It’s Time to Step Up Our Response to Rising IBD Rates in Black Communities

Sponsored by Johnson & Johnson

During my medical residency, I treated a young girl with Crohn’s disease—she was thrilled to meet me, a Black physician who looked like her, represented her community, and understood her background. This connection empowered her to openly discuss her symptoms with me.

Reflecting on that experience, I believe our cultural connection undoubtedly contributed to her positive health outcome; this patient depended on me, and I was determined to honor her trust. Unfortunately, many Black patients with inflammatory bowel disease (IBD), including Crohn’s and ulcerative colitis, do not experience this sense of empowerment. Only 5.7 percent of active physicians in the United States identify as Black or African American, highlighting the need for more diverse representation in health care.¹

Furthermore, the significant rise in IBD diagnoses among minority populations over recent decades is worth noting²: A population-based study comparing cohorts from 1970 and 2010 showed a 134 percent increase in IBD incidence for racial minorities compared to 39 percent for white populations.^3,4

Access to specialists, appropriate therapies, and follow-up visits are crucial to positive outcomes. However, a recent study found that Black individuals are significantly less likely to regularly see a gastroenterologist or IBD specialist. Limited access to specialists can lead to delayed diagnosis.² Additionally, multiple studies indicate that minority patients often seek care in the emergency rooms and present with complications or more advanced disease.²

Sadly, in predominantly Black communities, many individuals feel hesitant or embarrassed to discuss IBD symptoms or advocate for their needs, but we could help bridge that gap with culturally conscious care.⁴ Culturally conscious care is defined as the ability of healthcare providers and systems to meet the social, cultural, and linguistic needs of patients.⁵ Moreover, the understanding of these intricate and intersecting needs from a healthcare provider can have a strong impact on healthcare delivery and outcomes.

Too often, Black patients, like the young girl I met during my residency, face real diagnostic and treatment obstacles. The realization that so many patients of color lack access to culturally conscious care inspired me to become a gastroenterologist specializing in IBD.

Regardless of ethnic background, IBD symptoms can be severe, painful, and debilitating. Ulcerative colitis can cause abdominal pain, bloody stool, weight loss, loss of appetite, fatigue, and urgent bowel movements.⁶ Crohn’s disease symptoms may include diarrhea, cramping, abdomen pain, significant weight loss, nausea, vomiting, and loss of appetite.⁷ Some of these symptoms can sometimes mimic other conditions, such as irritable bowel syndrome, complicating the diagnosis.⁸

When adjusted for prevalence of IBD across populations, research has found that Black patients suffer more serious consequences from IBD than white patients. Hospitalizations* are higher in Black patients compared to white patients and Hispanic patients. The ratio of IBD-related mortality is also higher in Black patients compared to white patients and Hispanic patients.⁹

Yet, based on results from a cohort study, Black and Hispanic patients are statistically less likely to be prescribed advanced therapies, such as immunomodulators or a biologic, when presenting with severe disease symptoms.¹⁰ One study found that Black patients are three times more likely to be treated with steroids compared to white patients.¹¹ Addressing treatment disparities is crucial for us physicians treating Black patients with IBD.¹¹

Physicians serving Black patient populations must familiarize themselves with a culturally conscious care approach and treatment options for IBD. Embracing differences and engaging in dialogue with patients and other Black doctors about successful treatment are essential.

Identifying genetic factors and the diverse disease phenotypes can lead to individualized therapy, further advancing the goal of personalized medicine for patients with IBD.²

One option is the biologic STELARA^® (ustekinumab), approved for the treatment of adults with moderately to severely active Crohn’s disease or ulcerative colitis.

Physicians should consider recommending STELARA^®, which has demonstrated long-term efficacy and safety data across patient populations. The efficacy and safety of STELARA^® in adult patients were evaluated in the phase 3 clinical trials and long-term extension through 5 years in Crohn’s disease and 4 years in ulcerative colitis, making it a potential therapeutic option for appropriate patients. (Click here for Crohn’s disease data and here for ulcerative colitis data to see the full results).

STELARA^® is contraindicated in patients with clinically significant hypersensitivity to ustekinumab or excipients. Serious adverse reactions have been reported in STELARA^®– treated patients, including bacterial, mycobacterial, fungal, and viral infections, malignancies, hypersensitivity reactions, Posterior Reversible Encephalopathy Syndrome (PRES), and noninfectious pneumonia. STELARA^®should not be given to patients with any clinically important active infection. Patients should be evaluated for tuberculosis prior to initiating treatment with STELARA^®. Live vaccines should not be given to patients receiving STELARA^®. If PRES is suspected or if noninfectious pneumonia is confirmed, discontinue STELARA^®.

Please see related and other Important Safety Information below.

The long-term efficacy and safety profile of STELARA^®make it a therapy I recommend with confidence to many of my patients, and I encourage other healthcare providers to review the STELARA^®data to see if it’s appropriate for their patients.

As doctors serving the medical needs of Black patients, I hope we can make meaningful strides in the years ahead to foster trusting dialogue with patients experiencing IBD symptoms. I hope more of my colleagues will embrace their power to help patients living with Crohn’s disease and ulcerative colitis gain access to advanced therapeutics so they can receive the meaningful relief they deserve. As we look to better understand the prevalence and progression of IBD in the Black community, it’s critical that patients feel empowered to talk with their doctors about their symptoms. Let’s normalize the conversation around IBD because getting comfortable in discussing signs and symptoms is the first step to raising awareness and seeking treatment.

Dr. Diana Whitehead is a gastroenterologist at Woodholme Gastroenterology Associates, PA in Baltimore County. In consideration of the time Dr. Whitehead spent participating in this article, she was paid honoraria by Johnson & Johnson.

*Hospitalizations defined as prevalence to hospitalization ratio

INDICATIONS

STELARA^® (ustekinumab) is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease.

STELARA^® (ustekinumab) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis.

IMPORTANT SAFETY INFORMATION

STELARA^® (ustekinumab) is contraindicated in patients with clinically significant hypersensitivity to ustekinumab or to any of the excipients.

Infections

STELARA^® may increase the risk of infections and reactivation of latent infections. Serious bacterial, mycobacterial, fungal, and viral infections requiring hospitalization or otherwise clinically significant infections were reported. In patients with plaque psoriasis, these included diverticulitis, cellulitis, pneumonia, appendicitis, cholecystitis, sepsis, osteomyelitis, viral infections, gastroenteritis, and urinary tract infections. In patients with psoriatic arthritis, this included cholecystitis. In patients with Crohn’s disease, these included anal abscess, gastroenteritis, ophthalmic herpes zoster, pneumonia, and Listeria meningitis. In patients with ulcerative colitis, these included gastroenteritis, ophthalmic herpes zoster, pneumonia, and listeriosis.

Treatment with STELARA^® should not be initiated in patients with a clinically important active infection until the infection resolves or is adequately treated. Consider the risks and benefits of treatment prior to initiating use of STELARA^® in patients with a chronic infection or a history of recurrent infection. Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with STELARA^® and discontinue STELARA^® for serious or clinically significant infections until the infection resolves or is adequately treated.

Theoretical Risk for Vulnerability to Particular Infections

Individuals genetically deficient in IL-12/IL-23 are particularly vulnerable to disseminated infections from mycobacteria, Salmonella, and Bacillus Calmette-Guerin (BCG) vaccinations. Serious infections and fatal outcomes have been reported in such patients. It is not known whether patients with pharmacologic blockade of IL-12/IL-23 from treatment with STELARA^® may be susceptible to these types of infections. Consider diagnostic testing, eg, tissue culture, stool culture, as dictated by clinical circumstances.

Pre-Treatment Evaluation of Tuberculosis (TB)

Evaluate patients for TB prior to initiating treatment with STELARA^®. Do not administer STELARA^® to patients with active tuberculosis infection. Initiate treatment of latent TB before administering STELARA^®. Closely monitor patients receiving STELARA^® for signs and symptoms of active TB during and after treatment.

Malignancies

STELARA^® is an immunosuppressant and may increase the risk of malignancy. Malignancies were reported among patients who received STELARA^® in clinical trials. The safety of STELARA^® has not been evaluated in patients who have a history of malignancy or who have a known malignancy. There have been reports of the rapid appearance of multiple cutaneous squamous cell carcinomas in patients receiving STELARA^® who had risk factors for developing non-melanoma skin cancer (NMSC). All patients receiving STELARA^®, especially those >60 years or those with a history of PUVA or prolonged immunosuppressant treatment, should be monitored for the appearance of NMSC.

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with STELARA^®. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue STELARA^®.

Posterior Reversible Encephalopathy Syndrome (PRES)

Two cases of posterior reversible encephalopathy syndrome (PRES), also known as Reversible Posterior Leukoencephalopathy Syndrome (RPLS), were reported in clinical trials. Cases have also been reported in postmarketing experience in patients with psoriasis, psoriatic arthritis and Crohn’s disease. Clinical presentation included headaches, seizures, confusion, visual disturbances, and imaging changes consistent with PRES a few days to several months after ustekinumab initiation. A few cases reported latency of a year or longer. Patients recovered with supportive care following withdrawal of ustekinumab.

Monitor all patients treated with STELARA^® for signs and symptoms of PRES. If PRES is suspected, promptly administer appropriate treatment and discontinue STELARA^®.

Immunizations

Prior to initiating therapy with STELARA^®, patients should receive all age-appropriate immunizations as recommended by current immunization guidelines. Patients being treated with STELARA^® should avoid receiving live vaccines. Avoid administering BCG vaccines during treatment with STELARA^® or for one year prior to initiating treatment or one year following discontinuation of treatment. Caution is advised when administering live vaccines to household contacts of patients receiving STELARA^® because of the potential risk for shedding from the household contact and transmission to patient. Non-live vaccinations received during a course of STELARA^® may not elicit an immune response sufficient to prevent disease.

Noninfectious Pneumonia

Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported during post-approval use of STELARA^®. Clinical presentations included cough, dyspnea, and interstitial infiltrates following one to three doses. Serious outcomes have included respiratory failure and prolonged hospitalization. Patients improved with discontinuation of therapy and, in certain cases, administration of corticosteroids. If diagnosis is confirmed, discontinue STELARA^® and institute appropriate treatment.

Allergen Immunotherapy

STELARA^® may decrease the protective effect of allergen immunotherapy (decrease tolerance) which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Therefore, caution should be exercised in patients receiving or who have received allergen immunotherapy, particularly for anaphylaxis.

Most Common Adverse Reactions

The most common adverse reactions (≥3% and higher than that with placebo) in adults from plaque psoriasis clinical trials for STELARA^® 45 mg, STELARA^® 90 mg, or placebo were: nasopharyngitis (8%, 7%, 8%), upper respiratory tract infection (5%, 4%, 5%), headache (5%, 5%, 3%), and fatigue (3%, 3%, 2%), respectively. The safety profile in pediatric patients with plaque psoriasis was similar to that of adults with plaque psoriasis. In psoriatic arthritis (PsA) trials, a higher incidence of arthralgia and nausea was observed in patients treated with STELARA^® when compared with placebo (3% vs 1% for both).

In Crohn’s disease induction trials, common adverse reactions (3% or more of patients treated with STELARA^® and higher than placebo) reported through Week 8 for STELARA^® 6 mg/kg intravenous single infusion or placebo included: vomiting (4% vs 3%). In the Crohn’s disease maintenance trial, common adverse reactions (3% or more of patients treated with STELARA^® and higher than placebo) reported through Week 44 for STELARA^® 90 mg subcutaneous injection or placebo were: nasopharyngitis (11% vs 8%), injection site erythema (5% vs 0%), vulvovaginal candidiasis/mycotic infection (5% vs 1%), bronchitis (5% vs 3%), pruritus (4% vs 2%), urinary tract infection (4% vs 2%) and sinusitis (3% vs 2%). In the ulcerative colitis induction trial, common adverse reactions (3% or more of patients treated with STELARA^® and higher than placebo) reported through Week 8 for STELARA^® 6 mg/kg intravenous single infusion or placebo included: nasopharyngitis (7% vs 4%). In the ulcerative colitis maintenance trial, common adverse reactions (3% or more of patients treated with STELARA^® and higher than placebo) reported through Week 44 for STELARA^® 90 mg subcutaneous injection or placebo included: nasopharyngitis (24% vs 20%), headache (10% vs 4%), abdominal pain (7% vs 3%), influenza (6% vs 5%), fever (5% vs 4%), diarrhea (4% vs 1%), sinusitis (4% vs 1%), fatigue (4% vs 2%), and nausea (3% vs 2%).

Please see full Prescribing Information and Medication Guide for STELARA^®. Provide the Medication Guide to your patients and encourage discussion.

Association of American Medical Colleges. Workforce. 2022 physician specialty data report. Accessed August 2024. https://www.aamc.org/what-we-do/mission-areas/health-care/workforce-studies/interactive-data/number-people-active-physician-specialty-2019
Barnes E, Loftus Jr. E, Kappelman M. Effects of race and ethnicity on diagnosis and management of inflammatory bowel diseases. Gastroenterology. 2021;160(3):677-689. doi:10.1053/j.gastro.2020.08.064
Nguyen GC, Chong CA, Chong RY. National estimates of the burden of inflammatory bowel disease among racial and ethnic groups in the United States. J Crohns Colitis. 2014;8(4):288–95.
Odufalu FD, Aboubakr A, Anyane-Yeboa A. (2022). Inflammatory bowel disease in underserved populations: lessons for practice. Current opinion in gastroenterology. 38(4), 321–327. https://doi.org/10.1097/MOG…
Betancourt JR, Green AR, Carrillo JE. 2002. Cultural competence in health care: Emerging frameworks and practical approaches. New York: The Commonwealth Fund. Accessed August 2024. https://www.imiaweb.org/uploads…
Crohn’s & Colitis Foundation. Overview of Ulcerative Colitis. Accessed June 2024. https://www.crohnscolitis…
Crohn’s & Colitis Foundation. What is Crohn’s Disease Overview. Accessed June 2024. https://www.crohnscolitis…
Crohn’s and Colitis Foundation of America. Inflammatory Bowel Disease and Irritable Bowel Syndrome Similarities and Differences. Accessed August 2024. https://www.crohnscolitis…
Liu JJ, Abraham BP, Adamson P, et al. The current state of care for black and hispanic inflammatory bowel disease patients. Inflammatory Bowel Diseases. 2022;29(2):297-307. doi:10.1093/ibd/izac124
Flasar MH, Johnson T, Roghmann MC, et al. Disparities in the use of immunomodulators and biologics for the treatment of inflammatory bowel disease: a retrospective cohort study. Inflamm Bowel Dis. 2008;14(1):13–9.
Straus WL, Eisen GM, Sandler RS, et al. Crohn’s disease: does race matter? The Mid-Atlantic Crohn’s Disease Study Group. Am J Gastroenterol. 2000;95(2):479–83.