Dose Escalation in Patients With Crohnʼs Disease Who Are Newly Initiated to Therapy With an Anti-TNF

Abstract

BACKGROUND: Anti-TNF agents are indicated for the treatment of moderate to severe Crohn's disease. Loss of clinical response is an important consideration with anti-TNF treatment since up to 40% of patients may lose response to their first anti-TNF in the first year of treatment. Options for patients that lose response include transition to a different medication or increasing existing medication dose to regain response. This loss of response has important clinical as well as cost and resource utilization implications. The aim of this analysis is to evaluate anti-TNF dosing over time in a US patient claims database. METHODS: An independent analysis was conducted using OptumInsight's Clinformatics DataMart, a database of administrative health claims from a large national health insurer, for patients with a diagnosis of Crohn's disease who received a prescription for a first anti-TNF during April 2008-January 2012. Patients were eligible for inclusion in the analysis if they were aged >18 years, had not received an anti- TNF in the 6 months prior to first anti-TNF, and had 24-months pharmacy and medical continuous enrollment in the database. The number of patients with a dose increase above the approved and initially prescribed maintenance dose of adalimumab, certolizumab pegol, or infliximab as a first treatment change at any point during the 24-month analysis period was evaluated. To identify a dose increase, data were converted to weekly milligrams or vials. A dose increase for certolizumab pegol was defined as an increase above 400 mg every 4 weeks. Split dosing of certolizumab pegol to 200 mg every 2 weeks was not considered a dose increase. A dose increase for adalimumab was defined as an increase above 40 mg every 2 weeks and for infliximab as any increase in the number of vials per week. RESULTS: There were 393, 137, and 326 patients with CD who met the eligibility requirements and initiated treatment on adalimumab, certolizumab pegol, or infliximab, respectively. Of these patients, 55 (14%), 4 (3%), and 107 (33%), respectively, received an increase from their initial maintenance dose as the first treatment change during the 24-month analysis period. The median times to dose escalation were 106, 162, and 154 days for adalimumab, certolizumab pegol, and infliximab, respectively. CONCLUSION(S): This analysis of patient level claims data demonstrates that fewer patients prescribed certolizumab pegol as a first anti-TNF had a dose increase as a first treatment change within the 24-month period, as compared with adalimumab or infliximab. In addition, the median length of time to this first treatment change was the longest for certolizumab pegol. Further studies are needed to explore prescribing habits with anti-TNFs, such as choice for first anti-TNF, change of dose, as well as discontinuation and switch of agents, and the impact of these changes from both a clinical and economic perspective