Evidence map›Paper›PMID 37458875›Full record

ArticleAdvances in therapy2023

Unmet Needs in Real-World Advanced Therapy-Naïve and -Experienced Patients with Moderately to Severely Active Ulcerative Colitis in the United States.

Anita Afzali, Rina Lukanova, Fritha Hennessy, Sumie Kakehi, Hannah Knight, Gary Milligan, Komal Gupte-Singh

Open access · hybridAbstract read
In one paragraph

Article in Advances in therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.5field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 8 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 2 countries.

Anita AfzaliDivision of Digestive Diseases, Department of Internal Medicine, University of Cincinnati, College of Medicine, 231 Albert Sabin Way, ML 0551, Room 6065, Cincinnati, OH, 45267, USA. afzaliaa@ucmail.uc.edu.ORCID http://orcid.org/0000-0002-4397-9576
Rina LukanovaAdelphi Real World, Bollington, UK.ORCID http://orcid.org/0000-0002-1414-0720
Fritha HennessyAdelphi Real World, Bollington, UK.ORCID http://orcid.org/0000-0002-3387-5423
Sumie KakehiBristol Myers Squibb, Princeton, NJ, USA.ORCID http://orcid.org/0000-0002-4398-7269
Hannah KnightAdelphi Real World, Bollington, UK.ORCID http://orcid.org/0000-0002-8379-4381
Gary MilliganAdelphi Real World, Bollington, UK.ORCID http://orcid.org/0000-0002-1427-3339
Komal Gupte-SinghBristol Myers Squibb, Princeton, NJ, USA.ORCID http://orcid.org/0000-0002-4886-6183
Adelphi Group (United Kingdom) · GBBristol-Myers Squibb (United States) · USSabin Vaccine Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDespite availability of advanced therapies (ATs) for ulcerative colitis (UC), many patients fail to respond to treatment. This study examined real-world clinical and humanistic outcomes associated with current treatments in patients with UC.

methodsThis cross-sectional study used US data from the Adelphi Real World Disease Specific Programme for inflammatory bowel disease from before (2017-2018) and during the COVID-19 pandemic (2020-2021). Physicians (gastroenterologists) seeing > 5 patients/month reported patients' disease characteristics, current symptoms and treatments, and reasons for treatment choices for their next seven consecutive patients aged ≥ 18 years with moderately to severely active UC before current treatment. Patients were asked to complete the EQ-5D-5L health-related quality of life (HRQoL) measure. ATs included tumor necrosis factor inhibitors (TNFis), integrin receptor antagonists, interleukin-12/23 antagonists, and Janus kinase inhibitors. Patients were classified as AT-naïve or AT-experienced based on current treatment received for ≥ 8 weeks and further classified as responders or non-responders based on symptoms, disease flare status, and remission. Descriptive analyses are presented.

resultsThe 2017-2018 cohort included 92 physicians and 539 patients (208 [38.6%] AT-experienced). The 2020-2021 cohort included 73 physicians and 448 patients (349 [77.9%] AT-experienced). TNFis were the most common ATs. In 2017-2018, 195 (58.9%) AT-naïve and 113 (54.3%) AT-experienced patients were non-responders; in 2020-2021 this was 57 (57.6%) and 182 (52.1%). Efficacy and induction of remission were physicians' most common reasons for AT choice. Dislike of injections/infusions was the most common reason for eligible patients not receiving biologic therapy. Numerically, non-responders (both AT-naïve and AT-experienced) had more symptoms, overall pain and fatigue, and lower HRQoL scores than responders.

conclusionsBefore (2017-2018) and during the pandemic (2020-2021), over half of patients with UC did not respond to AT. Non-responders carried a high burden of disease. Alternative therapies are urgently needed to treat UC.

Indexed as

Colitis, UlcerativeCOVID-19Cross-Sectional StudiesHumansPandemicsQuality of LifeUnited StatesAdvanced therapyJanus kinase inhibitorQuality of lifeTreatmentTumor necrosis factor inhibitorUlcerative colitisUnmet needs

Identifiers

PMID37458875
PMCPMC10499754
OpenAlexW4384525177

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.