Infusing biologic agents, such as infliximab and vedolizumab, for the treatment of IBD in a patient's home is becoming increasingly common. Smaller studies have raised concern about the safety of infusing biologic agents at home. However, the large-scale national experience with safety of home infusions has not been reported. Additionally, the patient experience with home infusions is unknown. Therefore, we conducted a mixed-methods study to better understand home infusions of infliximab and vedolizumab for patients with IBD.

Researchers included nearly 1500 women with Crohn's disease and ulcerative colitis who became pregnant. To better understand pregnancy outcomes, those on medications like biologics were compared to those not on these medications. Children were followed for the first year of life.

Importantly, being on biologics and thiopurine medications did not increase any pregnancy or neonatal complications. In fact, higher disease activity of IBD was associated with complications like miscarriage and preterm birth. Researchers concluded that medications should be continued throughout pregnancy to control IBD symptoms and reduce pregnancy-related complications.

We studied whether patients starting Entyvio® (vedolizumab), who had previously used an anti-TNF biologic, such as Remicade® (infliximab) or Humira® (adalimumab), responded differently than people who had not used one of these therapies. We studied 380 patients with Crohn's disease and ulcerative colitis in the IBD Partners cohort who were starting vedolizumab. We found that patients who had not previously used an anti-TNF biologic had higher remission rates and improved quality of life.

CCFA Partners has been successful for survey-based research for many years. The purpose of this study was to determine whether or not it would be feasible to use the CCFA Partners Internet-based platform to collect biologic or biospecimen data such as saliva, blood and stool samples. We found that nearly 40% of participants contributed saliva and about 25% contributed blood samples. The majority of participants who contributed saliva or blood also sent a stool sample. All samples provided sufficient quantity and quality of material for genetic testing. Saliva and blood samples were genotyped for common mutations ("single nucleotide polymorphisms") known to be associated with inflammatory bowel disease. Stool samples were analyzed for bacterial content, which may be related to inflammatory bowel disease. Overall, this study supports that it is feasible to collect biospecimens using an Internet-based platform and will be successful on a larger scale to be used for many different types of research.

Variation in care of patients with Crohn's disease (CD) and ulcerative colitis (UC) has been used as a marker for quality differences. We studied whether important aspects of IBD patients' care in CCFA Partners varied based on where their GI doctor was in practice. We compared patients who saw an academic (university) GI physician, a private practice GI physician, or other GI physician (such as a Veteran's Affairs physician). The study included about 12,000 IBD patients. Almost 95% reported visiting a GI provider at least once a year: about 74% saw a private practice physician, 15% academic, and 11% other. Those patients with CD seen by academic physicians were younger, has completed higher education, used less mesalamine medications, and used more biologics and immunomodulators. They were more likely to be in remission, were more likely to get a flu shot, smoked less, and were less likely to be on steroids when compared to private or other physicians. Patients with UC seen by academic providers were younger, had more hospitalizations and surgery, with greater biologic and immunomodulator use. There was no difference in steroid use, and no differences in any of the other measures like remission rates, flu shot, quality of life. In summary, there was much more variation in CD care as compared to UC care, with improved outcomes for CD patients seen by academic providers. Studying why this is the case, could help us to improve the quality of care delivered to all IBD patients.

A biobank is a collection of samples from patients (including spit, stool or blood). Biobanks are very important for understanding risk factors for developing disease or for severity of disease. We wanted to understand more about why patients with inflammatory bowel disease (IBD) would or would not participate in a biobank. We first did a series of interviews over the phone with patients who were participating in the CCFA Partners study. This helped us to understand the important concerns about biobanks and develop a survey for use in CCFA Partners. We then sent a survey to over 800 people with IBD in CCFA Partners. We did a total of 26 phone interviews. Patients doing the interviews told us that they had concerns about how samples would be collected/stored; who would be allowed access; whether these samples would be used for other things (not only research); and whether this would affect whether they could get life insurance. Most people were not that worried about using the blood for genetic studies. People thought that that biobanks were important for research, that they might lead to a cure; that by donating they would be helping others or family members with IBD; and hoped that they might personally benefit, although most understood that they likely would not. These themes aided in the development of a survey instrument to assess perceptions of biobanking. A total of 476 people initially finished the survey. Almost 40% said that they would 'definitely yes' donate samples, 56.0% would 'probably yes' donate, 5.1% 'probably no' and 0.7% 'definitely no'. There were no factors that made someone more likely to donate (reported donation rates were not different for Crohn's disease (CD) versus ulcerative colitis (UC), remission versus active disease, or education level. People were most willing to donate spit, followed by blood and lastly stool. Knowing these important thoughts on sample donation/biobanks will help researchers to develop consents for IBD biobanks and design educational materials on biobanks for IBD A biobank is a collection of biological samples, such as saliva, blood, and stool, from individuals with a common condition such as inflammatory bowel disease (IBD). Biobanks are important for understanding risk factors for developing disease or for severity of disease. We wanted to learn more about IBD patients' understanding of and willingness to participate in a biobank. We first did 26 phone interviews with patient volunteers participating in the CCFA Partners study. Those interviews helped us better understand concerns related to biobanks. Patients doing the interviews told us that they had concerns about how samples would be collected/stored, who would be allowed access, whether these samples would be used for anything other than research, and whether participation in a biobank would affect life insurance eligibility. Most patients were not that worried about using blood for genetic studies. Participants thought biobanks were important for research, that they might lead to a cure, that by donating they would be helping others or family members with IBD, and hoped that they might personally benefit. These results from the phone interviews were used to develop an online survey instrument to assess perceptions of biobanking. In a larger sample, a total of 1,007 people with IBD completed the online survey. Almost 40% said they would 'definitely' donate samples, 56.4% would ‘probably’ donate, 3.6% ‘probably not’, and 0.6% 'definitely not'. There were no differences in willingness to donate specimens based on disease type (Crohn's vs. ulcerative colitis) or on disease activity (in remission vs. currently active disease). People were most willing to donate saliva specimens, followed by blood and lastly stool samples. Knowing these important attitudes and beliefs about sample donations and biobanks will help researchers develop consents and educational materials related to biobanks that will encourage wider involvement.

Patients with celiac disease (an autoimmune disorder where eating gluten can damage the small intestine) benefit from a gluten free diet (GFD). Few data are available to tell us if patients with inflammatory bowel diseases (IBD) may also benefit from this diet. Individuals with GI symptoms such as bloating, abdominal pain, diarrhea, fatigue and nausea can have non-celiac gluten sensitivity, for which a GFD can be beneficial. Non-celiac gluten sensitivity can also co-exist with IBD. We therefore asked patients enrolled in CCFA Partners whether they have ever tried a gluten free diet (GFD), whether they followed this diet closely, and whether it helped with any symptoms. A total of 1647 people took the survey on GFD. A total of 314 (19.1%) reported that they had ever tried a GFD and 135 (8.1%) were currently following the diet. Overall, 206/314 (65.6%) trying a GFD reported improvement in any GI symptom while on this diet. Over a 1/3 of people (38.3%) felt that they experienced fewer or less severe flares while on the diet. Improvements in clinical symptoms were reported for bloating (56.5%), diarrhea (42.6%), abdominal pain (41.5%), fatigue (27.5%), and nausea (26.3%) while on a GFD. Fatigue was significantly improved with excellent adherence to the diet. Because many patients had improved symptoms on the GFD, it is possible that patients with IBD could suffer from non-celiac gluten sensitivity. Fewer people who felt better on a GFD were taking biologics medications, suggesting that flare symptoms in those with more severe disease may not respond to a GFD. Future studies are needed to understand the benefits of this diet in IBD patients, and the mechanism of improvement with this dietary intervention.

After the successful launch of CCFA Partners for adult patients with inflammatory bowel disease, the kids and teens component (CCFA Partners Kids & Teens) started in 2013. In partnership with the Crohn's and Colitis Foundation of America (CCFA), children <18 years of age were asked to join the internet-based study through email invitations and promotion on social media sites. After informed consent, the children and their parents completed surveys asking questions about their disease, their medications and other patient reported outcomes (such as quality of life, fatigue, sleep, peer relations, mood, etc). In the first month, 419 children joined. The average age was 13, with about 1/2 being female and about 3/4 having Crohn's disease (CD). Common medications used by patients with CD were biologics, thiopurines (6mp or azathioprine) or mesalamine-based medications (Pentasa, Lialda, Apriso, etc). The most common medication for patients with ulcerative colitis (UC) was mesalamine-based medications. Most of the CD patients were in remission and most UC patients had mild disease. Children who had active disease had more depression and anxiety. Following this group of children over time will help us to learn a great deal about living with IBD as a child, and will allow us to follow these children into adulthood to learn even more about the disease itself, the impact of medications, and how symptoms change over time.