When IBD patients start taking a new medication, it can be hard to know if it will finally be the medication to help achieve remission, or if the side effects will impact sleep, social life, and ability to work. Over 400 IBD Partners participants took part in the COMPARE study to compare the effects of Entyvio vs. Stelara for Crohn's disease and Entyvio vs. Xeljanz for ulcerative colitis. Our patient partners identified fatigue and pain as outcomes of particular interest for this research to focus on.

For Crohn's disease, the study showed that there were no significant differences in the way Entyvio and Stelara affected patients' fatigue levels or the way pain impacted their lives. The results were similar for most other measures as well, although Stelara was associated with lower steroid use and more patients discontinued Entyvio.

For ulcerative colitis, study participants using Xeljanz experienced less pain as compared to participants using Entyvio. There were no significant differences in fatigue or other outcomes.

The results suggest that for both Crohn's disease and ulcerative colitis, patients generally function similarly with either medication. Patients and their physicians need to consider many factors that may influence which medication is right for them.

Full Published Manuscript for Crohn's Disease

Full Published Manuscript for Ulcerative Colitis

Post-traumatic stress (PTS) is a chronic psychological reaction to an event where the person experiences actual or perceived threat to life or bodily harm. PTS symptoms include nightmares, flashbacks, irritability or low mood, feeling keyed up or on edge, and avoiding situations that trigger trauma memories.

Before this study, only one study on PTS and IBD, with 140 patients, had been conducted in the US. In the previous study, a much higher than expected proportion of patients (32%) reported moderate to severe symptoms of PTS. Because of the nature of IBD and its treatment, researchers aimed to see if there was a similar proportion of PTS in a larger patient sample through IBD Partners and to see how PTS symptoms are related to patient outcomes.

Researchers measured PTS symptoms in a large study of 797 participants using a standard symptom questionnaire and collected other data from IBD Partners including IBD disease activity, hospitalizations, surgeries, and quality of life. Researchers then looked at relationships between PTS symptom severity and each of these important IBD metrics. As expected, PTS was associated with more severe IBD, increased hospitalizations and surgeries, and increased anxiety, depression, fatigue, and pain impact in daily life. Researchers also found women, and racial and ethnic minorities were disproportionally affected by PTS.

Inflammatory bowel diseases (IBD) affect 200-400 people per 100,000 in the United States, about half of whom are women. Our goal was to research how common it is for women with IBD to experience vulvovaginal symptoms. For this study, we recruited women more than 18 years old with IBD (1250) who agreed to complete an online survey that asks questions about the presence and severity of vulvar or vaginal itch, burn, or irritation, vaginal discharge or dryness, and vulvovaginal pain. The survey collected information on background information and a history of their IBD activity history. Women with and withou t symptoms were compared for analyses. For the results, we found a total of 512 women reported at least 1 moderate-severe vulvovaginal symptom. All vulvovaginal symptoms except vaginal dryness were more common in women with active IBD and vulvovaginal discomfort frequently or always decreased interest in sex or ability to have sex. In conclusion, we found that women with more active IBD have increased prevalence of vulvovaginal discomfort, compared to women in remission. These symptoms affect sexual health.

The rate of diagnoses has increased for both obesity and IBD, and some research suggests that obesity may play a part in the development of IBD. About 15-40% of patients with IBD are obese, which is defined as having a body mass index (BMI) of 30 or higher. However, there has been little research on how obesity might affect outcomes in patients with IBD. In this study of nearly 7300 patients with IBD, we found that about one in 5 patients with IBD were obese. Obese patients were more likely to have active symptoms related to IBD, as compared to patients with normal BMI. Over a period of 12-18 months, we obs erved that obese patients with active disease were significantly less likely to achieve remission. Similarly, among patients in remission at baseline, obese patients were 2-3 times more likely to relapse on follow-up, as compared to patients with normal BMI. Obese patients with IBD were more likely to have anxiety, depression, fatigue, and experience pain. They were also less satisfied with their ability to participate in social roles. These effects were seen in patients with both ulcerative colitis and Crohn's disease. Future studies to find out whether treating obesity may improve outcomes in patients with IBD are needed.

Marijuana is legal in a number of states for indications that include inflammatory bowel diseases (IBD), and patients are interested in its potential benefits. For this study, we aimed to describe the legal use of marijuana in individuals with IBD in the USA who participate within the IBD Partners Patient Network. Approximately 2400 participants who lived in states where prescription or recreational marijuana was legal, were offered the chance to complete a survey on marijuana use and IBD symptoms. Surveys were completed by 1666 participants (71%). Within the surveyed group, 234 participants lived where both medical and recreational marijuana is legal and 49 mentioned recreational marijuana use specifically for IBD. Most of the users reported positive benefits, but users also reported more depression, anxiety, pain, and lower social satisfaction than non-users. Overall, we found that few IBD patients consulted their medical doctors about marijuana use or used prescription marijuana. Where recreational marijuana was available, usage rates were higher. Users reported benefits but also more I BD symptoms, depression, anxiety, and pain. Marijuana use may be higher in patients with IBD symptoms not well treated by traditional medical treatments.

Little research has been done exploring how inflammatory bowel disease (IBD) affects sexual health. In this study, investigators asked a large group of IBD patients to complete a 6-question online survey. The questions asked about sexual interest and satisfaction. Researchers found that these IBD patients had similar levels of sexual interest as the general population, but they had lower sexual satisfaction and lower quality of life as it related to their IBD. Older age, disease activity, depression, anxiety, and pain were associated with these findings. Exploring these sexual health topics during clinical encounters can help improve IBD quality of life.

Patient reported outcomes (PROs) are important measures of how well treatments work in inflammatory bowel disease (IBD). PROs are symptoms reported directly by patients, rather than tests like colonoscopies or blood work. The PRO Measurement Information System (PROMIS) is a scale for measuring PROs for physical, mental, and social health. A gastrointestinal (GI) PROMIS scale was recently developed based on responses from people across the United States. The GI PROMIS scale includes questions about eight common GI symptoms: gas, reflux, diarrhea, soilage, constipation, belly pain, nausea and vomiting, and difficulty swallowing. We studied these questions in 2,378 people with Crohn's disease (CD) and 1,455 people with ulcerative colitis (UC) in CCFA Partners. About half of the participants reported being in remission. Compared to participants in remission, those with active CD reported worse symptoms on the GI-PROMIS scale for all symptoms. The same was true for participants with active UC with the exception of difficulty swallowing. Participants with worse quality of life reported worse symptoms on the GI-PROMIS scale for all symptoms. Participants with more diarrhea, belly pain, and gas reported poorer mental and social PROs. In summary, participants who reported worse GI-PROMIS symptoms also reported worse qualify of life, disease activity, and mental and social outcomes. These results suggest that the GI-PROMIS scales could be an important way to measure symptoms in the future.

Symptoms (pain, fatigue, sleep disturbance, depression, and anxiety) are common among people with Inflammatory Bowel Disease (IBD). We know people do not experience only one symptom and symptoms may occur is clusters. Symptom clusters are two or more symptoms that occur together and are related. Understanding how symptoms cluster is needed so that we can develop methods that decrease multiple symptoms in IBD. The purpose of this study was to (a) describe how symptoms cluster in IBD, and (b) to describe the relationship between demographic and clinical factors and symptom cluster membership.

In this study, we used the CCFA Partners Cohort and the symptoms of pain interference, fatigue, sleep disturbance, anxiety, and depression. There were 5,296 participants with an average age of 44 years, and the sample was 72% female. We discovered four symptom cluster groups. The first group was labeled "low symptom burden" (26%), and this group had symptoms of pain, fatigue, sleep disturbance, depression, and anxiety. The second, and largest group (38%) was labeled "high symptom burden," and included pain, fatigue, sleep disturbance, depression, and anxiety. The third group included 22.09% of participants, was labeled "physical symptoms," and had the symptoms of pain, fatigue, and sleep disturbance. The fourth group "psychological symptoms," was the smallest group at 14.22%, and included the symptoms of anxiety and depression. Being female, having a history of smoking, currently taking corticosteroids, Crohn's disease, and active disease state were associated with belonging to the high symptom burden group compared to the low symptom burden group. Additional research is needed to test strategies that may be effective at reducing symptoms in people with IBD.

People with inflammatory bowel disease, or IBD, commonly experience diarrhea and abdominal pain. These symptoms are often related to inflammation associated with IBD. Sometimes these symptoms are related to both IBD and irritable bowel syndrome, or IBS. IBS is sensitivity of the intestine without inflammation. Patients with IBD who are diagnosed with IBS may experience changes in their care and well-being. We looked at the rate of IBD-IBS diagnosis in the CCFA Partners network. We also looked at how a diagnosis of IBD-IBS impacts outcomes, such as ability to perform normal daily activities, and use of specific medications. A total of 6309 patients were included, of these, 20% reported being diagnosed with IBS after their IBD diagnosis. Patients with both an IBD and IBS diagnosis had higher rates of narcotic use compared to patients with an IBD diagnosis alone. An IBS diagnosis was associated with anxiety, depression, fatigue, poor sleep quality, pain interference, and decreased social satisfaction. Appropriate diagnosis, treatment, and counseling may help improve outcomes experienced by IBD-IBS patients and reduce narcotic use in this group.

Patients with Crohn's disease, or CD, may require surgery during the course of their disease. This can result in the need to create a permanent or a temporary ostomy. Ostomy is the term used to describe the surgically created connection between the intestine and the abdominal wall. It allows for the evacuation of the fecal matter through the abdominal wall. The potential need for an ostomy is a major concern for many patients with inflammatory bowel disease as it may impact their daily function and quality of life. Within the CCFA Partners network, we evaluated the characteristics of CD patients who had an ostomy for at least 6 months. We also looked at how ostomy impacts their daily function and quality of life. A total of 4733 patients were included, of these, 402 reported an ostomy for at least 6 months. Patients with ostomy were more likely to be in clinical remission compared to those with no ostomy. Also, only half the patients with ostomy were receiving specific IBD therapies. Having an ostomy did not impact the quality of life or sexual function (interest and satisfaction) of CD patients. Additionally, there was no association between having an ostomy and anxiety, depression, or sleep disturbances. However, having an ostomy was associated with increased pain interference, fatigue and lower social satisfaction. It was also associated with higher rated of narcotic use. Appropriate counseling before and after surgery can help improving social satisfaction for patients with ostomy. Further studies are needed to determine the nature of pain and fatigue in this population.

Patient reported outcomes (PROs) are important measures of how well treatment works in Crohn's disease (CD). PROs are symptoms reported directly by patients, rather than tests like colonoscopies or blood work. The PRO Measurement Information System (PROMIS) is a new scale for measuring PROs for physical, mental and social health. The results can be compared to those from people that don't have IBD. A gastrointestinal (GI) PROMIS scale was recently developed. The GI scales were not studied in large numbers of Crohn's patients, but were studied in people all across the United States. We studied these questions in 1839 people with Crohn's disease in CCFA Partners. Most (75%) were women. People with Crohn's disease reported more fatigue, anxiety and pain compared to people without Crohn's disease. People with Crohn's disease reported less reflux, problems swallowing and constipation than people without Crohn's disease. Other GI symptoms for people with Crohn's disease were similar to those reported by people without Crohn's disease. Compared to people in remission, people with active CD reported worse symptoms on the GI-PROMIS scales for all symptoms except problems swallowing and constipation. Those with a worse quality of life, as measured by the Short IBD Questionnaire (SIBDQ), reported worse symptoms on the GI-PROMIS scales all symptoms. People who reported more nausea, diarrhea, gas/bloat and abdominal pain reported more psychosocial symptoms on the PROMIS scales. In summary, those with worse symptoms on the GI-PROMIS scales scored worse disease activity scales, quality of life scales and more symptoms of depression and anxiety. These scales could be important ways to measure symptoms in the future.

Women with inflammatory bowel disease, or IBD, frequently experience changes in abdominal symptoms (e.g. bowel frequency and pain) in relation to the different stages of the menstrual cycle. This may be related to the hormonal changes during the various stages of the cycle. Menopause is the state when the menstrual cycles and associated hormonal fluctuations stop permanently. This can occur naturally in relation to age or can be secondary to surgery or medical therapy that impact the reproductive organs. The impact of menopause on disease activity of patients with IBD is unknown. We assessed the disease characteristics of menopausal women within the CCFA Partners network. We also evaluated the impact of menopause and hormone replacement therapy, or HRT, on disease activity. A total of 2252 women were included in this study. Of these, 799 indicated that they had gone through menopause. The majority of post-menopausal women reported natural menopause with an average age of 50 in both Crohn's disease and ulcerative colitis patients. About half the post-menopausal women indicated a current or prior use of HRT. The post-menopausal state was associated with increased disease activity in both Crohn's disease and ulcerative colitis patients. This association was more prominent for women at age = 45 compared to those older than 45 years. Interestingly, the use of HRT did not impact disease activity at any age. Those findings suggest that the cessation of hormonal fluctuation in post-menopausal women as well as the age play role in predicting disease activity in women with IBD.

Depression is common among patients with Crohn's disease (CD). In this study, we wanted to understand if CD patients in remission who reported symptoms of depression were more likely to experience worsened CD symptoms later in time. To answer this question we looked at responses to CCFA Partners survey questions submitted by more than 2,000 CD patients about negative mood (I felt depressed), negative beliefs about the self (I felt worthless, I felt hopeless), and decreased life engagement/negativity (I felt hopeless) during the past seven days. Twelve months later, we asked about the severity of their CD activity using a standard CD questionnaire about diarrhea, pain, and well-being. We found that symptoms of depression predicted CD activity a year later. In other words, CD patients who were depressed were more likely to have CD symptoms a year later than those who were not depressed.

Nonsteroidal anti-inflammatory drugs (NSAIDs, medications such as Advil, ibuprofen, naproxen, etc.) may cause GI inflammation in patients with inflammatory bowel disease (IBD). IBD patients are often told to avoid these medications. We looked at patients in CCFA Partners in who were in remission (with few to no symptoms) and asked about regular NSAID use. We then looked at whether they flared 6 months later. A total of 791 patients were included, of these, 40.6% reported ever using NSAIDS at baseline. Patients with Crohn's disease (CD) who regularly used NSAIDS (at least 5 times/monthly) had a 65% increased risk of later flare. No effect of regular NSAID use was seen for ulcerative colitis (UC). Those with CD who used acetaminophen (Tylenol) also had a 72% increased risk of later flare. Lower doses of NSAIDs had no association with flare. Therefore, regular NSAID use or acetaminophen use may increase the risk of flare in CD, but not UC. This may be related to effects of the medications. It is also possible that those people with IBD who require pain medications at baseline may not be in as full a remission, which may increase the risk of later flare.

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.