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. 2022 Jun 1;5(5):214-220.
doi: 10.1093/jcag/gwac018. eCollection 2022 Oct.

Financial Conflicts of Interest in Propensity Score-Matched Studies Evaluating Biologics and Biosimilars for Inflammatory Bowel Disease

Affiliations

Financial Conflicts of Interest in Propensity Score-Matched Studies Evaluating Biologics and Biosimilars for Inflammatory Bowel Disease

Karam Elsolh et al. J Can Assoc Gastroenterol. .

Abstract

Background: Propensity score matching (PSM), a statistical technique that estimates a treatment effect by accounting for predictor covariates, has been used to evaluate biologics for inflammatory bowel disease (IBD). Financial conflicts of interest are prevalent in the marketing of biologic medications. It is unclear whether this burden of conflicts is present among authors of PSM studies comparing IBD biologics and biosimilars.

Objective: This study was aimed to determine the prevalence of financial conflicts of interest among authors of PSM studies evaluating IBD biologics and biosimilars.

Methods: We conducted a systematic search for PSM studies comparing biologics and biosimilars in IBD treatment. We identified 21 eligible studies. Two independent authors extracted self-declared conflicts from the disclosures section. Each participating author was searched on the Centers for Medicare & Medicaid Services Open Payments to identify payment amounts and undisclosed conflicts. Primary outcome was the prevalence of author conflicts. Secondary analyses assessed for an association between conflict prevalence and reporting of positive outcomes.

Results: Among 283 authors, conflicts were present among 41.0% (116 of 283). Twenty-three per cent (27 of 116) of author conflicts involved undisclosed payments. Studies with positive outcomes were significantly more likely to include conflicted authors than neutral studies (relative risk = 2.34, 95% confidence interval: 1.71 to 3.21, P < 0.001).

Conclusions: Overall, we found a high burden of undisclosed conflicts among authors of PSM studies comparing IBD biologics and biosimilars. Given the importance of PSM studies as a means for biologic comparison and the potential for undue industry influence from these payments, authors should ensure greater transparency with reporting of industry relationships.

Keywords: Biologic drugs; Biosimilar pharmaceuticals; Conflict of Interest; Inflammatory bowel disease; Propensity score.

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Figures

Figure 1.
Figure 1.
Study flow chart.
Figure 2.
Figure 2.
Proportion of author FCOI by payment type and disclosure status. FCOI, Financial conflict of interest.

References

    1. Yokomizo L, Limketkai B, Park KT. Cost-effectiveness of adalimumab, infliximab or vedolizumab as first-line biological therapy in moderate-to-severe ulcerative colitis. BMJ Open Gastroenterol. 2016;3:e000093e000093. - PMC - PubMed
    1. Sulz M, Burri E, Michetti P, et al. Treatment algorithms for Crohn’s disease. Digestion. 2020;101:43–57. - PubMed
    1. Panaccione R, Steinhart AH, Bressler B, et al. Canadian Association of Gastroenterology Clinical Practice Guideline for the Management of Luminal Crohn’s Disease. J Can Assoc Gastroenterol. 2019;2:e1–34. - PMC - PubMed
    1. Rosenbaum PR, Rubin DB. The central role of the propensity score in observational studies for causal effects. Biometrika. 1983;70:41–55.
    1. Lamb CA, Kennedy NA, Raine T, et al. British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults. Gut. 2019;68:s1–106. - PMC - PubMed

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