Persistence with Biologic Treatment in Patients with Inflammatory Bowel Disease: A German Claims Data Analysis

Abstract

Objectives: This study aimed to assess the real-world rates of treatment discontinuation and switching of biologic therapies in patients with inflammatory bowel disease (IBD). Methods: A retrospective claims data analysis on all continuously insured adult IBD patients with initiation of a biologic therapy was conducted. Observation started with the date of the first prescription of index tumor necrosis factor α-inhibitors (anti-TNFα) or vedolizumab (VDZ) therapy and lasted 12 months. Non-persistence was assumed in case of a switch to another biologic or a treatment gap of >90 days. Results: We included 1,248 IBD biologic treatment starters (502 adalimumab, 77 golimumab, 441 infliximab, 228 VDZ); 837/411 were biologic-naïve (bio-naïve)/ biologic-experienced (bio-experienced). Mean age of bio-naïve/bio-experienced anti-TNFα patients was 39.2/38.1 years (54.9%/56.7% female) and 42.6/37.8 years for VDZ patients (56.3%/54.9% female). Seven hundred and seventy-two patients (61.9%) were persistent with their index biologic therapy after 12 months (61.9%/61.8% bio-naïve/bio-experienced). Percentage of persistent patients was 69.7% for VDZ (65.6%/71.3%) and 60.1% for anti-TNFα (61.4%/55.5%). VDZ was associated with later non-persistence in a multivariable Cox regression analysis (hazard ratio 0.675; p = 0.003) compared to anti-TNFα. Conclusions: Only 60–70% of IBD ­patients are still persistent with their biologic therapy after 12 months. VDZ therapy is associated with a higher persistence than anti-TNFα therapy in this analysis.

Superior treatment persistence with ustekinumab in Crohn’s disease and vedolizumab in ulcerative colitis compared with anti‐TNF biological agents: real‐world registry data from the Persistence Australian National IBD Cohort (PANIC) study

“…prescribing according to insurance agency contracts, co-payment costs, requirement to initiate treatment using biosimilars, or from single-centre study bias, which are limitations in other persistence studies. [13][14][15][16][17][18][19] Our study was the first to simultaneously report on the persistence of both ustekinumab and vedolizumab and found them to have significantly higher persistence than anti-TNF agents for luminal CD and moderate-to-severe UC respectively. In both luminal CD and moderate-severe UC, non-anti-TNF agents had highest persistence compared to anti-TNF agents.…”

“…Vedolizumab improved persistence by 40% compared to anti‐TNF agents in moderate‐to‐severe UC. The 1‐year persistence of 73.4% compared with 64.0%‐69.7% previously reported but with smaller sample sizes and from an insurance database that might contain bias 13,16 . We hypothesise that the improved persistence of ustekinumab and vedolizumab vs anti‐TNF agents may be associated with reduced immunogenicity from their production using phage display transgenic technology, in contrast to the more immunogenic mouse chimeric or humanised structures of anti‐TNF agents 22 .…”

“…This study utilised a large national population‐based registry with 8219 patient‐years of follow‐up, in which biological agents were fully funded without stipulated hierarchical prescribing order. There was no bias from prescribing according to insurance agency contracts, co‐payment costs, requirement to initiate treatment using biosimilars, or from single‐centre study bias, which are limitations in other persistence studies 13‐19 …”

“…The 1-year persistence of 73.4% compared with 64.0%-69.7% previously reported but with smaller sample sizes and from an insurance database that might contain bias. 13,16 We hypothesise that the improved persistence of ustekinumab and vedolizumab vs anti-TNF agents may be associated with reduced immunogenicity from their production using phage display transgenic technology, in contrast to the more immunogenic mouse chimeric or humanised structures of anti-TNF agents. 22 Anti-TNF drugs also are associated with a wider range of adverse effects and less favourable safety profile, especially in vulnerable populations, 23 which may have led to out-of-class treatment switches.…”

Evaluation of economic burden with biologic treatments in Crohn’s disease patients: A mirror image study using an insurance database in Japan

“…However, HRU and direct costs after 36 months of follow-up were higher than the 24-month data, suggesting that some patients undergoing biologic treatment may not respond optimally after 24 months of treatment, and hence may have to switch treatment or undergo surgery to manage CD. This seems plausible since previous research has reported a reduction in persistence with biologics as time passes, with a wide range in the rate of non-persistence due to treatment discontinuation or switching [36][37][38][39].…”