Safety and effectiveness of tofacitinib in ulcerative colitis : Data from TOFA-UC, a SN-IBD study
Copyright © 2023 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved..
BACKGROUND: Real-world evidence is needed to determine the value of tofacitinib (TOFA) for the treatment of ulcerative colitis (UC).
AIM: To assess the safety and effectiveness of TOFA in clinical practice.
METHODS: TOFA-UC is a multicenter, observational study performed among the Sicilian Network for Inflammatory Bowel Disease (SN-IBD). All consecutive patients with UC starting TOFA from its introduction in Sicily (July 2021) to July 2022 were included.
RESULTS: 111 patients were included (mean follow-up: 31.7 ± 14.9 weeks; biologic-experienced: 92.8%). Nineteen adverse events were reported (17.1%; incidence rate: 28.2 per 100 patient years), including 11 cases of hypercholesterolemia and 3 infections (no cases of herpes zoster reactivation. At week 8, the rates of clinical response, steroid free clinical remission, and CRP normalization were 74.8%, 45.0%, and 56.9%, respectively, and 68.5%, 51.4%, and 65.2%, respectively, at the end of follow-up. Eighteen patients experienced a loss of response after successful induction (21.7%; incidence rate: 33.2 per 100 patient years). Twenty-six patients (23.4%) discontinued TOFA over time, of whom 3 due to AEs, and 23 to non response or loss of response.
CONCLUSIONS: TOFA is safe and effective in patients with UC, including those with history of multiple failures to biological therapies.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:56 |
|---|---|
| Enthalten in: |
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver - 56(2024), 1 vom: 22. Jan., Seite 15-20 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Macaluso, Fabio Salvatore [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
5-(tetradecyloxy)-2-furancarboxylic acid |
|---|
| Anmerkungen: |
Date Completed 29.12.2023 Date Revised 29.12.2023 published: Print-Electronic Citation Status MEDLINE |
|---|
| doi: |
10.1016/j.dld.2023.08.061 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM362382344 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM362382344 | ||
| 003 | DE-627 | ||
| 005 | 20240108135922.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231226s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1016/j.dld.2023.08.061 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1242.xml |
| 035 | |a (DE-627)NLM362382344 | ||
| 035 | |a (NLM)37741749 | ||
| 035 | |a (PII)S1590-8658(23)00913-1 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Macaluso, Fabio Salvatore |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Safety and effectiveness of tofacitinib in ulcerative colitis |b Data from TOFA-UC, a SN-IBD study |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 29.12.2023 | ||
| 500 | |a Date Revised 29.12.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved. | ||
| 520 | |a BACKGROUND: Real-world evidence is needed to determine the value of tofacitinib (TOFA) for the treatment of ulcerative colitis (UC) | ||
| 520 | |a AIM: To assess the safety and effectiveness of TOFA in clinical practice | ||
| 520 | |a METHODS: TOFA-UC is a multicenter, observational study performed among the Sicilian Network for Inflammatory Bowel Disease (SN-IBD). All consecutive patients with UC starting TOFA from its introduction in Sicily (July 2021) to July 2022 were included | ||
| 520 | |a RESULTS: 111 patients were included (mean follow-up: 31.7 ± 14.9 weeks; biologic-experienced: 92.8%). Nineteen adverse events were reported (17.1%; incidence rate: 28.2 per 100 patient years), including 11 cases of hypercholesterolemia and 3 infections (no cases of herpes zoster reactivation. At week 8, the rates of clinical response, steroid free clinical remission, and CRP normalization were 74.8%, 45.0%, and 56.9%, respectively, and 68.5%, 51.4%, and 65.2%, respectively, at the end of follow-up. Eighteen patients experienced a loss of response after successful induction (21.7%; incidence rate: 33.2 per 100 patient years). Twenty-six patients (23.4%) discontinued TOFA over time, of whom 3 due to AEs, and 23 to non response or loss of response | ||
| 520 | |a CONCLUSIONS: TOFA is safe and effective in patients with UC, including those with history of multiple failures to biological therapies | ||
| 650 | 4 | |a Observational Study | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a JAK-inhibitors | |
| 650 | 4 | |a Real-world | |
| 650 | 4 | |a SN-IBD | |
| 650 | 4 | |a Safety | |
| 650 | 4 | |a Tofacitinib | |
| 650 | 7 | |a tofacitinib |2 NLM | |
| 650 | 7 | |a 87LA6FU830 |2 NLM | |
| 650 | 7 | |a 5-(tetradecyloxy)-2-furancarboxylic acid |2 NLM | |
| 650 | 7 | |a 54857-86-2 |2 NLM | |
| 650 | 7 | |a Piperidines |2 NLM | |
| 700 | 1 | |a D'Antonio, Elvira |e verfasserin |4 aut | |
| 700 | 1 | |a Fries, Walter |e verfasserin |4 aut | |
| 700 | 1 | |a Viola, Anna |e verfasserin |4 aut | |
| 700 | 1 | |a Ksissa, Omar |e verfasserin |4 aut | |
| 700 | 1 | |a Cappello, Maria |e verfasserin |4 aut | |
| 700 | 1 | |a Muscarella, Stefano |e verfasserin |4 aut | |
| 700 | 1 | |a Belluardo, Nunzio |e verfasserin |4 aut | |
| 700 | 1 | |a Giangreco, Emiliano |e verfasserin |4 aut | |
| 700 | 1 | |a Mocciaro, Filippo |e verfasserin |4 aut | |
| 700 | 1 | |a Di Mitri, Roberto |e verfasserin |4 aut | |
| 700 | 1 | |a Ferracane, Concetta |e verfasserin |4 aut | |
| 700 | 1 | |a Vitello, Alessandro |e verfasserin |4 aut | |
| 700 | 1 | |a Grova, Mauro |e verfasserin |4 aut | |
| 700 | 1 | |a Renna, Sara |e verfasserin |4 aut | |
| 700 | 1 | |a Casà, Angelo |e verfasserin |4 aut | |
| 700 | 1 | |a De Vivo, Simona |e verfasserin |4 aut | |
| 700 | 1 | |a Ventimiglia, Marco |e verfasserin |4 aut | |
| 700 | 1 | |a Orlando, Ambrogio |e verfasserin |4 aut | |
| 700 | 0 | |a Sicilian Network for Inflammatory Bowel Disease (SN-IBD) |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver |d 2000 |g 56(2024), 1 vom: 22. Jan., Seite 15-20 |w (DE-627)NLM108968790 |x 1878-3562 |7 nnns |
| 773 | 1 | 8 | |g volume:56 |g year:2024 |g number:1 |g day:22 |g month:01 |g pages:15-20 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1016/j.dld.2023.08.061 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 56 |j 2024 |e 1 |b 22 |c 01 |h 15-20 | ||