Choosing the most appropriate biologic therapy for Crohn’s disease according to concomitant extra-intestinal manifestations, comorbidities, or physiologic conditions

Romano, Ciro; Esposito, Sergio; Ferrara, Roberta; Cuomo, Giovanna

doi:10.1080/14712598.2020.1689953

Cited by 8 publications

(10 citation statements)

References 157 publications

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“…Alternatively, EIMs may be independent inflammatory events that arise due to the same genetic or environmental factors that predispose patients to IBD 10,11 . Data from various studies and the European Crohn's and Colitis Organisation (ECCO) guidelines on EIMs have established the use of antitumor necrosis factor (anti‐TNF), nonsteroidal anti‐inflammatory drugs, and methotrexate as treatments for some of the manifestations listed above 2,4,12 …”

Section: Introductionmentioning

confidence: 99%

“…10,11 Data from various studies and the European Crohn's and Colitis Organisation (ECCO) guidelines on EIMs have established the use of antitumor necrosis factor (anti-TNF), nonsteroidal anti-inflammatory drugs, and methotrexate as treatments for some of the manifestations listed above. 2,4,12 Ustekinumab (UST) is a human IgG1κ monoclonal antibody that inhibits the biologic activity of cytokines interleukin-12 and interleukin-23 through their common p40 subunit, which are involved in the pathogenesis of CD. UNITI-1/2 and IM-UNITI demonstrated that UST was effective in inducing and maintaining clinical remission in moderate to severe CD patients.…”

Section: Introductionmentioning

confidence: 99%

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The impact of ustekinumab on extraintestinal manifestations of Crohn's disease: A post hoc analysis of the UNITI studies

et al. 2021

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Summary This post hoc analysis of the UNITI studies found ustekinumab (UST) did not significantly improve overall extraintestinal manifestations (EIMs) of Crohn's disease compared to placebo‐treated patients at weeks 6 and 52. Background and Aims The UNITI trials demonstrated that UST was effective in inducing and maintaining clinical remission in Crohn's disease (CD). However, limited data exists regarding its effectiveness for treatment of EIMs. This post hoc analysis evaluated the efficacy of UST in treatment of EIMs. Methods Data from UNITI‐1/2 and IM‐UNITI (NCT01369329, NCT01369342, NCT01369355) were obtained from the Yale Open Data Access Project (2019‐4104). Nine hundred and fourty‐one patients eligible for UST induction and 263 patients eligible for maintenance UST were included. The primary outcome of interest was EIM resolution at Week 6 in UST and placebo‐treated patients using the chi‐square test. EIM resolution at Week 52 was also assessed. McNemar's test was used to compare the proportion of patients who reported active EIMs at weeks 6 and 52 versus baseline. Results From 941 UST‐treated patients in UNITI‐1/2, 504 had 527 EIMs at baseline. Overall, there was no significant difference in EIM resolution observed in UST‐treated patients (186/504, 36.9%) compared to placebo (90/230, 39.1%; p = 0.564) at Week 6. Patients treated with continuous UST (91/119, 76.4%) had no significant difference in overall EIMs resolved at Week 52 compared to placebo (72/90, 80.0%; p = 0.542). Although many EIMs demonstrated reduction in prevalence compared to baseline at initiation of UST, only erythema nodosum was more likely to improve at Week 52 on treatment versus placebo. Conclusion Overall, UST did not lead to significant resolution of EIMs for CD compared to placebo at weeks 6 and 52.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The impact of ustekinumab on extraintestinal manifestations of Crohn's disease: A post hoc analysis of the UNITI studies

et al. 2021

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“…In addition, it is known that anti-TNF therapy is not appropriate in a patient who has a demyelinating disease (e.g., optic neuritis or multiple sclerosis) because such treatment can worsen outcomes. Therefore, UST or VDZ may be prioritized in IBD patients with these comorbidities [113].…”

Section: Comorbiditiesmentioning

confidence: 99%

How to Choose the Biologic Therapy in a Bio-naïve Patient with Inflammatory Bowel Disease

Laredo

Gargallo-Puyuelo

Gomollón

2022

JCM

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The availability of biologic therapies in inflammatory bowel disease (IBD) is increasing significantly. This represents more options to treat patients, but also more difficulties in choosing the therapies, especially in the context of bio-naïve patients. Most evidence of safety and efficacy came from clinical trials comparing biologics with placebo, with a lack of head-to-head studies. Network meta-analysis of biologics and real-world studies have been developed to solve this problem. Despite the results of these studies, there are also other important factors to consider before choosing the biologic, such as patient preferences, comorbidities, genetics, and inflammatory markers. Given that resources are limited, another important aspect is the cost of biologic therapy, since biosimilars are widely available and have been demonstrated to be effective with a significant decrease in costs. In this review, we summarize the evidence comparing biologic therapy in both Crohn´s disease (CD) and ulcerative colitis (UC) in different clinical situations. We also briefly synthesize the evidence related to predictors of biologic response, as well as the biologic use in extraintestinal manifestations and the importance of the drug-related costs.

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“…Infections affect 39.8%, 13.2% and 12.9% of IBD patients with pneumonia, sepsis, or candidiasis, respectively [ 73 ]. Old-age susceptibility, anti-TNF-α or immunomodulatory therapy, polypharmacy and the presence of other comorbidities, such as diabetes (19.2%), cancer (16.5%), anaemia (16.3%) and chronic obstructive pulmonary disease (COPD) (11.4%), are described as the main factors of this high risk of infection, present in IBD patients [ 36 , 74 ]. Table S1 identifies the main IBD-associated comorbidities.…”

Section: Ibd Symptoms and Treatment Optionsmentioning

confidence: 99%

Drug Targeting of Inflammatory Bowel Diseases by Biomolecules

et al. 2021

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Inflammatory bowel disease (IBD) is a group of disabling, destructive and incurable immune-mediated inflammatory diseases comprising Crohn’s disease (CD) and ulcerative colitis (UC), disorders that are highly prevalent worldwide and demand a large investment in healthcare. A persistent inflammatory state enables the dysfunction and destruction of healthy tissue, hindering the initiation and endurance of wound healing. Current treatments are ineffective at counteracting disease progression. Further, increased risk of serious side effects, other comorbidities and/or opportunistic infections highlight the need for effective treatment options. Gut microbiota, the key to preserving a healthy state, may, alternatively, increase a patient’s susceptibility to IBD onset and development given a relevant bacterial dysbiosis. Hence, the main goal of this review is to showcase the main conventional and emerging therapies for IBD, including microbiota-inspired untargeted and targeted approaches (such as phage therapy) to infection control. Special recognition is given to existing targeted strategies with biologics (via monoclonal antibodies, small molecules and nucleic acids) and stimuli-responsive (pH-, enzyme- and reactive oxygen species-triggered release), polymer-based nanomedicine that is specifically directed towards the regulation of inflammation overload (with some nanosystems additionally functionalized with carbohydrates or peptides directed towards M1-macrophages). The overall goal is to restore gut balance and decrease IBD’s societal impact.

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Choosing the most appropriate biologic therapy for Crohn’s disease according to concomitant extra-intestinal manifestations, comorbidities, or physiologic conditions

Cited by 8 publications

References 157 publications

The impact of ustekinumab on extraintestinal manifestations of Crohn's disease: A post hoc analysis of the UNITI studies

The impact of ustekinumab on extraintestinal manifestations of Crohn's disease: A post hoc analysis of the UNITI studies

How to Choose the Biologic Therapy in a Bio-naïve Patient with Inflammatory Bowel Disease

Drug Targeting of Inflammatory Bowel Diseases by Biomolecules

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