Real-World Efficacy and Safety Monitoring for Predicting Continuation of Tofacitinib Therapy in Patients with Ulcerative Colitis.
Dig Dis Sci
; 67(8): 3984-3992, 2022 08.
Article
en En
| MEDLINE
| ID: mdl-34460029
ABSTRACT
BACKGROUND:
Although the clinical efficacy of tofacitinib in patients with ulcerative colitis (UC) has been assessed in the OCTAVE trial, there is a lack of adequate data on its efficacy in real-world clinical settings.AIMS:
To analyze the efficacy of tofacitinib and the predictors of its continuation.METHODS:
Changes in clinical activity index (CAI), blood test results (C-reactive protein [CRP], albumin [Alb], and hemoglobin), and endoscopic scores (Mayo endoscopic subscore [MES], ulcerative colitis endoscopic index of severity [UCEIS]) were evaluated, and we investigated the factors that affect the rate and continuity of tofacitinib.RESULTS:
Twenty-two patients with UC who were treated with tofacitinib were enrolled. Tofacitinib was continued in 16/22 (72.7%) patients. CAI significantly improved 4 weeks after tofacitinib induction (P < 0.01). In the blood tests, only Alb level improved significantly at week 2 compared with baseline (P = 0.03). In the non-failure group, serum Alb and CRP levels improved significantly from week 0 to week 24; however, similar changes were not observed in the failure group. After 6 months, the overall MES and UCEIS had significantly improved (P = 0.03 and P = 0.02, respectively). Kaplan-Meier analysis demonstrated that those with baseline UCEIS ≥ 5 had significantly lower tofacitinib continuation rate than those with baseline UCEIS ≤ 4, suggesting that baseline UCEIS may be a predictor of tofacitinib continuation (log-rank test P < 0.01).CONCLUSIONS:
Tofacitinib is a promising therapeutic agent for the induction and maintenance therapy in UC. Baseline UCEIS may predict its therapeutic effects.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Colitis Ulcerosa
Tipo de estudio:
Diagnostic_studies
/
Prognostic_studies
/
Risk_factors_studies
Límite:
Humans
Idioma:
En
Revista:
Dig Dis Sci
Año:
2022
Tipo del documento:
Article
País de afiliación:
Japón