2019 Wrapped: IBD Edition

It's hard to believe that 2020 is right around the corner—where did the year go?

As we begin to plan for the new year, we wanted to look back on the past year to highlight the big news and successes for the IBD community. After going back through the year, all I can say is 2019 was an exciting year for IBD! Below you'll find a recap of some of the exciting news and hot topics from the past year:

New five-year Challenges in IBD Research agenda unveiled

In May, we released our new five-year research agenda to address unmet needs in the IBD research community and provide a roadmap for not only the Foundation but also the IBD community at-large. Published in Inflammatory Bowel Diseases journal, the 2019 Challenges in IBD Research identified five focus areas for the Foundation, including precision medicine, pragmatic clinical research, preclinical human IBD mechanisms, novel technologies, and environmental triggers.

Step therapy reform passes in Georgia, Ohio, and Washington

Over the past few years, we've been working tirelessly with local volunteers in Georgia, Ohio, and Washington State to pass step therapy reform. Step therapy (also known as fail first) is an insurer practice by which they require a patient fail one or more drugs before they will approve the original provider preferred treatment. We were THRILLED when all three states passed this critical legislation within weeks of each other! This legislation creates a more transparent and expeditious appeals process for those who are subjected to step therapy to ensure that patients can get the treatments they need when they need them.

Cost of care for IBD patients identified through new Foundation study

The findings from our new cost of care study were released in May, showing that cost of care for IBD has increased over the past five years. Specifically, the study found:

• IBD patients incurred over three-times higher annual costs than non-IBD patients
• IBD patients absorb more than twice the annual out-of-pocket costs than non-IBD patients
• Annual costs of IBD were substantially higher in the year of the initial diagnosis 
• The biggest drivers of costs are therapeutics (biologics, opioids, and steroids), comorbidities (anemia and psychiatric illness), and emergency room visits

We are continuing to learn from the study results and will be publishing additional papers and creating new financial management resources to help patients manage the high cost of living with IBD. 

Precision nutrition becomes new area of study for the Foundation

Earlier this year, the Foundation received a generous donation from Jonathan D. Rose, MD, PhD to advance research in precision nutrition! With Dr. Rose’s support, we are launching a national, multi-investigator research program that has the capability of guiding the development of personalized nutrition for IBD disease management. The ultimate goal of our Precision Nutrition initiative is to answer a key question of IBD patients: “What should I eat?”  Being able to prescribe a personalized diet, based on a patient’s individual response to different foods and food elements – tailored to their individual clinical, biological, and lifestyle characteristics – would be transformational to the IBD community. We are grateful for Dr. Rose’s generous support allowing us to launch this game-changing research initiative. 

The Safe Step Act is introduced in the U.S. Senate

After two years of work, we were excited when the Safe Step Act, our federal bill to reform the practice of step therapy, was introduced in the U.S. Senate by Senators Lisa Murkowski (R-AK), Bill Cassidy (R-LA), and Doug Jones (D-AL). The legislation was introduced in the House of Representatives in the 115th and 116th Congress; however, this was the first time it was introduced in the Senate. 

Crohn's & Colitis Foundation selected for FDA Real-World Evidence Program project using MyStudies App

The U.S. Food & Drug Administration (FDA) selected the Foundation as one of just two patient organizations to take part in a Real-World Evident Program project using its MyStudies App. Through this program, we will launch a digital IBD tracker—IBD PROdigy—just for patients enrolled in IBD Plexus®, our research information exchange platform designed to centralize data and biosamples from diverse research studies.

We believe IBD PROdigy will help reduce the time and cost needed to get a study started and let researchers dive deeper into how patient’s everyday experiences impact their disease. Additionally, data collected through the app could also help clinicians enhance interventions and improve patient health.

New educational resources developed for patients, caregivers, and providers

2019 was a big year for our education and advocacy team. We launched a series of new educational resources to help empower patients and caregivers in their disease journey, and provide tools to providers to allow them to best support their patients. We launched:

• An animated video series discussing the impact that IBD can have on your mental health and emotional well-being
• A video providing patient and caregiver perspectives about IBD surgery
• A digital toolkit to empower patients to pass restroom access legislation in their state
• State-specific step therapy resources for providers 

Medication news over the past year

In addition to the highlights above, 2019 also saw major news for IBD treatments, with the FDA approving the following medications:

• Adalimumab-bwwd (HADLIMA™), a biosimilar referencing adalimumab (HUMIRA®), for the treatment of ulcerative colitis and adult Crohn's disease
• Ustekinumab (STELARA®) for the treatment of moderately-to-severely active ulcerative colitis
• Infliximab-axxq (AVSOLA™), the fourth biosimilar referencing infliximab (REMICADE®), for the treatment of both adult and pediatric Crohn's disease and ulcerative colitis
• Tofacitinib extended release (XELJANZ XR®) for the once-daily treatment of adult patients with moderate-to-severe ulcerative colitis

The FDA also released new warnings about an increased risk of blood clots among patients taking the 10-milligram twice-daily dose of tofacitinib (XELJANZ®). Because of the risk of blood clots, use of tofacitinib will be limited to patients who are not treated effectively or who experience severe side effects with other medications known as tumor necrosis factor (TNF) blockers (such as adalimumab, golimumab, and infliximab).

We could not have accomplished as much as we did in 2019 without the support of every member of the IBD community—patients, caregivers, providers, researchers, donors, volunteers, partners, and so many more. Your ongoing support and commitment to our mission helps make these, and so many other, milestones possible. Together, we can realize our vision of a future free from Crohn's & colitis.

Rebecca Kaplan is the Public Affairs and Social Media Manager for the Crohn's & Colitis Foundation and the caregiver of a Crohn's disease patient