Real-world efficacy and safety of advanced therapies in hospitalized patients with ulcerative colitis.

Humans Colitis, Ulcerative / drug therapy Treatment Outcome Infliximab / adverse effects Tacrolimus / therapeutic use Adrenal Cortex Hormones / therapeutic use

Acute severe ulcerative colitis Advanced therapy Biologics Janus kinase inhibitor

Journal

Journal of gastroenterology

ISSN: 1435-5922

Titre abrégé: J Gastroenterol

Pays: Japan

ID NLM: 9430794

Informations de publication

Date de publication:
12 2023

Historique:

received: 06 07 2023

accepted: 25 09 2023

medline: 27 11 2023

pubmed: 13 10 2023

entrez: 13 10 2023

Statut: ppublish

Résumé

This multicenter observational cohort study aimed to evaluate the utilization and short-term efficacy of advanced therapy (AT) in hospitalized patients with acute severe ulcerative colitis (ASUC). In total, 221 patients with ASUC were enrolled between August 2020 and July 2021. The primary endpoint was clinical remission (CR, defined as a patient-reported outcome score < 2 with no blood in the stool) rate on Day 7 and 14 in hospitalized patients who received corticosteroids (CS) and AT. Among patients with ASUC, 120 and 101 patients received CS or any AT as first-line treatment, respectively. The CR rates on Day 7 and 14 were 22.5% and 35.0%, respectively, in hospitalized patients who received CS as first-line treatment. Most patients who used ATs had CS-dependent or frequent recurrences. Eight different ATs (apheresis, tacrolimus, infliximab, golimumab, tofacitinib, vedolizumab, ustekinumab, and cyclosporine) were used as first-line treatment in patients with ASUC, and the CR rates on Day 7 and 14 were 16.8% and 29.7%, respectively. Twenty-five patients received the second ATs after hospitalizations, and the CR rates on Day 7 and 14 were 0% and 12%, respectively. The CR rates on Day 14 were significantly higher in patients who changed to AT than in those whose dose of CS increased (34.0% vs 10.7%, p = 0.020) among patients who had already used CS before hospitalization. Most first-use ATs were effective for patients with ASUC, while second-use ATs might have had limited benefits in inducing CR. These findings may contribute to considerations for the management of hospitalized patients.

Sections du résumé

BACKGROUND

This multicenter observational cohort study aimed to evaluate the utilization and short-term efficacy of advanced therapy (AT) in hospitalized patients with acute severe ulcerative colitis (ASUC).

METHODS

In total, 221 patients with ASUC were enrolled between August 2020 and July 2021. The primary endpoint was clinical remission (CR, defined as a patient-reported outcome score < 2 with no blood in the stool) rate on Day 7 and 14 in hospitalized patients who received corticosteroids (CS) and AT.

RESULTS

Among patients with ASUC, 120 and 101 patients received CS or any AT as first-line treatment, respectively. The CR rates on Day 7 and 14 were 22.5% and 35.0%, respectively, in hospitalized patients who received CS as first-line treatment. Most patients who used ATs had CS-dependent or frequent recurrences. Eight different ATs (apheresis, tacrolimus, infliximab, golimumab, tofacitinib, vedolizumab, ustekinumab, and cyclosporine) were used as first-line treatment in patients with ASUC, and the CR rates on Day 7 and 14 were 16.8% and 29.7%, respectively. Twenty-five patients received the second ATs after hospitalizations, and the CR rates on Day 7 and 14 were 0% and 12%, respectively. The CR rates on Day 14 were significantly higher in patients who changed to AT than in those whose dose of CS increased (34.0% vs 10.7%, p = 0.020) among patients who had already used CS before hospitalization.

CONCLUSION

Most first-use ATs were effective for patients with ASUC, while second-use ATs might have had limited benefits in inducing CR. These findings may contribute to considerations for the management of hospitalized patients.

Identifiants

DOI: 10.1007/s00535-023-02048-w PMID: 37831183

pubmed: 37831183

doi: 10.1007/s00535-023-02048-w

pii: 10.1007/s00535-023-02048-w

doi:

Substances chimiques

Infliximab B72HH48FLU

Tacrolimus WM0HAQ4WNM

Adrenal Cortex Hormones 0

Types de publication

Multicenter Study Observational Study Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

1198-1210

Subventions

Organisme : he Japan Agency for Medical Research and Development

ID : 20314259

Investigateurs

Souichiro Ogawa (S)

Hotaka Tamura (H)

Keisuke Uchida (K)

Toshiro Fukui (T)

Norimasa Fukata (N)

Masakazu Nagahori (M)

Ryuichi Okamoto (R)

Miki Miura (M)

Yusuke Yoshimatsu (Y)

Ryota Hokari (R)

Yoichi Kakuta (Y)

Tomohiro Fukuda (T)

Aya Hojyo (A)

Shintaro Sagami (S)

Toshufumi Hibi (T)

Yasuhisa Sakata (Y)

Kozo Tsuruta (K)

Masaru Morita (M)

Keiichi Mitsuyama (K)

Naoki Shibuya (N)

Ryosuke Miyazaki (R)

Ryohei Hayashi (R)

Sakiko Hiraoka (S)

Kiyonori Kobayashi (K)

Mariko Kajiwara (M)

Tomohisa Takagi (T)

Hiroyuki Imaeda (H)

Eri Tokunaga (E)

Mitsuru Ooi (M)

Nobuhiro Ueno (N)

Toshiyuki Tahara (T)

Ayumu Yokoyama (A)

Shun Murasugi (S)

Tomoko Kuriyama (T)

Teppei Ohmori (T)

Ken Takeuchi (K)

Shinichi Hashimoto (S)

Daisuke Hirayama (D)

Tomoe Kazama (T)

Hiroshi Nakase (H)

Takako Miyazaki (T)

Shiro Nakamura (S)

Akihiko Oka (A)

Kohsaku Kawashima (K)

Shunji Ishihara (S)

Shunichi Yanai (S)

Takayuki Matsumoto (T)

Toshiyuki Sato (T)

Yoko Yokoyama (Y)

Kenji Watanabe (K)

Yasunori Yamamoto (Y)

Yoichi Hiasa (Y)

Hideki Bamba (H)

Akira Ando (A)

Yuki Ohta (Y)

Kengo Kanayama (K)

Jun Kato (J)

Naoki Ohmiya (N)

Sohachi Nanjyo (S)

Informations de copyright

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