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CME / ABIM MOC / CE

Does the Use of Biologics for Inflammatory Bowel Disease in Hispanics Result in Higher Risk?

  • Authors: News Author: Marcia Frellick; CME Author: Laurie Barclay, MD
  • CME / ABIM MOC / CE Released: 9/16/2022
  • Valid for credit through: 9/16/2023
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  • Credits Available

    Physicians - maximum of 0.25 AMA PRA Category 1 Credit(s)™

    ABIM Diplomates - maximum of 0.25 ABIM MOC points

    Nurses - 0.25 ANCC Contact Hour(s) (0.25 contact hours are in the area of pharmacology)

    Pharmacists - 0.25 Knowledge-based ACPE (0.025 CEUs)

    Physician Assistant - 0.25 AAPA hour(s) of Category I credit

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Target Audience and Goal Statement

This activity is intended for gastroenterologists, nurses, family medicine and primary care clinicians, internists, physician assistants, pharmacists, nurses, public health and prevention officials, and other members of the health care team for Hispanic patients with inflammatory bowel disease.

The goal of this activity is that learners will be better able to describe risks for hospitalization, surgery, and serious infections in Hispanic compared with non-Hispanic patients with inflammatory bowel disease in a multicenter, electronic health record-based cohort of new users of biologic agents from 5 academic institutions in California between 2010 and 2017.

Upon completion of this activity, participants will:

  • Assess the risks for hospitalization, surgery, and serious infections in Hispanic compared with non-Hispanic patients with inflammatory bowel disease in a multicenter, electronic health record-based cohort of new users of biologic agents
  • Evaluate the risks for hospitalization, surgery, and serious infections in Hispanic compared with non-Hispanic patients with inflammatory bowel disease in a multicenter, electronic health record-based cohort of new users of biologic agents, based on a systematic review and meta-analysis
  • Outline implications for the healthcare team


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News Author

  • Marcia Frellick

    Freelance writer, Medscape

    Disclosures

    Marcia Frellick has no relevant financial relationships.

CME Author

  • Laurie Barclay, MD

    Freelance writer and reviewer
    Medscape, LLC

    Disclosures

    Laurie Barclay, MD, has the following relevant financial relationships:
    Formerly owned stocks in: AbbVie

Editor/Compliance Reviewer

  • Amanda Jett, PharmD, BCACP

    Associate Director, Accreditation and Compliance, Medscape, LLC

    Disclosures

    Amanda Jett, PharmD, BCACP, has no relevant financial relationships.

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  • Leigh Schmidt, MSN, RN, CMSRN, CNE, CHCP

    Associate Director, Accreditation and Compliance, Medscape, LLC

    Disclosures

    Leigh Schmidt, MSN, RN, CMSRN, CNE, CHCP, has no relevant financial relationships.

Peer Reviewer

This activity has been peer reviewed and the reviewer has no relevant financial relationships.


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CME / ABIM MOC / CE

Does the Use of Biologics for Inflammatory Bowel Disease in Hispanics Result in Higher Risk?

Authors: News Author: Marcia Frellick; CME Author: Laurie Barclay, MDFaculty and Disclosures

CME / ABIM MOC / CE Released: 9/16/2022

Valid for credit through: 9/16/2023

processing....

Clinical Context

Among Hispanic adults in the United States, inflammatory bowel disease (IBD) prevalence is currently 1.2% and is anticipated to increase progressively in coming years, with global immigration patterns and changing demographics.

Previous research has identified lower rates of biologic and immunomodulatory use among Hispanics, despite a similar disease phenotype and behavior to non-Hispanic Caucasians. Studies in hospitalized patients with IBD indicate that Hispanics have higher inpatient mortality rates and health care costs.

Study Synopsis and Perspective

Biologic agents may not be as safe or effective in Hispanic patients with IBD as they are in non-Hispanic patients, suggest new data published online in Clinical Gastroenterology and Hepatology.

To compare risk for hospitalization, surgery, and serious infections, Nghia H. Nguyen, MD, and colleagues at the Inflammatory Bowel Disease Center at the University of California, San Diego, in La Jolla included a multicenter, electronic health record-based cohort of biologic-treated Hispanic and non-Hispanic patients with IBD, using 1:4 propensity score matching.

They compared 240 Hispanic patients (53% male, 45% with ulcerative colitis, 73% treated with tumor necrosis factor alpha [TNF-alpha] antagonist, 20% with prior biologic exposure) with 960 non-Hispanic patients (51% male, 44% with ulcerative colitis, 67% treated with TNF-alpha antagonist, 27% with prior biologic exposure). Patients were new users of biologics (TNF-alpha antagonist, ustekinumab, or vedolizumab).

Compared with non-Hispanic patients, Hispanic patients had a higher risk for all-cause hospitalization (31% vs 23%) within 1 year of starting a biologic agent.

Hispanic patients also had almost twice the risk for IBD-related surgeries (7.1% vs 4.6%, respectively) and trended toward a higher risk for serious infection (8.8% vs 4.9%, respectively).

The findings are particularly important because incidence and prevalence of IBD in Hispanic adults are increasing rapidly, according to the authors.

"Currently, 1.2% of Hispanic adults in the United States report having IBD, and this number is expected to increase progressively over the next few years with global immigration patterns and changing demographics of the United States," the authors write.

Potential Drivers of Disparities

Hispanic patients have been underrepresented in clinical trials of biologic agents in IBD, making up fewer than 5% of participants, the authors note. This has resulted in limited data and created challenges in discerning reasons for the disparity.

The authors note the potential role of genetics in the effectiveness of some biologic agents, although that has not been well studied in Hispanic patients.

In addition, according to this study, Hispanic patients with IBD lived with more negative social determinants of health, particularly related to food insecurity (27%) and lack of adequate social support (83%), compared with non-Hispanic patients (unpublished data).

"In other studies on health care utilization, Hispanic patients were found to have limited access to appropriate specialist care and lack of insurance coverage," the authors point out.

The authors acknowledge that limitations of their study include the inability to pinpoint the primary reason for hospitalization because data on primary vs secondary discharge diagnoses were not available. Also, they relied on prescription information in electronic health records and could not confirm that medications were dispensed or that patients took them.

They also acknowledged selection bias as a limitation because the focus was only on patients treated with biologics, and not on outcomes for those who may have warranted a biologic treatment but were unable to receive it.

"Future studies are needed to investigate the biological, social, and environmental drivers of these differences," the authors write.

The authors' complete financial disclosures are available with the full text of the paper.

Clin Gastroenterol Hepatol. Published online May 26, 2022.[1]

Study Highlights

  • The investigators identified adult patients with IBD who were new users of biologic agents (TNF-alpha antagonists, ustekinumab, vedolizumab) from 5 academic institutions in California between 2010 and 2017.
  • Using 1:4 propensity score matching and survival analysis, they compared risks for all-cause hospitalization, IBD-related surgery, and serious infections in 240 Hispanic vs 960 non-Hispanic patients.
  • Hispanic patients were 53% male, 73% were TNF-alpha antagonist-treated, 20% had prior biologic exposure, and 45% had ulcerative colitis.
  • Non-Hispanic patients were 51% male, 67% were TNF-alpha antagonist-treated, 27% had prior biologic exposure, and 44% had ulcerative colitis.
  • Before propensity score matching, Hispanic patients were significantly younger, more likely to be overweight and obese, more likely to have increased C-reactive protein and low albumin levels, more likely to be receiving a concomitant immunomodulator and opiates when biologics were started, and more likely to be hospitalized at baseline 1 year before biologic initiation.
  • After propensity score matching, Hispanics were younger (37±15 vs 40±16 years; P=.02) and had a higher comorbidity burden (Elixhauser index, >0; 37% vs 26%; P<.01), but patterns of medication use, inflammation burden, and hospitalizations did not differ.
  • Within 1 year of starting a biologic, Hispanics had higher rates of hospitalizations (31% vs 23%; adjusted hazard ratio [aHR], 1.32; 95% CI, 1.01-1.74) and IBD-related surgery (7.1% vs 4.6%; aHR, 2.00; 95% CI, 1.07-3.72), and a trend toward higher risk for serious infections (8.8% vs 4.9%; aHR, 1.74; 95% CI, 0.99-3.05).
  • Results for hospitalization and IBD surgery were similar in the full cohort in patients with Crohn's disease and ulcerative colitis.
  • Hispanics treated with TNF-alpha antagonists had higher hospitalization risks than non-Hispanics (32% vs 21%; P<.01), but those treated with vedolizumab (30% vs 27%; P=.88) and ustekinumab (29% vs 28%; P=1.00) did not.
  • In Cox proportional hazard analysis adjusting for demographic-, disease-, and treatment-related factors and health care use, Hispanics were 33% more likely to be hospitalized than non-Hispanics (aHR, 1.33; 95% CI, 1.05-1.70) and 71% more likely to undergo IBD-related surgery (aHR, 1.71; 95% CI, 1.01-1.92).
  • Risks for hospitalization were increased with Hispanic ethnicity, higher comorbidity burden (aHR, 1.45; 95% CI, 1.23-1.70), prior hospitalization at baseline (aHR, 1.40; 95% CI, 1.18-1.65), and concomitant use of opiates (aHR, 3.37; 95% CI, 2.89-3.92) and corticosteroids (aHR, 1.43; 95% CI, 1.23-1.67).

Risks for IBD-related surgery were increased with Hispanic ethnicity, increased baseline C-reactive protein (aHR, 2.83; 95% CI, 1.66-4.85), prior IBD-related surgery (aHR, 1.92; 95% CI, 1.01-3.64), prior biologic exposure (aHR, 1.77; 95% CI, 1.08-2.72), and concomitant opiate use (aHR, 3.45; 95% CI, 2.25-5.29). 

Table 1.

Rate, % Hispanic Patients (N = 240) Non-Hispanic Patients (N = 960) Adjusted HR (95% CI)
Hospitalization 31 23 1.32 (1.01-1.74)
IBD-related surgery 7.1 4.6 2.00 (1.07-3.72)
Serious infection 8.8 4.9 1.74 (0.99-3.05)
CI = confidence interval; HR = hazard ratio.
  • The investigators concluded that in a multicenter cohort of biologic-treated patients with IBD, Hispanic patients had higher rates of hospitalization, surgery, and serious infections after propensity score matching accounting for differences in demographic, clinical, and treatment-related factors, including inflammatory burden and prior medication exposure.
  • Combined with evidence from previous studies, these findings suggest that biologic agents may not be as effective or safe in Hispanic patients as they are in non-Hispanic Caucasians, with differences perhaps driven by biological or socioeconomic factors.
  • Lower effectiveness of biologics may be driven by differences in disease duration resulting from potential delays in biologic initiation in Hispanics, endoscopic severity, and other unmeasured factors.
  • The findings suggest disproportionately higher rates of unplanned health care use compared with non-Hispanic patients, as well as ethnicity driving potential differences in biologic agent effectiveness.
  • Genetic determinants also may influence the effectiveness of specific biologic agents, but this has been incompletely studied in Hispanic patients.
  • National Health Interview Survey data showed that Hispanic patients with IBD had a higher prevalence of negative social determinants of health, particularly food insecurity (27%) and lack of adequate social support (83%) compared with non-Hispanic Caucasians.
  • Previous research has also shown limited access of Hispanics to appropriate specialist care and lack of insurance coverage.
  • Risk for hospitalization and surgery was higher in Hispanic patients treated with TNF-alpha antagonists but not in ustekinumab-treated patients, but this should be interpreted with caution because of the small number of Hispanic patients treated with non-TNF biologics.
  • The investigators recommend additional research to identify biological, social, and environmental drivers of these disparities in health care use and treatment outcomes.
  • Study limitations include lack of data on primary vs secondary discharge diagnoses preventing determination of the primary reason for hospitalization, reliance on prescriptions written rather than filled, and selection bias as only patients treated with biologics were included, not those who may have needed a biologic treatment but were unable to receive it.

Clinical Implications

  • Among biologic-treated patients with IBD, Hispanics had higher rates of hospitalization, surgery, and serious infections than non-Hispanics, after propensity score matching.
  • Additional research is needed to identify biological, social, and environmental drivers of these disparities in health care use and treatment outcomes.

Implications for the Healthcare Team

Biologic agents for IBD may not be as effective or safe in Hispanic patients as they are in non-Hispanic Caucasians.

 

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