Rapid prediction of 1-year efficacy of tofacitinib for treating refractory ulcerative colitis

Abstract

UC who had started TOF treatments between May and November 2018. The observation periods lasted up to 52 weeks after TOF administration. Patients were refractory to multiple treatments, such as corticosteroids, biologic agents, and a calcineurin inhibitor. TOF was initiated at 20 mg a day and decreasing to 10 mg a day after 8 weeks or more. All immunesuppressive agents, such as corticosteroids, immunomodulators, biologic agents, and calcineurin inhibitors, were withdrawn before starting TOF treatment. Disease activity was evaluated using the partial Mayo score (pMS), and laboratory data were collected at 4, 8, 12, 24, and 52 weeks after TOF administration. Our primary outcome was the clinical remission rate at 52 weeks; we also analyzed treatment efficacy and adverse events. We defined remission as pMS ≤ 2 without individual subscores > 1, response as a decrease of pMS by at least 2, and meeting one of the following conditions: (1) a decrease of the bleeding subscore by at least 1; (2) bleeding subscore < 1; or (3) above-defined remission induced. 6,7 Failure was defined as TOF discontinuation due to symptom recurrence in patients in remission, nonresponse to TOF treatment, and serious adverse events. 8 Differences in medians between the groups were compared using a non-parametric (Mann-Whitney), and comparisons between categorical variables were performed using chi-square test. TOF discontinuation-free survival was calculated. Kaplan-Meier curves were drawn for each subgroup and compared with log-rank (Mantel-Cox) test. SPSS version 26 (IBM Corp.

Real-World Effectiveness and Safety of Tofacitinib in Patients With Ulcerative Colitis: Systematic Review With Meta-Analysis

“…Eleven studies 5, 6, 11-13, 15, 19, 20, 22-24 reported clinical remission rates (n = 755) (Supplementary Table 1). Remission was achieved in 34.7% of patients at week 8 (95% CI, 24.4-45.1; 9 studies 6, 11-13, 15, 19, 20 ,22 ,24 ) and in 47% at weeks 12 to 16 (95% CI, 40.3-53.6; 8 studies 5,6,11,13,15,19,22,23 ; Fig. 1).…”

“…2). At months 6 and 12, 50.8% of patients (95% CI, 42.1-59.5; 6 studies 5-7, 11, 12, 23 ) and 41.8% of patients (95% CI, 31.8-51.8; 3 studies 7,11,12 ), respectively, had sustained response.…”

“…1). At month 6, 38.3% of patients (95% CI, 29.2-47.5; 5 studies 5,6,11,12,23 ) were in clinical remission. Clinical remission at month 12 was assessed in 1 study, with 12 of 29 patients (41.4%) in remission.…”

Real-world experience with tofacitinib in ulcerative colitis - a systematic review and meta-analysis

“…Recurrence of symptoms after an initial response that require therapeutic change 36,22 Worsening of symptoms with endoscopic, radiological or serological (CRP or FCAL) evidence of inflammation that led to escalation/change in medication 20 Failure Interruption of tofacitinib before the end of follow-up 36 Tofacitinib discontinuation due to symptom recurrence in patients in remission, non-response to tofacitinib treatment and serious adverse events 38 . CC-BY-NC 4.0 International license It is made available under a is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity.…”

“…Descriptors of tofacitinib efficacy outcomes across real-world studies. 675 676 Clinical response Decrease of ≥2 points38,39 , 3 PMS/ decrease >30% from baseline40,20,24 Decrease ≥1 point on RBS 38 /absolute RBS=0/1 from baseline36,20 Reduction in SSCAI of 323…”