According to U.S. Census expert and demographer, William H. Frey, approximately half the U.S. population will be non-Caucasian come 2045.[i] Of the total U.S. population, less than ten percent participate in clinical trials. And the number of racial and ethnic minorities partaking is an even smaller number, approximately five to fifteen percent of those who participate in clinical trials.[ii]
As a woman of color living with Crohn’s Disease, I advocate for various marginalized communities (racial and ethnic minorities, LGBTQ+, etc.) suffering from chronic illnesses and disabilities. To me, the above data on clinical trials isn’t just an important set of numbers. These statistics are crucial for our future and become even more relevant as inflammatory bowel disease (IBD) incidence rises all over the globe. In my mind, ensuring diversity in IBD clinical trials is essential, not just because inclusivity is important, but because IBD is truly a global force affecting all races and ethnicities. Perhaps, just as importantly, advancing science means understanding how disease affects a variety of populations in similar and different ways in order to develop more targeted and personalized treatments.
However, what appears to be a great barrier is recruiting for clinical trials especially in the IBD space where there are a number of new medications to treat both Crohn’s Disease and ulcerative colitis. But the reality is that many of those medications have remission rates of approximately 30%, so what can be done for the remainder of the population that suffers from IBD? That’s where clinical trials come into the picture for many patients, me included.
As a patient who has had over 20 colorectal surgeries for a severe, aggressive form of perianal, fistulizing Crohn’s Disease, I have tried a number of medications over the years to treat my condition. However, many of those medications did not work until I was put in a trial for Stelara (Ustekinumab) in September 2015. This was 12 months before Ustekinumab was approved by the FDA for the treatment of moderate-to-severe Crohn’s Disease. After starting Ustekinumab, it took several months and many weekly doctor’s visits to keep up with my progress, but finally, my last fistula closed, and I was declared in clinical remission for the first time in nearly a decade.
While remission wasn’t a cure-all for me, it certainly gave me back significant quality of life. I didn’t live in the hospital anymore even though I had many maintenance doctors’ appointments. I began to travel internationally again for the first time in nearly a decade, visiting cities in Spain, France, Italy and England. And even though I haven’t been able to work full-time, I was still able to begin pursuing a passion of mine: patient advocacy work via my blog. This has allowed me to help educate and inform patients about how to navigate IBD from flare-ups to surgery and fistulae to the importance of medication, including clinical trials.
Since then, I learned that the FDA approved Ustekinumab differently from how it was administered to me the year prior. Researchers tweaked dosing and added an induction loading dose followed by maintenance doses so that patients would respond more quickly. So, in my very own way, I felt like I had contributed to science and research because my response to Ustekinumab indicated that the medication took some time to bring patients like myself into remission, necessitating a loading dose to ensure quicker response time.
Fast forward to a month ago, nearly 4 years into taking Ustekinumab, I developed mild inflammation from the Crohn’s. As a result, I was strongly advised by my doctor to participate in yet another clinical trial called the POWER study to reinduce Ustekinumab (see blog post: “In the Name of Science & Research.”) Last month, over a one-hour intravenous infusion in the hospital, I was given nearly four times my current dose of Ustekinumab (determined by weight) so that I wouldn’t lose response to the medication. And the infusion went as smoothly as it could have with no allergic or adverse reactions to the high dose of medication.
Now as I await the results of a recent MR enterography to confirm how this reinduction dose worked, I know that I have not only put my best foot forward to take care of my body but I have also contributed to science and research. Whether or not the reinduction dose works, I have helped doctors and their patients gain a greater understanding of what works for patients versus what doesn’t. And just as importantly, I have represented not only IBD patients; I have represented people of color in their struggles with IBD and hopefully given them more hope for the future of medicine and IBD care. And to me as a patient, that kind of hope is priceless.
No matter your racial or ethnic background, your sexual orientation or gender, I invite you to join me in learning more about and considering participating in clinical trials in order to contribute to your own health and to the future of medicine. There is much work to be done, much research to be gathered, and much hope to be given to diverse populations living with IBD. Together we can make remission and a cure possible someday in the near future!
[i] https://www.brookings.edu/blog/the-avenue/2018/03/14/the-us-will-become-minority-white-in-2045-census-projects/
[ii] https://www.fda.gov/media/106725/download
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LOVE, LIGHT & PEACE ALWAYS
One Comment
Coti
I was diagnosed with Crohn’s last January after 23 years of Ulcerative colitis. Now I am experiencing fatigue. I am taking Humira shots every two weeks. What do you recommend for the fatigue and languish
Thanks,
Coti