels. Standard ADA dosing may be insufficient for overweight children with PCD. Among IFX initiators, there was no observed difference in clinical outcomes or drug levels, perhaps due to weight-based dosing and/or greater use of proactive drug monitoring.
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Adalimumab , Índice de Masa Corporal , Enfermedad de Crohn , Quimioterapia Combinada , Infliximab , Metotrexato , Factor de Necrosis Tumoral alfa , Humanos , Enfermedad de Crohn/tratamiento farmacológico , Masculino , Femenino , Infliximab/uso terapéutico , Adalimumab/uso terapéutico , Niño , Adolescente , Metotrexato/uso terapéutico , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Insuficiencia del Tratamiento , Fármacos Gastrointestinales/uso terapéutico , Obesidad Infantil/complicaciones , Obesidad Infantil/tratamiento farmacológicoRESUMEN
Children with very early onset inflammatory bowel disease (VEO-IBD) may respond differently to coronavirus disease 2019 (COVID-19) immunization compared to healthy children or other patients with IBD. We recruited children with VEO-IBD <6 years of age and younger following receipt of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine. Demographics, IBD characteristics, medication use, adverse events (AEs) and IBD exacerbations were collected. Blood draws (optional) were obtained for measurement of antireceptor binding domain (RBD) IgG antibodies following vaccination. Of 41 participants, none required emergency department visit or hospitalization due to AE, and only one experienced IBD exacerbation. Detectable antibody was present in 19/19 participants who provided blood sample; 6/7 participants (86%) had durable humoral response 12 months postvaccination. Children with VEO-IBD experience robust humoral immune response to COVID-19 immunization. Severe AEs were rare. These findings provide reassurance that children with VEO-IBD respond well and safely to SARS-CoV-2 vaccination.
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COVID-19 , Enfermedades Inflamatorias del Intestino , Niño , Humanos , Inmunidad Humoral , Vacunas contra la COVID-19/efectos adversos , SARS-CoV-2 , COVID-19/prevención & control , Vacunación/efectos adversos , Inmunoglobulina G , Anticuerpos AntiviralesRESUMEN
Introduction: Disparities in the recruitment of minority populations in research are well-documented. However, the degree of participation and retention of minorities following enrollment is less known, particularly in decentralized studies. Although decentralized clinical research methods may allow researchers to engage broader study populations with less participation burden, they may present different retention challenges. To evaluate racial and ethnic differences in the degree of participation after enrollment in a decentralized study, we analyzed data from a cohort of patients with inflammatory bowel diseases following COVID-19 immunization. Methods: We compared by race and ethnicity the following post-enrollment participation metrics: response to > 50% of follow-up surveys, donation of a blood sample for antibody testing, consent to use of bio samples for future research, and withdrawal prior to study completion. Results: Overall, we observed higher levels of post-enrollment study participation among non-Hispanic White (NHW) participants as compared to Black or Hispanic participants: 95% of NHW participants completed follow-up versus 87% of Black participants and 91% of Hispanic participants, 73% of NHW participants provided bio samples versus 64% Black participants and 67% Hispanic participants, and 65% of NHW participants provided consent for future research versus 62% of Black participants and 52% of Hispanic participants. Conclusions: Our findings demonstrate that the degree of study participation after enrollment in this decentralized study differed by race and ethnicity, indicating that attention to diversity, equity, and inclusion is needed not only in clinical research recruitment but also throughout study administration.
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BACKGROUND AND AIMS: COVID-19 vaccination prevents severe disease in most patients with inflammatory bowel disease (IBD), but immunosuppressive medications can blunt serologic response. We followed adults with IBD for >1 year post-COVID-19 vaccination to describe factors associated with SARS-CoV-2 infection after vaccination, evaluate for a protective SARS-CoV-2 antibody level, characterize SARS-CoV-2 antibody persistence, and identify factors associated with humoral immune response durability. METHODS: Using a prospective cohort of COVID-19 immunized adults with IBD, we analyzed factors associated with SARS-CoV-2 infection after vaccination. We evaluated for an association between SARS-CoV-2 antibody level 12 weeks postvaccination and subsequent SARS-CoV-2 infection and assessed for a threshold of protection using receiver-operating characteristic curve analysis. We then conducted a separate analysis evaluating factors associated with persistence of SARS-CoV-2 antibodies 52 weeks postimmunization. RESULTS: Almost half (43%) of 1869 participants developed COVID-19 after vaccination, but most infections were mild, and <1% required hospitalization. Older age and corticosteroid use were associated with a decreased risk of SARS-CoV-2 infection postvaccination (50-59 years of age vs 18-29 years of age: adjusted hazard ratio, 0.57; 95% confidence interval, 0.44-0.74; steroid users vs nonusers: adjusted hazard ratio, 0.58; 95% confidence interval, 0.39-0.87). Most (98%) participants had detectable antibody levels at 52 weeks postvaccination. Antibody levels at 12 weeks and number of vaccine doses were positively associated with higher antibody levels at 52 weeks, while anti-tumor necrosis factor α therapy was negatively associated. CONCLUSIONS: COVID-19 vaccination generates an effective and durable protective response for the vast majority of adults with IBD, including vulnerable populations such as corticosteroid users and older individuals. Patients with IBD benefit from COVID-19 booster vaccination.
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Anticuerpos Antivirales , Vacunas contra la COVID-19 , COVID-19 , Enfermedades Inflamatorias del Intestino , SARS-CoV-2 , Humanos , COVID-19/prevención & control , COVID-19/inmunología , Masculino , Femenino , Persona de Mediana Edad , Enfermedades Inflamatorias del Intestino/inmunología , Adulto , Vacunas contra la COVID-19/administración & dosificación , Vacunas contra la COVID-19/inmunología , Estudios Prospectivos , Anticuerpos Antivirales/sangre , SARS-CoV-2/inmunología , Vacunación , Anciano , Adulto JovenRESUMEN
Background: Longitudinal research reveals a unidirectional relationship between a nonsomatic symptom of depression, a negative view of the self, and later reported Crohn's disease (CD) activity. We evaluated whether health behaviors mediated this association using a longitudinal design. Methods: We studied 3304 adult volunteers with a self-reported diagnosis of CD who completed a baseline survey that included demographics, CD activity, a symptom-specific index of depression, and measures of physical activity, smoking, and sleep quality. Crohn's disease status and the cognitive index of depression were also measured 6 and 12 months after the baseline evaluation. We specified single-mediator and multiple-mediator models to elucidate the depression-disease activity relationship. Results: Among 2395 females and 909 males, we found a significant mediation effect for activity level (P < .001) after adjusting for age, sex, and body mass index. There was no evidence that sleep quality and smoking are significant single mediators. When we considered multiple mediation models, smoking and less activity partially mediate the depression-CD association. Conclusions: Smoking and lower levels of physical activity are potential mediators of the unidirectional association between a nonsomatic symptom of depression-a negative view of the self-and patient-reported CD activity. Evaluating and treating specific symptoms of depression may reduce the frequency of CD exacerbations.
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BACKGROUND: Antitumor necrosis factor (anti-TNF) inhibitors are first-line treatment among patients with ulcerative colitis (UC). With time, patients tend to lose response or become intolerant, necessitating switching to small cell biologics such as tofacitinib or vedolizumab. In this real-world study of a large, geographically diverse US population of TNF-experienced patients with UC, we evaluated the effectiveness and safety of newly initiating treatment with tofacitinib vs vedolizumab. METHODS: We conducted a cohort study using secondary data from a large US insurer (Anthem, Inc.). Our cohort included patients with UC newly initiating treatment with tofacitinib or vedolizumab. Patients were required to have evidence of treatment with anti-TNF inhibitors in the 6 months prior to cohort entry. The primary outcome was treatment persistence >52 weeks. Additionally, we evaluated the following secondary outcomes as additional measures of effectiveness and safety: (1) all-cause hospitalization; (2) total abdominal colectomy; (3) hospitalization for infection; (4) hospitalization for malignancy; (5) hospitalization for cardiac events; and (6) hospitalization for thromboembolic events. We used fine stratification by propensity scores to control for confounding by demographics, clinical factors, and treatment history at baseline. RESULTS: Our primary cohort included 168 new users of tofacitinib and 568 new users of vedolizumab. Tofacitinib was associated with lower treatment persistence (adjusted risked ratio, 0.77; 95% CI, 0.60 -0.99). Differences in secondary measures of effectiveness or safety between tofacitinib initiators vs vedolizumab initiators were not statistically significant (all-cause hospitalization, adjusted hazard ratio, 1.23; 95% CI, 0.83-1.84; total abdominal colectomy, adjusted HR, 1.79; 95% CI, 0.93-3.44;and hospitalization for any infection, adjusted HR, 1.94; 95% CI, 0.83-4.52). DISCUSSION: Ulcerative colitis patients with prior anti-TNF experience initiating tofacitinib demonstrated lower treatment persistence compared with those initiating vedolizumab. This finding is in contrast to other recent studies suggesting superior effectiveness of tofacitinib. Ultimately, head-to-head randomized, controlled trials that focus on directly measured end points may be needed to best inform clinical practice.
Anti-TNF-experienced patients with UC initiating vedolizumab demonstrated higher treatment persistence compared with those initiating tofacitinib in this real-world evaluation of comparative effectiveness. Ultimately, head-to-head randomized trials that focus on directly measured end points are needed to best inform clinical practice.
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Anticuerpos Monoclonales Humanizados , Colitis Ulcerosa , Piperidinas , Pirimidinas , Humanos , Estudios de Cohortes , Colitis Ulcerosa/patología , Resultado del Tratamiento , Inhibidores del Factor de Necrosis Tumoral/uso terapéuticoRESUMEN
BACKGROUND AND AIMS: There is a paucity of validated measures to evaluate how patients feel and function after restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) for ulcerative colitis. We performed a systematic review to evaluate all published patient reported outcomes (PROs) to assess symptom burden, functional status, and quality of life (QoL) after IPAA. METHODS: An electronic literature search on PubMed, Embase, and Web of Science was performed from inception through October 12, 2021. Eligible full texts were further characterized by the type of assessment as well as the individual domains assessed by questions in the PRO measure. RESULTS: Among the 129 full texts analyzed, 51 specific PRO measures were utilized. In the evaluation of all PRO measures, 46% included an assessment of disease-specific QoL with 27% evaluating more general QoL, and 15% assessing symptoms related to pouch function. Among the studies using disease-specific instruments, the Cleveland Clinic Global Quality of Life (42%) and the Inflammatory Bowel Disease Questionnaire (21%) were the most commonly used PRO measures. PRO questions were mapped to individual domains using binning methodology, with the greatest number of questions from individual PRO measures mapped to the bowel function domain (122). CONCLUSION: In our assessment of PRO measures among patients after IPAA, the studies and individual measures varied widely in both the patient populations being evaluated as well as outcomes and specific domains being assessed. A valid measure that assesses the range of outcomes after IPAA could standardize assessment and advance the study of patients after IPAA.
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BACKGROUND: Patient-reported outcomes (PRO) measures relevant to domains most important to patients with HCC who received locoregional therapies are needed to advance patient-centered research. Furthermore, electronic PRO monitoring in clinical care has been shown to reduce hospitalizations and deaths in patients with other cancers. We conducted a qualitative study among patients with HCC who recently received locoregional therapies to (1) identify common and distressing posttreatment symptoms to prioritize PRO domain selection and (2) gauge interest in an electronic PRO symptom monitoring system. METHODS: We performed semi-structured telephone interviews among adult patients who received locoregional therapies (median of 26 days after treatment) for treatment-naïve HCC at a single tertiary care center. Interviews were conducted until thematic saturation was reached. Qualitative content analysis was conducted to identify emerging themes and sub-themes. RESULTS: Ten of 26 patients (38%) reported at least 1 symptom before treatment. In contrast, all participants (n = 26) with recently treated HCC reported at least 1 posttreatment physical symptom, with the most common being appetite loss (73%), fatigue (58%), abdominal pain (46%), and nausea (35%). Most participants (77%) stated they saw potential benefits in posttreatment ePRO symptom monitoring. CONCLUSIONS: Posttreatment symptoms after HCC locoregional therapies are common and often severe. These data can inform and prioritize PRO domain selection. Patients are interested in ePRO monitoring to monitor and proactively address posttreatment symptoms. Given the clinical benefits in patients with metastatic cancers, ePRO monitoring warrants investigation in patients with HCC.
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Carcinoma Hepatocelular , Neoplasias Hepáticas , Adulto , Humanos , Carcinoma Hepatocelular/terapia , Neoplasias Hepáticas/terapia , Investigación Cualitativa , Medición de Resultados Informados por el PacienteRESUMEN
Background Hypertension and diabetes are associated with increased COVID-19 severity. The association between level of control of these conditions and COVID-19 severity is less well understood. Methods and Results This retrospective cohort study identified adults with COVID-19, March 2020 to February 2022, in 43 US health systems in the National Patient-Centered Clinical Research Network. Hypertension control was categorized as blood pressure (BP) <130/80, 130 to 139/80 to 89, 140 to 159/90 to 99, or ≥160/100 mm Hg, and diabetes control as glycated hemoglobin <7%, 7% to <9%, ≥9%. Adjusted, pooled logistic regression assessed associations between hypertension and diabetes control and severe COVID-19 outcomes. Among 1 494 837 adults with COVID-19, 43% had hypertension and 12% had diabetes. Among patients with hypertension, the highest baseline BP was associated with greater odds of hospitalization (adjusted odds ratio [aOR], 1.30 [95% CI, 1.23-1.37] for BP ≥160/100 versus BP <130/80), critical care (aOR, 1.30 [95% CI, 1.21-1.40]), and mechanical ventilation (aOR, 1.32 [95% CI, 1.17-1.50]) but not mortality (aOR, 1.08 [95% CI, 0.98-1.12]). Among patients with diabetes, the highest glycated hemoglobin was associated with greater odds of hospitalization (aOR, 1.61 [95% CI, 1.47-1.76] for glycated hemoglobin ≥9% versus <7%), critical care (aOR, 1.42 [95% CI, 1.31-1.54]), mechanical ventilation (aOR, 1.12 [95% CI, 1.02-1.23]), and mortality (aOR, 1.18 [95% CI, 1.09-1.27]). Black and Hispanic adults were more likely than White adults to experience severe COVID-19 outcomes, independent of comorbidity score and control of hypertension or diabetes. Conclusions Among 1.5 million patients with COVID-19, higher BP and glycated hemoglobin were associated with more severe COVID-19 outcomes. Findings suggest that adults with poorest control of hypertension or diabetes might benefit from efforts to prevent and initiate early treatment of COVID-19.
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COVID-19 , Diabetes Mellitus , Hipertensión , Adulto , Humanos , Estados Unidos , COVID-19/complicaciones , Estudios Retrospectivos , Hemoglobina Glucada , Hipertensión/tratamiento farmacológico , Atención Dirigida al PacienteRESUMEN
OBJECTIVE: To evaluate the relative prevalence of 8 rheumatic and musculoskeletal diseases (RMDs) across racial and ethnic groups within the National Patient-Centered Clinical Research Network (PCORnet). METHODS: Electronic health records from participating PCORnet institutions and systems from January 1, 2013, to December 31, 2018, were used to identify adult patients with ≥ 2 diagnosis codes for rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), osteoporosis (OP), granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA), eosinophilic granulomatosis with polyangiitis (EGPA), giant cell arteritis (GCA), and Takayasu arteritis (TAK). Among those with race and ethnicity data available, we compared prevalence of RMDs by race and ethnicity. RESULTS: Data from 28,059,546 patients were available for analysis. RA was more common in patients who were American Indian or Alaska Native vs White, with a prevalence of 11.57 vs 10.11/1000 (odds ratio [OR] 1.15, 95% CI 1.09-1.22). SLE was more common in patients who were Black or African American (6.73/1000), American Indian or Alaska Native (3.82/1000), and Asian (3.39/1000) vs White (2.80/1000; OR 2.43, 95% CI 2.39-2.46; OR 1.39, 95% CI 1.25-1.53; OR 1.26, 95% CI 1.21-1.31, respectively). SLE was more common in patients who were Hispanic vs non-Hispanic (prevalence 3.93 vs 3.45/1000, OR 1.14, 95% CI 1.12-1.16). TAK was more common in patients who were Asian vs White (prevalence 0.05 vs 0.04/1000, OR 1.43, 95% CI 1.00-2.03). OP, RA, and the vasculitides were all more common in patients who were White vs Black or African American. CONCLUSION: These data provide important information on the prevalence of RMDs by race and ethnicity in the United States. PCORnet can be used as a reliable data source to study RMDs within a large representative population.
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Artritis Reumatoide , Síndrome de Churg-Strauss , Granulomatosis con Poliangitis , Lupus Eritematoso Sistémico , Adulto , Humanos , Estados Unidos/epidemiología , Lupus Eritematoso Sistémico/diagnóstico , Artritis Reumatoide/epidemiología , Atención Dirigida al PacienteRESUMEN
BACKGROUND AND AIMS: Immunosuppressed individuals are at higher risk for COVID-19 complications, yet data in patients with inflammatory bowel disease (IBD) are limited. We evaluated the risk of COVID-19- severe sequelae by medication utilization in a large cohort of patients with IBD. METHODS: We conducted a retrospective cohort study utilizing insurance claims data between August 31, 2019, and August 31, 2021.We included IBD patients identified by diagnosis and treatment codes. Use of IBD medications was defined in the 90 days prior to cohort entry. Study outcomes included COVID-19 hospitalization, mechanical ventilation, and inpatient death. Patients were followed until the outcome of interest, outpatient death, disenrollment, or end of study period. Due to the aggregate nature of available data, we were unable to perform multivariate analyses. RESULTS: We included 102â 986 patients (48â 728 CD, 47â 592 UC) with a mean age of 53 years; 55% were female. Overall, 412 (0.4%) patients were hospitalized with COVID-19. The incidence of hospitalization was higher in those on corticosteroids (0.6% vs 0.3%; Pâ <â .0001; 13.6 per 1000 person-years; 95% confidence interval [CI], 10.8-16.9) and lower in those receiving anti-tumor necrosis factor α therapy (0.2% vs 0.5%; Pâ <â .0001; 3.9 per 1000 person-years; 95% CI, 2.7-5.4). Older age was associated with increased hospitalization with COVID-19. Overall, 71 (0.07%) patients required mechanical ventilation and 52 (0.05%) died at the hospital with COVID-19. The proportion requiring mechanical ventilation (1.9% vs 0.05%; Pâ <â .0001; 3.9 per 1000 person-years; 95% CI, 2.5-5.9) was higher among users of corticosteroids. CONCLUSIONS: Among patients with IBD, those on corticosteroids had more hospitalizations and mechanical ventilation with COVID-19. Anti-tumor necrosis factor α therapy was associated with a decreased risk of hospitalization. These findings reinforce previous guidance to taper and/or discontinue corticosteroids in IBD.
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Background: The most reliable and meaningful approach for inclusion of patient-reported outcomes (PROs) in the evaluation of real-world clinical effectiveness of biologics in the treatment of autoimmune diseases is u ncertain. This study aimed to assess and compare the proportions of patients who had abnormalities in PROs measuring important general health domains at the initiation of treatment with biologics, as well as the effects of baseline abnormalities on subsequent improvement. Methods: PROs were collected for patient participants with inflammatory arthritis, inflammatory bowel disease, and vasculitis using Patient-Reported Outcomes Measurement Information System instruments. Scores were reported as T-scores normalized to the general population in the United States. Baseline PROs scores were collected near the time of biologic initiation, and follow-up scores were collected 3 to 8 months later. In addition to summary statistics, the proportion of patients with PROs abnormalities (scores ≥5 units worse than the population norm) was determined. Baseline and follow-up scores were compared, and an improvement of ≥5 units was considered significant. Results: There was wide variation across autoimmune diseases in baseline PROs scores for all domains. For example, the proportion of participants with abnormal baseline pain interference scores ranged from 52% to 93%. When restricted to participants with baseline PROs abnormalities, the proportion of participants experiencing an improvement of ≥5 units was substantially higher. Conclusion: As expected, many patients experienced improvement in PROs following initiation of treatment with biologics for autoimmune diseases. Nevertheless, a substantial proportion of participants did not exhibit abnormalities in all PROs domains at baseline, and these participants appear less likely to experience improvement. For PROs to be reliably and meaningfully included in the evaluation of real-world medication effectiveness, more knowledge and careful consideration are needed to select the most appropriate patient populations and subgroups for inclusion and evaluation in studies measuring change in PROs.
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Background: Primary and secondary nonresponse to anti-tumor necrosis factor (TNF) therapy is common in patients with ulcerative colitis (UC), yet limited research has compared the effectiveness of subsequent biological therapy. Objective: We sought to compare the effectiveness of vedolizumab and tofacitinib in anti-TNF experienced patients with UC, focusing on patient-prioritized patient-reported outcomes (PROs). Methods: We conducted a prospective cohort study nested within the Crohn's & Colitis Foundation's IBD Partners and SPARC IBD initiatives. We identified anti-TNF experienced patients with UC initiating vedolizumab or tofacitinib and analyzed PROs reported approximately 6 months later (minimum 4 months, maximum 10 months). Co-primary outcomes were Patient Reported Outcome Measurement Information System (PROMIS) domains of Fatigue and Pain Interference. Secondary outcomes included PRO2, treatment persistence, and need for colectomy. Results: We compared 72 vedolizumab initiators and 33 tofacitinib initiators. At follow-up, Pain Interference (P = .04), but not Fatigue (P = .53) was lower among tofacitinib initiators. A trend toward higher Social Role Satisfaction was not significant. The remainder of secondary outcomes (PRO2, treatment persistence, colectomy) did not differ between treatment groups. Conclusions: Among anti-TNF experienced patients with UC, Pain Interference 4-10 months after treatment initiation was lower among tofacitinib users as compared with vedolizumab users. Many, but not all, secondary endpoints and subanalyses also favored tofacitinib. Future studies with larger sample sizes are needed to further evaluate these findings.
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INTRODUCTION: Patients with medically refractory ulcerative colitis who previously would have undergone surgery can now elect for subsequent medical therapy. METHODS: In a commercially insured population, we evaluated the proportion of patients initiating second-line, third-line, or fourth-line treatment who underwent colectomy in the following 12 months. RESULTS: Among 3,325 patients with ulcerative colitis, the colectomy rate within 12 months of a switch in therapy increased from 12% with the first switch to 17% and 19% with the second and third switches, respectively ( P < 0.001). DISCUSSION: Treatment effectiveness declines with successive switching; however, even after initiating fourth-line therapy, most patients remain surgery-free.
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Colitis Ulcerosa , Humanos , Colitis Ulcerosa/tratamiento farmacológico , Colitis Ulcerosa/cirugía , Colitis Ulcerosa/etiología , Estudios Retrospectivos , Colectomía/efectos adversos , Resultado del Tratamiento , InfliximabRESUMEN
BACKGROUND AND AIMS: The BNT162b2 and mRNA-1273 COVID-19 vaccines are efficacious in patients with inflammatory bowel disease; but there is a lack of data examining if holding immunosuppressive therapy around vaccination improves immune response. We studied the effect of holding IBD medications around the time of vaccination on antibody response and breakthrough COVID-19 infection. METHODS: Partnership to Report Effectiveness of Vaccination in populations Excluded from iNitial Trials of COVID is a prospective cohort of individuals with IBD receiving COVID-19 vaccination. Quantitative measurement of anti-receptor binding domain IgG antibodies to SARS-CoV-2 was performed 8 weeks after completing a vaccination series. RESULTS: A total of 1854 patients were included; 59% were on anti-tumour necrosis factor [TNF] [10% of these on combination therapy], 11% on vedolizumab, and 14% on ustekinumab; 11% of participants held therapy before or after vaccine administration for at least 2 weeks. Antibody levels were similar in participants continuing versus holding anti-TNF monotherapy before or after the second vaccine [BNT162b2: 10 µg/mL vs 8.9 µg/mL; mRNA-1273: 17.5 µg/mL vs 14.5 µg/mL]. Comparable results were seen in those on combination therapy. Antibody titres in those on ustekinumab or vedolizumab were higher compared with anti-TNF users, but there was no significant difference if the drug was held or continued [BNT162b2: 22.5 µg/mL vs 23 µg/mL; mRNA-1273: 88 µg/mL vs 51 µg/mL]. Holding therapy was not associated with decreased rate of COVID-19 infection compared with those not holding therapy [BNT162b2: 28% vs 29%; mRNA-1273: 19% vs 31%]. CONCLUSION: We recommend continuing IBD medications while receiving mRNA COVID-19 vaccination without interruption.
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COVID-19 , Enfermedades Inflamatorias del Intestino , Humanos , Inmunidad Humoral , COVID-19/prevención & control , Vacunas contra la COVID-19 , Vacuna BNT162 , Vacuna nCoV-2019 mRNA-1273 , Estudios Prospectivos , Inhibidores del Factor de Necrosis Tumoral , Ustekinumab , SARS-CoV-2 , Enfermedades Inflamatorias del Intestino/tratamiento farmacológico , Factor de Necrosis Tumoral alfa , Anticuerpos Antivirales , VacunaciónRESUMEN
Introduction: Computerized-adaptive testing (CAT) may increase reliability or reduce respondent burden for assessing patient-reported outcomes compared with static short forms (SFs). We compared CAT versus SF administration of the Patient-Reported Outcomes Measurement Information System® (PROMIS®) Pediatric measures in pediatric inflammatory bowel disease (IBD). Methods: Participants completed 4-item CAT, 5- or 6-item CAT, and 4-item SF versions of the PROMIS Pediatric measures. We compared average T-scores, intra-class correlations (ICCs), floor and ceiling effects, and standard error of measurement (SEM) across forms, along with mean effect sizes between active versus quiescent IBD disease activity groups. Results: Average PROMIS T-scores across forms were <3 points (minimally important difference) of each other. All forms correlated highly with each other (ICCs ≥0.90) and had similar ceiling effects, but the CAT-5/6 had lower floor effects. The CAT-5/6 had lower SEM than the CAT-4 and SF-4, and the CAT-4 had a lower SEM than the SF-4. Mean effect sizes were similar across forms when contrasting disease activity groups. Conclusions: The CAT and SF forms produced similar score results, but the CAT had better precision and lower floor effects. Researchers should consider PROMIS pediatric CAT if they anticipate that their sample will skew toward symptom extremes.