The Psychosocial Aspect of Living with GI Conditions
When talking about one’s health journey, it can be uncomfortable, even triggering. That emotional burden is why having good mental health support, or social support is necessary. It’s important to find the kind of support one is most comfortable with, and ideally, physicians should play a role in connecting patients with those options.
“There are other alternatives,” explained Cedric, “Art therapy, music therapy, yoga, other types of fitness. But I don’t think we’re exploring them enough in IBD and the other autoimmune spaces.”
Megan added that, though research into the mechanisms of disease is vital, the goal of getting patients back to the activities that bring value to their lives is just as meaningful.
Erica talked about how in Celiac disease, quality of life studies have found that the psychological burden is quite high for patients and caregivers, “Second only,” she asserted, “to end stage renal failure.” Psychosocial issues in Celiac communities revolve around the challenge of dietary restrictions; restrictions which go well beyond just abstaining from gluten, they must also be “Celiac safe”.
Dating, for example, is especially hard, and a good example of the diet-related challenges Celiac patients face. “Dating is the biggest thing we’re studying now that we haven’t before. I myself went through it and it’s awful. Hello, my name’s Erica and I have a digestive disease and I talk a lot about poop. Happy first date! Sixty eight percent of people felt their Celiac had a major or moderate impact on their dating life.”
“There’s a lot of disordered eating in Celiac disease patients, especially teenagers. Not nearly enough people are having these open conversations about how hard it is living with this or any digestive disease. If food makes them feel bad, they’re going to have unhealthy eating habits.”
Role of Support Groups
“I really struggled,” explained Cedric, who sought out one-on-one therapy that was LGBTQ-supportive. As he relocated across the country, he went through his insurance to find a provider who was Black and supportive of LGBTQ. His search led him to support organizations, where ultimately, he found a provider that fit his needs. “A lot of people don’t have that kind of support, but we need it.”
Erica added, “I love therapy, so I’ll always recommend that.” But she shared a caveat about online social media groups. Facebook support groups are often led by non-experts, and so don’t have the same benefits of a live, professionally led support group. Patients should beware bad science and unsubstantiated claims.
“Social media,” added Megan, “Is a double-edged sword. You can connect with all these amazing people and access resources we couldn’t access a few years ago. But I’ve found groups I had to walk away from because they were not constructive, or supportive. Don’t be afraid to try a few out until you find the one that’s trustworthy and mentally and physically healthy for you.”
Equitable Access to Clinical Trials
“Currently in the US,” proceeded Cedric, “IBD has 250 active clinical trials being conducted. When I look closer, very seldom do I see clinical trials that focus on People of Color. More inclusion and diversity are needed.” A shortage of doctors, medical professionals, researchers, that represent Black and Hispanic populations makes this difficult. And also, though some minorities are hesitant to participate in clinical research, many are just not offered the opportunity.
“The issue we’re struggling with as a nation is accessibility,” added Erica. Telehealth and online research may provide some solution, but excludes those without reliable internet. The need for equitable access – be it by gender, age, technology, socioeconomics, race, sexuality, geography – was very much on the minds of the panel.
Cedric added that clinical trials need to provide internet access, and not just for the duration of the trial. Trials would serve better to ask about things like food insecurity. Such matters of social wellness should be built into clinical trials.
To meet these diverse categories means there needs to be more funding and awareness to push research forward. But that won’t make a difference if patients don’t also get engaged and involved. And engagement will grow as patients become empowered with education and the tools of support.
Dr. Higgins on Medications in Clinical Trial Pipelines
Anti-Interleukin-monoclonal antibodies are biologic, injectable therapies. They are “roughly as effective as the anti-TNFs like Remicade and Humira but with about half the infection rates of the anti-TNFs.”
Another category are the Janus Kinase inhibitors (JAK inhibitors) – small molecule biologics that can be made into tablets. They are the first ever long-term oral biologic treatment options.
“(JAK inhibitors) do have some specific issues – they are all seen to be associated with increased rates of shingles infection, so it’s worth getting the Shingrix vaccine, which is approved for all immunosuppressed patients. Blood clots and cardiac events (have been seen) especially in folks over 60 years old and folks taking methotrexate.”
S1P receptor modulators are also small-molecule, and therefore viable as oral biologics. “They cause the immune cells to kind of get stuck in the lymph nodes and not recirculate back into the intestines. They are not quite as good as the injectables or the new JAK inhibitors but they look much better than placebo. There are possible rare safety issues with brain infection, and heart and eye issues.”
There are several new biologics for autoimmune eosinophilic esophagitis (EoE) – a narrowing and ‘ribbing’ of the esophagus making swallowing difficult. Therapies that have been successful in asthma and other conditions are being investigated as therapies for EoE.
There are also several therapies, including a biologic, being looked at for Celiac Sprue (Celiac Disease) and the leaky gut associated with it. “There are a lot of new approaches that are in clinical trials that may, if effective and safe, become available for patient use in the next two or three years.
What Innovations in Treatment are Made Possible, with Brandon Pomish
“I had developed an abscess in the perianal region and had eight surgeries to cut and drain, cut and drain. My surgeon opted for a diverted ostomy but after several complications I finally got a revised ostomy. That’s when I got introduced to Dr. Higgins. He prescribed me Remicade.
Despite treatment the fistulas weren’t healing. I was a young man with a young child, trying to run a company, and half the day I’m battling nausea, fatigue and the typical things an IBD patient experiences.”
Desperate for improvement, Brandon found several clinical trials looking at complex perianal fistulas. He began reaching out to the researchers and learned that he would qualify, not for the trial itself, but for a promising stem cell therapy – in Spain. Insurance would not cover this international treatment, but Brandon was fortunately able to cover the costs himself. After nine months and two treatments the fistulas had completely healed. Brandon had his ostomy reversed.
Dr. Higgins added that, at that time, no one knew whether the perianal fistulas would return if Brandon’s ostomy was reversed. Fortunately, so far, they have not. Brandon does live with plaque psoriasis in that region, but it is managed well by Dr. Higgins.
Risk and Reward in Clinical Trials
When discussing the risks and benefits of participating in a clinical trial, “We provide as much data as we have,” said Dr. Higgins. “Oftentimes in a phase III trial we have really good data on the people who’ve had this drug before. In IBD we’re often talking about a drug that’s already been tested in rheumatoid arthritis or psoriasis, so we have even more data. What we don’t know is if there is something rare that is only going to happen in 1 in 10,000 patients. And that’s why we do phase IV trials, just to be sure there aren’t rare events.”
Brandon added, “You really have to think long term – what’s the risk threshold for you and your family? If I were young and healthy, I’d go for a more aggressive option than if I were in my seventies.”
“The Crohn’s and Colitis Foundation,” added Laura, “like several other patient support organizations, offers people the ability to talk to another patient who’s been through a clinical trial.” This is a good way for patients to explore the experienced risks and benefits and possible long-term outcomes.
“Everyone should be talking to their physician about clinical trials,” says Laura Wingate. “Many of the GI advocacy groups and professional societies have resources to help you find clinical trials. Clinical trials are here to help us get to better treatments and address areas of disease that may be underserved.”