Study Finds Significant Room for Improvement in Ulcerative Colitis Treatments

In the past decade or so, the number of medications approved to treat ulcerative colitis (UC) has increased. But because the drugs haven’t been around long, we don’t have many details about the people taking them, how people respond to treatments in the real world, or how newer therapies compare with older ones. Clinical trial data is limited, and it doesn’t really capture the impact of UC on people’s day-to-day lives.

However, a new study published in Crohn’s & Colitis 360 helps shed light on some of that missing information. Although we have more treatment options available than ever, the study shows there’s still a need for new and more effective UC treatments.

About the study

The study looked at disease burden and patient-reported outcomes of 605 people who were taking different types of UC medications. 

The researchers categorized participants by drug class at the time of their enrollment into CorEvitas’ Inflammatory Bowel Disease (IBD) Registry between May 2017 and September 2019. This research registry contains information on U.S. adults with IBD who are under the care of a board-certified gastroenterologist. It’s intended to improve patient care by providing real-world insights into UC and Crohn’s disease and their treatments.

 
Doctors often treat people with mild-to-moderate UC with older medications first – 5-aminosalicylic acid (5-ASA) medications – before prescribing newer treatments, like biologics or Janus kinase (JAK) inhibitors. Therefore, the researchers grouped study participants into two classes: 
•    Those taking  5-ASA medications( mesalamine, balsalazide, and sulfasalazine) alone – a total of 290 participants 
•    Those taking biologics or JAK inhibitors (adalimumab, certolizumab, golimumab, infliximab and its biosimilar, ustekinumab, natalizumab, vedolizumab, or tofacitinib) alone or in combination with immunosuppressant therapies (methotrexate, 6 mercaptopurine, azathioprine, tacrolimus, cyclosporine, or others) or 5-ASAs – a total of 315 participants

Additionally, the researchers collected data on: 
•    Measures of disease activity, including absence of symptoms (remission), mild disease, moderate disease, or severe disease
•    Disease characteristics, including the location of disease, history of emergency department visits or hospital admissions related to UC, and history of disease-related symptoms outside of the colon (e.g., arthritis, eye involvement)
•    Doctor-reported secondary medical conditions (comorbidities) occurring in the people with UC
•    Patient-reported outcomes, including fatigue, sleep disturbances, depression, pain, anxiety, work hours missed, and lost work productivity 
•    Social and demographic characteristics, including age, gender, race, education, and type of health insurance plan 
•    Treatment history, including information about the medication patients were on in the past

What the study found

The study provided several interesting findings. For instance, when compared to those taking 5-ASAs, patients on biologics or JAK inhibitors were younger, more likely to be female, and more likely to be employed. They were also more likely to have inflammation throughout their entire colon.

Overall, when comparing the two groups of study participants, those taking biologics and JAK inhibitors had less remission and worse patient-reported outcomes, likely due to the severity of their disease rather than as a result of their treatments. Among other things, patients on biologics and JAK inhibitors had more hospitalizations and emergency department use for problems related to UC, more missed work, and greater impact on daily life activities.

Researchers said their findings support other recent studies of real-world evidence. One study they mentioned found that people treated with biologics for moderate-to-severe UC still had quality of life issues, including those centered around work and daily activities.

Together, these findings show that, despite more treatments being available, many UC patients continue dealing with challenges affecting their health and quality of life. Ultimately, the study highlights the importance of developing new and improved UC treatments, determining the timing and order in which patients should receive treatments, and learning how to best use existing treatments. 

You can help move treatment forward

The Crohn’s & Colitis Foundation is dedicated to funding innovative research to advance our understanding of IBD, improve patient quality of life, and ultimately, find cures for Crohn’s disease and ulcerative colitis. That depends on adequate participation in clinical trials and research.

Through our Clinical Trials Community, you can learn about the importance of participating in clinical trials and find trials taking place in your area. Our helpful resources also include stories from research participants and highlights of findings from the most up-to-date IBD research. You can also start a conversation with your doctor on how clinical trials can play a role in your treatment.