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  1. Article ; Online: Optimizing Medication Access and Use in Inflammatory Bowel Disease: The Roles and Impact of Clinical Pharmacists and Pharmacy Technicians.

    Bhat, Shubha

    Crohn's & colitis 360

    2023  Volume 5, Issue 2, Page(s) otad014

    Language English
    Publishing date 2023-03-09
    Publishing country England
    Document type Editorial
    ISSN 2631-827X
    ISSN (online) 2631-827X
    DOI 10.1093/crocol/otad014
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  2. Article ; Online: Biosimilars in IBD: What Every Clinician Needs to Know.

    Angyal, Anthony / Bhat, Shubha

    Current gastroenterology reports

    2024  Volume 26, Issue 3, Page(s) 77–85

    Abstract: Purpose of review: Biosimilars were introduced to decrease biologic-related expenditures, but their uptake in inflammatory bowel disease (IBD) remains suboptimal. Herein, we review biosimilar concepts, current products available for IBD treatment, and ... ...

    Abstract Purpose of review: Biosimilars were introduced to decrease biologic-related expenditures, but their uptake in inflammatory bowel disease (IBD) remains suboptimal. Herein, we review biosimilar concepts, current products available for IBD treatment, and resources to support biosimilar utilization.
    Recent findings: Although a cornerstone of IBD treatment, biologics are costly due to their development. Biosimilars, which are biologic products highly similar to a reference product, aim to decrease these expenditures. Infliximab, adalimumab, and ustekinumab biosimilars are approved for IBD, but uptake remains low due to biosimilar efficacy and safety concerns and delayed market entry. Clinicians can effectively address some of these barriers and help patients and healthcare systems reap the benefits of decreased costs and increased treatment access. Data shows comparable efficacy and safety outcomes with biosimilars in IBD. Several biosimilar products are available and in the pipeline, but efforts are needed from various stakeholders to bolster utilization and generate benefits.
    MeSH term(s) Humans ; Biosimilar Pharmaceuticals ; Inflammatory Bowel Diseases/therapy ; Infliximab
    Chemical Substances Biosimilar Pharmaceuticals ; Infliximab (B72HH48FLU)
    Language English
    Publishing date 2024-01-20
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2041376-2
    ISSN 1534-312X ; 1522-8037
    ISSN (online) 1534-312X
    ISSN 1522-8037
    DOI 10.1007/s11894-023-00913-5
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    Zs.A 5751: Show issues Location:
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  3. Article ; Online: Mirikizumab: A New Therapeutic Option for the Treatment of Ulcerative Colitis.

    Choi, David / Sheridan, Hilary / Bhat, Shubha

    The Annals of pharmacotherapy

    2024  , Page(s) 10600280241229742

    Abstract: Objective: To review the pharmacologic and clinical profile of mirikizumab in the treatment of moderate to severe ulcerative colitis (UC).: Data sources: A PubMed search was performed from inception to December 2023 using keywords : Study selection ...

    Abstract Objective: To review the pharmacologic and clinical profile of mirikizumab in the treatment of moderate to severe ulcerative colitis (UC).
    Data sources: A PubMed search was performed from inception to December 2023 using keywords
    Study selection and data extraction: Phase 3 studies plus relevant literature on mirikizumab pharmacologic and clinical profile were reviewed.
    Data synthesis: Mirikizumab approval was based on LUCENT-1 and LUCENT-2. In the phase 3 studies involving patients with moderate to severe UC, mirikizumab, when compared to placebo, resulted in clinical remission in a significantly higher proportion of patients in both the induction and maintenance phase. In addition, mirikizumab met the secondary endpoints of alternate definition of clinical remission, endoscopic remission, glucocorticoid-free clinical remission, histologic-endoscopic mucosal remission, and improvement in bowel urgency status, bowel-urgency remission, and maintenance of clinical remission. Common adverse events noted include infection (15.1%), injection-site reaction (8.7%), nasopharyngitis (7.2%), and headache (3.3%).
    Relevance to patient care and clinical practice in comparison to existing agents: Mirikizumab is the first selective interleukin 23 (IL-23) inhibitor approved for UC. Additional studies are required to determine how to position mirikizumab in both biologic-naïve and biologic-experienced patients with moderate to severe UC.
    Conclusion: Mirikizumab provides a novel mechanism of action for the treatment of moderate to severe UC and is another welcomed treatment advance in the treatment arsenal, providing a more selective mechanism of action while maintaining a comparable safety profile.
    Language English
    Publishing date 2024-02-12
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 1101370-9
    ISSN 1542-6270 ; 1060-0280
    ISSN (online) 1542-6270
    ISSN 1060-0280
    DOI 10.1177/10600280241229742
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  4. Article ; Online: Etrasimod: A Sphingosine-1-Phosphate Receptor Modulator for the Treatment of Ulcerative Colitis.

    Choi, David / Becker, Michelle / Ivanov, Marina / Bhat, Shubha

    The Annals of pharmacotherapy

    2024  , Page(s) 10600280231225770

    Abstract: Objective: To review the pharmacologic and clinical profile of etrasimod in the treatment of ulcerative colitis (UC).: Data sources: A PubMed search was conducted from inception to November 2023 using the keywords : Study selection and data ... ...

    Abstract Objective: To review the pharmacologic and clinical profile of etrasimod in the treatment of ulcerative colitis (UC).
    Data sources: A PubMed search was conducted from inception to November 2023 using the keywords
    Study selection and data extraction: Phase 2 and 3 studies plus relevant literature on etrasimod pharmacologic and clinical profile were reviewed.
    Data synthesis: Per ELEVATE, 2 phase 3 studies, a higher proportion of patients with moderately to severely active UC achieved clinical remission in the induction and maintenance phase with etrasimod compared with placebo. In addition, a higher proportion of patients achieved secondary endpoints of clinical response, endoscopic improvement-histologic remission, corticosteroid-free remission, and endoscopic improvement with etrasimod vs placebo. Common adverse events include anemia and headache.
    Relevance to patient care and clinical practice in comparison with existing drugs: Etrasimod is now the second orally administered sphingosine-1-phosphate modulator approved for UC, providing patients with additional treatment options. Efficacy rates of this treatment are in line with other UC medication options. Similar to other sphingosine-1-phosphate receptor modulators, various assessments are required at baseline and during treatment to ensure safe and appropriate use.
    Conclusion: Etrasimod is another possibility in the armamentarium of UC treatment, providing patients with more oral medication options. Prior to treatment initiation, several assessments relating to safety, drug interactions, and pharmacogenomics factors are advised.
    Language English
    Publishing date 2024-01-23
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 1101370-9
    ISSN 1542-6270 ; 1060-0280
    ISSN (online) 1542-6270
    ISSN 1060-0280
    DOI 10.1177/10600280231225770
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    Zs.A 900: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
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    ab Jg. 2022: Lesesaal (EG)

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  5. Article ; Online: Rapid Adoption of Pneumococcal 20-Valent Conjugate Vaccination in Adult Patients With Inflammatory Bowel Disease: An Analysis One Year After Availability.

    Karime, Christian / Crosby, Sheena / Bhat, Shubha / Hashash, Jana G / Farraye, Francis A

    Journal of clinical gastroenterology

    2024  Volume 58, Issue 2, Page(s) 207–209

    MeSH term(s) Adult ; Humans ; Vaccination ; Inflammatory Bowel Diseases ; Pneumococcal Vaccines ; Antibodies, Bacterial
    Chemical Substances Pneumococcal Vaccines ; Antibodies, Bacterial
    Language English
    Publishing date 2024-02-01
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 448460-5
    ISSN 1539-2031 ; 0192-0790
    ISSN (online) 1539-2031
    ISSN 0192-0790
    DOI 10.1097/MCG.0000000000001954
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    Zs.A 1523: Show issues Location:
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  6. Article ; Online: Hypoxia-Inducible Factor 1-Alpha Stabilizers in the Treatment of Inflammatory Bowel Diseases: Oxygen as a Novel IBD Therapy?

    Bhat, Shubha / Rieder, Florian

    Journal of Crohn's & colitis

    2022  Volume 16, Issue 12, Page(s) 1924–1932

    Abstract: Despite the significant advances in the medical armamentarium for inflammatory bowel diseases [IBD], current treatment options have notable limitations. Durable remission rates remain low, loss of response is common, administration routes are largely ... ...

    Abstract Despite the significant advances in the medical armamentarium for inflammatory bowel diseases [IBD], current treatment options have notable limitations. Durable remission rates remain low, loss of response is common, administration routes are largely parenteral for novel biologics, and medication safety remains a concern. This explains an ongoing unmet need for safe medications with novel mechanisms of action that are administered orally. In line with these criteria, hypoxia-inducible factor [HIF]-1α stabilizers, acting via inhibition of prolyl hydroxylase enzymes, are emerging as an innovative therapeutic strategy. We herein review the mechanism of action and available clinical data for HIF-1α stabilizers and their potential place in the future IBD treatment algorithm.
    MeSH term(s) Humans ; Hypoxia-Inducible Factor 1, alpha Subunit ; Inflammatory Bowel Diseases/drug therapy ; Oxygen
    Chemical Substances Hypoxia-Inducible Factor 1, alpha Subunit ; Oxygen (S88TT14065)
    Language English
    Publishing date 2022-06-15
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2390120-2
    ISSN 1876-4479 ; 1873-9946
    ISSN (online) 1876-4479
    ISSN 1873-9946
    DOI 10.1093/ecco-jcc/jjac092
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    Zs.A 6634: Show issues Location:
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  7. Article ; Online: Safety and Monitoring of Inflammatory Bowel Disease Advanced Therapies.

    Bhat, Shubha / Click, Benjamin / Regueiro, Miguel

    Inflammatory bowel diseases

    2023  

    Abstract: The recent approval of new medications with novel mechanisms of action and emergence of updated safety information for existing therapies has changed the treatment landscape of inflammatory bowel disease (IBD). These advances led to unique adverse effect ...

    Abstract The recent approval of new medications with novel mechanisms of action and emergence of updated safety information for existing therapies has changed the treatment landscape of inflammatory bowel disease (IBD). These advances led to unique adverse effect profiles and identification of new safety signals, resulting in the evolution of the safety, monitoring, and positioning of IBD therapies. In this updated review, we (1) examine the existing and updated safety data of monoclonal antibodies and small molecules for IBD, with a focus on recently Food and Drug Administration (FDA)-approved therapies, and (2) propose risk stratification and assessment considerations prior to and during IBD treatment.
    Language English
    Publishing date 2023-07-14
    Publishing country England
    Document type Journal Article
    ZDB-ID 1340971-2
    ISSN 1536-4844 ; 1078-0998
    ISSN (online) 1536-4844
    ISSN 1078-0998
    DOI 10.1093/ibd/izad120
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    Zs.A 4530: Show issues Location:
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  8. Article ; Online: Additional clinical pharmacists roles during COVID-19.

    Bhat, Shubha / Kehasse, Amanuel

    Journal of the American College of Clinical Pharmacy : JACCP

    2020  Volume 3, Issue 4, Page(s) 825

    Keywords covid19
    Language English
    Publishing date 2020-04-22
    Publishing country United States
    Document type Journal Article
    ISSN 2574-9870
    ISSN (online) 2574-9870
    DOI 10.1002/jac5.1243
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  9. Article ; Online: Pharmacist-Managed

    Bhat, Shubha / Nunes, David

    The Annals of pharmacotherapy

    2021  Volume 56, Issue 2, Page(s) 162–169

    Abstract: Background: Treatment eradication rates of : Objective: We aimed to evaluate the impact of a pharmacist-managed : Methods: We conducted a retrospective observational cohort study of all patients referred to and seen in the pharmacist-managed : ... ...

    Abstract Background: Treatment eradication rates of
    Objective: We aimed to evaluate the impact of a pharmacist-managed
    Methods: We conducted a retrospective observational cohort study of all patients referred to and seen in the pharmacist-managed
    Results: The clinical pharmacist managed 60 referrals for 55 unique patients over a mean of 5 ± 2 visits. Five patients failed
    Conclusion and relevance: This study described and assessed the impact of a pharmacist-managed
    MeSH term(s) Gastroenterology ; Helicobacter Infections/drug therapy ; Helicobacter pylori ; Humans ; Pharmacists ; Retrospective Studies ; Treatment Outcome ; Workflow
    Language English
    Publishing date 2021-05-28
    Publishing country United States
    Document type Journal Article ; Observational Study
    ZDB-ID 1101370-9
    ISSN 1542-6270 ; 1060-0280
    ISSN (online) 1542-6270
    ISSN 1060-0280
    DOI 10.1177/10600280211021501
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  10. Article ; Online: Switching from Infliximab to Biosimilar in Inflammatory Bowel Disease: A Review of Existing Literature and Best Practices.

    Bhat, Shubha / Qazi, Taha

    Crohn's & colitis 360

    2021  Volume 3, Issue 1, Page(s) otaa093

    Abstract: Biosimilars are highly similar but nonidentical biologic agents with no differences in clinical efficacy and safety when compared to bio-originator products. Considering the long-term costs of managing inflammatory bowel disease (IBD), biosimilars, ... ...

    Abstract Biosimilars are highly similar but nonidentical biologic agents with no differences in clinical efficacy and safety when compared to bio-originator products. Considering the long-term costs of managing inflammatory bowel disease (IBD), biosimilars, through economic competition, provide an opportunity for cost savings to payors, may increase access to IBD medications, and could decrease health care spending in the long run. Studies investigating the use of biosimilars in IBD have shown a comparable clinical efficacy and safety profile compared to originator products. Moreover, studies have also suggested that solitary switches between bio-originators and biosimilars are acceptable and do not lead to worsening disease burden or increased immunogenicity or safety concerns. Despite available data and proposed benefits of biosimilars, skepticism about the widespread adoption of biosimilars throughout the United States continues to be present and creates many barriers. Herein, we detail the real-world, nonmedical switching experiences of 2 IBD centers in the United States and review best practices, which can be used as a potential roadmap for successful biosimilar adoption in other institutions.
    Language English
    Publishing date 2021-02-15
    Publishing country England
    Document type Journal Article
    ISSN 2631-827X
    ISSN (online) 2631-827X
    DOI 10.1093/crocol/otaa093
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