Presence of risk factors associated with colectomy among patients with ulcerative colitis: a analysis of data from the tofacitinib OCTAVE ulcerative colitis clinical program
Background: Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Objective: To assess colectomy incidence rates (IRs) and baseline characteristics for the presence of identified colectomy risk factors among patients in the tofacitinib OCTAVE UC c...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
SAGE Publishing
2023-08-01
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| Series: | Therapeutic Advances in Gastroenterology |
| Online Access: | https://doi.org/10.1177/17562848231189122 |
| _version_ | 1827874627549921280 |
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| author | David T. Rubin Leonardo Salese Mitchell Cohen Paulo G. Kotze John C. Woolcott Chinyu Su Rajiv Mundayat Jerome Paulissen Joana Torres Millie D. Long |
| author_facet | David T. Rubin Leonardo Salese Mitchell Cohen Paulo G. Kotze John C. Woolcott Chinyu Su Rajiv Mundayat Jerome Paulissen Joana Torres Millie D. Long |
| author_sort | David T. Rubin |
| collection | DOAJ |
| description | Background: Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Objective: To assess colectomy incidence rates (IRs) and baseline characteristics for the presence of identified colectomy risk factors among patients in the tofacitinib OCTAVE UC clinical program. Design: This post hoc analysis evaluated patients in the 8-week OCTAVE Induction 1 and 2, 52-week OCTAVE Sustain, and OCTAVE Open (open-label, long-term extension) studies. Methods: IRs [95% confidence interval (CI)] for colectomy were analyzed. Baseline risk factors based on clinical guidelines: aged <40 years at diagnosis, extensive colitis, severe endoscopic disease [Mayo endoscopic subscore (MES) = 3], hospitalization for UC within 12 months, C-reactive protein (CRP) >3 mg/L, and serum albumin <3.5 g/dL. Baseline risk factors were evaluated in patients who underwent colectomy by study and summarized descriptively. Results: Over a maximum of 7.8 years of tofacitinib exposure, 14 patients underwent colectomy: 3/1139 (0.3%) in OCTAVE Induction 1 and 2 [tofacitinib 10 mg twice daily (BID): n = 2; placebo: n = 1], 3/593 (0.5%) in OCTAVE Sustain (placebo: n = 3), and 8/944 (0.8%) in OCTAVE Open (tofacitinib 10 mg BID: n = 8). Colectomy IR per 100 patient-years for all patients who received ⩾1 tofacitinib dose was 0.34 (95% CI: 0.16–0.63). All patients who underwent colectomy had ⩾1 risk factor and prior tumor necrosis factor inhibitor (TNFi) failure, among which the most common risk factors were a MES of 3 ( n = 13), CRP >3 mg/L ( n = 11), and aged <40 years at diagnosis ( n = 9). Conclusions: Among patients with moderate to severe UC receiving tofacitinib, colectomies were infrequent; all patients undergoing colectomy had prior TNFi failure, and most had multiple additional risk factors. This provides important information to discuss with patients and inform management decisions. Registration: NCT01465763; NCT01458951; NCT01458574; and NCT01470612. |
| first_indexed | 2024-03-12T16:54:31Z |
| format | Article |
| id | doaj.art-4f14d6481d204724942026dae5b142a5 |
| institution | Directory Open Access Journal |
| issn | 1756-2848 |
| language | English |
| last_indexed | 2024-03-12T16:54:31Z |
| publishDate | 2023-08-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Therapeutic Advances in Gastroenterology |
| spelling | doaj.art-4f14d6481d204724942026dae5b142a52023-08-08T09:03:37ZengSAGE PublishingTherapeutic Advances in Gastroenterology1756-28482023-08-011610.1177/17562848231189122Presence of risk factors associated with colectomy among patients with ulcerative colitis: a analysis of data from the tofacitinib OCTAVE ulcerative colitis clinical programDavid T. RubinLeonardo SaleseMitchell CohenPaulo G. KotzeJohn C. WoolcottChinyu SuRajiv MundayatJerome PaulissenJoana TorresMillie D. LongBackground: Tofacitinib is an oral small molecule Janus kinase inhibitor for the treatment of ulcerative colitis (UC). Objective: To assess colectomy incidence rates (IRs) and baseline characteristics for the presence of identified colectomy risk factors among patients in the tofacitinib OCTAVE UC clinical program. Design: This post hoc analysis evaluated patients in the 8-week OCTAVE Induction 1 and 2, 52-week OCTAVE Sustain, and OCTAVE Open (open-label, long-term extension) studies. Methods: IRs [95% confidence interval (CI)] for colectomy were analyzed. Baseline risk factors based on clinical guidelines: aged <40 years at diagnosis, extensive colitis, severe endoscopic disease [Mayo endoscopic subscore (MES) = 3], hospitalization for UC within 12 months, C-reactive protein (CRP) >3 mg/L, and serum albumin <3.5 g/dL. Baseline risk factors were evaluated in patients who underwent colectomy by study and summarized descriptively. Results: Over a maximum of 7.8 years of tofacitinib exposure, 14 patients underwent colectomy: 3/1139 (0.3%) in OCTAVE Induction 1 and 2 [tofacitinib 10 mg twice daily (BID): n = 2; placebo: n = 1], 3/593 (0.5%) in OCTAVE Sustain (placebo: n = 3), and 8/944 (0.8%) in OCTAVE Open (tofacitinib 10 mg BID: n = 8). Colectomy IR per 100 patient-years for all patients who received ⩾1 tofacitinib dose was 0.34 (95% CI: 0.16–0.63). All patients who underwent colectomy had ⩾1 risk factor and prior tumor necrosis factor inhibitor (TNFi) failure, among which the most common risk factors were a MES of 3 ( n = 13), CRP >3 mg/L ( n = 11), and aged <40 years at diagnosis ( n = 9). Conclusions: Among patients with moderate to severe UC receiving tofacitinib, colectomies were infrequent; all patients undergoing colectomy had prior TNFi failure, and most had multiple additional risk factors. This provides important information to discuss with patients and inform management decisions. Registration: NCT01465763; NCT01458951; NCT01458574; and NCT01470612.https://doi.org/10.1177/17562848231189122 |
| spellingShingle | David T. Rubin Leonardo Salese Mitchell Cohen Paulo G. Kotze John C. Woolcott Chinyu Su Rajiv Mundayat Jerome Paulissen Joana Torres Millie D. Long Presence of risk factors associated with colectomy among patients with ulcerative colitis: a analysis of data from the tofacitinib OCTAVE ulcerative colitis clinical program Therapeutic Advances in Gastroenterology |
| title | Presence of risk factors associated with colectomy among patients with ulcerative colitis: a analysis of data from the tofacitinib OCTAVE ulcerative colitis clinical program |
| title_full | Presence of risk factors associated with colectomy among patients with ulcerative colitis: a analysis of data from the tofacitinib OCTAVE ulcerative colitis clinical program |
| title_fullStr | Presence of risk factors associated with colectomy among patients with ulcerative colitis: a analysis of data from the tofacitinib OCTAVE ulcerative colitis clinical program |
| title_full_unstemmed | Presence of risk factors associated with colectomy among patients with ulcerative colitis: a analysis of data from the tofacitinib OCTAVE ulcerative colitis clinical program |
| title_short | Presence of risk factors associated with colectomy among patients with ulcerative colitis: a analysis of data from the tofacitinib OCTAVE ulcerative colitis clinical program |
| title_sort | presence of risk factors associated with colectomy among patients with ulcerative colitis a analysis of data from the tofacitinib octave ulcerative colitis clinical program |
| url | https://doi.org/10.1177/17562848231189122 |
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