Frequency, predictors, and consequences of maintenance infliximab therapy intensification in ulcerative colitis

Abstract

Introduction: Infliximab (IFX) therapy intensification in ulcerative colitis (UC) is more common than established in pivotal studies.Objectives: To establish the frequency and form of intensification for UC in clinical practice, as well as predictors, and to compare outcomes between intensified and non-intensified treatment.Methods: A retrospective study of 10 hospitals and 144 patients with response to infliximab (IFX) induction. Predictive variables for intensification were analyzed using a Cox regression analysis. Outcome, loss of response to IFX, and colectomy were compared between intensified and non-intensified therapy.Results: Follow-up time from induction to data collection: 38 months [interquartile range (IQR), 20-62]. Time on IFX therapy: 24 months (IQR, 10-44). In all, 37% of patients required intensification. Interval was shortened for 36 patients, dose was increased for 7, and 10 subjects received both. Concurrent thiopurine immunosuppressants (IMM) and IFX initiation was an independent predictor of intensification [Hazard ratio, 0.034; p, 0.006; CI,. In patients on intensified therapy IFX discontinuation for loss of response (30.4% vs. 10.2%; p, 0.002), steroid reintroduction (35% vs. 18%; p, 0.018), and colectomy (22% vs. 6.4%; p, 0.011) were more common. Of patients on intensification, 17% returned to receiving 5 mg/kg every 8 weeks.

Dose escalation and switching of biologics in ulcerative colitis: a systematic literature review in real-world evidence

“…For induction responders of IFX, dose escalation was reported in seven studies and ranged from 15.2% in 257 patients 26 (time to dose escalation was not reported by Cappello et al 26 ) to 70.8% in 24 patients at 8 weeks 55 . For IFX patients in mucosal healing at maintenance and in response or remission at induction, dose escalation occurred in respectively 15% of 40 patients within the second year 21 and 36.8% of 144 at 9 months 33 .…”

“…IFX initial and escalated regimen was commonly reported as 5 mg/kg q8w and 10 mg/kg q8w or 5 mg/kg q4-6w respectively in seven studies 28,30,33,34,45,52,55 . The most frequent initial and escalated regimen for ADA was 40 mg or 80 mg q2w and 40 mg q1w respectively 16,20,29,36,37 .…”

“…Four studies reported the proportion of dose deescalation under IFX treated patients 28,31,33,52 , which ranged from 15% of 79 dose escalated patients at a median time to dose de-escalation of 6 months 52 to 51% of 41 dose escalated patients at a mean time to dose de-escalation of 13.6 months 28 . In the totality of cases, patients were deescalated to a regimen of 5 mg/kg every 8 weeks.…”

I costi dei pazienti con patologie infiammatorie dell’intestino (Malattia di Crohn e colite ulcerosa). Studio real world in Italia

“…[3][4][5][6] Sono stati presi in considerazione anche studi economici applicati specificamente alle IBD. [7][8][9][10][11][12] I costi sono stati suddivisi per le principali categorie di spesa: diagnostica di laboratorio e per immagini, farmaci, ricoveri ospedalieri, visite specialistiche. Ai valori in termini di risorse consumate sono stati associati i costi unitari, prezzi e tariffe specialistiche regionali in relazione alla risorsa specifica (ad esempio prezzi di acquisizione per farmaci e tariffe DRG per i ricoveri e per la diagnostica).…”

“…3–6 Sono stati presi in considerazione anche studi economici applicati specificamente alle IBD. 7–12…”