REAL-WORLD RATE AND MAGNITUDE OF DOSE ESCALATION WITH BIOLOGICS IN PATIENTS WITH ULCERATIVE COLITIS

Abstract

Abstract INTRODUCTION Advanced therapies (ATs), such as adalimumab (ADA), infliximab (INF), golimumab (GOL), vedolizumab (VED), and ustekinumab (UST), referred to as biologics, are regularly used to treat moderate-to-severe ulcerative colitis (UC). Loss of response is a common problem with biologics in UC and one solution is to increase dose of biologics, affecting the cost of UC management. Assessing real-world dosing with biologics is important to inform the estimated treatment cost. The objective of this study was to assess the rate and magnitude of dose escalation with biologics in treatment of UC. METHODS This retrospective cohort study identified adult American patients in the IQVIA PharMetrics® Plus database who were diagnosed with UC and started an AT for UC between 01 Jan 2015 and 31 May 2021. Index date was the start date of a qualifying AT. Patients had ≥12 months of continuous pre- and post-index enrollment in a health plan, no claims for AT during the pre-index period, and no autoimmune diseases or indeterminate colitis. Rate and magnitude of dose escalation were assessed from the start of maintenance phase with AT until the end of follow-up period. Dose escalation was measured in first-line (1L) and second-line (2L) settings and defined as an increase in average dose ≥20% than expected dosing per FDA label during follow-up period after maintenance dose was reached. Dose escalations of ≥50% and ≥100% were also measured. RESULTS The study identified 5,997 UC patients starting an AT (1L setting) (median age, 40 years; 55.5% male; median follow-up, 27.5 [18.5-41.8] months), and 1,896 (31.6%) patients who received treatment with AT in a 2L setting. More patients reached maintenance dose in a 1L setting (86.6% [INF] to 92.7% [ADA]) than in a 2L setting (82.0% [INF] to 87.4% [ADA]). The rate of dose escalation in patients who reached maintenance dose for ADA, IFX, GOL, VED, UST was 22.0%, 17.9%, 7.0%, 28.8%, 50.6%, respectively, in a 1L setting, vs 21.9%, 19.2%, 7.7%, 25.9%, 55.1%, respectively, in a 2L setting (Figure 1). The frequency of dose escalation ≥50% varied for different therapies, 15.0% [ADA], 5.7% [IFX], 4.3% [GOL], 21.0% [VED], and 44.6% [UST] in a 1L setting vs 16.4% [ADA], 8.4% [IFX], 1.9% [GOL], 19.2% [VED], and 46.5% [UST] in a 2L setting (Figure 2). Dose escalation ≥100% was uncommon with both 1L therapies (0.4% [ADA] to 10.0% [VED]) and 2L therapies (0% [GOL] to 7.0% [VED]). CONCLUSIONS A meaningful percentage of ulcerative colitis patients treated with adalimumab, infliximab, vedolizumab, or ustekinumab had dose escalation regardless of line of treatment. Understanding the impact of these utilization patterns may inform real-world cost management. Figure 1 Rate of dose escalation with advanced therapies in ulcerative colitis Figure 2 Magnitude of dose escalation with advanced therapies in ulcerative colitis